Marvelon 28

Marvelon 28

desogestrel + ethinylestradiol

Manufacturer:

Organon

Distributor:

Organon
Concise Prescribing Info
Contents
Desogestrel 150 mcg, ethinylestradiol 30 mcg (21 active tab plus 7 small, inert tabs)
Dosage/Direction for Use
1 tab daily for 21 consecutive days. Each subsequent pack is starting after a 7-day tab-free interval, during which time a w/drawal bleed usually occurs. Starts on day 2-3 after the last tab & may not have finished before the next pack is started. No hormonal contraceptive has been used in the past mth Start on the 1st day of menstrual bleeding. Use barrier method for the 1st 7 days of tab-taking during the 1st cycle. When changing from another combined hormonal contraceptive (combined OC, vag ring or transdermal patch) Start on the day after the last active tab of combined OC, or on the day of removal of vag ring or patch). When changing from progestogen-only method (minipill, inj, implant) or progestogen-releasing IUS May switch to Marvelon 28 right away but should use barrier method for the 1st 7 days of tab-taking. Following 1st-trimester abortion Start immediately. After delivery or 2nd-trimester abortion Start at day 21-28 after delivery or 2nd trimester abortion.
Administration
May be taken with or without food: Take at about the same time every day w/ some liqd.
Contraindications
Hypersensitivity. Presence or history of venous thrombosis (DVT, pulmonary embolism), arterial thrombosis (MI, CVA) or prodromal conditions (eg, transient ischemic attack, angina pectoris); known predisposition for venous or arterial thrombosis eg, activated protein C (APC) resistance, antithrombin-III deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinaemia & antiphospholipid antibodies; history of migraine w/ focal neurological symptoms; DM w/ vascular involvement; severe or multiple risk factor(s) for venous or arterial thrombosis; major surgery w/ prolonged immobilisation; pancreatitis or a history associated w/ severe hypertriglyceridemia; severe hepatic disease; liver tumors; known or suspected sex steroid-influenced malignancies (eg, breast or genital organs); undiagnosed vag bleeding. Concomitant use w/ hepatitis C virus combination drug regimen ombitasvir/paritaprevir/ritonavir w/ or w/o dasabuvir. Known or suspected pregnancy.
Special Precautions
Increased risk of venous thromboembolism w/ increasing age, +ve family history of venous thromboembolism, obesity (BMI >30 kg/m2), prolonged immobilization, major surgery, any surgery to the legs or major trauma, superficial thrombophlebitis & varicose veins. Increased risk of arterial thromboembolic complications w/ increasing age, smoking, dyslipoproteinemia, obesity (BMI >30 kg/m2), HTN, migraine, valvular heart disease, atrial fibrillation, +ve family history of arterial thrombosis. Increased risk of thromboembolism in the puerperium. DM, SLE, hemolytic uremic syndrome, Crohn's disease or ulcerative colitis & sickle-cell disease. Increase in frequency or severity of migraine. Long-term use of combined OCs contributes to this increased risk of cervical cancer; slightly increased relative risk of breast cancer. Discontinue prior to starting therapy w/ the HCV combination drug regimen ombitasvir/paritaprevir/ritonavir w/ or w/o dasabuvir. Women w/ hypertriglyceridemia or family history thereof may be at increased risk of pancreatitis when using combined OCs. Discontinue if a sustained clinically significant HTN develops during use of combined OCs. Jaundice &/or pruritus related to cholestasis; gallstone formation; porphyria; SLEs; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; (hereditary) angioedema have been reported w/ COC use. Discontinue if acute or chronic disturbances of liver function occur. Avoid too much exposure to sun or UV radiation for women w/ tendency to chloasma. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Measure BP & perform physical exam prior to therapy. Irregular bleeding may occur during the 1st mth of use. Lactation.
Adverse Reactions
Depressed mood, altered mood; headache; nausea, abdominal pain; breast pain, breast tenderness; increased wt.
Drug Interactions
Decreased effectiveness w/ drugs that induce microsomal enzymes, specifically CYP450 enzymes including phenytoin, phenobarb, primidone, bosentan, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, griseofulvin, some HIV PIs (eg, ritonavir) & NNRTIs (eg, efavirenz) & products containing St. John's wort. May increase or decrease plasma conc of progestins w/ combinations of HIV PIs (eg, nelfinavir), NNRTIs (eg, nevirapine) &/or combinations w/ HCV drugs (eg, boceprevir, telaprevir). May increase serum conc of estrogens or progestins w/ strong (eg, ketoconazole, itraconazole, clarithromycin) or moderate (eg, fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors. Plasma & tissue conc may either increase of ciclosporin, or decrease of lamotrigine. May elevate ALT >5x ULN w/ HCV combination drug regimen ombitasvir/paritaprevir/ritonavir w/ or w/o dasabuvir.
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 28 tab
Packing/Price
1 × 28's (P119.2/box)
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