desogestrel + ethinylestradiol




Agencia Lei Va Hong
Concise Prescribing Info
Desogestrel 0.15 mg, ethinylestradiol 0.03 mg
Dosage/Direction for Use
1 tab daily for 21 consecutive days. Each subsequent strip is started after a 7-day tab-free interval.
May be taken with or without food.
Hypersensitivity. Presence or risk of venous & arterial thromboembolism. Presence or history of pancreatitis associated w/ severe hypertriglyceridaemia; severe hepatic disease as long as liver function values have not returned to normal; liver tumours (benign or malignant). Known or suspected sex steroid-influenced malignancies. Endometrial hyperplasia. Undiagnosed vag bleeding. Concomitant use w/ medicinal products containing ombitasvir/paritaprevir/ritonavir & dasabuvir.
Special Precautions
Increased risk of venous thromboembolism; arterial thromboembolism; CVA (eg, transient ischaemic attack, stroke). Risk of developing cervical cancer in women infected w/ human papillomavirus (HPV); breast cancer; liver tumours. ALT elevations in HCV patients treated w/ ombitasvir/paritaprevir/ritonavir & dasabuvir, w/ or w/o ribavirin. Increased risk of pancreatitis in women w/ hypertriglyceridaemia or family history thereof. Small increases in BP. Consider discontinuation in case of acute or chronic disturbances of liver function. Diabetic women. Associated w/ Crohn's disease & ulcerative colitis. Chloasma may occasionally occur, especially in women w/ history of chloasma gravidarum. Irregular bleeding may occur, especially during the 1st mth of use. Reduced efficacy in case of missed tab, GI disturbances, concomitant medications that decrease plasma conc of ethinyloestradiol &/or etonogestrel. Should not be used w/ herbal prep containing St. John's wort. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption. May influence results of certain laboratory tests (eg, biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins eg, corticosteroid-binding globulin, lipid/lipoprotein fractions & parameters of carbohydrate metabolism, coagulation & fibrinolysis). Not indicated during pregnancy. Consider increased risk of venous thromboembolism during postpartum period when restarting Marvelon. Lactation.
Adverse Reactions
Depressed & altered mood, headache, nausea, abdominal pain, breast pain & tenderness, increased wt.
Drug Interactions
Increased clearance w/ phenytoin, phenobarb, primidone, bosentan, carbamazepine, rifampicin, some HIV PIs (eg, ritonavir) & NNRTIs (eg, efavirenz, nevirapine), & possibly oxcarbazepine, topiramate, rifabutin, felbamate, griseofulvin, St. John's wort. Increased/decreased plasma conc w/ combinations of HIV PIs (eg, nelfinavir) & NNRTIs (eg, nevirapine), &/or combinations of HCV medicinal products (eg, boceprevir, telaprevir). Increased serum conc w/ strong (eg, ketoconazole, itraconazole, clarithromycin) or moderate (eg, fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors. Increased plasma conc of ethinylestradiol w/ etoricoxib. Increased plasma & tissue conc of ciclosporine. Decreased plasma & tissue conc of lamotrigine. Weak increases in plasma conc of theophylline. Moderate increases in plasma conc of tizanidine.
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.
Marvelon tab
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