Drospirenone

Drospirenone is a prescription medication used as contraception to prevent pregnancy.

• Drospirenone is available under the following different brand names: Slynd

Adult dosage

Tablet

• 4 mg (pack contains 24 active [white] and 4 inert [green] tablets)

Contraception

Adult dosage

• 1 tablet once a day for 28 consecutive days; 1 white active tablet/day during the first 24 days and 1 green inert tablet/day during the 4 following days
• Starting with no current hormonal contraception use:
  • Take the first white active tablet on the first day of menses
  • Take subsequent white active tablets once a day at the same time each day for a total of 24 days
  • Take 1 green inert tablet daily for 4 days and at the same time of day that active tablets were taken
• Switching from another contraceptive method
  • Combined oral contraceptive (COC): Start drospirenone on the day when the new pack of the previous COC would have started
  • Transdermal patch: Start drospirenone on the day when the next application would have been scheduled
  • Vaginal ring: Start drospirenone on the day when the next insertion would have been scheduled
  • Injection: Start drospirenone on the day when the next injection would have been scheduled
  • Intrauterine contraceptive: Start drospirenone on the day of removal
  • Implant: Start drospirenone on the day of removal

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Drospirenone include:

• acne,
• irregular menstrual bleeding,
• headache,
• breast pain,
• weight gain,
• menstrual cramps,
• nausea,
• vaginal bleeding,
• decreased sex drive, and
• breast tenderness

Serious side effects of Drospirenone include:

• severe or ongoing nausea,
• vomiting,
• diarrhea,
• weakness,
• tingly feeling,
• chest pain,
• irregular heartbeats,
• loss of movement,
• 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,
• loss of appetite,
• upper stomach pain,
• tiredness,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• sleep problems,
• weakness,
• tired feeling, and
• mood changes

Rare side effects of Drospirenone 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 such as fast, irregular, or pounding heartbeats; fluttering in your 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.

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 has severe interactions with no other drugs.
• Drospirenone has serious interactions with the following drugs
  • amiloride
  • belzutifan
  • calaspargase pegol
  • eplerenone
  • fedratinib
  • isavuconazonium sulfate
  • lonafarnib
  • mavacamten
  • mobocertinib
  • potassium acid phosphate
  • potassium chloride
  • potassium citrate
  • potassium phosphates, IV
  • spironolactone
  • triamterene
• Drospirenone has moderate interactions with at least 140 other drugs.
• Drospirenone has minor interactions with at least 34 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

• Renal impairment
• Adrenal insufficiency
• Presence or history of cervical cancer or progestin-sensitive cancers
• Liver tumors, benign or malignant, or hepatic impairment
• Undiagnosed abnormal uterine bleeding

Effects of drug abuse

• None

Short-Term Effects

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

Long-Term Effects

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

Cautions

• Use leads to decreased estradiol serum levels; unknown if clinically relevant loss of bone mineral density may occur
• Some studies suggest COC containing progestin and estradiol is associated with an increased risk of cervical cancer or intraepithelial neoplasia; however, controversy continues about the extent to which such findings may be due to differences in sexual behavior and other factors
• Discontinue if jaundice or acute or chronic disturbances of liver function develop; do not resume until LFTs return to normal and causation identified; drospirenone contraindicated with hepatic impairment or benign or malignant liver tumors
• Consider the possibility of ectopic pregnancy in women who become pregnant or report lower abdominal pain
• Progestins may decrease insulin sensitivity; patients with diabetes may be at greater risk of hyperglycemia and may require additional medication adjustments or monitoring
• Bleeding irregularities (.g, breakthrough or tetracyclic bleeding or spotting) may occur, especially during the first 3 months; may resolve over time or by changing to a different contraceptive; if persists, evaluate for causes (.g, pregnancy, malignancy)
• Carefully observe females for the history of depression and discontinue drospirenone if depression recurs to a serious degree
• Thromboembolic risk
  • Thromboembolism risk with combined oral contraceptives containing drospirenone and Ethinyl estradiol higher than those containing some other progestins plus Ethinyl estradiol
  • Epidemiological studies have not indicated an association between progestin-only preparations and an increased risk of myocardial infarction, cerebral thromboembolism, or venous thromboembolism
  • Discontinue if arterial or venous thromboembolic events occur; consider discontinuing prolonged immobilization due to surgery or illness
• Hyperkalemia
  • Drospirenone has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk females, comparable to spironolactone 25 mg
  • Contraindicated in females with conditions that predispose to hyperkalemia (e.g., renal impairment, hepatic impairment, adrenal insufficiency, long-term coadministration with strong CYP3A4 inhibitor)
• Drug interaction overview
• Effects of another drug on hormonal contraception
  • Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease systemic concentrations of hormonal contraceptives and potentially diminish the effectiveness or increase breakthrough bleeding
  • Instruct women to use a nonhormonal backup contraceptive for 28 days after discontinuing the enzyme inducer
  • Strong CYP3A4 inhibitors may result in a moderate increase of drospirenone systemic exposure
• Effects of drospirenone on other drugs
  • Potential for increased serum potassium concentration if drospirenone is coadministered with other drugs that increase potassium levels

Pregnancy & Lactation

• Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use oral progestins during early pregnancy
• Discontinue if pregnancy occurs, as there is no reason to use hormonal contraceptives during pregnancy
• Human data
  • Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following maternal use of oral progestins before conception or during early pregnancy
• Lactation
  • Negligible amounts of drospirenone are excreted in the breast milk
  • At therapeutic doses, no effects on breastfed newborns/infants are anticipated
• Human data
  • After daily administration of 4 mg, the average drospirenone concentration in breast milk over 24 hours is 5.6 ng/mL
  • Based on this concentration, the estimated average infant daily dosages for an exclusively breastfed infant are 840 ng/kg/day (relative infant dose is 1.5%)