📋 Indications & Clinical Dosage
*Female infertility due to oligomenorrhoea, Secondary amenorrhea (associated with polycystic ovarian disease):*
Adults (female):1 tab daily for 5 consecutive days, started within 5 days of menstruation (preferably 2nd day) or at any time (normally preceded by a progestogen induced withdrawal bleed) if cycles have ceased. Second course of 100 mg daily for 5 days, may be given in the absence of ovulation. Most patients respond to first course; max 3 courses.
*Male infertility:*
Adults (male):25 mg/day for 25 days with 5 days rest, or 100 mg every Monday, Wednesday, Friday.
Children: Not applicable.
⛔ Contraindications
Abnormal uterine bleeding of undetermined cause, hormone-dependent tumours, ovarian cysts, severe liver disease, endometrial carcinoma, uncontrolled thyroid or adrenal dysfunction in the presence of an organic intracranial lesion such as pituitary tumour
⚠️ Precautions & Warnings
Ectopic pregnancy, incidence of multiple births increased (consider ultrasound monitoring), ovarian hyperstimulation syndrome, polycystic ovary syndrome (cysts may enlarge during treatment, also risk ofexaggerated response to usual doses), uterine fibroids. Exclude pregnancy before treatment. Patients sensitive to pituitary gonadotrophins (e.g. polycystic ovary disease), multiple pregnancies, blurring or other visual symptoms can occur, ovarian hyper-stimulation syndrome and abdominal pain.
🔄 Drug Interactions
Danazol, oestradiol.
⚠️ Adverse Reactions / Side Effects
Abdominal discomfort, breast tenderness,
Convulsions, depression, dizziness, endometriosis, hair loss, headache, hot flushes, insomnia, inter-menstrual spotting, menorrhagia, nausea, ovarian hyper-stimulation (withdraw), rashes, visual disturbances (withdraw and initiate ophthalmological examination), vomiting, weight gain
🤰 Pregnancy & Lactation Safety
Pregnancy Risk:
Possible effects on fetal development.
Lactation / Breastfeeding:
May inhibit lactation.
📚 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.