Junel FE 1.5/30 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 is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Contraceptive, Oral; Iron Supplement
Pharmacologic Class
Estrogen/Progestin Combination; Iron Salt
Pregnancy Category
Category X
FDA Approved
Sep 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Junel FE 1.5/30 is a birth control pill that contains two female hormones, norethindrone and ethinyl estradiol, which work together to prevent pregnancy. It also contains iron tablets for the last week of your cycle to help prevent iron deficiency. It works by stopping your body from releasing an egg (ovulation), thickening the fluid in your cervix to block sperm, and changing the lining of your uterus.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food to help alleviate discomfort.
If you 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-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If 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 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, protected from light, and in a dry place. Avoid storing it in a bathroom.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions. 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 certain period 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 discomfort.
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-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If 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 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, protected from light, and in a dry place. Avoid storing it in a bathroom.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions. 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 certain period 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.
- Take one tablet at the same time every day to ensure maximum effectiveness.
- 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).
- Maintain regular physical activity and a healthy diet to support overall cardiovascular health.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily, starting on the first day of menstruation or the first Sunday after menstruation begins. Follow the 28-day regimen: 21 active tablets (Norethindrone 1.5 mg / Ethinyl Estradiol 30 mcg) followed by 7 inactive tablets (Ferrous Fumarate 75 mg).
Condition-Specific Dosing:
missed_dose:
If one active tablet is missed, take it as soon as remembered. If two consecutive active tablets are missed 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 consecutive active tablets are missed in Week 3 or three or more consecutive active tablets are missed anytime, discard the rest of the pack and start a new pack on the same day (Sunday start) or discard the rest of the pack and start a new pack on the first day of the next period (Day 1 start). Use back-up contraception for 7 days. If any inactive tablets are missed, discard them and continue with the next pack as scheduled.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Dosing is the same as for adults for contraception once menstruation has begun.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required for the contraceptive components. For ferrous fumarate, monitor iron levels if long-term use is anticipated.
Moderate:
No specific dose adjustment required for the contraceptive components. For ferrous fumarate, monitor iron levels if long-term use is anticipated.
Severe:
No specific dose adjustment required for the contraceptive components. For ferrous fumarate, use with caution due to potential for iron accumulation; monitor iron levels closely.
Dialysis:
No specific dose adjustment required for the contraceptive components. For ferrous fumarate, use with caution; iron supplementation may be managed by a nephrologist.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; consider alternative contraception. Estrogen and progestin metabolism may be impaired.
Severe:
Contraindicated due to impaired steroid metabolism and potential for exacerbation of liver disease.
Pharmacology
Mechanism of Action
Norethindrone and Ethinyl Estradiol act primarily by suppressing gonadotropins (Luteinizing Hormone and Follicle-Stimulating Hormone), thereby inhibiting ovulation. They also induce changes in the cervical mucus, making it less permeable to sperm, and alter the endometrium, making it less receptive to implantation. Ferrous Fumarate provides elemental iron, which is an essential component of hemoglobin, myoglobin, and various enzymes. It is used to prevent or treat iron deficiency anemia.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-60% (due to significant first-pass metabolism). Norethindrone: Approximately 60-90% (due to significant first-pass metabolism). Ferrous Fumarate: Varies, typically 10-30% of elemental iron is absorbed, depending on iron stores and dietary factors.
Tmax:
Ethinyl Estradiol: 1-2 hours. Norethindrone: 1-2 hours. Ferrous Fumarate: 2-4 hours for peak serum iron.
FoodEffect:
Ethinyl Estradiol/Norethindrone: Food may slightly decrease Cmax but does not significantly affect AUC. Ferrous Fumarate: Absorption is reduced by food, especially dairy products, tea, coffee, and whole grains. Best absorbed on an empty stomach, but often taken with food to reduce GI upset.
Distribution:
Vd:
Ethinyl Estradiol: Approximately 2-4 L/kg. Norethindrone: Approximately 4 L/kg. Ferrous Fumarate: Iron is widely distributed, primarily bound to transferrin in plasma.
ProteinBinding:
Ethinyl Estradiol: Approximately 98% (to albumin and sex hormone-binding globulin [SHBG]). Norethindrone: Approximately 96-97% (to albumin and SHBG). Ferrous Fumarate: Iron is bound to transferrin for transport.
CnssPenetration:
Limited for contraceptive steroids; Not applicable for iron in therapeutic doses.
Elimination:
HalfLife:
Ethinyl Estradiol: Approximately 10-20 hours. Norethindrone: Approximately 5-14 hours. Ferrous Fumarate: Iron has no true half-life as it is conserved in the body; red blood cell lifespan is about 120 days.
Clearance:
Ethinyl Estradiol: Approximately 5-13 mL/min/kg. Norethindrone: Approximately 0.4 L/hr/kg. Ferrous Fumarate: Iron is primarily excreted via desquamation of cells from the skin and gastrointestinal tract, and through menstruation.
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and Fecal (60%). Norethindrone: Renal (50-80%) and Fecal (20-50%). Ferrous Fumarate: Minimal excretion; primarily conserved and recycled.
Unchanged:
Ethinyl Estradiol: <5%. Norethindrone: <1%. Ferrous Fumarate: Not applicable (elemental iron).
Pharmacodynamics
OnsetOfAction:
Contraceptive effect: After 7 consecutive days of active tablet use. Iron effect: Gradual, typically 3-4 weeks for initial hemoglobin rise, 2-3 months to replenish iron stores.
PeakEffect:
Contraceptive effect: Achieved after 7 days of consistent use. Iron effect: Hemoglobin levels peak after several weeks to months of consistent supplementation.
DurationOfAction:
Contraceptive effect: Maintained with continuous daily use. Iron effect: As long as supplementation continues and iron stores are maintained.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events 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 Junel FE 1.5/30, 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, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out or changes in eyesight
Signs of gallbladder problems, including:
+ 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
Changes in eyesight or loss of eyesight, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, changes in color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
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 (avoid sun exposure, use sunscreen, and wear 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, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out or changes in eyesight
Signs of gallbladder problems, including:
+ 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
Changes in eyesight or loss of eyesight, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, changes in color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
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 (avoid sun exposure, use sunscreen, and wear 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 (severe), coughing, or shortness of breath
- **H**eadaches (severe, sudden, or worse than usual)
- **E**ye problems (blurred vision, flashing lights, partial or complete loss of vision) or speech problems
- **S**evere leg pain (calf or thigh), swelling, or redness
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Depressed mood or severe mood changes
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, 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 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 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, 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 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
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, 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 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.
Consuming grapefruit juice or eating grapefruit regularly may interact with this medication. Discuss this with your doctor.
This medication may affect certain lab tests. Inform all your healthcare providers and lab workers 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 conditions. 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 sex. 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. Consult your doctor about this risk.
Some studies suggest that taking hormone-based birth control for an extended period may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, discuss this with your doctor.
Research on the link between hormone-based birth control and breast cancer is ongoing, with some studies indicating a potential increased risk. If you have concerns, consult 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 experience any signs of pregnancy 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, 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 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.
Consuming grapefruit juice or eating grapefruit regularly may interact with this medication. Discuss this with your doctor.
This medication may affect certain lab tests. Inform all your healthcare providers and lab workers 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 conditions. 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 sex. 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. Consult your doctor about this risk.
Some studies suggest that taking hormone-based birth control for an extended period may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, discuss this with your doctor.
Research on the link between hormone-based birth control and breast cancer is ongoing, with some studies indicating a potential increased risk. If you have concerns, consult 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 experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Dizziness
- Abdominal pain
- Drowsiness/lethargy (especially in children with iron overdose)
- Vaginal bleeding (withdrawal bleeding)
What to Do:
Seek immediate medical attention. For iron overdose, chelation therapy may be necessary. For contraceptive overdose, treatment is generally supportive. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (risk of ALT elevations)
- Glecaprevir/Pibrentasvir (risk of ALT elevations)
- Tranexamic acid (increased risk of thrombosis)
- Certain aromatase inhibitors (e.g., anastrozole, letrozole) - theoretical antagonism of effect
Major Interactions
- CYP3A4 inducers (e.g., Carbamazepine, Phenytoin, Rifampin, Barbiturates, Topiramate, Griseofulvin, St. John's Wort) - decreased contraceptive efficacy and increased breakthrough bleeding.
- Certain protease inhibitors/NNRTIs (e.g., Ritonavir, Efavirenz, Nevirapine) - altered contraceptive levels.
- Lamotrigine (decreased lamotrigine levels, loss of seizure control).
- Warfarin (decreased anticoagulant effect of warfarin due to increased clotting factors).
- Tetracyclines, Fluoroquinolones (decreased iron absorption).
- Levothyroxine (decreased levothyroxine absorption by iron).
Moderate Interactions
- Antibiotics (e.g., Penicillins, Cephalosporins) - theoretical decrease in contraceptive efficacy due to altered gut flora, though clinical significance is debated; advise backup contraception.
- Grapefruit juice (increased ethinyl estradiol levels).
- Antacids, Proton Pump Inhibitors, H2 Blockers (decreased iron absorption).
- Bisphosphonates (decreased bisphosphonate absorption by iron).
- Mycophenolate mofetil (decreased mycophenolate levels).
- Cyclosporine (increased cyclosporine levels).
- Theophylline (increased theophylline levels).
- Corticosteroids (increased corticosteroid levels).
Minor Interactions
- Acetaminophen (increased ethinyl estradiol levels).
- Ascorbic acid (increased iron absorption).
- Caffeine (decreased caffeine clearance).
Monitoring
Baseline Monitoring
Complete Medical History and Physical Exam
Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by or affect oral contraceptive use.
Timing: Prior to initiation
Blood Pressure
Rationale: To screen for hypertension, a contraindication or risk factor for COC use.
Timing: Prior to initiation
Pregnancy Test
Rationale: To rule out existing pregnancy, as COCs are contraindicated.
Timing: Prior to initiation
Lipid Profile (optional)
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation, if indicated by risk factors
Liver Function Tests (optional)
Rationale: To assess baseline liver function, especially if history of liver disease.
Timing: Prior to initiation, if indicated
Routine Monitoring
Blood Pressure
Frequency: Annually or as clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg; consider discontinuation or alternative contraception.
Adherence and Side Effects
Frequency: At follow-up visits (e.g., 3 months, then annually)
Target: Consistent daily use; tolerable side effects
Action Threshold: Frequent missed doses, intolerable side effects, or signs of serious adverse events (e.g., ACHES symptoms).
CBC with differential (if iron deficiency anemia is present)
Frequency: Every 3-6 months until hemoglobin normalizes, then annually for maintenance
Target: Hemoglobin within normal limits for age/sex; ferritin >30 ng/mL
Action Threshold: Persistent anemia or signs of iron overload.
Symptom Monitoring
- Severe abdominal pain (A)
- Chest pain, shortness of breath, or coughing up blood (C)
- Headaches (severe, sudden, or worse than usual) (H)
- Eye problems (blurred vision, loss of vision) or speech problems (E)
- Severe leg pain (calf or thigh), swelling, or redness (S)
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
- Unusual vaginal bleeding or spotting
- Signs of allergic reaction (rash, itching, swelling)
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for oral contraceptives in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects reported from inadvertent exposure.
Second Trimester:
No increased risk of birth defects reported from inadvertent exposure.
Third Trimester:
No increased risk of birth defects reported from inadvertent exposure.
Lactation
Not recommended during lactation. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant. Progestin-only contraceptives are generally preferred if contraception is needed during breastfeeding.
Infant Risk:
Potential for decreased milk supply and possible adverse effects on the infant (e.g., jaundice, breast enlargement), though generally considered low risk for serious harm.
Pediatric Use
Not indicated before menarche. Once menarche has occurred, safety and efficacy are expected to be similar to adults. Iron component is generally safe for adolescents requiring iron supplementation.
Geriatric Use
Not indicated for postmenopausal women. Risk of cardiovascular events increases with age, making COCs generally unsuitable for this population.
Clinical Information
Clinical Pearls
- Emphasize the importance of taking the pill at the same time every day for optimal efficacy.
- Counsel patients on the ACHES warning signs for serious adverse events and when to seek immediate medical attention.
- Remind patients that this medication does not protect against STIs.
- Advise patients about potential drug interactions, especially with antibiotics, anticonvulsants, and St. John's Wort, and the need for backup contraception.
- For the iron component, advise taking it with vitamin C (e.g., orange juice) to enhance absorption, and avoid taking it with dairy products, antacids, or calcium supplements.
- Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves. If persistent or heavy, evaluate for other causes.
Alternative Therapies
- Progestin-only pills (POPs)
- Contraceptive patch (Xulane)
- Vaginal ring (NuvaRing, Annovera)
- Contraceptive injection (Depo-Provera)
- Contraceptive implant (Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm)
- Surgical sterilization (vasectomy, tubal ligation)
- For iron deficiency: other oral iron salts (ferrous sulfate, gluconate), IV iron preparations.
Cost & Coverage
Average Cost:
$15 - $50 per 28-tablet pack
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered with no or low co-pay under ACA for contraception)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it happened.