Microgestin 1/20 FE Tabs 28s

Manufacturer MAYNE PHARMA 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 ETH in il es tra DYE ole, nor eth IN drone, & 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
Hormonal Contraceptive; Iron Supplement
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Pharmacologic Class
Estrogen-Progestin Combination; Iron Supplement
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Pregnancy Category
Category X
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FDA Approved
Aug 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Microgestin 1/20 FE is a daily birth control pill that contains two female hormones (estrogen and progestin) to prevent pregnancy, and iron pills for the last week to help prevent iron deficiency. It works by stopping your body from releasing an egg and by changing the lining of your uterus and cervical mucus.
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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 stomach upset, 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 additional form of birth control and contact your doctor for advice. 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

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 contact your doctor for instructions. 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.
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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 and heart attack.
  • Take one pill at the same time every day to ensure maximum effectiveness.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
  • Attend regular check-ups, including blood pressure monitoring, as advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily, starting on the first day of menstruation or the first Sunday after menstruation begins. Follow 28-day regimen (21 active tablets, 7 ferrous fumarate tablets).
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.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (not indicated before menarche)
Adolescent: Same as adult dosing (after menarche)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, monitor for fluid retention.
Moderate: No specific adjustment needed, monitor for fluid retention.
Severe: Use with caution; monitor for fluid retention. Not specifically studied.
Dialysis: Use with caution; not specifically studied. Consider alternative methods.

Hepatic Impairment:

Mild: Use with caution.
Moderate: Use with caution; monitor liver function.
Severe: Contraindicated (due to impaired steroid metabolism).

Pharmacology

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Mechanism of Action

Ethinyl Estradiol and Norethindrone: Primarily inhibit ovulation by suppressing gonadotropin-releasing hormones (GnRH) from the hypothalamus, leading to suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary. This prevents follicular development and ovulation. They also cause changes in the cervical mucus (making it thicker and less permeable to sperm) and the endometrium (making it less receptive to implantation). Ferrous Fumarate: Provides elemental iron, an essential component in the formation of hemoglobin, myoglobin, and various enzymes; used to prevent or treat iron deficiency anemia.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45% (due to significant first-pass metabolism); Norethindrone: ~60-100%
Tmax: Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect: Food may slightly decrease Cmax for both, but generally not clinically significant for efficacy. Iron absorption can be affected by food.

Distribution:

Vd: Ethinyl Estradiol: ~2.8-8.6 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin, also to SHBG); Norethindrone: ~96-97% (primarily to albumin, also to SHBG)
CnssPenetration: Limited (hormones cross blood-brain barrier to some extent)

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: Ethinyl Estradiol: Renal (40%), Fecal (60%); Norethindrone: Renal (50-80%), Fecal (20-50%)
Unchanged: Ethinyl Estradiol: <5%; Norethindrone: <1%
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Pharmacodynamics

OnsetOfAction: Contraceptive effect typically after 7 consecutive days of active pill use (if started on Day 1 of menses, immediate protection; if started on Sunday, 7 days of backup contraception needed).
PeakEffect: Steady-state concentrations achieved within 3-4 days of daily dosing.
DurationOfAction: Daily dosing required for continuous contraceptive effect.

Safety & Warnings

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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 1/20 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: 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
Eyesight changes or loss, 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
Signs of 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; or trouble speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help 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

This list is not exhaustive, and you may experience other 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**bdominal pain (severe)
  • **C**hest pain (severe), cough, shortness of breath
  • **H**eadaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
  • **E**ye problems (vision loss or blurring)
  • **S**evere leg pain (calf or thigh), swelling, redness, warmth
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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 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 problems
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical cancer, 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 the sun 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, as this medication is contraindicated during pregnancy.
Breastfeeding or plans to breastfeed, as the medication may pass into breast milk.
A history of jaundice (yellowing of the skin and eyes) 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. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use and minimize potential interactions.
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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 will be required to remain still 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 with 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 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 recommended 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 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 or concerns, consult with 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 pause of 4 weeks or more. Consult with your doctor to understand 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 increased risk of breast cancer associated with long-term use of hormone-based birth control, while others have not found this association. If you have concerns, consult with 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
  • Withdrawal bleeding (in females)

What to Do:

Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is generally supportive.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir, dasabuvir (risk of ALT elevation)
  • Tranexamic acid (increased risk of thrombosis)
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Major Interactions

  • CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy
  • Protease inhibitors (e.g., Ritonavir, Nelfinavir) - variable effects on COC levels
  • Non-nucleoside reverse transcriptase inhibitors (e.g., Efavirenz, Nevirapine) - may decrease COC levels
  • Lamotrigine (COCs may decrease lamotrigine levels, leading to loss of seizure control)
  • Thyroid hormones (COCs may increase thyroid-binding globulin, requiring increased thyroid hormone dose)
  • Warfarin (COCs may alter anticoagulant effect, monitor INR)
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Moderate Interactions

  • Broad-spectrum antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of decreased efficacy due to altered enterohepatic recirculation, but clinical significance is debated. Backup method often recommended.
  • Grapefruit juice (may increase ethinyl estradiol levels via CYP3A4 inhibition, but clinical significance is usually minor)
  • Colesevelam (may decrease absorption of COCs, administer COCs at least 4 hours before colesevelam)
  • Iron absorption inhibitors (e.g., Antacids, Proton Pump Inhibitors, H2-receptor antagonists, Calcium supplements, Tetracyclines, Fluoroquinolones) - for ferrous fumarate component
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Minor Interactions

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

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To identify pre-existing hypertension and monitor for drug-induced hypertension, a risk factor for cardiovascular events.

Timing: Prior to initiation

Medical History (including family history of VTE, breast cancer)

Rationale: To identify contraindications and risk factors for adverse events.

Timing: Prior to initiation

Physical Examination (including breast and pelvic exam, Pap test)

Rationale: To assess overall health, rule out contraindications, and establish baseline.

Timing: Prior to initiation (as per clinical guidelines, not always mandatory before starting COCs)

Lipid Profile (optional)

Rationale: To assess cardiovascular risk, especially in patients with other risk factors.

Timing: Prior to initiation (consider)

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Routine Monitoring

Blood Pressure

Frequency: Annually

Target: <140/90 mmHg

Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or change in contraception.

Annual Physical Examination

Frequency: Annually

Target: N/A

Action Threshold: N/A

Symptoms of Thromboembolism (e.g., leg pain/swelling, chest pain, shortness of breath, sudden severe headache, vision changes)

Frequency: Ongoing, patient self-monitoring

Target: Absence of symptoms

Action Threshold: Immediate medical attention if symptoms occur.

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Symptom Monitoring

  • Abdominal pain (severe)
  • Chest pain (severe), shortness of breath, coughing blood
  • Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
  • Eye problems (vision loss or blurring)
  • Severe leg pain (calf or thigh), swelling, redness, warmth
  • Jaundice (yellowing of skin or eyes)
  • Mood changes, depression

Special Patient Groups

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Pregnancy

Contraindicated. Microgestin 1/20 FE should not be used during pregnancy. If pregnancy occurs while taking this medication, discontinue use immediately.

Trimester-Specific Risks:

First Trimester: Category X; potential for fetal harm, though data on specific risks are limited and conflicting.
Second Trimester: Category X; potential for fetal harm.
Third Trimester: Category X; potential for fetal harm.
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Lactation

Not recommended. Estrogens and progestins can decrease the quantity and quality of breast milk and are excreted in breast milk. Consider alternative contraceptive methods while breastfeeding.

Infant Risk: Low risk of adverse effects in breastfed infants, but potential for hormonal exposure and impact on milk supply.
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Pediatric Use

Not indicated for use before menarche. Once menarche occurs, adolescent dosing is the same as adult dosing for contraception.

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Geriatric Use

Not indicated for contraception in postmenopausal women. No specific dosing recommendations for geriatric population.

Clinical Information

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Clinical Pearls

  • Emphasize the importance of taking the pill at the same time every day to maintain contraceptive efficacy.
  • Counsel patients on missed dose instructions thoroughly, as efficacy can be compromised.
  • Remind patients that COCs do not protect against sexually transmitted infections (STIs).
  • The ferrous fumarate tablets are included to prevent iron deficiency anemia, which can be common in menstruating women.
  • Patients should be advised to report any symptoms of blood clots (ACHES) immediately.
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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 (e.g., Xulane)
  • Vaginal ring (e.g., NuvaRing)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $20 - $100+ per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generics often Tier 1, brand may be Tier 2 or 3)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 reporting the incident, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred.