Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg+12.5mg Technical Specification:

Product Name:Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg+12.5mg
Brand Name:Generic
Strength:(2.5mg+6.25mg), (5mg+6.25mg), (5mg+12.5mg), (10mg+6.25mg)
Dosage Form:Tablets (film-coated)
Route of Administration:Via Oral Route
Packing:10s, 30s, 100s, 500s
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Antihypertensive
Indication: Bisoprolol Fumarate and Hydrochlorothiazide is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1 selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide).
Storage:Store at 20°C to 25°C (68°F to 77°F). Store in dry place protected from light and moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg+12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg+12.5mg
    Each film-coated tablet contains:
    Bisoprolol Fumarate USP………………….5mg
    Hydrochlorothiazide USP………………….12.5mg
    Excipients……………………..………………… q.s
    Colour: Sunset yellow

THERAPEUTIC INDICATIONS:

Bisoprolol Fumarate and Hydrochlorothiazide is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1 selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT CONTAINER.
TAKE THIS PREPARATION IN THE MORNING WITH OR WITHOUT FOOD.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.

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

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 2.5mg+6.25mg
2. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg+6.25mg
3. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg+12.5mg
4. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 10mg+6.25mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 2.5mg+6.25mg
Each film-coated tablet contains:
Bisoprolol Fumarate USP………………….2.5mg
Hydrochlorothiazide USP………………….6.25mg
Excipients……………………..………………… q.s
Colour: Ferric oxide red

2. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg+6.25mg
Each film-coated tablet contains:
Bisoprolol Fumarate USP………………….5mg
Hydrochlorothiazide USP………………….6.25mg
Excipients……………………..………………… q.s
Colour: Ferric oxide yellow

3. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 5mg+12.5mg
Each film-coated tablet contains:
Bisoprolol Fumarate USP………………….5mg
Hydrochlorothiazide USP………………….12.5mg
Excipients……………………..………………… q.s
Colour: Sunset yellow


4. Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP 10mg+6.25mg
Each film-coated tablet contains:
Bisoprolol Fumarate USP………………….10mg
Hydrochlorothiazide USP………………….6.25mg
Excipients……………………..………………… q.s
Colour: Sunset yellow lake

THERAPEUTIC INDICATIONS:

Bisoprolol Fumarate and Hydrochlorothiazide is indicated for the treatment of hypertension. It combines two antihypertensive agents in a once-daily dosage: a synthetic beta1 selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide).

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT CONTAINER.
TAKE THIS PREPARATION IN THE MORNING WITH OR WITHOUT FOOD.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20°C to 25°C (68°F to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.