GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Terazosin Capsules USP 2mg
C. Terazosin Capsules USP 5mg
D. Terazosin Capsules USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each hard gelatin capsule contains:
Terazosin Hydrochloride USP
Equivalent to Terazosin………………1mg
Excipients…………………………………… q.s
Approved Colours are used in capsule shells.
B. Terazosin Capsules USP 2mg
Each hard gelatin capsule contains:
Terazosin Hydrochloride USP
Equivalent to Terazosin……………………2mg
Excipients…………………………………………q.s
Approved Colours are used in capsule shells.
C. Terazosin Capsules USP 5mg
Each hard gelatin capsule contains:
Terazosin Hydrochloride USP
Equivalent to Terazosin…………………5mg
Excipients……………………………………….q.s
Approved Colours are used in capsule shells.
D. Terazosin Capsules USP 10mg
Each hard gelatin capsule contains:
Terazosin Hydrochloride USP
Equivalent to Terazosin…………………10mg
Excipients……………………………………….q.s
Approved Colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.
Keep the container tightly closed.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Terazosin Capsules USP 2mg Technical Specification:
| Product Name: | Terazosin Capsules USP |
| Brand Name: | Generic |
| Strength: | (1mg), (2mg), (5mg), (10mg) |
| Dosage Form: | Capsules (Hard gelatin) |
| 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: | Andrology |
| Indication: | Terazosin helps to lower blood pressure by relaxing blood vessels so that blood passes through them more easily. Terazosin is also used to treat benign enlargement of the prostate (benign prostatic hyperplasia [BPH]). Benign enlargement of the prostate is a problem that can occur in men as they get older. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Terazosin Capsules USP 1mg
2. Terazosin Capsules USP 2mg
3. Terazosin Capsules USP 5mg
4. Terazosin Capsules USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Terazosin Capsules USP 1mg
Each hard gelatin capsule contains:
Terazosin Hydrochloride USP
Equivalent to Terazosin…………………….1mg
Excipients…………………………………………q.s
Approved Colours are used in capsule shells.
2. Terazosin Capsules USP 2mg
Each hard gelatin capsule contains:
Terazosin Hydrochloride USP
Equivalent to Terazosin…………………….2mg
Excipients…………………………………………q.s
Approved Colours are used in capsule shells.
3. Terazosin Capsules USP 5mg
Each hard gelatin capsule contains:
Terazosin Hydrochloride USP
Equivalent to Terazosin…………………….5mg
Excipients…………………………………………q.s
Approved Colours are used in capsule shells.
4. Terazosin Capsules USP 10mg
Each hard gelatin capsule contains:
Terazosin Hydrochloride USP
Equivalent to Terazosin…………………….10mg
Excipients…………………………………………q.s
Approved Colours are used in capsule shells.
THERAPEUTIC INDICATIONS:
Terazosin helps to lower blood pressure by relaxing blood vessels so that blood passes through them more easily. Terazosin is also used to treat benign enlargement of the prostate (benign prostatic hyperplasia [BPH]). Benign enlargement of the prostate is a problem that can occur in men as they get older.
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, light-resistant container as defined in the USP with a child-resistant closure.
keep the container tightly closed.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
