Loette

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.

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 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/ ombitasvir-/paritaprevir-/ritonavir-/dasabuvir-containing medicinal products. Hepatic adenomas or carcinomas, active liver disease. Known or suspected pregnancy.

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; ALT elevations; headache; angioedema; depressed serum folate levels; vomiting/diarrhea; impaired glucose tolerance or DM, hyperlipidemias; genital bleeding; acute vision, hearing or speech disturbances; prolonged immobilization; 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. Concomitant use w/ rifampicin. Hepatic neoplasia/liver disease. Discontinue use in cholestasis recurrence, acute or chronic hepatic function disturbances; renal dysfunction. Not to be used during pregnancy. Not recommended during lactation. Not to be used in premenarche & postmenopausal women.

Headache eg, migraines; breakthrough bleeding/spotting. Vaginitis eg, candidiasis; mood changes eg, 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.

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, 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.

Oral Contraceptives

G03AA07 - levonorgestrel and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

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