Marvelon

Marvelon

desogestrel + ethinylestradiol

Manufacturer:

Organon

Distributor:

Zuellig Pharma

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Desogestrel 150 mcg, ethinylestradiol 30 mcg
Dosage/Direction for Use
1 tab daily starting on 1st day of menstruation w/o interruption for 21 days, then 7 tab-free days.
Administration
May be taken with or without food: Take at the same time each day.
Contraindications
Hypersensitivity. Presence or history of venous & arterial thrombosis or prodromal conditions (eg, transient ischaemic attack, angina pectoris). Known predisposition & presence of severe or multiple risk factors for venous or arterial thrombosis. History of migraine w/ focal neurological symptoms. DM w/ vascular involvement. Pancreatitis or history associated w/ severe hypertriglyceridaemia. Known or suspected sex steroid-influence malignancies; undiagnosed vag bleeding. Major surgery w/ prolonged immobilisation. Concomitant use w/ HCV combination drug regimen. Severe hepatic disease, benign or malignant liver tumours. Known or suspected pregnancy.
Special Precautions
Increased risk of arterial & venous thrombotic & thromboembolic diseases; increasing age, +ve family history of venous or arterial thromboembolism, obesity, prolonged immobilisation, major surgery & trauma, leg surgery, superficial thrombophlebitis, varicose veins, smoking, dyslipoproteinaemia, HTN, migraine, valvular heart disease, atrial fibrillation; DM; SLE; haemolytic uraemic syndrome; Crohn's disease or ulcerative colitis; sickle cell disease. Hypertriglyceridaemia; gallstone formation; porphyria; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; hereditary angioedema. Chloasma; GI disturbances. Concomitant use w/ HCV combination drugs. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Exclude malignancy prior to therapy; irregular bleeding (eg, spotting or breakthrough bleeding) during 1st mth of use. Benign or malignant liver tumours; jaundice &/or pruritus related to cholestasis. Not to be used during pregnancy. Not recommended during lactation.
Adverse Reactions
Depression, altered mood; headache; nausea, abdominal pain; breast pain & tenderness; increased wt.
Drug Interactions
Increased clearance, reduced plasma conc & decreased efficacy by phenytoin, phenobarb, primidone, bosentan, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, HIV PIs, NNRTIs, St. John's wort. Increased or decreased plasma conc w/ nelfinavir, nevirapine, boceprevir, telaprevir. Increased serum conc w/ strong (eg, ketoconazole, itraconazole, clarithromycin) or moderate (eg, fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors. Increased plasma & tissue conc of ciclosporin. Decreased plasma & tissue conc of lamotrigine.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA09 - desogestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Presentation/Packing
Form
Marvelon tab
Packing/Price
3 × 21's
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