Prometrium: Natural Progesterone Support for Hormonal Balance
Prometrium
| Product dosage: 100mcg | |||
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| Product dosage: 200mcg | |||
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Synonyms
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Prometrium is a bioidentical progesterone medication designed to support and regulate the female endocrine system. As a micronized oral formulation, it offers targeted hormonal therapy with enhanced bioavailability and a favorable safety profile. This prescription medication is commonly utilized in hormone replacement therapy (HRT) and fertility treatments, providing a critical component for managing progesterone deficiency. Its unique delivery system ensures consistent hormonal support while minimizing potential side effects associated with synthetic alternatives.
Features
- Contains 100mg or 200mg micronized progesterone per softgel capsule
- Bioidentical hormone structure identical to endogenous progesterone
- Peanut oil-based delivery system for enhanced absorption
- FDA-approved formulation with established clinical efficacy
- Available in easy-to-swallow soft gelatin capsules
- Manufactured under strict pharmaceutical quality standards
Benefits
- Restores natural progesterone levels to support menstrual cycle regulation
- Reduces risk of endometrial hyperplasia in women receiving estrogen therapy
- Supports successful embryo implantation in assisted reproductive technology
- Provides neuroprotective benefits through allopregnanolone metabolites
- Maintains bone density and cardiovascular health in perimenopausal women
- Offers natural hormone replacement with reduced synthetic side effects
Common use
Prometrium is primarily prescribed for women experiencing progesterone deficiency across various clinical scenarios. It serves as crucial hormone replacement therapy during perimenopause and menopause, particularly for women with an intact uterus who are receiving estrogen therapy. The medication is extensively used in reproductive medicine to support luteal phase deficiency, prepare the endometrium for embryo transfer in IVF cycles, and maintain early pregnancy. Additionally, it’s indicated for the treatment of secondary amenorrhea and abnormal uterine bleeding related to hormonal imbalances. Off-label uses include management of premenstrual dysphoric disorder (PMDD) and certain cases of infertility where progesterone support is warranted.
Dosage and direction
Dosage must be individually tailored based on the specific indication and patient response. For menopausal hormone therapy, the typical dosage is 200 mg taken orally at bedtime for 12 sequential days per 28-day cycle. In fertility treatments and luteal phase support, doses range from 200-400 mg daily, usually divided into two or three administrations. For secondary amenorrhea, the standard protocol involves 400 mg daily at bedtime for 10 days. Administration should always occur at the same time each day to maintain stable hormone levels. Capsules must be swallowed whole with a full glass of water, preferably with food to enhance absorption and minimize dizziness. Duration of treatment varies from cyclic administration to continuous use based on therapeutic goals.
Precautions
Patients should undergo comprehensive medical evaluation before initiating therapy, including breast examination and endometrial assessment. Regular monitoring of liver function is recommended during prolonged treatment. Use with caution in patients with history of depression, as progesterone can affect mood and emotional stability. Those with cardiac or renal impairment require careful dose adjustment and close supervision. Diabetic patients may experience altered glucose tolerance requiring insulin adjustment. The medication may cause drowsiness and dizziness, particularly during the initial treatment phase, necessitating caution when operating machinery or driving. Patients should be advised that Prometrium contains peanut oil and is contraindicated in those with peanut allergies.
Contraindications
Absolute contraindications include known hypersensitivity to progesterone or any component of the formulation, particularly peanut oil. The medication is prohibited in patients with active or history of thromboembolic disorders, including deep vein thrombosis, pulmonary embolism, and cerebral vascular accident. Other contraindications include undiagnosed abnormal genital bleeding, known or suspected progesterone-dependent neoplasms, missed abortion, and active liver disease or dysfunction. Women with current or history of breast cancer should not use Prometrium due to potential stimulation of hormone-sensitive tissues. The medication is also contraindicated during pregnancy when used for non-fertility indications.
Possible side effect
Common side effects (occurring in >10% of patients) include drowsiness, dizziness, breast tenderness, and headache. Gastrointestinal disturbances such as nausea, abdominal bloating, and constipation affect approximately 5-10% of users. Less frequently (1-5%), patients may experience mood changes, including depression, irritability, and anxiety. Vasomotor symptoms like hot flashes and night sweats occasionally occur during treatment initiation. Rare but serious adverse effects (<1%) include allergic reactions, thromboembolic events, visual disturbances, and significant changes in lipid profile. Most side effects are dose-dependent and often diminish with continued use or dose adjustment.
Drug interaction
Prometrium demonstrates significant interactions with hepatic enzyme inducers including rifampin, carbamazepine, and St. John’s Wort, which may reduce its efficacy. Concurrent use with CNS depressants like benzodiazepines, opioids, or alcohol may potentiate sedative effects. The medication may alter the metabolism of cyclosporine, requiring close monitoring of blood levels. Anticoagulants such as warfarin may have altered effectiveness when used concomitantly. Ketoconazole and other strong CYP3A4 inhibitors can increase progesterone levels, potentially enhancing both therapeutic and adverse effects. Grapefruit juice should be avoided due to inhibition of cytochrome P450 3A4 metabolism.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Doubling the dose to make up for a missed administration is not recommended as it may increase the risk of side effects. For patients using Prometrium in fertility treatments or cycle regulation, consistent timing is critical, and any missed doses should be reported to the prescribing physician immediately. The impact of missed doses depends on the treatment indication and timing within the therapeutic cycle.
Overdose
Acute overdose may manifest as enhanced pharmacological effects including severe drowsiness, dizziness, and nausea. There is no specific antidote for progesterone overdose. Management involves symptomatic and supportive care, including monitoring of vital signs and neurological status. Gastric lavage may be considered if ingestion occurred within 1-2 hours. Due to the drug’s lipophilic nature, forced diuresis is not effective. Hemodialysis is unlikely to be beneficial given progesterone’s high protein binding and extensive tissue distribution. Medical attention should be sought immediately for any suspected overdose, particularly in cases involving significant neurological depression.
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep the container tightly closed and protect from light and moisture. Do not freeze the capsules. Keep out of reach of children and pets. Do not transfer capsules to other containers, as this may affect stability. Discard any medication that has passed the expiration date or shows signs of deterioration such as discoloration or capsule damage. Proper disposal should follow local regulations for pharmaceutical waste.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Prometrium is a prescription medication that should be used only under the supervision of a qualified healthcare professional. Individual response to therapy may vary, and treatment decisions should be based on comprehensive medical evaluation. The manufacturer and distributors are not liable for any adverse outcomes resulting from the use or misuse of this information. Patients should always consult their healthcare provider for personalized medical advice and report any adverse effects experienced during treatment.
Reviews
Clinical studies demonstrate high patient satisfaction with Prometrium, particularly regarding its natural hormone profile and reduced side effects compared to synthetic progestins. Many users report effective management of menopausal symptoms and successful outcomes in fertility treatments. Some patients note initial drowsiness that typically resolves with continued use. Healthcare providers appreciate the predictable pharmacokinetics and established safety data supporting its use in various hormonal indications. The peanut oil base remains a concern for allergic individuals, but overall, the medication receives positive evaluations for its efficacy in hormonal balance restoration.