GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Warfarin Sodium Tablet IP 1mg (Rifataj)
B) Warfarin Sodium Tablet IP 2mg (Rifataj)
C) Warfarin Sodium Tablet IP 3mg (Rifataj)
D) Warfarin Sodium Tablet IP 5mg (Rifataj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Warfarin Sodium Tablet IP 1mg
Each uncoated tablet contains:
Warfarin Sodium Clathrate IP
Eq. to Warfarin Sodium (anhydrous) …….1mg
Excipients…………………………………………………q.s.

B) Warfarin Sodium Tablet IP 2mg
Each uncoated tablet contains:
Warfarin Sodium Clathrate IP
Eq. to Warfarin Sodium (anhydrous) …….2mg
Excipients…………………………………………………q.s.

C) Warfarin Sodium Tablet IP 3mg
Each uncoated tablet contains:
Warfarin Sodium Clathrate IP
Eq. to Warfarin Sodium (anhydrous) …….3mg
Excipients…………………………………………………q.s.

D) Warfarin Sodium Tablet IP 5mg
Each uncoated tablet contains:
Warfarin Sodium Clathrate IP
Eq. to Warfarin Sodium (anhydrous) …….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 & SCHEDULE:

CAUTION: Dispense in a tight, light-resistance container as defined in the USP, with a child-resistance closer.
HIGHLY POTENT ANTICOAGULANT
Serious bleeding result from overdose
Do not use or dispense before reading direction and warning in package insert.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 25°C. Store in cool & dry. Protect from light.
KEEP OUT OF REACH AND SIGHT OF CHILDREN.
Dosage: As directed by the Physician.

Warfarin Sodium Tablets IP 5mg Technical Specification

Product Name:                       Warfarin Sodium Tablets IP 5mg
Brand Name:Rifataj
Strength:1mg, 2mg, 3mg, 5mg
Dosage Form:Uncoated Tablets
Route of Administration:Via oral Route
Packing:30s, 100s
Pack Insert/Leaflet:PIL (Patient Information Leaflet)
Regulatory Documents:COA, MOA, Product Permission, Stability Studies, GMP
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 anticoagulants (‘blood thinners’). It works by decreasing the clotting ability of the blood
Storage:Store at 25°C. Store in cool & dry. Protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT: 

  • Warfarin Sodium Tablet IP 1mg (Rifataj)
  • Warfarin Sodium Tablet IP 2mg (Rifataj)
  • Warfarin Sodium Tablet IP 3mg (Rifataj)
  • Warfarin Sodium Tablet IP 5mg (Rifataj)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Warfarin Sodium Tablet IP 1mg
    Each uncoated tablet contains:
    Warfarin Sodium Clathrate IP
    Eq. to Warfarin Sodium (anhydrous) …….1mg
    Excipients…………………………………………………q.s.
  • Warfarin Sodium Tablet IP 2mg
    Each uncoated tablet contains:
    Warfarin Sodium Clathrate IP
    Eq. to Warfarin Sodium (anhydrous) …….2mg
    Excipients…………………………………………………q.s.
  • Warfarin Sodium Tablet IP 3mg
    Each uncoated tablet contains:
    Warfarin Sodium Clathrate IP
    Eq. to Warfarin Sodium (anhydrous) …….3mg
    Excipients…………………………………………………q.s. 
  • Warfarin Sodium Tablet IP 5mg
    Each uncoated tablet contains:

    Warfarin Sodium Clathrate IP
    Eq. to Warfarin Sodium (anhydrous) …….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 & SCHEDULE:

CAUTION: Dispense in a tight, light-resistance container as defined in the USP, with a child-resistance closer.
HIGHLY POTENT ANTICOAGULANT
Serious bleeding result from overdose
Do not use or dispense before reading direction and warning in package insert.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG-Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 25°C. Store in cool & dry. Protect from light.
Keep out of reach AND SIGHT of children.
Dosage: As directed by the Physician.