Norethindrone Acet/eth FE Tabs 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
Estrogens; Progestins; Iron Preparations
Pregnancy Category
Category X
FDA Approved
Jul 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a birth control pill that contains two female hormones (estrogen and progestin) to prevent pregnancy. It also contains iron (ferrous fumarate) in the inactive pills to help prevent iron deficiency anemia, which can be common with menstrual bleeding.
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, for a period of time to prevent pregnancy. 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 for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy.
To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food to help alleviate 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, for a period of time to prevent pregnancy. 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 for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
- Take one pill at the same time every day to ensure maximum effectiveness.
- Use a backup method of birth control (like condoms) if you miss pills, are starting the medication, or are taking medications that may reduce its effectiveness.
- This medication does not protect against sexually transmitted infections (STIs), including HIV/AIDS. Use condoms to prevent STIs.
- Maintain regular check-ups with your doctor, including blood pressure monitoring.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally once daily, starting on the first day of menstruation or the first Sunday after menstruation begins. Active tablets are taken for 21 days, followed by 7 days of ferrous fumarate (or placebo) tablets.
Condition-Specific Dosing:
missed_dose:
If one active tablet is missed, take it as soon as remembered and the next tablet at the usual time. If two or more active tablets are missed, refer to package insert for specific instructions, as backup contraception may be needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for post-menarcheal adolescents requiring contraception.
Prepubertal:
Not indicated.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Use with caution due to potential for iron accumulation with ferrous fumarate component; monitor iron levels. Oral contraceptives generally not renally dose adjusted.
Dialysis:
Use with caution due to potential for iron accumulation with ferrous fumarate component; monitor iron levels. Oral contraceptives generally not renally dose adjusted.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Contraindicated.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Norethindrone acetate and Ethinyl Estradiol act primarily by suppressing gonadotropins, thereby inhibiting ovulation. Other mechanisms include changes in the cervical mucus (increasing viscosity to impede sperm penetration) and the endometrium (rendering it unsuitable for 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: ~40-45%; Norethindrone Acetate: ~60-80% (after deacetylation to norethindrone); Ferrous Fumarate: Variable, typically 10-30% of elemental iron.
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours; Ferrous Fumarate: 2-4 hours.
FoodEffect:
Food may slightly decrease the rate but not the extent of absorption for oral contraceptives. Food may decrease absorption of iron but can reduce gastrointestinal upset.
Distribution:
Vd:
Ethinyl Estradiol: ~5-15 L/kg; Norethindrone: ~4 L/kg; Ferrous Fumarate: Not applicable (iron distributed throughout body, primarily in hemoglobin).
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: ~96-98% (to albumin and SHBG); Ferrous Fumarate: Iron binds to transferrin for transport.
CnssPenetration:
Limited for hormonal components; Not applicable for iron.
Elimination:
HalfLife:
Ethinyl Estradiol: ~10-20 hours; Norethindrone: ~5-14 hours; Ferrous Fumarate: Not applicable (iron is conserved in the body, minimal excretion).
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4 mL/min/kg; Ferrous Fumarate: Not applicable.
ExcretionRoute:
Ethinyl Estradiol: Renal and fecal (as metabolites); Norethindrone: Renal and fecal (as metabolites); Ferrous Fumarate: Primarily fecal (unabsorbed iron), minimal urinary/biliary excretion of absorbed iron.
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%; Ferrous Fumarate: Not applicable (absorbed iron is utilized).
Pharmacodynamics
OnsetOfAction:
Contraceptive effect: Within the first cycle if initiated correctly. Iron supplementation: Gradual, over weeks to months for correction of anemia.
PeakEffect:
Contraceptive effect: Maintained with daily dosing. Iron supplementation: Hemoglobin levels begin to rise within 1-2 weeks, peak effect on anemia correction within 1-2 months.
DurationOfAction:
Contraceptive effect: Maintained with daily dosing. Iron supplementation: As long as supplementation continues and iron stores are replenished.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to 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 immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ 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
+ 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
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
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, change of 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Appetite changes
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged breasts
Tender breasts
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
Period (menstrual) changes, including:
+ Heavy bleeding
+ Spotting
+ Bleeding between cycles
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ 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
+ 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
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
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, change of 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Appetite changes
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged breasts
Tender breasts
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
Period (menstrual) changes, including:
+ Heavy bleeding
+ Spotting
+ Bleeding between cycles
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- A: Abdominal pain (severe)
- C: Chest pain (severe), cough, shortness of breath
- H: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- E: Eye problems (sudden vision loss or blurring)
- S: Severe leg pain (calf or thigh), swelling, redness, warmth
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions 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 that causes severe swelling.
Dark skin patches (chloasma) or increased sensitivity to the sun or radiation.
Recent use of certain medications, including ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy.
Breastfeeding or plans to breastfeed.
A history 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. 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, 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 that causes severe swelling.
Dark skin patches (chloasma) or increased sensitivity to the sun or radiation.
Recent use of certain medications, including ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy.
Breastfeeding or plans to breastfeed.
A history 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, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing health conditions and medications. 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. If you need to stop taking this medication, your doctor will instruct you on when to resume taking it after your 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. Consult your doctor about this risk.
Some studies suggest that the risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have questions, discuss this with your doctor.
Long-term use of hormone-based birth control may be associated with an increased risk of breast cancer, although not all studies confirm this. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication 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. If you need to stop taking this medication, your doctor will instruct you on when to resume taking it after your 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. Consult your doctor about this risk.
Some studies suggest that the risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have questions, discuss this with your doctor.
Long-term use of hormone-based birth control may be associated with an increased risk of breast cancer, although not all studies confirm this. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication 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 due to iron toxicity)
- Gastrointestinal bleeding (due to iron toxicity)
- Transient vaginal bleeding (in females)
What to Do:
Seek immediate medical attention. For iron overdose, chelation therapy may be necessary. For hormonal overdose, symptomatic and supportive care. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (increased ALT)
Major Interactions
- CYP3A4 inducers (e.g., Carbamazepine, Phenytoin, Rifampin, St. John's Wort, Topiramate, Barbiturates, Griseofulvin, Modafinil) - decreased contraceptive efficacy
- Lamotrigine (decreased lamotrigine levels, loss of seizure control)
- Warfarin (decreased anticoagulant effect, monitor INR)
- Tranexamic acid (increased risk of thrombosis)
- Hepatitis C virus (HCV) direct-acting antivirals (e.g., Ledipasvir/Sofosbuvir, Velpatasvir/Sofosbuvir) - potential for increased estrogen levels or liver enzyme elevations
Moderate Interactions
- CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin; Grapefruit juice) - increased estrogen/progestin levels, increased adverse effects
- Tetracyclines, Penicillins (potential for decreased contraceptive efficacy, though evidence is debated)
- Thyroid hormones (oral contraceptives may increase thyroid binding globulin, leading to increased thyroid hormone requirements)
- Corticosteroids (increased corticosteroid levels)
- Cyclosporine (increased cyclosporine levels)
- Theophylline (increased theophylline levels)
- Iron chelators (e.g., Deferoxamine) - avoid co-administration with ferrous fumarate
- Antacids, Proton Pump Inhibitors, H2-receptor antagonists (decreased iron absorption)
- Calcium supplements, Zinc supplements (decreased iron absorption)
Minor Interactions
- Ascorbic acid (may enhance iron absorption)
- Vitamin E (may interfere with iron absorption)
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., cardiovascular disease, thrombosis), and establish baseline health status.
Timing: Prior to initiation of therapy.
Lipid profile (cholesterol, triglycerides)
Rationale: To assess cardiovascular risk, as oral contraceptives can affect lipid metabolism.
Timing: Prior to initiation, especially in patients with risk factors.
Iron status (hemoglobin, hematocrit, ferritin)
Rationale: If ferrous fumarate is prescribed for iron deficiency anemia, to establish baseline and guide therapy.
Timing: Prior to initiation if indicated for anemia.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if hypertension develops or worsens.
Target: <140/90 mmHg (or individualized)
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)
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Iron status (hemoglobin, hematocrit, ferritin)
Frequency: Every 3-6 months, or as clinically indicated, if ferrous fumarate is for anemia treatment.
Target: Hemoglobin: within normal range; Ferritin: >30 ng/mL
Action Threshold: Failure to respond or persistent anemia requires investigation for other causes.
Symptom Monitoring
- Severe abdominal pain (possible liver tumor, blood clot)
- Chest pain, shortness of breath, coughing up blood (possible pulmonary embolism, myocardial infarction)
- Severe headaches, sudden partial or complete loss of vision, speech disturbances, weakness or numbness in an arm or leg (possible stroke)
- Severe leg pain, swelling, warmth, redness (possible deep vein thrombosis)
- Yellowing of skin or eyes (jaundice), dark urine, light-colored stools (possible liver problems)
- Depressed mood, mood changes
- Unusual vaginal bleeding or spotting
- Breast lumps
Special Patient Groups
Pregnancy
Contraindicated. There is no indication for oral contraceptives in pregnancy, and there is evidence of fetal harm. Discontinue immediately if pregnancy is confirmed.
Trimester-Specific Risks:
First Trimester:
Category X. Potential for adverse effects on fetal development, though data on specific malformations are inconsistent.
Second Trimester:
Category X. Not applicable, as use is contraindicated.
Third Trimester:
Category X. Not applicable, as use is contraindicated.
Lactation
Not recommended. Estrogens can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant. Non-hormonal or progestin-only methods are preferred during lactation.
Infant Risk:
Potential for decreased milk supply, and theoretical risk of adverse effects from hormones on the infant (e.g., jaundice, breast enlargement), though generally considered low.
Pediatric Use
Not indicated for prepubertal children. For post-menarcheal adolescents, dosing is the same as adults. Safety and efficacy are established for contraception in this population.
Geriatric Use
Not typically used. Oral contraceptives are generally discontinued at menopause. Increased risk of cardiovascular events in older women.
Clinical Information
Clinical Pearls
- Emphasize the importance of taking the pill at the same time every day for optimal contraceptive efficacy.
- Counsel patients on the black box warning regarding smoking and cardiovascular risk, especially for women over 35.
- Advise patients about potential drug interactions, particularly with CYP3A4 inducers (e.g., certain antibiotics, anticonvulsants, St. John's Wort), which can reduce contraceptive effectiveness.
- Explain that the ferrous fumarate pills are for iron supplementation and are taken during the inactive week, not for contraception.
- Educate patients on the ACHES warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and to seek immediate medical attention if experienced.
- Remind patients that oral contraceptives do not protect against STIs.
Alternative Therapies
- Progestin-only pills (mini-pill)
- Contraceptive patch
- Vaginal ring
- Contraceptive injection (Depo-Provera)
- Contraceptive implant (Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Surgical sterilization (tubal ligation, vasectomy)
- Emergency contraception (e.g., levonorgestrel, ulipristal acetate)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generics often preferred)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about this 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.