ethinylestradiol + levonorgestrel




Zuellig Pharma
Concise Prescribing Info
Levonorgestrel 100 mcg, ethinylestradiol 20 mcg
Prevention of pregnancy. Moderate acne vulgaris not controlled by conventional therapy eg, topical prep & oral antibiotics in postmenarchal, premenopausal women ≥14 yr who accept contraception.
Dosage/Direction for Use
Beginning on day 1 of cycle, 1 tab at about same time daily for 21 consecutive days, followed by 7-day tab-free interval.
May be taken with or without food: Take at the same time each day, preferably after the evening meal or at bedtime.
Hypersensitivity. Current or history of DVT, thromboembolism, pancreatitis associated w/ severe hypertriglyceridemia. Known or suspected breast carcinoma or estrogen-dependent neoplasia; cerebrovascular or CAD; thrombogenic rhythm disorders & valvulopathies; hereditary or acquired thrombophilias; headache w/ focal neurological symptoms; diabetes w/ vascular involvement; uncontrolled HTN; undiagnosed vag bleeding; lipometabolic disorders; sickle-cell anemia. Concomitant use w/ certain HCV antivirals eg, ombitasvir, paritaprevir, ritonavir, dasabuvir. Hepatic adenomas or carcinomas, active liver disease. Known or suspected pregnancy.
Special Precautions
Not for protection against HIV infection or other STDs. Discontinue use if deterioration of DM or tendency towards DM, HTN, varicose veins, history of phlebitis & clinical depression, otosclerosis, multiple sclerosis, migraine, epilepsy, porphyria, tetany, chorea, SLE, obesity, family history of breast cancer & patient history of breast nodules, conditions aggravated by fluid retention occur. Venous & arterial thrombosis & thromboembolism; ocular lesions; increased BP; breast & cervical cancer; gallbladder disease; hepatitis C; migraine/headache; angioedema; depressed serum folate levels; vomiting/diarrhea; impaired glucose tolerance or DM; genital bleeding, depression; smoking. Perform breast, liver, extremities & pelvic organ exam, pap smear prior to therapy. Avoid prolonged exposure to sun. Contact lens users. Long-term therapy w/ hepatic enzyme inducers. Hepatic neoplasia/liver disease. Discontinue use in cholestasis recurrence, acute or chronic hepatic function disturbances; renal dysfunction. Not indicated in premenarche & postmenopausal women. Not to be used during pregnancy. Not recommended during lactation. Not for premenarche & postmenopausal women.
Adverse Reactions
Headache including migraines; breakthrough bleeding/spotting. Vaginitis including candidiasis; mood changes including depression, changes in libido; nervousness, dizziness; nausea, vomiting, abdominal pain; acne; breast pain, tenderness, enlargement & secretion, dysmenorrhea, change in menstrual flow, cervical ectropion & secretion, amenorrhea; fluid retention/edema; increased/decreased wt.
Drug Interactions
Increased risk of ALT elevations w/ ombitasvir/paritaprevir/ritonavir & dasabuvir, w/or w/o ribavirin. Decreased ethinylestradiol serum conc w/ drugs reducing GI transit time & absorption, rifampicin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, griseofulvin, topiramate, some PIs, modafinil, St. John's wort, ritonavir. Increased ethinylestradiol serum conc w/ atorvastatin, ascorbic acid, paracetamol, indinavir, fluconazole, troleandomycin. Increased plasma & tissue conc w/ cyclosporine, theophylline, corticosteroids. Decreased plasma & tissue conc w/ lamotrigine. Increased risk of galactorrhea w/ flunarizine. Increased risk of intrahepatic cholestasis w/ troleandomycin. Reports of pregnancy w/ certain antibiotics eg, ampicillin, other penicillin & tetracyclines. Interference w/ LFTs, thyroid, adrenal & renal function, other lab & diagnostic tests.
MIMS Class
Oral Contraceptives
ATC Classification
G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Loette tab
1 × 21's
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