Manufacturer:

Bayer HealthCare

Pharmacological Class:

Combination oral contraceptive (progestin + estrogen) + folate.

Active Ingredient(s):

Drospirenone 3mg + ethinyl estradiol (as betadex clathrate) 20micrograms + levomefolate calcium 0.451mg (24 pink tabs); levomefolate calcium 0.451mg (4 light orange tablets).

Indication(s):

Oral contraception. Premenstrual dysphoric disorder (PMDD) in women who choose an oral contraceptive for contraception. Moderate acne vulgaris in women ≥14 years old who choose an oral contraceptive for contraception. To raise folate levels in women who choose to use an oral contraceptive for contraception.

Pharmacology:

Combined oral contraceptives ­reduce the risk of pregnancy primarily by ­inhibiting ovulation. This product combines drospirenone, an analogue of spironolactone that has both antimineralocorticoid and anti­androgenic activities, with an estrogen plus ­folate supplementation. Levomefolate calcium 0.451mg (equivalent to folic acid 0.4mg) is included for reducing the risk of neural tube defects in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Legal Classification:

Rx

Adults:

1 tablet daily for 28 days; repeat. Take at the same time daily. Use Day 1 or Sunday start for 1^st cycle; use backup method for first 7 days. Allow at least 4 weeks postpartum, if not breastfeeding, to begin cycle.

Children:

Premenarchal: not recommended.

Contraindication(s):

Renal impairment. Adrenal insufficiency. High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Breast or other estrogen or progestin-sensitive neoplasms. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy (Cat.X).

Warnings/Precautions:

Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Hyperkalemia or risk thereof. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Pregnancy-related cholestasis. Depression. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Monitor blood pressure. Nursing mothers: not recommended.

Interaction(s):

May potentiate drugs that can cause hyperkalemia in chronic use (eg, ACE ­inhibitors, ARBs, NSAIDs, K⁺ sparing diuretics, K⁺ supplementation, heparin, aldosterone blockers) (check serum K⁺ during 1^st cycle). May be antagonized by CPY3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenyt­oin, rifampin, St. John’s wort, topiramate) (use backup contraception). May be affected by pro­tease inhibitors, acetaminophen, ascorbic acid, itraconazole, ketoconazole. May antagonize lam­o­tri­gine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hor­mones. May mask vitamin B₁₂ deficiency (folate).

Adverse Reaction(s):

Irregular uterine bleeding, headache, nausea, mastodynia, fatigue, irrita­bility, decreased libido, increased weight, fluid retention, mood changes; others (see literature).

Notes:

Use backup method or restart if 2 or more pink pills are missed (see literature); consider severe nausea/diarrhea as missed pill. Continue folate supplementation if pills are discontinued due to pregnancy.

How Supplied:

Packs—3 (3x28 day cycles)