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Mercilon

Mercilon

desogestrel + ethinylestradiol

Manufacturer:

N.V. Organon

Distributor:

Organon
Concise Prescribing Info
Contents
Desogestrel 150 mcg, ethinylestradiol 20 mcg
Dosage/Direction for Use
1 tab daily for 21 consecutive days. Each subsequent pack is started after a 7-day tab-free interval, during which w/drawal bleed occurs (usually starts on day 2-3 after the last tab & may not have finished before the next pack is started). No preceding hormonal contraceptive use in the past mth Start on day 1 of menstrual bleeding. May also start on days 2-5 but use a barrier method during the 1st cycle for the 1st 7 days of tab-taking. Changing from combined hormonal contraceptive (combined OC, vag ring or transdermal patch) Start on the day after the last active tab of previous combined OC or on the day of removal of vag ring or patch. May also switch on any day of the cycle if previous method has been consistently & correctly used & if patient is certainly not pregnant. Changing from progestogen-only method (minipill, inj, implant) or progestogen-releasing intrauterine system (IUS) May switch any day (from day of removal of implant or IUS or from when next inj is due) but use a barrier method for the 1st 7 days of tab-taking. Following 1st-trimester abortion May start immediately. Following delivery or 2nd-trimester abortion Start at day 21-28 after delivery or 2nd trimester abortion. When starting later, use a barrier method for the 1st 7 days of tab-taking. When intercourse has already occurred, exclude pregnancy before actual start or wait for 1st menstrual period.
Administration
May be taken with or without food: Take at about the same time every day w/ some liqd as needed.
Contraindications
Hypersensitivity. Presence or history of venous thrombosis (DVT, pulmonary embolism); arterial thrombosis (MI, CVA) or prodromal conditions (eg, transient ischaemic attack, angina pectoris); severe hepatic disease w/ liver function values that have not returned to normal; benign or malignant liver tumours. Known predisposition for venous or arterial thrombosis eg, activated protein C resistance, antithrombin-III, proteins C & S deficiency, hyperhomocysteinaemia, & antiphospholipid Abs. History of migraine w/ focal neurological symptoms. DM w/ vascular involvement. Presence of severe or multiple risk factor(s) for venous or arterial thrombosis. Major surgery w/ prolonged immobilisation. Pancreatitis or history thereof associated w/ severe hypertriglyceridaemia. Known or suspected sex steroid-influenced malignancies (eg, of genitals or breasts). Undiagnosed vag bleeding. Concomitant use w/ HCV combination drug regimen ombitasvir/paritaprevir/ ritonavir w/ or w/o dasabuvir. Known or suspected pregnancy.
Special Precautions
Discontinuation of use may be necessary in event of increased frequency or severity of migraine; acute or chronic disturbances of liver function; recurrence of cholestatic jaundice (which occurred 1st during pregnancy or previous sex steroid use). Does not protect against HIV infections (AIDS) & other STDs. Increased risk of arterial & venous thrombotic & thromboembolic diseases eg, MI, stroke, DVT, & pulmonary embolism; cervical & breast cancer. Increased risk of VTE during 1st year of combined hormonal contraceptive (CHC) use; after initially starting or restarting same or different CHC after break in use of ≥4 wk. Rare cases of benign & more rarely malignant liver tumours. Women w/ hypertriglyceridaemia or family history thereof may be at increased risk of pancreatitis. Crohn's disease & ulcerative colitis have been associated w/ combined OC use. Efficacy may be reduced in event of missed tab, GI disturbances or concomitant medications that decrease plasma conc of etonogestrel. Irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the 1st mth of use. Consider increased risk of VTE during postpartum when restarting therapy. W/draw use if clinically significant HTN develops. Carefully observe diabetic women during treatment. Avoid sun or UV radiation exposure in women w/ tendency to chloasma during treatment. Prior to initiation or reinstitution, take complete medical & family history, rule out pregnancy, measure BP & if clinically indicated perform physical exam. Rule out pregnancy before continuing use if combined OC has not been taken as directed prior to the 1st missed w/drawal bleed or if 2 w/drawal bleeds are missed. Discontinue use prior to starting therapy w/ ombitasvir/paritaprevir/ritonavir w/ & w/o dasabuvir. Patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Reports of the following conditions w/ pregnancy & combined OC use: jaundice &/or pruritus related to cholestasis; gallstone formation; porphyria; SLE; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; hereditary angioedema. Not recommended during lactation until nursing mother has completely weaned her child.
Adverse Reactions
Depressed or altered mood; headache; nausea, abdominal pain; breast pain & tenderness; increased wt.
Drug Interactions
Clearance may be increased & effectiveness may be decreased w/ CYP inducers eg, phenytoin, phenobarb, bosentan, primidone, carbamazepine, rifampicin, & possibly oxcarbazepine, topiramate, felbamate, griseofulvin, some HIV PIs (eg, ritonavir) & NNRTIs (eg, efavirenz), & St. John's wort. Increased or decreased plasma conc w/ combinations of HIV PIs (eg, nelfinavir) & NNRTIs (eg, nevirapine), &/or combinations w/ HCV medicinal products (eg, boceprevir, telaprevir). Serum conc may be increased w/ strong (eg, ketoconazole, itraconazole, clarithromycin) or moderate (eg, fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors. May increase plasma & tissue conc of ciclosporin. May decrease plasma & tissue conc of lamotrigine. Significantly more frequent ALT elevations >5 times ULN w/ ombitasvir/paritaprevir/ritonavir w/ & w/o dasabuvir. May influence results of 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.
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
Mercilon tab
Packing/Price
1 × 21's
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