Duphaston: Progesterone Support for Hormonal Balance
| Product dosage: 10mg | |||
|---|---|---|---|
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Duphaston (dydrogesterone) is a progestogen medication specifically engineered to mimic the effects of natural progesterone in the body. It is a cornerstone of hormonal therapy, offering a well-tolerated and effective option for managing a range of conditions linked to progesterone deficiency. Its molecular structure provides targeted action with a reduced incidence of the androgenic and estrogenic side effects often associated with other synthetic progestogens. This makes it a preferred choice for gynecologists and endocrinologists seeking to restore hormonal equilibrium with precision.
Features
- Active Ingredient: Dydrogesterone (10 mg per tablet).
- Drug Class: Progestogen (specifically, a retroprogesterone).
- Administration: Oral tablet.
- Bioavailability: High oral bioavailability due to its specific molecular structure.
- Selectivity: High affinity for progesterone receptors with minimal binding to other steroid receptors.
- Metabolism: Primarily metabolized in the liver via hydroxylation into inactive metabolites.
- Excretion: Metabolites are excreted primarily in the urine.
- Presentation: Blister packs of 20 or 14 tablets.
Benefits
- Effectively supports and maintains the secretory endometrium, which is crucial for embryo implantation and sustaining early pregnancy.
- Provides reliable relief from symptoms of endometriosis, such as pelvic pain and dysmenorrhea, by inducing decidualization in ectopic endometrial tissue.
- Manages dysfunctional uterine bleeding (DUB) by transforming the proliferative endometrium into a secretory state, allowing for a organized and complete shedding.
- Alleviates symptoms of premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD) by counteracting estrogen dominance in the luteal phase.
- Serves as the progestogenic component in hormone replacement therapy (HRT) for postmenopausal women with an intact uterus, effectively protecting the endometrium from the proliferative effects of estrogen.
- Offers a favorable safety and tolerability profile, with a low incidence of androgenic side effects like acne, hirsutism, or voice changes.
Common use
Duphaston is indicated for the treatment of a variety of gynecological disorders stemming from progesterone deficiency or an imbalance in the estrogen-to-progesterone ratio. Its primary uses include:
- Luteal Phase Support: Treatment of infertility due to luteal insufficiency. It is used to prepare the endometrium for implantation and to support early pregnancy.
- Threatened and Habitual Miscarriage: Management and prevention of miscarriage in women with a documented history of habitual miscarriage due to progesterone deficiency.
- Endometriosis: Management of pain and other symptoms associated with endometriosis.
- Dysfunctional Uterine Bleeding (DUB): Treatment of irregular, heavy, or frequent uterine bleeding not caused by pathology (e.g., fibroids or cancer).
- Secondary Amenorrhea: Treatment of amenorrhea in conjunction with estrogen therapy.
- Premenstrual Syndrome (PMS): Alleviation of severe physical and emotional symptoms occurring in the luteal phase of the menstrual cycle.
- Hormone Replacement Therapy (HRT): Used cyclically with continuous estrogen to protect the endometrium from hyperplasia and carcinoma in non-hysterectomized postmenopausal women.
Dosage and direction
Dosage is highly indication-specific and must be determined by a healthcare professional. The following are common regimens:
- Endometriosis: 10 mg two or three times daily from day 5 to day 25 of the cycle, or continuously.
- Infertility due to luteal insufficiency: 10 mg daily from day 14 to day 25 of the cycle. Treatment should be continued for at least six consecutive cycles. In the event of confirmed pregnancy, treatment should be continued for at least until the 20th week of pregnancy.
- Threatened miscarriage: 40 mg immediately as a single dose, then 10 mg every 8 hours until symptoms resolve.
- Habitual miscarriage: 10 mg daily until the 12th-20th week of pregnancy.
- Dysfunctional Uterine Bleeding: 10 mg twice daily for 5 to 7 days to stop bleeding. To prevent recurrence, 10 mg twice daily from day 11 to day 25 of the cycle.
- HRT: 10 mg daily for the last 12-14 days of each estrogen therapy cycle. Tablets should be swallowed whole with water, with or without food. Adherence to the prescribed schedule is critical for efficacy.
Precautions
- Before initiation, a thorough medical history and physical examination should be performed, with special attention to the breasts and pelvic organs, including a Pap smear.
- It is not a contraceptive. However, if used in a cyclic regimen for conditions like endometriosis, it may inhibit ovulation in some women.
- Use with caution in patients with a history of depression, as progestogens can exacerbate symptoms. Discontinue if severe depression recurs.
- Monitor patients with conditions that may be influenced by fluid retention (e.g., epilepsy, migraine, asthma, cardiac or renal dysfunction).
- Breakthrough bleeding occurring under treatment requires diagnostic investigation (e.g., endometrial biopsy) to rule out malignancy.
- Long-term use requires regular monitoring of liver function.
Contraindications
Duphaston is contraindicated in patients with:
- Known hypersensitivity to dydrogesterone or any excipients in the formulation.
- Known or suspected progestogen-dependent neoplasia (e.g., meningioma).
- Undiagnosed vaginal bleeding.
- Severe liver dysfunction or hepatic tumors.
- Active arterial or venous thromboembolic disease, or a history of these conditions.
- Porphyria.
Possible side effect
Duphaston is generally well-tolerated. Reported side effects are usually mild and transient. They may include:
- Common (≥1/100 to <1/10): Headache, nausea, abdominal pain, breast tenderness/discomfort.
- Uncommon (≥1/1,000 to <1/100): Dizziness, vomiting, diarrhea, pruritus, skin rash, urticaria, edema, weight changes.
- Rare (<1/1,000): Hemolytic anemia, jaundice, fatigue, malaise, breakthrough bleeding/spotting.
- Very Rare: hypersensitivity reactions (including anaphylaxis), angioedema. The incidence of androgenic effects (acne, hirsutism) is very low.
Drug interaction
- Enzyme Inducers: Drugs that induce hepatic enzymes (e.g., rifampicin, rifabutin, carbamazepine, phenytoin, phenobarbital, St. John’s Wort) may increase the metabolism of dydrogesterone, leading to a reduction in its therapeutic effect. Dose adjustment may be necessary.
- While not extensively documented, interactions similar to other progestogens are theoretically possible. Always inform your physician of all medications, including over-the-counter drugs and herbal supplements.
Missed dose
If a dose is missed, it should be taken as soon as remembered, unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Do not take a double dose to make up for a missed one. Maintaining the prescribed schedule is important for the drug’s efficacy, particularly in cyclical regimens for fertility or cycle control.
Overdose
There have been no reports of serious deleterious effects from acute overdose. Due to the low toxicity of dydrogesterone, no specific antidote exists. Symptomatic treatment should be initiated. Gastric lavage may be considered if ingestion was very recent. Medical observation and supportive care are recommended.
Storage
- Store below 30°C (86°F).
- Keep the blister strips in the outer carton to protect from light and moisture.
- Keep out of the sight and reach of children.
- Do not use after the expiration date printed on the packaging.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. It is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or before starting any new treatment. Never disregard professional medical advice or delay in seeking it because of something you have read here. The information provided is based on the product’s characteristic and may not be fully comprehensive or reflect the most recent regulatory updates.
Reviews
- Clinical Perspective (Gynecologist): “In my practice, Duphaston is a first-line agent for luteal phase support. Its selective action and excellent safety profile make it ideal for long-term use in fertility patients without the concerns of other synthetic progestins. Patient compliance is high due to the low incidence of side effects.”
- Patient Review (Endometriosis): “After years of debilitating pain, starting a cyclic regimen of Duphaston has been life-changing. My pain levels have decreased significantly, and my cycles are finally predictable. I experienced some mild breast tenderness initially, but it subsided after the first few months.”
- Research Summary: “Systematic reviews and meta-analyses consistently demonstrate the efficacy of dydrogesterone in supporting early pregnancy and reducing miscarriage rates in women with a history of recurrent pregnancy loss, with a safety profile comparable to placebo.”
- Patient Review (HRT): “As part of my HRT, taking Duphaston for two weeks a month gives me peace of mind that my uterus is protected. I don’t experience the mood swings or bloating I had with previous progestogen tablets.”