Bisoprolol Fumarate Tablets USP 5mg Technical Specification:

Product Name:Bisoprolol Fumarate Tablets USP 5mg
Brand Name:Generics
Strength:10mg, 5mg, 2.5mg, 1.5mg
Dosage Form:Tablets (Film-coated)
Route Of Administration:Via Oral Route
Packing:100s, 500s, 1000s
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-hypertensive, Cardiovascular System, Diuretics.
Indication: Bisoprolol is used with or without other medications to treat high blood pressure (hypertension).
Storage:Store below 25°C.
Store in the original package in order to protect from light.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bisoprolol Fumarate Tablets USP 5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bisoprolol Fumarate Tablets USP 5mg
    Each film-coated tablet contains:
    Bisoprolol fumarate USP………….5mg
    Excipients………………………. q.s.
    Colour: Iron Oxide Black

THERAPEUTIC INDICATIONS:

Treatment of Hypertension, Treatment of stable chronic angina, Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of CHILDREN.

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

STORAGE & DOSAGE:

Storage: Store below 25°C. Preserve in tight container. Keep in a cool & dry place. Protect from Light & Moisture. Do not freeze.

Dosage:  As directed by the Physician.

Attach dispensing label as per end country.

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Bisoprolol Fumarate Tablets USP 10mg
B. Bisoprolol Fumarate Tablets USP 5mg
C. Bisoprolol Fumarate Tablets USP 2.5mg
D. Bisoprolol Fumarate Tablets USP 1.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Bisoprolol Fumarate Tablets USP 10mg
Each film-coated tablet contains:
Bisoprolol fumarate USP………….10mg
Excipients………………………. q.s.
Colour: Titanium Dioxide USP

B. Bisoprolol Fumarate Tablets USP 5mg
Each film-coated tablet contains:
Bisoprolol fumarate USP………….5mg
Excipients………………………. q.s.
Colour: Iron Oxide Black


C. Bisoprolol Fumarate Tablets USP 2.5mg
Each film-coated tablet contains:
Bisoprolol fumarate USP…………...2.5mg
Excipients……………………….…. q.s.
Colour: Iron Oxide Yellow

D. Bisoprolol Fumarate Tablets USP 1.5mg
Each film-coated tablet contains:
Bisoprolol fumarate USP…………...1.5mg
Excipients……………………….…. q.s.
Colour: Iron Oxide Yellow

THERAPEUTIC INDICATIONS:

Treatment of Hypertension, Treatment of stable chronic angina, Treatment of stable chronic heart failure with reduced systolic left ventricular function in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.

CAUTION & WARNING:

CAUTION:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C. Preserve in tight container. Keep in a cool & dry place. Protect from Light & Moisture. Do not freeze.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.