TYDEMY (Generic for SAFYRAL)

Drospirenone 3mg, Ethinyl Estradiol 0.03mg, 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 Estrogens 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. Drospirenone can increase the level of potassium in the blood. Your health care provider may need to monitor your potassium level in the first month of treatment, and as needed thereafter.

· Notes for Professionals: Drospirenone has antimineralocorticoid effects; the progestin may increase serum potassium. Consider monitoring serum potassium concentrations during the first month of dosing in high-risk patients who take strong CYP3A4 inhibitors long-term and concomitantly. Strong CYP3A4 inhibitors include grapefruit juice. Grapefruit juice contains a furano-coumarin compound, 6,7-dihydroxybergamottin that inhibits CYP3A4 in enterocytes. In addition, grapefruit juice has been reported to decrease the metabolism of some estrogens. Estrogen levels may increase by up to 30%. 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.

Drospirenone 3mg, Ethinyl Estradiol 0.03mg, 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 0.03mg, Levomefolate Calcium 0.451mg, Oral tablet

Tobacco

· Severity: Major

· Notes for Consumers: You are strongly advised not to smoke while taking this medication. Tobacco smoking can increase the risk of a blood clot, stroke, heart attack or other serious problem while taking this medication. This is especially true if you are a female over 35 years of age or if you smoke > 15 cigarettes per day. While taking this medication, you should report any of the following "ACHES" to your prescriber immediately: Abdominal pain, Chest pain, severe or frequent Headaches or migraines; Eye pain or Severe leg pain in the calves or the thighs.

· Notes for Professionals: Females receiving combined hormonal contraceptives should be advised not to smoke tobacco. Tobacco smoking appears to enhance the procoagulant effect of estrogens. Tobacco smoking pharmacodynamically increases the risk of DVT, myocardial infarction, stroke and other thromboembolic disease. Risk is especially high for female smokers 35 years of age or older and in those who smoke greater than or equal to 15 cigarettes per day.

Drospirenone 3mg, Ethinyl Estradiol 0.03mg, 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.

Drospirenone 3mg, Ethinyl Estradiol 0.03mg, 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.

<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>