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warfarin sodium
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Overview
What is COUMADIN?
COUMADIN (warfarin sodium) tablets contain warfarin sodium, an anticoagulant that acts by inhibiting vitamin K‑dependent coagulation factors. The chemical name of warfarin sodium is 3-(α-acetonylbenzyl)-4-hydroxycoumarin sodium salt, which is a racemic mixture of the - and -enantiomers. Crystalline warfarin sodium is an isopropanol clathrate. Its empirical formula is CHNaO, and its structural formula is represented by the following:
Crystalline warfarin sodium occurs as a white, odorless, crystalline powder that is discolored by light. It is very soluble in water, freely soluble in alcohol, and very slightly soluble in chloroform and ether.
COUMADIN tablets for oral use also contain:
What does COUMADIN look like?
What are the available doses of COUMADIN?
What should I talk to my health care provider before I take COUMADIN?
• Pregnant women with mechanical heart valves: COUMADIN may cause fetal harm; however, the benefits may outweigh the risks.
• Lactation: Monitor breastfeeding infants for bruising or bleeding.
• Renal Impairment: Instruct patients with renal impairment to frequently monitor their INR.
How should I use COUMADIN?
COUMADIN is indicated for:
Limitations of Use
COUMADIN has no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. Once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae.
The dosage and administration of COUMADIN must be individualized for each patient according to the patient’s International Normalized Ratio INR response to the drug. Adjust the dose based on the patient’s INR and the condition being treated. Consult the latest evidence-based clinical practice guidelines regarding the duration and intensity of anticoagulation for the indicated conditions.
What interacts with COUMADIN?
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What are the warnings of COUMADIN?
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What are the precautions of COUMADIN?
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What are the side effects of COUMADIN?
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What should I look out for while using COUMADIN?
COUMADIN is contraindicated in:
• Pregnancy
COUMADIN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism . COUMADIN can cause fetal harm when administered to a pregnant woman. COUMADIN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If COUMADIN is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus .
COUMADIN is contraindicated in patients with:
• Hemorrhagic tendencies or blood dyscrasias
• Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces
• Bleeding tendencies associated with:
- Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract
- Central nervous system hemorrhage
- Cerebral aneurysms, dissecting aorta
- Pericarditis and pericardial effusions
- Bacterial endocarditis
• Threatened abortion, eclampsia, and preeclampsia
• Unsupervised patients with conditions associated with potential high level of non-compliance
• Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding
• Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis)
• Major regional or lumbar block anesthesia
• Malignant hypertension
What might happen if I take too much COUMADIN?
How should I store and handle COUMADIN?
Topiramate tablets should be stored in tightly-closed containers at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Product: 50090-0028NDC: 50090-0028-0 30 TABLET in a BOTTLEProduct: 50090-0028NDC: 50090-0028-0 30 TABLET in a BOTTLE
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Clinical Information
Chemical Structure
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Clinical Pharmacology
Warfarin acts by inhibiting the synthesis of vitamin K-dependent clotting factors, which include Factors II, VII, IX, and X, and the anticoagulant proteins C and S. Vitamin K is an essential cofactor for the post ribosomal synthesis of the vitamin K-dependent clotting factors. Vitamin K promotes the biosynthesis of γ-carboxyglutamic acid residues in the proteins that are essential for biological activity. Warfarin is thought to interfere with clotting factor synthesis by inhibition of the C1 subunit of vitamin K epoxide reductase (VKORC1) enzyme complex, thereby reducing the regeneration of vitamin K epoxide .
Non-Clinical Toxicology
COUMADIN is contraindicated in:
• Pregnancy
COUMADIN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism . COUMADIN can cause fetal harm when administered to a pregnant woman. COUMADIN exposure during pregnancy causes a recognized pattern of major congenital malformations (warfarin embryopathy and fetotoxicity), fatal fetal hemorrhage, and an increased risk of spontaneous abortion and fetal mortality. If COUMADIN is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus .
COUMADIN is contraindicated in patients with:
• Hemorrhagic tendencies or blood dyscrasias
• Recent or contemplated surgery of the central nervous system or eye, or traumatic surgery resulting in large open surfaces
• Bleeding tendencies associated with:
- Active ulceration or overt bleeding of the gastrointestinal, genitourinary, or respiratory tract
- Central nervous system hemorrhage
- Cerebral aneurysms, dissecting aorta
- Pericarditis and pericardial effusions
- Bacterial endocarditis
• Threatened abortion, eclampsia, and preeclampsia
• Unsupervised patients with conditions associated with potential high level of non-compliance
• Spinal puncture and other diagnostic or therapeutic procedures with potential for uncontrollable bleeding
• Hypersensitivity to warfarin or to any other components of this product (e.g., anaphylaxis)
• Major regional or lumbar block anesthesia
• Malignant hypertension
Chlorthalidone may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic peripheral adrenergic blocking drugs.
Medication such as digitalis may also influence serum electrolytes. Warning signs, irrespective of cause, are: dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.
Insulin requirements in diabetic patients may be increased, decreased, or unchanged. Higher dosage of oral hypoglycemic agents may be required. Latent diabetes mellitus may become manifest during chlorthalidone administration.
Chlorthalidone and related drugs may increase the responsiveness to tubocurarine.
Chlorthalidone and related drugs may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use.
COUMADIN can cause major or fatal bleeding. Bleeding is more likely to occur within the first month. Risk factors for bleeding include high intensity of anticoagulation (INR >4.0), age greater than or equal to 65, history of highly variable INRs, history of gastrointestinal bleeding, hypertension, cerebrovascular disease, anemia, malignancy, trauma, renal impairment, certain genetic factors , certain concomitant drugs , and long duration of warfarin therapy.
Perform regular monitoring of INR in all treated patients. Those at high risk of bleeding may benefit from more frequent INR monitoring, careful dose adjustment to desired INR, and a shortest duration of therapy appropriate for the clinical condition. However, maintenance of INR in the therapeutic range does not eliminate the risk of bleeding.
Drugs, dietary changes, and other factors affect INR levels achieved with COUMADIN therapy. Perform more frequent INR monitoring when starting or stopping other drugs, including botanicals, or when changing dosages of other drugs .
Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding .
The following serious adverse reactions to COUMADIN are discussed in greater detail in other sections of the labeling:
• Hemorrhage
• Tissue Necrosis
• Calciphylaxis
• Acute Kidney Injury
• Systemic Atheroemboli and Cholesterol Microemboli
• Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS
• Other Clinical Settings with Increased Risks
Other adverse reactions to COUMADIN include:
• Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions)• Vascular disorders: vasculitis• Hepatobiliary disorders: hepatitis, elevated liver enzymes. Cholestatic hepatitis has been associated with concomitant administration of COUMADIN and ticlopidine.• Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating• Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia• Respiratory disorders: tracheal or tracheobronchial calcification• General disorders: chills
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Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
Clonazepam Description
Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake.
Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula:
C15H10ClN3O3 M.W. 315.72
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Tips
Tips
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Interactions
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib).
228 major drug interactions (854 brand and generic names)
210 moderate drug interactions (691 brand and generic names)
2 minor drug interactions (4 brand and generic names)
Show all medications in the database that may interact with Imbruvica (ibrutinib).
