Lanzonium may be available in the countries listed below.
Ingredient matches for Lanzonium
Lansoprazole
Lansoprazole is reported as an ingredient of Lanzonium in the following countries:
- Vietnam
International Drug Name Search
Saturday, 22 October 2011
Tuesday, 18 October 2011
Sandoz Flunitrazepam
Sandoz Flunitrazepam may be available in the countries listed below.
Ingredient matches for Sandoz Flunitrazepam
Flunitrazepam
Flunitrazepam is reported as an ingredient of Sandoz Flunitrazepam in the following countries:
- South Africa
International Drug Name Search
Monday, 17 October 2011
Ontak
Generic Name: denileukin diftitox (de ni LOO kin DIF ti tox)
Brand Names: Ontak
What is Ontak (denileukin diftitox)?
Denileukin diftitox is a designed protein containing toxins that attach themselves to certain types of malignant cells in the body. Denileukin diftitox works by destroying these malignant cells to slow the progression of cancer.
Denileukin diftitox is used to treat leukemia and lymphomas, including cutaneous (of the skin) T-cell lymphoma.
Denileukin diftitox may also be used for purposes not listed in this medication guide.
What is the most important information I should know about Ontak (denileukin diftitox)?
You should not use denileukin diftitox if you have ever had an allergic reaction to a diphtheria vaccine or to medicines containing interleukin-2 (IL-2).
Denileukin diftitox is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. This medication must be given slowly, and the IV infusion can take at least 15 minutes to complete.
You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.
Some patients receiving denileukin diftitox have had permanent changes in their vision or ability to see colors. Talk with your doctor about your individual risk. Tell your doctor if you have any vision changes during your treatment.
What should I discuss with my health care provider before using Ontak (denileukin diftitox)?
You should not use denileukin diftitox if you have ever had an allergic reaction to a diphtheria vaccine or to medicines containing interleukin-2 (IL-2).
If you have heart disease, you may need a dose adjustment or special tests.
FDA pregnancy category C. It is not known whether denileukin diftitox will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether denileukin diftitox 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.
Some patients receiving denileukin diftitox have had permanent changes in their vision or ability to see colors. Talk with your doctor about your individual risk. Tell your doctor if you have any vision changes during your treatment.
How should I use Ontak (denileukin diftitox)?
Denileukin diftitox is injected into a vein through an IV. You will receive this injection in a clinic or hospital setting. This medication must be given slowly, and the IV infusion can take at least 15 minutes to complete. During this time you will be observed for side effects.
Denileukin diftitox is usually given each day for 5 days, followed by 3 weeks off the medication.
To be sure this medication is helping your condition, your blood will need to be tested on a regular basis before and during your treatment. Visit your doctor regularly.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your denileukin diftitox injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose may cause severe nausea or vomiting, fever, chills, and extreme weakness.
What should I avoid while receiving Ontak (denileukin diftitox)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using denileukin diftitox.
Ontak (denileukin diftitox) side effects
You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.
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. Call your doctor at once if you have a serious side effect such as:
blurred vision, changes in color vision;
swelling in your hands, ankles, or feet;
easy bruising or bleeding, unusual weakness;
fever, chills, body aches, cough, flu symptoms;
fast heart rate;
feeling light-headed, fainting;
back pain, trouble breathing, chest pain or tightness;
trouble swallowing, tight feeling in your throat; or
warmth or redness in your face, neck, or chest.
Less serious side effects may include:
headache, dizziness, or nervousness;
numbness or tingling;
runny or stuffy nose;
skin itching or rash;
weight gain or loss;
mild diarrhea or constipation; or
nausea, vomiting, loss of appetite.
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 Ontak (denileukin diftitox)?
There may be other drugs that can interact with denileukin diftitox. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Ontak resources
- Ontak Side Effects (in more detail)
- Ontak Dosage
- Ontak Use in Pregnancy & Breastfeeding
- Ontak Drug Interactions
- Ontak Support Group
- 0 Reviews for Ontak - Add your own review/rating
- Ontak Prescribing Information (FDA)
- Ontak MedFacts Consumer Leaflet (Wolters Kluwer)
- Ontak Monograph (AHFS DI)
- Ontak Advanced Consumer (Micromedex) - Includes Dosage Information
- Denileukin Diftitox Professional Patient Advice (Wolters Kluwer)
Compare Ontak with other medications
- Lymphoma
Where can I get more information?
- Your doctor or pharmacist can provide more information about denileukin diftitox.
See also: Ontak side effects (in more detail)
Sunday, 16 October 2011
Starasid
Starasid may be available in the countries listed below.
Ingredient matches for Starasid
Cytarabine
Cytarabine ocphosphate (a derivative of Cytarabine) is reported as an ingredient of Starasid in the following countries:
- Japan
International Drug Name Search
Friday, 14 October 2011
dextrothyroxine
Generic Name: dextrothyroxine (dex troe thye ROCK sin)
Brand Names: Choloxin
What is dextrothyroxine?
Dextrothyroxine is used to lower high cholesterol (a type of fat) levels in the blood.
Dextrothyroxine may also be used for purposes other than those listed in this medication guide.
What is the most important information I should know about dextrothyroxine?
Follow any diet or exercise plan outlined by your doctor. Diet and exercise are very important factors in controlling cholesterol.
Call your doctor immediately if you experience chest pain, shortness of breath, an irregular heartbeat, sweating, headache, or a skin rash. These could be early signs of serious side effects.
Who should not take dextrothyroxine?
Do not take dextrothyroxine if you
have had a heart attack,
have heart disease,
have angina,
have irregular heartbeats,
have rheumatic heart disease,
have congestive heart failure,
have high blood pressure,
have a history of iodism (iodine poisoning),
have liver disease, or
have kidney disease.
Dextrothyroxine can have serious effects on the heart, and it should not be taken if you have any of the conditions listed above.
Dextrothyroxine is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not take dextrothyroxine without first talking to your doctor if you are pregnant. It is not known whether dextrothyroxine passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.
How should I take dextrothyroxine?
Take dextrothyroxine exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Take each dose with a full glass of water. Store dextrothyroxine at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.
What happens if I overdose?
Seek emergency medical attention or call a poison control center near you.
Symptoms of a dextrothyroxine overdose are unknown.
What should I avoid while taking dextrothyroxine?
Follow any diet or exercise plans outlined by your doctor. Diet and exercise are very important factors in controlling cholesterol.
Dextrothyroxine side effects
If you experience any of the following serious side effects, stop taking dextrothyroxine and seek emergency medical attention:
an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
chest pain or an irregular heartbeat;
sweating;
diarrhea;
headache; or
skin rash.
Other, less serious side effects may be more likely to occur. Continue to take dextrothyroxine and talk to your doctor if you experience
insomnia, nervousness or tremor;
ringing in your ears; or
nausea, vomiting, decreased appetite, or weight loss.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
What other drugs will affect dextrothyroxine?
Dextrothyroxine may increase the effects of the following drugs, which could lead to dangerous side effects:
anticoagulants (blood thinners) such as warfarin (Coumadin), which could lead to bleeding (a dose reduction may be necessary);
tricyclic antidepressants (TCAs) such as amitriptyline (Elavil), doxepin (Sinequan), and nortriptyline (Pamelor), which could lead to nervousness, a fast heart rate and other side effects;
other commonly used TCAs, including amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), imipramine (Tofranil), protriptyline (Vivactil), and trimipramine (Surmontil); and
thyroid replacement hormones (dextrothyroxine is a form of thyroid hormone and may affect thyroid hormone therapy).
Dextrothyroxine may decrease the activity of the following drugs:
antidiabetic agents such as insulin, glyburide (Micronase, Diabeta, Glynase), glipizide (Glucotrol), tolbutamide (Orinase), and tolazamide (Tolinase), which could lead to high blood sugar levels;
digoxin (Lanoxin, Lanoxicaps) (used to treat heart conditions);
beta-blockers (used to treat high blood pressure) such as acebutolol (Sectral), propranolol (Inderal) and metoprolol (Lopressor), which could lead to high blood pressure; and
other commonly used beta-blockers, including betaxolol (Kerlone), carteolol (Cartrol), carvedilol (Coreg), labetalol (Normodyne, Trandate), nadolol (Corgard), pindolol (Visken), and timolol (Blocadren).
The cholesterol-lowering effects of dextrothyroxine may be reduced by cholestyramine (Questran), which is another cholesterol-lowering drug. These drugs should not be taken at the same time.
Drugs other than those listed here may also interact with dextrothyroxine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.
More dextrothyroxine resources
- Dextrothyroxine Drug Interactions
- Dextrothyroxine Support Group
- 0 Reviews for Dextrothyroxine - Add your own review/rating
Compare dextrothyroxine with other medications
- High Cholesterol
- High Cholesterol, Familial Heterozygous
- High Cholesterol, Familial Homozygous
Where can I get more information?
- Your pharmacist has more information about dextrothyroxine written for health professionals that you may read.
What does my medication look like?
Dextrothyroxine is available with a prescription under the brand name Choloxin. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.
Choloxin 2 mg--round, yellow, scored tablets
Choloxin 4 mg--round, white, scored tablets
Alkagin
Alkagin may be available in the countries listed below.
Ingredient matches for Alkagin
Metamizole
Metamizole is reported as an ingredient of Alkagin in the following countries:
- Croatia (Hrvatska)
International Drug Name Search
Tuesday, 11 October 2011
Darvon-N
propoxyphene napsylate
Dosage Form: tablet, film coated
Darvon-N - propoxyphene napsylate tablet, film coated
Darvon-N Description
Darvon-N contains propoxyphene napsylate, USP which is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (αS,1R)-α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2-naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72
Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride.
Each tablet of Darvon-N contains 100 mg (176.8 μmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide.
Darvon-N - Clinical Pharmacology
Pharmacology
Propoxyphene is a centrally acting opiate analgesic. In vitro studies demonstrated propoxyphene and the metabolite norpropoxyphene inhibit sodium channels (local anesthetic effect) with norpropoxyphene being approximately 2-fold more potent than propoxyphene and propoxyphene approximately 10-fold more potent than lidocaine. Propoxyphene and norpropoxyphene inhibit the voltage-gated potassium current carried by cardiac rapidly activating delayed rectifier (hERG) channels with approximately equal potency. It is unclear if the effects on ion channels occur within therapeutic dose range.
Pharmacokinetics Absorption
Peak plasma concentrations of propoxyphene are reached in 2 to 2.5 h. After a 65-mg oral dose of propoxyphene hydrochloride, peak plasma levels of 0.05 to 0.1 μg/mL for propoxyphene and 0.1 to 0.2 μg/mL for norpropoxyphene (major metabolite) are achieved. Repeated doses of propoxyphene at 6 h intervals lead to increasing plasma concentrations, with a plateau after the ninth dose at 48 h. Propoxyphene has a half-life of 6 to 12 h, whereas that of norpropoxyphene is 30 to 36 h.
Distribution
Propoxyphene is about 80% bound to proteins and has a large volume of distribution, 16 L/kg.
Metabolism
Propoxyphene undergoes extensive first-pass metabolism by intestinal and hepatic enzymes. The major route of metabolism is cytochrome CYP3A4 mediated N-demethylation to norpropoxyphene, which is excreted by the kidneys. Ring hydroxylation and glucuronide formation are minor metabolic pathways.
Excretion
In 48 h, approximately 20 to 25% of the administered dose of propoxyphene is excreted via the urine, most of which is free or conjugated norpropoxyphene. The renal clearance rate of propoxyphene is 2.6 L/min.
SPECIAL POPULATIONS Geriatric Patients
After oral administration of propoxyphene in elderly patients (70-78 years), much longer half-lives of propoxyphene and norpropoxyphene have been reported (propropoxyphene 13 to 35 h, norpropoxyphene 22 to 41 h). In addition, the AUC was an average of 3-fold higher and the Cmax was an average of 2.5-fold higher in the elderly when compared to a younger (20-28 years) population. Longer dosage intervals may be considered in the elderly because the metabolism of propoxyphene may be reduced in this patient population. After multiple oral doses of propoxyphene in elderly patients (70-78 years), the Cmax of the metabolite (norpropoxyphene) was increased 5-fold.
Pediatric Patients
Propoxyphene has not been studied in pediatric patients.
Hepatic Impairment
No formal pharmacokinetic study of propoxyphene has been conducted in patients with mild, moderate or severe hepatic impairment.
After oral administration of propoxyphene in patients with cirrhosis, plasma concentrations of propoxyphene were considerably higher and norpropoxyphene concentrations were much lower than in control patients. This is presumably because of a decreased first-pass metabolism of orally administered propoxyphene in these patients. The AUC ratio of norpropoxyphene: propoxyphene was significantly lower in patients with cirrhosis (0.5 to 0.9) than in controls (2.5 to 4).
Renal Impairment
No formal pharmacokinetic study of propoxyphene has been conducted in patients with mild, moderate or severe renal impairment.
After oral administration of propoxyphene in anephric patients, the AUC and Cmax values were an average of 76% and 88% greater, respectively. Dialysis removes only insignificant amounts (8%) of administered dose of propoxyphene.
Drug Interactions
The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. On the other hand, strong CYP3A4 inducers such as rifampin may lead to enhanced metabolite (norpropoxyphene) levels.
Propoxyphene is also thought to possess CYP3A4 and CYP2D6 enzyme inhibiting properties. Coadministration with a drug that is a substrate of CYP3A4 or CYP2D6, may result in higher plasma concentrations and increased pharmacologic or adverse effects of that drug.
INDICATION
Darvon-N is indicated for the relief of mild to moderate pain.
Contraindications
Darvon-N is contraindicated in patients with known hypersensitivity to propoxyphene.
Darvon-N is contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia.
Darvon-N is contraindicated in any patient who has or is suspected of having paralytic ileus.
Warnings
Risk of Overdose
There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbances or suicidal ideation/attempts and/or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.
Respiratory Depression
Respiratory depression is the chief hazard from all opioid agonist preparations. Respiratory depression occurs most frequently in elderly or debilitated patients, usually following large initial doses in non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration. Darvon-N should be used with extreme caution in patients with significant chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of Darvon-N may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
Hypotensive Effect
Darvon-N, like all opioid analgesics, may cause severe hypotension in an individual whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone. Darvon-N may produce orthostatic hypotension in ambulatory patients. Darvon-N, like all opioid analgesics, should be administered with caution to patients in circulatory shock, since vasodilatation produced by the drug may further reduce cardiac output and blood pressure.
Head Injury and Increased Intracranial Pressure
The respiratory depressant effects of narcotics and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, narcotics produce adverse reactions which may obscure the clinical course of patients with head injuries.
Drug Interactions
The concomitant use of propoxyphene and CNS depressants, including alcohol, can result in potentially serious adverse events including death. Because of its added depressant effects, propoxyphene should be prescribed with caution for those patients whose medical condition requires the concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs.
Usage in Ambulatory Patients
Propoxyphene may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly.
Use with Alcohol
Patients should be cautioned about the concomitant use of propoxyphene products and alcohol because of potentially serious CNS-additive effects of these agents that can lead to death.
BOXED WARNING
Warnings
There have been numerous cases of accidental and intentional overdose with propoxyphene products either alone or in combination with other CNS depressants, including alcohol. Fatalities within the first hour of overdosage are not uncommon. Many of the propoxyphene-related deaths have occurred in patients with previous histories of emotional disturbance or suicidal ideation/attempts and /or concomitant administration of sedatives, tranquilizers, muscle relaxants, antidepressants, or other CNS-depressant drugs. Do not prescribe propoxyphene for patients who are suicidal or have a history of suicidal ideation.
The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erthromycin, fulconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted (see Clinical Pharmacology - Drug Interactions, Warnings, Precautions and Dosage and Administration for further information.)
Precautions
Tolerance and Physical Dependence
Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. In general, opioids should not be abruptly discontinued (see Dosage and Administration: Cessation of Therapy).
If Darvon-N is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur (see Drug Abuse and Dependance). If signs and symptoms of withdrawal occur, patients should be treated by reinstitution of opioid therapy followed by gradual tapered dose reduction of Darvon-N combined with symptomatic support (see Dosage and Administration: Cessation of Therapy).
Use in Pancreatic/Biliary Tract Disease
Darvon-N may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids like Darvon-N may cause increases in the serum amylase level.
Hepatic or Renal Impairment
Insufficient information exists to make appropriate dosing recommendations regarding the use of either propoxyphene in patients with hepatic or renal impairment as a function of degree of impairment. Higher plasma concentrations and/or delayed elimination may occur in case of impaired hepatic function and/or impaired renal function (see Clinical Pharmacology). If the drug is used in these patients, it should be used with caution because of the hepatic metabolism and renal excretion of propoxyphene metabolites.
Information for Patients/Caregivers
- Patients should be advised to report pain and adverse experiences occurring during therapy. Individualization of dosage is essential to make optimal use of this medication.
- Patients should be advised not to adjust the dose of Darvon-N without consulting the prescribing professional.
- Patients should be advised that Darvon-N may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery).
- Patients should not combine Darvon-N with central nervous system depressants (e.g., sleep aids, tranquilizers) except by the orders of the prescribing physician, because additive effects may occur.
- Patients should be instructed not to consume alcoholic beverages, including prescription and over-the-counter medications that contain alcohol, while using Darvon-N because of risk of serious adverse events including death.
- Women of childbearing potential who become, or are planning to become, pregnant should be advised to consult their physician regarding the effects of analgesics and other drug use during pregnancy on themselves and their unborn child.
- Patients should be advised that Darvon-N is a potential drug of abuse. They should protect it from theft, and it should never be given to anyone other than the individual for whom it was prescribed.
- Patients should be advised that if they have been receiving treatment with Darvon-N for more than a few weeks and cessation of therapy is indicated, it may be appropriate to taper the Darvon-N dose, rather than abruptly discontinue it, due to the risk of precipitating withdrawal symptoms. Their physician can provide a dose schedule to accomplish a gradual discontinuation of the medication.
Drug Interactions with Propoxyphene
Propoxyphene is metabolized mainly via the human cytochrome P450 3A4 isoenzyme system (CYP3A4), therefore potential interactions may occur when propoxyphene is administered concurrently with agents that affect CYP3A4 activity.
The metabolism of propoxyphene may be altered by strong CYP3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazadone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) leading to enhanced propoxyphene plasma levels. Coadministration with agents that induce CYP3A4 activity may reduce the efficacy of propoxyphene. Strong CYP3A4 inducers such as rifampin may lead to enhanced metabolite (norpropoxyphene) levels.
Propoxyphene is also thought to possess CYP3A4 and CYP2D6 enzyme inhibiting properties and coadministration with drugs that rely on either of these enzymes for metabolism may result in increased pharmacologic or adverse effects of that drug. Severe neurologic signs, including coma, have occurred with concurrent use of carbamazepine (metabolized by CYP3A4).
Increased risk of bleeding has been observed with warfarin-like agents when given along with propoxyphene; however, the mechanistic basis of this interaction is unknown.
CNS Depressants
Patients receiving narcotic analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with propoxyphene may exhibit an additive CNS depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of Darvon-N. When such combined therapy is contemplated, the dose of one or both agents should be reduced.
Mixed Agonist/Antagonist Opioid Analgesics
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as Darvon-N. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of Darvon-N and/or may precipitate withdrawal symptoms in these patients.
Monoamine Oxidase Inhibitors (MAOIs)
MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of Darvon-N is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
Carcinogenesis, Mutagenesis, Impairment of Fertility
The mutagenic and carcinogenic potential of propoxyphene has not been evaluated.
In animal studies there was no effect of propoxyphene on mating behavior, fertility, duration of gestation, or parturition when rats were fed propoxyphene as a component of their daily diet at estimated daily propoxyphene intake up to 8-fold greater than the maximum human equivalent dose (HED) based on body surface area comparison. At this highest dose, fetal weight and survival on postnatal day 4 was reduced.
Pregnancy Risk summary Pregnancy category C.
There are no adequate and well-controlled studies of propoxyphene in pregnant women. While there are limited data in the published literature, adequate animal reproduction studies have not been conducted with propoxyphene. Therefore, it is not known whether propoxyphene can affect reproduction or cause fetal harm when administered to a pregnant woman. Propoxyphene should be given to a pregnant woman only if clearly needed.
Clinical considerations
Propoxyphene and its major metabolite, norpropoxyphene, cross the human placenta. Neonates whose mothers have taken opiates chronically may exhibit respiratory depression or withdrawal symptoms.
Data
In published animal reproduction studies, no teratogenic effects occurred in offspring born to pregnant rats or rabbits that received propoxyphene during organogenesis. Pregnant animals received propoxyphene doses approximately 10-fold (rats) and 4-fold (rabbits) the maximum recommended human dose (based on mg/m2 body surface area comparison).
Nursing Mothers
Propoxyphene, norpropoxyphene (major metabolite), are excreted in human milk. Published studies of nursing mothers using propoxyphene detected no adverse effects in nursing infants. Based on a study of six mother-infant pairs, an exclusively breastfed infant receives approximately 2% of the maternal weight-adjusted dose. Norpropoxyphene is renally excreted and renal clearance is lower in neonates than in adults. Therefore, it is possible that prolonged maternal propoxyphene use could result in norpropoxyphene accumulation in a breastfed infant. Watch breastfeeding infants for signs of sedation including poor feeding, somnolence, or respiratory depression. Caution should be exercised when Darvon-N is administered to a nursing woman.
Pediatric Patients
Safety and effectiveness in pediatric patients have not been established.
Elderly Patients
Clinical studies of Darvon-N did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, postmarketing reports suggest that patients over the age of 65 may be more susceptible to CNS-related side effects. Therefore, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Decreased total daily dosage should be considered (see Dosage and Administration).
Adverse Reactions
In hospitalized patients, the most frequently reported were dizziness, sedation, nausea, and vomiting. Other adverse reactions include constipation, abdominal pain, skin rashes, lightheadedness, headache, weakness, euphoria, dysphoria, hallucinations, and minor visual disturbances.
The most frequently reported postmarketing adverse events have included completed suicide, accidental and intentional overdose, drug dependence, cardiac arrest, coma, drug ineffective, drug toxicity, nausea, respiratory arrest, cardio-respiratory arrest, death, vomiting, dizziness, convulsion, confusional state, and diarrhea.
Additional adverse experiences reported through postmarketing surveillance include:
Cardiac disorders: arrhythmia, bradycardia, cardiac/respiratory arrest, congestive arrest, congestive heart failure (CHF), tachycardia, myocardial infarction (MI)
Eye disorder: eye swelling, vision blurred
General disorder and administration site conditions: drug ineffective, drug interaction, drug tolerance, influenza type illness, drug withdrawal syndrome
Gastrointestinal disorder: gastrointestinal bleed, acute pancreatitis
Hepatobiliary disorder: hepatic steatosis, hepatomegaly, hepatocellular injury
Immune system disorder: hypersensitivity
Injury poisoning and procedural complications: drug toxicity, hip fracture, multiple drug overdose, narcotic overdose
Investigations: blood pressure decreased, heart rate elevated/abnormal
Metabolism and nutrition disorder: metabolic acidosis
Nervous system disorder: ataxia, coma, dizziness, somnolence, syncope
Psychiatric: abnormal behavior, confusional state, hallucinations, mental status change
Respiratory, thoracic, and mediastinal disorders: respiratory depression, dyspnoea
Skin and subcutaneous tissue disorder: rash, itch
Liver dysfunction has been reported in association with Darvon-N. Propoxyphene therapy has been associated with abnormal liver function tests and, more rarely, with instances of reversible jaundice (including cholestatic jaundice).
Subacute painful myopathy has been reported following chronic propoxyphene overdosage.
Drug Abuse and Dependence
Controlled Substance
Darvon-N is a Schedule IV narcotic under the U.S. Controlled Substances Act. Darvon-N can produce drug dependence of the morphine type, and therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration. Darvon-N should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications.
Abuse
Since Darvon-N is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. Addiction to opioids prescribed for pain management has not been estimated. However, requests for opioids from opioid-addicted patients occur. As such, physicians should take appropriate care in prescribing Darvon-N.
Dependence
Opioid analgesics may cause psychological and physical dependence. Physical dependence results in withdrawal symptoms in patients who abruptly discontinue the drug after long term administration. Also, symptoms of withdrawal may be precipitated through the administration of drugs with mu-opioid antagonist activity, e.g., naloxone or mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine, dezocine) (see Overdosage). Physical dependence usually does not occur to a clinically significant degree, until after several weeks of continued opioid usage. Tolerance, in which increasingly larger doses are required to produce the same degree of analgesia, is initially manifested by a shortened duration of an analgesic effect and subsequently, by decreases in the intensity of analgesia.
In chronic pain patients, and in opioid-tolerant cancer patients, the administration of Darvon-N should be guided by the degree of tolerance manifested and the doses needed to adequately relieve pain.
The severity of the Darvon-N abstinence syndrome may depend on the degree of physical dependence. Withdrawal is characterized by rhinitis, myalgia, abdominal cramping, and occasional diarrhea. Most observable symptoms disappear in 5 to 14 days without treatment; however, there may be a phase of secondary or chronic abstinence which may last for 2 to 6 months characterized by insomnia, irritability, and muscular aches. The patient may be detoxified by gradual reduction of the dose. Gastrointestinal disturbances or dehydration should be treated with supportive care.
Overdosage
Overdose of Darvon-N may present with the signs and symptoms of propoxyphene overdose. Fatalities within the first hour of overdosage are not uncommon.
In all cases of suspected overdosage, call your regional Poison Control Center to obtain the most up-to-date information about the treatment of overdose. This recommendation is made because, in general, information regarding the treatment of overdosage may change more rapidly than do package inserts.
Initial consideration should be given to the management of the CNS effects of propoxyphene overdosage. Resuscitative measures should be initiated promptly.
Symptoms of Propoxyphene Overdosage
The manifestations of acute overdosage with propoxyphene are those of narcotic overdosage. The patient is usually somnolent but may be stuporous or comatose and convulsing. Respiratory depression is characteristic. The ventilatory rate and/or tidal volume is decreased, which results in cyanosis and hypoxia. Pupils, initially pinpoint, may become dilated as hypoxia increases. Cheyne-Stokes respiration and apnea may occur. Blood pressure and heart rate are usually normal initially, but blood pressure falls and cardiac performance deteriorates, which ultimately results in pulmonary edema and circulatory collapse, unless the respiratory depression is corrected and adequate ventilation is restored promptly. Cardiac arrhythmias and conduction delay may be present. A combined respiratory-metabolic acidosis occurs owing to retained CO2 (hypercapnia) and to lactic acid formed during anaerobic glycolysis. Acidosis may be severe if large amounts of salicylates have also been ingested. Death may occur.
Treatment of Propoxyphene Overdosage
Attention should be directed first to establishing a patent airway and to restoring ventilation. Mechanically assisted ventilation, with or without oxygen, may be required, and positive pressure respiration may be desirable if pulmonary edema is present. The opioid antagonist naloxone will markedly reduce the degree of respiratory depression, and should be administered promptly, preferably intravenously. The duration of action of the antagonist may be brief. If no response is observed after 10 mg of naloxone have been administered, the diagnosis of propoxyphene toxicity should be questioned.
In addition to the use of an opioid antagonist, the patient may require careful titration with an anticonvulsant to control convulsions. Activated charcoal can adsorb a significant amount of ingested propoxyphene. Dialysis is of little value in poisoning due to propoxyphene. Efforts should be made to determine whether other agents, such as alcohol, barbiturates, tranquilizers, or other CNS depressants, were also ingested, since these increase CNS depression as well as cause specific toxic effects or death.
DOSAGE AND ADMINISTRATION
Darvon-N is intended for the management of mild to moderate pain. The dose should be individually adjusted according to severity of pain, patient response and patient size.
Darvon-N is given orally. The usual dosage is one 100 mg propoxyphene napsylate tablet every 4 hours as needed for pain. The maximum dose of Darvon-N is 6 tablets per day. Do not exceed the maximum daily dose.
Patients receiving propoxyphene and any CYP3A4 inhibitor should be carefully monitored for an extended period of time and dosage adjustments should be made if warranted.
Consideration should be given to a reduced total daily dosage in elderly patients and in patients with hepatic or renal impairment.
Cessation of Therapy
For patients who used Darvon-N on a regular basis for a period of time, when therapy with Darvon-N is no longer needed for the treatment of their pain, it may be useful to gradually discontinue the Darvon-N over time to prevent the development of an opioid abstinence syndrome (narcotic withdrawal). In general, therapy can be decreased by 25% to 50% per day with careful monitoring for signs and symptoms of withdrawal (see Drug Abuse and Dependence for description of the signs and symptoms of withdrawal). If the patient develops these signs or symptoms, the dose should be raised to the previous level and titrated down more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both.
How is Darvon-N Supplied
Darvon-N Tablets are available in:
The 100 mg tablets are buff colored, elliptical shaped, film coated, and imprinted with the script “Darvon-N 100” on one side of the tablet, using edible black ink. They are available as follows:
| Bottles of 100 | NDC 66479-512-10 |
Store at 25°C (77°F); excursions are permitted to 15°- 30°C (59°- 86°F) [see USP Controlled Room Temperature].
Inform patients of the availability of a Medication Guide for Darvon/Darvon-N that accompanies each prescription dispensed. Instruct patients to read the Darvon/Darvon-N Medication Guide prior to using Darvon.
Darvon, Darvon-N, Darvocet, and Darvocet-N are registered trademarks of
Xanodyne Pharmaceuticals, Inc.
© 2009 Xanodyne Pharmaceuticals, Inc.
Marketed by:
Xanodyne Pharmaceuticals, Inc.
Newport, KY
41071
PI-512-A
REV. 09-2009
MEDICATION GUIDE
Darvon-N® [dar-von-N] (C-IV)
(propoxyphene napsylate)
Tablets
DARVON® [dar-von](C-IV)
(propoxyphene hydrochloride capsules)
Puvules®
Read this Medication Guide before you start taking Darvon-N or Darvon, and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
What is the most important information I should know about Darvon-N and Darvon?
Darvon-N and Darvon, and other medicines that contain propoxyphene can cause serious side effects, including:
Overdoses by accident or on purpose (intentional overdose). Overdoses with Darvon-N and Darvon may happen when it is taken by itself, or with alcohol or other medicines that can also decrease your breathing and make you very sleepy.
Death can happen within 1 hour of taking an overdose of Darvon-N or Darvon.
Many of the deaths that happen in people who take Darvon-N and Darvon happen in those who:
- have emotional problems
- have thoughts of suicide or attempted suicide, or
- also take antidepressants, sedatives, tranquilizers, muscle relaxants, or other medicines that affect your breathing and make you very sleepy. You should not use any of these medicines with Darvon-N or Darvon without talking to your doctor.
- Before taking Darvon-N or Darvon tell your doctor if you:
- have a lung problem, such as COPD or cor pulmonale
- have liver or kidney problems
- have problems with your pancreas or gallbladder
- have a history of head injury
- are over age 65
- have a history of drug or alcohol abuse or addiction
Take Darvon-N and Darvon exactly as prescribed. Do not change your dose or stop taking Darvon-N or Darvon without first talking to your doctor.
- If you take Darvon-N, do not take more than 6 tablets in one day.
- If you take Darvon, do not take more than 6 capsules in one day.
- Before taking Darvon-N or Darvon, tell your doctor about all the medicines you take. Darvon-N or Darvon and many other medicines may interact with each other and may cause serious side effects. Certain medicines can affect how your liver breaks down other medicines. See “What should I tell my doctor before taking Darvon-N or Darvon?”
- Do not drink grapefruit juice or eat grapefruit while you take Darvon-N or Darvon. Grapefruit juice may interact with Darvon-N or Darvon.
- Do not drink alcohol while using Darvon-N or Darvon. Using alcohol with Darvon-N or Darvon may increase your risk of having dangerous side effects.
What are Darvon-N and Darvon?
- Darvon-N and Darvon are prescription medicines used to treat mild to moderate pain.
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It is not known if Darvon-N and Darvon are safe and effective in children younger than age 18.
Who should not take Darvon-N or Darvon?
Do not take Darvon-N or Darvon if you:
- are allergic to propoxyphene. Ask your doctor if you are not sure. See the end of this Medication Guide for a list of the ingredients in Darvon-N and Darvon.
- are having an asthma attack or have severe asthma, trouble breathing, or have a lung problem
- have a bowel blockage called paralytic ileus
What should I tell my doctor before taking Darvon-N or Darvon?
Before you take Darvon-N or Darvon, tell your doctor:
- if you have any of the conditions listed in the section “What is the most important information I should know about Darvon-N and Darvon?”
- if you are allergic to propoxyphene
- if you plan to have surgery with general anesthesia
- if you are pregnant or plan to become pregnant.
- if you take Darvon-N or Darvon regularly before your baby is born, your newborn baby may have withdrawal symptoms because their body has become used to the medicine. Symptoms of withdrawal in a newborn baby may include:
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- if you take Darvon-N or Darvon right before your baby is born, your baby could have breathing problems.
- if you are breast-feeding or plan to breast-feed. Some Darvon-N or Darvon passes into breast milk.
Tell your doctor about all the medicines you take, including prescription, and non-prescription medicines, vitamins, and herbal supplements. Darvon-N and Darvon interacts with many medicines and may lead to serious side effects. The doses of certain medicines may need to be changed.
Especially tell your doctor if you take:
See “What is the most important information I should know about Darvon-N and Darvon?”
- certain medicines that can affect how your liver breaks down other medicines
- a monoamine oxidase inhibitor (MAOI) medicine
- other medicines that make you sleepy, such as: other medicines for pain, including other opioid medicines, anti-depressant medicines, sleeping pills, anti-anxiety medicines, muscle relaxants, anti-nausea medicines, or tranquilizers
- a blood pressure medicine
- a blood-thinner medicine. You may have an increased risk of bleeding while also taking Darvon-N or Darvon.
Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Know the medicines you take. Keep a list of them to show to your doctor and pharmacist when you get a new medicine.
How should I take Darvon-N or Darvon?
See “What is the most important information I should know about Darvon-N and Darvon?”
- Take Darvon-N or Darvon exactly as prescribed.
- If you take too much Darvon-N or Darvon, or take it with alcohol or other medicines, you may overdose. See “What is the most important information I should know about Darvon-N or Darvon?” You will need medical help right away if you think you have taken an overdose of Darvon-N or Darvon. A large overdose could cause you to become unconscious and die.
Signs and symptoms of an overdose of Darvon-N or Darvon include:
- you are very sleepy or do not respond to others
- confusion
- have trouble breathing or stop breathing
- changes in blood pressure and heart rate
What are the possible side effects of Darvon-N and Darvon?
Darvon-N and Darvon can cause serious side effects, including:
See “What is the most important information I should know about Darvon-N and Darvon?”
- Serious breathing problems that can become life-threatening. This is especially true if you already have a serious lung or breathing problem, or your body is not used to opioid pain medicines. This can happen even if you take Darvon-N or Darvon exactly as prescribed by your doctor. Call your doctor or get medical help right away if:
- your breathing slows down
- you have shallow breathing (little chest movement with breathing)
- you feel faint, dizzy, confused, or
- you have any other unusual symptoms
- Darvon-N and Darvon can cause your blood pressure to drop. This can make you feel dizzy and faint if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lose blood or take certain other medicines.
- Sleepiness. Darvon-N and Darvon can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how Darvon-N or Darvon affects you.
- Darvon-N and Darvon can cause physical dependence if you take it for more than a few weeks. Do not stop taking Darvon-N or Darvon all of a sudden. You could become sick with uncomfortable withdrawal symptoms (for example, nausea, vomiting, diarrhea, anxiety, and shivering) because your body has become used to the medicine. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction.
Tell your doctor if you have any of these withdrawal symptoms while you slowly stop taking Darvon-N or Darvon. You may need to stop Darvon-N or Darvon more slowly.
Common side effects of Darvon-N and Darvon include:
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Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Xanodyne Pharmaceuticals, Inc. at 1-877-773-7793.
How should I store Darvon-N and Darvon?
- Store Darvon-N between 59°F to 86°F (15°C to 30°C).
- Store Darvon between 68°F to 77°F (20°C to 25°C).
Keep Darvon-N, Darvon and all medicines out of the reach of children.
General information about Darvon-N and Darvon
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Darvon-N or Darvon for a purpose for which it was not prescribed. Do not give Darvon-N or Darvon to others even if they have the same symptoms you have. It may harm them and is against the law.
This Medication Guide summarizes the most important information about Darvon-N and Darvon. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Darvon-N and Darvon that is written for health professionals. For more information, go to www.Xanodyne.com or call 1-877-773-7793.
What are the ingredients in Darvon-N and Darvon?
Darvon-N:
Active ingredient: propoxyphene napsylate
Inactive ingredients: cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide
Darvon:
Active ingredient: propoxyphene hydrochloride
Inactive ingredients: D and C Red No. 33, FD and C Yellow No. 6, gelatin, magnesium stearate, silicone, starch, titanium dioxide, and other inactive ingredients
Xanodyne Pharmaceuticals, Inc.
Newport, KY 41071
Issued 09/2009
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Darvon, Darvon-N, Darvocet-N and Darvocet are registered trademarks of Xanodyne Pharmaceuticals, Inc.
© 2009 Xanodyne Pharmaceuticals, Inc.
Marketed by:
Xanodyne Pharmaceuticals, Inc.
MG-510/512-A
Rev. 09/2009
Revised: 09/2009Xanodyne Pharmaceuticals, Inc.
PRODUCT LABEL
| Darvon-N propoxyphene napsylate tablet, film coated | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA016862 | 09/25/2009 | |
| Labeler - Stat Rx USA (786036330) |
More Darvon-N resources
- Darvon-N Side Effects (in more detail)
- Darvon-N Dosage
- Darvon-N Use in Pregnancy & Breastfeeding
- Drug Images
- Darvon-N Drug Interactions
- Darvon-N Support Group
- 1 Review for Darvon-N - Add your own review/rating
- Darvon-N Concise Consumer Information (Cerner Multum)
- Darvon-N MedFacts Consumer Leaflet (Wolters Kluwer)
- Darvon-N Advanced Consumer (Micromedex) - Includes Dosage Information
- Propoxyphene Professional Patient Advice (Wolters Kluwer)
- Propoxyphene Hydrochloride Monograph (AHFS DI)
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