Drospirenone/ Ethinyl Estradiol

Drospirenone Ethinyl Estradiol is a prescription medication used to treat Moderate Acne Vulgaris, Premenstrual Dysphoric Disorder, and as Contraception to prevent pregnancy. 

• Drospirenone Ethinyl Estradiol is available under the following different brand names: Yasmin, Yaz, Gianvi, Loryna, Ocella, Syeda, Vestura, Zarah, Yaela

Adult and pediatric dosage

Tablet

• 3mg/0.02mg (Yaz, Gianvi, Loryna, Vestura)
• 3mg/0.03mg (Yasmin, Ocella, Syeda, Yaela, Zarah)

Contraception

Adult dosage

Yasmin, Ocella, Syeda, Yaela, Zarah

• 1 active tablet (3 mg drospirenone/0.03 mg EE) orally once daily for 21 days, then 1 inert tablet orally once daily for 7 days

Yaz, Gianvi, Loryna, Vestura

• 1 active tablet (3 mg drospirenone/0.02 mg EE) orally once daily for 24 days, then 1 inert tablet orally once daily for 4 days

Pediatric dosage

• Children younger than 14 years of age: Safety and efficacy not established
• Children 14 years of age or older: 
  • Yasmin, Ocella, Syeda, Yaela, Zarah
  • 1 active tablet (3 mg drospirenone/0.03 mg EE) orally once daily for 21 days, then 1 inert tablet orally once daily for 7 days
  • Yaz, Gianvi, Loryna, Vestura
  • 1 active tablet (3 mg drospirenone/0.02 mg EE) orally once daily for 24 days, then 1 inert tablet orally once daily for 4 days

Moderate Acne Vulgaris

Adult dosage

Yaz, Gianvi, Loryna

• 1 active tablet (3 mg drospirenone/0.02 mg EE) orally once daily for 24 days, then 1 inert tablet orally once daily for 4 days

Pediatric dosage

• Children younger than 14 years of age: Safety and efficacy not established
• Children 14 years of age or older: 
  • Yaz, Gianvi, Loryna
    • 1 active tablet (3 mg drospirenone/0.02 mg EE) orally once daily for 24 days, then 1 inert tablet orally once daily for 4 days

Premenstrual Dysphoric Disorder

Adult dosage

Yaz, Gianvi

• 1 active tablet (3 mg drospirenone/0.02 mg EE) orally once daily for 24 days, then 1 inert tablet orally once daily for 4 days

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Drospirenone Ethinyl Estradiol include:

• nausea, 
• vomiting, 
• breast tenderness, 
• headache, 
• mood changes, 
• tiredness, 
• irritableness, 
• weight gain, 
• changes in the menstrual periods, and 
• decreased sex drive

Serious side effects of Drospirenone/Ethinyl Estradiol include:

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

Rare side effects of Drospirenone Ethinyl Estradiol include:

• none 

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 has severe interactions with the following drugs:
  • ombitasvir/paritaprevir/ritonavir & dasabuvir
  • tranexamic acid oral
• Drospirenone Ethinyl Estradiol has serious interactions with at least 72 other drugs.
• Drospirenone Ethinyl Estradiol has moderate interactions with at least 259 other drugs.
• Drospirenone Ethinyl Estradiol has 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 drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Documented hypersensitivity
• Active/history of breast cancer or estrogen- or progestin-sensitive cancer
• 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 Ethinyl Estradiol?”

Long-Term Effects

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

Cautions

• Due to increased risk of hyperkalemia, monitor serum potassium during the first month if coadministered with potassium-elevating/sparing drugs (e.g., spironolactone); consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly; strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin
• Family history of breast cancer and or DVT/PE
• Current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE
• Conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)
• Discontinue immediately if any of the following occur: jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, a significant increase in BP, severe depression, increased risk of thromboembolic complications after surgery
• Discontinue therapy 4 weeks before major surgery or prolonged immobilization; may resume 2 weeks afterward
• Monitor patients on oral anticoagulants (eg, warfarin); increased anticoagulant dose may be warranted due to thromboembolic risk with oral contraceptives
• Some studies have shown a link between the use of oral contraceptive pills (OCPs) and increased risk of breast cancer, whereas other studies have not; risk depends on conditions in which naturally high hormone levels persist for long periods, including early-onset menstruation before age 12 years, late-onset menopause, age 55 years of age or older, the first child born after age 30 years, nulliparity
• Studies have shown an increased risk of cervical cancer with OCP use; however, HPV remains the main risk factor for cervical cancer; evidence suggests long-term use of OCPs (greater than 5 years or more) may be associated with increased risk
• Studies have shown a significantly decreased endometrial cancer risk with OCP use; protective effect increases with longer duration of OCP use and may continue to persist years after OCP discontinuation
• The risk of ovarian cancer may decrease with increasing duration of OCP use
• Discontinue hormonal therapy before starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with a combination drug regimen
• Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use
• Monitor prediabetic and diabetic women with dyslipidemias

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 for 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 use of combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives. 

Pregnancy and Lactation

• Do not use it in pregnancy. The risks involved outweigh the potential benefits. Safer alternatives exist.
• Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing).