Microgestin 1.5/30 FE 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 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Microgestin 1.5/30 FE is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone), to prevent pregnancy. It works by stopping ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining. The last 7 pills in the pack contain iron (ferrous fumarate) to help prevent iron deficiency anemia, which can be common in women who menstruate.
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 is essential to take your medication as directed, even if you do not 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. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you are 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 are 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 is essential to take your medication as directed, even if you do not 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. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you are 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 are 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 and heart attack.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms to protect against STIs.
- Take the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
- If you experience severe vomiting or diarrhea, the effectiveness of the pill may be reduced; use a backup method of contraception.
- Maintain regular follow-up appointments with your healthcare provider for blood pressure checks and annual exams.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One light yellow tablet daily for 21 days, followed by one brown (ferrous fumarate) tablet daily for 7 days. Begin new pack on day 29.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missedDose:
If one active tablet is missed, take as soon as remembered and continue next tablet at usual time. If two or more active tablets are missed, refer to package insert for specific instructions, use back-up contraception, and consider emergency contraception if appropriate.
postpartum:
Initiate no earlier than 4 weeks postpartum in non-breastfeeding women. Consider risk of VTE.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for post-menarcheal adolescents requiring contraception.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed for contraceptive components. Iron absorption may be altered in chronic kidney disease, monitor iron status.
Moderate:
No adjustment needed for contraceptive components. Iron absorption may be altered in chronic kidney disease, monitor iron status.
Severe:
Contraindicated in severe renal impairment with iron overload. For contraceptive components, generally no specific adjustment, but monitor for fluid retention.
Dialysis:
Not recommended due to potential for fluid retention and iron considerations. Consult specialist.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Contraindicated.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone: Primarily inhibit ovulation by suppressing gonadotropins (FSH and LH). Also cause changes in the cervical mucus (making it less permeable to sperm) and the endometrium (making it less receptive to implantation). Ferrous Fumarate: Replenishes iron stores, essential for hemoglobin formation and oxygen transport, preventing iron deficiency anemia.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-80%; Ferrous Fumarate: Varies (typically 10-30% of elemental iron, higher in deficiency)
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours; Ferrous Fumarate: Not applicable (absorption is continuous)
FoodEffect:
Ethinyl Estradiol/Norethindrone: Food may slightly decrease Cmax but does not significantly affect AUC. Ferrous Fumarate: Absorption is reduced by food, especially dairy, tea, coffee, and whole grains; best taken on an empty stomach, but often taken with food to reduce GI upset.
Distribution:
Vd:
Ethinyl Estradiol: ~2.8-8.6 L/kg; Norethindrone: ~2-4 L/kg; Ferrous Fumarate: Iron is widely distributed, primarily bound to transferrin.
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and SHBG); Norethindrone: ~96-97% (to albumin and SHBG); Ferrous Fumarate: Iron is bound to transferrin in plasma.
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~5-14 hours; Ferrous Fumarate: Not applicable (iron is conserved in the body)
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone: ~0.4-0.8 mL/min/kg; Ferrous Fumarate: Not applicable (minimal excretion)
ExcretionRoute:
Ethinyl Estradiol/Norethindrone: Renal and fecal (via enterohepatic recirculation). Ferrous Fumarate: Primarily via unabsorbed iron in feces; minimal loss via desquamation of cells, sweat, urine, and menstrual blood.
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <10%; Ferrous Fumarate: Not applicable (absorbed iron is utilized)
Pharmacodynamics
OnsetOfAction:
Contraceptive effect: After 7 consecutive days of active pill use. Iron supplementation: Gradual, over weeks to months for full iron repletion.
PeakEffect:
Contraceptive effect: Sustained with continuous use. Iron supplementation: Hemoglobin levels begin to rise after 2-4 weeks.
DurationOfAction:
Contraceptive effect: Maintained with daily use. Iron supplementation: As long as therapy continues and iron stores are replenished.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, combination oral contraceptives, including Microgestin 1.5/30 FE, 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 immediate medical attention:
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
+ 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 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
+ Severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
If you experience any of these symptoms, contact your doctor immediately.
Additional Side Effects:
Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, 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:
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 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
+ 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 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
+ Severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
If you experience any of these symptoms, contact your doctor immediately.
Additional Side Effects:
Most people do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following side effects, 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:
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:
- ACHES: Abdominal pain (severe), Chest pain (severe), Headaches (severe), Eye problems (blurred vision, loss of vision), Severe leg pain (calf or thigh)
- Yellowing of skin or eyes (jaundice)
- Sudden, unexplained swelling or pain in a leg
- Sudden shortness of breath or chest pain
- Severe mood changes or depression
- Unusual or heavy vaginal bleeding
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health 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. Do not take this medication if you are pregnant.
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. Verify that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health 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. Do not take this medication if you are pregnant.
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. Verify that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.
If you 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. Additionally, this drug may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as recommended.
Regular breast exams, gynecology check-ups, and breast self-exams, as directed by your doctor, are crucial while taking this medication.
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 drug.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the potential need for non-hormone birth control methods, such as condoms.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sexual activity to reduce the risk of transmission. If you have questions, consult your doctor.
Taking 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 use and when restarting hormone-based birth control after a pause of 4 weeks or more.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be attributed to other factors. If you have concerns, discuss them with your doctor. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not found this association. 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.
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. Additionally, this drug may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as recommended.
Regular breast exams, gynecology check-ups, and breast self-exams, as directed by your doctor, are crucial while taking this medication.
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 drug.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the potential need for non-hormone birth control methods, such as condoms.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use latex or polyurethane condoms during sexual activity to reduce the risk of transmission. If you have questions, consult your doctor.
Taking 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 use and when restarting hormone-based birth control after a pause of 4 weeks or more.
Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be attributed to other factors. If you have concerns, discuss them with your doctor. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not found this association. 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
- Vaginal bleeding (especially in females)
- Drowsiness, lethargy (iron overdose)
- Abdominal pain, diarrhea, black tarry stools (iron overdose)
- In severe iron overdose: metabolic acidosis, shock, liver damage, coma
What to Do:
Seek immediate medical attention. For iron overdose, gastric lavage, chelation therapy (e.g., deferoxamine) may be necessary. For contraceptive overdose, treatment is symptomatic and supportive. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
- Drugs that induce CYP3A4 (e.g., carbamazepine, phenytoin, phenobarbital, rifampin, St. John's Wort, topiramate, bosentan, griseofulvin) due to potential for reduced contraceptive efficacy and increased breakthrough bleeding.
Major Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use may reduce efficacy of both.
- Thyroid hormones (e.g., levothyroxine) - OCs can increase thyroid binding globulin, requiring increased thyroid hormone dose.
- Lamotrigine - OCs can significantly decrease lamotrigine plasma concentrations, leading to loss of seizure control.
- Tetracyclines, Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) - Iron absorption can be significantly reduced.
- Bisphosphonates (e.g., alendronate) - Iron can impair absorption.
Moderate Interactions
- Ascorbic acid (Vitamin C) - May increase ethinyl estradiol levels.
- Acetaminophen - May increase ethinyl estradiol levels.
- CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole; macrolide antibiotics like erythromycin, clarithromycin; verapamil, diltiazem) - May increase plasma concentrations of ethinyl estradiol and norethindrone.
- Antacids, proton pump inhibitors, H2 blockers - May reduce iron absorption.
- Levodopa - Iron can reduce levodopa absorption.
Minor Interactions
- Corticosteroids - OCs may decrease clearance of corticosteroids, leading to increased effects.
- Theophylline - OCs may decrease clearance of theophylline, leading to increased effects.
Monitoring
Baseline Monitoring
Complete medical history (including family history)
Rationale: To identify contraindications, risk factors for cardiovascular disease, VTE, and other conditions.
Timing: Prior to initiation
Blood pressure
Rationale: To screen for hypertension, a risk factor for cardiovascular events with OCs.
Timing: Prior to initiation
Physical examination (including breast and pelvic exam, Pap test)
Rationale: To screen for underlying conditions and ensure suitability for OC use.
Timing: Prior to initiation (as clinically indicated)
Hemoglobin/Hematocrit, Ferritin (if iron deficiency suspected)
Rationale: To assess baseline iron status.
Timing: Prior to initiation (if indicated)
Routine Monitoring
Blood pressure
Frequency: Annually
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg; consider discontinuation or alternative contraception.
Annual physical examination (including breast and pelvic exam, Pap test)
Frequency: Annually (as per general health guidelines)
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Lipid profile (optional)
Frequency: Periodically, based on risk factors
Target: Normal
Action Threshold: Significant dyslipidemia may warrant re-evaluation of OC use.
Liver function tests (if symptoms of hepatic dysfunction)
Frequency: As clinically indicated
Target: Normal
Action Threshold: Elevated LFTs require investigation and potential discontinuation.
Hemoglobin/Hematocrit (for iron component)
Frequency: Every 3-6 months initially, then annually or as needed
Target: Normal for age/sex
Action Threshold: Persistent anemia despite therapy, or signs of iron overload.
Symptom Monitoring
- Severe abdominal pain (possible liver tumor, pancreatitis)
- Chest pain, shortness of breath, coughing up blood (possible pulmonary embolism)
- Severe headache, sudden partial or complete loss of vision, speech disturbances, weakness or numbness in an arm or leg (possible stroke)
- Leg pain, swelling, warmth, redness (possible deep vein thrombosis)
- Yellowing of skin or eyes (jaundice), dark urine, light-colored stools (possible liver problems)
- Sudden, severe vaginal bleeding
- Signs of depression or mood changes
- Symptoms of iron overload (e.g., fatigue, joint pain, abdominal pain, heart problems) if taking other iron supplements or have hemochromatosis.
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for combination oral contraceptives in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure during early pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects identified 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 and may be excreted in breast milk. Progestins may also be excreted in breast milk. Consider alternative contraception for breastfeeding mothers.
Infant Risk:
Low risk of adverse effects on the infant, but potential for reduced milk supply and altered milk composition.
Pediatric Use
Not indicated for use in pre-menarcheal females. For post-menarcheal adolescents, dosing is the same as for adults. Safety and efficacy are expected to be similar to adults.
Geriatric Use
Not indicated for use in post-menopausal women. Risk of cardiovascular events increases with age.
Clinical Information
Clinical Pearls
- Emphasize the importance of taking the pill at the same time every day for maximum contraceptive efficacy.
- Counsel patients on the black box warning regarding smoking and cardiovascular risk, especially for women over 35.
- Advise patients that breakthrough bleeding is common, especially during the first few cycles, and usually resolves.
- Remind patients that this medication does not protect against STIs.
- Instruct patients on proper missed pill management, and the need for backup contraception if pills are missed.
- For the iron component, advise taking the brown pills with food if GI upset occurs, but note that food can reduce iron absorption. Avoid taking with dairy, tea, or coffee.
- Be aware of potential drug interactions, especially with CYP3A4 inducers (e.g., certain antibiotics, anticonvulsants, St. John's Wort) which can reduce contraceptive efficacy.
Alternative Therapies
- Progestin-only pills (mini-pill)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive injection (e.g., Depo-Provera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Permanent contraception (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$25 - $100 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often preferred generic)
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 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.