Drospirenone & Ethyl Estradiol
Common Brand Names: Yasmin, Zarah, Syeda, Ocella
Tablets, 28 day blister packs: Each pack contains 21 active yellow round, film-coated tablets containing 3 mg drospirenone and 0.03 mg ethinyl estradiol, and 7 inert white round, film-coated tablets.
For the prevention of pregnancy: Take 1 tablet daily for 28 days beginning on the first day of the menstrual cycle or on the Sunday after the onset of the menstrual period. If not started on the first day of the menstrual period, use a second method of birth control during the first week of continuous oral contraceptive use. Patients should visit their physician yearly for an examination.
Pharmacology/Pharmacokinetics:
Oral contraceptives cause suppression of luteinizing hormone (LH) and follicle stimulating hormone (FSH) resulting in the inhibition of ovulation. Thickening of the cervical mucus (inhibiting sperm penetration_ and alteration of the endometrium (which inhibits implantation) may also contribute to their effectiveness. The progestin drospirenone is a spironolactone analogue with antimineralocorticoid activity including the retention of potassium.
Drug Interactions:
Broad-spectrum antibiotics (ampicillin, amoxicillin, metronidazole, tetracycline) may alter the absorption of estrogens. Barbiturates and hydantoins may increase the metabolism of estrogens. Pharmacological effects may be decreased when used with rifampin. St. John’s Wort may induce hepatic enzymes and p-glycoprotein transporter and may reduce the effectiveness of oral contraceptives. Drospirenone may increase serum potassium and should be used with caution in patients receiving other potassium-increasing drugs such as ACE inhibitors, potassium-sparing diuretics, heparin, aldosterone antagonists, and NSAIDs. Ethinyl estradiol may inhibit the metabolism of theophylline, prednisolone, and cyclosporine.
Contraindications/Precautions:
Contraindicated in women with known or suspected: Hepatic or renal dysfunction, adrenal insufficiency, thromboembolic disorders, breast carcinoma or estrogen dependent neoplasia, pregnancy, undiagnosed abnormal genital bleeding, benign or malignant liver tumors developed during oral contraceptive use (past or present), and cerebral vascular or cardiovascular disease (past or present). Also contraindicated in women who smoke more than 15 cigarettes a day and are over 35 years of age. Use may cause mental depression, fluid retention, and depressed serum folate levels. Pregnancy Category X.
Adverse Effects:
Nausea, vomiting, abdominal cramping, changes in menstrual flow, amenorrhea, edema, breast tenderness or enlargement, weight changes, migraine, depression, and CARDIOVASCULAR or THROMBOEMBOLIC disorders.
Store in a cool, dry place away from sunlight and children.
Oral contraceptives are intended to prevent pregnancy. The do not protect against sexually-transmitted diseases including HIV infection (AIDS).
Contact a physician immediately if you experience any sharp chest pains, shortness of breath, coughing of blood, calf pain, tightness in the chest, sudden severe headache or vomiting, dizziness, numbness in the arms or legs, vision loss, breast lumps, severe pain or tenderness in the stomach area, jaundice, or signs of depression.
Breakthrough bleeding may occur during the first few months, notify a physician if it continues.
Missing a period the first month of oral contraceptive use us normal although missing two months in a row may be a sign of pregnancy. Call your physician of you miss two periods in a row.
If 1 yellow tablet is missed at any time during therapy, take it as soon as possible or take 2 tablets the next day and then continue regular cycle. If 2 yellow tablets are missed during the first 2 weeks of a cycle, take 2 tablets daily for 2 days then continue normal schedule. Use an additional method of birth control for 7 days after missing 2 tablets. If 3 tablets are missed or 2 yellow tablets are missed in the third week of the cycle, start a new cycle that day or the following Sunday.
Use a second method of birth control during the first week of oral contraceptive use and during treatment with a broad-spectrum antibiotic. Breakthrough bleeding and/or diarrhea may be signs of decreased birth control effect.
