Description:

Progestyl Depot 250mg/ml (Hydroxyprogesterone Caproate Injection USP by Donpak) is a long-acting injectable progestogen used to prevent recurrent miscarriage in women with a history of spontaneous abortion due to progesterone deficiency. It is administered as a depot injection to provide sustained progesterone support during early pregnancy, helping maintain the uterine lining and reduce the risk of miscarriage. It is typically used in women with proven or suspected luteal phase defect or recurrent pregnancy loss. In Ghana (Accra), it is a common prescription medication used in obstetrics and gynecology clinics for threatened or recurrent miscarriage prophylaxis.

Prescription: Prescription-only (requires a doctor’s prescription in Ghana; administered only by healthcare professionals via intramuscular injection in hospitals/clinics; not OTC due to pregnancy use, injection route, and need for proper obstetric monitoring).

Therapeutic Category:

Progestogen / Depot Progesterone (Long-acting synthetic progestin for pregnancy support.

Active Ingredients/Composition:

• Active ingredient: Hydroxyprogesterone caproate – 250 mg per ml (250 mg/ml).
• Each 1 ml ampoule contains 250 mg hydroxyprogesterone caproate. Other ingredients: Benzyl benzoate (solvent), castor oil (carrier oil for depot release), benzyl alcohol (preservative). The solution is clear, colourless to pale yellow, sterile, and oil-based for slow release over 1–2 weeks.

Vitamins: None.

Minerals: None.

Variant:

• Progestyl Depot 250mg/ml Injection (standard 1 ml ampoule). Related variants: Hydroxyprogesterone caproate 250mg/ml in 2ml or 5ml ampoules (higher volume), Makena (original brand), or progesterone in oil (shorter-acting alternative). The 250mg/ml 1ml ampoule is the most common strength and dose unit.

Consume Type:

Injectable – Intramuscular (IM) injection (deep IM, usually gluteal or deltoid muscle; administered only by healthcare professionals).

Directions/Usage: Administered only in clinical settings.

• Prevention of recurrent miscarriage: Typically 250 mg (1 ml) IM once weekly, starting from early pregnancy (as soon as pregnancy is confirmed) and continuing until 16–20 weeks gestation or as directed by obstetrician.
• Some protocols: 500 mg (2 ml) weekly if higher dose needed.
• Deep IM injection (rotate sites to avoid irritation).
• Continue until risk period passes or as prescribed (usually 12–20 weeks).
• Always confirm fatal viability (ultrasound) before starting and monitor pregnancy progress.

Common Side Effects: Common (local/systemic):

• Injection site pain, swelling, redness, or nodule (common due to oil base).
• Mild drowsiness or fatigue.
• Headache.
• Nausea.
• Breast tenderness.
• Weight gain or fluid retention. Rare/serious (seek help): Allergic reactions (rash, itching, breathing difficulty), thromboembolic events (blood clots – rare), jaundice (liver effects), or fatal harm (if misused).

Package Type:

Glass ampoules of 1 ml (each containing 250 mg hydroxyprogesterone caproate; packs of 5 or 10 ampoules; labelled carton with administration instructions and warnings).

Storage Advice: Store at room temperature (below 25–30°C) in original packaging, protected from light. Do not freeze. Keep out of reach of children.

Safety Advice:

• Administered only under medical supervision (pregnancy use – monitor fetal heartbeat and growth).
• Contraindicated in hypersensitivity to hydroxyprogesterone, known/suspected breast or genital cancer, undiagnosed vaginal bleeding, severe liver disease, or active thromboembolic disorders.
• Caution in history of thromboembolism, depression, migraine, epilepsy, asthma, or cardiac/renal impairment.
• Not for use in threatened abortion with bleeding without fetal viability confirmation.
• Report severe headache, vision changes, chest pain, leg swelling, jaundice, or signs of allergic reaction immediately.
• Keep out of reach of children (overdose risk).

Product Substitutes: Similar hydroxyprogesterone caproate 250mg/ml injections in Ghana include:

• Generic hydroxyprogesterone caproate 250mg/ml injection (various importers).
• Makena (original Covis brand if stocked).
• Progestyl Depot (same strength, other brands). Alternatives: Natural micronized progesterone oral/vaginal (Utrogestan, Susten), progesterone in oil injection (shorter-acting), or dydrogesterone oral (Duphaston). Consult gynaecologist/obstetrician in Accra for alternatives.

Manufacturer/Marketer:

Donpak Pharma or similar (often Indian manufacturers like Neon Laboratories, Samarth Life Sciences, or local Ghanaian partners produce generics under brands like Progestyl or MIKA). Marketed/distributed in Ghana by local importers/pharmacies (widely stocked as imported generic).

Country of Origin:

India (primary source for generic hydroxyprogesterone caproate 250mg/ml injections imported to Ghana; BP/USP-compliant generics common in African markets).