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Luprodex 11.25mg - Leuprolide Acetate Injection

Luprodex 11.25mg is a long-acting hormonal therapy injection used to manage prostate cancer, endometriosis, and other hormone-responsive conditions. It delivers controlled hormone suppression over 3 months with a single administration.

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General Information:
Generic Name: Leuprolide Acetate
Brand Name: Luprodex 11.25mg
Packing: Single-dose vial with diluent
Strength: 11.25 mg
Manufacturer: Bharat Serums and Vaccines Ltd.
Form: Injectable (Depot formulation)
Category: GnRH Agonist / Antineoplastic Agent / Hormonal Therapy
Product Introduction:
Luprodex 11.25mg contains Leuprolide Acetate, a synthetic analog of Gonadotropin-Releasing Hormone (GnRH). It is designed for extended-release over 12 weeks, offering convenience and efficacy in the management of hormone-dependent conditions. It is administered as a depot intramuscular injection by a healthcare provider.

Uses:
Luprodex 11.25mg is indicated for the treatment of:
  1. Advanced Prostate Cancer – testosterone suppression
  2. Endometriosis – controls estrogen-driven symptoms
  3. Uterine Fibroids – reduces fibroid size and symptoms
  4. Central Precocious Puberty (CPP) – delays early puberty in children
  5. Breast Cancer – in premenopausal women with hormone-positive tumors (off-label)
  6. Assisted Reproductive Technology (ART) – used in IVF cycles for hormonal regulation

Storage Instructions:
  1. Store below 25°C (77°F)
  2. Protect from direct sunlight and moisture
  3. Do not freeze
  4. Use immediately after reconstitution
  5. Keep out of reach of children

How It Works (Mechanism of Action):
Leuprolide Acetate initially stimulates the release of LH and FSH, causing a short-term rise in testosterone or estrogen levels (flare effect). With continuous use, it downregulates GnRH receptors, reducing LH and FSH secretion, which leads to a reduction in sex hormone levels, halting the progression of hormone-sensitive diseases.

Side Effects:
Common side effects:
  1. Hot flashes
  2. Sweating
  3. Headache
  4. Fatigue
  5. Mood changes
  6. Injection site pain
  7. Decreased libido
Serious side effects:
  1. Osteoporosis or bone thinning
  2. Depression or emotional changes
  3. Blood sugar elevation or new-onset diabetes
  4. Irregular heart rhythm (QT prolongation)
  5. Tumor flare during initial treatment phase
  6. Severe allergic reactions (e.g., anaphylaxis, angioedema)

Dosage (Typical Recommended Dose):
  1. One 11.25 mg injection administered once every 3 months (12 weeks)
  2. Dosage frequency and duration depend on the disease being treated
  3. To be administered by a qualified medical professional

Method of Administration:
  1. Given via deep intramuscular injection (usually gluteal muscle)
  2. Requires reconstitution with provided sterile diluent prior to administration
  3. Only to be given under medical supervision
  4. Injection sites should be rotated for repeated doses

Precautions:
  1. Contraindicated in pregnancy and lactation
  2. Use non-hormonal contraception during treatment
  3. Monitor for bone density loss, especially in long-term therapy
  4. Be cautious in patients with heart conditions, psychiatric history, or diabetes
  5. May worsen symptoms initially due to hormonal surge (tumor flare)

Drug Interactions:
Luprodex 11.25mg may interact with:
  1. Medications that prolong QT interval (e.g., amiodarone, fluoroquinolones)
  2. Diabetes medications (can affect blood sugar levels)
  3. Corticosteroids (may exacerbate bone loss)
  4. Other hormone therapies
    Always inform your doctor about all medications and supplements you are using.

Allergies:
  1. Do not use if allergic to Leuprolide, GnRH agonists, or any component of the injection
  2. Signs of an allergic reaction may include rash, itching, swelling, dizziness, or difficulty breathing

Overdose Information:
  1. Overdose is rare and usually due to misadministration
  2. Symptoms may include excess hormonal suppression, mood changes, or fatigue
  3. No specific antidote; supportive treatment is recommended
  4. Seek immediate medical help if overdose is suspected

Missed Dose Instructions:
  1. Contact your doctor immediately if a dose is missed
  2. Timely dosing is crucial for effective hormone suppression
  3. Do not self-administer or adjust the schedule without medical advice

Additional Notes:
  1. Bone health should be monitored with DEXA scans during long-term therapy
  2. Consider calcium and vitamin D supplementation
  3. Regular PSA (for prostate cancer) or hormonal level tests are advised
  4. Patients may carry a medical alert card indicating treatment with Luprodex
  5. Inform the healthcare provider of any planned surgeries or major procedures

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