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Bdsure 11.25mg - Leuprolide Acetate Injection

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Bdsure 11.25mg - Leuprolide Acetate Injection

Bdsure 11.25mg is a long-acting injectable formulation of Leuprolide Acetate, a synthetic hormone used primarily in hormone-sensitive cancers such as prostate and breast cancer, as well as in gynecological disorders. It works by suppressing the body’s production of certain hormones to slow or halt disease progression.

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Description Product Details
General Information:
Generic Name: Leuprolide Acetate
Brand Name: Bdsure 11.25mg
Packing: Single-dose vial with solvent for reconstitution
Strength: 11.25 mg
Manufacturer: BDR Pharmaceuticals Intl Pvt. Ltd.
Form: Injection (Depot – long-acting)
Category: GnRH agonist / Hormonal therapy / Anti-neoplastic agent
Product Introduction:
Bdsure 11.25mg is a GnRH (Gonadotropin-Releasing Hormone) agonist administered via intramuscular or subcutaneous injection. It is designed for extended-release over 3 months, making it a convenient option for long-term hormone therapy. This medication is frequently prescribed in cases requiring suppression of sex hormones such as testosterone or estrogen.
Uses:
Bdsure 11.25mg is indicated for the treatment of:
  1. Advanced Prostate Cancer – hormone-sensitive cases
  2. Endometriosis – to suppress endometrial tissue growth
  3. Uterine Fibroids – as part of pre-surgical or medical management
  4. Central Precocious Puberty (CPP) – in children to delay early puberty
  5. Breast Cancer – hormone receptor-positive types (in premenopausal women)
  6. Assisted Reproduction – to suppress the natural hormonal cycle during IVF
Storage Instructions:
  1. Store below 25°C (77°F).
  2. Do not freeze.
  3. Protect from direct sunlight and moisture.
  4. Use immediately after reconstitution.
  5. Keep out of reach of children.
How It Works (Mechanism of Action):
Leuprolide is a GnRH agonist that initially stimulates, then suppresses the pituitary release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). This suppression leads to reduced levels of testosterone in men and estrogen in women, which helps in slowing the progression of hormone-sensitive cancers or controlling gynecological conditions.
Side Effects:
Common side effects:
  1. Hot flashes
  2. Decreased libido
  3. Fatigue
  4. Headache
  5. Sweating
  6. Injection site reactions (redness, swelling, pain)
Serious side effects:
  1. Bone density loss (osteoporosis)
  2. Mood changes, depression
  3. Irregular heartbeat or QT prolongation
  4. Blood sugar level changes (hyperglycemia or diabetes onset)
  5. Initial tumor flare in prostate cancer (temporary hormone surge)
Dosage (Typical Recommended Dose):
  1. 11.25 mg injection is typically administered once every 3 months (12 weeks) via intramuscular or subcutaneous injection, depending on the condition.
  2. The dosage schedule may vary based on the indication and patient response.
Method of Administration:
  1. Administered by a healthcare professional.
  2. Given as a deep intramuscular (IM) or subcutaneous (SC) injection.
  3. Comes with a diluent that must be reconstituted before use.
  4. Rotate injection sites to avoid irritation.
Precautions:
  1. Not recommended during pregnancy or breastfeeding – may cause fetal harm.
  2. Monitor for mood swings, bone health, and blood sugar levels during long-term use.
  3. Use with caution in patients with heart conditions, diabetes, or depression.
  4. Regular bone density scans may be advised for long-term users.
  5. May cause initial symptom flare before suppression takes effect – concurrent medications may be prescribed to manage this.
Drug Interactions:
  1. Use caution with medications that prolong QT interval (e.g., certain antiarrhythmics, antipsychotics).
  2. Steroids and antidiabetics may need adjustment due to hormone changes.
  3. Let your doctor know about all prescription and OTC medicines or supplements.
Allergies:
  1. Do not use if allergic to Leuprolide, GnRH agonists, or any component of the injection.
  2. Allergic reactions may include rash, itching/swelling, dizziness, or difficulty breathing.
Overdose Information:
  1. Overdose is rare due to physician-administered dosing.
  2. If accidentally administered in excess, monitor for hormonal imbalance symptoms or severe reactions.
  3. Supportive care is provided as needed—there’s no specific antidote.
Missed Dose Instructions:
  1. Since this is a long-acting injection administered by a healthcare provider, missing a dose should be reported to your physician immediately.
  2. Try to maintain the scheduled timing every 12 weeks.
  3. Delays in administration may lead to return of symptoms or hormonal imbalance.
Additional Notes:
  1. Bone protection strategies (e.g., calcium, vitamin D, weight-bearing exercises) may be recommended.
  2. Blood tests to check hormone levels and PSA (in prostate cancer) may be done regularly.
  3. Patients should report any signs of depression, bone pain, or cardiac symptoms.
  4. Inform your dentist and surgeon if you're receiving Leuprolide before any procedure.

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