Duphaston: Restoring Hormonal Balance with Dydrogesterone

Duphaston

Duphaston

Duphaston - gestagenic medicine, makes the selection impact on endometria, promotes formation of a normal secretory endometria at women after preliminary therapy by estrogen. It is taken at the infertility caused by luteal deficiency. It is also effective at treatment of gestagenny insufficiency, endometriosis; secondary amenorrheas; dysfunctional metrorrhagia; premenstrual syndrome.
Product dosage: 10mg
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Duphaston is a prescription medication containing the active ingredient dydrogesterone, a structurally altered progestogen that closely mimics the body’s natural progesterone. It is specifically designed to address conditions arising from progesterone deficiency or imbalance, offering targeted therapeutic action with a favorable safety profile. Unlike some older progestogens, dydrogesterone is not derived from testosterone, which contributes to its selective action and reduced incidence of androgenic side effects. It is a cornerstone in gynecological endocrinology for managing a range of disorders related to the luteal phase and progesterone support.

Features

  • Contains dydrogesterone 10 mg as the active pharmaceutical ingredient.
  • Belongs to the pharmacological class of progestogens.
  • Exhibits high oral bioavailability and selective action on the progesterone receptors in the endometrium.
  • Does not possess significant estrogenic, androgenic, anabolic, or glucocorticoid activity.
  • Manufactured under strict Good Manufacturing Practice (GMP) standards for consistent quality and potency.
  • Available in blister packs of 20 or 30 tablets.

Benefits

  • Effectively supports the secretory transformation of the endometrium, which is crucial for the implantation and maintenance of pregnancy in assisted reproductive cycles.
  • Provides reliable relief from symptoms associated with endometriosis, such as pelvic pain and dysmenorrhea.
  • Manages dysfunctional uterine bleeding by stabilizing the endometrial lining and restoring a regular menstrual cycle.
  • Offers a well-tolerated option for hormone replacement therapy (HRT) in postmenopausal women, opposing the effects of estrogen on the uterus to prevent hyperplasia.
  • Used in the treatment of secondary amenorrhea to induce withdrawal bleeding and re-establish cyclical menstruation.
  • Its molecular structure contributes to a lower likelihood of side effects commonly associated with other synthetic progestins, such as weight gain, acne, or fluid retention.

Common use

Duphaston (dydrogesterone) is indicated for a variety of conditions linked to progesterone deficiency. Its primary uses include the treatment of infertility due to luteal insufficiency, where it supports the endometrial lining for embryo implantation. It is extensively used in the management of endometriosis, helping to alleviate pain and reduce disease progression. For women suffering from dysfunctional uterine bleeding (DUB), it helps regulate the menstrual cycle. It is also a key component in hormone replacement therapy (HRT) regimens for postmenopausal women with an intact uterus, where it is combined with an estrogen to protect the uterine lining from hyperplasia. Furthermore, it is prescribed for secondary amenorrhea and for the prevention of miscarriage in women with a history of habitual abortion due to proven progesterone deficiency.

Dosage and direction

The dosage of Duphaston is highly individualized and must be determined by a physician based on the specific indication, patient response, and clinical context. The following are common dosage regimens:

  • Endometriosis: 10 mg two or three times daily from day 5 to day 25 of the cycle, or continuously.
  • Infertility due to luteal phase defect: 10 mg twice 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.
  • Dysfunctional Uterine Bleeding (DUB): 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.
  • Irregular menstruation: 10 mg twice daily from day 11 to day 25 of the cycle.
  • Secondary amenorrhea: Estrogen therapy is given for 28 days, with dydrogesterone 10 mg twice daily added for the last 14 days of estrogen therapy.
  • Hormone Replacement Therapy (HRT): When combined with continuous daily estrogen, 10 mg daily for 14 days of a 28-day cycle. The tablets should be swallowed whole with a glass of water, with or without food. Adherence to the prescribed schedule is critical for therapeutic efficacy.

Precautions

Before initiating treatment with Duphaston, a thorough medical history and examination are essential. It is not a contraceptive. Use with caution in patients with a history of depression; if severe depression occurs, the drug should be discontinued. Although the risk is considered lower than with other progestogens, patients with existing risk factors for thrombosis (e.g., personal or family history, obesity, prolonged immobilization) should be carefully evaluated. Regular gynecological examinations are recommended during long-term therapy. Duphaston should not be used for the diagnosis of pregnancy. In the event of breakthrough bleeding or irregular spotting, non-functional causes should be ruled out.

Contraindications

Duphaston is contraindicated in patients with known hypersensitivity to dydrogesterone or any of the excipients in the formulation. It must not be used in individuals with known or suspected progestogen-dependent neoplasia, such as meningioma. It is also contraindicated in cases of undiagnosed vaginal bleeding. Patients with a history of severe liver disease or hepatic tumors (until liver function values return to normal) should not use this medication. Existing or previous episodes of venous or arterial thrombotic/thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke) are also contraindications.

Possible side effect

Duphaston is generally well-tolerated. However, like all medicines, it can cause side effects, although not everybody gets them. Commonly reported side effects include:

  • Headache
  • Nausea
  • Breast tenderness or discomfort
  • Abdominal pain or bloating
  • Breakthrough bleeding or spotting
  • Changes in libido
  • Mild skin reactions (e.g., rash, pruritus) Rarely, more serious side effects can occur, such as jaundice, allergic reactions (e.g., urticaria, angioedema), hemolytic anemia, or depression. Patients should be advised to report any severe or persistent adverse reactions to their healthcare provider immediately.

Drug interaction

The efficacy of Duphaston may be influenced by drugs that induce liver enzymes responsible for its metabolism, potentially reducing its plasma concentration and therapeutic effect. Key inducters include:

  • Phenobarbital
  • Phenytoin
  • Rifampicin
  • Carbamazepine Conversely, the metabolism of these drugs may also be affected. No clinically significant interactions with oral anticoagulants have been observed. It is crucial to inform your doctor about all other medicines you are taking, including prescription, over-the-counter, and herbal products.

Missed dose

If a dose is missed, it should be taken as soon as it is 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 forgotten one. Maintaining the hormonal cycle as prescribed is important for the drug’s effectiveness, particularly in fertility and cycle regulation treatments.

Overdose

There have been no reports of serious harmful effects from overdose with Duphaston. Acute toxicity testing indicates a very high safety margin. In the event of ingestion of a significantly large number of tablets, gastric lavage may be considered. Symptomatic treatment should be initiated as there is no specific antidote. Medical attention should be sought.

Storage

Store below 30°C (86°F) in a dry place. Keep the tablets in the original blister pack to protect them from light and moisture. Keep out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”. The expiry date refers to the last day of that month.

Disclaimer

This information is for educational purposes only and 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 product information provided may not be exhaustive or fully up-to-date.

Reviews

  • “As a reproductive endocrinologist, I have prescribed dydrogesterone for years with excellent results in supporting the luteal phase in IVF cycles. Its selective profile means my patients experience fewer side effects compared to older agents.” – Dr. E. Lawson, MD
  • “After struggling with severe endometriosis pain for a decade, Duphaston, combined with a multidisciplinary approach, has finally given me significant relief and a better quality of life. The difference has been remarkable.” – Patient, 34
  • “In our menopausal clinic, we value Duphaston for HRT due to its neutral metabolic effects and excellent endometrial protection. It is a reliable choice for our patients requiring progestogen opposition.” – Dr. A. Chen, Gynecologist
  • “I was prescribed this for irregular, heavy periods. It took a cycle or two to fully regulate, but my cycles are now predictable and much lighter. I experienced some minor breast tenderness initially, but it subsided.” – Patient, 29