Qlaira

OC. Treatment of heavy &/or prolonged menstrual bleeding in women w/o organic pathology who elect to use OC.

1 tab daily starting from 1st day of menstrual cycle for 28 consecutive days.

May be taken with or without food.

Hypersensitivity. Presence or history of venous or arterial thrombotic/thromboembolic events (eg, DVT, pulmonary embolism, MI) or CVA; prodromi of a thrombosis (eg, transient ischemic attack, angina pectoris); liver tumors (benign or malignant). A high risk of venous or arterial thrombosis. History of migraine w/ focal neurologic symptoms. DM w/ vascular involvement. Severe hepatic disease as long as liver function have not returned to normal. Known or suspected sex-steroid influenced malignancies (eg, of genital organs or breasts). Undiagnosed vag bleeding. Known or suspected pregnancy.

Increased risk of arterial & venous thrombotic & thromboembolic diseases (eg, MI, DVT, pulmonary embolism & CVA). Highest risk of VTE during 1st yr of use. Consider potential for an increased synergistic risk of thrombosis in women who possess combination of risk factors or exhibit greater severity of an individual risk factor. Immediately discontinue if an increase in frequency or severity of migraine occurs. Long-term use may contribute to the increased risk of cervical cancer. Rare reports of benign or malignant liver tumors. Women w/ hypertriglyceridemia, or a family history thereof, may be at increased risk of pancreatitis. W/draw combined OC (COC) if a sustained clinically significant HTN develops during use. Reports of occurrence or deterioration of the following conditions w/ COC use (inconclusive): Jaundice &/or pruritus related to cholestasis; gallstone formation; porphyria; SLE; hemolytic uremic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss. May induce or exacerbate symptoms of angioedema in women w/ hereditary angioedema. Acute or chronic disturbances of liver function may necessitate discontinuation of use until markers return to normal. Carefully observe diabetic women during COC use. Associated w/ Crohn's disease & ulcerative colitis. Chloasma may occasionally occur, especially in women w/ history of chloasma gravidarum. Not to be used in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Perform a complete medical history & physical exam prior to therapy or reinstitution of COC & should be repeated periodically. Advise women that OCs do not protect against HIV infections (AIDS) & other STDs. Efficacy may be reduced in the event of missed hormone-containing FC tab, GI disturbances during taking of hormone-containing FC tab or concomitant medication. Irregular bleeding (spotting or breakthrough bleeding) may occur, especially during 1st mth. May reduce the quantity & change the composition of breast milk; not recommended until the nursing mother has completely weaned her child. Only indicated after menarche. Not indicated after menopause.

Depression/depressed mood, emotional lability, decreased & loss of libido; migraine; nausea; breast pain, unscheduled uterine bleeding.

Increased clearance which may lead to breakthrough bleeding &/or contraceptive failure w/ drugs that induce microsomal enzymes eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, possibly oxcarbazepine, topiramate, felbamate, griseofulvin, St. John's wort. Decreased steady state conc & systemic exposures w/ rifampicin (CYP3A4 inducer). Co-administration w/ HIV/HCV PIs & NNRTIs can increase or decrease plasma conc of estrogen or progestin. Strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice can increase plasma conc of estrogen or progestin or both. May affect metabolism of other drugs; plasma & tissue conc may either increase (eg, ciclosporin) or decrease (eg, lamotrigine). May influence results of certain lab tests including biochemical parameters of liver, thyroid, adrenal & renal function, plasma levels of (carrier) proteins eg, corticosteroids binding globulin & lipid/lipoprotein fractions, carbohydrate metabolism parameters & parameters of coagulation & fibrinolysis.

Oral Contraceptives / Oestrogens, Progesterones & Related Synthetic Drugs

G03AB08 - dienogest and estradiol ; Belongs to the class of progestogens and estrogens in sequential preparations. Used as systemic contraceptives.

Rx