Exprogest 200mg

Contents: Progesterone

Indication: Replacement of progesterone during course of complete deficits in women w/ non-functioning ovaries (ovum transplant). Supplementation of luteal phase during course of cycles of in vitro fertilization (IVF) & spontaneous or induced cycles in case of hypofertility or primary or secondary sterility due to dysovulation. Threat of abortion or prevention of repetitive abortions due to luteal insufficiency.

Dosage: Vag Insert cap into the vagina deeply. Replacement of progesterone during course of complete deficits in women w/ non-functioning ovaries (ovum transplant) As complement of appropriate estrogenic treatment: 100 mg daily on 13th & 14th day of transfer cycle, then 200 mg daily (100 mg in the morning & at night) from 15th-25th day of cycle. Increased dose by 100 mg daily every wk from day 26 & in case of pregnancy to reach max dose of 600 mg daily divided into 3 doses. Maintain dosage until 60th day. Supplementation of luteal phase during course of IVF 400-600 mg daily from the day HCG is injected until 12th wk of pregnancy. Supplementation of luteal phase during course of spontaneous or induced cycles in case of hypofertility or primary or secondary sterility due to dysovulation 200-300 mg daily from 17th day of cycle for 10 days & resume as soon as possible in case of absence of periods & diagnosis of pregnancy. Threat of abortion or prevention of repetitive abortions due to luteal insufficiency 200-400 mg daily in 2 doses.

Contraindications: Hypersensitivity. Allergy to peanut or soya. Undiagnosed genital bleeding; liver tumors; suspected or confirmed breast or genital organ neoplasia; active or history of thromboembolic diseases; cerebral haemorrhage; porphyria; in case of contraindication related w/ estrogens when progesterone is used for HRT in conjunction w/ estrogen. Severe liver dysfunction.

Special Precautions: Discontinue use in event of ocular disorders (eg, reduced vision, diplopia & retinal vascular lesions), venous thromboembolic or thrombotic events & severe headaches. Not a contraceptive under recommended conditions for use. Use in threatened abortion or prevention of repetitive abortion should be reserved for cases in which secretion of corpus luteum is insufficient. Do not prescribe before establishing a cause, particularly w/ endometrial investigations, in case of uterine bleeding. Ensure patient is not pregnant if she develops amenorrhoea during treatment. Regular period-like bleeding is likely to occur in women w/ intact uterus upon w/drawal during treatment w/ estrogen & progesterone; in the absence of w/drawal bleeding, endometrial hyperplasia should be excluded. Breakthrough bleeding & spotting may occur during 1st few mth of treatment. Long-term treatment (>5 yr) w/ combinations of estrogen & progesterone may offer less endometrial protection than combination of estrogen/progestogen; regular endometrial monitoring is recommended. Closely monitor patients if they have past history of venous thrombosis. Take complete personal & family medical history prior to initiating or reinstituting HRT. Perform periodic check-ups during treatment. Use in the course of pregnancy should be reserved for 1st trimester. Not to be used during lactation. No relevant use in paed population.

Drug Interactions: Metabolism & elimination may be increased w/ drugs known to induce hepatic CYP450-3A4 eg, barbiturates, antiepileptics (eg, phenytoin, carbamazepine), rifampicin, phenylbutazone, spironolactone, griseofulvin, ampicillins, tetracyclines & herbal products containing St. John's wort. Bioavailability may be increased w/ ketoconazole & other CYP450-3A4 inhibitors. May affect results of lab tests of hepatic &/or endocrine functions. May decrease glucose tolerance & may increase insulin resistance or resistance to any other antidiabetics.