Loestrin 1.5/30 Tablets 21

Manufacturer TEVA/WOMENS HEALTH Active Ingredient Ethinyl Estradiol and Norethindrone Tablets(ETH in il es tra DYE ole & nor eth IN drone) Pronunciation ETH-in-il es-tra-DYE-ol & nor-ETH-in-drone
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 may be given to you for other reasons. Talk with the doctor.
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Drug Class
Contraceptive
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Pharmacologic Class
Estrogen/Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Jan 1973
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a birth control pill that contains two female hormones, an estrogen (ethinyl estradiol) and a progestin (norethindrone). It works primarily by preventing the release of an egg from the ovary (ovulation). It also thickens the fluid around the cervix to prevent sperm from reaching the egg and changes the lining of the uterus to prevent a fertilized egg from implanting.
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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 alleviate discomfort.

If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication.

After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's guidance on using non-hormone birth control.

It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy.

If you vomit or have diarrhea, the medication may not work as well. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.

If you miss two periods in a row, take a pregnancy test before starting a new cycle of medication.

Storing and Disposing of Your Medication

Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.

What to Do If You Miss a Dose

If you miss a dose, refer to the package insert or consult 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 certain period to prevent pregnancy.
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Lifestyle & Tips

  • Take one tablet at the same time every day to maximize effectiveness and minimize breakthrough bleeding.
  • Do not smoke, especially if you are over 35 years old, due to increased risk of serious cardiovascular events.
  • Use a backup method of birth control (e.g., condoms) for the first 7 days of the first pack, or if you miss pills.
  • Report any unusual or severe symptoms immediately to your healthcare provider.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally once daily for 21 consecutive days, followed by 7 tablet-free days (or 7 days of inactive tablets for 28-day packs).
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

contraception: One tablet daily at the same time each day.
menstrual_disorders: One tablet daily at the same time each day, as directed by physician.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Use with caution; monitor for fluid retention and electrolyte imbalances. Not extensively studied.
Dialysis: Not extensively studied; use with caution. Consider alternative methods.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; monitor liver function. May require dose adjustment or alternative.
Severe: Contraindicated due to impaired steroid metabolism and potential for cholestasis.

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (FSH and LH), which in turn inhibits ovulation. Additional mechanisms include changes in the cervical mucus, increasing its viscosity and making it more difficult for sperm to penetrate, and alterations in the endometrium, making it less receptive to implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-90%
Tmax: Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours
FoodEffect: Food may slightly decrease Cmax for both components but generally does not significantly affect bioavailability.

Distribution:

Vd: Ethinyl Estradiol: ~5 L/kg; Norethindrone: ~4 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (to albumin and SHBG); Norethindrone: ~61% (to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~5-14 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4-0.8 L/hr/kg
ExcretionRoute: Renal and fecal (via enterohepatic recirculation for Ethinyl Estradiol)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically achieved after 7 consecutive days of active pill use, assuming proper initiation.
PeakEffect: Suppression of ovulation maintained throughout active pill cycle.
DurationOfAction: Daily dosing maintains therapeutic levels for contraceptive effect.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combined 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, combined oral contraceptives, including Loestrin 1.5/30, 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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or 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:
+ A 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 immediately.

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 notice any of the following side effects, contact your doctor or seek medical help if they bother you or persist:

Appetite changes
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 protective measures)
Period (menstrual) changes, including:
+ Heavy bleeding
+ Spotting
+ 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.
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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)
  • E: Eye problems (blurred vision, flashing lights, partial or complete loss of vision)
  • S: Severe leg pain (calf or thigh), swelling, warmth, or redness
  • Jaundice (yellowing of skin or eyes)
  • Depressed mood or changes in mood
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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
+ Angina (chest pain) or a history of heart attack
+ Stroke or 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
A history of jaundice (yellowing of the skin) 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 health conditions and medications. Never start, stop, or change the dose of any medication without consulting your doctor.
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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 anticipate being inactive for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. Prolonged inactivity 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. Follow your doctor's instructions for regular blood pressure checks.

Additionally, this medication may lead to increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as advised by your doctor.

It is crucial to maintain regular breast exams and gynecology check-ups. Also, 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. Furthermore, if you frequently consume grapefruit juice or eat grapefruit, 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.

Taking this medication may increase your 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 to discuss this risk.

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 questions, discuss this with your doctor.

Additionally, some studies have shown a potential link between long-term use of hormone-based birth control and an increased risk of breast cancer, while other studies have not found this association. If you have concerns, consult your doctor.

If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not yet 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 (especially in young girls)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Contact a poison control center or seek immediate medical attention. Call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (risk of ALT elevations)
  • Glecaprevir/Pibrentasvir (risk of ALT elevations)
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Carbamazepine, Phenytoin, Rifampin, St. John's Wort, Barbiturates, Topiramate, Oxcarbazepine, Felbamate, Griseofulvin) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Lamotrigine (oral contraceptives may decrease lamotrigine levels, leading to loss of seizure control).
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Moderate Interactions

  • CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin) - may increase estrogen/progestin levels, potentially increasing adverse effects.
  • Certain antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic recirculation, though clinical significance is debated.
  • Thyroid hormone replacement (oral contraceptives may increase thyroid binding globulin, leading to increased thyroid hormone requirements).
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Minor Interactions

  • Acetaminophen (may increase ethinyl estradiol levels)
  • Ascorbic acid (Vitamin C) (may increase ethinyl estradiol levels)

Monitoring

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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., VTE, cardiovascular disease), and establish baseline health status.

Timing: Prior to initiation of therapy.

Pregnancy test

Rationale: To rule out existing pregnancy, as the drug is contraindicated.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood pressure

Frequency: Annually, or more frequently if clinically indicated.

Target: <140/90 mmHg (or individualized target)

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

Annual physical examination (including breast and pelvic exam)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation.

Lipid profile (optional, for high-risk patients)

Frequency: Periodically, as clinically indicated.

Target: Within normal limits

Action Threshold: Significant dyslipidemia may warrant re-evaluation of contraceptive choice.

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Symptom Monitoring

  • Severe abdominal pain (A)
  • Severe chest pain, shortness of breath, or coughing blood (C)
  • Severe headaches (H)
  • Eye problems (blurred vision, loss of vision) (E)
  • Severe leg pain (calf or thigh), swelling, warmth, or redness (S)
  • Jaundice (yellowing of skin or eyes)
  • Mood changes, depression
  • Unusual vaginal bleeding or spotting
  • Lump in breast

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. There is no indication for use of 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 reported with inadvertent exposure.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk and may be excreted in breast milk. Progestins are generally considered compatible with breastfeeding, but the combination is best avoided, especially in the immediate postpartum period until breastfeeding is well established.

Infant Risk: L3 (Moderate risk) - Potential for decreased milk supply and possible transfer of hormones to the infant, though adverse effects on the infant are generally not well-documented.
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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.

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Geriatric Use

Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, and alternative therapies are preferred for hormone replacement therapy.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of taking the pill at the same time every day to maintain efficacy and minimize breakthrough bleeding.
  • Counsel patients on the 'ACHES' warning signs for serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
  • Reinforce that COCs do not protect against STIs and that condoms should be used for STI prevention.
  • Discuss missed pill instructions thoroughly, as they vary based on the number of pills missed and the week of the cycle.
  • Be aware of potential drug interactions, especially with CYP3A4 inducers, which can significantly reduce contraceptive efficacy.
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Alternative Therapies

  • Progestin-only pills (POPs)
  • Progestin injection (Depo-Provera)
  • Progestin implant (Nexplanon)
  • Intrauterine devices (IUDs - hormonal and non-hormonal)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Natural family planning methods
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: Varies, typically $15-$50 per 21 or 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered with no co-pay under ACA)
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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 taken, the amount, and the time it happened.