GynProgesterone 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 Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Progesterone

Indications/Uses

Oral: Disorders related to progesterone insufficiency & particularly primary & secondary amenorrhea, premenstrual disorder, bleeding due to fibroma, & adjunctive use w/ oestrogen in post-menopausal women. Vag: Luteal phase support during in vitro fertilisation (IVF) cycles; threatened miscarriage or prevention of habitual miscarriage due to luteal phase deficiency up to 12^th wk of pregnancy; preterm labour.

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Dosage/Direction for Use

Oral Progesterone insufficiency 200-300 mg daily. Pre-menstrual disorders, primary & secondary amenorrhea & bleeding due to fibroma 200-300 mg daily: 200 mg as single evening dose before going to bed, or 300 mg in 2 divided doses (200 mg before going to bed & 100 mg in the morning if necessary), 10 days per cycle, usually from 17^th-26^th day inclusive. HRT in women receiving isolated estrogen 100 mg single dose at bedtime from day 1-25 of each cycle, or 200 mg as single dose or two 100 mg doses in the evening to bedtime, 12-14 days/mth, or last 2 wk of each treatment sequence, & must be followed by total discontinuation of any replacement therapy for approx 1 wk. Vag Supplementation of luteal phase during IVF cycles 400-600 mg daily in 2-3 divided doses from day of hCG inj until 12^th wk of pregnancy. Threatened miscarriage or prevention of habitual miscarriage due to luteal phase insufficiency 200-400 mg daily in 2 divided doses up until 12^th wk of pregnancy. Preterm labour Women w/ history of preterm labour 100 mg daily from 20 wk of gestation until risk of prematurity is low, women w/ cervix shorter than 15 mm detected at 22-26 wk 200 mg daily until 36^th wk of pregnancy.

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Overdosage

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Administration

Should be taken on an empty stomach.

Contraindications

History of hypersensitivity & thromboembolic disorders. Patients allergic to peanuts or soy. Undiagnosed vag bleeding; mammary or genital tract carcinoma; thrombophlebitis; cerebral haemorrhage; porphyria. Oral: Abnormal liver function.

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Special Precautions

Not to be used as contraceptive. Patients w/ conditions that might be aggravated by fluid retention (eg, cardiac & renal disease, epilepsy, migraine, asthma); history of depression, diabetes, mild to moderate hepatic dysfunction, & migraine. Assess patient prior to taking hormone & at regular intervals thereafter. Perform personal & family medical history, & physical exam including reference to breast & pelvic organ as well as cervical cytology. May affect ability to drive & use machines. Risk of undesirable effects on liver during 2nd & 3rd trimesters use. Use only as vag during pregnancy. Not to be used during 1st trimester of pregnancy. Not recommended during lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness, headache, abdominal pain & distension, fatigue, viral infection, musculoskeletal pain, emotional lability, irritability, URTI; menstrual disturbances, premenstrual-like syndrome (including bloating, fluid retention, breast tenderness), wt change, nausea, insomnia, depression, change in libido; skin reactions (including urticaria, pruritus, rash & acne), hirsutism & alopecia; jaundice, anaphylactoid reactions. Extreme dizziness &/or drowsiness, blurred vision, slurred speech, difficulty walking, loss of consciousness, vertigo, confusion, disorientation, shortness of breath.

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Drug Interactions

Enhanced clearance w/ enzyme-inducing drugs eg, carbamazepine, griseofulvin, phenobarb, phenytoin & rifampicin. Increased bioavailability w/ ketoconazole & other CYP450-3A4 inhibitors eg, ritonavir & nelfinavir; food. May affect results of hepatic &/or endocrine function lab tests.

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Caution For Usage

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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.

Thai FDA Category

Presentation/Packing

Form

GynProgesterone soft cap 100 mg

Packing/Price

1 × 15's

Form

GynProgesterone soft cap 200 mg

Packing/Price

1 × 15's

GynProgesterone

progesterone

Manufacturer:

Exeltis

Distributor:

DKLL