Aranelle Tablets 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 may be given to you for other reasons. Talk with the doctor.
Drug Class
Contraceptive
Pharmacologic Class
Estrogen/Progestin Combination
Pregnancy Category
Category X
FDA Approved
Jul 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Aranelle is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone). It works by preventing your body from releasing an egg (ovulation) and by making it harder for sperm to reach the egg. It also changes the lining of your uterus to prevent pregnancy. It is taken once a day to prevent pregnancy.
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 this issue.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this 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. Follow your doctor's guidance on using non-hormonal birth control methods.
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 this occurs within 3 to 4 hours after 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, protected from light, and in a dry place. Avoid storing it in a bathroom.
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.
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 this issue.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this 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. Follow your doctor's guidance on using non-hormonal birth control methods.
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 this occurs within 3 to 4 hours after 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, protected from light, and in a dry place. Avoid storing it in a bathroom.
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.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms to prevent STIs.
- Maintain a healthy diet and exercise regularly to support overall cardiovascular health.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking, especially St. John's Wort, as they can reduce the effectiveness of birth control.
- If you experience severe vomiting or diarrhea, the effectiveness of the pill may be reduced; use a backup method of contraception.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. The first 21 tablets contain active ingredients, and the last 7 are inert (placebo).
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missed_dose_1_active:
Take as soon as remembered, then continue daily. No backup method needed.
missed_dose_2_active_consecutive:
Take 2 tablets on the day remembered and 2 tablets the next day, then continue daily. Use backup contraception for 7 days. Consider emergency contraception if unprotected intercourse occurred.
missed_dose_3_plus_active_consecutive:
Discard remaining pills in current pack. Start new pack immediately. Use backup contraception for 7 days. Consider emergency contraception if unprotected intercourse occurred.
missed_dose_placebo:
Discard missed placebo pills. Continue with next scheduled pill. No backup method needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Indicated only after menarche and establishment of regular menstrual cycles. Dosing is the same as adults.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required, but monitor for fluid retention.
Moderate:
No specific adjustment required, but monitor for fluid retention.
Severe:
Use with caution; monitor for fluid retention. No specific dose adjustment data.
Dialysis:
Not specifically studied; use with caution due to potential fluid retention.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Use with caution; monitor liver function. Consider lower dose or alternative if liver function deteriorates.
Severe:
Contraindicated in severe hepatic impairment, liver adenomas, or hepatocellular carcinoma.
Pharmacology
Mechanism of Action
Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), which in turn inhibits ovulation. They also induce changes in the cervical mucus, increasing its viscosity and making it more difficult for sperm to penetrate, and alter the endometrium, making it less receptive to implantation.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-45% (due to first-pass metabolism). Norethindrone: Approximately 60-80%.
Tmax:
Ethinyl Estradiol: 1-2 hours. Norethindrone: 0.5-4 hours.
FoodEffect:
Food does not significantly affect the absorption of either component.
Distribution:
Vd:
Ethinyl Estradiol: Approximately 5 L/kg. Norethindrone: Approximately 4 L/kg.
ProteinBinding:
Ethinyl Estradiol: Approximately 98% (primarily to albumin, also to sex hormone-binding globulin (SHBG)). Norethindrone: Approximately 96-98% (primarily to albumin and SHBG).
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: 6-20 hours (terminal half-life). Norethindrone: 5-14 hours (terminal half-life).
Clearance:
Ethinyl Estradiol: Approximately 5 mL/min/kg. Norethindrone: Approximately 0.4 mL/min/kg.
ExcretionRoute:
Both Ethinyl Estradiol and Norethindrone metabolites are excreted in urine and feces (via enterohepatic recirculation).
Unchanged:
Less than 5% of either drug is excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy begins after 7 consecutive days of active pill use. For immediate protection, start on Day 1 of menstruation.
PeakEffect:
Sustained throughout daily dosing.
DurationOfAction:
Requires daily administration for continuous contraceptive effect.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, oral contraceptives, including Aranelle, are contraindicated in women who are over 35 years of age and smoke. Postmarketing reports of significant elevations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have occurred in patients receiving ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, and glecaprevir/pibrentasvir regimens, who are also using ethinyl estradiol-containing products such as Aranelle. Aranelle must be discontinued prior to initiation of these HCV regimens.
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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, 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: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Vision changes or loss, bulging eyes, or changes in contact lens comfort.
Severe or persistent vaginal bleeding or spotting.
Fluid retention, swelling, weight gain, or breathing difficulties.
If you experience any of these symptoms, contact your doctor immediately.
This medication may also increase your risk of blood clots. Seek medical help right away if you experience:
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
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects and they bother you or persist, contact your doctor:
Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Breast enlargement or tenderness
Period (menstrual) changes, including heavy bleeding, spotting, or bleeding between cycles
This medication may also cause dark skin patches on your face. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
Reporting 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 immediate medical attention:
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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Vision changes or loss, bulging eyes, or changes in contact lens comfort.
Severe or persistent vaginal bleeding or spotting.
Fluid retention, swelling, weight gain, or breathing difficulties.
If you experience any of these symptoms, contact your doctor immediately.
This medication may also increase your risk of blood clots. Seek medical help right away if you experience:
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
Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects and they bother you or persist, contact your doctor:
Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Breast enlargement or tenderness
Period (menstrual) changes, including heavy bleeding, spotting, or bleeding between cycles
This medication may also cause dark skin patches on your face. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear.
Reporting 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:
- A: Abdominal pain (severe)
- C: Chest pain (severe), cough, shortness of breath
- H: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- E: Eye problems (sudden blurred vision, partial or complete loss of vision)
- S: Severe leg pain (calf or thigh), swelling, redness, warmth
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 and circumstances to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain (angina) or heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or potential pregnancy, as this medication is contraindicated during pregnancy.
Breastfeeding or plans to breastfeed.
Previous experiences of jaundice during pregnancy or with estrogen use, such as hormonal birth control.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use of this medication. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and circumstances to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain (angina) or heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or potential pregnancy, as this medication is contraindicated during pregnancy.
Breastfeeding or plans to breastfeed.
Previous experiences of jaundice during pregnancy or with estrogen use, such as hormonal birth control.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use of this medication. Do not initiate, stop, or adjust the dosage 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.
If you anticipate being immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar levels as directed by your doctor.
This medication may also cause an increase in blood pressure. Have your blood pressure checked regularly, as advised by your doctor. Additionally, high cholesterol and triglyceride levels have been associated with this drug. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as recommended.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Furthermore, if you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor.
This medication may interfere with certain lab tests, so it is essential to inform all your healthcare providers and lab workers that you are taking this drug.
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, and discuss the need for additional non-hormonal birth control methods, such as condoms.
It is crucial to note that this medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity, and consult your doctor if you have any questions.
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor, particularly during the first year of use or when restarting hormone-based birth control after a period of 4 weeks or more without use.
Some studies suggest a potential increased risk of cervical cancer associated with long-term use of hormone-based birth control, although the evidence is not conclusive. If you have concerns, discuss them with your doctor. Additionally, there is conflicting evidence regarding the risk of breast cancer with long-term use of hormone-based birth control. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication is not intended for use in children who have not yet had their first menstrual period.
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
If you anticipate being immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar levels as directed by your doctor.
This medication may also cause an increase in blood pressure. Have your blood pressure checked regularly, as advised by your doctor. Additionally, high cholesterol and triglyceride levels have been associated with this drug. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as recommended.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Furthermore, if you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor.
This medication may interfere with certain lab tests, so it is essential to inform all your healthcare providers and lab workers that you are taking this drug.
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, and discuss the need for additional non-hormonal birth control methods, such as condoms.
It is crucial to note that this medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity, and consult your doctor if you have any questions.
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor, particularly during the first year of use or when restarting hormone-based birth control after a period of 4 weeks or more without use.
Some studies suggest a potential increased risk of cervical cancer associated with long-term use of hormone-based birth control, although the evidence is not conclusive. If you have concerns, discuss them with your doctor. Additionally, there is conflicting evidence regarding the risk of breast cancer with long-term use of hormone-based birth control. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication is not intended for use in children who have not yet had their first menstrual period.
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (vaginal bleeding)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Call 911 or Poison Control at 1-800-222-1222 immediately.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (risk of ALT elevations)
- Glecaprevir/pibrentasvir (risk of ALT elevations)
Major Interactions
- CYP3A4 inducers (e.g., Carbamazepine, Phenytoin, Rifampin, Barbiturates, Topiramate, Oxcarbazepine, Felbamate, Griseofulvin, St. John's Wort) - decrease contraceptive efficacy.
- Lamotrigine - decreased lamotrigine levels, leading to loss of seizure control.
- Warfarin - may alter anticoagulant effect (monitor INR).
- Cyclosporine - increased cyclosporine levels (monitor cyclosporine levels).
Moderate Interactions
- CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin) - may increase estrogen/progestin levels, potentially increasing adverse effects.
- Atorvastatin, Rosuvastatin - increased AUC of ethinyl estradiol.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
- Acetaminophen - may increase ethinyl estradiol levels.
- Thyroid hormone replacement (e.g., Levothyroxine) - increased thyroid binding globulin, requiring increased thyroid hormone dose.
Minor Interactions
- Tricyclic antidepressants - may increase TCA levels.
- Benzodiazepines (e.g., Diazepam) - may increase benzodiazepine levels.
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To identify contraindications, risk factors for adverse events (e.g., VTE, cardiovascular disease), and establish baseline health status.
Timing: Prior to initiation of therapy.
Pregnancy test
Rationale: To rule out existing pregnancy, as the drug is contraindicated in pregnancy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <140/90 mmHg (or individualized based on patient risk factors)
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may necessitate discontinuation or change in contraceptive method.
Annual physical examination (including breast exam, pelvic exam, Pap test)
Frequency: Annually, or as clinically indicated per national guidelines.
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Weight and BMI
Frequency: Annually
Target: Healthy range (18.5-24.9 kg/m²)
Action Threshold: Significant weight gain or obesity increases cardiovascular risk.
Symptom Monitoring
- Severe abdominal pain (possible liver tumor, blood clot)
- Severe chest pain, shortness of breath, coughing up blood (possible pulmonary embolism, myocardial infarction)
- Severe headaches, dizziness, weakness, numbness, vision changes (possible stroke, migraine with aura)
- Eye problems (e.g., blurred vision, loss of vision, double vision) (possible blood clot in eye)
- Severe leg pain, swelling, warmth, redness (possible deep vein thrombosis)
- Jaundice (yellowing of skin or eyes), dark urine, light-colored stools (possible liver problems)
- Depressed mood, changes in mood
- New or worsening migraines
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for oral contraceptive use in pregnancy, and there is no evidence of increased risk of birth defects with inadvertent use during early pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects observed with inadvertent exposure.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended for use during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of hormonal steroids are excreted in breast milk and may affect the infant.
Infant Risk:
L4 (Possibly hazardous). Potential for decreased milk supply and transfer of hormones to the infant. Observe infant for jaundice or breast enlargement.
Pediatric Use
Not indicated before menarche. Once menarche has occurred, safety and efficacy are expected to be similar to adults. Not for use in prepubertal girls.
Geriatric Use
Not indicated for use in postmenopausal women. The safety and efficacy have not been established in geriatric patients.
Clinical Information
Clinical Pearls
- Breakthrough bleeding or spotting may occur, especially during the first few cycles. This is usually temporary and resolves with continued use. If persistent or heavy, consult a healthcare provider.
- If a dose is missed, follow specific instructions in the package insert carefully, as missing pills can reduce contraceptive effectiveness. A backup method (e.g., condoms) may be needed.
- Oral contraceptives can offer non-contraceptive benefits, including improvement of acne, reduction of dysmenorrhea (painful periods), reduction of menorrhagia (heavy periods), and a decreased risk of ovarian and endometrial cancers.
- Consider the patient's cardiovascular risk factors, especially smoking status and age, before prescribing. Emphasize smoking cessation.
- Patients should be advised to use a backup method of contraception if they are taking medications that may reduce the effectiveness of oral contraceptives (e.g., certain antibiotics, anticonvulsants, St. John's Wort).
Alternative Therapies
- Progestin-only pills (mini-pill)
- 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 or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generics); Tier 3 or higher (for brand-name)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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 emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.