Amrubicin Hydrochloride may be available in the countries listed below.
Amrubicin Hydrochloride (USAN) is also known as Amrubicin (Rec.INN)
International Drug Name Search
Glossary
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Antalerg may be available in the countries listed below.
Azelastine hydrochloride (a derivative of Azelastine) is reported as an ingredient of Antalerg in the following countries:
International Drug Name Search
In the US, Desvenlafaxine (desvenlafaxine systemic) is a member of the drug class serotonin-norepinephrine reuptake inhibitors and is used to treat ADHD, Anxiety, Bipolar Disorder, Depression, Fibromyalgia, Hot Flashes, Narcolepsy, Neuralgia, Obesity, Panic Disorder, Post Traumatic Stress Disorder and Postmenopausal Symptoms.
US matches:
Rec.INN
N06AX23
0093413-62-8
C16-H25-N-O2
263
Antidepressant: Selective serotonin and noradrenalin reuptake inhibitor (SSNRI)
(+-)-1-{α-[(Dimethylamino)methyl]-4-hydroxybenzyl}cyclohexanol (IUPAC)
4-(2-(Dimethylamino)-1-(1-hydroxycyclohexyl)ethyl)phenol
4-[(RS)-2-(Dimethylamino)-1-(1-hydroxycyclohexyl)ethyl]phenol (WHO)
Phenol, 4-(2-(dimethylamino)-1-(1-hydroxycyclohexyl)ethyl)-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IUPAC | International Union of Pure and Applied Chemistry |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
| WHO | World Health Organization |
Bebulin VH (Factor IX Complex), Vapor Heated, (Bebulin VH) is a purified, sterile, stable, freeze-dried concentrate of the coagulation Factors IX (Christmas Factor) as well as II (Prothrombin) and X (Stuart Prower Factor) and low amounts of Factor VII. In addition, the product contains small amounts of heparin (≤ 0.15 IU heparin per IU Factor IX).
Bebulin VH is standardized in terms of Factor IX content and each vial is labeled for the Factor IX content indicated in International Units (IU). One International Unit of Factor IX (according to the current International Standard for Human Blood Coagulation Factors II, IX, and X in Concentrates) corresponds to the activity of Factor IX in 1 mL of fresh normal human plasma.
Bebulin VH is a combination of vitamin K-dependent clotting factors found in normal plasma. The administration of Bebulin VH provides an increase in plasma levels of Factor IX and can temporarily correct the coagulation defect of patients with Factor IX deficiency. Plasma levels of Factors II and X will also be increased. However, no clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency.
In vivo recovery of Bebulin VH was determined by investigators in Germany, Japan, and the United States using the former International Standard, WHO 72/32 and was found to be 53.3% ±9.6%, 57.5% ±21.8%, and 53.24% ±16.95%, respectively. In the same studies, using different methodologies, half-lives were determined to be 19.4 hrs ±3.8 hrs, 24.6 hrs ±3.2 hrs, and 19.97 hrs ±8.24 hrs, respectively 1,2,3.
During the manufacture Bebulin VH is subjected to virus inactivation by two-step vapor heating at 60°C and 80°C4, where Bebulin VH intermediate bulk is heated for a total of 10 hours at >60°C and 1 hour at 80°C. Reduction factor for Parvovirus B19 claimed for the Lyophilization and Vapor Heat Treatment step is based on results derived from experimental infectivity and titration assays. The effectiveness of vapor heating was evaluated in vitro using human immunodeficiency virus (HIV-1) as a relevant blood-borne pathogen as well as hepatitis A virus (HAV) and human parvovirus B19 (B19V) as relevant non-enveloped RNA and DNA viruses, respectively. Furthermore, model viruses have been used to evaluate the virus inactivation capacity of vapor heat treatment: Bovine viral diarrhea virus (BVDV) as a model for lipid enveloped RNA viruses such as hepatitis C virus and pseudorabies virus (PRV) was included as a model for enveloped DNA viruses. MMV was employed as a model for non-enveloped DNA viruses less heat sensitive than B19V5-7. These studies indicate that this specific step during the manufacture of Bebulin VH is capable of eliminating/ inactivating a wide range of relevant target and model viruses exhibiting diverse physicochemical properties. The in vitro viral reduction studies performed on Bebulin VH are summarized in Table 1.
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In Vitro Virus Clearance During Lyophilization and | ||||||
| Process Step Evaluated | Viral Reduction Factor (log10) | |||||
| Lipid-enveloped | Non- Enveloped | |||||
| HIV-1 | BVDV | PRV | HAV | B19V* | MMV | |
| Lyophilization and Vapor Heat Treatment at 60°C and 80°C | 6.7 | > 6.9 | > 7.4 | > 5.0 | 4.6 | < 1.0 |
In the context of two prospective clinical studies 8,9 and a retrospective survey 10, BEBULIN VH was followed up for the risk of transfusion-transmitted viral infections. All patients received blood products for the first time. Using criteria established by the ICTH, 16 patients could be followed up for non-A, non-B hepatitis, 9 for HCV seroconversion, 3 for hepatitis B, and 24 for HIV seroconversion. None tested positive for any of these infections. An additional 3 patients with 2 or more consecutive test samples missing tested negative for non-A, non-B hepatitis for all samples available. Three studies using ICTH criteria for testing 8-10, a retrospective survey 11 and a case report 12 on other vapor heated factors of the prothrombin complex that were subjected to the same inactivation process as Bebulin VH, gave the following results: 27 patients tested negative for non-A, non-B hepatitis, 15 for HCV seroconversion, 25 for hepatitis B, and 75 for HIV seroconversion.
Bebulin VH is indicated for the prevention and control of hemorrhagic episodes in hemophilia B patients.
Bebulin VH is not indicated for use in the treatment of Factor VII deficiency. No clinical studies have been conducted to show benefit from this product for treating deficiencies other than Factor IX deficiency.
None known.
Bebulin VH is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by effective donor screening, testing for the presence of certain current virus infections, by inactivating and/or removing certain viruses. Despite these measures, such products can still potentially transmit disease. Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jacob disease (CJD) agent. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxter Healthcare Corporation at 1-800-423-2862 (in the U.S.). The physician should discuss the risks and benefits of this product with the patient.
Individuals who receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly non-A, non-B hepatitis. Hepatitis B vaccination is essential for patients with hemophilia and it is recommended that this be done at birth or diagnosis. The risk of thromboembolic complications including DIC and hyperfibrinolysis is present with the administration of Factor IX Complex, particularly in the postoperative period and in patients with risk factors predisposing to thrombosis.
In patients with risk factors predisposing to thrombosis the Factor IX level should not be raised to more than approximately 60% of normal 13. In addition, it is recommended that such patients as well as patients who require high doses of Factor IX because of major surgical interventions be monitored for the possible development of DIC and/or thrombosis. In case changes occur in blood pressure or pulse rate or symptoms such as respiratory distress, chest pain or cough, treatment should be stopped immediately.
Some viruses, such as parvovirus B19, are particularly difficult to remove or inactivate at this time. Parvovirus B19 most seriously affects pregnant women or immune-compromised individuals. Symptoms of parvovirus B19 infection include fever, drowsiness, chills, and runny nose followed about two weeks later by a rash, and joint pain.
Patients should be informed of the early signs of hypersensitivity reactions such as fever, urticaria, rashes, nausea or retching and should be advised to discontinue use of the product and contact their physician if these symptoms occur.
Animal reproduction studies have not been conducted with Bebulin VH It is also not known whether Bebulin VH can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. BEBULIN should be given to a pregnant woman only if clearly needed.
As with any other infused plasma derivatives, anaphylactoid or anaphylactic reactions may occur in rare cases. The occurrence of these reactions (e.g. fever, urticarial rashes, nausea, retching, dyspnea, anaphylactic shock) necessitates the interruption of replacement therapy. Mild reactions can be managed with antihistamines; severe hypotensive reactions require immediate intervention using current principles of shock therapy.
Bebulin VH is intended for intravenous administration only.
As a general rule, 1 International Unit of Factor IX activity/kg will increase the plasma level of Factor IX by 0.8%.
Accordingly, the following formula is provided for dosage calculations
| Number of Factor | bodyweight | desired Factor IX increase | x | 1.2 | ||
| IX IU required | = | (kg) | x | (% of normal) |
It must, however, be emphasized that the response to treatment will vary from patient to patient and that occasionally larger doses than those derived from the above formula will be required, particularly if treatment is delayed. Exact dosage determination should be based on localization and extent of hemorrhage, and the level of Factor IX to be achieved. It must be emphasized that particularly with severe hemorrhage and major surgery, close laboratory monitoring of the Factor IX level is required to determine proper dosage.
Approximate Factor IX levels, typical initial doses, and the average duration of treatment are suggested in the table below. For minor bleeding a single dose will usually be sufficient, otherwise a second dose may be given after 24 hours. More severe hemorrhage will require the administration of several doses at approximately 24 hours intervals. For maintenance therapy, usually two thirds of the initial dose is infused.
| |||
| Type of Bleeding | Approximate Factor IX Level (% Normal) | Typical Initial Dose (IU/kg) | Average Duration of Treatment (Days) |
Minor early hemarthrosis, and gingival bleeding, mild hematuria | 20 | 25-35 | 1 |
Moderate severe joint bleeding, major open bleeding, minor trauma, minor hemoptysis hematemesis, and melena, major hematuria | 40 | 40-55 | 2 or until adequate wound healing |
Major Severe hemoptysis, Hematemesis, and melena | ≥60* | 60-70 | 2-3 or until adequate wound healing |
Dosage guidelines for surgical procedures are suggested below. The preoperative loading dose should be administered one hour prior to surgery. Depending on the type of surgery, replacement therapy has to be continued over one to several weeks until adequate wound healing is achieved. The average treatment interval will initially be 12 hours, while in the later postoperative period 24 hours is generally adequate.
| ||||||
Type of Surgery | Day of Operation | Init. Postop. Period (1st to 2nd Week) | Late Postop. Period (from 3rd Week Onwards) | |||
Approx. Level F IX (% Normal) | Dose (I.U./kg) | Approx. Level F IX (% Normal) | Dose (I.U./kg) | Approx. Level F IX (% Normal) | Dose (I.U./kg) | |
| Major | ≥60* | 70-95 | 60-20 | 70-35 | 20 | 35-25 |
| Minor | 40-60 | 50-60 | 40-20 | 55-25 | N/A | N/A |
For tooth extraction the same initial dose as for minor surgery is recommended.
Generally, one infusion will be sufficient. In case of extraction of several teeth, replacement therapy for up to one week may be necessary using the same doses as for minor surgery 13-15
Prophylactic doses of 20-30 IU/kg administered once, or preferably up to twice a week have been shown to significantly reduce the frequency of spontaneous hemorrhage 13,16. It is, however, recommended that prophylactic dosage regimens be tailored to individual needs.
Bebulin VH should be reconstituted immediately before application. The solution does not contain a preservative and must be used within 3 hours after reconstitution.
For reconstitution proceed as follows:
Do not refrigerate after reconstitution!
Parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
Bebulin VH is supplied in single dose vials with Sterile Water for Injection, U.S.P., double-ended needle, and filter needle for reconstitution and withdrawal.
Some components of the packaging material contain Dry Natural Rubber Latex.
Factor IX activity in International Units is stated on the label of each vial.
Rx only
When stored at refrigerated temperature (2°C-8°C, 35°F-46°F), Bebulin VH is stable for the period indicated by the expiration date on its label. Avoid freezing, which may damage the diluent vial.
To enroll in the confidential, Industry-wide Patient Notification System, call 1-888-UPDATE U(1 888-873-2838).
BEBULIN is a trademark of Baxter AG, Vienna Austria; Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark office.
Baxter Healthcare Corporation
Westlake Village, CA-91362
USA
U.S. License No. 140 Revised: 09/2006
U.S. Pat. No 4,640,834 and 4,388,232
Bebulin VH 200-1200 unit carton
20 mL size, dried
NDC 64193-244-02
Bebulin VH
(Factor IX Complex),
Vapor Heated
BAXTER (Logo)
WARNING: This product is prepared from large pools of human plasma. Human blood and its components may transmit infectious agents. The physician and patient should discuss the risks and benefits of this product.
Some components of the packaging material contain Dry Natural Rubber Latex.
The process has been subjected to in-process virus inactivation. For details, see package insert.
Rx Only
BEBULIN is a trademark of Baxter AG, Vienna, Austria: Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.
Bebulin VH 200-1200 vial label
20 mL size, dried
NDC 64193-244-03
Bebulin VH (Factor IX Complex), Vapor Heated
BAXTER (logo)
Contains no preservative. Reconstituted with 20 mL of Sterile Water of Injection, U.S.P. and keep at room temperature. Use within 3 hours after reconstitution. Administer by the intravenous route only. For complete information and dosage see accompanying directions for use. WARNING: This product is prepared from large pools of human plasma. Human blood and its components may transmit infectious agents. The physician and patient should discuss the risks and benefits of this product. Rx only. Store between 2º and 8ºC (35º and 46ºF).
BEBULIN is a trademark of Baxter AG, Vienna, Austria: Baxter is a trademark of Baxter International Inc., registered in the U.S. Patent and Trademark Office.
Baxter Healthcare Corporation
Westlake Village, CA 91362 USA
U.S. License No. 140
U.S. Pat. Nos. 4,640,834
20 mL Sterile Water for Injection
NDC 0338-0764-62
20 mL
Single-Dose Container
Nonpyrogenic
Sterile Water for Injection, USP for reconstitution of accompanying product
Do not use unless clear. No antimicrobial agent or other substances has been added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion. Rx Only. This Product Contains Dry Natural Rubber.
BAXTER
Manufactured by
Baxter Healthcare Corporation
Deerfield, IL 60015 USA
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| BLA | BLA103112 | 03/16/2011 | |
| Labeler - Baxter Healthcare Corporation (085206634) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Baxter Healthcare Corporation | 001728059 | MANUFACTURE, LABEL | |
NAC Sandoz may be available in the countries listed below.
Acetylcysteine is reported as an ingredient of NAC Sandoz in the following countries:
International Drug Name Search
In the US, Sodium Thiosalicylate is a member of the drug class salicylates.
Thiosalicylic Acid is reported as an ingredient of Sodium Thiosalicylate in the following countries:
International Drug Name Search
In the US, Prevalite (cholestyramine systemic) is a member of the drug class bile acid sequestrants and is used to treat Crohn's Disease, Hyperlipoproteinemia, Hyperlipoproteinemia Type IIa - Elevated LDL, Hyperlipoproteinemia Type IIb - Elevated LDL VLDL, Irritable Bowel Syndrome and Pruritus of Partial Biliary Obstruction.
US matches:
Colestyramine is reported as an ingredient of Prevalite in the following countries:
International Drug Name Search
Stamlo Beta may be available in the countries listed below.
Amlodipine is reported as an ingredient of Stamlo Beta in the following countries:
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Stamlo Beta in the following countries:
Atenolol is reported as an ingredient of Stamlo Beta in the following countries:
International Drug Name Search
Selegil may be available in the countries listed below.
Selegiline hydrochloride (a derivative of Selegiline) is reported as an ingredient of Selegil in the following countries:
International Drug Name Search
Miclo may be available in the countries listed below.
Clobetasone 17α-butyrate (a derivative of Clobetasone) is reported as an ingredient of Miclo in the following countries:
International Drug Name Search
Roxylid may be available in the countries listed below.
Roxithromycin is reported as an ingredient of Roxylid in the following countries:
International Drug Name Search
Trubin may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Kitasamycin is reported as an ingredient of Trubin in the following countries:
International Drug Name Search
Sanorin may be available in the countries listed below.
Naphazoline nitrate (a derivative of Naphazoline) is reported as an ingredient of Sanorin in the following countries:
International Drug Name Search
Sandoz Sertraline may be available in the countries listed below.
Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sandoz Sertraline in the following countries:
International Drug Name Search
Staklos may be available in the countries listed below.
Dicloxacillin sodium salt (a derivative of Dicloxacillin) is reported as an ingredient of Staklos in the following countries:
International Drug Name Search
Corsafen may be available in the countries listed below.
Thiamphenicol is reported as an ingredient of Corsafen in the following countries:
International Drug Name Search
Lanzonium may be available in the countries listed below.
Lansoprazole is reported as an ingredient of Lanzonium in the following countries:
International Drug Name Search
Sandoz Flunitrazepam may be available in the countries listed below.
Flunitrazepam is reported as an ingredient of Sandoz Flunitrazepam in the following countries:
International Drug Name Search
Generic Name: denileukin diftitox (de ni LOO kin DIF ti tox)
Brand Names: Ontak
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.
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.
If you have heart disease, you may need a dose adjustment or special tests.
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.
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.
Call your doctor for instructions if you miss an appointment for your denileukin diftitox injection.
Overdose may cause severe nausea or vomiting, fever, chills, and extreme weakness.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using denileukin diftitox.
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.
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.
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.
See also: Ontak side effects (in more detail)
Starasid may be available in the countries listed below.
Cytarabine ocphosphate (a derivative of Cytarabine) is reported as an ingredient of Starasid in the following countries:
International Drug Name Search
Generic Name: dextrothyroxine (dex troe thye ROCK sin)
Brand Names: Choloxin
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.
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.
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.
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 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.
Symptoms of a dextrothyroxine overdose are unknown.
Follow any diet or exercise plans outlined by your doctor. Diet and exercise are very important factors in controlling cholesterol.
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.
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.
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 may be available in the countries listed below.
Metamizole is reported as an ingredient of Alkagin in the following countries:
International Drug Name Search
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.
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.
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.
Propoxyphene is about 80% bound to proteins and has a large volume of distribution, 16 L/kg.
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.
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.
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.
Propoxyphene has not been studied in pediatric patients.
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).
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.
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.
Darvon-N is indicated for the relief of mild to moderate pain.
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.
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 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.
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.
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.
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.
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.
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.)
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).
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.
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.
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.
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.
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.
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.
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.
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.
Propoxyphene and its major metabolite, norpropoxyphene, cross the human placenta. Neonates whose mothers have taken opiates chronically may exhibit respiratory depression or withdrawal symptoms.
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).
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.
Safety and effectiveness in pediatric patients have not been established.
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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:
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.
What are Darvon-N and Darvon?
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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:
What should I tell my doctor before taking Darvon-N or Darvon?
Before you take Darvon-N or Darvon, tell your doctor:
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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?”
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?”
Signs and symptoms of an overdose of Darvon-N or Darvon include:
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?”
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?
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
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) |
