Loestrin 24 FE Tablets 28s

Manufacturer ACTAVIS Active Ingredient Ethinyl Estradiol, Norethindrone, and Ferrous Fumarate(ETH in il es tra DYE ole, nor eth IN drone, & FER uhs FYOO mar rate) Pronunciation LO-es-trin twenty-four F-E (Ethinyl Estradiol: ETH-in-il es-tra-DYE-ole, Norethindrone: nor-ETH-in-drone, Ferrous Fumarate: FER-uhs FYOO-mar-rate)
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.
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Drug Class
Contraceptive, Oral; Iron Supplement
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Pharmacologic Class
Estrogen/Progestin Combination; Mineral Supplement
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Pregnancy Category
Category X
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FDA Approved
Feb 2006
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Loestrin 24 Fe is a birth control pill that contains two female hormones (estrogen and progestin) and iron. The hormones work by preventing ovulation (release of an egg from the ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. The iron helps prevent or treat iron deficiency anemia, which can sometimes occur with menstrual bleeding.
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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 minimize 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.

Important: Pregnancy Testing

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.

Missing a Dose

If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. 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.
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Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
  • Take the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
  • Use a backup method of birth control (like condoms) if you miss pills, are starting the pill, or are taking medications that can reduce its effectiveness.
  • This medication does not protect against sexually transmitted infections (STIs). Use condoms to prevent STIs.
  • Maintain regular physical activity and a healthy diet to support overall cardiovascular health.

Dosing & Administration

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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 last 4 tablets are ferrous fumarate.

Condition-Specific Dosing:

missedDose: Refer to package insert for specific instructions based on number of missed pills and week of cycle. Generally, take missed pill as soon as remembered, then continue daily. Use backup contraception if multiple pills missed.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Indicated for post-menarcheal adolescents for contraception or acne, following adult dosing guidelines.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for hormonal components; monitor iron if severe impairment.
Moderate: No specific adjustment needed for hormonal components; monitor iron if severe impairment.
Severe: Use with caution; not specifically studied. Consider alternative contraception. Iron absorption may be altered.
Dialysis: Not specifically studied. Consider alternative contraception. Iron absorption may be altered.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated due to impaired steroid metabolism.
Severe: Contraindicated due to impaired steroid metabolism.

Pharmacology

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Mechanism of Action

Ethinyl Estradiol and Norethindrone: Suppress gonadotropins (luteinizing hormone and follicle-stimulating hormone), thereby inhibiting 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, an essential component of hemoglobin, myoglobin, and various enzymes, to prevent or treat iron deficiency anemia.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-80%
Tmax: Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours
FoodEffect: Food may slightly decrease Cmax but does not significantly affect bioavailability of hormonal components. Iron absorption is enhanced by vitamin C and inhibited by certain foods (e.g., dairy, tea, coffee).

Distribution:

Vd: Ethinyl Estradiol: ~5 L/kg; Norethindrone: ~4 L/kg
ProteinBinding: Ethinyl Estradiol: >95% (to albumin and SHBG); Norethindrone: >95% (to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: 18-24 hours; Norethindrone: 5-14 hours
Clearance: Not available
ExcretionRoute: Renal and fecal (for hormonal components); minimal excretion for iron, primarily via desquamation of GI cells, skin, and urine.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Contraceptive effect begins after 7 consecutive days of active pill use, if started correctly.
PeakEffect: Steady-state concentrations reached within 3-4 days for hormonal components.
DurationOfAction: Daily dosing maintains contraceptive efficacy.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Loestrin 24 Fe, are contraindicated in women who are over 35 years of age and smoke.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ 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
Breast changes, such as:
+ Lump in the breast
+ Breast pain or soreness
+ 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
Fluid retention, which may cause swelling, weight gain, or trouble breathing

If you experience any of these symptoms, contact your doctor right away.

Additional Side Effects:

This medication may cause other side effects. If you experience any of the following, contact your doctor 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 (avoid sun exposure and use sunscreen)
Period changes, including:
+ Heavy bleeding
+ Spotting
+ Bleeding between cycles

Reporting Side Effects:

If you have questions about side effects or experience any unusual symptoms, contact your doctor for medical advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • ACHES: Abdominal pain (severe)
  • ACHES: Chest pain (severe), shortness of breath, coughing up blood
  • ACHES: Headaches (severe, sudden, or worse than usual, especially with aura)
  • ACHES: Eye problems (sudden partial or complete vision loss, bulging eyes, double vision)
  • ACHES: Severe leg pain (calf or thigh), swelling, warmth, redness
  • Yellowing of skin or eyes (jaundice)
  • Dark urine, light-colored stools
  • Severe mood changes or symptoms of depression
  • Lump in the breast
  • Unusual vaginal bleeding or spotting that is heavy or lasts a long time
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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 treatment:

Any allergies you have, including allergies to this medication, 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 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 suspected 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 conditions with your doctor and pharmacist. They will help you determine the safety of taking this medication with your existing treatments and health status. Never start, stop, or adjust the dose of any medication without consulting your doctor.
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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 provide guidance 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 other studies have not confirmed this risk. 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.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Breast tenderness
  • Dizziness
  • Abdominal pain
  • Drowsiness
  • Fatigue
  • Vaginal bleeding (in females)
  • Iron overdose symptoms: severe stomach pain, bloody diarrhea, vomiting, shallow breathing, weak rapid pulse, bluish skin, seizures, coma.

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive; for iron overdose, gastric lavage, chelation therapy (e.g., deferoxamine) may be necessary.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir (risk of ALT elevations)
  • Glecaprevir/Pibrentasvir (risk of ALT elevations)
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Major Interactions

  • CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, St. John's Wort - may decrease contraceptive efficacy)
  • Certain antibiotics (e.g., Rifampin - may decrease contraceptive efficacy)
  • Protease inhibitors (some may decrease or increase OC levels)
  • Lamotrigine (OCs may decrease lamotrigine levels, leading to loss of seizure control)
  • Warfarin (OCs may alter anticoagulant effects, requiring INR monitoring)
  • Iron chelators (e.g., Deferoxamine - concurrent use with iron supplements is contraindicated)
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Moderate Interactions

  • CYP3A4 inhibitors (e.g., Azole antifungals, Macrolide antibiotics, Grapefruit juice - may increase OC levels)
  • Thyroid hormones (OCs may increase thyroid-binding globulin, requiring increased thyroid hormone dose)
  • Corticosteroids (OCs may increase corticosteroid levels)
  • Cyclosporine (OCs may increase cyclosporine levels)
  • Tetracyclines, Fluoroquinolones (iron absorption may be reduced)
  • Levothyroxine (iron may reduce levothyroxine absorption)
  • Antacids, Calcium supplements, Dairy products, Coffee, Tea (may reduce iron absorption)
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Minor Interactions

  • Acetaminophen (may increase ethinyl estradiol levels)
  • Ascorbic acid (may increase ethinyl estradiol levels and iron absorption)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To establish baseline and identify hypertension, a contraindication or risk factor.

Timing: Prior to initiation

Physical Examination (including breast and pelvic exam)

Rationale: To assess overall health and rule out contraindications.

Timing: Prior to initiation

Lipid Profile

Rationale: To assess cardiovascular risk factors.

Timing: Consider prior to initiation, especially with risk factors.

Liver Function Tests

Rationale: To rule out hepatic impairment, a contraindication.

Timing: Prior to initiation if history of liver disease or symptoms.

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Routine Monitoring

Blood Pressure

Frequency: Annually or more frequently if clinically indicated.

Target: <140/90 mmHg

Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraception.

Weight

Frequency: Annually

Target: Stable or healthy BMI

Action Threshold: Significant unexplained weight gain may warrant investigation.

Annual Physical Examination

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation.

Iron status (e.g., Ferritin, CBC)

Frequency: Periodically, especially if treating iron deficiency anemia or if symptoms persist.

Target: Ferritin >30 ng/mL, Hemoglobin within normal range

Action Threshold: Persistent anemia or low ferritin despite therapy.

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Symptom Monitoring

  • Signs of deep vein thrombosis (DVT) or pulmonary embolism (PE): leg pain, swelling, warmth, redness; sudden chest pain, shortness of breath, coughing up blood.
  • Signs of stroke: sudden severe headache, weakness or numbness on one side of the body, vision changes, speech difficulty.
  • Signs of myocardial infarction (MI): chest pain, discomfort, pressure, radiating pain to arm/shoulder, shortness of breath, sweating, nausea.
  • Signs of liver problems: yellowing of skin/eyes (jaundice), dark urine, light-colored stools, severe abdominal pain, unusual tiredness.
  • Signs of severe headache/migraine with aura.
  • Signs of depression: persistent sadness, loss of interest, changes in sleep/appetite.
  • Signs of severe allergic reaction: rash, itching, swelling (especially face/tongue/throat), severe dizziness, trouble breathing.

Special Patient Groups

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Pregnancy

Contraindicated. There is no indication for Loestrin 24 Fe in pregnancy, and there is evidence of fetal harm. Discontinue immediately if pregnancy is confirmed.

Trimester-Specific Risks:

First Trimester: Potential for virilization of female fetus (though rare with low-dose OCs), increased risk of cardiovascular defects (though data are conflicting and generally not supported by large studies).
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended. Estrogens and progestins are excreted in breast milk and may decrease the quantity and quality of breast milk. Small amounts of hormonal steroids may be transferred to the infant. Consider progestin-only methods or non-hormonal contraception if breastfeeding.

Infant Risk: Low risk of adverse effects, but potential for decreased milk supply and exposure to hormones.
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Pediatric Use

Not indicated before menarche. For post-menarcheal adolescents, dosing is the same as for adults. Safety and efficacy have been established in women of reproductive age.

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Geriatric Use

Not indicated for postmenopausal women. Use is generally not applicable in the geriatric population for contraception.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of taking the pill at the same time every day for maximum efficacy.
  • Counsel patients on the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
  • Remind patients that oral contraceptives do not protect against STIs.
  • Be aware of drug interactions, especially with CYP3A4 inducers (e.g., rifampin, certain anticonvulsants, St. John's Wort), which can significantly reduce contraceptive efficacy.
  • For missed pills, always refer to the specific instructions in the package insert, as protocols vary.
  • The ferrous fumarate component is for iron supplementation and does not contribute to contraceptive efficacy.
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Alternative Therapies

  • Progestin-only pills (POPs)
  • 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 and non-hormonal)
  • Barrier methods (e.g., condoms, diaphragm)
  • Surgical sterilization (tubal ligation, vasectomy)
  • Emergency contraception (for post-coital use)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 or 4 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.