Hydroxyprogesterone Caproate Injection

Hydroxyprogesterone Caproate Injection

  • Packing: 1 Ml, 2 Ml Ampoule, 1 Ml, 2 Ml PFS
  • Available Strength : 250 Mg/Ml

Description

Product Description: Hydroxyprogesterone Caproate Injection is a sterile solution containing hydroxyprogesterone caproate, a synthetic progestin derivative of progesterone. It is formulated for intramuscular administration and is commonly used in the management of certain medical conditions.

Indications and Usage: Hydroxyprogesterone Caproate Injection is indicated for the prevention of recurrent preterm birth in pregnant women with a history of spontaneous preterm birth. It is administered during the second and third trimesters of pregnancy to reduce the risk of preterm delivery.

Dosage and Administration: The dosage of Hydroxyprogesterone Caproate Injection is based on the patient's gestational age and other clinical factors. It is typically administered as a 250 mg intramuscular injection once weekly from 16 to 37 weeks of gestation. Treatment should be initiated by a healthcare professional experienced in obstetrical care.

Dosage Forms and Strengths: Hydroxyprogesterone Caproate Injection is available as a sterile solution in vials. Each mL of the solution contains 250 mg of hydroxyprogesterone caproate.

Contraindications: Hydroxyprogesterone Caproate Injection is contraindicated in patients with a history of hypersensitivity to hydroxyprogesterone or any component of the formulation. It should not be used in patients with known or suspected fetal abnormalities or in those with active thrombophlebitis or thromboembolic disorders.

Warnings and Precautions: Before initiating treatment with Hydroxyprogesterone Caproate Injection, healthcare providers should assess patients for contraindications and preexisting conditions, including cardiovascular disease and hepatic dysfunction. Patients should be monitored closely for signs of preterm labor and adverse reactions during treatment.

Adverse Reactions/Side Effects: Common adverse reactions associated with Hydroxyprogesterone Caproate Injection include injection site reactions, including pain, swelling, and erythema. Other potential side effects may include nausea, fatigue, and headache. Rarely, hypersensitivity reactions, including anaphylaxis, may occur.

Drug Interactions: Hydroxyprogesterone Caproate Injection may interact with certain medications, including anticoagulants and corticosteroids. Concomitant use with other progestins or hormonal contraceptives may increase the risk of adverse effects, including thromboembolism and hypertension.

Use In Specific Populations Description: Hydroxyprogesterone Caproate Injection is intended for use in pregnant women at risk of preterm birth. It has not been studied in pediatric patients or in non-pregnant populations. Safety and efficacy have not been established in these populations.

How Supplied/Storage and Handling: Hydroxyprogesterone Caproate Injection is supplied as a sterile solution in vials. It should be stored at controlled room temperature between 20°C to 25°C (68°F to 77°F), protected from light and moisture. Unused portions should be discarded according to local regulations for biohazardous waste disposal.