GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Warfarin Sodium Tablet USP 1mg
B) Warfarin Sodium Tablet USP 2mg
C) Warfarin Sodium Tablet USP 2.5mg
D) Warfarin Sodium Tablet USP 3mg
E) Warfarin Sodium Tablet USP 4mg
F) Warfarin Sodium Tablet USP 5mg
G) Warfarin Sodium Tablet USP 6mg
H) Warfarin Sodium Tablet USP 7.5 mg
I) Warfarin Sodium Tablet USP 10 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Warfarin Sodium Tablet USP 1mg
Each uncoated tablet contains:
Warfarin Sodium USP …….1mg
Excipients…………………………q.s.

B) Warfarin Sodium Tablet USP 2mg
Each uncoated tablet contains:
Warfarin Sodium USP …….2mg
Excipients…………………………q.s.

C) Warfarin Sodium Tablet USP 2.5 mg
Each uncoated tablet contains:
Warfarin Sodium USP …….2.5mg
Excipients…………………………q.s.

D) Warfarin Sodium Tablet USP 3mg
Each uncoated tablet contains:
Warfarin Sodium USP …….3mg
Excipients…………………………q.s.

E) Warfarin Sodium Tablet USP 4mg
Each uncoated tablet contains:
Warfarin Sodium USP …….4mg
Excipients…………………………q.s.

F) Warfarin Sodium Tablet USP 5mg
Each uncoated tablet contains:
Warfarin Sodium USP …….5mg
Excipients…………………………q.s.


G) Warfarin Sodium Tablet USP 6mg
Each uncoated tablet contains:
Warfarin Sodium USP …….6mg
Excipients…………………………q.s.

H) Warfarin Sodium Tablet USP 7.5mg
Each uncoated tablet contains:
Warfarin Sodium USP …….7.5mg
Excipients…………………………q.s.

I) Warfarin Sodium Tablet USP 10mg
Each uncoated tablet contains:
Warfarin Sodium USP …….10mg
Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Warfarin is also used to treat or prevent venous thrombosis (swelling and blood clot in a vein) and pulmonary embolism (a blood clot in the lung).
Warfarin is in a class of medications called anticoagulants ('blood thinners'). It works by decreasing the clotting ability of the blood.
There are most common indications for warfarin therapy are; atrial fibrillation (AF), venous thromboembolism (VTE), and prosthetic heart valves. Atrial fibrillation is probably the most common indication for warfarin therapy in our community.

CAUTION & WARNING:

CAUTION: Dispense in a tight, light-resistance container as defined in the USP, with a child-resistance closer.
Swallow whole do not chew or crush.
RESEAL CAP TIGHTLY
HIGHLY POTENT ANTICOAGULANT
Dispense with medication guide.
For use under medical supervision only.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
WARNING: Serious bleeding results from overdose. Do not use or dispense before reading directions and warning in accompanying product information.

STORAGE & DOSAGE:

Storage: Store at 25°C. Store in cool, dry & dark place. Protect from light.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Dosage: As directed by the Physician.
Note: DO NOT EXCEED THE STATED DOSE

Warfarin Sodium Tablet USP 5mg Technical Specification:

Product Name:
Warfarin Sodium Tablet USP 5mg
Brand Name:Rifataj
Strength:1mg, 2mg, 2.5mg, 3mg, 4mg, 5mg, 6mg, 7.5mg, 10mg
Dosage Form:Uncoated Tablets
Route of Administration:Via oral Route
Packing:10s, 30s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-coagulant (Highley potent)
Indication: Warfarin is also used to treat or prevent venous thrombosis and pulmonary embolism. Warfarin is in a class of medications called anticoagulant medication (‘blood thinners’). It works by decreasing the clotting ability of the blood
Storage:Store at 25°C. Store in cool, dry & dark place. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Warfarin Sodium Tablet USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Warfarin Sodium Tablet USP 5mg
    Each uncoated tablet contains:
    Warfarin Sodium USP …….5mg
    Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

Warfarin is also used to treat or prevent venous thrombosis (swelling and blood clot in a vein) and pulmonary embolism (a blood clot in the lung).

Warfarin is in a class of medications called anticoagulants (‘blood thinners’). It works by decreasing the clotting ability of the blood.

There are most common indications for warfarin therapy are; atrial fibrillation (AF), venous thromboembolism (VTE), and prosthetic heart valves. Atrial fibrillation is probably the most common indication for warfarin therapy in our community.

CAUTION & WARNING:

CAUTION: Dispense in a tight, light-resistance container as defined in the USP, with a child-resistance closer.

Swallow whole do not chew or crush.

RESEAL CAP TIGHTLY
HIGHLY POTENT ANTICOAGULANT

Dispense with medication guide.
For use under medical supervision only.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Warning: Serious bleeding results from overdose. Do not use or dispense before reading directions and warning in accompanying product information.

STORAGE & DOSAGE:

Storage:  Store at 25°C. Store in cool, dry & dark place. Protect from light.

Keep medicine out of reach of children.

Dosage:  As directed by the Physician.

Note: DO NOT EXCEED THE STATED DOSE