Utrogestan Dosage & Drug Information

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

Concise Prescribing Info

Contents

Micronized progesterone

Indications/Uses

Progesterone-deficiency related disorders. Oral: Menstrual irregularity due to dysovulation. HRT; adjunct use w/ oestrogen in postmenopausal women w/ intact uterus. Vag: In vitro fertilization (IVF) cycles; alternative to oral route if not tolerable.

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Dosage/Direction for Use

Not >200 mg/intake. PO Progesterone insufficiencies 200-300 mg daily in 1 or 2 divided doses, 100 mg in the morning & 100 or 200 mg at bedtime. May increase dose to 600 mg daily in 3 divided doses, in case of aiding pregnancy. Oestrogen replacement therapy in women w/ intact uterus 200 mg daily at bedtime for 12 days in the last ½ of each therapeutic cycle (beginning on day 15 and ending on day 26). Alternatively, 100 mg daily at bedtime from day 1 to day 25 of each therapeutic cycle. Vag Insert 1 cap deeply in the vag. Duration of treatment may depend on indication & efficacy of treatment.

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Overdosage

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Administration

PO: Should be taken on an empty stomach: Swallow whole w/ a glass of water.

Contraindications

Hypersensitivity. Allergy to sunflower, severe hepatic dysfunction, undiagnosed vag bleeding, mammary or genital tract carcinoma, thrombophlebitis, thromboembolic disorder, cerebral haemorrhage, porphyria.

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Warnings

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Special Precautions

Not for premature labour; contraceptive. Discontinue if unexplained, sudden or gradual, partial or complete loss of vision, proptosis or diplopia, papilloedema, retinal vascular lesions or migraine occur. Intended to be co-prescribed w/ an estrogen product as HRT. Increased risk of developing DVT or pulmonary embolism. Assess women prior to taking HRT & at regular intervals thereafter. Perform breast & pelvic exam when clinically indicated rather than as routine procedures. 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. May affect ability to drive & use machines. May reveal gravidic cholestasis upon use beyond 1st trimester of pregnancy. Lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Somnolence or transient dizziness. Acne, urticaria, rashes, fluid retention, wt changes, GI disturbances, changes in libido, breast discomfort, premenstrual symptoms, menstrual disturbances; chloasma, depression, pyrexia, insomnia, alopecia, hirsutism. VTE. Vag administration: Local irritation. PO: Altered menstrual cycles, amenorrhea, intermenstrual bleeding, headache.

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Drug Interactions

May interfere w/ bromocriptine effects & may raise plasma conc of cyclosporine. May affect the results of lab tests of hepatic &/or endocrine functions. Accelerated Utrogestan metabolism by rifamycin. Ketoconazole may increase bioavailability of progesterone.

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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

Utrogestan cap 100 mg

Packing/Price

2 × 15's (Rp360,000/boks)

Form

Utrogestan cap 200 mg

Packing/Price

7's;8's (Rp330,000/blister)

Utrogestan

progesterone

Manufacturer:

Besins Healthcare