Norethindrone Acet/eth 1/20 Tb 21's
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, Hormonal
Pharmacologic Class
Estrogen and Progestin Combination
Pregnancy Category
Category X
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication 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 changing your cervical mucus and uterine lining to make it harder for sperm to reach an egg or for a fertilized egg to implant. It is taken daily to prevent pregnancy.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from this medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take this medication at the same time every day to establish a routine.
You can take it with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
If you're also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication to avoid any potential interactions.
Important Information for Women Taking This Medication for Birth Control
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 methods.
Do not skip doses, even if you don't have sex frequently, as this can reduce the medication's effectiveness in preventing pregnancy.
If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy. If this happens 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 contact your doctor for further guidance. If you're unsure what to do, don't hesitate to reach out to your doctor.
If you miss two periods in a row, take a pregnancy test before starting a new cycle of medication.
Storing and Disposing of Your Medication
To maintain the medication's potency and safety:
Store it at room temperature, away from direct light.
Keep it in a dry place, avoiding storage in a bathroom where moisture levels can be higher.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert for guidance or contact your doctor to determine the best course of action. 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 get the most benefit from this medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely.
Take this medication at the same time every day to establish a routine.
You can take it with or without food, but if it causes stomach upset, take it with food to help minimize discomfort.
If you're also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication to avoid any potential interactions.
Important Information for Women Taking This Medication for Birth Control
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 methods.
Do not skip doses, even if you don't have sex frequently, as this can reduce the medication's effectiveness in preventing pregnancy.
If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy. If this happens 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 contact your doctor for further guidance. If you're unsure what to do, don't hesitate to reach out to your doctor.
If you miss two periods in a row, take a pregnancy test before starting a new cycle of medication.
Storing and Disposing of Your Medication
To maintain the medication's potency and safety:
Store it at room temperature, away from direct light.
Keep it in a dry place, avoiding storage in a bathroom where moisture levels can be higher.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert for guidance or contact your doctor to determine the best course of action. 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 this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
- This medication does not protect against sexually transmitted infections (STIs). Use condoms to prevent STIs.
- Take the pill at the same time every day to maximize effectiveness and minimize breakthrough bleeding.
- If you miss a pill, follow the specific instructions in the package insert or consult your healthcare provider.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they can interact with birth control pills.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally once daily for 21 consecutive days, followed by 7 days of inactive tablets or no tablets.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
contraception:
Take at the same time each day. Start on the first day of menstruation or the first Sunday after menstruation begins.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Dosing is similar to adult dosing once menarche has occurred and contraception is indicated.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Use with caution; no specific dose adjustment, but monitor for fluid retention.
Dialysis:
Considerations: Not specifically studied, but generally not contraindicated. Monitor for fluid retention.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; monitor for adverse effects. May be contraindicated in some cases.
Severe:
Contraindicated in women with acute or chronic liver disease or hepatic adenomas/carcinomas.
Pharmacology
Mechanism of Action
Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]), which inhibits ovulation. They also induce changes in the cervical mucus, making it less permeable to sperm, and alter the endometrium, reducing the likelihood of implantation.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-60%; Norethindrone: Approximately 60-100%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours
FoodEffect:
Food may slightly decrease the rate but not the extent of absorption for both components.
Distribution:
Vd:
Ethinyl Estradiol: Approximately 2-4 L/kg; Norethindrone: Approximately 4 L/kg
ProteinBinding:
Ethinyl Estradiol: Highly bound to albumin and sex hormone-binding globulin (SHBG); Norethindrone: Highly bound to albumin and SHBG
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: 10-20 hours (terminal); Norethindrone: 5-14 hours (terminal)
Clearance:
Ethinyl Estradiol: Approximately 5-10 mL/min/kg; Norethindrone: Approximately 0.4 mL/min/kg
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and fecal (60%); Norethindrone: Renal (50-80%) and fecal (20-50%)
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%
Pharmacodynamics
OnsetOfAction:
Contraceptive effect begins after 7 consecutive days of active pill use in the first cycle.
PeakEffect:
Not directly applicable for contraceptive effect; hormonal levels peak within hours of dosing.
DurationOfAction:
Daily dosing maintains contraceptive effect.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combination 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, combination oral contraceptives, including Norethindrone Acetate and Ethinyl Estradiol Tablets, 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 blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
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, changes in balance, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent spotting or vaginal bleeding.
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, 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:
Changes in appetite.
Weight gain or loss.
Dizziness or headache.
Upset stomach or vomiting.
Stomach cramps.
Bloating.
Enlarged or tender breasts.
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear).
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles.
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
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, changes in balance, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent spotting or vaginal bleeding.
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, 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:
Changes in appetite.
Weight gain or loss.
Dizziness or headache.
Upset stomach or vomiting.
Stomach cramps.
Bloating.
Enlarged or tender breasts.
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear).
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles.
Reporting Side Effects
This list is not exhaustive, and you may experience other 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, shortness of breath, or coughing up blood
- H: Headaches (severe, sudden, or worse than usual)
- E: Eye problems (sudden vision loss or blurring)
- S: Severe leg pain (calf or thigh), warmth, swelling, or redness
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 use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting problems
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems, heart disease, or abnormal heart rhythms like atrial fibrillation
+ Chest pain caused by angina, heart attack, or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
+ Chloasma (dark skin patches) or increased sensitivity to sunlight or radiation
Recent use of certain medications, such as:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
* A history of jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use of this medication. 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 use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting problems
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems, heart disease, or abnormal heart rhythms like atrial fibrillation
+ Chest pain caused by angina, heart attack, or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
+ Chloasma (dark skin patches) or increased sensitivity to sunlight or radiation
Recent use of certain medications, such as:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
* A history of jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions to ensure safe use of this medication. Do not start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Precautions
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 will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing 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 levels as directed by your doctor.
This medication may cause high 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.
Regularly schedule blood work and other lab tests, as recommended by your doctor. It is also crucial to have regular breast exams and gynecology check-ups, and to 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 frequently consume grapefruit juice or eat grapefruit, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel 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, as you may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases, such as HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions or concerns, consult your doctor.
Using this medication may increase your risk of blood clots, stroke, or heart attack. Discuss this with your doctor, as the risk is highest during the first year of use and when restarting hormone-based birth control after a pause of 4 weeks or more.
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. Additionally, there is conflicting evidence regarding the risk of breast cancer associated with long-term use of hormone-based birth control. If you have questions or concerns, discuss them with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used 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.
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 will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing 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 levels as directed by your doctor.
This medication may cause high 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.
Regularly schedule blood work and other lab tests, as recommended by your doctor. It is also crucial to have regular breast exams and gynecology check-ups, and to 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 frequently consume grapefruit juice or eat grapefruit, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel 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, as you may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases, such as HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions or concerns, consult your doctor.
Using this medication may increase your risk of blood clots, stroke, or heart attack. Discuss this with your doctor, as the risk is highest during the first year of use and when restarting hormone-based birth control after a pause of 4 weeks or more.
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. Additionally, there is conflicting evidence regarding the risk of breast cancer associated with long-term use of hormone-based birth control. If you have questions or concerns, discuss them with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used 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
- Withdrawal bleeding (in females)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US).
Drug Interactions
Contraindicated Interactions
- Hepatitis C antiviral combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
- Certain aromatase inhibitors (e.g., anastrozole, letrozole) due to potential for reduced efficacy of the aromatase inhibitor
- Tizanidine (increased tizanidine exposure)
Major Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, topiramate, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- Certain HIV protease inhibitors (e.g., nelfinavir, ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g., nevirapine, efavirenz) - may decrease contraceptive efficacy.
- Lamotrigine - COCs may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
- Cyclosporine - COCs may increase cyclosporine plasma concentrations, increasing risk of toxicity.
Moderate Interactions
- Broad-spectrum antibiotics (e.g., ampicillin, tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic recirculation, though clinical significance is debated. Backup contraception often advised.
- Antifungals (e.g., fluconazole, itraconazole) - may increase COC levels.
- Grapefruit juice - may increase ethinyl estradiol levels (minor effect).
Minor Interactions
- Acetaminophen - may increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To establish baseline and identify hypertension, a risk factor for cardiovascular events.
Timing: Prior to initiation
Physical Examination (including breast and pelvic exam)
Rationale: To rule out contraindications (e.g., undiagnosed abnormal uterine bleeding, breast cancer) and establish baseline.
Timing: Prior to initiation
Lipid Profile
Rationale: Consider if patient has risk factors for cardiovascular disease.
Timing: Prior to initiation (if indicated)
Liver Function Tests
Rationale: To rule out liver disease, a contraindication.
Timing: Prior to initiation (if history of liver disease or symptoms)
Routine Monitoring
Blood Pressure
Frequency: Annually
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or change in contraception.
Annual Physical Exam (including breast and pelvic exam)
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Symptom Monitoring
- Severe abdominal pain (especially right upper quadrant)
- Chest pain, shortness of breath, or coughing up blood (signs of pulmonary embolism)
- Severe headache, sudden partial or complete loss of vision, or double vision (signs of stroke or retinal thrombosis)
- Sudden severe leg pain, warmth, swelling, or redness (signs of deep vein thrombosis)
- Yellowing of skin or eyes (jaundice), dark urine, light-colored stools (signs of liver problems)
- New or worsening migraine headaches
- Unexplained vaginal bleeding or spotting
Special Patient Groups
Pregnancy
Contraindicated during pregnancy. There is no indication for COC use in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure during early pregnancy.
Trimester-Specific Risks:
First Trimester:
Contraindicated. No increased risk of birth defects has been found with inadvertent use.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
Not recommended. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids and/or their metabolites are excreted into breast milk. Non-hormonal methods or progestin-only methods are generally preferred during lactation.
Infant Risk:
Low risk of adverse effects in the breastfed infant, but potential for exposure to hormones and possible reduction in milk supply.
Pediatric Use
Not indicated before menarche. Once menarche has occurred, safety and efficacy are expected to be similar to adults. Efficacy may be reduced in adolescents with poor adherence.
Geriatric Use
Not indicated for post-menopausal women. Risk of cardiovascular events increases with age.
Clinical Information
Clinical Pearls
- Emphasize the importance of taking the pill at the same time every day for maximum effectiveness.
- Provide clear instructions on how to handle missed pills, as this is a common cause of contraceptive failure.
- Counsel patients that COCs do not protect against STIs and that condoms should be used for STI prevention.
- Discuss the black box warning regarding smoking and cardiovascular risk, especially for women over 35.
- Advise patients to report any signs or symptoms of serious adverse events (e.g., ACHES symptoms) immediately.
- Inform patients that breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves.
Alternative Therapies
- Progestin-only pills (POPs)
- Progestin implant (e.g., Nexplanon)
- Progestin injection (e.g., Depo-Provera)
- Intrauterine devices (IUDs) - hormonal (e.g., Mirena, Kyleena) or non-hormonal (e.g., Paragard)
- Barrier methods (e.g., condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning/fertility awareness methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 21 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 for generics, often covered fully under Affordable Care Act (ACA) mandates for contraception.
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 medication taken, the amount, and the time it occurred.