📋 Indications & Clinical Dosage
*Anovulation infertility in women with proven hypopituitarism or not responded to clomifene:*
BY SC INJ: Adults (female): Initially usually 75-150 IU daily. Monitor response.
*Super ovulation treatment for assisted conception (such as in vitro fertilization):
BY SC INJ: Adults: Usually 150-225 IU daily starting on day 2 or 3 of cycle usually 2 wk after starting GnRH agonist treatment. Monitor response. See literature.
*Adjunct to HCG therapy to stimulate spermatogenesis in hypogonadotropic hypogonadism:*
BY SC INJ: Adults (male):150 IU 3 times a week for a minimum of 4 months. Monitor semen samples after 4-6 months; treatment for 18 months or more may be necessary.
💊 Mode of Administration
Administer by SC. Single-dose ampoule: Dissolve the contents of one or more ampoules in 0.5-1 ml SWFI (conc. should not exceed 225 IU/0.5 ml). Multi-dose vial: Dissolve the contents of multi-dose vial with the contents of pre-filled syringe (bacteriostatic WFI). Do not shake. Use within 28 days.
⛔ Contraindications
Ovarian cysts or ovarian enlargement (not caused by polycystic ovarian syndrome), tumours of breast, tumours of hypothalamus, tumours of ovaries, tumours of pituitary, tumours of prostate, tumours of testes, tumours of uterus, vaginal bleeding of unknown cause
⚠️ Precautions & Warnings
Acute porphyrias, history of tubal disease. Exclude anatomical abnormalities. Monitor ovarian size and oestrogen response to avoid hyper-stimulation
⚠️ Adverse Reactions / Side Effects
Fever, GIdisturbances, headache, hypersensitivity reactions, injection site reactions, joint pain, ovarian hyper-stimulation, varicocele, acne, gynaecomastia, increased risk of miscarriage, increased risk of multiple pregnancy, weight gain. Rare: Exacerbation or aggravation of asthma, thromboembolism
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Contraindicated in pregnancy.
Lactation / Breastfeeding:
Contraindicated, avoid
🧪 Compatibility & Storage Stability
Stability & Storage: Store powder refrigerated or at room temperature, 2C-25C (36F-77F). Protect from light.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.