Caprogen

Hydroxyprogesterone Caproate USP 250 mg

Dosage Form: Injection
Pack Size: 1 X 1 ml
Composition:

Hydroxyprogesterone Caproate is a pale yellow color oil base sterile injection which is filled and sealed in amber color glass ampoule. Caprogen® IM Injection: Each 1 ml Ampoule contains Hydroxyprogesterone Caproate USP 250 mg. Caprogen® DS IM Injection: Each 2 ml Ampoule contains Hydroxyprogesterone Caproate USP 500 mg.

Description:

Caprogen® (Hydroxyprogesterone caproate) is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester

derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid).

Indications:

Caprogen® is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Caprogen® Injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation.

Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Caprogen® Injection has been demonstrated only in women with a

prior spontaneoussingleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

Dosage & Administration:

Administer intramuscularly (IM) at a dose of 250 mg (1 mL) once weekly (every 7 days). Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation. Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first. In recurrent miscarriage associated with proven progesterone deficiency, doses of 250 to 500 mg weekly by intramuscular injection can be given during the first half of pregnancy.

Contraindications:

Current thrombosis or thromboembolic disorders or history of these conditions.

Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions

Undiagnosed abnormal vaginal bleeding unrelated to pregnancy.

Cholestatic jaundice of pregnancy

Liver tumors (benign or malignant) or active liver disease

Uncontrolled hypertension

Warning & Precautions:

Thromboembolic Disorders: Discontinue Caprogen® if an arterial or deep venous thrombotic or thromboembolic event occurs.

Allergic Reactions: Allergic reactions, including urticaria, pruritusand angioedema, have been reported with use of Caprogen® or with other products containing

castor oil. Consider discontinuing the drug if such reactions occur.

Decrease in Glucose Tolerance: A decrease in glucose tolerance has been observed in some patients on progestin treatment. The mechanism of this decrease is not known. Carefully monitor pre-diabetic and diabetic women while they are receiving Caprogen®.

Fluid Retention: Because progestational drugs may cause some degree of fluid retention, carefully monitor women with conditions that might be influenced by this effect (e.g., preeclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction).

Depression: Monitor women who have a history of clinical depression and discontinue Caprogen® if clinical depression recurs.

Jaundice: Carefully monitor women who develop jaundice while receiving Caprogen® and consider whether the benefit of use warrants continuation.

Hypertension: Carefully monitor women who develop hypertension while receiving Caprogen® and consider whether the benefit of use warrants continuation.

Overdose:

In the case of overdosage, the patient should be treated symptomatically.

Storage Conditions:

Store below 300C. & dry place. Keep away from light and out of the reach of children.

Commercial Pack:

Caprogen® IM Injection: Each commercial pack contains 1x1 ml ampoule of 250 mg/ml Hydroxyprogesterone caproate USP in Alu-PVC blister strip, 1 sterile

disposable syringe, 1 alcohol pad & 1 ampoule breaker.

Caprogen® DS IM Injection: Each commercial pack contains 1x2 ml ampoule of 500 mg/2ml Hydroxyprogesterone caproate USP, 1 sterile disposable syringe,

1 alcohol pad & 1 ampoule breaker.