DUPHASTON 10/MG FC TAB 20/FC TAB

Indications

Approved Uses

Indications include menstrual disorders (e.g., dysmenorrhea, irregular cycles, secondary amenorrhea), endometriosis, premenstrual syndrome, dysfunctional uterine bleeding, infertility due to luteal insufficiency, threatened miscarriage and recurrent (habitual) miscarriage associated with progesterone deficiency, and as the progestogen component of menopausal hormone therapy with estrogen.

Off-Label Uses

Off-label: luteal phase support in ART/IVF; other off-label gynecologic uses may include adenomyosis-related symptom control depending on local practice.

Dosage & Administration

Dosing by Condition

Typical adult regimens (10 mg tablets): Dysmenorrhea: 10 mg twice daily on days 5-25 of cycle. Endometriosis: 10 mg 2-3 times daily on days 5-25 or continuously. PMS: 10 mg twice daily on days 11-25. Irregular cycles: 10 mg twice daily on days 11-25. Secondary amenorrhea (with estrogen): 10 mg twice daily on days 11-25 of a 28‑day cycle. Dysfunctional uterine bleeding: to stop bleeding 10 mg twice daily for 5-7 days; to prevent recurrence 10 mg twice daily on days 11-25. Infertility due to luteal insufficiency: 10 mg twice daily on days 14-25 for at least 6 cycles (continue if pregnancy occurs as directed). Threatened miscarriage: 40 mg once, then 10 mg every 8 hours until symptoms resolve. Habitual (recurrent) miscarriage: 10 mg twice daily until about week 20 of pregnancy (then taper per clinician). HRT with estrogen: 10 mg daily for 12-14 days of each 28‑day cycle (or per sequential/continuous combined regimen).

Initial Dose

10 mg once or twice daily depending on indication

Maintenance Dose

10 mg twice daily (most indications); 10 mg once daily (HRT component)

Maximum Dose

Depends on indication; commonly up to 30 mg/day in divided doses, with some protocols using a 40 mg loading dose then 20 mg/day for threatened miscarriage.

Children's Dosage

Not approved for children; indicated only in women of reproductive age

How to Take

Oral use: swallow the 10 mg film‑coated tablet whole with water; may be taken with or without food; take exactly as prescribed (often on specific cycle days) and try to take doses at the same time each day.

Drug Interactions

Food Interaction

No restriction

Special Populations

Children

Not approved for children; indicated only in women of reproductive age

Elderly

Standard adult dosing when used as HRT component; no specific dose reduction required but monitor for thromboembolic risk

Pharmacology

Mechanism of Action

Orally active synthetic progestogen that binds progesterone receptors to produce secretory transformation of estrogen-primed endometrium and support luteal function/pregnancy maintenance; at therapeutic doses it generally does not suppress ovulation and has minimal androgenic/estrogenic activity.

Product Information

Available Dosage Forms

Film-coated tablet (10 mg), oral use.

Composition per Dose

Each film-coated tablet: 10 mg dydrogesterone

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Hormone Type

Progesterone

Method

Oral

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