Miprogen

Miprogen

progesterone

Manufacturer:

Unosource Pharma

Distributor:

BSV Bioscience Phils
Concise Prescribing Info
Contents
Progesterone
Indications/Uses
Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogen tab. Secondary amenorrhea.
Dosage/Direction for Use
Prevention of endometrial hyperplasia in postmenopausal woman w/ uterus receiving daily conjugated estrogen tab 200 mg orally as single dose at bedtime for 12 days sequentially per 28-day cycle. Secondary amenorrhea 400 mg as single dose at bedtime for 10 days. Premenstrual syndrome, benign mastopathies, menstrual irregularities, pre-menopause Initially 200-300 mg daily for 10 days per cycle, usually from 14th day to until onset of menstruation.
Administration
Should be taken on an empty stomach: May be taken w/ glass of water while in standing position in women experiencing difficulty in swallowing cap.
Contraindications
Hypersensitivity. Thrombophlebitis, thromboembolic disorders, cerebral hemorrhage; breast carcinoma; suspected or confirmed breast/genital organ neoplasia; undiagnosed vag bleeding. Severe liver disease (if LFT results have failed to return to normal), hepatic cell tumors, rotor syndrome & Dubin-Johnson syndrome.
Special Precautions
Not a treatment for premature labour. May reveal gravidic cholestasis when prescribed beyond 1st trimester of pregnancy. Not suitable for use as a contraceptive. Discontinue & institute appropriate diagnostic & therapeutic measures if unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur during therapy. Intended to be co-prescribed w/ an estrogen product as HRT. Increased risk of developing DVT or pulmonary embolism; breast cancer w/ estrogen replacement therapy. Only be used in pregnancy during 1st trimester & only by vag route. Development of cholestatic jaundice of pregnancy or hepatocellular liver disease during 2nd & 3rd trimesters of pregnancy. Assess patient by taking personal & family medical history & physical exam prior to taking HRT (& at regular intervals thereafter). Increased bioavailability w/ concomitant food ingestion. Patients w/ conditions that might be aggravated by fluid retention (eg, HTN, cardiac disease, renal disease, epilepsy, migraine, asthma); history of depression, diabetes, photosensitivity. Perform clinical exam of breasts & pelvis where clinically indicated. May cause drowsiness &/or dizziness; caution is advised in drivers & users of machines. Mild to moderate hepatic dysfunction. Pregnancy & lactation.
Adverse Reactions
Breakthrough bleeding, change in menstrual flow, amenorrhoea, cervical erosion & secretions changes, breast changes, oedema, wt gain, catabolism, cholestatic jaundice, allergic reactions & rashes, acne, chloasma, mental depression, pyrexia, insomnia, somnolence, nausea, alopecia, hirsutism.
Drug Interactions
May interfere w/ the effects of bromocriptine. May raise plasma conc of ciclosporin. May affect lab tests results of hepatic &/or endocrine functions. Accelerated metabolism w/ rifamycin. Inhibited metabolism & may increase bioavailability w/ ketoconazole.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Form
Miprogen soft-gelatin cap 200 mg
Packing/Price
100's
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