Dydrogesterone

Indications
Treatment of progesterone deficiencies such as:
Treatment of dysmenorrhoea
Treatment of endometriosis
Treatment of secondary amenorrhoea
Treatment of irregular cycles
Treatment of dysfunctional uterine bleeding
Treatment of pre-menstrual syndrom
Treatment of threatened and habitual abortion, associated with proven progesterone deficiency
Treatment of infertility due to luteal insufficiency

Therapeutic Class
Female Sex hormones

Pharmacology
Dydrogesterone is a progestogen structurally related to progesterone. However, unlike progesterone, it does not induce an increase in temp nor inhibit ovulation and may be preferred over other progestational agents when contraceptive effect is not required. It does not have oestrogenic or androgenic properties.

Dosage & Administration
Recurrent miscarriage: 10 mg bid given cyclically until conception, then continuously until wk 20 of pregnancy, after which dose may be gradually reduced.
Infertility: 10 mg bid.
Menstrual disorders: 10 mg bid in a cyclical regimen.
Endometriosis: 10 mg bid-tid cyclically or continuously.
Threatened miscarriage: Initially, 40 mg followed by 10 mg or more every 8 hr, continued for a wk after symptoms are relieved. Reduce dose gradually after that unless symptoms return.
Endometrial protection during menopausal hormonal replacement therapy: 10 mg 1-2 times daily in a cyclical regimen or 5 mg daily.

Interaction
Carbamazepine, griseofulvin, phenobarbital, rifampicin enhances the clearance of progestogens.

Contraindications
Hypersensitivity to the active substance or to any of the excipients. Known or suspected progestogen dependent neoplasms. Undiagnosed vaginal bleeding

Side Effects
Dizziness, nausea, headache, fatigue, emotional lability, irritability; abdominal pain and distention; muskuloskeletal pain.

Pregnancy & Lactation
From spontaneous surveillance systems to date, there is no evidence that dydrogesterone can not be used during pregnancy.
Dydrogesterone is excreted in the milk of nursing mothers. A risk to the suckling child cannot be excluded. Dydrogesterone should not be used during breast-feeding.
There is no evidence that dydrogesterone decreases fertility at therapeutic dose.

Precautions & Warnings
Monitor closely for loss of vision, proptosis, diplopia, migraine, signs and symptoms of embolic disorders. CVD or renal impairment, epilepsy, asthma, other conditions which may be aggravated by fluid retention. Lactation.

Overdose Effects
Limited data are available with regard to overdose in humans. Dydrogesterone was well tolerated after oral dosing (maximum daily dose taken to date in humans 360 mg). No reports of ill-effects from overdose have been recorded. If a large overdose is discovered within two or three hours and treatment seems desirable, gastric lavage is recommended. There are no specific antidotes and treatment should be symptomatic. Aforementioned information is also applicable for overdosing in children.

Storage Conditions
Do not store above 30˚C. Keep in a dry place. Keep the blister in the outer carton, in order to protect from moisture.