Utrogestan

Utrogestan

progesterone

Manufacturer:

Besins Healthcare

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Micronised progesterone
Indications/Uses
Oral: Primary & secondary amenorrhea, premenstrual disorders, bleeding due to fibroma. Adjunctive use w/ oestrogen in post-menopausal women. Vag: Helps pregnancy in luteal phase support during in vitro fertilisation (IVF) cycles, threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to 12th wk of pregnancy & in preterm labour.
Dosage/Direction for Use
Max: Not exceeding 200 mg. Oral Progesterone insufficiency 200-300 mg daily. Pre-menstrual disorders, primary & secondary amenorrhea, & bleeding due to fibroma 200 mg in single evening dose or 200 mg at bedtime & 100 mg in the morning in 10 days/cycle from 17th-26th day inclusive. HRT in women receiving isolated estrogen 1 dose of 100 mg at bedtime from day 1-25 of each therapeutic cycle. 2 doses each of 100 mg or single dose of 200 mg in the evening 12-14 days mthly, or last 2 wk of each treatment sequence. Vag Supplementation of luteal phase during IVF cycles 400-600 mg daily in 2-3 divided doses from day of HCG inj until 12th wk of pregnancy. Threatened miscarriage or prevention of habitual miscarriage due to luteal phase insufficiency 200-400 mg daily in 2 divided doses until 12th wk of pregnancy. Preterm labour Women w/ history of preterm labour 100 mg daily until 36th wk pregnancy, cervix <15 mm detected at 22-26 wk 200 mg daily until 36th wk pregnancy.
Administration
Should be taken on an empty stomach: Preferably taken at bedtime.
Contraindications
Known allergy or hypersensitivity. Allergy to sunflower seeds. Undiagnosed vag bleeding; mammary or genital tract carcinoma; thrombophlebitis & thromboembolic disorders; cerebral haemorrhage; porphyria.
Special Precautions
Not suitable for use as contraceptive. Patients w/ conditions that might be aggravated by fluid retention eg, cardiac & renal disease, epilepsy, asthma. History of depression, diabetes; migraine. Assess woman prior to taking hormone & at regular interval thereafter. Consider personal/family history & physical exam for breast, pelvic organ & cervical cytology. Gravidic cholestasis-like; mild to moderate hepatic dysfunction. May affect ability to drive & use machines. Pregnancy (beyond 1st trimester) & lactation.
Adverse Reactions
GI disturbances, changes in appetite or wt, fluid retention, oedema, acne, chloasma (melasma), urticarial allergic skin rashes, mental depression, breast changes including discomfort or gynaecomastia, changes in libido, hair loss, hirsutism, fatigue, drowsiness or insomnia, fever, headache, premenstrual syndrome-like symptoms, altered menstrual cycles or irregular menstrual bleeding.
Drug Interactions
Increased bioavailability w/ concomitant food ingestion; ketoconazole. Accelerated metabolism by hepatic inducers eg, barbiturates, antiepileptics, rifampicin.
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 100 mg
Packing/Price
30's
Form
Utrogestan softgel 200 mg
Packing/Price
15's
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