GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Alprostadil for Injection 20mcg
B. Alprostadil for Injection 40mcg
C. Alprostadil for Injection 10mcg
D. Alprostadil for Injection 5mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Alprostadil for Injection 20mcg
a) Each vial contains:
Alprostadil USP…………………..23.2mcg
Lactose Monohydrate USP……193.8mg
Sodium citrate USP ………………53mcg
Hydrochloric Acid USP………q.s
Sodium Hydroxide USP……..q.s
b) Bacteriostatic Water for Injection USP….1ml
Benzyl Alcohol USP……0.9% w/v

B. Alprostadil for Injection 40mcg
a) Each vial contains:
Alprostadil USP…………………..46.4mcg
Lactose Monohydrate USP……193.8mg
Sodium citrate USP ……………..53mcg
Hydrochloric Acid USP………….q.s
Sodium Hydroxide USP ………..q.s
b) Bacteriostatic Water for Injection USP….1ml
Benzyl Alcohol USP……0.9% w/v

C. Alprostadil for Injection 10mcg
a) Each vial contains:
Alprostadil USP….……………….11.6mcg
Lactose Monohydrate USP……193.8mg
Sodium citrate USP ………………53mcg
Hydrochloric Acid USP…………..q.s
Sodium Hydroxide USP …………q.s
b) Bacteriostatic Water for Injection USP….1ml
Benzyl Alcohol USP……0.9% w/v


D. Alprostadil for Injection 5mcg
a) Each vial contains:
Alprostadil USP…………………..5.08mcg
Lactose Monohydrate USP……193.8mg
Sodium citrate USP……………....53mcg
Hydrochloric Acid USP………..…q.s
Sodium Hydroxide USP ………...q.s
b) Bacteriostatic Water for Injection USP….1ml
Benzyl Alcohol USP……0.9%w/v

THERAPEUTIC INDICATIONS:

Alprostadil injection is used to treat men who have erectile dysfunction (also called sexual impotence). It belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. This medicine causes an erection because it increases the blood flow to the penis.

DIRECTION OF USE:

For Intracavernosal use only.
Aseptically add 1ml diluent (bacteriostatic water for Injection USP preserved with benzyl alcohol 0.945%w/v).
Gently swirl vial until powder has gone into solution.
See accompanying prescribing information.

CAUTION & WARNING:

CAUTION: The injection should not be used if it contains visible particulate matter.
The reconstituted solution should be used within 24 hours.
Diluent to be used with product should contain benzyl alcohol as a preservative. This package does not contain diluent.
Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store between at 20°C to 25°C (68°F to 77°F).
Reconstituted solution should be stored at or below 25°C (77°F) and not refrigerated or frozen.
Keep all medicines out of reach of children.
Dosage: As directed by the Physician.

Alprostadil for Injection 10mcg Technical Specification:

Product Name:Alprostadil for Injection
Brand Name:Generic
Strength:20mcg,  40mcg,  10mcg5mcg
Dosage Form:Lyophilized Powder for Injection
Packing:Single Dose Vials + WFI Tray
Route of Administration:For Intracavernosal use only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Genito Urinary System, Vasodilator
Indication: Alprostadil injection is used to treat men who have erectile dysfunction (also called sexual impotence). It belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. This medicine causes an erection because it increases the blood flow to the penis.
Storage:Store between at 20°C to 25°C (68°F to 77°F).
Reconstituted solution should be stored at or below 25°C (77°F) and not refrigerated or frozen.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Alprostadil for Injection 10mcg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Alprostadil for Injection 10mcg
    a. Each vial contains:
    Alprostadil USP…………………..11.6mcg
    Lactose Monohydrate USP……193.8mg
    Sodium citrate USP ………………53mcg
    Hydrochloric Acid USP…………….q.s
    Sodium Hydroxide USP……………q.s
    b. Bacteriostatic Water for Injection USP….1ml
    Benzyl Alcohol USP……0.9% w/v

THERAPEUTIC INDICATIONS:

Alprostadil injection is used to treat men who have erectile dysfunction (also called sexual impotence). It belongs to a group of medicines called vasodilators that can increase blood flow by expanding blood vessels. This medicine causes an erection because it increases the blood flow to the penis.

DIRECTION OF USE:

For Intracavernosal use only.
Aseptically add 1ml diluent (bacteriostatic water for Injection USP preserved with benzyl alcohol 0.945%w/v).
Gently swirl vial until powder has gone into solution.
See accompanying prescribing information.

CAUTION & Warning:

CAUTION: The injection should not be used if it contains visible particulate matter.
The reconstituted solution should be used within 24 hours.
Diluent to be used with product should contain benzyl alcohol as a preservative.
This package does not contain diluent.

Warning: Not to be sold by retail without the prescription of a Registered Medical Practitioner.

STORAGE & DOSAGE:

Storage: Store between at 20°C to 25°C (68°F to 77°F).
Reconstituted solution should be stored at or below 25°C (77°F) and not refrigerated or frozen.
Keep all medicines out of reach of children.

Dosage: As directed by the Physician.