Cyclogest 400

Cyclogest 400

progesterone

Manufacturer:

Accord-UK

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Progesterone
Indications/Uses
Premenstrual syndrome including PMT & depression. Puerperal depression. Luteal phase support as part of an assisted reproductive technology (ART) treatment for women.
Dosage/Direction for Use
Premenstrual syndrome & puerperal depression 400 mg bd by vag or rectal insertion. For premenstrual syndrome, start treatment on day 14 of menstrual cycle & continue treatment until onset of menstruation. If symptoms are present at ovulation, start treatment on day 12. Luteal phase support as part of an ART treatment 400 mg vaginally bd starting at oocyte retrieval, continue for 38 days if pregnancy has been confirmed.
Contraindications
Hypersensitivity. Undiagnosed vag bleeding. Known or suspected progesterone sensitive malignant tumours. Porphyria. Known missed abortion or ectopic pregnancy. Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. Severe hepatic dysfunction or disease.
Special Precautions
Not for threatened miscarriage. Discontinue treatment in the event of a missed miscarriage; if w/ suspected MI, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis or retinal thrombosis. May increase risk of thromboembolism in women w/ generally recognized risk factors eg, personal or family history. Closely observe patients w/ history of depression; conditions that might be influenced by degree of fluid retention (eg, epilepsy, migraine, asthma, cardiac or renal dysfunction); diabetic patients while receiving therapy. Patients w/ hormone-sensitive conditions. Use rectally if barrier methods of contraception are used or if patients suffer from vag infection (especially moniliasis) or recurrent cystitis. Use vaginally if patients suffer from colitis or fecal incontinence. Hepatic dysfunction. Not to be used during pregnancy (except as indicated during the 1st trimester as part of an ART treatment) & lactation. Childn. Elderly >65 yr.
Adverse Reactions
Somnolence; hot flush; abdominal distension & pain, constipation; breast pain; fatigue.
Drug Interactions
May increase elimination rate & decrease bioavailability w/ known CYP450-3A4 inducers (eg, rifampicin, carbamazepine or phenytoin). Not recommended to be used concomitantly w/ vag products.
ATC Classification
G03DA04 - progesterone ; Belongs to the class of pregnen (4) derivative progestogens.
Presentation/Packing
Form
Cyclogest 400 pessary 400 mg
Packing/Price
3 × 5's
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