Progesterone - oral


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Progestogen component of menopausal HRT 200 mg at bedtime for 12-14 days of each mth. Amenorrhoea; Dysfunctional uterine bleeding 400 mg/day for 10 days. IM Amenorrhoea; Dysfunctional uterine bleeding 5-10 mg/day for 5-10 days until 2 days before expected onset of menstruation. Recurrent miscarriage w/ progesterone deficiency 25-100 mg twice wkly from the 15th day of pregnancy until 8-16 wk. May increase to daily inj if needed. Vag Amenorrhoea; Dysfunctional uterine bleeding 45 mg every other day from the 15th-25th day of the cycle. Rectal/Vag Premenstrual syndrome 200 mg/day, up to 400 mg twice daily. Start on days 12-14 of the cycle and continue till onset of menstruation. Intrauterine Contraception As device containing progesterone 38 mg: Insert into the uterine cavity.
Dosage Details
Intramuscular
Dysfunctional uterine bleeding, Amenorrhoea
Adult: 5-10 mg daily for 5-10 days until 2 days prior to expected onset of menstruation.

Intramuscular
Recurrent miscarriage with progesterone deficiency
Adult: 25-100 mg twice wkly from the 15th day of pregnancy until 8-16 wk. May increase to daily inj, if necessary.

Intrauterine
Contraception
Adult: Insert the device (containing 38 mg of progesterone) into the uterine cavity; efficacy can last up till 1 yr.

Oral
Progestogen component of menopausal hormonal replacement therapy
Adult: 200 mg daily as a single daily dose at night for 12-14 days of each mth.

Oral
Amenorrhoea, Dysfunctional uterine bleeding
Adult: 400 mg daily for 10 days.

Vaginal
Premenstrual syndrome
Adult: 200 mg daily, may increase to 400 mg bid. Treatment is usually started on days 12-14 of the cycle and continues until onset of menstruation. Same doses may also be given rectally.

Vaginal
Dysfunctional uterine bleeding, Amenorrhoea
Adult: 45 mg every other day from the 15th-25th day of the cycle. May increase dose to 90 mg in non-responders.
Administration
Should be taken on an empty stomach.
Contraindications
Hypersensitivity; thrombophloebitis; cerebral apoplexy; severe hepatic impairment; undiagnosed vag bleeding, incomplete abortion, hormone-dependent carcinoma, as a diagnostic test for pregnancy; pregnancy. History or current high risk of arterial disease.
Special Precautions
Discontinue medications if there is sudden partial or complete loss of vision, proptosis or diplopia; migraine and embolic disorders; epilepsy, migraine, asthma, cardiac or renal dysfunction. History of depression, glucose tolerance and diabetic patients. May impair ability to drive or operate machinery. Avoid sudden withdrawal of progesterone; lactation.
Adverse Reactions
GI disturbances, appetite/wt change, fluid retention, oedema, acne, skin rash, urticaria, depression, headache, fever, fatigue, breast changes, hirsutism, changes in libido, altered menstrual cycles or irregular menstrual bleeding (rare).
Drug Interactions
Enhanced clearance with enzyme-inducing drugs eg, carbamazepine, griseofulvin, phenobarbital, phenytoin and rifampicin. Ketoconazole may increase serum levels of progesterone. May inhibit ciclosporin metabolism.
Lab Interference
May alter serum lipid profile and rarely, LFTs.
Action
Description: Progesterone is the main hormone secreted by corpus luteum. It induces secretory changes in the endometrium, promotes mammary gland development, relaxes uterus, blocks follicular maturation and ovulation, and maintains pregnancy.
Pharmacokinetics:
Absorption: Oral bioavailability is low.
Distribution: Highly bound to plasma proteins. Distributes into breast milk.
Metabolism: Hepatic; extensive 1st-pass effect.
Excretion: Via the urine (as sulfate and glucuronide conjugates).
Disclaimer: This information is independently developed by MIMS based on Progesterone from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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