Progesterone 50 mg Injection (Generic)

Product Overview

Progesterone 50 mg injection is a sterile, ready‑to‑use formulation supplied by Sanzyme Biologics (P) Ltd. Each vial contains 1 ml of 50 mg progesterone in a clear glass ampoule. The product is indicated for female infertility and hormone replacement therapy. Pack sizes include 10, 20, or 30 injections per pack, each delivering a single 50 mg dose. Shelf life is maintained under refrigerated conditions and the product complies with WHO GMP standards.

What is Progesterone 50 mg Injection

Progesterone is a steroid hormone that prepares the endometrium for implantation and maintains early pregnancy. In clinical practice, exogenous progesterone is administered to support luteal phase deficiency, assist assisted reproductive techniques, and replace deficient hormone in menopausal women. The injectable route provides rapid systemic availability and bypasses first‑pass metabolism.

Uses and Benefits

This medication is primarily used to treat luteal phase defect, a common cause of infertility, and to support endometrial preparation in IVF cycles. Additional benefits include reduction of menstrual irregularities, alleviation of menopausal hot flashes when combined with estrogen, and prevention of endometrial hyperplasia in women receiving estrogen therapy. Clinical studies indexed in PubMed have demonstrated improved pregnancy rates when progesterone is added to standard protocols.

How It Works

After administration, progesterone binds to intracellular receptors and modulates gene transcription, promoting secretory changes in the uterine lining. This hormonal action stabilizes the endometrium, reduces uterine contractility, and creates a receptive environment for embryo implantation. The 50 mg dose delivers a pharmacologic level that mimics the natural luteal phase, providing a consistent therapeutic effect.

Dosage Guidelines

Dosage must be individualized by a qualified physician. Typical regimens involve a single 50 mg intramuscular injection every 24‑48 hours for up to 10 days, depending on the clinical indication. For hormone replacement in menopausal patients, a single injection may be given every 2‑3 weeks, adjusted based on serum hormone levels. Patients should never self‑administer without medical supervision and must adhere to the prescribed schedule.

Side Effects

Most injectable progesterone is well tolerated. Common side effects include mild pain or irritation at the injection site, dizziness, fatigue, and transient breast tenderness. Less frequent adverse events reported in FDA safety reviews include mood changes, headache, and mild gastrointestinal discomfort. Serious reactions such as venous thromboembolism or severe allergic responses are rare but require immediate medical attention.

Warnings and Precautions

Progesterone should not be used in patients with known or suspected breast cancer, active liver disease, or unexplained vaginal bleeding. Caution is advised in individuals with a history of thromboembolic disorders, severe obesity, or hypertension. The product is contraindicated during the first trimester of pregnancy unless prescribed for specific fertility indications. Patients should inform their clinician of all concomitant medications, especially anticoagulants or corticosteroids, to avoid drug interactions.

Frequently Asked Questions

1. What is the difference between oral progesterone and the injectable form?
2. Can Progesterone 50 mg be used alongside fertility drugs like clomiphene?
3. How should the injection be stored to preserve potency?
4. Is the product safe for women with a history of polycystic ovary syndrome (PCOS)?
5. Where can I verify the authenticity of the medication before purchase?

For detailed prescribing information, refer to the official product monograph or consult a healthcare professional. Additional scientific resources are available through the National Center for Biotechnology Information and the U.S. Food and Drug Administration.

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