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Oligest

Oligest

dienogest

Manufacturer:

OLIC

Distributor:

DKSH

Marketer:

OLIC
Concise Prescribing Info
Contents
Dienogest
Dosage/Direction for Use
1 tab daily w/o interruption, taken preferably at the same time each day, starting on any day of the menstrual cycle.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Active venous thromboembolic disorder. Past or present arterial & CV disease (eg, MI, CVA, ischemic heart disease). DM w/ vascular involvement. Known or suspected sex hormone-dependent malignancies. Undiagnosed vag bleeding. Ocular lesions due to ophth vascular disease eg, partial or complete vision loss or visual defect. Presence or history of migraine w/ focal aura. Presence or history of severe hepatic disease as long as liver function values have not returned to normal; liver tumors (benign or malignant). Pregnancy & lactation.
Special Precautions
Not a contraceptive. Consider discontinuation of therapy w/ prolonged heavy bleeding; significant HTN; symptoms of arterial or venous thrombotic event or suspicion thereof; serious depression recurrence in patients w/ history of depression; prior history of cholestatic jaundice &/or pruritus during pregnancy or due to sex steroid use. Rule out endometrial pathology if bleeding irregularities continue w/ prolonged use. Changes in bleeding pattern (eg, amenorrhea, infrequent or frequent bleeding, prolonged bleeding). Patients w/ risk factors for VTE including personal or family history, obesity, prolonged immobilization, major surgery or trauma. May impair glucose tolerance. DM (especially w/ history of gestational DM). History of chloasma; avoid sun or UV radiation exposure. Persistent ovarian follicles (functional ovarian cysts) which are often asymptomatic may occur. Increased risk of breast cancer in women using OCs. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not indicated in childn prior to menarche. Evaluate prior to & regularly during therapy in adolescents (12-18 yr) due to risk of bone mineral density loss.
Adverse Reactions
Increased wt; depressed mood, sleep disorder, nervousness, loss of libido, nausea; depression; headache, migraine; nausea, abdominal pain & distension; flatulence; acne, alopecia; back pain; breast discomfort, ovarian cyst, hot flushes, uterine/vag bleeding including spotting, asthenic conditions, irritability.
Drug Interactions
Increased clearance (diminished efficacy) w/ CYP3A4 inducers eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin & possibly oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort. Increased/decreased plasma conc w/ combinations of HIV/HCV PIs & NNRTIs. Increased plasma conc w/ strong CYP3A4 inhibitors eg, ketoconazole & moderate inhibitor erythromycin. May influence lab test results including liver, thyroid, adrenal, renal function, protein plasma levels, carbohydrate metabolism, coagulation & fibrinolysis parameters.
MIMS Class
Oestrogens, Progesterones & Related Synthetic Drugs
ATC Classification
G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.
Presentation/Packing
Form
Oligest tab 2 mg
Packing/Price
2 × 14's
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