The pill imprinted with A80 (or A 8 0), appearing as an orange, oval-shaped (capsule/oblong) soft gelatin capsule, is identified as Progesterone 200 mg.
Manufactured by Amneal Pharmaceuticals, this oral softgel capsule is a bioidentical, micronized form of the naturally occurring female sex hormone progesterone. It is the generic equivalent of the brand-name drug Prometrium.
Pill Identification Summary
Characteristic – Detail
- Imprint Code –
A80 - Active Ingredient – Micronized Progesterone, USP (200 mg)
- Shape – Oval / Capsule / Oblong
- Color – Orange
- Size – Approximately 15 mm
- Formulation – Liquid-filled soft gelatin capsule (suspended in peanut oil or heavy mineral oil base)
- Drug Class – Progestogens (Endogenous Progestin)
- Controlled Status – Non-controlled substance (Rx required) |
Mechanism of Action
Progesterone is a steroid hormone essential for regulating the female reproductive system and maintaining endometrial health.
- Receptor Binding: Micronized progesterone enters target cell cytoplasm and binds to specific nuclear progesterone receptors (PR-A and PR-B).
- Endometrial Transformation: In the uterus, it transforms an estrogen-primed proliferative endometrium into a secretory endometrium.
- Estrogen Opposition: When postmenopausal women take unopposed estrogen therapy, endometrial cells proliferate rapidly, significantly raising the risk of endometrial hyperplasia and uterine carcinoma. Progesterone opposes this effect by downregulating estrogen receptors and enhancing local enzymatic conversion of estradiol to less potent estrone, maintaining a healthy, shed-ready uterine lining.
- Pituitary Feedback: By exerting negative feedback on the hypothalamus and anterior pituitary gland, progesterone suppresses the surge of luteinizing hormone (LH) and follicle-stimulating hormone (FSH).
Indications & Clinical Dosing
- Note: Micronized progesterone softgels are formulated to be taken orally, typically with food or water at bedtime to minimize daytime sedation.
Prevention of Endometrial Hyperplasia
- Target Population: Postmenopausal women with an intact uterus who are receiving conjugated estrogen therapy.
- Standard Dosage: 200 mg daily taken as a single dose at bedtime for 12 consecutive days per 28-day cycle.
Secondary Amenorrhea
- Target Population: Premenopausal women experiencing the abnormal cessation of menstrual periods not caused by pregnancy.
- Standard Dosage: 400 mg daily (given as a single 400 mg dose or divided as two 200 mg doses) or 200 mg daily at bedtime for 10 consecutive days.
Side Effects
Because progesterone acts on central nervous system receptors and systemic vasculature, side effects can range from mild to severe:
Common Side Effects
- Central Nervous System: Drowsiness, fatigue, dizziness, headaches, or lightheadedness.
- Gastrointestinal: Nausea, abdominal pain or cramping, bloating.
- Reproductive / Endocrine: Breast tenderness or pain, mood swings, spotty vaginal bleeding, or changes in menstrual flow.
Serious Adverse Reactions
- Thromboembolic Events: Deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, or myocardial infarction.
- Hepatic Dysfunction: Cholestatic jaundice, elevated liver enzymes, or hepatic failure.
- Vision Changes: Partial or complete loss of vision, diplopia, or retinal vascular lesions.
- Severe Mental Health: Deep depression or exacerbation of pre-existing mood disorders.
Contraindications & Precautions
Absolute Contraindications
Progesterone capsules should not be used in patients with any of the following conditions:
- Hypersensitivity/Allergies: Known severe allergy to progesterone, gelatin, or inactive ingredients (e.g., peanut oil or soy lecithin used in softgel suspensions).
- Active or Past Thromboembolic Disease: History of arterial or venous blood clots, pulmonary embolism, stroke, or heart attack.
- Malignancy: Known, suspected, or past breast cancer or estrogen/progesterone-dependent neoplasia.
- Undiagnosed Genital Bleeding: Unexplained abnormal vaginal bleeding.
- Severe Liver Impairment: Active liver disease or significantly impaired hepatic function.
- Pregnancy: Not indicated during known pregnancy except under specialized reproductive endocrinology protocols.
Precautions & Warnings
- Sedative Effect: Progesterone metabolites interact with GABA-A receptors in the brain, causing significant sedation and somnolence. Patients should take the dose at bedtime and avoid driving or operating dangerous machinery immediately after ingestion.
- Fluid Retention: May cause fluid accumulation; exercise caution in patients with conditions aggravated by fluid retention (e.g., hypertension, cardiac dysfunction, renal impairment, epilepsy, or asthma).
- Cardiovascular & Neoplastic Risks: Clinical trials (such as the Women’s Health Initiative) indicate that combining progestins with estrogen increases risks for stroke, DVT, pulmonary embolism, and invasive breast cancer compared to placebo.
Pill Verification Notice
If you possess a pill and are unsure of its identity:
- Compare physical features: It should be a softgel capsule, orange, oval/oblong, approx 15 mm long, with
A80printed on one side. - Do not consume unidentified prescription medications. Consult a licensed pharmacist or healthcare practitioner to inspect the physical medication before taking it.