Generic Prometrium (Progesterone)

Introduction

Prometrium is a progesterone-containing oral medication indicated for hormone replacement therapy (HRT) in women with an intact uterus who are receiving estrogen, and for luteal-phase support in assisted reproductive technology (ART). The product is supplied as hard gelatin capsules in 100 mg and 200 mg strengths. Progesterone belongs to the class of natural steroid hormones that regulate the menstrual cycle, support early pregnancy, and modulate the effects of estrogen on the endometrium. In addition to its approved uses, clinicians sometimes employ progesterone for several off-label purposes, such as management of premenstrual syndrome or prevention of preterm birth, but these applications are not formally approved by regulatory agencies.

What is Prometrium?

Prometrium is the generic version of well-known medications, containing the active compound Progesterone. Our online pharmacy provides this generic alternative as a cost-effective treatment option. Progesterone is a naturally occurring steroid hormone produced primarily by the ovaries after ovulation and, during pregnancy, by the placenta.

• Classification: Natural hormone; steroid; progestogen.
• Development history: Synthetic progesterone for oral use was first approved in the United States in the s, offering a bioidentical alternative to animal-derived progestins.
• Manufacturer: The branded product Prometrium is marketed by the TherapeuticsMD/Abbott partnership, but the generic formulation is produced by multiple FDA-registered manufacturers under strict Good Manufacturing Practice (GMP) standards.

How Prometrium Works

Progesterone binds to intracellular progesterone receptors (PR-A and PR-B) located in target tissues such as the uterus, breast, and brain. After receptor binding, the hormone-receptor complex translocates to the nucleus and modulates gene transcription. The key therapeutic actions include:

1. Endometrial transformation: Progesterone converts the estrogen-primed proliferative endometrium into a secretory state, making it unsuitable for uncontrolled growth and thus reducing the risk of endometrial hyperplasia.
2. Luteal support: By mimicking the natural luteal phase, progesterone prepares the uterine lining for embryo implantation and maintains early pregnancy until placental progesterone production is established.
3. Neuro-modulatory effects: Progesterone exerts anti-inflammatory and myelin-protective actions in the central nervous system, which underlie some experimental uses.

Oral capsules are absorbed in the gastrointestinal tract, undergo hepatic first-pass metabolism, and produce peak serum concentrations within 2-4 hours. The elimination half-life of progesterone after oral dosing ranges from 3 to 5 hours, with metabolites excreted primarily in urine.

Conditions Treated with Prometrium

Both indications rely on the hormone’s ability to create a secretory endometrium and to maintain the hormonal environment necessary for embryo survival.

Off-Label and Investigational Uses of Prometrium

All off-label applications must be considered only after a thorough risk-benefit discussion with a qualified healthcare provider.

Is Prometrium the Right Medication for You?

Prometrium is most appropriate for:

• Post-menopausal women who require estrogen-progesterone combination therapy and have a uterus, to protect the endometrium.
• Women undergoing ART who need luteal-phase support, especially when a non-injectable oral option is preferred.

The medication is generally not recommended for:

• Women with a known hypersensitivity to progesterone, gelatin, or any inactive ingredients in the capsule.
• Pregnant women beyond the first trimester unless prescribed for specific obstetric indications.
• Individuals with active breast or endometrial cancer, uncontrolled liver disease, or a history of thrombophilia without medical supervision.

A thorough medical history and, when appropriate, baseline laboratory evaluation (e.g., liver function tests) help determine suitability.

Risks, Side Effects, and Interactions

Common

• Nausea or vomiting - Usually transient and may be reduced by taking the capsule with food.
• Headache - Mild to moderate, often responsive to over-the-counter analgesics.
• Breast tenderness or swelling - Typical of progestogenic activity.
• Drowsiness or fatigue - May affect alertness; caution when operating machinery.

Rare

• Depressive mood changes - Some patients experience mood swings; monitor closely if a history of depression exists.
• Weight gain or fluid retention - May be related to hormonal effects on renal sodium handling.
• Acne or oily skin - Sporadic dermatologic reactions.

Serious

• Allergic reactions - Rash, pruritus, angio-edema, or anaphylaxis require immediate medical attention.
• Hepatic dysfunction - Elevated transaminases or jaundice have been reported rarely; discontinue if liver injury suspected.
• Venous thromboembolism (VTE) - Although oral progesterone carries a lower VTE risk than estrogen, concomitant estrogen therapy can increase clotting risk.

Drug-Drug Interactions

• CYP3A4 inducers (e.g., carbamazepine, rifampin) - May reduce progesterone plasma concentrations, potentially compromising efficacy.
• CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) - Can increase progesterone levels, raising the risk of side effects.
• Anticoagulants (warfarin, DOACs) - Hormonal therapy may modestly affect coagulation parameters; periodic INR monitoring is advisable.

Drug-Food Interactions

• High-fat meals - Increase oral absorption; taking the capsule with a light snack is usually sufficient.
• Alcohol - May exacerbate drowsiness and liver stress; limit intake while on therapy.

Use: Dosing, Missed Dose, Overdose

• Standard dosing for HRT: 100 mg orally once daily at bedtime, combined with estrogen therapy.
• Standard dosing for luteal-phase support: 200 mg orally twice daily, beginning after ovulation or embryo transfer and continuing for 10-14 days.

Missed dose: If a dose is forgotten within 12 hours, take it as soon as remembered. If more than 12 hours have passed, skip the missed dose and resume the regular schedule. Do not double-dose.

Overdose: Symptoms may include severe nausea, vomiting, drowsiness, and abdominal pain. In the event of suspected overdose, seek immediate medical assistance; supportive care (e.g., activated charcoal, monitoring of vital signs) is the mainstay of treatment.

Practical administration tips:

• Swallow the capsule whole with a full glass of water.
• Prefer taking the medication with a small snack to minimise gastrointestinal irritation.
• Avoid operating heavy machinery or driving until you know how the drug affects you, especially during the first few days of therapy.

FAQ

• What should I do if I need to travel internationally with Prometrium?   Carry the medication in its original packaging with the pharmacy label visible. Keep it in your carry-on luggage to protect it from temperature extremes, and ensure you have a copy of the prescription or a doctor’s note if required by customs.

• Can I take Prometrium with caffeine or coffee?   Caffeine does not significantly affect progesterone absorption or metabolism, so moderate coffee consumption is permissible. Excessive caffeine may worsen insomnia, a side effect of progesterone, so monitor your tolerance.

• What inactive ingredients are in the capsules?   Common excipients include gelatin, maize starch, and titanium dioxide. Patients with gelatin allergy or severe corn sensitivity should discuss alternatives with their prescriber.

• Is there a difference between micronised progesterone capsules and other oral formulations?   Micronisation reduces particle size, enhancing gastrointestinal absorption and providing more consistent serum levels compared with non-micronised oral tablets. Prometrium utilizes micronised progesterone for this reason.

• Do urinary drug tests detect Prometrium?   Standard employment or roadside drug screens do not test for progesterone, as it is an endogenous hormone and not a controlled substance.

• How long can I store Prometrium at room temperature?   Capsules remain stable for up to 24 months when stored in a dry place below 25 °C (77 °F). Do not expose them to moisture or direct sunlight.

• What is the relationship between Prometrium and other progesterone products like Utrogestan or Crinone?   All contain the same active hormone, progesterone, but differ in formulation: Utrogestan is also an oral micronised capsule, while Crinone is a vaginal gel. Choice depends on the clinical indication and patient preference.

• Can I use Prometrium while breast-feeding?   Progesterone passes into breast milk in minimal amounts. Although not contraindicated, clinicians weigh the benefits against any potential infant exposure, especially in the early postpartum period.

• Why might I experience increased sleepiness when taking Prometrium?   Progesterone has a sedative effect mediated through its metabolite allopregnanolone, which modulates GABA-A receptors. Taking the dose at bedtime often reduces daytime drowsiness.

• Are there any special considerations for patients with liver disease?   Because progesterone is metabolised hepatically, severe liver impairment can alter drug clearance, increasing the risk of side effects. Dose adjustment or alternative therapy may be necessary.

Glossary

Progesterone Receptor (PR)

A cellular protein that binds progesterone, triggering changes in gene expression that mediate the hormone’s physiological effects.

Micronisation

A pharmaceutical process that reduces particle size to improve dissolution and absorption of poorly soluble compounds, such as oral progesterone.

Luteal Phase

The post-ovulatory segment of the menstrual cycle (approximately days 15-28) during which progesterone prepares the endometrium for possible implantation.

First-Pass Metabolism

The rapid breakdown of a drug by the liver after oral ingestion, which can significantly reduce the amount reaching systemic circulation.

Buying Prometrium from Our Online Pharmacy

Prometrium can be obtained securely through our online pharmacy. We partner with licensed overseas suppliers that adhere to stringent quality-control standards, ensuring every capsule meets or exceeds the specifications set by regulatory authorities.

• Cost-effective pricing: By sourcing directly from manufacturers, we keep prices close to the wholesale cost, offering a substantial saving compared with many retail pharmacies.
• Verified quality: All batches are accompanied by authentic certificates of analysis and are stored under controlled conditions to preserve potency.
• Discreet, reliable delivery: Orders are packed in unmarked packaging and shipped via express (typically 5-7 days) or regular airmail (approximately 2-3 weeks), with tracking available for every shipment.
• Privacy-focused service: Our pharmacy broker model protects your personal information; we never disclose your health data to third parties, and billing is handled through secure, encrypted channels.

For patients who encounter limited stock, insurance barriers, or geographic constraints, our platform provides a convenient alternative to obtain the generic progesterone they need, while maintaining the highest standards of safety and confidentiality.

Disclaimer

The information presented about Prometrium is intended for general educational purposes only and does not substitute for personalized medical advice. All therapeutic decisions, including any consideration of off-label applications, should be undertaken under the direct supervision of a qualified healthcare professional. Readers are presumed to be adults capable of making informed choices regarding their health. Our online pharmacy facilitates access to Prometrium for individuals who may encounter limited availability through conventional pharmacy channels or who are seeking an affordable generic alternative. Prior to initiating, modifying, or discontinuing any medication, it is essential to consult a qualified clinician.