Drospirenone-Ethinyl 3-0.03mg T 28s

Manufacturer CAMBER PHARMACEUTICALS Active Ingredient Ethinyl Estradiol and Drospirenone(ETH in il es tra DYE ole & droh SPYE re none) Pronunciation ETH-in-il es-TRA-dye-ol & droh-SPY-re-none
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.
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Drug Class
Contraceptive, Oral
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Pharmacologic Class
Estrogen/Progestin Combination; Anti-mineralocorticoid; Anti-androgenic
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Pregnancy Category
Category X
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FDA Approved
Mar 2006
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (drospirenone). It works by preventing ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. It can also help with acne and symptoms of premenstrual dysphoric disorder (PMDD).
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food to help alleviate discomfort.

If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with your medication. 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 non-hormonal birth control.

It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If you vomit or have diarrhea within 3 to 4 hours of taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.

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 call your doctor for instructions on what to do. If you're 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.
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Lifestyle & Tips

  • Do not smoke, especially if you are over 35, as this significantly increases your risk of serious side effects like blood clots and heart attack.
  • Take the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
  • If you miss a pill, follow the instructions in the package insert carefully. Use a backup birth control method (like condoms) if you are unsure or have missed multiple pills.
  • Be aware of symptoms of blood clots (e.g., severe leg pain, chest pain, sudden shortness of breath) and seek immediate medical attention if they occur.
  • Inform your doctor about all medications, supplements, and herbal products you are taking, especially St. John's Wort, as they can affect the pill's effectiveness.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally once daily at the same time each day for 28 consecutive days. The first 24 tablets are active (containing hormones), followed by 4 inactive tablets.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

contraception: Start on the first day of menstrual period or the first Sunday after the period begins. Use back-up contraception for the first 7 days if not starting on day 1.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment needed, but monitor potassium levels.
Moderate: Contraindicated due to risk of hyperkalemia.
Severe: Contraindicated due to risk of hyperkalemia.
Dialysis: Contraindicated.

Hepatic Impairment:

Mild: Contraindicated.
Moderate: Contraindicated.
Severe: Contraindicated.

Pharmacology

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Mechanism of Action

Drospirenone and Ethinyl Estradiol act primarily by suppressing gonadotropins, which in turn inhibits ovulation. Other mechanisms include changes in the cervical mucus (making it more difficult for sperm to penetrate the uterus) and changes in the endometrium (reducing the likelihood of implantation). Drospirenone also possesses anti-mineralocorticoid activity, which may counteract estrogen-induced fluid retention, and anti-androgenic activity.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~44%; Drospirenone: ~76%
Tmax: Ethinyl Estradiol: 1-2 hours; Drospirenone: 1-3 hours
FoodEffect: Food does not significantly affect the extent of absorption of either component.

Distribution:

Vd: Ethinyl Estradiol: ~4.3 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: Biphasic, terminal half-life ~24 hours; Drospirenone: Biphasic, terminal half-life ~30 hours
Clearance: Ethinyl Estradiol: ~5 mL/min/kg; Drospirenone: ~1.5 mL/min/kg
ExcretionRoute: Ethinyl Estradiol: Renal and fecal (glucuronide and sulfate conjugates); Drospirenone: Renal and fecal (as metabolites)
Unchanged: Ethinyl Estradiol: <5%; Drospirenone: <1%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically begins after 7 consecutive days of active pill use if started correctly (e.g., Day 1 of menses).
PeakEffect: Steady-state concentrations are reached within 8 days for drospirenone and 3-4 days for ethinyl estradiol.
DurationOfAction: Daily dosing maintains contraceptive effect.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combination 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.
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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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes (jaundice)
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion or weakness
+ Lightheadedness, dizziness, or feeling faint
+ Numbness or tingling
+ Shortness of breath
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder, or between the shoulder blades
+ Yellow skin or eyes (jaundice)
+ Fever with chills
+ Bloating or severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Depression or other mood changes
Difficulty urinating or changes in urine output
Breast lump, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Changes in vision, bulging eyes, or changes in how contact lenses feel
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Difficulty speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Changes in appetite
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, 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.
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Seek Immediate Medical Attention If You Experience:

  • ACHES: Abdominal pain (severe)
  • Chest pain (severe), cough, shortness of breath
  • Headache (severe, sudden, or worse than usual), dizziness, weakness, numbness
  • Eye problems (sudden vision loss or blurring)
  • Severe leg pain (calf or thigh), swelling, redness, warmth
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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:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, 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
+ Chest pain (angina)
+ 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
+ Vaginal bleeding with an unknown cause
If you experienced jaundice during pregnancy or with estrogen use, such as hormonal birth control
If you have taken ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
If you are pregnant or may be pregnant. Note: This medication is contraindicated during pregnancy.
If you are breast-feeding or plan to breast-feed

Additionally, inform your doctor and pharmacist about all medications you are taking, including:

Prescription and over-the-counter medications
Natural products
* Vitamins

It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor. This is not an exhaustive list of all potential interactions, so it is essential to discuss all your medications and health problems with your doctor.
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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. Be sure to talk to your doctor about this risk.

If you will be immobile for an extended period, 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. Additionally, this medication may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have regular blood work checks as directed.

Regular breast exams, gynecology check-ups, and breast self-exams are crucial while taking this medication. Perform breast self-exams as instructed by your doctor.

This medication may interfere with certain laboratory tests. Inform all your healthcare providers and lab 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 when going outside.

Certain medications, herbal products, or health conditions may reduce the effectiveness of this hormone-based birth control. Ensure your doctor is aware of all your medications and health conditions, and discuss the potential need for additional non-hormonal birth control methods, such as condoms.

This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.

Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be attributed to other factors. Discuss any concerns with your doctor. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not. If you have questions, talk to 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.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Vaginal bleeding (withdrawal bleeding)

What to Do:

Overdose is generally not life-threatening. Treatment is supportive. Call 1-800-222-1222 (Poison Control) for advice.

Drug Interactions

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Contraindicated Interactions

  • Drugs that inhibit CYP3A4 (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, diltiazem, verapamil, grapefruit juice) in patients with renal or hepatic impairment due to increased drospirenone exposure and hyperkalemia risk.
  • Hepatitis C virus (HCV) drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to risk of ALT elevations.
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, eplerenone, amiloride, triamterene) due to increased risk of hyperkalemia.
  • ACE inhibitors (e.g., lisinopril, enalapril) due to increased risk of hyperkalemia.
  • Angiotensin II receptor blockers (ARBs) (e.g., valsartan, losartan) due to increased risk of hyperkalemia.
  • NSAIDs (chronic use) due to increased risk of hyperkalemia.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort, topiramate) can decrease contraceptive efficacy and increase breakthrough bleeding.
  • Lamotrigine (decreased lamotrigine levels, loss of seizure control).
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Moderate Interactions

  • Thyroid hormone replacement therapy (may require increased thyroid hormone dose as COCs can increase thyroid binding globulin).
  • Corticosteroids (COCs can increase plasma concentrations of corticosteroids).
  • Tricyclic antidepressants (COCs can increase plasma concentrations of TCAs).
  • Cyclosporine (COCs can increase plasma concentrations of cyclosporine).
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Minor Interactions

  • Acetaminophen (may increase ethinyl estradiol levels slightly).
  • Ascorbic acid (Vitamin C) (may increase ethinyl estradiol levels slightly).

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To establish baseline and identify hypertension, a risk factor for cardiovascular events with COCs.

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.

Serum Potassium

Rationale: Due to drospirenone's anti-mineralocorticoid activity, especially in patients with renal impairment or concomitant use of potassium-increasing drugs.

Timing: Prior to initiation, particularly if risk factors for hyperkalemia are present.

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Routine Monitoring

Blood Pressure

Frequency: Annually or more frequently if clinically indicated.

Target: <140/90 mmHg

Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraception.

Serum Potassium

Frequency: Periodically, especially during the first cycle or when co-administered with drugs that increase potassium.

Target: 3.5-5.0 mEq/L

Action Threshold: Levels >5.5 mEq/L require immediate evaluation and potential discontinuation.

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Symptom Monitoring

  • Severe chest pain, shortness of breath, sudden cough (signs of pulmonary embolism)
  • Sudden severe headache, weakness or numbness on one side of the body, speech changes, vision changes (signs of stroke)
  • Sudden loss of vision, bulging eyes (signs of retinal thrombosis)
  • Severe leg pain, swelling, warmth, redness (signs of deep vein thrombosis)
  • Severe abdominal pain (signs of liver tumor or pancreatitis)
  • Jaundice (yellowing of skin or eyes)
  • Mood changes, depression
  • Breast lumps

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. There is no indication for use in pregnancy, and there is evidence of fetal risk.

Trimester-Specific Risks:

First Trimester: Potential for adverse effects on fetal development, though data on specific risks are limited and conflicting.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of steroids are excreted in breast milk and may affect the infant.

Infant Risk: Low risk of adverse effects in the infant, but potential for reduced milk supply and changes in milk composition. Consider progestin-only methods if contraception is needed during breastfeeding.
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Pediatric Use

Safety and efficacy are established for post-menarcheal adolescents. Not indicated for use before menarche.

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Geriatric Use

Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, especially in smokers.

Clinical Information

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Clinical Pearls

  • Drospirenone has anti-mineralocorticoid properties, which can lead to a slight diuretic effect and may help with bloating, but also carries a risk of hyperkalemia, especially in patients with renal impairment or those taking potassium-sparing drugs.
  • This formulation is often chosen for its benefits in treating moderate acne and symptoms of premenstrual dysphoric disorder (PMDD) in addition to contraception.
  • Patients should be counseled on the increased risk of venous thromboembolism (VTE) with drospirenone-containing COCs compared to some other progestins, although the absolute risk remains low.
  • Strict adherence to the daily dosing schedule is crucial for contraceptive efficacy and to minimize breakthrough bleeding.
  • Always inquire about smoking status and age before prescribing, as these are major contraindications.
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Alternative Therapies

  • Progestin-only pills (POPs)
  • Contraceptive patch (e.g., Xulane)
  • Vaginal ring (e.g., NuvaRing, Annovera)
  • Contraceptive injection (e.g., Depo-Provera)
  • Contraceptive implant (e.g., Nexplanon)
  • Intrauterine devices (IUDs) (hormonal and non-hormonal)
  • Barrier methods (condoms, diaphragm)
  • Spermicides
  • Natural family planning
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $50 - $200 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.