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Utrogestan

Utrogestan

progesterone

Manufacturer:

Besins Healthcare

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Progesterone
Indications/Uses
Menace of abortion or prevention of recurrent spontaneous abortions due to luteal phase defect. Menace of preterm delivery. Oral Disorders associated w/ a progesterone deficit: pre-menstrual syndrome, menstrual irregularity, benign breast disease, pre-menopause. Menopause (adjuvant to oestrogen therapy). Infertility caused by luteal phase defect. Vag In vitro fertilization cycles (IVF).
Dosage/Direction for Use
Oral Standard daily dose: 200-300 mg in 1 or 2 doses. Luteal phase defect (pre-menstrual syndrome, menstrual irregularity, pre-menopause, benign breast disease) Administered over 10 days/menstrual cycle, usually from cycle days 17-26. Menopause As adjuvant therapy given during the last 2 wk of treatment sequence, followed by 1 wk susp of all replacement therapy. Threatened abortion or prevention of LPD-related recurrent spontaneous abortions 200-400 mg, spread over 2 doses, to be taken until wk 12 of gestation. Threatened preterm delivery 400 mg every 6-8 hr depending on the clinical results during the acute phase, followed by a maintenance dose to be taken up until 36 wk of gestation. Vag Usual daily dose: 200 mg to be inserted deep into the vag. Partial luteal phase defect (dysovulation, irregular menstrual cycles) 200 mg over 10 days/menstrual cycle, usually from cycle days 17-26. Infertility associated w/ total luteal phase defect (oocyte donation) Initially 100 mg on days 13 & 14 of the transfer cycle, followed by 100 mg in the morning & evening cycle days 15-25. From day 26 onwards, in the event of conception, increase dose in wkly increments of 100 mg/day to a max daily dose of 600 mg, spread over 3 doses. Dose is maintained until day 60. Luteal phase supplementation during IVF 600 mg spread over 3 doses. Threatened abortion or prevention of LPD-related recurrent spontaneous abortions 200-400 mg spread over 2 doses taken up until wk 12 of gestation. Threatened preterm delivery Active treatment: 200-300 mg bid-tid in 3 days. Maintenance: 100-200 mg/day until suppression of contraction.
Administration
Should be taken on an empty stomach.
Contraindications
Hypersensitivity. Severe changes in hepatic function.
Special Precautions
Menstrual cycle may be shortened &/or bleeding may occur if treatment sequence is initiated too early, particularly before cycle day 15. Must not be prescribed in the presence of uterine bleeding. Suspend treatment at the onset of eye disorders (eg, vision loss, diplopia, vascular lesions of the retina), VTE or thrombotic events, severe headaches. Administer over a min of 12 days/cycle during HRT involving oestrogens. Closely monitor patients w/ history of thrombophlebitis. May affect ability to drive or operate machinery. Lactation.
Adverse Reactions
Oral Altered menstrual cycles, amenorrhoea, intermenstrual bleeding, headaches. Vag Local irritation may occur.
Drug Interactions
Enhanced metabolization w/ enzyme inducers eg, barbiturates, phenytoin, rifampicin, phenylbutazone, spironolactone & griseofulvin. Change in enterohepatic circulation of steroids w/ ampicillin & tetracyclines. May reduce glucose tolerance.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Form
Utrogestan softgel cap (oral) 100 mg
Packing/Price
30's
Form
Utrogestan softgel cap (oral) 200 mg
Packing/Price
15's
Form
Utrogestan softgel cap (vag) 200 mg
Packing/Price
15's
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