Composition
Inj: Hydroxyprogesterone caproate 250 mg in 1 ml oily solution.
Indications & Dosage
Habitual abortion: BY IM INJ: Adult (female):250-500 mg at weekly intervals. Imminent abortion: BY IM INJ: Adult (female): 500 mg 2-3 times wkly until bleeding ceases. Treatment must be continued with 250 mg twice wkly for several weeks. Infertility due to corpus-luteum insufficiency: BY IM INJ: Adult (female): 250 mg about 3 days after rise in basal body temp. Children: Not recommended.
Administration
After preparing the skin, inject IM in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over 1 min or longer) is recom-mended. Apply pressure to the injection site to minimize bruising and swelling. Discard any unused product 5 weeks after 1st use. For restitution, draw up 1 ml of drug into a 3 ml syringe with an 18-gauge needle. Change the needle to a 21st-gauge 1 1/2 inch needle.
Stability
Store at 15C-30C (59F-86F). Use within 5 weeks after first use Protect vial from light and store upright in its box.
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
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.
Interactions
Rifamycin, anticoagulants, antidepressants, antidiabetics, anti-epileptics, antifungals, antivirals, aprepitant, barbiturates, bosentan, cyclosporin, diuretics, dopaminergics, lipid-regulating drugs, muscle relaxants.
Side Effects
Liver disturbances, virilization, irregular, prolonged or heavy vaginal bleeding during first 2 or 3 cycles, menstrual disturbances, premenstrual-like syndrome (including bloating, fluid retention, breast tenderness), weight change, nausea, headache, dizziness, insomnia, drowsiness, depression, change in libido; also skin re-actions (including urticaria, pruritus, rash, and acne), hirsutism and alopecia, jaundice, fatigue, emotional liability, abdominal pain/distension, musculoskeletal pain and anaphylactoid reactions have also been reported.