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Luprodex 22.5mg - Leuprolide Acetate Injection

Luprodex 22.5mg is a long-acting depot formulation of Leuprolide Acetate used in hormone-dependent conditions such as prostate cancer, endometriosis, and uterine fibroids. A single dose provides 6 months of sustained hormone suppression, enhancing patient compliance.

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General Information:
Generic Name: Leuprolide Acetate
Brand Name: Luprodex 22.5mg
Packing: Single-dose vial + sterile diluent
Strength: 22.5 mg
Manufacturer: Bharat Serums and Vaccines Ltd.
Form: Injectable (Depot/Long-acting Injection)
Category: GnRH Agonist / Hormonal Therapy / Antineoplastic Agent
Product Introduction:
Luprodex 22.5mg is a Gonadotropin-Releasing Hormone (GnRH) agonist used to suppress sex hormones (testosterone and estrogen) in patients with hormone-responsive conditions. It offers extended control with biannual dosing, making it suitable for long-term therapeutic management. The drug is administered intramuscularly under medical supervision.

Uses:
Luprodex 22.5mg is indicated for:
  1. Advanced Prostate Cancer – to lower testosterone levels
  2. Endometriosis – to reduce estrogen and control symptoms
  3. Uterine Fibroids – to shrink fibroids pre-surgery or manage bleeding
  4. Central Precocious Puberty (CPP) – to delay early puberty in children
  5. Hormone-responsive Breast Cancer (in premenopausal women – off-label use)
  6. In Vitro Fertilization (IVF) – as part of ovarian suppression in fertility protocols

Storage Instructions:
  1. Store below 25°C (77°F)
  2. Protect from light and moisture
  3. Do not freeze
  4. Reconstituted solution should be used immediately
  5. Keep out of reach of children

How It Works (Mechanism of Action):
Leuprolide Acetate acts by mimicking GnRH. Initially, it stimulates the release of LH and FSH, causing a temporary spike in sex hormones. Continuous administration results in downregulation of pituitary GnRH receptors, leading to a sharp decline in LH and FSH, which ultimately reduces estrogen or testosterone production, halting the growth of hormone-dependent tumors or tissues.

Side Effects:
Common side effects include:
  1. Hot flashes
  2. Headache
  3. Tiredness
  4. Mood swings
  5. Decreased libido
  6. Sweating
  7. Vaginal dryness (in women)
  8. Injection site reactions (pain, swelling)
Serious side effects include:
  1. Osteoporosis (bone thinning)
  2. Depression or anxiety
  3. Increased blood sugar (risk of diabetes)
  4. Prolonged QT interval (heart rhythm issues)
  5. Tumor flare (temporary worsening of symptoms at start)
  6. Severe allergic reactions (rash, difficulty breathing, facial swelling)

Dosage (Typical Recommended Dose):
  1. 22.5 mg intramuscular injection administered once every 6 months (24 weeks)
  2. Dosage schedule may vary depending on indication and patient response
  3. Administered under medical supervision only

Method of Administration:
  1. Deep intramuscular (IM) injection into the gluteal muscle
  2. Requires reconstitution with provided sterile diluent before administration
  3. Must be given by a qualified healthcare professional
  4. Do not self-administer

Precautions:
  1. Not to be used in pregnancy or breastfeeding
  2. Use non-hormonal contraception during treatment
  3. Monitor for mood changes, bone density loss, and blood glucose levels
  4. Use with caution in patients with cardiovascular disorders, psychiatric illness, or osteoporosis
  5. Initial tumor flare is possible in prostate cancer – may need additional medications initially

Drug Interactions:
Luprodex 22.5mg may interact with:
  1. QT-prolonging medications (e.g., certain antibiotics, antidepressants, antiarrhythmics)
  2. Diabetes medications – may alter blood sugar control
  3. Corticosteroids – can increase bone loss
  4. Other hormone therapies or anti-cancer drugs
  5. Always inform your healthcare provider of all medications, herbs, and supplements being taken

Allergies:
  1. Contraindicated in patients allergic to Leuprolide Acetate, GnRH agonists, or any excipients in the formulation
  2. Watch for signs of anaphylaxis, rash, itching, or swelling immediately after injection

Overdose Information:
  1. Overdose is rare with depot formulations
  2. Symptoms may include prolonged hormone suppression, fatigue, or mood changes
  3. No specific antidote available – supportive medical care is essential
  4. In case of suspected overdose, seek immediate medical help

Missed Dose Instructions:
  1. If a scheduled dose is missed, consult your doctor as soon as possible
  2. Hormone levels may rebound if the dose is delayed
  3. Do not take two doses to make up for a missed one
  4. Do not self-medicate or change the dosing schedule

Additional Notes:
  1. Patients may require calcium and vitamin D supplements to support bone health
  2. Regular monitoring of PSA (for prostate cancer) or hormone levels is recommended
  3. May carry a medical alert card indicating use of GnRH therapy
  4. Inform all treating physicians and dentists about this treatment before procedures
  5. Periodic DEXA scans (bone density tests) may be advised in long-term therapy

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