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Endometrin

Endometrin

progesterone

Manufacturer:

Ferring

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Progesterone
Indications/Uses
Luteal support as part of an Assisted Reproductive Technology treatment program for infertile women.
Dosage/Direction for Use
Adult 100 mg vag bd-tds starting at oocyte retrieval & continuing for up to 10 wk total duration (or 12 wk of gestation).
Contraindications
Hypersensitivity. Undiagnosed vag bleeding. Known missed abortion or ectopic pregnancy. Severe hepatic dysfunction or disease. Known or suspected breast or genital tract cancer. Active arterial or VTE, severe thrombophlebitis or history of these events. Porphyria.
Special Precautions
Discontinue treatment if MI, cerebrovascular disorders, arterial or VTE (VTE or pulmonary embolism), thrombophlebitis or retinal thrombosis are suspected. Mild to moderate hepatic dysfunction. Closely observe patients w/ history of depression; consider discontinuation if symptoms worsen. Carefully observe conditions that might be influenced by fluid retention (eg, epilepsy, migraine, asthma, cardiac or renal dysfunction) & diabetic patients while receiving therapy. May increase risk of retinal vascular lesions; patients >35 yr, smokers & those w/ atherosclerosis risk factors. Terminate use in case of transient ischemic events, appearance of sudden severe headaches or vision impairments related to papillary edema or retinal hemorrhage. Abrupt discontinuation may cause increased anxiety, moodiness & increased sensibility to seizures. Assess patient & her partner for causes for infertility before starting treatment. May cause drowsiness &/or dizziness; minor or moderate influence on ability to drive & use machines. Impaired liver or renal function. Pregnancy. Not to be used during lactation. Elderly >65 yr.
Adverse Reactions
Headache; abdominal distention & pain, nausea; uterine spasm.
Drug Interactions
May increase elimination rate w/ drugs known to induce hepatic CYP450-3A4 system (eg, rifampicin, carbamazepine or St. John's wort-containing herbal products). May decrease elimination rate w/ ketoconazole & other CYP450-3A4 inhibitors. May alter progesterone release & absorption from vag tab when used w/ other vag products (eg, antifungals).
MIMS Class
Preparations for Vaginal Conditions
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Form
Endometrin vag tab 100 mg
Packing/Price
21's
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