Duphaston 10 mg

Description

Indications

Duphaston (Dydrogesterone) is prescribed for progesterone deficiencies and is used in the following conditions:

• Treatment of threatened miscarriage
• Treatment of habitual miscarriage
• Management of dysmenorrhea (painful periods)
• Treatment of endometriosis
• Management of secondary amenorrhea
• Regulation of irregular menstrual cycles
• Treatment of dysfunctional uterine bleeding
• Management of infertility due to luteal phase insufficiency
• Luteal support in Assisted Reproductive Technology (ART) treatments
• Hormone Replacement Therapy (HRT) to counteract unopposed estrogen effects on the endometrium in menopausal women with an intact uterus

Use this medication as directed by a registered physician.

Pharmacology

Dydrogesterone is an orally active progestogen that induces a fully developed secretory endometrium in an estrogen-primed uterus, providing protection against endometrial hyperplasia and the carcinogenic effects of estrogen. It is indicated in cases of endogenous progesterone deficiency. Unlike some other progestogens, Dydrogesterone does not exhibit estrogenic, androgenic, thermogenic, anabolic, or corticoid activity.

Dosage & Administration

Take Duphaston 10 mg exactly as prescribed by your doctor. The recommended dosage varies depending on the condition being treated:

• Threatened miscarriage: Initial dose of 40 mg (four tablets) followed by 10 mg (one tablet) every eight hours until symptoms resolve.
• Habitual miscarriage: 10 mg (one tablet) twice daily until the 20th week of pregnancy.
• Dysmenorrhea: 10 mg (one tablet) twice daily from day 5 to day 25 of the menstrual cycle.
• Endometriosis: 10 mg (one tablet) two or three times daily from day 5 to day 25 of the cycle or continuously.
• Dysfunctional uterine bleeding:
  • To stop bleeding: 10 mg (one tablet) twice daily for 5 to 7 days (used alongside estrogen).
  • To prevent bleeding: 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle (used alongside estrogen).
• Amenorrhea: Estrogen therapy from day 1 to day 25 of the cycle combined with Duphaston 10 mg twice daily from day 11 to day 25.
• Irregular menstrual cycles: 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle.
• Infertility due to luteal insufficiency: 10 mg (one tablet) daily from day 14 to day 25 of the cycle, continued for at least six cycles. If pregnancy occurs, continue as per habitual miscarriage treatment guidelines.
• Luteal support in ART treatments: 10 mg (one tablet) three times daily starting on the day of oocyte retrieval, continuing for 10 weeks if pregnancy is confirmed.
• Hormone Replacement Therapy:
  • With continuous estrogen therapy: 10 mg (one tablet) daily for 14 consecutive days in a 28-day cycle.
  • With cyclical estrogen therapy: 10 mg (one tablet) daily during the last 12 to 14 days of estrogen treatment.

For patients unsure about their estrogen therapy type, consult your doctor before taking Duphaston. This medication is not intended for use before menarche, and its safety and efficacy in adolescents (ages 12-18) have not been established.

Use this medication as directed by a registered physician.

Contraindications

Duphaston should not be used in individuals with:

• Known hypersensitivity to Dydrogesterone or any of its components
• Suspected or confirmed progestogen-dependent neoplasms (e.g., meningioma)

Side Effects

The most commonly reported side effects in clinical trials include:

• Headache or migraines
• Nausea
• Menstrual irregularities
• Breast tenderness or pain

Pregnancy & Lactation

Dydrogesterone has been used in over 10 million pregnancies with no confirmed harmful effects. However, data on its excretion in breast milk is unavailable. Other progestogens are known to pass into breast milk in small quantities, and the potential risk to infants is unknown. Therefore, it is advised to avoid Duphaston during lactation.

Precautions & Warnings

Before starting Duphaston for abnormal uterine bleeding, the underlying cause should be identified. Breakthrough bleeding or spotting may occur initially and should be evaluated if it persists. Medical evaluation, including endometrial biopsy, may be necessary to rule out malignancy.

Treatment should be reconsidered if any of the following occur:

• Severe headache or migraines suggestive of cerebral ischemia
• Significant increase in blood pressure
• Development of venous thromboembolism (VTE)

For cases of habitual or threatened miscarriage, fetal viability should be confirmed. Ongoing monitoring is essential to ensure pregnancy progression and fetal well-being. Patients with a history of depression should be closely observed, and treatment should be discontinued if severe depression recurs.

Overdose Effects

Duphaston has been well tolerated in doses up to 360 mg per day. No significant adverse effects have been reported. In case of overdose, gastric lavage may be considered within two to three hours. There is no specific antidote, and treatment should be symptomatic.

Therapeutic Class

Female sex hormones

Storage Conditions

• Store below 30°C in a dry place, away from direct light.
• Keep out of reach of children.