Drospirenone/ethy EST 3/0.02mg T 28
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age. @ COMMON USES: It is used to prevent pregnancy.It is used to treat pimples (acne).It is used to ease painful period (menstrual) cycles.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Contraceptive
Pharmacologic Class
Estrogen and Progestin Combination
Pregnancy Category
Category X
FDA Approved
May 2001
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a birth control pill that contains two female hormones, an estrogen (ethinyl estradiol) and a progestin (drospirenone). It works by preventing ovulation (the release of an egg from the ovary) and also changes the cervical mucus and uterine lining to prevent pregnancy. It can also be used to treat moderate acne and severe premenstrual syndrome (PMDD).
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take your medication at the same time every day, with or without food. If you experience stomach upset, taking it with food may help. However, if you consume grapefruit juice or eat grapefruit regularly, consult your doctor.
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy. Be sure to follow your doctor's guidance on using this additional form of birth control. Do not skip doses, even if you do not have frequent sexual intercourse.
If you vomit or have diarrhea, the medication may not be as effective in preventing pregnancy. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and contact your doctor. If you are unsure what to do, call your doctor for advice.
If you miss two consecutive periods, take a pregnancy test before starting a new cycle of medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms.
Missing a Dose
If you miss a dose, refer to the package insert or contact your doctor for guidance. If you are using this medication for birth control, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take your medication at the same time every day, with or without food. If you experience stomach upset, taking it with food may help. However, if you consume grapefruit juice or eat grapefruit regularly, consult your doctor.
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy. Be sure to follow your doctor's guidance on using this additional form of birth control. Do not skip doses, even if you do not have frequent sexual intercourse.
If you vomit or have diarrhea, the medication may not be as effective in preventing pregnancy. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and contact your doctor. If you are unsure what to do, call your doctor for advice.
If you miss two consecutive periods, take a pregnancy test before starting a new cycle of medication.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms.
Missing a Dose
If you miss a dose, refer to the package insert or contact your doctor for guidance. If you are using this medication for birth control, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as this significantly increases the risk of serious side effects like blood clots and heart attack.
- Maintain regular follow-up appointments with your healthcare provider for blood pressure checks and overall health monitoring.
- Report any unusual or severe symptoms immediately.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
- If you miss a dose, follow the specific instructions in the package insert for missed pills to maintain contraceptive effectiveness.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally once daily for 28 consecutive days, starting on the first day of menstrual bleeding or the first Sunday after the onset of menstruation. The first 24 tablets are active (containing drospirenone 3 mg and ethinyl estradiol 0.02 mg), followed by 4 inert tablets.
Condition-Specific Dosing:
contraception:
One tablet orally once daily.
PMDD:
One tablet orally once daily.
moderateAcneVulgaris:
One tablet orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for postmenarcheal females requiring contraception, PMDD, or acne treatment.
Dose Adjustments
Renal Impairment:
Mild:
Contraindicated in patients with renal insufficiency (creatinine clearance < 50 mL/min).
Moderate:
Contraindicated in patients with renal insufficiency (creatinine clearance < 50 mL/min).
Severe:
Contraindicated in patients with renal insufficiency (creatinine clearance < 50 mL/min).
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
Contraindicated in patients with hepatic dysfunction or liver tumors.
Moderate:
Contraindicated in patients with hepatic dysfunction or liver tumors.
Severe:
Contraindicated in patients with hepatic dysfunction or liver tumors.
Pharmacology
Mechanism of Action
Combined oral contraceptives (COCs) primarily work by inhibiting ovulation through suppression of gonadotropins (FSH and LH). Ethinyl estradiol suppresses FSH, preventing follicular development, while drospirenone suppresses LH, preventing ovulation. Other mechanisms include changes to the cervical mucus, making it more difficult for sperm to penetrate, and alterations to the endometrium, making it less receptive to implantation.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-60%; Drospirenone: ~76%
Tmax:
Ethinyl Estradiol: 1-2 hours; Drospirenone: 1-2 hours
FoodEffect:
Food does not significantly affect the extent of absorption of drospirenone or ethinyl estradiol.
Distribution:
Vd:
Ethinyl Estradiol: ~2.8-8.6 L/kg; Drospirenone: ~4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (primarily to albumin); Drospirenone: ~97% (primarily to albumin, not SHBG or CBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~18-24 hours; Drospirenone: ~30-34 hours
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Drospirenone: ~1.5 mL/min/kg
ExcretionRoute:
Ethinyl Estradiol: Renal (40%), Fecal (60%); Drospirenone: Renal (38-47%), Fecal (53-62%)
Unchanged:
Ethinyl Estradiol: <2%; Drospirenone: <1%
Pharmacodynamics
OnsetOfAction:
Contraceptive effect begins after 7 consecutive days of active pill use. Full protection typically after the first full cycle.
PeakEffect:
Not directly applicable for contraceptive effect, but hormonal suppression is sustained with daily dosing.
DurationOfAction:
24 hours (requires daily dosing for continuous effect)
Confidence:
High
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Drospirenone/Ethinyl Estradiol, are contraindicated in women who are over 35 years of age and smoke.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of high potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling like passing out, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin or eyes, fever with chills, bloating, or severe upset stomach or vomiting.
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Urination problems or changes in urine output.
Breast changes: lump, pain, or soreness, or nipple discharge.
Vaginal itching or discharge.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or trouble speaking or swallowing.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Appetite changes.
Weight gain.
Headache.
Upset stomach or vomiting.
Cramps.
Bloating.
Menstrual changes, including spotting or bleeding between cycles.
Enlarged or tender breasts.
Fatigue or weakness.
Decreased interest in sex.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of high potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling like passing out, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin or eyes, fever with chills, bloating, or severe upset stomach or vomiting.
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Urination problems or changes in urine output.
Breast changes: lump, pain, or soreness, or nipple discharge.
Vaginal itching or discharge.
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or trouble speaking or swallowing.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Appetite changes.
Weight gain.
Headache.
Upset stomach or vomiting.
Cramps.
Bloating.
Menstrual changes, including spotting or bleeding between cycles.
Enlarged or tender breasts.
Fatigue or weakness.
Decreased interest in sex.
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache, especially if accompanied by vision changes or weakness
- Sudden numbness or weakness on one side of the body
- Sudden chest pain, shortness of breath, or coughing up blood
- Sudden severe pain or swelling in one leg
- Sudden partial or complete loss of vision
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- Symptoms of hyperkalemia: muscle weakness, fatigue, slow or irregular heartbeat, numbness or tingling in hands/feet
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Certain health problems, such as:
+ Adrenal gland problems
+ High potassium levels
+ Kidney problems
A history of:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you experienced jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control.
If you have taken a combination of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
If you are breast-feeding or plan to breast-feed.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Any health problems you have
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
Certain health problems, such as:
+ Adrenal gland problems
+ High potassium levels
+ Kidney problems
A history of:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you experienced jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control.
If you have taken a combination of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
If you are breast-feeding or plan to breast-feed.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
* Any health problems you have
This information will help your doctor determine if it is safe for you to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. The hormone drospirenone in this medication may further increase the risk of blood clots compared to other birth control pills. Consult your doctor to understand this risk.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this may increase your risk of blood clots.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly as advised by your doctor. It may also lead to high cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regular blood tests are necessary; follow your doctor's instructions.
Regular breast exams, gynecology check-ups, and breast self-exams (as directed by your doctor) are crucial while taking this medication.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Prolonged sun exposure may cause dark skin patches on your face while taking this medication. Avoid sun, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, as you may need to use a non-hormone birth control method, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sexual activity. If you have questions, consult your doctor.
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be attributed to other factors. Discuss any concerns with your doctor.
Some studies suggest a potential increased risk of breast cancer associated with long-term use of hormone-based birth control, while others have not found this link. If you have questions, consult your doctor.
This medication is not intended for use in children who have not yet had their first menstrual period. If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. The hormone drospirenone in this medication may further increase the risk of blood clots compared to other birth control pills. Consult your doctor to understand this risk.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this may increase your risk of blood clots.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, inform your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly as advised by your doctor. It may also lead to high cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regular blood tests are necessary; follow your doctor's instructions.
Regular breast exams, gynecology check-ups, and breast self-exams (as directed by your doctor) are crucial while taking this medication.
This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Prolonged sun exposure may cause dark skin patches on your face while taking this medication. Avoid sun, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, as you may need to use a non-hormone birth control method, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sexual activity. If you have questions, consult your doctor.
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be attributed to other factors. Discuss any concerns with your doctor.
Some studies suggest a potential increased risk of breast cancer associated with long-term use of hormone-based birth control, while others have not found this link. If you have questions, consult your doctor.
This medication is not intended for use in children who have not yet had their first menstrual period. If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Vaginal bleeding (withdrawal bleeding)
What to Do:
Seek medical attention. There is no specific antidote. Treatment is symptomatic and supportive. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, indinavir, nelfinavir, ritonavir, telithromycin) in patients with renal or adrenal insufficiency (due to increased drospirenone exposure and hyperkalemia risk)
Major Interactions
- Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene), potassium supplements, ACE inhibitors, ARBs, NSAIDs, heparin (increased risk of hyperkalemia due to drospirenone's anti-mineralocorticoid activity)
- CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, barbiturates, topiramate, St. John's Wort) (decreased contraceptive efficacy and increased breakthrough bleeding)
- Lamotrigine (decreased lamotrigine levels, loss of seizure control)
- Thyroid hormone replacement therapy (increased thyroid binding globulin, requiring increased thyroid hormone dose)
- Corticosteroids (increased corticosteroid levels)
Moderate Interactions
- Grapefruit juice (may increase ethinyl estradiol levels)
- Ascorbic acid (may increase ethinyl estradiol levels)
- Atorvastatin (may increase ethinyl estradiol levels)
- Paracetamol (acetaminophen) (may increase ethinyl estradiol levels)
- Troleandomycin (increased risk of intrahepatic cholestasis)
- Cyclosporine (increased cyclosporine levels)
- Theophylline (increased theophylline levels)
- Voriconazole (may increase ethinyl estradiol levels)
Minor Interactions
- Not specifically categorized as minor for this drug, but general interactions with other drugs metabolized by CYP enzymes or affecting gut flora could occur.
Monitoring
Baseline Monitoring
Blood pressure
Rationale: To identify pre-existing hypertension, which is a contraindication or risk factor for cardiovascular events.
Timing: Prior to initiation
Medical history (personal and family)
Rationale: To assess for contraindications and risk factors for VTE, arterial thrombotic disease, liver disease, migraines, and estrogen-dependent neoplasms.
Timing: Prior to initiation
Physical examination (including breast and pelvic exam)
Rationale: To rule out contraindications and establish baseline health status.
Timing: Prior to initiation (as clinically indicated)
Serum potassium
Rationale: To assess for baseline hyperkalemia, especially in patients with renal impairment or those on concomitant medications that may increase potassium.
Timing: Prior to initiation, particularly in at-risk patients
Routine Monitoring
Blood pressure
Frequency: Annually or as clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or change in contraception.
Serum potassium
Frequency: Periodically, especially during the first cycle, in patients at risk for hyperkalemia (e.g., concomitant medications, mild renal impairment)
Target: 3.5-5.0 mEq/L
Action Threshold: Levels >5.5 mEq/L require immediate evaluation and potential discontinuation.
Review of medical history and medication list
Frequency: Annually
Target: N/A
Action Threshold: New risk factors or interacting medications may necessitate a change in contraception.
Symptom Monitoring
- Signs of venous thromboembolism (VTE): severe leg pain, chest pain, shortness of breath, sudden vision changes, sudden severe headache
- Signs of arterial thrombotic events: sudden numbness or weakness, severe headache, vision changes, speech difficulties
- Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, severe abdominal pain
- Signs of hyperkalemia: muscle weakness, fatigue, heart palpitations, numbness/tingling
- Changes in menstrual bleeding patterns (e.g., breakthrough bleeding, amenorrhea)
- Mood changes, depression
- Severe abdominal pain (possible ovarian cyst rupture or ectopic pregnancy)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for use in pregnancy, and there is evidence of fetal risk. Discontinue if pregnancy is confirmed.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, though data on specific risks with accidental exposure are limited and generally do not show increased risk of birth defects.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended during breastfeeding. Estrogens can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant. Progestins are also excreted in breast milk.
Infant Risk:
L4 (Possibly Hazardous) - Potential for decreased milk supply and possible adverse effects on the infant (e.g., jaundice, breast enlargement), though generally considered low risk for healthy, full-term infants once lactation is well-established. Non-hormonal methods or progestin-only methods are generally preferred.
Pediatric Use
Indicated for postmenarcheal females for contraception, PMDD, and moderate acne. Safety and efficacy are established for this population. Not for use in prepubertal girls.
Geriatric Use
Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, and COCs are generally not used in women over 65.
Clinical Information
Clinical Pearls
- Drospirenone has anti-mineralocorticoid activity, which can lead to hyperkalemia, especially in patients with renal impairment or those taking other potassium-sparing drugs. Monitor potassium levels in at-risk patients.
- Counsel patients on the importance of consistent daily dosing to maintain contraceptive efficacy.
- Emphasize the black box warning regarding smoking and cardiovascular risk, especially for women over 35.
- Inform patients about potential for breakthrough bleeding, especially during the first few cycles, which usually resolves.
- Advise patients to use a backup method of contraception (e.g., condoms) if they miss pills, experience vomiting or severe diarrhea, or are taking interacting medications (e.g., antibiotics, anticonvulsants, St. John's Wort).
- This formulation (3mg drospirenone/0.02mg ethinyl estradiol) is also approved for the treatment of moderate acne and premenstrual dysphoric disorder (PMDD).
Alternative Therapies
- Progestin-only pills (mini-pill)
- Progestin injection (e.g., Depo-Provera)
- Progestin implant (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal and non-hormonal)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Sterilization (tubal ligation, vasectomy)
- For acne: topical retinoids, oral antibiotics, spironolactone, isotretinoin
- For PMDD: SSRIs, lifestyle modifications
Cost & Coverage
Average Cost:
$25 - $100 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered by most insurance plans, especially generics, due to ACA mandate for contraception)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.