Loestrin 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
Jun 1976
DEA Schedule
Not Controlled
Overview
What is this medicine?
Loestrin FE 1.5/30 was a birth control pill that contained two female hormones (estrogen and progestin) to prevent pregnancy, and iron to help prevent iron deficiency. It worked by stopping ovulation, changing cervical mucus, and altering the uterine lining. The iron pills are taken during the inactive week to replenish iron lost during menstruation.
How to Use This Medicine
Taking Your Medication Correctly
To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food. If you experience an upset stomach, taking it with food may help.
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 while. 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 happens within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an extra form of birth control and consult your doctor. If you're unsure what to do, call your doctor for advice.
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
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, avoiding the bathroom.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or call your doctor for guidance. If you're using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a while to prevent pregnancy.
To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food. If you experience an upset stomach, taking it with food may help.
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 while. 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 happens within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an extra form of birth control and consult your doctor. If you're unsure what to do, call your doctor for advice.
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
Keep your medication at room temperature, away from light and moisture. Store it in a dry place, avoiding the bathroom.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or call your doctor for guidance. If you're using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a while to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if over 35 years old, due to increased risk of serious cardiovascular events.
- Take one pill at the same time every day to maximize effectiveness.
- Use a backup method of contraception (e.g., condoms) if pills are missed, or during the first 7 days of the first cycle.
- Report any unusual or severe side effects to your doctor immediately.
- Attend regular check-ups, including blood pressure monitoring.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. The first 21 tablets contain active ingredients (Ethinyl Estradiol and Norethindrone), and the last 7 tablets contain Ferrous Fumarate.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missedDose:
Refer to package insert for specific instructions based on number of missed pills and week in cycle. Generally, take missed pill as soon as remembered; if multiple pills missed, use backup contraception.
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 specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; monitor for fluid retention. Ferrous fumarate generally safe.
Dialysis:
Use with caution; monitor for fluid retention. Ferrous fumarate generally safe.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Contraindicated.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone act primarily by suppressing gonadotropins, which inhibits ovulation. They also cause changes in the cervical mucus (making it less permeable to sperm) and the endometrium (making it less receptive to implantation). Ferrous Fumarate provides elemental iron, which is essential for hemoglobin formation and oxygen transport, addressing potential iron deficiency anemia associated with menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45% (due to first-pass metabolism); Norethindrone: ~60-80%; Ferrous Fumarate: Variable, depends on iron stores and dietary factors (typically 10-30% of elemental iron).
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours; Ferrous Fumarate: Not directly applicable for Tmax of iron absorption, but peak serum iron levels typically 2-4 hours post-dose.
FoodEffect:
Ethinyl Estradiol/Norethindrone: Minimal effect on absorption. Ferrous Fumarate: Absorption is reduced by food, especially dairy products, tea, coffee, and whole grains. Best taken on an empty stomach, but can be taken with food to reduce GI upset.
Distribution:
Vd:
Ethinyl Estradiol: ~2-4 L/kg; Norethindrone: ~4 L/kg; Ferrous Fumarate: Iron is widely distributed, primarily bound to transferrin in plasma.
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin); Norethindrone: ~96-98% (to albumin and sex hormone-binding globulin); Ferrous Fumarate: Iron is transported bound to transferrin.
CnssPenetration:
Limited for Ethinyl Estradiol/Norethindrone; Not applicable for Ferrous Fumarate in terms of direct CNS penetration as a drug.
Elimination:
HalfLife:
Ethinyl Estradiol: ~10-20 hours; Norethindrone: ~5-14 hours; Ferrous Fumarate: Not applicable (iron is conserved and recycled).
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone: ~0.4 mL/min/kg; Ferrous Fumarate: Not applicable (minimal excretion).
ExcretionRoute:
Ethinyl Estradiol/Norethindrone: Renal (primarily as glucuronide and sulfate conjugates) and biliary/fecal; Ferrous Fumarate: Primarily via GI tract (unabsorbed iron), minimal renal excretion.
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <10%; Ferrous Fumarate: Not applicable (absorbed iron is utilized).
Pharmacodynamics
OnsetOfAction:
Contraceptive effect begins after 7 consecutive days of active pill use in the first cycle, if started correctly. Full protection typically achieved within the first cycle.
PeakEffect:
Sustained throughout daily dosing.
DurationOfAction:
Daily dosing maintains contraceptive efficacy.
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 Loestrin FE 1.5/30, are contraindicated in women who are over 35 years of age and smoke.
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Depression or other mood changes.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Swelling or fluid retention in the body, which can cause weight gain or trouble breathing.
Blood Clots: Seek Medical Help Immediately
If you experience any of the following symptoms, contact your doctor or seek medical attention right away, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Other Side Effects
Most people who take this medication do not experience serious side effects. However, some people may experience mild or moderate side effects. If you experience 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, use sunscreen, and wear protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes.
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting.
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight.
Depression or other mood changes.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Swelling or fluid retention in the body, which can cause weight gain or trouble breathing.
Blood Clots: Seek Medical Help Immediately
If you experience any of the following symptoms, contact your doctor or seek medical attention right away, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing
Other Side Effects
Most people who take this medication do not experience serious side effects. However, some people may experience mild or moderate side effects. If you experience 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, use sunscreen, and wear protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
If you have questions about side effects or experience any side effects not listed here, 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).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema
+ Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
Recent use of certain medications, such as:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
* A history of jaundice during pregnancy or with estrogen use, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Before starting, stopping, or changing the dose of any medication, consult your doctor to ensure safe use and minimize potential interactions.
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding
+ Hereditary angioedema
+ Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation
Recent use of certain medications, such as:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed
* A history of jaundice during pregnancy or with estrogen use, such as hormonal birth control
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Before starting, stopping, or changing the dose of any medication, consult your doctor to ensure safe use and minimize potential interactions.
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. 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 an extended period, 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 an extended period, 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
- Withdrawal bleeding (in females)
- Iron overdose symptoms: abdominal pain, diarrhea, vomiting (sometimes bloody), lethargy, pallor, cyanosis, shock, metabolic acidosis, liver damage.
What to Do:
Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). For iron overdose, gastric lavage, chelation therapy (e.g., deferoxamine) may be necessary.
Drug Interactions
Contraindicated Interactions
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (increased ALT elevations)
- Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Barbiturates, Topiramate, Oxcarbazepine, Felbamate) due to potential contraceptive failure
Major Interactions
- Aromatase inhibitors (e.g., Anastrozole, Exemestane, Letrozole) - reduced efficacy of aromatase inhibitor
- Bosentan (reduced contraceptive efficacy)
- Griseofulvin (reduced contraceptive efficacy)
- St. John's Wort (reduced contraceptive efficacy)
- Lamotrigine (decreased lamotrigine levels, leading to loss of seizure control)
- Thyroid hormones (e.g., Levothyroxine) - increased thyroid binding globulin, requiring higher thyroid hormone dose
- Warfarin (potential for altered anticoagulant effect, monitor INR)
Moderate Interactions
- Corticosteroids (e.g., Prednisolone) - increased corticosteroid levels
- Cyclosporine (increased cyclosporine levels)
- Theophylline (increased theophylline levels)
- Acetaminophen (increased ethinyl estradiol levels)
- Ascorbic acid (increased ethinyl estradiol levels)
- Certain antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic recirculation, though clinical significance is debated, backup contraception often recommended.
- Iron chelators (e.g., Deferoxamine) - reduced iron absorption
Minor Interactions
- Not typically categorized for OCs in this manner, but many drugs can have minor or theoretical interactions.
Monitoring
Baseline Monitoring
Complete Medical History (including family history of cardiovascular disease, breast cancer)
Rationale: To identify contraindications, risk factors for adverse events (e.g., VTE, stroke, MI, breast cancer).
Timing: Prior to initiation.
Physical Examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To assess overall health, identify contraindications, and establish baseline for future monitoring.
Timing: Prior to initiation.
Lipid Profile (if indicated by risk factors)
Rationale: To assess cardiovascular risk.
Timing: Prior to initiation.
Routine Monitoring
Blood Pressure
Frequency: Annually, or more frequently if hypertension develops.
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or change in contraception.
Annual Physical Examination (including breast exam, Pap test as per guidelines)
Frequency: Annually.
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Weight
Frequency: Annually.
Target: Stable or healthy BMI
Action Threshold: Significant weight gain may warrant discussion.
Symptoms of Thromboembolism, Stroke, MI, Liver Disease
Frequency: Ongoing patient education and self-monitoring.
Target: Absence of symptoms
Action Threshold: Immediate medical attention for new or worsening symptoms.
Symptom Monitoring
- Severe leg pain (DVT)
- Sudden chest pain, shortness of breath, coughing up blood (PE)
- Sudden severe headache, weakness/numbness on one side of body, vision changes, speech difficulty (Stroke)
- Chest pain, arm pain, jaw pain, sweating, nausea (MI)
- Yellowing of skin or eyes (jaundice), dark urine, light-colored stools, severe abdominal pain (Liver problems)
- New or worsening migraine headaches
- Breast lumps
- Unusual vaginal bleeding or discharge
Special Patient Groups
Pregnancy
Contraindicated. Oral contraceptives should not be used during pregnancy. If pregnancy occurs, discontinue immediately.
Trimester-Specific Risks:
First Trimester:
No evidence of teratogenicity, but not recommended.
Second Trimester:
Not applicable, contraindicated.
Third Trimester:
Not applicable, contraindicated.
Lactation
Not recommended. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant.
Infant Risk:
Low risk of adverse effects, but potential for decreased milk supply and exposure to hormones. Progestin-only methods are generally preferred during lactation.
Pediatric Use
Not indicated for pre-menarcheal girls. For post-menarcheal adolescents, dosing is the same as adults. Safety and efficacy are expected to be similar to adults.
Geriatric Use
Not indicated for post-menopausal women. Risk of cardiovascular events increases with age, especially in smokers.
Clinical Information
Clinical Pearls
- Loestrin FE 1.5/30 is a discontinued brand; generic equivalents are widely available.
- Consistent daily use at the same time is crucial for contraceptive efficacy.
- Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves.
- The iron-containing pills are inert for contraception and are included to help prevent iron deficiency anemia due to menstrual blood loss.
- Patients should be advised to use a backup method of contraception if they miss pills, especially during the first week of a new pack or if multiple pills are missed.
- Counsel patients on the serious risks associated with smoking while on oral contraceptives.
Alternative Therapies
- Progestin-only pills (POPs)
- Intrauterine devices (IUDs - hormonal or copper)
- Contraceptive implant (e.g., Nexplanon)
- Contraceptive injection (e.g., Depo-Provera)
- Contraceptive patch
- Vaginal ring
- Barrier methods (condoms, diaphragm, cervical cap)
- Surgical sterilization (tubal ligation, vasectomy)
- Emergency contraception
Cost & Coverage
Average Cost:
Discontinued. Generic equivalents typically range from $10-$50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generics), often covered fully under ACA for contraception.
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 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.