P - Contraindicated in pregnancy
L - Caution when used during lactation
Dydrogesterone is a progestogen hormone. The brand name is Duphaston and manufactured by Solvay Pharmaceuticals.
Dydrogesterone was first introduced to the market in 1961, and is currently approved in over 100 countries world-wide. It has an estimated cumulative exposure of more than 28 million patients.
Dydrogesterone is a potent, orally active progestogen indicated in a wide variety of gynaecological conditions. Although similar in molecular structure and pharmacological effects to endogenous progesterone. It is orally active at far lower doses. Its freedom from oestrogenic, androgenic, anabolic, corticoid and other undesirable hormonal effects gives it additional benefits over most other synthetic progestogens. The therapeutic use of dydrogesterone is closely related to its physiological action on the neuro-endocrine control of ovarian function, as well as on the endometrium. As such, it is indicated in all cases of relative or absolute endogeneous progesterone deficiency.
Dydrogesterone has proven effective in the following conditions:
menstrual disorders
infertility
threatened and habitual abortion
endometriosis
premenstrual syndrome
Dydrogesterone has also been registered as hormone replacement therapy (HRT) to counteract the negative effects of unopposed oestrogen on the endometrium. Dydrogesterone is safe and well-tolerated. The incidence of side-effects is remarkably low.
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.
Absorption: Absorbed following buccal, rectal, and vag administration; rapidly absorbed following (IM).
Metabolism: Hepatic: Extensive first-pass effect.
Excretion: Via urine (as sulfate and glucuronide conjugates).
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Dizziness, nausea, headache, fatigue, emotional lability, irritability; abdominal pain and distention; muskuloskeletal pain.
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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.
Carbamazepine, griseofulvin, phenobarbital, rifampicin enhances the clearance of progestogens.
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Oral
Endometriosis
Adult: 10 mg bid-tid cyclically or continuously.
Oral
Recurrent miscarriage
Adult: 10 mg bid given cyclically until conception, then continuously until wk 20 of pregnancy, after which dose may be gradually reduced.
Oral
Menstrual disorders
Adult: 10 mg bid in a cyclical regimen.
Oral
Threatened miscarriage
Adult: 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.
Oral
Infertility
Adult: 10 mg bid.
Oral
Endometrial protection during menopausal HRT
Adult: 10 mg 1-2 times daily in a cyclical regimen or 5 mg daily.
May be taken with or without food
Contraindicated in pregnancy
Caution when used during lactation
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Hypersensitivity; pregnancy. Undiagnosed abnormal vag bleeding, thromboembolic disorders, history or existing cerebrovascular or coronary artery disease, missed or incomplete abortion, known or suspected carcinoma of the breast or genital organs, severe hepatic dysfunction, as a diagnostic test for pregnancy.
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