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 (dydrogesterone) is a progestogen medication specifically engineered to mimic the effects of natural progesterone, a key hormone in the female reproductive system. It is a first-line therapeutic choice for gynecologists and endocrinologists worldwide, prized for its selective action on the progesterone receptors in the endometrium without exhibiting other hormonal activities. This results in a targeted, effective treatment with a favorable tolerability profile, making it a cornerstone in managing a spectrum of hormone-dependent conditions. Its molecular structure and pharmacological profile are designed for precision, offering clinicians a reliable tool for hormonal regulation.

Features

• Active ingredient: Dydrogesterone 10 mg per tablet.
• Pharmacological class: Progestogen.
• High selectivity for progesterone receptors.
• No estrogenic, androgenic, anabolic, or glucocorticoid activity.
• Does not inhibit ovulation at therapeutic doses.
• Well-established bioavailability and predictable pharmacokinetics.
• Manufactured under strict pharmaceutical quality control standards.

Benefits

• Effectively supports and maintains the secretory endometrium, which is crucial for embryo implantation and sustaining early pregnancy.
• Provides reliable relief from symptoms associated with progesterone deficiency, such as dysfunctional uterine bleeding and severe dysmenorrhea.
• Offers a well-tolerated hormonal treatment option with a lower incidence of androgenic side effects (e.g., acne, hirsutism) compared to some other progestogens.
• Can be used in Estrogen Replacement Therapy (ERT) to provide endometrial protection, significantly reducing the risk of endometrial hyperplasia.
• Helps regulate the menstrual cycle, providing predictability and reducing the physical and emotional burden of irregular bleeding.
• Its non-suppressive effect on ovulation allows for its use in fertility treatments while monitoring the natural cycle.

Common use

Duphaston is indicated for the treatment of a variety of disorders stemming from progesterone deficiency or an imbalance between estrogen and progesterone. Its primary uses include:

• Endometriosis: Managing pain and symptoms.
• Infertility due to luteal insufficiency: Supporting the luteal phase to facilitate implantation.
• Threatened or habitual abortion: Preventing miscarriage in women with a documented progesterone deficiency.
• Dysmenorrhea: Alleviating severe menstrual pain.
• Irregular menstruation: Regulating an irregular cycle, including treatment of amenorrhea.
• Dysfunctional uterine bleeding: Controlling abnormal bleeding without a pathological cause.
• Hormone Replacement Therapy (HRT): Combined with estrogen to protect the uterine lining.

Dosage and direction

Dosage is highly individualized based on the specific indication and patient response. It must be precisely determined by a qualified healthcare professional. General guidelines include:

• 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 three months.
• Threatened abortion: 40 mg immediately, then 10 mg every 8 hours until symptoms resolve.
• Habitual abortion: 10 mg daily until week 12-20 of pregnancy.
• Dysmenorrhea: 10 mg twice daily from day 5 to day 25 of the cycle.
• Irregular cycles / Amenorrhea: Estrogen therapy from day 1 to day 25 of the cycle with Duphaston 10 mg daily added from day 11 to day 25.
• Dysfunctional uterine bleeding: 10 mg twice daily for 5-7 days to stop bleeding. For prevention: 10 mg twice daily from day 11 to day 25 of the cycle.
• HRT (with estrogen): 10 mg daily for the last 12-14 days of estrogen therapy. Tablets should be swallowed whole with water, with or without food. Adherence to the prescribed schedule is critical for efficacy.

Precautions

A thorough medical evaluation is required before initiation. Key precautions include:

• A complete medical history should be taken, with special attention to any previous or existing conditions such as cardiovascular disease, epilepsy, migraine, asthma, or renal dysfunction.
• Not intended for contraception. Non-hormonal contraceptive methods are recommended if pregnancy is not desired.
• Use with caution in patients with a history of depression; discontinue if severe depression recurs.
• Breakthrough bleeding may occur, especially if doses are missed. Any irregular bleeding must be investigated to rule out malignancy.
• May cause fluid retention; therefore, caution is advised in patients with conditions that could be influenced by this factor (e.g., cardiac or renal disease, epilepsy, migraine, asthma).
• Long-term use requires regular monitoring and re-evaluation of the benefit-risk ratio.

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 hepatic dysfunction (existing or in history), as the liver metabolizes the drug.
• Porphyria.
• Active arterial or venous thromboembolic disorders, or a history of these conditions.

Possible side effect

Duphaston is generally well-tolerated. Side effects, when they occur, 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, skin rash, pruritus, urticaria, edema, weight changes.
• Rare (<1/1,000): Hemolytic anemia, jaundice, fatigue, malaise, breakthrough bleeding, changes in libido.
• Very rare: hypersensitivity reactions, including anaphylaxis. Hepatic dysfunction has been reported extremely rarely. Patients should report any severe or persistent side effects to their physician.

Drug interaction

The potential for interactions exists, though dydrogesterone is primarily metabolized by CYP3A4 in the liver. Concomitant use with other substances should be monitored.

• Enzyme inducers: Drugs such as rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine may increase the metabolism of dydrogesterone, potentially reducing its therapeutic efficacy. Dose adjustment may be necessary.
• Enzyme inhibitors: Ketoconazole and other potent CYP3A4 inhibitors could potentially increase plasma levels of dydrogesterone.
• Although not extensively documented, interactions similar to other progestogens are theoretically possible. A comprehensive review of the patient’s complete medication list is essential.

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 double the dose to make up for the missed one. Maintaining the prescribed rhythm is more important than taking a delayed dose that disrupts the cycle.

Overdose

There have been no reports of serious deleterious effects from acute overdose. No specific antidote exists. Given the pharmacological profile, symptoms of overdose could be an exaggeration of known side effects (e.g., nausea, vomiting, drowsiness). Treatment should be symptomatic and supportive. Gastric lavage may be considered if ingestion was very recent.

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 and professional reference purposes only and is not a substitute for the expert knowledge, judgment, and therapeutic decision-making of a qualified healthcare professional. The prescribing physician remains solely responsible for the diagnosis, treatment choice, dosage determination, and monitoring of the patient based on their individual clinical presentation and medical history. Always refer to the official local prescribing information and approved product monograph for the most current and complete guidance.

Reviews

• “As a reproductive endocrinologist, I find Duphaston to be an invaluable tool for luteal phase support in our IVF and RPL clinics. Its specificity and tolerability are superior to older agents.” – Dr. E. Lorenz, MD.
• “In my gynecological practice, it is my progestogen of choice for endometrial protection in menopausal women on HRT. The incidence of breakthrough bleeding is notably lower.” – Dr. A. Schmidt.
• “Extensive clinical experience and a robust body of evidence support its use for a range of indications. It has a well-defined safety profile that we have trusted for decades.” – Prof. J. Miller, Clinical Pharmacologist.
• “For patients suffering from severe endometriosis-related pain, adding Duphaston to the management plan has provided significant symptomatic relief and improved quality of life.” – Dr. K. Ito.