📋 Indications & Clinical Dosage
*Habitual abortion:*
Adults (female): 400 mg vaginally or rectally twice daily for three months.
BY IM INJ: See product literature.
*Threatened abortion:*
Adults (female): Starting dose 800 mg rectally, followed by 400 mg every 12 hr, till bleeding stops.
BY IM INJ: See product literature.
*Pre-menstrual syndrome:*
Adults (female): Start on day 14 of cycle with 200 mg daily to 400 mg twice daily, vaginally or rectally continue until menstruation. If symptoms present at ovulation, start by day 12.
BY IM INJ: See product literature.
*Post-natal depression:*
Adults (female): 200 mg daily to 400 mg twice daily rectally continue until menstruation.
BY IM INJ: See product literature.
*Luteal phase support:*
Adults (female): 400 mg twice daily, vaginally or rectally. BY IM INJ: See product literature.
*Premenstrual Syndrome, Prevention of en-dometrial hyperplasia:*
ORAL: Adult (female): 200 mg cap single dose daily every evening for 12 days sequentially per 28-days cycle for women having intact uterus and receiving, daily conjugated oestrogen tab.
*Amenorrhea:*
ORAL: Adult (female):400 mg cap every evening for 10 days.
⛔ Contraindications
Severe arterial disease, undiagnosed vaginal bleeding and acute porphyria, history during pregnancy of idiopathic jaundice, severe pruritus, or pemphigoid gestations, incomplete miscarriage, missed miscarriage. Avoid in hepatic impairment. Avoid in active liver disease including disorders of hepaticexcretion (e.g. Dublin-Johnson or Rotor Syndromes),infective hepatitis (until liver function returns to normal) and liver tumours and lactation
⚠️ Precautions & Warnings
Renal impairment, conditions that may worsen with fluid retention, epilepsy, hypertension, migraine, asthma, or cardiac dysfunction, susceptible to thromboembolism (particular caution with high dose, history of depression. Progestogens can decrease glucose tolerance and patients with diabetes should be monitored closely.While using as contraceptive wait 6 weeks post-partum if lactating.
🔄 Drug Interactions
Rifamycin, anticoagulants, antidepressants, anti-diabetics, anti-epileptics, antifungals, antivirals, aprepitant, barbiturates, bosentan, cyclosporin, diuretics, dopaminergics, lipid-regulating drugs, muscle relaxants.
⚠️ Adverse Reactions / Side Effects
Menstrual disturbances, premenstrual-like syndrome (including bloating, fluid retention, breast tenderness), weight change, nausea, headache, dizziness, insomnia, drowsiness, depression, change in libido; also skin reactions (including urticaria, pruritus, rash, and acne), hirsutism, alopecia, jaundice and anaphylactoid reactions
📚 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.