Yaz

OC w/ antimineralocorticoid & antiandrogenic effects beneficial for women who experience hormone-related fluid retention & resulting symptoms. Moderate acne vulgaris, symptoms of premenstrual dysphoric disorder & dysmenorrhea in women who elect to use OC.

1 tab daily for 28 consecutive days, followed by the next pack. Missed dose: Take the missed tab as soon as it is remembered & continue the medication.

May be taken with or without food. Take in the order directed on the package every day at about the same time w/ some liqd as needed.

Hypersensitivity. Presence or history of venous or arterial thrombotic/thromboembolic events (eg, DVT, pulmonary embolism, MI) or CVA; prodromi of thrombosis (eg, transient ischaemic attack, angina pectoris); liver tumors (benign or malignant). High risk of venous or arterial thrombosis; history of migraine w/ focal neurological symptoms; DM w/ vascular involvement. Use of direct-acting antiviral medicinal products containing ombitasvir, paritaprevir, or dasabuvir, & combinations of these. Known or suspected sex-steroid influenced malignancies (eg, of genital organs or breasts); undiagnosed vag bleeding. Severe hepatic disease as long as liver function values have not returned to normal. Severe renal insufficiency or acute renal failure. Known or suspected pregnancy.

Circulatory disorders. Risk of VTE is highest during 1st yr of use. VTE, manifesting as DVT &/or pulmonary embolism, may occur during use. Consider potential for increased synergistic risk of thrombosis in women who possess combination of risk factors or exhibit greater severity of individual risk factor eg, age; obesity; +ve family history (ie, VTE or arterial thromboembolism in sibling or parent at relatively early age); prolonged immobilization, major surgery, any surgery to legs, or major trauma; smoking; dyslipoproteinemia; HTN; migraine; valvular heart disease; atrial fibrillation. Discontinue immediately if there is increase in frequency or severity of migraine during use. Tumors. Theoretical risk for hyperkalemia for patients w/ renal impairment whose pretreatment serum K is in upper reference range, & who are additionally using K sparing drugs. Increased risk of pancreatitis when using combined OCs in women w/ hypertriglyceridemia, or family history thereof. W/draw combined OC & treat HTN if sustained clinically significant HTN develops during use. 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. May necessitate discontinuation of use if acute or chronic disturbances of liver function or recurrence of cholestatic jaundice develops. Diabetic women; Crohn's disease & ulcerative colitis. Avoid exposure to sun or UV radiation whilst taking combined OCs in women w/ tendency to chloasma, especially those w/ history of chloasma gravidarum. Contains lactose; patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption who are on lactose-free diet. Take a complete medical history & physical exam prior to initiation or reinstitution of use & repeat periodically. Advise women that OCs do not protect against HIV infections (AIDS) & other STD. Reduced efficacy in the event of eg, missed hormone-containing tab, GI disturbances during hormone-containing tab taking or concomitant medication. Irregular bleeding (spotting or breakthrough bleeding) may occur, especially during the 1st mth of use. Not recommended during lactation or until nursing mother has completely weaned the child. Ped patients (only indicated after menarche). Elderly (not applicable, not indicated after menopause).

Emotional lability, depression/depressive mood; migraine; nausea; breast pain, unscheduled uterine bleeding, genital tract bleeding. Decrease & loss of libido. Venous & arterial thromboembolic events. Erythema multiforme.

Interactions w/ drugs that induce microsomal enzymes which can result in increased clearance of sex hormones & which may lead to breakthrough bleeding &/or contraceptive failure. Substances increasing clearance of combined OCs (diminished efficacy by enzyme-induction) eg, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, & possibly oxcarbazepine, topiramate, felbamate, griseofulvin & products containing St. John's wort. Increased/decreased plasma conc of estrogen/progestin w/ many HIV/HCV PIs & NNRTIs. Increased plasma conc of estrogen or progestin, or both w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (itraconazole, voriconazole, fluconazole), verapamil, macrolides (clarithromycin, erythromycin), diltiazem & grapefruit juice. Increased plasma conc of ethinylestradiol w/ etoricoxib. May either increase (eg, cyclosporin) or decrease (eg, lamotrigine) plasma & tissue conc of certain drugs. Weak increase in plasma conc of CYP3A4 substrates (eg, midazolam) while plasma conc of CYP1A2 substrates can increase weakly (eg, theophylline) or moderately (eg, melatonin & tizanidine). Increased ALT levels to >20 times ULN in healthy female subjects & HCV infected women w/ direct-acting antiviral medicinal products containing ombitasvir, paritaprevir, or dasabuvir, & combinations of these. Theoretical potential for increased serum K in women taking Yaz hormone-containing tab w/ other drugs that may increase serum K levels including AIIA, K-sparing diuretics, & aldosterone antagonists. Drospirenone causes increase in plasma renin activity & plasma aldosterone induced by its mild antimineralocorticoid activity.

Oral Contraceptives / Acne Treatment Preparations

G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.

Rx