Duphaston (dydrogesterone) is a progestogen medication specifically engineered to mimic the natural effects of progesterone in the body. It is widely prescribed to address a spectrum of hormonal disorders, particularly those related to progesterone deficiency or imbalance. Its molecular structure allows for targeted action with a high affinity for uterine progesterone receptors, making it a cornerstone in gynecological and fertility treatments. This product card provides a comprehensive, expert-level overview for healthcare professionals and informed patients.

Features

• Active ingredient: Dydrogesterone 10 mg per tablet
• High selectivity for progesterone receptors, minimizing androgenic, estrogenic, glucocorticoid, or anabolic activity
• Oral administration with predictable pharmacokinetics and high bioavailability
• Synthetic progestogen with a structure closely related to endogenous progesterone
• Well-established safety profile supported by extensive clinical use and research
• Manufactured under strict pharmaceutical quality control standards

Benefits

• Effectively treats luteal phase defects by supporting endometrial maturation and stability, crucial for embryo implantation and maintaining early pregnancy.
• Manages dysfunctional uterine bleeding by regulating endometrial proliferation and promoting orderly shedding.
• Alleviates symptoms of endometriosis through its antiproliferative effect on estrogen-stimulated endometrial tissue.
• Provides reliable secondary amenorrhea treatment by transforming a proliferative endometrium into a secretory one, inducing withdrawal bleeding.
• Supports hormone replacement therapy (HRT) in postmenopausal women by opposing estrogenic effects on the endometrium, significantly reducing the risk of hyperplasia.
• Used in threatened and habitual abortion to provide progestational support for maintaining pregnancy.

Common use

Duphaston is primarily indicated for disorders related to progesterone deficiency. Its most frequent applications include the treatment of infertility due to luteal phase insufficiency, where it supports the secretory transformation of the endometrium to facilitate nidation. It is extensively used in managing dysfunctional uterine bleeding (DUB), helping to establish a regular menstrual cycle. For endometriosis, it is employed to cause decidualization and subsequent atrophy of ectopic endometrial tissue. It is also a critical component in sequential hormone replacement therapy for postmenopausal women with an intact uterus, protecting the endometrium from unopposed estrogen stimulation. Furthermore, it is prescribed for threatened or recurrent miscarriage attributed to proven progesterone deficiency.

Dosage and direction

Dosage is highly indication-specific and must be individualized under medical supervision.

• Endometriosis: 10 mg two or three times daily from day 5 to day 25 of the cycle, or continuously.
• Dysfunctional Uterine Bleeding: To stop bleeding: 10 mg twice daily for 5-7 days. To prevent bleeding: 10 mg twice daily from day 11 to day 25 of the cycle.
• Infertility due to Luteal Phase Defect: 10 mg daily from day 14 to day 25 of the cycle. Treatment should be continued for at least six consecutive cycles; upon confirmed pregnancy, treatment should be continued for at least three months.
• Threatened Abortion: 40 mg immediately as a first dose, then 10 mg every 8 hours until symptoms resolve.
• Habitual Abortion: 10 mg daily until week 12-20 of pregnancy.
• Hormone Replacement Therapy (with an estrogen): 10 mg daily for the last 12-14 days of estrogen therapy per 28-day cycle. Tablets should be swallowed whole with water, with or without food. Adherence to the prescribed schedule is critical for efficacy.

Precautions

A thorough medical history should be obtained prior to initiation, with special attention to previous or existing conditions. Use with caution in patients with a history of depression, as progestogens can sometimes exacerbate symptoms. Although the risk is considered lower than with some other progestogens, monitor patients for signs of thromboembolic disorders (e.g., thrombophlebitis, cerebrovascular incidents, pulmonary embolism). In cases of irregular bleeding, organic pathology should be ruled out before attributing it to hormonal causes. Liver function should be monitored in patients with pre-existing hepatic disease, as the drug is metabolized in the liver. Long-term continuous use requires regular medical review to assess ongoing need and monitor for any adverse effects.

Contraindications

Duphaston is contraindicated in patients with known hypersensitivity to dydrogesterone or any excipients in the formulation. It must not be used in individuals with known or suspected progesterone-dependent neoplasms, such as meningioma. Its use is contraindicated in cases of undiagnosed vaginal bleeding. It should not be used for primary prevention of cardiovascular disease or dementia. There are no known absolute contraindications for use during pregnancy for its approved indications; in fact, it is prescribed to support pregnancy.

Possible side effect

Duphaston is generally well-tolerated. The following side effects have been reported, though not all occur frequently.

• Common (≥1/100 to <1/10): Headache, nausea, breast discomfort/tenderness, breakthrough bleeding/spotting.
• Uncommon (≥1/1,000 to <1/100): Dizziness, vomiting, pruritus, skin rash, urticaria, edema, mild hepatic dysfunction (alterations in liver function tests).
• Rare (≥1/10,000 to <1/1,000): Hemolytic anemia, hypersensitivity reactions.
• Frequency not known: Depression, libido changes, fatigue, abdominal pain, weight changes. Most side effects are mild and transient, often resolving without intervention. Severe reactions are uncommon.

Drug interaction

Dydrogesterone is primarily metabolized by the cytochrome P450 (CYP) 3A4 enzyme system in the liver. Concomitant use with potent inducers or inhibitors of this enzyme may alter its plasma concentrations.

• Inducers of CYP3A4 (e.g., rifampicin, phenobarbital, phenytoin, carbamazepine, St. John’s Wort) may increase the metabolism of dydrogesterone, potentially reducing its therapeutic efficacy. Dose adjustment may be required.
• Inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin, grapefruit juice) may decrease the metabolism of dydrogesterone, potentially increasing the risk of side effects. No clinically significant interactions with other commonly co-prescribed medications have been established, but a comprehensive review of a patient’s medication list is always advised.

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 a consistent dosing schedule is important for optimal therapeutic effect, particularly in cyclical regimens for conditions like infertility or endometriosis.

Overdose

There have been no reports of serious deleterious effects from acute overdose. Based on the extensive profile of the drug, no specific antidote is known. In the event of a significant overdose, symptomatic and supportive treatment is recommended. Gastric lavage may be considered if ingestion was very recent. Given the drug’s mechanism, monitoring for potential enhanced progestogenic effects (e.g., nausea, drowsiness) is prudent. Medical attention should be sought for advice.

Storage

Store in the original package below 30°C (86°F) to protect from light and moisture. Keep the blister strips in the outer carton. Keep out of sight and reach of children. Do not use after the expiration date printed on the packaging. Do not dispose of medication via wastewater or household waste; consult a pharmacist on proper disposal methods to minimize environmental impact.

Disclaimer

This information is intended for educational and informational 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 medication. 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 approved labeling and clinical expertise but may not be exhaustive.

Reviews

“As a reproductive endocrinologist, Duphaston is my go-to progestogen for luteal phase support in ART cycles. Its predictable action and excellent safety profile provide confidence in managing our most challenging patients.” – Dr. E. Lawson, MD “After struggling with irregular and heavy periods for years, my gynecologist prescribed Duphaston. It has regulated my cycle perfectly and significantly improved my quality of life with minimal side effects.” – Maria K. “In our menopause clinic, we rely on dydrogesterone for endometrial protection in HRT. Its neutral metabolic profile and lack of androgenic effects make it superior for long-term use in our patient population.” – Prof. A. Singh, Gynecology “Prescribed for recurrent pregnancy loss due to low progesterone. I truly believe Duphaston is what supported my pregnancy until the placenta took over. I now have a healthy baby boy.” – Sarah T. “From a pharmacological perspective, dydrogesterone’s receptor selectivity minimizes off-target interactions, making it a cleaner option compared to older generation progestins for a variety of indications.” – Clinical Pharmacologist