Drospirenone and Ethinyl estradiol

Drospirenone and Ethinyl estradiol is a combination birth control pill containing female hormones that prevent pregnancy. 

• Drospirenone and Ethinyl estradiol is available under various brand names: Gianvi, Jasmiel, Loryna, Lo-Zumandimine, Nikki, Ocella, Syeda, Vestura, Yasmin, Yaz, Zarah, Zumandimine

Common side effects of Drospirenone and Ethinyl estradiol include:

• nausea, vomiting;
• breast tenderness;
• headache, mood changes, feeling tired or irritable;
• weight gain; or
• changes in the menstrual periods, and decreased sex drive.

Serious side effects of Drospirenone and Ethinyl estradiol 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 the hands, ankles, or feet;
• a change in the pattern or severity of migraine headaches; or
• symptoms of depression--sleep problems, weakness, tiredness, mood changes.

Rare side effects of Drospirenone and Ethinyl estradiol 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 dosage

Tablet

• 3 mg/0.02 mg (Yaz, Gianvi, Loryna, Vestura)
• 3 mg/0.03 mg (Yasmin, Ocella, Syeda, Yaela, Zarah)
• Contraception
• Adult dosage
• Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day.

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

• Documented hypersensitivity
• Active/history of breast cancer or estrogen- or progestin-sensitive caner
• Active/history of arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease
• Uncontrolled hypertension
• Diabetes mellitus with vascular involvement
• History of migraine with aura
• Undiagnosed abnormal uterine bleeding
• Benign or malignant liver tumors, hepatic impairment, or development of jaundice with prior oral contraceptive use
• Pregnancy
• Renal impairment
• Adrenal insufficiency
• Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• You should not take this medicine if you have: an adrenal gland disorder, kidney disease, uncontrolled high blood pressure, heart disease, coronary artery disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease or liver cancer, severe migraine headaches, if you also take certain hepatitis C medication, if you will have major surgery, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, jaundice caused by pregnancy or birth control pills, or cancer of the breast, uterus/cervix, or vagina.
• Taking this medicine can increase your risk of blood clots, stroke, or heart attack.
• Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

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 slight increase in the risk of breast cancer among current or recent users(below 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 menstruation before age 12, late-onset menopause, after age 55, first child after age 30, nulliparity

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.