ethinylestradiol + drospirenone




Four Star
Concise Prescribing Info
Drospirenone 3 mg, ethinylestradiol 0.03 mg
Dosage/Direction for Use
1 tab daily at about the same time for 21 consecutive days starting on 1st day of menstrual cycle, followed by 7 tab-free days.
May be taken with or without food.
Hypersensitivity. Presence or history of thrombophlebitis or thromboembolic disorders; presence or history of cerebrovascular disorders; presence or history of MI or CAD; valvular heart disease w/ complications; presence or history of prodromi of a thrombosis (eg, transient ischemic attack, angina pectoris); presence of severe or multiple risk factor(s) for arterial or venous thrombosis [eg, severe HTN (persistent values of ≥160/100 mmHg), hereditary or acquired predisposition for venous or arterial thrombosis (eg, Factor V Leiden mutation & activated protein C resistance, antithrombin-III-deficiency, protein C deficiency, protein S deficiency, hyperhomocysteinemia & antiphospholipid Abs (anticardiolipin Abs, lupus anticoagulant)), severe dyslipoproteinemia; smoking, if over age 35; DM w/ vascular involvement; major surgery associated w/ an increased risk of post-op thromboembolism; prolonged immobilization]; active liver disease; presence or history of actual benign or malignant liver tumors; known or suspected carcinoma of the breast; carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia; undiagnosed abnormal vag bleeding; steroid-dependent jaundice, cholestatic jaundice, history of jaundice in pregnancy; any ocular lesion arising from ophth vascular disease eg, partial or complete loss of vision or defect in visual fields; current or history of migraine w/ focal aura; presence or history of pancreatitis if associated w/ severe hypertriglyceridemia; renal insufficiency; hepatic dysfunction; adrenal insufficiency. Known or suspected pregnancy.
Special Precautions
A thorough history & physical exam should be performed prior to use. 1st follow-up visit should be done 3 mth after OCs are prescribed; thereafter, exam should be performed at least once a yr, or more frequently if indicated. Discontinue medication at the earliest manifestation of thromboembolic & CV disorders; conditions that predispose to venous stasis & vascular thrombosis; partial or complete visual defects; papilledema or ophth vascular lesions; severe headache of unknown etiology or worsening of pre-existing migraine headache; increase in epileptic seizures. Potential for hyperkalemia in high-risk patients. Regularly check the breasts & consult a physician in the presence of any lump. Risk of breast cancer, hepatocellular carcinoma, cervical cancer upon long-term use. Patients w/ predisposing factors for CAD; essential HTN; DM or family history of diabetes; fibroids; jaundice. Risk of adverse lipid changes while on OC; vag bleeding; elevated liver enzymes; gallbladder disease; hepatic nodules (particularly in long-term use); angioedema particularly in women w/ hereditary angioedema; corneal edema; fluid retention; chloasma especially in women w/ history of chloasma gravidarum. Possible association w/ development of Crohn's disease & ulcerative colitis; increased risk of arterial & venous thrombotic & thromboembolic diseases eg, MI, DVT, pulmonary embolism, & CVA. Women should be counselled not to smoke. If feasible, OCs should be discontinued & an alternative method substituted at least 1 mth prior to major elective surgery. OC use should not be resumed until the 1st menstrual period after hospital discharge following surgery. Patients w/ history of emotional disturbances, especially the depressive type, may be more prone to have a recurrence of depression while taking OCs. Efficacy of combined OCs may be reduced in the event of missed tab, GI disturbances, or concomitant medication. Results of laboratory tests should be interpreted w/ the knowledge that the patient is taking an OC: liver function tests, coagulation tests, thyroid function tests, lipoproteins, gonadotropins, glucose tolerance, tissue specimens. If possible, nursing mother should be advised not to use OCs, but to use other forms of contraception, until she has completely weaned her child. Not indicated for use in premenarchal & postmenopausal females.
Adverse Reactions
Headache, menstrual disorder, breast pain, abdominal pain, nausea, leukorrhea, flu syndrome, acne, vag moniliasis, depression, diarrhea, asthenia, dysmenorrhea, back pain, infection, pharyngitis, intermenstrual bleeding, migraine, vomiting, dizziness, nervousness, vaginitis, sinusitis, cystitis, bronchitis, gastroenteritis, allergic reaction, UTI, pruritus, emotional lability, surgery, rash, upper resp infection.
Drug Interactions
Possible decreased efficacy w/ antacids, ampicillin, cotrimoxazole, penicillin, rifabutin, rifampin, chloramphenicol, metronidazole, neomycin, nitrofurantoin, sulfonamides, tetracyclines, troleandomycin; carbamazepine, ethosuximide, felbamate, lamotrigine, oxcarbazepine, phenobarb, phenytoin, primidone, topiramate; griseofulvin; clofibrate; boceprevir, telaprevir; ritonavir; nevirapine; barbiturates, benzodiazepines, chloral hydrate, glutethimide, meprobamate; antihistamines, analgesics, antimigraine prep, phenylbutazone prep, vit E. Possible increased plasma conc w/ strong & moderate CYP3A4 inhibitors eg, azole antifungals (eg, ketoconazole, itraconazole, voriconazole, fluconazole), verapamil, macrolides (eg, clarithromycin, erythromycin), diltiazem, grapefruit juice. Possible modified action of alcohol; clonidine; anticoagulants; anticonvulsants; lamotrigine; oral hypoglycemics, insulin; guanethidine, methyldopa; β-blockers; acetaminophen; antipyrine, aspirin; aminocaproic acid; isoproterenol; caffeine; clofibrate; prednisone; cyclosporine; folic acid; meperidine; phenothiazine tranquilizers, reserpine & similar drugs; chlordiazepoxide, diazepam, lorazepam, oxazepam; theophylline; clomipramine (possibly other TCAs); vit B12. Potential for increased K levels w/ other drugs that can also increase K levels. Reduced effectiveness w/ St. John's wort (Hypericum perforatum).
MIMS Class
Oral Contraceptives
ATC Classification
G03AA12 - drospirenone and ethinylestradiol ; Belongs to the class of progestogens and estrogens in fixed combinations. Used as systemic contraceptives.
Yasmin tab
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