📋 Indications & Clinical Dosage
*Hyper-sexuality in males, Sexual deviation in males:*
Adult: 50 mg twice daily, to be taken after food.
*Prevention of tumour flare with initial gonadorelin analogue therapy:*
Adult (male): 200 mg daily in 2-3 divided doses for 5-7 days before initiation of gonadorelin analogue, followed by 200 mg daily in 2-3 divided doses for 3-4 weeks after initiation of gonadorelin analogue; max. 300 mg per day.
*Long-term palliative therapy where gonadorelin analogues or orchidectomy contraindicated, not tolerated, or where oral therapy preferred:*
Adult (male): 200-300 mg daily in 2-3 divided doses.
*Hot flushes with gonadorelin analogue therapy or after Orchidectomy:*
Adult (male): Initially 50 mg daily, then adjusted according to response to 50-150 mg daily in1-3 divided doses.
Children: Not applicable.
⛔ Contraindications
Dubin-Johnson syndrome, history of thromboembolic disorders, liver-disease, malignant diseases, previous or existing liver tumours, Rotor syndrome, severe depression, severe diabetes (with vascular changes), sickle-cell anaemia, wasting diseases, meningioma or history of meningioma
⚠️ Precautions & Warnings
Diabetes mellitus, liver disease. Check haemoglobin levels and spermatogenesis. Ensure consent of patient to treatment. See literature.
🔄 Drug Interactions
Insulin and antidiabetic requirements may change.
⚠️ Adverse Reactions / Side Effects
Breathlessness, changes in hair
Pattern, fatigue, gynaecomastia (rarely leading to galactorrhoea and benign breast nodules),hepatic failure, hepatitis, hepatotoxicity, inhibition of spermatogenesis, jaundice, lassitude, risk of recurrence of thromboembolic disease. Rare: Hypersensitivity reactions, osteoporosis, rash
📚 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.