Drospirenone, Ethinyl estradiol, and levomefolate

Drospirenone, Ethinyl estradiol, and levomefolate are combination medications used as contraceptives to prevent pregnancy.

• Drospirenone, Ethinyl estradiol, and levomefolate are available under various brand names: Beyaz, Rajani, Safyral, Tydemy

Common side effects of Drospirenone, Ethinyl estradiol, and levomefolate include:

• nausea;
• breast tenderness;
• headache; or
• breakthrough bleeding.

Serious side effects of Drospirenone, Ethinyl estradiol, and levomefolate include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to the jaw or shoulder, nausea, sweating;
• liver problems--loss of appetite, upper stomach pain, tiredness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• increased blood pressure--severe headache, blurred vision, pounding in the neck or ears;
• swelling in your hands, ankles, or feet;
• a change in the pattern or severity of migraine headaches; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Rare side effects of Drospirenone, Ethinyl estradiol, and levomefolate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet

• 3 mg/0.02 mg/0.451 mg (Beyaz)
• 3 mg/0.03 mg/0.451 mg (Safyral, Tydemy)
• Contraception
• Adult dosage
• Safyral, Tydemy
  • 1 active tablet (3 mg drospirenone/0.03 mg EE) orally every day or 21 days, THEN 1 inert tablet orally every day for 7 days
• Beyaz
  • 1 active tablet (3 mg drospirenone/0.02 mg EE) orally every day for 24 days, THEN 1 inert tablet orally every day for 4 days

Pediatric dosage

• Aged below 14 years
  • Safety and efficacy not established
• Aged above 14 years
  • Safyral, Tydemy
    • 1 active tablet (3 mg drospirenone/0.03 mg EE) orally every day for 21 days, THEN 1 inert tablet orally every day for 7 days
  • Beyaz
    • 1 active tablet (3 mg drospirenone/0.02 mg EE) orally every day for 24 days, THEN 1 inert tablet orally every day for 4 days

Moderate Acne Vulgaris

• Adult dosage
• Beyaz
  • 1 active tablet (3 mg drospirenone/0.02 mg EE) orally every day for 24 days, THEN 1 inert tablet orally every day for 4 days

Pediatric dosage

• Aged below 14 years
  • Safety and efficacy not established
• Aged above 14 years
  • Beyaz
    • 1 active tablet (3 mg drospirenone/0.02 mg EE) orally every day for 24 days, THEN 1 inert tablet orally every day for 4 days

Premenstrual dysphoric disorder

Adult dosage

• Beyaz
  • 1 active tablet (3 mg drospirenone/0.02 mg EE) orally every day for 24 days, THEN 1 inert tablet orally every day for 4 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Drospirenone, Ethinyl estradiol, and levomefolate have severe interactions with the following drugs:
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • tranexamic acid oral
• Drospirenone, Ethinyl estradiol, and levomefolate have serious interactions with at least 72 other drugs.
• Drospirenone, Ethinyl estradiol, and levomefolate have moderate interactions with at least 264 other drugs.
• Drospirenone, Ethinyl estradiol, and levomefolate have minor interactions with at least 58 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• an adrenal gland disorder;
• kidney disease;
• untreated or uncontrolled high blood pressure;
• heart disease (coronary artery disease, history of heart attack, stroke, or blood clot);
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• circulation problems (especially if caused by diabetes);
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes), especially if you are older than 35;
• a history of jaundice caused by pregnancy or birth control pills;
• if you smoke and are over 35 years old; or
• if you take any hepatitis C medication containing ombitasvir/paritaprevir/ritonavir (Technivie).

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Drospirenone, Ethinyl estradiol, and levomefolate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Drospirenone, Ethinyl estradiol, and levomefolate?”

Cautions

• Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or you are overweight. Your risk of stroke or blood clots is highest during your first year of taking this medicine. Your risk is also high when you restart this medicine after not taking it for 4 weeks or longer.
• Smoking can greatly increase your risk of blood clots, stroke, or heart attack. Your risk increases the older you are and the more you smoke. You should not take this medicine if you smoke and are over 35 years old.
• You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.
• If you need major surgery or will be on long-term bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using this medicine.
• This medicine will not protect you from sexually transmitted diseases, including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.
• Breast cancer
• Epidemiology studies have not found a consistent association between the use of combined oral contraceptives (COCs) and breast cancer risk; studies do not show an association between ever (current or past) use of COCs and risk of breast cancer
• Some studies report a small increase in the risk of breast cancer among current or recent users(less than 6 months since last use) and current users with a longer duration of COC use
• A woman's risk depends on conditions where naturally high hormone levels persist for long periods including early-onset
• Thromboembolic disorders
• Discontinue immediately if a thrombotic event occurs
• The risk of VTE is highest during the first year of use; interim data from a large, prospective cohort safety study of various combined oral contraceptives (COCs) suggest that this increased risk, as compared with that in non-COC users, is greatest during the first 6 months of COC use
• Women taking drospirenone-containing contraceptives may have up to 3-fold increased risk of developing VTE compared with women taking other combined hormonal contraceptives
• To decrease the risk of VTE events, CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section before initiating the use of combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives

Pregnancy & Lactation

• Do not use it if you are pregnant. Stop using this medicine and tell your doctor right away if you become pregnant, or if you miss 2 menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking this medicine.

Lactation

• The hormones in this medicine can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use it if you are breastfeeding