desogestrel + ethinylestradiol


Gedeon Richter


Pahang Pharmacy
Concise Prescribing Info
Ethinylestradiol 0.03 mg, desogestrel 0.15 mg
Dosage/Direction for Use
1 tab daily for 21 days followed by 7 tab-free days.
May be taken with or without food.
Hypersensitivity. Presence or risk of VTE & arterial thromboembolism (ATE); known hereditary or acquired predisposition for VTE & ATE; major surgery w/ prolonged immobilisation; cerebrovascular disease, current stroke, history of stroke or prodromal condition eg, transient ischaemic attack; history of migraine w/ focal neurological symptoms; multiple risk factor(s) for VTE & ATE eg, DM w/ vascular symptoms, severe HTN & dyslipoproteinemia; presence or history of benign or malignant liver tumours, pancreatitis associated w/ severe hypertriglyceridaemia; known or suspected sex steroid-influenced malignancies of genital organs or breasts; undiagnosed vag bleeding; endometrial hyperplasia. Concomitant use w/ ombitasvir-/paritaprevir-/ritonavir-/dasubuvir-/ glecaprevir-/pibrentasvir-containing medicinal products. Severe hepatic disease. Known or suspected pregnancy.
Special Precautions
Not for protection against HIV infections & other STD. Increased risk of VTE or ATE; +ve family history of VTE or ATE, obesity (BMI >30 kg/m2), increasing age (>35 yr), smoking, cancer, SLE, haemolytic uraemic syndrome, Crohn's disease or ulcerative colitis, sickle cell disease; HTN, migraine, DM, hyperhomocysteinaemia, valvular heart disease, atrial fibrillation, dyslipoproteinaemia; breast cancer; benign or malignant liver tumours. Depression; hypertriglyceridaemia, pancreatitis; glucose intolerance/diabetes; GI disturbances; irregular bleeding. Prolonged immobilisation, major surgery or trauma, any leg or pelvis surgery. May induce or exacerbate symptoms of angioedema. Recurrence of cholestatic jaundice. Chloasma; avoid exposure to sun or UV radiation. Perform medical & physical exam including BP measurement prior to therapy. Not to be used w/ St. John's wort. Concomitant use of ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin; glecaprevir/pibrentasvir. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Acute or chronic hepatic function disturbances. Not indicated during pregnancy. Not recommended during lactation.
Adverse Reactions
Irregular menstruation. Depressed & altered mood, nervousness; headache, dizziness; nausea, abdominal pain; acne; breast pain & tenderness, amenorrhea, dysmenorrhea, premenstrual syndrome; increased wt.
Drug Interactions
Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir w/ or w/o ribavirin; glecaprevir/pibrentasvir. Increased clearance w/ drugs inducing microsomal enzymes. Diminished efficacy by barbiturates, bosentan, carbamazepine, phenytoin, primidone, rifampicin, ritonavir, nevirapine, efavirenz, felbamate, griseofulvin, oxcarbazepine, topiramate, rifabutin, St. John's wort. Increased or decreased plasma conc w/ HIV PIs, NNRTIs HCV inhibitors. Increased serum conc w/ strong (eg, ketoconazole, itraconazole, clarithromycin) or moderate (eg, fluconazole, diltiazem, erythromycin) CYP3A4 inhibitors. Increased plasma conc w/ etoricoxib. Inhibited metabolism of ciclosporin. Induced metabolism of lamotrigine. Increased plasma conc of theophylline. Enhanced BP-lowering effect of tizanidine. Reduction of free thyroxine & increased TSH w/ l-thyroxine. Interference w/ lab tests results.
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.
Regulon FC tab
1 × 21's;3 × 21's;6 × 21's
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