Generic Duphaston (Dydrogesterone)

Introduction

Duphaston is a synthetic progestogen whose active ingredient is dydrogesterone. It is supplied as a 10 mg oral tablet and is classified among hormone-replacement and reproductive-health agents. The medication is primarily indicated for conditions caused by insufficient natural progesterone, such as luteal-phase deficiency, irregular menstrual cycles, and certain aspects of assisted reproductive technology. Duphaston is also incorporated into combined hormone-replacement regimens for post-menopausal women. In clinical practice it is sometimes employed off-label for disorders like adenomyosis or preterm-labor risk, but such uses have not received formal regulatory approval.

What is Duphaston?

• Definition - Duphaston is a brand-name preparation that contains 10 mg of the synthetic progesterone analogue dydrogesterone per tablet.
• Classification - It belongs to the group of progestogens, a subclass of steroid hormones that act on progesterone receptors.
• Development history - Dydrogesterone was first synthesized in the s by Schering (now part of Bayer) and later commercialised under several trade names. In Europe and many other markets Duphaston has been marketed alongside other brand names such as Femoston (combined with estradiol) and Gynesin.
• Manufacturer - The Duphaston tablet is produced by Abbott Laboratories (or its regional affiliates) and distributed in over 70 countries.

How Duphaston Works

Dydrogesterone is a selective agonist of the progesterone receptor (PR). After oral absorption, the drug is metabolised primarily by CYP3A4 to inactive metabolites, leaving sufficient parent compound to bind PRs in the uterus, breast, and central nervous system. Activation of these receptors reproduces the physiological actions of endogenous progesterone:

• Endometrial transformation - The drug stabilises the secretory phase of the endometrium, preparing it for implantation and preventing excessive proliferation.
• Inhibition of gonadotropin release - By providing negative feedback to the hypothalamic-pituitary axis, dydrogesterone reduces luteinising hormone (LH) surges that could otherwise trigger premature ovulation.
• Anti-estrogenic effect on breast tissue - The hormone competes with estrogen-driven proliferation, which contributes to its usefulness in premenstrual syndrome and certain benign breast disorders.

Onset of therapeutic effect generally occurs within 24-48 hours after the first dose, whereas steady-state plasma concentrations are reached after 5-7 days of daily dosing. The drug’s half-life is approximately 5-7 hours, allowing once-daily administration for most indications.

Conditions Treated with Duphaston

In each of these conditions, the therapeutic benefit derives from the drug’s ability to mimic natural progesterone without the pronounced androgenic or mineralocorticoid side effects seen with some older progestins.

Off-Label and Investigational Uses of Duphaston

• Adenomyosis - Small case series have reported symptom relief when dydrogesterone is administered continuously, suggesting suppression of ectopic endometrial tissue within the myometrium. Formal superiority trials are lacking.
• Preterm-labor prophylaxis - Some obstetric protocols incorporate dydrogesterone in women with a history of spontaneous preterm birth; meta-analyses show modest risk reduction but the approach remains off-label.
• Polycystic ovary syndrome (PCOS)-related infertility - Limited pilot studies indicate that dydrogesterone, combined with lifestyle measures, may improve ovulatory rates. Regulatory bodies have not approved this use.
• Adjunctive therapy for breast fibroadenoma - Experimental data suggest a possible reduction in fibroadenoma size through anti-estrogenic mechanisms, but evidence is preliminary.

Important: Off-label applications are not sanctioned by the FDA, EMA, or other major regulatory agencies. Patients should only consider such uses under the direct supervision of a qualified healthcare professional, and after a thorough risk-benefit assessment.

Is Duphaston the Right Medication for You?

Duphaston is most appropriate for adult women who have a documented progesterone deficiency or who require luteal-phase support for assisted reproduction. It is also suitable for post-menopausal women undergoing combined HRT where a progestogenic component is mandatory.

Ideal candidates typically:

• Have regular follow-up with a clinician confirming a need for supplemental progesterone.
• Are not pregnant (unless prescribed for luteal support) and have a functioning uterus (for endometrial protection).
• Do not have a history of thromboembolic disease, hormone-sensitive malignancies, or severe liver dysfunction.

Contraindications (absolute):

• Known hypersensitivity to dydrogesterone or any tablet excipient.
• Active or unexplained vaginal bleeding.
• Current pregnancy when the indication is not luteal support.
• Severe hepatic impairment or cholestasis.

Relative cautions include uncontrolled hypertension, diabetes mellitus, and a personal or family history of thromboembolism; dose adjustment or alternative therapy may be required.

Risks, Side Effects, and Interactions

Common

• Headache or migraine-type pain.
• Nausea, mild abdominal discomfort, or bloating.
• Breast tenderness or swelling.
• Mood fluctuations, including irritability or mild depression.

Rare

• Menstrual irregularities such as breakthrough spotting.
• Acne or oily skin.
• Elevated triglyceride levels.

Serious

• Severe allergic reactions (urticaria, angio-edema, anaphylaxis).
• Hepatic dysfunction manifested as jaundice, elevated transaminases, or cholestasis.
• Venous thrombo-embolism (deep-vein thrombosis, pulmonary embolism), particularly in patients with predisposition.

If any serious reaction occurs, immediate medical attention is required.

Drug-Drug Interactions

• CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) may increase plasma concentrations of dydrogesterone, potentially heightening side-effect risk.
• CYP3A4 inducers (e.g., rifampicin, carbamazepine) can lower exposure, possibly compromising efficacy.
• Anticoagulants (e.g., warfarin) - occasional reports of altered INR; monitor coagulation status when initiating or discontinuing Duphaston.
• Antidiabetic agents - progestogens may affect glucose tolerance; periodic blood-sugar monitoring is advisable for diabetic patients.

Food & Lifestyle Interactions

• No significant food effect; tablets may be taken with or without meals.
• Moderate alcohol consumption does not markedly alter pharmacokinetics, but excessive intake may increase hepatic stress.

Use: Dosing, Missed Dose, Overdose

Standard dosing varies with indication:

• Luteal-phase support (IVF) - 10 mg taken twice daily (morning and evening) from the day of embryo transfer until 10-12 weeks of gestation.
• Menstrual disorders / HRT - 10 mg once daily, preferably at the same time each day.
• Premenstrual syndrome - 10 mg taken from day 14 of the cycle until the start of menstruation.

Missed dose: If a dose is forgotten, take it as soon as remembered unless the next scheduled dose is due within 4 hours; in that case, skip the missed dose and continue the regular schedule. Do not double-dose.

Overdose: Acute overdose of dydrogesterone is uncommon. Reported symptoms include severe nausea, vomiting, dizziness, and excessive sedation. Management is primarily supportive-monitor vital signs, ensure hydration, and treat symptomatic manifestations. No specific antidote exists.

Practical precautions:

• Swallow tablets whole with water; do not crush or chew.
• Avoid concomitant use of strong CYP3A4 modulators without professional guidance.
• Refrain from operating heavy machinery if you experience dizziness or severe headache.

FAQ

• Can I travel internationally with Duphaston tablets? Yes, the medication can be taken while traveling. Keep the tablets in the original packaging with the label intact, and carry a copy of the prescription or a physician’s note if required by customs authorities.

• How should Duphaston be stored in hot climates? Store the tablets at temperatures below 30 °C (86 °F) and protect them from direct sunlight or moisture. If you live in a region with high humidity, keep the bottle in a sealed plastic bag or a temperature-controlled container.

• What does a Duphaston tablet look like? The 10 mg tablet is round, white to off-white, and may be scored to facilitate splitting. Imprints typically include the brand name “DUPHASTON” and the dosage “10 mg.”

• Are there any inactive ingredients that could cause allergies? Common excipients include lactose, microcrystalline cellulose, and magnesium stearate. Patients with lactose intolerance or known hypersensitivity to any of these substances should discuss alternatives with their clinician.

• Does Duphaston appear on drug-testing panels for athletes? Dydrogesterone is not listed as a prohibited substance by the World Anti-Doping Agency (WADA). However, athletes should verify the latest prohibited-substance list, as regulations can change.

• Is Duphaston considered a controlled substance? No, dydrogesterone is not classified as a controlled drug in most jurisdictions. It is regulated as a prescription-only medication due to its hormonal activity.

• How does Duphaston differ from natural progesterone? Dydrogesterone is a selective progesterone receptor agonist with a higher oral bioavailability and fewer androgenic side effects compared with micronised natural progesterone, which is metabolised extensively in the liver.

• Can I take Duphaston together with hormonal contraceptives? Concurrent use may interfere with the progestogenic component of combined oral contraceptives, potentially reducing contraceptive efficacy. Discuss alternative birth-control methods with a healthcare professional.

• Is alcohol consumption safe while using Duphaston? Moderate alcohol intake does not significantly affect the drug’s pharmacokinetics, but excessive drinking can increase liver enzyme activity and exacerbate gastrointestinal side effects. Limit alcohol to occasional, low-volume consumption.

• What happens if I miss several consecutive doses? A gap of several days may disrupt the hormonal balance required for the therapeutic effect, especially during luteal-phase support. Restart the regimen as soon as possible under medical guidance; in IVF cycles, missed doses may necessitate cycle cancellation.

• Does Duphaston have any impact on blood pressure? While most users experience no change, rare cases of mild hypertension have been reported. Patients with pre-existing hypertension should monitor blood pressure regularly.

Glossary

Progestogen

A class of steroid hormones that activate progesterone receptors, imitating the action of natural progesterone.

Luteal phase

The post-ovulatory segment of the menstrual cycle (approximately days 15-28) during which the corpus luteum secretes progesterone to prepare the endometrium for possible implantation.

CYP3A4 induction

An increase in the activity of the liver enzyme CYP3A4, which can accelerate the metabolism of drugs like dydrogesterone, potentially lowering their effectiveness.

Bioavailability

The proportion of an administered dose that reaches systemic circulation in an active form; oral dydrogesterone has relatively high bioavailability compared with natural progesterone.

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Disclaimer

The material presented here regarding Duphaston is intended for general educational purposes only and does not substitute professional medical advice. Treatment decisions-including those pertaining to off-label applications-must be made under the supervision of a qualified healthcare provider. Readers are assumed to be competent adults capable of making informed health choices. Our online pharmacy provides a means to obtain Duphaston for individuals who encounter limited availability through conventional pharmacies or who seek more affordable generic options. Always consult a medical professional before initiating, modifying, or discontinuing any medication.