COUMADIN Tablet (2020)

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BOXED WARNING SECTION

h3. 0.101 WARNING: BLEEDING RISK COUMADIN can cause major or fatal bleeding [see Warnings and Precautions (5.1)]. Perform regular monitoring of INR in all treated patients [see Dosage ...

1. Indications and Usage

COUMADIN is indicated for: Prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE). Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation ...

2. Dosage and Administration

2.1 Individualized Dosing The dosage and administration of COUMADIN must be individualized for each patient according to the patients International Normalized Ratio (INR) response to the drug. Adjust the ...

3. Dosage Forms and Strengths

Tablets: COUMADIN Single-Scored Tablets Strength Color Superimposed Imprint 1 mg Pink 1 2 mg Lavender 2 2.5 mg Green 2-1/2 3 mg Tan 3 4 mg Blue 4 5 mg Peach 5 6 mg Teal ...

4. Contraindications

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 [see ...

5. Warnings and Precautions

5.1 Hemorrhage 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 ...

6. Adverse Reactions

The following serious adverse reactions to COUMADIN are discussed in greater detail in other sections of the labeling: Hemorrhage [see Boxed Warning, Warnings and Precautions (5.1), and Overdosage ...

7. Drug Interactions

7.1 General Information Drugs may interact with COUMADIN through pharmacodynamic or pharmacokinetic mechanisms. Pharmacodynamic mechanisms for drug interactions with COUMADIN are synergism (impaired hemostasis, ...

8.1. Pregnancy

Risk Summary COUMADIN is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism, and for whom the benefits of COUMADIN ...

8.2. Lactation

Risk Summary Warfarin was not present in human milk from mothers treated with warfarin from a limited published study. Because of the potential for serious adverse reactions, including bleeding in a breastfed ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing COUMADIN can cause fetal harm [see Use in Specific Populations (8.1)]. Verify the pregnancy status of females of reproductive potential prior to initiating COUMADIN therapy. ...

8.4. Pediatric Use

Adequate and well-controlled studies with COUMADIN have not been conducted in any pediatric population, and the optimum dosing, safety, and efficacy in pediatric patients is unknown. Pediatric use of COUMADIN ...

8.5. Geriatric Use

Of the total number of patients receiving warfarin sodium in controlled clinical trials for which data were available for analysis, 1885 patients (24.4%) were 65 years and older, while 185 patients (2.4%) ...

8.6. Renal Impairment

Renal clearance is considered to be a minor determinant of anticoagulant response to warfarin. No dosage adjustment is necessary for patients with renal impairment. Instruct patients with renal impairment ...

8.7. Hepatic Impairment

Hepatic impairment can potentiate the response to warfarin through impaired synthesis of clotting factors and decreased metabolism of warfarin. Conduct more frequent monitoring for bleeding when using ...

10. Overdosage

10.1 Signs and Symptoms Bleeding (e.g., appearance of blood in stools or urine, hematuria, excessive menstrual bleeding, melena, petechiae, excessive bruising or persistent oozing from superficial injuries, ...

11. Description

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 ...

12.1. Mechanism of Action

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 ...

12.2. Pharmacodynamics

An anticoagulation effect generally occurs within 24 hours after warfarin administration. However, peak anticoagulant effect may be delayed 72 to 96 hours. The duration of action of a single dose of racemic ...

12.3. Pharmacokinetics

COUMADIN is a racemic mixture of the R- and S-enantiomers of warfarin. The S-enantiomer exhibits 2 to 5 times more anticoagulant activity than the R-enantiomer in humans, ...

12.5. Pharmacogenomics

CYP2C9 and VKORC1 Polymorphisms The S-enantiomer of warfarin is mainly metabolized to 7-hydroxywarfarin by CYP2C9, a polymorphic enzyme. The variant alleles, CYP2C9*2 and CYP2C9*3, result in decreased ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, or fertility studies have not been performed with warfarin.

14. Clinical Studies

14.1 Atrial Fibrillation In five prospective, randomized, controlled clinical trials involving 3711 patients with non-rheumatic AF, warfarin significantly reduced the risk of systemic thromboembolism including ...

15. References

OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16.1. How Supplied

Tablets COUMADIN tablets are single-scored with one face imprinted numerically with 1, 2, 2-1/2, 3, 4, 5, 6, 7-1/2, or 10 superimposed and inscribed with COUMADIN and with the opposite face plain. COUMADIN ...

16.2. Storage and Handling

Protect from light and moisture. Store at controlled room temperature (59°-86°F, 15°-30°C). Dispense in a tight, light-resistant container as defined in the USP. Store the hospital unit-dose blister packages ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Instructions for Patients Advise patients to: Strictly adhere to the prescribed dosage schedule [see Dosage and Administration ...