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Bdrelin (3.75mg / 11.25mg) - Triptorelin Acetate for Injection

Bdrelin is a long-acting gonadotropin-releasing hormone (GnRH) agonist injection used to treat advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty. It works by lowering the levels of sex hormones in the body.

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General Information:
Generic Name: Triptorelin Acetate
Brand Name: Bdrelin
Strengths Available: 3.75mg (1-month depot), 11.25mg (3-month depot)
Packing: Single-use vial with sterile diluent
Manufacturer: Bdr Pharmaceuticals Internationals Pvt Ltd
Form: Lyophilized powder for intramuscular injection
Category: Anti-cancer / Hormonal therapy / GnRH agonist
Product Introduction:
Bdrelin contains Triptorelin Acetate, a synthetic decapeptide analog of natural GnRH. It is used for hormonal suppression therapy in hormone-dependent conditions and is administered as an intramuscular injection in depot form for sustained release.

Uses:
Bdrelin is indicated for the treatment of:
  1. Advanced or metastatic prostate cancer
  2. Central precocious puberty (CPP)
  3. Endometriosis
  4. Uterine fibroids (pre-surgical shrinkage)
  5. Assisted reproductive technology (ART) protocols
  6. Hormone-sensitive breast cancer (off-label)

Storage Instructions:
  1. Store at 2°C–8°C (refrigerated)
  2. Protect from light
  3. Do not freeze
  4. Use immediately after reconstitution
  5. Keep out of reach of children

How It Works (Mechanism of Action):
Triptorelin initially stimulates the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), causing a temporary increase in sex hormones (testosterone or estrogen). Continued use leads to downregulation of GnRH receptors, resulting in suppressed production of testosterone in men and estrogen in women, thereby slowing hormone-sensitive tumor growth or disease progression.

Side Effects:
Common side effects:
  1. Hot flashes
  2. Injection site pain
  3. Headache
  4. Fatigue
  5. Muscle and joint pain
Serious side effects:
  1. Bone thinning (osteoporosis)
  2. Mood changes or depression
  3. Cardiovascular risks (especially in prostate cancer patients)
  4. Tumor flare (temporary worsening of symptoms in initial weeks)
  5. Decreased libido and erectile dysfunction (in men)

Dosage (Typical Recommended Dose):
  1. 3.75mg injection: Administered once every 4 weeks
  2. 11.25mg injection: Administered once every 12 weeks
  3. Dosage may vary depending on indication and patient-specific factors

Method of Administration:
  1. Intramuscular (IM) injection only
  2. Should be administered by a healthcare professional
  3. Reconstitute lyophilized powder with sterile diluent provided before injection
  4. Inject deep into the gluteal muscle

Precautions:
  1. Monitor bone mineral density with prolonged use
  2. Use with caution in patients with cardiovascular disease, diabetes, or depression
  3. Not recommended for use in pregnant or breastfeeding women
  4. Patients should be informed about initial symptom flare (especially in prostate cancer)
  5. Consider calcium and vitamin D supplementation

Drug Interactions: 
  1. May interfere with drugs affecting pituitary hormone secretion
  2. Can alter effects of hormone replacement therapy (HRT)
  3. Caution with QT-prolonging drugs

Allergies:
  1. Contraindicated in patients with hypersensitivity to Triptorelin, GnRH, or any excipients
  2. Symptoms may include rash, itching, swelling, or difficulty breathing

Overdose Information:
  1. Overdose is unlikely due to depot formulation
  2. If accidentally administered in excess, monitor for hormonal suppression symptoms
  3. Provide supportive care as needed

Missed Dose Instructions:
  1. Administer the missed dose as soon as possible
  2. Do not double dose
  3. Maintain scheduled dosing intervals (monthly or quarterly) as recommended by the physician

  


Additional Notes:
  1. Regular monitoring of hormone levels and disease progression is necessary
  2. Inform patients about possible menstrual irregularities or amenorrhea
  3. Therapy may lead to temporary worsening of symptoms before improvement
  4. Long-term therapy in children should include growth monitoring

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