Duphaston (dydrogesterone) is a synthetic progestogen medication specifically engineered to mimic the effects of natural progesterone in the body. It is widely prescribed to address a range of conditions linked to progesterone deficiency or hormonal imbalance. With its selective action on the progesterone receptors in the endometrium, it provides therapeutic benefits without the androgenic, estrogenic, or glucocorticoid effects associated with some other progestogens. This makes it a cornerstone in the management of gynecological and obstetric disorders, offering a well-tolerated and targeted approach to hormone therapy under medical supervision.

Features

• Active ingredient: Dydrogesterone 10 mg
• Synthetic progestogen with a molecular structure closely resembling that of natural progesterone
• High selectivity for progesterone receptors
• No androgenic, estrogenic, anabolic, or corticoid activity
• Oral tablet formulation for convenient administration
• Well-established pharmacokinetic profile with predictable absorption and metabolism

Benefits

• Effectively supports endometrial preparation and maintenance in infertility treatment and assisted reproductive technology
• Reduces the risk of endometrial hyperplasia in women undergoing estrogen replacement therapy
• Helps manage dysfunctional uterine bleeding by regulating menstrual cycles
• Provides luteal phase support to prevent miscarriage in women with proven progesterone deficiency
• Alleviates symptoms of premenstrual syndrome and endometriosis
• Offers a favorable safety profile with minimal impact on metabolic parameters, coagulation, or liver function

Common use

Duphaston is primarily indicated for conditions where progesterone supplementation is clinically warranted. Its most frequent applications include the treatment of endometriosis, where it helps reduce ectopic endometrial tissue growth and associated pain. It is extensively used in hormone replacement therapy (HRT) for postmenopausal women receiving estrogens, to protect the endometrium from hyperplasia and potential malignancy. In fertility medicine, it is employed for luteal phase support in natural and assisted cycles, and for the treatment of habitual or threatened abortion due to proven progesterone insufficiency. Additionally, it is prescribed for menstrual disorders such as irregular cycles, dysfunctional uterine bleeding, and severe premenstrual syndrome.

Dosage and direction

Dosage of Duphaston must be individualized based on the specific indication, severity of symptoms, and patient response. Typical regimens include:

• Endometriosis: 10 mg two to three times daily from day 5 to day 25 of the menstrual cycle, or continuously.
• Hormone replacement therapy (with estrogen): 10 mg daily for the last 12–14 days of each estrogen cycle.
• Infertility/Luteal phase support: 10 mg twice daily from day 14 to day 25 of the cycle, continued through early pregnancy if conception occurs.
• Dysfunctional uterine bleeding: 10 mg twice daily for 5–7 days to stop bleeding; followed by 10 mg twice daily from day 11 to day 25 for cycle regulation.
• Threatened abortion: 40 mg initially, then 10 mg every 8 hours until symptom resolution.

Tablets should be taken orally with water, with or without food. Adherence to the prescribed schedule is critical for optimal therapeutic outcomes.

Precautions

Prior to initiating Duphaston, a thorough medical evaluation should be conducted, including a detailed personal and family history. Use with caution in patients with a history of depression, as progestogens may exacerbate mood disorders. Renal or hepatic impairment necessitates careful monitoring and potential dose adjustment. Patients with diabetes should be monitored for changes in glucose tolerance. Duphaston is not a contraceptive; non-hormonal contraception should be used if pregnancy is not desired. Unexplained vaginal bleeding requires diagnostic investigation before treatment. Long-term use should be periodically reevaluated based on clinical need and benefit-risk assessment.

Contraindications

Duphaston is contraindicated in patients with known hypersensitivity to dydrogesterone or any excipient in the formulation. It must not be used in individuals with a history of or current venous thromboembolism (e.g., deep vein thrombosis, pulmonary embolism), arterial thromboembolic disorders (e.g., stroke, myocardial infarction), or severe hepatic disease. It is also contraindicated in cases of known or suspected progesterone-dependent neoplasms (e.g., meningioma), undiagnosed abnormal genital bleeding, and during pregnancy for indications other than proven progesterone deficiency (as unnecessary progestogen exposure should be avoided).

Possible side effect

Duphaston is generally well-tolerated, but some patients may experience adverse effects, including:

• Headache, migraine
• Nausea, abdominal discomfort
• Breast tenderness or enlargement
• Breakthrough bleeding or spotting
• Changes in libido
• Fatigue, dizziness
• Skin reactions such as rash, pruritus
• Mild peripheral edema
• Mood changes, including depression or irritability

Most side effects are mild and transient, often resolving with continued use or dose adjustment. Serious side effects such as allergic reactions, jaundice, or signs of thromboembolism are rare but require immediate medical attention.

Drug interaction

Dydrogesterone is primarily metabolized by CYP3A4 enzymes in the liver. Concomitant use with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, St. John’s wort) may reduce its plasma concentration and efficacy. Conversely, CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) may increase dydrogesterone levels, potentially enhancing both therapeutic and adverse effects. Duphaston may also interact with other hormonal therapies, anticoagulants, or antidiabetic agents, necessitating careful monitoring and possible dose adjustments. Always inform the prescribing physician of all concomitant 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. Doubling the dose to make up for a missed one is not recommended, as it may increase the risk of side effects. Consistency in dosing is important for maintaining stable hormone levels, particularly in cyclical regimens or during early pregnancy support.

Overdose

Acute overdose with Duphaston is unlikely to produce serious symptoms, given its favorable safety margin. There is no specific antidote. Symptomatic and supportive care should be provided if necessary. Gastric lavage may be considered if ingestion was recent. Monitor for enhanced side effects such as nausea, vomiting, dizziness, or drowsiness. Medical attention should be sought in cases of intentional or significant accidental overdose.

Storage

Store Duphaston tablets in their original packaging at room temperature (15–30°C), protected from light and moisture. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Proper storage ensures stability and efficacy of the medication throughout its shelf life.

Disclaimer

This information is intended for educational purposes and does not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before starting, changing, or discontinuing any medication. Individual patient needs and responses may vary. The prescribing physician should be informed of all relevant medical history and concurrent medications.

Reviews

Clinical studies and long-term use have established Duphaston as an effective and well-tolerated progestogen. It is frequently praised in medical literature for its endometrial selectivity and minimal adverse metabolic effects. Patient reviews often highlight its role in successful pregnancy outcomes and symptom relief in endometriosis and PMS, though individual experiences with side effects like breakthrough bleeding or mood changes may vary. Overall, it remains a trusted option in hormonal therapy under appropriate medical guidance.