Vyfemla Tablets 28s
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 and Progestin Combination
Pregnancy Category
Category X
FDA Approved
Aug 2017
DEA Schedule
Not Controlled
Overview
What is this medicine?
Vyfemla is a birth control pill that contains two female hormones, an estrogen (ethinyl estradiol) and a progestin (norethindrone). 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 is taken daily to prevent pregnancy.
How to Use This Medicine
Taking Your Medication Correctly
To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. You can take it with or without food, but if it upsets your stomach, take it with food.
If you're 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-hormone form of birth control, such as condoms, to prevent pregnancy for a while. Follow your doctor's advice on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Don't 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 happens 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 extra form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.
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
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, and avoid storing it in a bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or call your doctor for advice on what to do. If you're using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a while to prevent pregnancy.
To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. You can take it with or without food, but if it upsets your stomach, take it with food.
If you're 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-hormone form of birth control, such as condoms, to prevent pregnancy for a while. Follow your doctor's advice on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Don't 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 happens 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 extra form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.
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
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, and avoid storing it in a bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or call your doctor for advice on what to do. If you're using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a while to prevent pregnancy.
Lifestyle & Tips
- Take one tablet at the same time every day, without missing any doses, to ensure maximum effectiveness.
- 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.
- Use a backup method of birth control (like condoms) for the first 7 days when starting the pill, or if you miss pills.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms to protect against STIs.
- Inform your doctor about all medications, supplements, and herbal products you are taking, as some can reduce the effectiveness of birth control pills.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily at the same time each day, starting on the first day of menstruation or the first Sunday after menstruation begins. Follow the 28-day regimen (21 active tablets, 7 inactive tablets).
Condition-Specific Dosing:
missedDose:
If one active tablet is missed, take it as soon as remembered and the next tablet at the regular time. If two active tablets are missed in a row in Week 1 or 2, take two tablets on the day remembered and two tablets the next day, then continue with one tablet daily. Use back-up contraception for 7 days. If two active tablets are missed in a row in Week 3, or three or more active tablets are missed in a row anytime, discard the rest of the pack and start a new pack the same day (Sunday start: start new pack Sunday). Use back-up contraception for 7 days. Consult package insert for full missed dose instructions.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Indicated for post-menarcheal females for contraception. Dosing is the same as adults.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific adjustment, but caution due to potential fluid retention.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Contraindicated in women with acute or chronic liver disease or hepatic adenomas/carcinomas.
Severe:
Contraindicated in women with acute or chronic liver disease or hepatic adenomas/carcinomas.
Pharmacology
Mechanism of Action
Combined oral contraceptives (COCs) like Vyfemla primarily work by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), which in turn inhibits ovulation. They also cause changes in the cervical mucus, making it more viscous and less permeable to sperm, and alter the endometrium, making it less receptive to implantation.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-45%; Norethindrone: Approximately 60-80%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours
FoodEffect:
Food may slightly decrease Cmax for both components but does not significantly affect bioavailability.
Distribution:
Vd:
Ethinyl Estradiol: Approximately 4-10 L/kg; Norethindrone: Approximately 4 L/kg
ProteinBinding:
Ethinyl Estradiol: Approximately 98% (primarily to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: Approximately 96-98% (primarily to albumin and SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: Approximately 10-20 hours (terminal); Norethindrone: Approximately 5-14 hours (terminal)
Clearance:
Ethinyl Estradiol: Approximately 5-13 mL/min/kg; Norethindrone: Approximately 0.4 L/hr/kg
ExcretionRoute:
Ethinyl Estradiol: Primarily renal (60%) and fecal (40%); Norethindrone: Primarily renal (50-80%) and fecal (20-50%)
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy begins after 7 consecutive days of active tablet use, provided the first tablet was taken on the first day of menstruation or the first Sunday after menstruation begins.
PeakEffect:
Steady-state concentrations are typically reached within 3-4 days of daily dosing.
DurationOfAction:
Daily dosing is required to maintain contraceptive efficacy.
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 Vyfemla, 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 eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Eyesight changes or loss, 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 eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Eyesight changes or loss, 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**bdominal pain (severe)
- **C**hest pain, shortness of breath, or coughing up blood
- **H**eadaches (severe, sudden, or worse than usual), dizziness, weakness, or numbness
- **E**ye problems (sudden vision loss or blurring)
- **S**evere leg pain (in calf or thigh), swelling, or warmth
- Yellowing of the skin or eyes (jaundice)
- Dark urine or light-colored stools
- Lump in the breast
- Mood changes or depression
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, 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
+ 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 other specific health problems, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling
Dark skin patches (chloasma) or increased sensitivity to the sun 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 suspected pregnancy (do not take this medication if you are pregnant)
Breastfeeding or plans to breastfeed
A history of jaundice (yellowing of the skin and eyes) during pregnancy or with estrogen use, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use of this medication.
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, 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
+ 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 other specific health problems, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling
Dark skin patches (chloasma) or increased sensitivity to the sun 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 suspected pregnancy (do not take this medication if you are pregnant)
Breastfeeding or plans to breastfeed
A history of jaundice (yellowing of the skin and eyes) during pregnancy or with estrogen use, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use of this medication.
Precautions & Cautions
Important Warnings and 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 instruct you 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. Prolonged immobility 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 as directed by your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as directed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, 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. Also, if you consume grapefruit juice or eat grapefruit frequently, 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 medication.
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. 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 like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor. The risk of blood clots is highest during the first year of using this medication and when restarting hormone-based birth control after a break of 4 weeks or more.
There may be a higher risk of cervical cancer associated with long-term use of hormone-based birth control, although this may be due to other factors. If you have questions, consult your doctor.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, discuss this 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 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 instruct you 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. Prolonged immobility 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 as directed by your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as directed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, 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. Also, if you consume grapefruit juice or eat grapefruit frequently, 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 medication.
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. 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 like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor. The risk of blood clots is highest during the first year of using this medication and when restarting hormone-based birth control after a break of 4 weeks or more.
There may be a higher risk of cervical cancer associated with long-term use of hormone-based birth control, although this may be due to other factors. If you have questions, consult your doctor.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, discuss this 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 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 (vaginal bleeding)
What to Do:
There are no specific antidotes. Treatment is symptomatic and supportive. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used for Hepatitis C)
- Glecaprevir/pibrentasvir (used for Hepatitis C)
Major Interactions
- Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, Oxcarbazepine, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- Aromatase inhibitors (e.g., Anastrozole, Letrozole) - may reduce efficacy of aromatase inhibitors.
- Tranexamic acid - increased risk of thrombosis.
- Lamotrigine - decreased lamotrigine levels, potentially leading to loss of seizure control.
Moderate Interactions
- Moderate CYP3A4 inducers (e.g., Bosentan, Felbamate)
- CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Grapefruit juice) - may increase estrogen/progestin levels, potentially increasing adverse effects.
- Thyroid hormones (e.g., Levothyroxine) - may increase thyroid-binding globulin, requiring increased thyroid hormone dose.
- Cyclosporine - increased cyclosporine levels, leading to potential toxicity.
Minor Interactions
- Acetaminophen - may increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol 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, liver disease), and establish baseline health status.
Timing: Prior to initiation of therapy
Blood pressure
Rationale: To identify pre-existing hypertension, which is a contraindication or risk factor for cardiovascular events.
Timing: Prior to initiation of therapy
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 contraceptive method.
Annual physical examination (including breast exam, pelvic exam, Pap test as per guidelines)
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Symptoms of venous thromboembolism (VTE), arterial thromboembolism (ATE), liver dysfunction, depression
Frequency: Ongoing, patient education for self-monitoring
Target: Absence of symptoms
Action Threshold: Presence of symptoms (e.g., severe leg pain, chest pain, sudden vision changes, jaundice, severe headache) requires immediate medical evaluation.
Symptom Monitoring
- Severe abdominal pain (A)
- Chest pain, shortness of breath, or coughing up blood (C)
- Severe headaches, dizziness, weakness, or numbness (H)
- Eye problems (vision loss or blurring) (E)
- Severe leg pain in the calf or thigh (S)
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
- Lump in the breast
- Unusual vaginal bleeding
Special Patient Groups
Pregnancy
Contraindicated during pregnancy. There is no indication for COC use in pregnancy, and there is no evidence of increased risk of birth defects in women who have inadvertently used COCs during early pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects reported from inadvertent exposure.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids and/or metabolites are excreted into breast milk, which may affect the infant.
Infant Risk:
Potential for decreased milk supply and potential for adverse effects on the infant (e.g., jaundice, breast enlargement). Consider non-hormonal methods or progestin-only methods if contraception is needed during breastfeeding.
Pediatric Use
Safety and efficacy are established for post-menarcheal females. Use before menarche is not indicated.
Geriatric Use
Not indicated for use in post-menopausal women. Safety and efficacy have not been established in geriatric populations.
Clinical Information
Clinical Pearls
- Adherence is key: Emphasize taking the pill at the same time every day to maintain consistent hormone levels and maximize efficacy.
- Missed pills: Provide clear, concise instructions for missed pills, stressing the need for backup contraception if multiple pills are missed.
- Smoking cessation: Strongly advise women over 35 who smoke to quit or choose an alternative contraceptive method due to significantly increased cardiovascular risks.
- Drug interactions: Counsel patients about potential interactions with other medications, especially antibiotics (though evidence for efficacy reduction is weak for most), anticonvulsants, and St. John's Wort.
- No STI protection: Reinforce that oral contraceptives do not protect against sexually transmitted infections.
- Postpartum use: Advise waiting at least 3-4 weeks postpartum before initiating COCs due to increased VTE risk, longer if breastfeeding.
- ACHES mnemonic: Educate patients on the warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
Alternative Therapies
- Progestin-only pills (mini-pill)
- Progestin injection (Depo-Provera)
- Progestin implant (Nexplanon)
- Intrauterine devices (IUDs - hormonal and non-hormonal)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Sterilization (tubal ligation, vasectomy)
- Natural family planning methods
Cost & Coverage
Average Cost:
$20 - $50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered with no co-pay under ACA)
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.