Hydroxyprogesterone Caproate

Mechanism :

It is a synthetic progestin (steroidal hormone) similar in action to medroxyprogesterone acetate. It prevents preterm delivery by being a Synthetic progestin.

Indication :

Prophylaxis for preterm delivery in females with single pregnancy and who have a prior history of single intrauterine pregnancy which resulted in a spontaneous preterm birth.
Primary/Secondary amenorrhea or for DUB as a result of hormonal imbalance without organic pathology.
Metastatic endometrial carcinoma which is inoperable, recurrent (indicated only for adult females, not a pediatric indication).
To test for the endogenous production of estrogen (indicated only for adult females, not a pediatric indication).

Contraindications :

• Hypersensitivity

• Thromboembolism or previous history of thromboembolism

• Undiagnosed vaginal bleeding

• Present/previous history of breast carcinoma, hormone-sensitive carcinoma

• Cholestatic jaundice

• Active liver disease, benign/malignant hepatic tumors

• Uncontrolled hypertension

• Intravenous route of delivery is contraindicated

• Caution in case of renal disease, sensitivity to fluid retention

• Caution in case of diabetes mellitus

• Caution in case of pre-eclampsia

• Caution in case of migraine, epilepsy

• Caution in case of present/previous history of depression

• Caution in case of asthma

• There is no evidence to suggest presence of drug-associated to children born to progesterone-caproate treated mothers from the available data

• Not indicated during breastfeeding

Dosing :

Dosage forms:

Injection: 250 mg/ml.

Premature birth-risk reduction:

<16 years: Safety and efficacy not established.

16 years and older: 250 mg intramuscularly to be started between 16 weeks 0 days of gestation to 20 weeks 6 days of gestation, every week until 37 weeks of gestation or until delivery, whichever occurs first.

Subcutaneous dose is 275 mg (rest of the schedule is same as im dose).

Amenorrhea:

16 years or older: 375 mg intramuscularly as a single dose given anytime. Schedule for next dose is 4 days after desquamation of the epithelium, or 21 days after the initial dose in case of no bleeding. Discontinue the drug if there is no response at the end of 4 cycles.

Inoperable, recurrent, metastatic endometrial carcinoma: (adult females only)

1000 mg or more every week intramuscularly to be discontinued in case of relapse or after twelve weeks of therapy with no objective response.

Test for endogenous production of estrogen: (adult females only)

250 mg intramuscularly as a single dose to be repeated for confirmation four weeks after the initial injection. Discontinue after the second dose.

Adverse Effect :

• Common: pain at the site of injection, swelling at the site of injection, urticaria

• Uncommon: pruritis at the site of injection, nodule at the site of injection, nausea, loose stools

• Undefined frequency: thromboembolism, angioedema, retention of fluid, hypertension, jaundice, decreased glucose tolerance, bleeding per vaginum, depression

Hepatic Dose :

Impairment of hepatic function is possible – exercise caution