Zuellig Pharma
Concise Prescribing Info
For luteal support as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
Dosage/Direction for Use
Adult 100 mg administered vag bid-tid starting at oocyte retrieval & continuing for up to 10 wk total duration (or 12 wk of gestation). Patient >40 yr 100 mg vag tid.
Hypersensitivity. Undiagnosed vag bleeding, known missed abortion or ectopic pregnancy, severe hepatic dysfunction, known or suspected breast or genital tract cancer, history of or active arterial or venous thromboembolism or severe thrombophlebitis, porphyria.
Special Precautions
Discontinue use if MI, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis or retinal thrombosis are suspected, or if transient ischemic events, appearance of sudden severe headaches, or vision impairments related to papillary edema or retinal hemorrhage occurs. Closely observe patients w/ history of depression, epilepsy, migraine, asthma, cardiac or renal dysfunction & diabetics. Patients who are >35 yr, smokers, & those w/ risk factors for atherosclerosis. May cause increased anxiety, moodiness & increased sensibility to seizures w/ abrupt discontinuation. Mild to moderate hepatic dysfunction. May affect ability to drive or operate machinery. Pregnancy & lactation.
Adverse Reactions
Headache; abdominal distension & pain, nausea; uterine spasm.
Drug Interactions
Elimination may be increased by drugs known to induce hepatic CYP450-3A4 system eg, rifampicin, carbamazepine & St. John's wort (Hypericum perforatum). Bioavailability may be increased by ketoconazole & other inhibitors of CYP450-3A4. Release & absorption may be altered by other vag products eg, antifungals.
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Endometrin vag tab 100 mg
7 × 3's
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