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Leuren – Leuprolide Acetate

A single monthly injection of 3.75 mg or 11.25 mg 3 monthly results in an initial stimulation followed by a prolonged suppression of pituitary gonadotropins

COMPOSITION:
Each combi pack contains:
(I)  Leuprolide Acetate for Injection (Depot) 3.75 mg /11.25 mg
Each vial contains: Leuprolide Acetate ……………………… 3.75 mg or 11.25 mg
(II) Diluent for Leuprolide Acetate for Injection (Depot), 2 ml

DOSAGE FORM:
Depot Injection

LEUPROLIDE DEPOT-3 Month 11.25 mg is available as a single dose vial containing sterile microspheres which, when mixed with diluent, become a suspension intended as an intramuscular/subcutaneous injection to be given ONCE EVERY THREE MONTHS.

Indications:
Endometriosis
Uterine leiomyomata (Fibroids)

Dose:

Endometriosis:
3.75 mg SC/IM once per 4 weeks

Uterine leiomyoma: 3.75 mg SC/IM during 1st – 5th day after menstruation starts

For Pituitary down regulation
Patients were prospectively randomized to receive 3.75 mg depot formulations of leuprolide on days 21–23 of the menstrual cycle

Stimulation with gonadotropins was initiated after pituitary desensitization was achieved

For 11.25 mg: The recommended duration of treatment with LEUPROLIDE DEPOT-3 Month 11.25 mg alone or in combination with norethindrone acetate is six months.

How to administer

The lyophilized microspheres are to be reconstituted and administered monthly as a single subcutaneous/intramuscular injection.

In case particles are precipitated after suspension of this drug, resuspend them well by shaking the prepared injection to the extent that bubble formation does not take place, and then use it.

Since the product does not contain preservative, the suspension should be discarded if not used immediately.

Cautions while injecting Leuren Depot Injection subcutaneously

The injection region should be hypoderm of brachium, abdomen or hip.

Do not inject this drug into the same region repeatedly. Injection site should be changed periodically.

Make sure that the injection needle does not enter any blood vessel.

Instruct the patient not to rub the injection region.