Generic

Dydrogesterone

Indications

• Treatment for progesterone deficiency in women who are at risk of miscarriage
• Treatment for recurrent miscarriage
• Dysmenorrhoea treatment
• Endometriosis treatment Secondary amenorrhoea treatment
• Treatment for menstrual irregularities
• Treatment for uterine bleeding that isn't working
• Treatment for luteal insufficiency infertility
• As part of Assisted Reproductive Technology, luteal assistance is provided (ART)

Hormone Replacement Treatment: To counteract the effects of unopposed oestrogen on the endometrium in women with problems owing to natural or surgically induced menopause who have an intact uterus when using hormone replacement therapy.

Pharmacology

Dydrogesterone is an orally active progestogen that creates a full secretory endometrium in an oestrogen-primed uterus, hence protecting against oestrogen-induced endometrial hypertrophy and carcinogenesis. It's used to treat endogenous progesterone insufficiency in all situations. Dydrogesterone doesn't have any oestrogenic, androgenic, thermogenic, anabolic, or corticoid properties.

Dosage & Administration

Always take Presentation 10 mg tablet exactly as your doctor has prescribed.

Presentationerone deficiencies:

• Threatened miscarriage: 40 mg (four tablets) at once, then 10 mg (one tablet) every eight hours until symptoms remit.
• Habitual miscarriage: 10 mg (one tablet) twice daily until the twentieth week of pregnancy.
• Dysmenorrhoea: 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 bleeding (to arrest bleeding): 10 mg (one tablet) twice daily for five to seven days. Presentation should be given with oestrogen.
• Dysfunctional bleeding (to prevent bleeding): 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle. Presentation should be given with oestrogen.
• Amenorrhoea: An oestrogen once daily from day 1 to day 25 of the cycle, together with 10 mg Presentation twice daily from day 11 to day 25 of the cycle.
• Irregular 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. The treatment should be continued for at least 6 consecutive cycles. It is advisable to continue this treatment during the first month of any pregnancy using the doses stated with respect to habitual miscarriage.
• Luteal support as part of an Assisted Reproductive Technology (ART) treatment: 10 mg three times daily (three tablets daily) starting at the day of oocyte retrieval and continuing for 10 weeks if pregnancy is confirmed.

Hormone Replacement Therapy: In combination with continuous oestrogentherapy, take one tablet daily for 14 consecutive days of a 28 day cycle. In combination with cyclical oestrogen therapy take one tablet daily during the last 12 to 14 days of oestrogen therapy. For doctors: If endometrial biopsies or ultrasound reveal inadequate Presentationational response, 20 mg Dydrogesterone should be prescribed. For patients: If you are not sure what type of oestrogen therapy you are on, talk to your Doctor before taking Presentation. There is no relevant use of Dydrogesterone before menarche. The safety and efficacy of Dydrogesterone in adolescents aged 12 to 18 years has not been established.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients is known. Progestogen-dependent neoplasms that are known or suspected (e.g. meningioma).

Side Effects

Migraines/headaches, nausea, menstruation abnormalities, and breast pain/tenderness are the most commonly reported adverse medication responses in patients treated with Dydrogesterone in clinical studies of reasons without oestrogen therapy.

Pregnancy & Lactation

More than 10 million pregnancies are thought to have been exposed to Dydrogesterone. There have been no reports of Dydrogesterone use during pregnancy causing harm. Dydrogesterone excretion in mother's milk is unknown. Progestogens and their metabolites transfer to the mother's milk in tiny amounts, according to previous experience with other progestogens. It's unclear whether the child is in danger. As a result, Dydrogesterone should be avoided during lactation.

Precautions & Warnings

The etiology of irregular bleeding should be determined prior to starting dydrogesterone medication. During the first several months of treatment, you may experience breakthrough bleeding and spotting. If breakthrough bleeding or spotting occurs after a period of treatment or persists after treatment has been stopped, the cause should be examined, which may include an endometrial biopsy to rule out endometrial cancer. Stopping the medication should be considered if one of the following disorders appears for the first time or worsens during use.

Therapeutic Class

Female Sex hormones

Storage Conditions

Store below 30°C in a dry, light-protected location. Keep out of children's reach.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.