Safyron 10

Indications

Addressing Progesterone Deficiencies:

• Managing threatened miscarriage
• Handling habitual miscarriage
• Alleviating dysmenorrhoea
• Treating endometriosis
• Addressing secondary amenorrhoea
• Managing irregular cycles
• Dealing with dysfunctional uterine bleeding
• Resolving infertility due to luteal insufficiency
• Providing luteal support in Assisted Reproductive Technology (ART)

Hormone Replacement Therapy (HRT):

• Countering the effects of unopposed estrogen in HRT for women experiencing disorders due to natural or surgical menopause with an intact uterus.

Pharmacological Insights

Dydrogesterone, an orally-administered progestogen, facilitates the development of a complete secretory endometrium in an estrogen-primed uterus. This offers protection against the heightened risk of endometrial hyperplasia and carcinogenesis induced by estrogens. Indicated for all cases of endogenous progesterone deficiency, dydrogesterone exhibits no estrogenic, androgenic, thermogenic, anabolic, or corticoid activity.

Dosage & Administration

• Always adhere strictly to the prescribed dosage of 10 mg tablets.

Specific Instructions for Various Conditions:

• Threatened miscarriage: Initial dosage of 40 mg (four tablets) followed by 10 mg (one tablet) every eight hours until symptoms subside.
• 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 (arresting bleeding): 10 mg (one tablet) twice daily for five to seven days, preferably with estrogen.
• Dysfunctional bleeding (preventing bleeding): 10 mg (one tablet) twice daily from day 11 to day 25 of the cycle, preferably with estrogen.
• Amenorrhoea: Combined with daily estrogen from day 1 to day 25 of the cycle, with 10 mg dydrogesterone twice daily from day 11 to day 25.
• 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, continued for at least six consecutive cycles.
• Luteal support in ART: 10 mg three times daily (three tablets daily) from the day of oocyte retrieval, continuing for 10 weeks if pregnancy is confirmed.
• HRT: With continuous estrogen therapy, take one tablet daily for 14 consecutive days of a 28-day cycle. With cyclical estrogen therapy, take one tablet daily during the last 12 to 14 days of estrogen therapy.

Contraindications

• Avoid use in cases of known hypersensitivity to the active substance or any excipients, or suspected progestogen-dependent neoplasms.

Side Effects

The most commonly reported adverse reactions in clinical trials, when used without estrogen treatment, include migraines/headaches, nausea, menstrual disorders, and breast pain/tenderness.

Pregnancy & Lactation

While over 10 million pregnancies have been exposed to dydrogesterone with no indications of harm, caution is advised during lactation due to potential transfer of dydrogesterone and its metabolites into breast milk.

Precautions & Warnings

• Prior to initiating dydrogesterone treatment for abnormal bleeding, clarify the underlying cause. Monitor for breakthrough bleeding and spotting, investigate persistent bleeding post-treatment discontinuation, and consider endometrial biopsy to rule out malignancy.

Overdose Effects

Dydrogesterone has been well tolerated in oral dosages up to 360 mg daily, with no reported ill effects from overdose. Gastric lavage is recommended if overdose is discovered within two to three hours, with symptomatic treatment thereafter.

Therapeutic Class

Female sex hormones.

Storage Conditions

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