Delsia

Each tab Drospirenone 3 mg, ethinylestradiol 0.03 mg

Prevent pregnancy in women.

1 tab on Day 1 of menstrual cycle or on 1st Sunday after onset of menstrual period for 21 consecutive days, followed by 7-day tab-free interval. Switching from different birth control pill Start on same day that a new pack of previous OC would have been started. Switching from transdermal patch or vag ring or inj Start when next application would have been due. Switching from intrauterine contraceptive or implant Start on day of removal. Postpartum women who do not breastfeed or after 2nd trimester abortion Start no earlier than 4 wk postpartum.

May be taken with or without food: Take at the same time each day, preferably after evening meal or at bedtime w/ some liqd.

Adrenal insufficiency. High risk of arterial thrombotic diseases including, smoker >35 yr, history or current DVT or pulmonary embolism, cerebrovascular disease, CAD, thrombogenic valvular or thrombogenic rhythm diseases of heart (eg, subacute bacterial endocarditis w/ valvular disease, or atrial fibrillation), inherited or acquired hypercoagulopathies, uncontrolled HTN, DM w/ vascular disease, headaches w/ focal neurological symptoms or migraine headaches w/ or w/o aura if >35 yr. Undiagnosed abnormal uterine bleeding. Current or history of breast cancer or other estrogen- or progestin-sensitive cancer. Benign or malignant liver tumor or liver disease. Concomitant use w/ hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, w/ or w/o dasabuvir due to potential ALT elevations. Renal impairment. Pregnancy.

Discontinue if arterial or venous thrombotic event; unexplained vision loss, proptosis, diplopia, papilledema or retinal vascular lesions; jaundice; acute or chronic disturbances of liver function; recurrent, persistent or severe new headache; serious degree of depression occurs; at least 4 wk before & through 2 wk after major surgery or other surgery known to have elevated risk of thromboembolism; prior to starting therapy w/ combination drug regimen ombitasvir/paritaprevir/ritonavir, w/ or w/o dasabuvir. Immediately discontinue if increase in frequency or severity of migraine occur during use. Not to be used by women w/ current or history of breast cancer; as a test for pregnancy. Carefully monitor prediabetic & diabetic women. Consider alternative contraception for women w/ uncontrolled dyslipidemia. Increased risk of arterial thromboses eg, strokes & MI, especially in women w/ other risk factors; cervical cancer or intraepithelial neoplasia; developing hepatocellular carcinoma in long-term (>8 yr) use; pancreatitis in women w/ hypertriglyceridemia, or family history. Increased both relative & attributable risks thrombotic & hemorrhagic strokes among older (>35 yr), smoker hypertensive women & w/ other underlying risk factors. Increased BP in older women & w/ extended duration of use. Small increased relative risk of developing gallbladder disease. Hepatic adenomas; unscheduled (breakthrough or intracyclic) bleeding & spotting, especially during 1st 3 mth of use. Women w/ CV disease risk factors; history of COCs-related cholestasis; hereditary angioedema. Check serum K conc during 1st treatment cycle in women receiving daily, long-term treatment for chronic conditions or diseases w/ medications increasing serum K conc. Consider monitoring serum K conc in high-risk patients taking strong CYP3A4 inhibitor long-term & concomitantly. Monitor BP & discontinue if BP rises significantly. Consider yrly BP checking & other indicated healthcare. May change results of some lab tests, eg, coagulation factors, lipids, glucose tolerance, & binding proteins. Avoid sun or UV radiation exposure during use in women w/ history of chloasma gravidarum. Sugar intolerance. Concomitant administration w/ ACE inhibitors, angiotensin II receptor antagonists, K-sparing diuretics, K supplementation, heparin, aldosterone antagonists & NSAIDs. Not to be used during pregnancy. Nursing mother should use other forms of contraception until the mother has weaned the child.

Premenstrual syndrome, headache/migraine, breast & abdominal pain/tenderness/discomfort, nausea/vomiting & mood changes (depression, depressed mood, irritability, mood swings, altered mood & affect lability).

May decrease effectiveness w/ phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampin, topiramate & products containing St. John's wort. Increased AUC of ethinyl estradiol w/ atorvastatin; plasma conc w/ ascorbic acid & acetaminophen. Increased plasma conc of estrogen or progestin or both w/ moderate or strong CYP3A4 inhibitors eg, azole antifungals (eg, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem & grapefruit juice. Moderate increase of drospirenone & mild increase of ethinyl estradiol exposure w/ strong CYP3A4 inhibitor (eg, ketoconazole). Increased/decreased plasma conc w/ HIV/HCV PI or NNRTI. Decreased plasma conc of lamotrigine. Weak increased plasma conc of CYP3A4 substrates (eg, midazolam), & weak/moderate increased plasma conc of CYP2C19 substrates (eg, omeprazole & voriconazole) & CYP1A2 substrates (eg, theophylline & tizanidine). Increased serum conc of thyroid-binding globulin. Increased serum K conc w/ other drugs that may increase serum K conc. Increased plasma renin activity & aldosterone by drospirenone.

Oral Contraceptives

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

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