Stavudine Capsules

FULL PRESCRIBING INFORMATION

WARNING: LACTIC ACIDOSIS and HEPATOMEGALY with STEATOSIS; PANCREATITIS

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see Warnings and Precautions (5.1)].

Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression [see Warnings and Precautions (5.4)].

Indications and Usage for Stavudine Capsules

Stavudine Capsules, in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (HIV)-1 infection [see Clinical Studies (14)].

Stavudine Capsules Dosage and Administration

The interval between doses of Stavudine Capsules should be 12 hours. Stavudine Capsules may be taken with or without food.

Recommended Adult Dosage

The recommended adult dosage is based on body weight as follows:

• For patients weighing less than 60 kg: 30 mg every 12 hours.


• For patients weighing at least 60 kg: 40 mg every 12 hours.

Recommended Pediatric Dosage

• For newborns from birth to 13 days old: 0.5 mg/kg given every 12 hours.


• For pediatric patients at least 14 days old and weighing less than 30 kg: 1 mg/kg given every 12 hours.


• For pediatric patients weighing at least 30 kg: use the recommended adult dosage.

Dosage Adjustment

Renal Impairment

Adult Patients

Stavudine Capsules may be administered to adult patients with impaired renal function with an adjustment in dosage as shown in Table 1.

Table 1: Recommended Dosage Adjustment for Adult Patients with Renal Impairment

* Administered after the completion of hemodialysis on dialysis days and at the same time of day on non-dialysis days.
Creatinine Clearance (mL/min)	Recommended Stavudine Dose by Patient Weight
	at least 60 kg	less than 60 kg
greater than 50	40 mg every 12 hours	30 mg every 12 hours
26 to 50	20 mg every 12 hours	15 mg every 12 hours
10 to 25	20 mg every 24 hours	15 mg every 24 hours
Hemodialysis	20 mg every 24 hours*	15 mg every 24 hours*

 

Pediatric Patients

Since urinary excretion is also a major route of elimination of stavudine in pediatric patients, the clearance of stavudine may be altered in children with renal impairment. There are insufficient data to recommend a specific dose adjustment of Stavudine Capsules in this patient population.

Dosage Forms and Strengths

• The 15 mg capsules have a hard-shell gelatin capsule with an off-white opaque cap and a pink opaque body filled with a white to off-white powder. The capsule is axially printed with M 154 in black ink on both the cap and body.


• The 20 mg capsules have a hard-shell gelatin capsule with a pink opaque cap and a pink opaque body filled with a white to off-white powder. The capsule is axially printed with M 155 in black ink on both the cap and body.


• The 30 mg capsules have a hard-shell gelatin capsule with an off-white opaque cap and a light orange opaque body filled with a white to off-white powder. The capsule is axially printed with M 137 in black ink on both the cap and body.


• The 40 mg capsules have a hard-shell gelatin capsule with a light orange opaque cap and a light orange opaque body filled with a white to off-white powder. The capsule is axially printed with M 138 in black ink on both the cap and body.

Contraindications

Stavudine Capsules are contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation.

Warnings and Precautions

Lactic Acidosis/Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination, including stavudine and other antiretrovirals. Although relative rates of lactic acidosis have not been assessed in prospective well controlled trials, longitudinal cohort and retrospective studies suggest that this infrequent event may be more often associated with antiretroviral combinations containing stavudine. Female gender, obesity and prolonged nucleoside exposure may be risk factors. Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk [see Use in Specific Populations (8.1)].

Particular caution should be exercised when administering stavudine to any patient with known risk factors for liver disease; however, cases of lactic acidosis have also been reported in patients with no known risk factors. Generalized fatigue, digestive symptoms (nausea, vomiting, abdominal pain and unexplained weight loss); respiratory symptoms (tachypnea and dyspnea); or neurologic symptoms, including motor weakness [see Warnings and Precautions (5.3)] might be indicative of the development of symptomatic hyperlactatemia or lactic acidosis syndrome.

Treatment with stavudine should be suspended in any patient who develops clinical or laboratory findings suggestive of symptomatic hyperlactatemia, lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations). Permanent discontinuation of stavudine should be considered for patients with confirmed lactic acidosis.

Hepatic Toxicity

The safety and efficacy of stavudine have not been established in HIV-infected patients with significant underlying liver disease. During combination antiretroviral therapy, patients with preexisting liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities, including severe and potentially fatal hepatic adverse events, and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment must be considered.

Hepatotoxicity and hepatic failure resulting in death were reported during post-marketing surveillance in HIV-infected patients treated with hydroxyurea and other antiretroviral agents. Fatal hepatic events were reported most often in patients treated with the combination of hydroxyurea, didanosine and stavudine. This combination should be avoided [see Adverse Reactions (6)].

Use with Interferon and Ribavirin-based Regimens

In vitro studies have shown ribavirin can reduce the phosphorylation of pyrimidine nucleoside analogues such as stavudine. Although no evidence of a pharmacokinetic or pharmacodynamic (e.g., loss of HIV-1/HCV virologic suppression) interaction was seen when ribavirin was coadministered with stavudine in HIV-1/HCV co-infected patients [see Drug Interactions (7)],  hepatic decompensation (some fatal) has occurred in HIV-1/HCV co-infected patients receiving combination antiretroviral therapy for HIV-1 and interferon and ribavirin. Patients receiving interferon with or without ribavirin and stavudine should be closely monitored for treatment-associated toxicities, especially hepatic decompensation. Discontinuation of stavudine should be considered as medically appropriate. Dose reduction or discontinuation of interferon, ribavirin or both should also be considered if worsening clinical toxicities are observed, including hepatic decompensation (e.g., Child-Pugh > 6) (see the full prescribing information for interferon and ribavirin).

Neurologic Symptoms

Motor weakness has been reported rarely in patients receiving combination antiretroviral therapy including stavudine. Most of these cases occurred in the setting of lactic acidosis. The evolution of motor weakness may mimic the clinical presentation of Guillain-Barré syndrome (including respiratory failure). If motor weakness develops, stavudine should be discontinued. Symptoms may continue or worsen following discontinuation of therapy.

Peripheral sensory neuropathy, manifested by numbness, tingling or pain in the hands or feet, has been reported in patients receiving stavudine therapy. Peripheral neuropathy, which can be severe, is dose related and occurs more frequently in patients with advanced HIV-1 disease, a history of peripheral neuropathy, or in patients receiving other drugs that have been associated with neuropathy, including didanosine [see Adverse Reactions (6)].

Patients should be monitored for the development of peripheral neuropathy. Stavudine-related peripheral neuropathy may resolve if therapy is withdrawn promptly. If peripheral neuropathy develops permanent discontinuation of stavudine should be considered. In some cases, symptoms may worsen temporarily following discontinuation of therapy.

Pancreatitis

Fatal and nonfatal pancreatitis have occurred during therapy when stavudine was part of a combination regimen that included didanosine in both treatment-naive and treatment-experienced patients, regardless of degree of immunosuppression. The combination of stavudine and didanosine and any other agents that are toxic to the pancreas should be suspended in patients with suspected pancreatitis. Reinstitution of stavudine after a confirmed diagnosis of pancreatitis should be undertaken with particular caution and close patient monitoring; avoid use in combination with didanosine.

Fat Redistribution

Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement and “cushingoid appearance” have been observed in patients receiving antiretroviral therapy.

In randomized controlled trials of treatment-naive patients, clinical lipoatrophy or lipodystrophy developed in a higher proportion of patients treated with stavudine compared to other nucleosides (tenofovir or abacavir). Dual energy x-ray absorptiometry (DEXA) scans demonstrated overall limb fat loss in stavudine-treated patients compared to limb fat gain or no gain in patients treated with other nucleosides (abacavir, tenofovir or zidovudine). The incidence and severity of lipoatrophy or lipodystrophy are cumulative over time with stavudine-containing regimens. In clinical trials, switching from stavudine to other nucleosides (tenofovir or abacavir) resulted in increases in limb fat with modest to no improvements in clinical lipoatrophy. Patients receiving stavudine should be monitored for symptoms or signs of lipoatrophy or lipodystrophy and questioned about body changes related to lipoatrophy or lipodystrophy. Given the potential risks of using stavudine including lipoatrophy or lipodystrophy, a benefit-risk assessment for each patient should be made and an alternative antiretroviral should be considered.

Immune Reconstitution Syndrome

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including stavudine. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jiroveci pneumonia (PCP) or tuberculosis), which may necessitate further evaluation and treatment.

Autoimmune disorders (such as Graves’ disease, polymyositis and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.

Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• lactic acidosis and severe hepatomegaly with steatosis [see Boxed Warning and Warnings and Precautions (5.1)]


• hepatic toxicity [see Warnings and Precautions (5.2)]


• neurologic symptoms and motor weakness [see Warnings and Precautions (5.3)]


• pancreatitis [see Boxed Warning and Warnings and Precautions (5.4)]


• lipoatrophy/lipodystrophy [see Warnings and Precautions (5.5)]

When stavudine is used in combination with other agents with similar toxicities, the incidence of adverse reactions may be higher than when stavudine is used alone.

Clinical Trial Experience in Adults

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Selected adverse reactions that occurred in adult patients receiving stavudine in a controlled monotherapy study (Study AI455-019) are provided in Table 2.

Table 2: Selected Adverse Reactions in Study AI455-019* (Monotherapy)

* The incidences reported included all severity grades and all reactions regardless of causality. † Median duration of stavudine therapy = 79 weeks; median duration of zidovudine therapy = 53 weeks
Adverse Reaction	Percent (%)
	Stavudine† (40 mg twice daily) (n = 412)	Zidovudine (200 mg 3 times daily) (n = 402)
Headache	54	49
Diarrhea	50	44
Peripheral Neurologic      Symptoms/Neuropathy	52	39
Rash	40	35
Nausea and Vomiting	39	44

Pancreatitis was observed in three of the 412 adult patients who received stavudine in study AI455-019.

Selected adverse reactions that occurred in antiretroviral-naive adult patients receiving stavudine from two controlled combination studies are provided in Table 3.

Table 3: Selected Adverse Reactions* in START 1 and START 2† Studies (Combination Therapy)

* The incidences reported included all severity grades and all reactions regardless of causality. † START 2 compared two triple-combination regimens in 205 treatment-naive patients. Patients received either stavudine (40 mg twice daily) plus didanosine plus indinavir or zidovudine plus lamivudine plus indinavir. ‡ Duration of stavudine therapy = 48 weeks
Adverse Reaction	Percent (%)
	START 1		START 2†
	Stavudine + Lamivudine + Indinavir (n = 100‡)	Zidovudine + Lamivudine + Indinavir (n = 102)	Stavudine + Didanosine + Indinavir (n = 102‡)	Zidovudine + Lamivudine + Indinavir (n = 103)
Nausea	43	63	53	67
Diarrhea	34	16	45	39
Headache	25	26	46	37
Rash	18	13	30	18
Vomiting	18	33	30	35
Peripheral Neurologic      Symptoms/Neuropathy	8	7	21	10

Selected laboratory abnormalities reported in a controlled monotherapy study (Study AI455-019) are provided in Table 4.

Table 4: Selected Laboratory Abnormalities in Study AI455-019*†

ULN = upper limit of normal
* Data presented for patients for whom laboratory evaluations were performed. † Median duration of stavudine therapy = 79 weeks; median duration of zidovudine therapy = 53 weeks
Parameter	Percent (%)
	Stavudine (40 mg twice daily) (n = 412)	Zidovudine (200 mg 3 times daily) (n = 402)
AST (SGOT) (> 5 x ULN)	11	10
ALT (SGPT) (> 5 x ULN)	13	11
Amylase (≥ 1.4 x ULN)	14	13

Selected laboratory abnormalities reported in two controlled combination studies are provided in Tables 5 and 6.

Table 5: Selected Laboratory Abnormalities in START 1 and START 2 Studies (Grades 3 to 4)

ULN = upper limit of normal.
Parameter	Percent (%)
	START 1		START 2
	Stavudine + Lamivudine + Indinavir (n = 100)	Zidovudine + Lamivudine + Indinavir (n = 102)	Stavudine + Didanosine + Indinavir (n = 102)	Zidovudine + Lamivudine + Indinavir (n = 103)
Bilirubin (> 2.6 x ULN)	7	6	16	8
AST (SGOT) (> 5 x ULN)	5	2	7	7
ALT (SGPT) (> 5 x ULN)	6	2	8	5
GGT (> 5 x ULN)	2	2	5	2
Lipase (> 2 x ULN)	6	3	5	5
Amylase (> 2 x ULN)	4	< 1	8	2

 

Table 6: Selected Laboratory Abnormalities in START 1 and START 2 Studies (All Grades)

Parameter	Percent (%)
	START 1		START 2
	Stavudine + Lamivudine + Indinavir (n = 100)	Zidovudine + Lamivudine + Indinavir (n = 102)	Stavudine + Didanosine + Indinavir (n = 102)	Zidovudine + Lamivudine + Indinavir (n = 103)
Total Bilirubin	65	60	68	55
AST (SGOT)	42	20	53	20
ALT (SGPT)	40	20	50	18
GGT	15	8	28	12
Lipase	27	12	26	19
Amylase	21	19	31	17

 

Clinical Trial Experience in Pediatric Patients

Adverse reactions and serious laboratory abnormalities reported in pediatric patients from birth through adolescence during clinical trials were similar in type and frequency to those seen in adult patients [see Use in Specific Populations (8.4)].

Post-marketing Experience

The following adverse reactions have been identified during post-marketing use of stavudine. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These reactions have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to stavudine, or a combination of these factors.

Body as a Whole: abdominal pain, allergic reaction, chills/fever and redistribution/accumulation of body fat [see Warnings and Precautions (5.5)].

Digestive Disorders: anorexia.

Exocrine Gland Disorders: pancreatitis, including fatal cases [see Warnings and Precautions (5.4)].

Hematologic Disorders: anemia, leukopenia, thrombocytopenia, neutropenia and macrocytosis.

Liver: symptomatic hyperlactatemia/lactic acidosis and hepatic steatosis [see Warnings and Precautions (5.1)], hepatitis and liver failure.

Metabolic Disorders: lipoatrophy, lipodystrophy [see Warnings and Precautions (5.5)], diabetes mellitus and hyperglycemia.

Musculoskeletal: myalgia.

Nervous System: insomnia, severe motor weakness (most often reported in the setting of lactic acidosis) [see Warnings and Precautions (5.1, 5.3)].

Use with Didanosine- and Hydroxyurea-based Regimens

When stavudine is used in combination with other agents with similar toxicities, the incidence of these toxicities may be higher than when stavudine is used alone. Thus, patients treated with stavudine in combination with didanosine, with or without hydroxyurea, may be at increased risk for pancreatitis and hepatotoxicity, which may be fatal, and severe peripheral neuropathy [see Warnings and Precautions (5)]. The combination of stavudine and hydroxyurea, with or without didanosine, should be avoided.

Drug Interactions

Stavudine is unlikely to interact with drugs metabolized by cytochrome P450 isoenzymes.

Zidovudine: Zidovudine competitively inhibits the intracellular phosphorylation of stavudine. Therefore, use of zidovudine in combination with stavudine should be avoided.

Doxorubicin: In vitro data indicate that the phosphorylation of stavudine is inhibited at relevant concentrations by doxorubicin. The clinical significance of this interaction is unknown; therefore, concomitant use of stavudine with doxorubicin should be undertaken with caution.

Ribavirin: In vitro data indicate ribavirin reduces phosphorylation of lamivudine, stavudine and zidovudine. The clinical significance of the interaction with stavudine is unknown; therefore, concomitant use of stavudine with ribavirin should be undertaken with caution. No pharmacokinetic (e.g., plasma concentrations or intracellular triphosphorylated active metabolite concentrations) or pharmacodynamic (e.g., loss of HIV-1/HCV virologic suppression) interaction was observed when ribavirin and lamivudine (n = 18), stavudine (n = 10) or zidovudine (n = 6) were coadministered as part of a multi-drug regimen to HIV-1/HCV co-infected patients [see Warnings and Precautions (5.2)].

USE IN SPECIFIC POPULATIONS

Pregnancy

Teratogenic Effects

Pregnancy Category C

Reproduction studies have been performed in rats and rabbits with exposures (based on Cmax) up to 399 and 183 times, respectively, of that seen at a clinical dosage of 1 mg/kg/day and have revealed no evidence of teratogenicity. The incidence in fetuses of a common skeletal variation, unossified or incomplete ossification of sternebra, was increased in rats at 399 times human exposure, while no effect was observed at 216 times human exposure. A slight post-implantation loss was noted at 216 times the human exposure with no effect noted at approximately 135 times the human exposure. An increase in early rat neonatal mortality (birth to 4 days of age) occurred at 399 times the human exposure, while survival of neonates was unaffected at approximately 135 times the human exposure. A study in rats showed that stavudine is transferred to the fetus through the placenta. The concentration in fetal tissue was approximately one-half the concentration in maternal plasma. Animal reproduction studies are not always predictive of human response.

There are no adequate and well controlled studies of stavudine in pregnant women. Stavudine should be used during pregnancy only if the potential benefit justifies the potential risk.

Fatal lactic acidosis has been reported in pregnant women who received the combination of stavudine and didanosine with other antiretroviral agents. It is unclear if pregnancy augments the risk of lactic acidosis/hepatic steatosis syndrome reported in nonpregnant individuals receiving nucleoside analogues [see Boxed Warning and Warnings and Precautions (5.1)].The combination of stavudine and didanosine should be used with caution during pregnancy and is recommended only if the potential benefit clearly outweighs the potential risk. Healthcare providers caring for HIV-infected pregnant women receiving stavudine should be alert for early diagnosis of lactic acidosis/hepatic steatosis syndrome.

Antiretroviral Pregnancy Registry

To monitor maternal-fetal outcomes of pregnant women exposed to stavudine and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.

Nursing Mothers

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV. Studies in lactating rats demonstrated that stavudine is excreted in milk. Although it is not known whether stavudine is excreted in human milk, there exists the potential for adverse effects from stavudine in nursing infants. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breast-feed if they are receiving stavudine.

Pediatric Use

Use of stavudine in pediatric patients from birth through adolescence is supported by evidence from adequate and well controlled studies of stavudine in adults with additional pharmacokinetic and safety data in pediatric patients [see Dosage and Administration (2.2) and Adverse Reactions (6.2)].

Adverse reactions and laboratory abnormalities reported to occur in pediatric patients in clinical studies were generally consistent with the safety profile of stavudine in adults. These studies include ACTG 240, where 105 pediatric patients ages 3 months to 6 years received stavudine 2 mg/kg/day for a median of 6.4 months; a controlled clinical trial where 185 newborns received stavudine 2 mg/kg/day either alone or in combination with didanosine from birth through 6 weeks of age; and a clinical trial where 8 newborns received stavudine 2 mg/kg/day in combination with didanosine and nelfinavir from birth through 4 weeks of age.

Stavudine pharmacokinetics have been evaluated in 25 HIV-1-infected pediatric patients ranging in age from 5 weeks to 15 years and in weight from 2 to 43 kg after IV or oral administration of single doses and twice-daily regimens and in 30 HIV-1-exposed or -infected newborns ranging in age from birth to 4 weeks after oral administration of twice-daily regimens [see Clinical Pharmacology (12.3, Table 9)].

Geriatric Use

Clinical studies of stavudine did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Greater sensitivity of some older individuals to the effects of stavudine cannot be ruled out.

In a monotherapy Expanded Access Program for patients with advanced HIV-1 infection, peripheral neuropathy or peripheral neuropathic symptoms were observed in 15 of 40 (38%) elderly patients receiving 40 mg twice daily and 8 of 51 (16%) elderly patients receiving 20 mg twice daily. Of the approximately 12,000 patients enrolled in the Expanded Access Program, peripheral neuropathy or peripheral neuropathic symptoms developed in 30% of patients receiving 40 mg twice daily and 25% of patients receiving 20 mg twice daily. Elderly patients should be closely monitored for signs and symptoms of peripheral neuropathy.

Stavudine is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, it may be useful to monitor renal function. Dose adjustment is recommended for patients with renal impairment [see Dosage and Administration (2.3)].

Renal Impairment

Data from two studies in adults indicated that the apparent oral clearance of stavudine decreased and the terminal elimination half-life increased as creatinine clearance decreased. Based on these observations, it is recommended that the stavudine dosage be modified in patients with reduced creatinine clearance and in patients receiving maintenance hemodialysis [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

Overdosage

Experience with adults treated with 12 to 24 times the recommended daily dosage revealed no acute toxicity. Complications of chronic overdosage include peripheral neuropathy and hepatic toxicity. Stavudine can be removed by hemodialysis; the mean ± SD hemodialysis clearance of stavudine is 120 ± 18 mL/min. Whether stavudine is eliminated by peritoneal dialysis has not been studied.

Stavudine Capsules Description

Stavudine (d4T) is a synthetic thymidine nucleoside analogue, active against the human immunodeficiency virus type 1 (HIV-1). The chemical name for stavudine is 2',3'-didehydro-3'-deoxythymidine. Stavudine has the following structural formula:

Stavudine, USP is a white to off-white crystalline solid with the molecular formula C10H12N2O4 and a molecular weight of 224.21. The solubility of stavudine at 23°C is approximately 83 mg/mL in water and 30 mg/mL in propylene glycol. The n-octanol/water partition coefficient of stavudine at 23°C is 0.144.

Stavudine Capsules, USP are supplied for oral administration in strengths of 15 mg, 20 mg, 30 mg or 40 mg of stavudine, USP. Each capsule also contains inactive ingredients: lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. The empty hard shell gelatin capsules contain gelatin and titanium dioxide. In addition, the 15 mg empty capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6; the 20 mg empty capsules contain D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40; the 30 mg empty capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Red No. 40, FD&C Yellow No. 6; and the 40 mg empty capsules contain D&C Red No. 28, D&C Yellow No. 10, FD&C Yellow No. 6.

The imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol and shellac.

Stavudine Capsules - Clinical Pharmacology

Mechanism of Action

Stavudine is an antiviral drug [see Clinical Pharmacology (12.4)].

Pharmacokinetics

The pharmacokinetics of stavudine have been evaluated in HIV-1-infected adult and pediatric patients (Tables 7, 8, and 9). Peak plasma concentrations (Cmax) and area under the plasma concentration-time curve (AUC) increased in proportion to dose after both single and multiple doses ranging from 0.03 to 4 mg/kg. There was no significant accumulation of stavudine with repeated administration every 6, 8, or 12 hours.

Absorption

Following oral administration, stavudine is rapidly absorbed, with peak plasma concentrations occurring within one hour after dosing. The systemic exposure to stavudine is the same following administration as capsules or solution. Steady-state pharmacokinetic parameters of stavudine in HIV-1-infected adults are shown in Table 7.

Table 7: Steady-State Pharmacokinetic Parameters of Stavudine in HIV-1-Infected

AUC0-24 = Area under the curve over 24 hours Cmax = Maximum plasma concentration Cmin = Trough or minimum plasma concentration
Parameter	Stavudine 40 mg BID Mean ± SD (n = 8)
AUC0-24 (ng•h/mL)  Cmax (ng/mL) Cmin (ng/mL)	2568 ± 454 536 ± 146 8 ± 9

 

Distribution

Binding of stavudine to serum proteins was negligible over the concentration range of 0.01 to 11.4 mcg/mL. Stavudine distributes equally between red blood cells and plasma. Volume of distribution is shown in Table 8.

Metabolism

Metabolism plays a limited role in the clearance of stavudine. Unchanged stavudine was the major drug-related component circulating in plasma after an 80 mg dose of 14C-stavudine, while metabolites constituted minor components of the circulating radioactivity. Minor metabolites include oxidized stavudine, glucuronide conjugates of stavudine and its oxidized metabolite, and an N-acetylcysteine conjugate of the ribose after glycosidic cleavage, suggesting that thymine is also a metabolite of stavudine.

Elimination

Following an 80 mg dose of 14C-stavudine to healthy subjects, approximately 95% and 3% of the total radioactivity was recovered in urine and feces, respectively. Radioactivity due to parent drug in urine and feces was 73.7% and 62%, respectively. The mean terminal elimination half-life is approximately 2.3 hours following single oral doses. Mean renal clearance of the parent compound is approximately 272 mL/min, accounting for approximately 67% of the apparent oral clearance.

In HIV-1-infected patients, renal elimination of unchanged drug accounts for about 40% of the overall clearance regardless of the route of administration (Table 8). The mean renal clearance was about twice the average endogenous creatinine clearance, indicating active tubular secretion in addition to glomerular filtration.

Viracept

Generic Name: nelfinavir (nel FIN a veer)

Brand Names: Viracept

What is nelfinavir?

Nelfinavir is an antiviral medication in a group of HIV medicines called protease (PRO-tee-ayz) inhibitors. Nelfinavir prevents human immunodeficiency virus (HIV) cells from multiplying in your body.

Nelfinavir is used to treat HIV, which causes acquired immunodeficiency syndrome (AIDS). Nelfinavir is not a cure for HIV or AIDS.

Nelfinavir may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about nelfinavir?

A European version of nelfinavir was found to have high levels of an impurity known to cause cancer in animals. Nelfinavir in the U.S. was found to have lower levels of the impurity, which is created during the manufacturing process but can be minimized.

It is not known whether this impurity has caused harm to anyone taking nelfinavir, and it is important to keep treating your condition. Children and pregnant women should not take nelfinavir as a "first-line" treatment. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not stop taking nelfinavir or change your dose without your doctor's advice.

Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine. These drugs can cause life-threatening side effects if you use them while you are taking nelfinavir.

There are many other medicines that can interact with nelfinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors.

Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex.

What should I discuss with my healthcare provider before taking nelfinavir?

You should not take this medication if you are allergic to nelfinavir, or if you have severe liver or kidney disease.

Do not take nelfinavir with amiodarone (Cordarone, Pacerone), quinidine (Quinaglute, Quinidex), pimozide (Orap), midazolam (Versed), triazolam (Halcion), or an ergot medicine such as Ergomar, Cafergot, Wigraine, D.H.E. 45, Migranal, or Methergine. These medications can cause life-threatening side effects if you use them while you are taking nelfinavir.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take nelfinavir.

• liver disease;


• kidney disease;


• 
  

  diabetes;

  
  


• 
  

  a bleeding disorder such as hemophilia; or

  
  


• 
  

  high cholesterol or triglycerides.

  
  

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby, but HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV medicines as directed to control your infection while you are pregnant. Nelfinavir can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking nelfinavir.

If you are pregnant, your name may need to be listed on an antiviral pregnancy registry when you start using this medication.

You should not breast-feed while you are using nelfinavir. Women with HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass the virus to the baby in your breast milk. Do not give this medication to a child younger than 2 years old.

The powder form of nelfinavir may contain phenylalanine. Talk to your doctor before using this form of nelfinavir if you have phenylketonuria (PKU).

How should I take nelfinavir?

A European version of nelfinavir was found to have high levels of an impurity known to cause cancer in animals. This impurity is created during the manufacturing process but can be minimized. Nelfinavir in the U.S. is not made by the same manufacturer as the European version, and the U.S. version was found to have lower levels of the impurity.

It is not known whether this impurity has caused harm to anyone taking nelfinavir, and it is important to keep treating your condition. Children and pregnant women should not take nelfinavir as a "first-line" treatment. If you already take nelfinavir your doctor may recommend that you keep taking it. Do not stop taking nelfinavir or change your dose without your doctor's advice.

Take nelfinavir exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Take nelfinavir with a full glass (8 ounces) of water. Nelfinavir works best if you take it with food.

Swallow the nelfinavir tablet whole.

If you cannot swallow a whole tablet, dissolve it in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

A dose of nelfinavir powder must be mixed with liquid. You may use water, milk, formula, soy formula, soy milk, or a dietary supplement. Do not mix the powder with apple juice, orange juice, or other acidic juices or foods. Do not add the liquid directly to the bottle of nelfinavir powder.

Drink the mixture right away. If the mixture is not used right away, it may be stored in a refrigerator for up to 6 hours.

It is important to use nelfinavir regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor. Every person with HIV or AIDS should remain under the care of a doctor.

To be sure nelfinavir is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store nelfinavir at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a nelfinavir overdose are not known.

What should I avoid while taking nelfinavir?

If you also take didanosine, take it 1 hour before or 2 hours after you take nelfinavir.

Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this medication will not prevent you from passing HIV to other people. Talk with your doctor about safe methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.

Nelfinavir side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking nelfinavir and call your doctor at once if you have any of these serious side effects:

• 
  

  increased urination or extreme thirst;

  
  


• 
  

  easy bruising or bleeding; or

  
  


• 
  

  signs of a new infection, such as fever or chills, cough, or flu symptoms.

  
  

Less serious side effects may include:

• 
  

  nausea, vomiting, diarrhea, stomach pain, bloating, loss of appetite;

  
  


• 
  

  tired feeling;

  
  


• 
  

  headache, mood changes; or

  
  


• 
  

  changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and trunk).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect nelfinavir?

Before taking nelfinavir, tell your doctor if you are using any of the following drugs:

• 
  

  fluticasone (Advair, Flonase, Flovent);

  
  


• 
  

  itraconazole (Sporanox) or ketoconazole (Nizoral);

  
  


• 
  

  lopinavir/ritonavir (Kaletra);

  
  


• 
  

  methadone (Dolophine, Methadose);

  
  


• 
  

  omeprazole (Prilosec);

  
  


• 
  

  rifabutin (Mycobutin, or rifampin (Rifadin, Rimactane, Rifater);

  
  


• 
  

  St. John's wort;

  
  


• 
  

  antidepressants such as trazodone (Desyrel) and others;

  
  


• 
  

  a calcium channel blocker such as amlodipine (Caduet, Lotrel, Norvasc), diltiazem (Tiazac, Cartia, Dilacor), felodipine (Plendil), nifedipine (Procardia, Adalat), or verapamil (Calan, Covera, Isoptin, Verelan);

  
  


• 
  

  cholesterol-lowering medicine such as atorvastatin (Lipitor), lovastatin (Mevacor, Altocor), rosuvastatin (Crestor), or simvastatin (Zocor);

  
  


• 
  

  drugs that weaken the immune system, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);

  
  


• 
  

  insulin or diabetes medication you take by mouth;

  
  


• 
  

  medicines to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra); or

  
  


• 
  

  seizure medications such as carbamazepine (Carbatrol, Tegretol), phenobarbital (Luminal, Solfoton), or phenytoin (Dilantin).

  
  

This list is not complete and there are many other medicines that can interact with nelfinavir. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Viracept resources

• Viracept Side Effects (in more detail)
• Viracept Use in Pregnancy & Breastfeeding
• Drug Images
• Viracept Drug Interactions
• Viracept Support Group
• 0 Reviews for Viracept - Add your own review/rating

• Viracept Prescribing Information (FDA)


• Viracept Monograph (AHFS DI)


• Viracept Advanced Consumer (Micromedex) - Includes Dosage Information


• Viracept MedFacts Consumer Leaflet (Wolters Kluwer)


• Viracept Consumer Overview

Compare Viracept with other medications

• HIV Infection
• Nonoccupational Exposure
• Occupational Exposure

Where can I get more information?

• Your pharmacist can provide more information about nelfinavir.

See also: Viracept side effects (in more detail)

fluocinolone topical

Generic Name: fluocinolone topical (floo oh SIN oh lone TOP i kal)

Brand Names: Capex, Flurosyn, Synalar

What is fluocinolone topical?

Fluocinolone is a topical (for the skin) steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluocinolone topical is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, seborrhea, and psoriasis.

Fluocinolone topical may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fluocinolone topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. Plastic film covering (such as plastic wrap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluocinolone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period. Contact your doctor if your condition does not improve, or if you develop signs of a skin infection.

What should I discuss with my healthcare provider before using fluocinolone topical?

Do not use this medication if you are allergic to fluocinolone.

Before using fluocinolone topical, tell your doctor if you are allergic to any drugs, or if you have any type of skin infection.

Also tell your doctor if you have diabetes. Topical steroid medicines absorbed through the skin may increase the glucose (sugar) levels in your blood or urine.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether fluocinolone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

How should I use fluocinolone topical?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers.

Covering the skin that is treated with fluocinolone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. However, plastic film covering (such as plastic wrap or a shower cap) is sometimes used when treating psoriasis. Follow your doctor's instructions.

Wash your hands before and after using fluocinolone topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount of the medicine to the affected area and rub it gently into the skin. Do not use this medication over a large area of skin.

If you are using the shampoo form of this medication, apply a small amount (1 ounce or less) to wet hair and work into a lather. Leave the shampoo on the scalp for 5 minutes and then rinse thoroughly.

Contact your doctor if your skin condition does not improve, if it gets worse, or if you develop signs of a skin infection.

To be sure this medication is not causing harmful effects with long-term use, you may need blood tests. Do not miss any scheduled appointments.

Store fluocinolone topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of fluocinolone topical is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using fluocinolone topical?

Fluocinolone topical should not be used to treat any skin condition your doctor has not prescribed it for.

Avoid getting this medication in your eyes. If contact does occur, rinse with water. Do not use fluocinolone topical on broken or infected skin. Also avoid using this medication in open wounds.

Fluocinolone topical side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have severe irritation of any treated skin, or if you show signs of absorbing fluocinolone topical through your skin, such as:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  mood changes;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face; or

  
  


• 
  

  muscle weakness, feeling tired.

  
  

Less serious side effects may include:

• 
  

  mild skin itching, burning, peeling, or dryness;

  
  


• 
  

  thinning or softening of your skin;

  
  


• 
  

  skin rash or irritation around your mouth;

  
  


• 
  

  swollen hair follicles;

  
  


• 
  

  changes in color of treated skin;

  
  


• 
  

  blisters, pimples, or crusting of treated skin; or

  
  


• 
  

  stretch marks.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Fluocinolone topical Dosing Information

Usual Adult Dose for Dermatitis:

Apply a thin layer to affected area 2-4 times a day.

Fluocinolone 0.01% topical oil: Apply a thin layer to moistened skin of affected area three times a day for not more than 4 weeks.

Usual Pediatric Dose for Dermatitis:

>= 1 year:

Apply a thin layer to affected area 2 to 4 times a day.

fluocinolone 0.01% topical oil:

>=2 years:

Apply a thin layer to moistened skin of affected area twice daily for not more than 4 weeks.

What other drugs will affect fluocinolone topical?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluocinolone topical. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More fluocinolone topical resources

• Fluocinolone topical Dosage
• Fluocinolone topical Use in Pregnancy & Breastfeeding
• Fluocinolone topical Drug Interactions
• Fluocinolone topical Support Group
• 3 Reviews for Fluocinolone - Add your own review/rating

• Capex Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Capex Advanced Consumer (Micromedex) - Includes Dosage Information


• DermOtic Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Synalar Prescribing Information (FDA)


• Synalar Consumer Overview


• Synalar Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare fluocinolone topical with other medications

• Atopic Dermatitis
• Dermatitis
• Lichen Sclerosus

Where can I get more information?

• Your pharmacist can provide more information about fluocinolone topical.

Telithromycin

Pronunciation: tel-ITH-roe-MYE-sin
Generic Name: Telithromycin
Brand Name: Ketek

Do not take Telithromycin if you have myasthenia gravis. Severe and sometimes fatal breathing problems have occurred in patients with myasthenia gravis who have taken Telithromycin.

Telithromycin is used for:

Treating infections caused by certain bacteria.

Telithromycin is a ketolide antibiotic. It works by stopping the growth of or killing sensitive bacteria.

Do NOT use Telithromycin if:

• you are allergic to any ingredient in Telithromycin or any macrolide antibiotic (eg, erythromycin)


• you are taking astemizole, cisapride, ergot alkaloids (eg, ergotamine), pimozide, certain medicines for irregular heartbeat (eg, quinidine, procainamide, dofetilide), propafenone, ranolazine, rifampin, or terfenadine


• you are taking certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin); if you must take telithromycin, talk with your doctor about whether you should continue to take atorvastatin, lovastatin, or simvastatin while you are taking telithromycin


• you have a certain type of irregular heartbeat (prolonged QT syndrome, congenital QT prolongation), severely slow heartbeat, or untreated low blood potassium or magnesium


• you have myasthenia gravis


• you have ever had liver problems (eg, hepatitis) or yellowing of the eyes or skin while taking Telithromycin or any macrolide antibiotic (eg, erythromycin)


• you are taking colchicine and have kidney or liver problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Telithromycin:

Some medical conditions may interact with Telithromycin. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you or someone in your family has a history of a certain type of irregular heartbeat (prolonged QT syndrome)


• if you have a history of fast or slow heartbeat, heart failure, or other heart problems; blood problems; kidney problems; liver problems (eg, yellowing of the eyes or skin); or myasthenia gravis


• if you have diarrhea or a stomach infection

Some MEDICINES MAY INTERACT with Telithromycin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Certain antiarrhythmics (eg, quinidine, procainamide, dofetilide), astemizole, cisapride, pimozide, propafenone, or terfenadine because the risk of severe and possibly life-threatening irregular heartbeat may be increased


• Colchicine because the risk of its side effects, including severe and possibly fatal side effects, may be increased by Telithromycin


• Certain HMG-CoA reductase inhibitors (eg, atorvastatin, lovastatin, simvastatin) because the risk of severe muscle and kidney problems may be increased


• Certain calcium channel blockers (eg, amlodipine, diltiazem, verapamil) because the risk of fainting or loss of consciousness, low blood pressure, or slow heartbeat may be increased


• Rifampin because it may decrease Telithromycin's effectiveness


• Anticoagulants (eg, warfarin), benzodiazepines (eg, midazolam, triazolam), digoxin, diuretics (eg, furosemide, hydrochlorothiazide), ergot alkaloids (eg, ergotamine), ranolazine, or sleep medicines (eg, eszopiclone) because the risk of their side effects may be increased by Telithromycin


• Many other prescription and nonprescription medicines (eg, used for infections, inflammation, aches and pains, irregular heartbeat and other heart problems, high blood pressure, high cholesterol, immune system suppression, mood or mental problems, seizures), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo, St. John's wort) may interact with Telithromycin, increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Telithromycin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Telithromycin:

Use Telithromycin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Telithromycin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Telithromycin refilled.


• Take Telithromycin by mouth with or without food.


• Swallow Telithromycin whole. Do not break, crush, or chew before swallowing.


• Telithromycin works best if it is taken at the same time each day.


• To clear up your infection completely, take Telithromycin for the full course of treatment. Keep taking it even if you feel better in a few days.


• Do not miss any doses. If you miss a dose of Telithromycin, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Telithromycin.

Important safety information:

• Telithromycin may cause dizziness, lightheadedness, fainting, or vision problems (eg, blurred vision, double vision, difficulty focusing). These effects may be worse if you take it with alcohol or certain medicines. Use Telithromycin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. Do not drive or perform other possibly unsafe tasks if you experience vision problems, loss of consciousness, fainting, confusion, or hallucinations.


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Telithromycin only works against bacteria; it does not treat viral infections (eg, the common cold).


• Be sure to use Telithromycin for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Long-term or repeated use of Telithromycin may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Tell your doctor or dentist that you take Telithromycin before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including liver and kidney function and blood cell counts, may be performed while you use Telithromycin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Telithromycin should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is not known if Telithromycin can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Telithromycin while you are pregnant. It is not known if Telithromycin is found in breast milk. If you are or will be breast-feeding while you use Telithromycin, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Telithromycin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; headache; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or watery stools; blurred vision, double vision, difficulty focusing, or other vision problems; confusion; dark urine; fainting; fast, slow, or irregular heartbeat; hallucinations; hoarseness; loss of appetite; loss of consciousness; muscle cramps or weakness; pale stools; severe or persistent diarrhea; severe or persistent nausea or vomiting; severe stomach pain, cramps, or tenderness; unusual fatigue or tiredness; vaginal discharge, irritation, or odor; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Telithromycin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; nausea; stomach pain; vomiting.

Proper storage of Telithromycin:

Store Telithromycin at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Telithromycin out of the reach of children and away from pets.

General information:

• If you have any questions about Telithromycin, please talk with your doctor, pharmacist, or other health care provider.


• Telithromycin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Telithromycin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Telithromycin resources

• Telithromycin Side Effects (in more detail)
• Telithromycin Dosage
• Telithromycin Use in Pregnancy & Breastfeeding
• Telithromycin Drug Interactions
• Telithromycin Support Group
• 0 Reviews for Telithromycin - Add your own review/rating

• Telithromycin Professional Patient Advice (Wolters Kluwer)


• Telithromycin Monograph (AHFS DI)


• telithromycin Advanced Consumer (Micromedex) - Includes Dosage Information


• Ketek Prescribing Information (FDA)


• Ketek Consumer Overview

Compare Telithromycin with other medications

• Bronchitis
• Pneumonia
• Sinusitis
• Tonsillitis/Pharyngitis

Compazine Tablets

Pronunciation: pro-klor-PURR-uh-zeen
Generic Name: Prochlorperazine
Brand Name: Generic only. No brands available.

Compazine is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Compazine is not approved to treat mental problems caused by dementia. Discuss any questions or concerns with your doctor.

Compazine is used for:

Controlling severe nausea and vomiting and treating schizophrenia. It is also used for the short-term treatment of certain types of anxiety. It may also be used for other conditions as determined by your doctor.

Compazine is a phenothiazine. It is not known exactly how it works.

Do NOT use Compazine if:

• you are allergic to any ingredient in Compazine or to other phenothiazines (eg, thioridazine)


• you have severe drowsiness


• you have recently taken large amounts of alcohol or medicines that may cause drowsiness, such as barbiturates (eg, phenobarbital) or narcotic pain medicines (eg, codeine)


• you are taking astemizole, cabergoline, cisapride, dofetilide, metoclopramide, pergolide, terfenadine, or tramadol

Contact your doctor or health care provider right away if any of these apply to you.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using Compazine:

Some medical conditions may interact with Compazine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have developed severe side effects (eg, blood problems, yellowing of the skin or eyes) while taking another phenothiazine (eg, thioridazine)


• if you have a history of heart problems (eg, angina, mitral valve problems), blood problems (eg, anemia), diabetes, liver problems (eg, cirrhosis), high or low blood pressure, kidney problems, neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), bone marrow problems (eg, low white blood cell count), an enlarged prostate gland, seizures, trouble urinating, mental or mood problems (eg, depression), or an adrenal gland tumor (pheochromocytoma)


• if you have asthma, a lung infection, or other lung or breathing problems (eg, emphysema); or increased pressure in the eyes or glaucoma, or if you are at risk for glaucoma


• if you have Alzheimer disease, dementia, Parkinson disease, or Reye syndrome


• if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary, brain), or if you are at risk of breast cancer


• if you are in poor health or are regularly exposed to extreme heat or certain insecticides (organophosphorus insecticides)


• if you have a history of alcohol abuse, drink alcohol, or are in alcohol withdrawal


• if you will be having or have recently had a myelogram (x-ray of the spinal cord)


• if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Compazine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Many prescription and nonprescription medicines (eg, used for allergies, blood clotting problems, cancer, infections, inflammation, aches and pains, heart problems, high blood pressure, high cholesterol, irregular heartbeat, mental or mood problems, nausea or vomiting, Parkinson disease, seizures, stomach or bowel problems, overactive bladder), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, gingko, St. John's wort) may interact with Compazine. Ask your doctor if you are unsure if any of your medicines may interact with Compazine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Compazine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Compazine:

Use Compazine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Compazine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• If you miss a dose of Compazine and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Compazine.

Important safety information:

• Compazine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Compazine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Compazine may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do NOT take more than the recommended dose without checking with your doctor.


• Do not drink alcohol while you are taking Compazine.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Compazine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not become overheated in hot weather or while you are being active; heatstroke may occur.


• Tell your doctor or dentist that you take Compazine before you receive any medical or dental care, emergency care, or surgery.


• Compazine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Compazine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Compazine may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.


• Some patients who take Compazine may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Compazine in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Compazine.


• NMS is a possibly fatal syndrome that can be caused by Compazine. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Compazine may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.


• Diabetes patients - Compazine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• Compazine may cause the results of some pregnancy tests to be wrong. Check with your doctor if you have questions or concerns about your pregnancy test results.


• Compazine may interfere with certain lab tests, including phenylketonuria (PKU) tests. Be sure your doctor and lab personnel know you are taking Compazine.


• Lab tests, including liver and kidney function tests, complete blood cell counts, and eye exams, may be performed while you take Compazine. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Compazine with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion; constipation; dizziness or light-headedness, especially upon standing; drowsiness; fainting; trouble urinating; and uncontrolled muscle movements.


• Compazine should not be used in CHILDREN who are having surgery, who are younger than 2 years old, or who weigh less than 20 pounds; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Compazine while you are pregnant. Taking Compazine during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concern with your doctor. Compazine is found in breast milk. If you are or will be breast-feeding while you take Compazine, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Compazine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Agitation; constipation; dizziness; drowsiness; dry mouth; enlarged pupils; jitteriness; nausea; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness; wheezing); chest pain; confusion; decreased coordination; drooling; fainting; fast, slow, or irregular heartbeat; mask-like face; muscle spasms of the face, neck, or back; muscle weakness; new or worsening mental or mood problems; numbness of an arm or leg; prolonged or painful erection; restlessness; seizures; severe or persistent constipation; severe or persistent dizziness, drowsiness, or headache; shuffling walk; sleeplessness; stiff or rigid muscles; sudden shortness of breath or vomiting; swelling of the hands, ankles, or feet; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, stomach pain, or loss of appetite); tremor; trouble urinating; twisting or twitching movements; uncontrolled muscle movements (eg, twitching of the face or tongue; loss of balance; uncontrolled movements of arms or legs; trouble speaking, breathing, or swallowing); unusual bruising or bleeding; unusual eye movements or inability to move eyes; unusual or excessive sweating; unusual tiredness or weakness; unusually pale skin; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Compazine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; coma; confusion; difficulty breathing; fainting; fast, slow, or irregular heartbeat; loss of consciousness; muscle spasms or uncontrolled muscle movements; restlessness; seizures; severe constipation or stomach pain; severe drowsiness or dizziness; tremors; trouble urinating.

Proper storage of Compazine:

Store Compazine at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Compazine out of the reach of children and away from pets.

General information:

• If you have any questions about Compazine, please talk with your doctor, pharmacist, or other health care provider.


• Compazine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Compazine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Compazine resources

• Compazine Side Effects (in more detail)
• Compazine Dosage
• Compazine Use in Pregnancy & Breastfeeding
• Drug Images
• Compazine Drug Interactions
• Compazine Support Group
• 8 Reviews for Compazine - Add your own review/rating

Compare Compazine with other medications

• Anxiety
• Hiccups
• Nausea/Vomiting
• Psychosis

Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine

Pronunciation: a-SEET-a-MIN-oh-fen/DEX-troe-meth-OR-fan/gwye-FEN-e-sin/FEN-il-EF-rin and a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen/FEN-il-EF-rin
Generic Name: Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine
Brand Name: Sudafed PE Day & Night Cold

Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine is used for:

Relieving symptoms of fever, headache, pain, sinus congestion, runny nose, sneezing, itchy nose or throat, itchy or watery eyes, sore throat, and cough due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine is an analgesic, antihistamine, cough suppressant, decongestant, and expectorant combination. The analgesic works in the brain to decrease pain and reduce fever. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to reduce a dry or unproductive cough. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The expectorant works by loosening mucus and lung secretions in the chest, making coughs more productive.

Do NOT use Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine if:

• you are allergic to any ingredient in Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you are taking droxidopa, sodium oxybate (GHB), or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine:

Some medical conditions may interact with Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a fast, slow, or irregular heartbeat


• if you have a history of adrenal gland problems (eg, adrenal gland tumor), heart problems (eg, fast, slow, or irregular heartbeat), high blood pressure, diabetes, blood vessel problems, a stroke, glaucoma or increased pressure in the eye, or thyroid problems


• if you have a history of asthma, chronic cough, lung or breathing problems (eg, chronic bronchitis, emphysema, sleep apnea); chronic obstructive pulmonary disease (COPD); or if your cough occurs with large amounts of mucus


• if you have a history of stomach or bowel ulcers; a blockage of your stomach, bladder, or bowel; kidney problems; liver problems; an enlarged prostate or other prostate problems; or trouble urinating


• if you smoke, drink more than 3 alcohol-containing drinks per day, or have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), digoxin, or droxidopa because risk of bleeding, irregular heartbeat, or heart attack may be increased


• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine's side effects


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine:

Use Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• This product contains 2 different tablets, one for the morning and one for the evening. Be sure you understand how to take Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine. Check with your doctor or pharmacist if you are not sure which tablet to take in the morning and which to take in the evening.


• If you miss a dose of Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine.

Important safety information:

• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you use Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine unless your doctor tells you otherwise.


• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine contains acetaminophen, dextromethorphan, diphenhydramine, guaifenesin, and phenylephrine. Before you start any new medicine, check the label to see if it has any of these medicines in it. If it does or if you are not sure, check with your doctor or pharmacist.


• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine may harm your liver. Your risk may be greater if you drink alcohol while you are using Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine, if you take more than the recommended dose, or if you are taking another medicine that contains acetaminophen. Talk to your doctor before you take Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Do not use Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If new symptoms occur; if cough occurs with persistent rash or headache; or if your symptoms go away and come back, do not get better within 7 days, or get worse, check with your doctor.


• Contact your doctor if you have a sore throat that is severe; lasts more than 2 days; or occurs with a fever, rash, headache, nausea, or vomiting.


• Contact your doctor if you have a fever that lasts for more than 3 days.


• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• This product may contain tartrazine dye (FD&C Yellow No. 5). This may cause an allergic reaction in some patients. If you have ever had an allergic reaction to tartrazine, ask your pharmacist if your product has tartrazine in it.


• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine for a few days before the tests.


• Tell your doctor or dentist that you take Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine before you receive any medical or dental care, emergency care, or surgery.


• Use Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, dry mouth, nervousness, sleeplessness, and trouble urinating.


• Caution is advised when using Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine should not be used in CHILDREN younger than 12 years old. Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine contains more than the recommended dose of acetaminophen for children this age and may cause liver damage.


• Different brands of Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine while you are pregnant. It is not known if Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine is found in breast milk. Do not breast-feed while taking Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine.

Possible side effects of Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; nervousness; trouble sleeping; upset stomach.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; redness; seizures; severe dizziness, drowsiness, lightheadedness, or headache; severe or persistent nervousness or trouble sleeping; shortness of breath; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); tremor; trouble urinating or inability to urinate; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; dark urine; hallucinations; nausea, vomiting, or stomach pain; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat.

Proper storage of Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine:

Store Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine out of the reach of children and away from pets.

General information:

• If you have any questions about Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine, please talk with your doctor, pharmacist, or other health care provider.


• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine resources

• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine Side Effects (in more detail)
• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine Dosage
• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine Use in Pregnancy & Breastfeeding
• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine Drug Interactions
• Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine Support Group
• 0 Reviews for Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine - Add your own review/rating

Compare Acetaminophen/Dextromethorphan/Guaifenesin/Phenylephrine with other medications

• Cold Symptoms
• Influenza

Flatulence Preventer

Generic Name: chamomile, pimpinella saxifraga root, magnesium phosphate, dibasic trihydrate, activated charcoal and strychnos nux-vomica seed granules

Dosage Form: FOR ANIMAL USE ONLY
Flatulence Preventer

Relieves gas and improves digestion

Indications: Homeopathic remedy for flatulence and odor in pets.

Dosage: Initial dose: Administer every 30 minutes for up to 6 doses. Thereafter, 3 doses daily.  Cats and dogs under 20 lbs: Large pinch of granules sprinkled into mouth.  Dogs 20-50 lbs:Two pinches sprinkled into mouth.  Dogs over 50 lbs: ¼ cap of granules sprinkled into mouth.

Caution: Consult your vet if symptoms persist or worsen. Keep this and all medicines from the reach of children.

Ingredients: Each dose contains equal parts of Chamomilla (3X) (HPUS), Pimpinella (3X) (HPUS), Mag phos (6C) (HPUS), Carbo veg (30C) (HPUS), Nux vom (30C) (HPUS) Sucrose (inactive ingredient).

Contains no gluten, artificial flavors, colors or preservatives.

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.petalive.com

Distributed by

Native Remedies, LLC

6531 Park of Commerce Blvd. 

Suite 160

Boca Raton, FL 33487

Phone: +1.877.289.1235

International: +1.561.999.8857

The letters HPUS indicate that the component(s) in this product is (are) officially monographed in the Homeopathic Pharmacopoeia of the United States.

Flatulence Preventer  Flatulence Preventer  granule

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 68647-149 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMOMILE (CHAMOMILE) CHAMOMILE 3 [hp_X]  in 40 mg PIMPINELLA SAXIFRAGA ROOT (PIMPINELLA SAXIFRAGA ROOT) PIMPINELLA SAXIFRAGA ROOT 3 [hp_X]  in 40 mg MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_C]  in 40 mg ACTIVATED CHARCOAL (ACTIVATED CHARCOAL) ACTIVATED CHARCOAL 30 [hp_C]  in 40 mg STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 30 [hp_C]  in 40 mg

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68647-149-10 20000 mg In 1 BOTTLE, GLASS None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2010

Labeler - Feelgood Health (538418296)

Establishment
Name	Address	ID/FEI	Operations
W Last		567284153	manufacture

Revised: 06/2010Feelgood Health