Hydroxyprogesterone caproate: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the local prescribing information.

Generic Medicine Info

Indications and Dosage

Intramuscular
Recurrent miscarriage

Adult: 250-500 mg wkly during the 1st half of pregnancy.

Intramuscular
Palliative treatment of advanced, inoperable endometrial carcinoma

Adult: Usual dose: ≥1 g, may repeat once or more times wkly. Usual range: 1-7 g/wk. Discontinue treatment if relapse occurs or if the objective response is not achieved after 12 wk of treatment.

Intramuscular
Abnormal uterine bleeding, Amenorrhoea

Adult: Single dose of 375 mg; may repeat at 4-wkly intervals if needed. After 4 days of desquamation, or if there is no bleeding within 21 days after admin of the drug, may initiate cyclic therapy that includes an oestrogen. For cyclic treatment (28-day cycle): Administer 20 mg of estradiol valerate on day 1, and on day 15, administer 250 mg of hydroxyprogesterone caproate and 5 mg of estradiol valerate. May repeat cyclic therapy at 4-wkly intervals as needed.

Contraindications

Undiagnosed vaginal bleeding, breast cancer, pregnancy, lactation. Thrombophlebitis, thromboembolic disorders, cerebral apoplexy or a history of these conditions. Markedly impaired liver function.

Special Precautions

Physical examination is advised prior to starting therapy. Hepatic impairment, mental depression. Monitor blood glucose in diabetic patients. Discontinue treatment upon signs of thromboembolic and thrombotic disorders. Discontinue treatment if unexplained, sudden or gradual, partial or complete loss of vision, protopsis, diplopia or papilledema, retinal vascular lesions or migraine occur. Caution when used in patients with conditions that might be worsened by fluid retention (e.g. asthma, seizure disorders, migraine, cardiac or renal dysfunction).

Adverse Reactions

GI disturbances, increased appetite, wt gain or loss, oedema, acne, allergic skin rashes, urticaria, mental depression, discomfort in breast; cough, dyspnoea, circulatory disturbances. Pain at site of inj.

Pregnancy Category (US FDA)

IM/Parenteral: B

Drug Interactions

Increased clearance when used with enzyme inducers e.g. carbamazepine and phenytoin. May inhibit metabolism of ciclosporin.

Lab Interference

May cause abnormal thyroid function test results. May alter metyrapone test and LFT.

Action

Description: Hydroxyprogesterone caproate stimulates luteal actions, changes in uterus and vagina as seen in early pregnancy. It also has prolonged uterotrophic effect. Contractile response of the myometrium to oxytocin is inhibited.
Duration: 7-14 days.

Storage

Store at 15-30 °C.

MIMS Class

Oestrogens, Progesterones & Related Synthetic Drugs

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