Progestedin Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Progesterone

Indications/Uses

Prevention of endometrial hyperplasia in non-hysterectomized postmenopausal women who are receiving conjugated estrogen tab. Secondary amenorrhea.

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Dosage/Direction for Use

Prevention of endometrial hyperplasia in postmenopausal women w/ uterus who are receiving estrogen 200 mg for 12 days sequentially per 28-day cycle. Secondary amenorrhea 400 mg for 10 days. Premenstrual syndrome, benign mastopathies, menstrual irregularities, pre-menopause Starting dose: 200-300 mg/day for 10 days (usually from 14th day to until onset of menstruation).

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Overdosage

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Administration

Should be taken on an empty stomach: Should be taken at bedtime.

Contraindications

Hypersensitivity. Severe liver disease, hepatic cell tumors, rotor syndrome & Dublin-Johnson syndrome; suspected or confirmed breast or genital organ neoplasia (eg, breast carcinoma); undiagnosed vag bleeding; history of thrombophlebitis, thromboembolic disorders, cerebral hemorrhage. Not recommended during the first 4 mth of pregnancy.

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Special Precautions

Increased risk of breast cancer w/ estrogen replacement therapy, DVT or pulmonary embolism. Patients w/ conditions that might be aggravated by fluid retention eg, HTN, cardiac disease, renal disease, epilepsy, migraine, asthma; history of depression, diabetes, mild to moderate hepatic dysfunction, migraine or photosensitivity & breastfeeding mothers. W/hold if explained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occurs. Hepatic & renal impairment. May affect ability to drive & use machinery. Women w/ existing or history of breast cancer; known risk factors of breast cancer eg, strong family history of breast cancer. Use of micronized progesterone during second & third trimesters of pregnancy can develop cholestatic jaundice of pregnancy or hepato-cellular liver disease. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Breakthrough bleeding, change in menstrual flow, amenorrhea, changes in cervical erosion & secretions, breast changes, edema, wt gain, catabolism, cholestatic jaundice, allergic reactions & rashes, acne, chloasma, mental depression, pyrexia, insomnia, somnolence, nausea, alopecia, hirsutism.

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Drug Interactions

Interfere w/ the effects of bromocriptine. Increase plasma conc w/ ciclosporin. May affect lab tests results of hepatic & endocrine functions. Accelerated metabolism by rifamycin. May increase metabolism w/ ketoconazole.

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Storage

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Description

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Action

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MIMS Class

Oestrogens, Progesterones & Related Synthetic Drugs

ATC Classification

G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.

Regulatory Classification

Presentation/Packing

Form

Progestedin soft gel cap 200 mg

Packing/Price

30's (P1,495.5/box, P49.85/soft-gelatin cap)

Progestedin

progesterone

Manufacturer:

Akums Drug

Distributor:

MedChoice Women's Health