DROSPIRENONE-ETH ESTRA-LEVOMEF (Generic for BEYAZ)

Drospirenone 3mg, Ethinyl Estradiol 0.02mg, Levomefolate Calcium 0.451mg, Oral tablet

Grapefruit juice

· Severity: Mild

· Notes for Consumers: Grapefruit juice and grapefruit-containing foods may increase the side effects of estrogen in some females, such as nausea, breast tenderness, headache or fluid retention. There may be no interaction. Do not significantly change your grapefruit intake while taking estrogens for hormone replacement therapy or as part of hormonal birth control products. Report any unusual side effects, like unusual non-menstrual vaginal bleeding, promptly for evaluation.

· Notes for Professionals: Grapefruit juice has been reported to decrease the metabolism of some estrogens. Grapefruit juice contains a compound that inhibits CYP3A4 in enterocytes. Estrogen levels may increase by up to 30 percent with chronic use. The clinical significance of the interaction is unknown. It is possible that estrogen induced side effects could be increased in some individuals. Patients should be advised to not significantly alter their grapefruit juice ingestion.When chronically ingesting any CYP3A4 inhibitor ( > 30 days) with estrogens, adequate diagnostic measures, including directed or random endometrial sampling when indicated by signs and symptoms of endometrial hyperplasia, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Drospirenone 3mg, Ethinyl Estradiol 0.02mg, Levomefolate Calcium 0.451mg, Oral tablet

Marijuana

· Severity: Moderate

· Notes for Consumers: The effects of marijuana may be increased and side effects may get worse if it is combined with this medicine. Do not drive or operate machinery until you know how this combination will affect you. Contact your health care provider right away if you notice slurred speech, confusion, severe drowsiness, increased heart rate, or any other new or unusual side effects.

· Notes for Professionals: The incidence of marijuana associated adverse effects may change following coadministration with ethinyl estradiol. Ethinyl estradiol is an inhibitor of CYP3A4, an isoenzyme partially responsible for the metabolism of marijuana's most psychoactive compound, delta-9-tetrahydrocannabinol (Delta-9-THC). When given concurrently with ethinyl estradiol, the amount of Delta-9-THC converted to the active metabolite 11-hydroxy-delta-9-tetrahydrocannabinol (11-OH-THC) may be reduced. These changes in Delta-9-THC and 11-OH-THC plasma concentrations may result in an altered marijuana adverse event profile.

Drospirenone 3mg, Ethinyl Estradiol 0.02mg, Levomefolate Calcium 0.451mg, Oral tablet

Tobacco

· Severity: Mild

· Notes for Consumers: Although an interaction is possible, people who smoke may take Levomefolate. Smoking may decrease Levomefolate levels in the body. Additional Levomefolate may be recommended if you smoke. Ask your prescriber if you have questions regarding your Levomefolate intake.

· Notes for Professionals: Levomefolate plasma concentrations may be decreased in patients who use tobacco. Monitor patients who use tobacco products for decreased efficacy of levomefolate.

Drospirenone 3mg, Ethinyl Estradiol 0.02mg, Levomefolate Calcium 0.451mg, Oral tablet

Caffeine-containing Foods/Beverages

· Severity: Mild

· Notes for Consumers: Side effects from Caffeine may get worse if you take Ethinyl Estradiol (an estrogen hormone commonly found in birth control pills). Too much Caffeine can cause effects like nausea, nervousness, or sleeplessness. Although an interaction is possible, these drugs are often used together without problems.

· Notes for Professionals: Serum concentrations of caffeine may be increased during concurrent administration with ethinyl estradiol. Patients may desire to limit products that contain high amounts of caffeine in an effort to minimize caffeine-related side effects such as nausea or tremors.

Drospirenone 3mg, Ethinyl Estradiol 0.02mg, Levomefolate Calcium 0.451mg, Oral tablet

Alcohol

· Severity: Mild

· Notes for Consumers: If you regularly drink alcohol-containing drinks, you may have a lack of certain B-vitamins including folate. Discuss which supplements would be most appropriate for you with your health care provider. If you experience weakness, fatigue, numbness, tingling in fingers and toes, decreased appetite, diarrhea, hair loss, or depression, contact your health care prescriber.

· Notes for Professionals: Folate deficiency may result in patients with chronic alcohol or ethanol consumption, and especially in patients with alcoholic cirrhosis. Such patients may derive most of their caloric intake from alcoholic beverages, which do not contain adequate amounts of folic acid; in addition ethanol may affect folate metabolism increasing folate loss. Supplementation in patients known to have excessive alcohol intake is prudent. Avoidance of excessive intake of alcohol would be recommended to help treat the deficiency.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>