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Froniquiest

Froniquiest

progesterone

Manufacturer:

Unosource Pharma

Distributor:

Frontida Pharma

Marketer:

Ambica
Concise Prescribing Info
Contents
Progesterone
Indications/Uses
Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogen tab; recurrent spontaneous abortions due to luteal phase defect; preterm labor. 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 daily dose at bedtime for 12 days sequentially per 28-day cycle. Secondary amenorrhea 400 mg as single daily 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. Threatened abortion or prevention of LPD-related recurrent spontaneous abortions 200-400 mg daily spread over 2 doses, to be taken up until gestation wk 12. Threatened preterm delivery 400 mg every 6-8 hr, depending on clinical results obtained during acute phase, followed by maintenance dose (eg, 3 x 200 mg/day) to be taken up until gestation wk 36.
Administration
Should be taken on an empty stomach: For women who experience difficulty swallowing cap, take w/ a glass of water while in standing position.
Contraindications
Hypersensitivity. Thrombophlebitis, thromboembolic disorders, cerebral hemorrhage; breast carcinoma; suspected or confirmed breast/genital organ neoplasia; undiagnosed vag bleeding. Severe liver disease (if LFTs results have failed to return to normal), hepatic cell tumors, rotor syndrome & Dubin-Johnson syndrome.
Special Precautions
May reveal gravidic cholestasis when prescribed beyond 1st trimester of pregnancy. Not suitable for use as contraceptive. Discontinue & institute appropriate diagnostic & therapeutic measures if unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilledema, retinal vascular lesions or migraine occur during therapy. Intended to be co-prescribed w/ estrogen product eg, HRT. Increased risk of developing DVT or pulmonary embolism; breast cancer w/ estrogen replacement therapy. 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, migraine or 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, amenorrhea, cervical erosion & secretions changes, breast changes, edema, wt gain, catabolism, cholestatic jaundice, allergic reactions & rashes, acne, chloasma, mental depression, pyrexia, insomnia, somnolence, nausea, alopecia, hirsutism.
Drug Interactions
May interfere w/ 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 & increased 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
Froniquiest soft gelatin oral cap 200 mg
Packing/Price
100's;30's
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