Description:
Luprodex 11.25 mg is a depot (long‑acting) formulation of leuprolide acetate, a gonadotropin‑releasing hormone (GnRH) agonist. It is used to suppress hormone production (LH and FSH) after an initial stimulatory phase, resulting in reduced sex hormone levels (testosterone in men; estrogen/progesterone in women). Indications include hormone‑dependent conditions such as prostate cancer, endometriosis, uterine fibroids, and central precocious puberty.

Prescription:

• Prescription‑only medicine

 Therapeutic Category:

• Hormonal therapy

• GnRH agonist

• Endocrine / Oncologic therapy (depending on indication)

Active Ingredients / Composition:

• Active ingredient: Leuprolide Acetate (also called Leuprorelin Acetate) 11.25 mg per vial.

• Usually comes as dry powder (lyophilized) in a vial, to be reconstituted with a diluent before injection.

 Variant:

• The 11.25 mg is a “mid‑range” depot variant for monthly or 3‑month dosing depending on clinical protocol.

• Other variants include 3.75 mg (monthly), 22.5 mg (3‑monthly), etc. (Different depot strengths.)

Consume Type (Route of Administration):

• Injectable via intramuscular (IM) injection (or sometimes deep subcutaneous depending on protocol), given as a depot formulation. Not oral.

Directions / Usage:

• Typically given once every 4 weeks (once a month) for many indications.

• For some conditions (e.g. certain cancers, fibroids) duration may be months or even longer, depending on response.

• Administered by a health professional in a clinic or hospital setting.

 Common Side Effects:
Side effects known for leuprolide depot therapy include:

• Hot flashes, night sweats

• Fatigue

• Injection‑site reactions (pain, swelling) (common in depot injections)

• Mood changes, depression or mood swings

• Headache, dizziness

• Decreased libido, possible impotence (in men)

• Menstrual changes, amenorrhea (in women)

• Bone density loss / risk of osteoporosis with prolonged use

 Package Type:

• Supplied as a vial of powder for injection (dry vial) plus a diluent (ampoule) for reconstitution. Usually “1 vial in 1 vial pack” or “1 injection per vial” format.

• Pack of 2 mL vial is common in listings.

 Storage Advice:

• Store in refrigerated conditions: 2‑8 °C (cold chain) is specified in some sources.

• Protect from freezing.

• Keep in original packaging till use.

• Keep out of reach of children.

Safety Advice:

• Must be administered by trained healthcare professional.

• Do not use if hypersensitive/allergic to leuprolide or any excipients.

• Use with caution in patients with severe cardiovascular disease, depression, bone disorders.

• Since hormone suppression can reduce estrogen/testosterone, there is risk of bone mineral density loss, so monitoring (bone density, calcium/Vitamin D) may be required.

• In women, avoid pregnancy during treatment; in men, also avoid exposure of pregnant women to the drug if handling.

• Long‑term therapy risks: impact on lipid profile, metabolic changes.

 Product Substitutes:

• Other brands or generics of leuprolide acetate depot 11.25 mg. Examples include Lupron Depot 11.25 mg, Prostap 11.25 mg, etc. Generic equivalents manufactured by various pharma companies.

Manufacturer / Marketer:

• Bharat Serums & Vaccines Ltd.

 Country of Origin:

• India.