Microgestin 1/20 Tabs 21s Yellow

Manufacturer MAYNE PHARMA 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-ole & 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.
đŸˇī¸
Drug Class
Hormonal Contraceptives
đŸ§Ŧ
Pharmacologic Class
Estrogens; Progestins
🤰
Pregnancy Category
Category X
✅
FDA Approved
Jul 1982
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Microgestin 1/20 is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone). It works by preventing ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. It is taken daily.
📋

How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food to help alleviate discomfort.

If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication. After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's guidance on using non-hormone birth control.

It is essential to take your medication as directed, even if you do not have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet 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 are unsure what to do, call your doctor for guidance.

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

Storing and Disposing of Your Medication

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

What to Do If You Miss a Dose

If you miss a dose, refer to the package insert or call your doctor for instructions. If you are using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a certain period to prevent pregnancy.
💡

Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious cardiovascular side effects (blood clots, heart attack, stroke).
  • Maintain a healthy diet and exercise routine.
  • Report any unusual or severe symptoms immediately to your healthcare provider.
  • Use a backup method of contraception (like condoms) if you miss pills, are starting a new pack, or are taking medications that can reduce the effectiveness of birth control pills.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: One active tablet daily for 21 days, followed by one inactive tablet daily for 7 days. Begin new pack on day 29.

Condition-Specific Dosing:

contraception: Take one tablet orally at the same time each day. Start on the first day of menstruation or the first Sunday after menstruation begins.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Use with caution; monitor for fluid retention. No specific dose adjustment guidelines.
Dialysis: Not specifically studied; use with caution.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated in severe hepatic impairment or liver tumors.
Severe: Contraindicated.
Dialysis: Not applicable for hepatic impairment.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), which in turn inhibits 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). Ethinyl estradiol provides the estrogenic component, and norethindrone provides the progestational component.
📊

Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-80%
Tmax: Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect: Food may slightly decrease Cmax for norethindrone but does not significantly affect bioavailability.

Distribution:

Vd: Ethinyl Estradiol: ~2-4 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin); Norethindrone: ~96-98% (to albumin and sex hormone-binding globulin)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~10-20 hours; Norethindrone: ~5-14 hours
Clearance: Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone: ~0.4 L/hr/kg
ExcretionRoute: Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50-80%) and Fecal (20-50%)
Unchanged: Ethinyl Estradiol: <5%; Norethindrone: <1%
âąī¸

Pharmacodynamics

OnsetOfAction: Contraceptive efficacy begins after 7 consecutive days of active pill use, if started on the first day of menstruation, immediate protection is provided. If started on Sunday, backup contraception is needed for the first 7 days.
PeakEffect: Sustained throughout daily dosing.
DurationOfAction: Requires daily administration to maintain contraceptive effect.

Safety & Warnings

âš ī¸

BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
âš ī¸

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 immediately or seek emergency medical attention:

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 vision
Depression or other mood changes
Breast-related symptoms: lump in the breast, breast pain or soreness, or nipple discharge
Vaginal symptoms: itching or discharge
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent vaginal bleeding or spotting
Fluid retention: swelling, 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or do not go away, contact your doctor:

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, use sunscreen, and wear protective clothing and eyewear)
* Menstrual changes: 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, 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:

  • 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
  • Yellowing of the skin or eyes (jaundice)
  • Depressed mood or severe mood changes
📋

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
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ 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
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
Hereditary angioedema, a condition characterized by recurrent 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 (do not take this medication if you are pregnant)
Breastfeeding or plans to breastfeed
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. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without consulting your doctor.
âš ī¸

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, and will provide guidance on when to resume taking it after the surgery or procedure.

If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing blood clots.

If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar levels 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 increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as directed.

Regular breast exams and gynecology check-ups are crucial, and you should 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. 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 workers 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, and discuss the need for additional non-hormonal birth control methods, such as condoms.

This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Use a latex or polyurethane condom during sexual activity, and consult your doctor if you have questions.

Taking this medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor, as the risk is highest during the first year of use and when restarting hormone-based birth control after a 4-week or longer period of not using it.

Some studies suggest that long-term use of hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use, while others have not. If you have questions or concerns, discuss them 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 had their first menstrual period.

If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
🆘

Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Withdrawal bleeding (in females)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir
  • Dasabuvir
  • Glecaprevir/Pibrentasvir
  • Ledipasvir/Sofosbuvir
  • Sofosbuvir/Velpatasvir
  • Sofosbuvir/Velpatasvir/Voxilaprevir
🔴

Major Interactions

  • Rifampin (decreased contraceptive efficacy)
  • Anticonvulsants (e.g., Phenytoin, Carbamazepine, Barbiturates, Topiramate, Oxcarbazepine, Felbamate - decreased contraceptive efficacy)
  • Griseofulvin (decreased contraceptive efficacy)
  • St. John's Wort (decreased contraceptive efficacy)
  • Ritonavir-boosted protease inhibitors (variable effects on COC levels)
  • Bosentan (decreased contraceptive efficacy)
  • Modafinil (decreased contraceptive efficacy)
  • Lamotrigine (decreased lamotrigine levels)
  • Thyroid hormones (increased thyroid hormone binding globulin, requiring higher thyroid hormone dose)
🟡

Moderate Interactions

  • Broad-spectrum antibiotics (e.g., Amoxicillin, Doxycycline - theoretical risk of decreased efficacy due to altered enterohepatic recirculation, though clinical significance is debated)
  • Grapefruit juice (may increase ethinyl estradiol levels)
  • CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin - may increase COC levels)
  • Cyclosporine (increased cyclosporine levels)
  • Theophylline (increased theophylline levels)
  • Corticosteroids (increased corticosteroid levels)
  • Warfarin (may alter anticoagulant effect, monitor INR)
đŸŸĸ

Minor Interactions

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

Monitoring

đŸ”Ŧ

Baseline Monitoring

Complete medical history (including family history)

Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by COC use.

Timing: Prior to initiation of therapy.

Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)

Rationale: To establish baseline health status and screen for conditions that may contraindicate COC use or require monitoring.

Timing: Prior to initiation of therapy.

Lipid panel (optional, based on risk factors)

Rationale: To assess baseline cardiovascular risk.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Blood pressure

Frequency: Annually, or more frequently if hypertension develops or worsens.

Target: <120/80 mmHg

Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or change in contraceptive method.

Annual physical examination (including breast exam, pelvic 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 of lifestyle or alternative contraception.

đŸ‘ī¸

Symptom Monitoring

  • Severe abdominal pain (A)
  • Severe chest pain, shortness of breath, or coughing up blood (C)
  • Severe headaches (H)
  • Eye problems (e.g., blurred vision, loss of vision) (E)
  • Severe leg pain (e.g., calf or thigh), swelling, warmth, or redness (S)
  • Jaundice (yellowing of skin or eyes)
  • Mood changes, depression
  • New or worsening migraines
  • Unusual vaginal bleeding

Special Patient Groups

🤰

Pregnancy

Contraindicated. Oral contraceptives should not be used during pregnancy. If pregnancy occurs during use, the drug should be discontinued immediately.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of birth defects from inadvertent exposure during early pregnancy.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is 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. Progestin-only methods are generally preferred for breastfeeding mothers.

Infant Risk: Small amounts of steroids are excreted in breast milk. Potential for adverse effects on the infant (e.g., jaundice, breast enlargement) is low but possible. May reduce milk supply.
đŸ‘ļ

Pediatric Use

Safety and efficacy are established for post-menarcheal adolescents. Use is not indicated before menarche.

👴

Geriatric Use

Not indicated for postmenopausal women. Risk of cardiovascular events increases with age.

Clinical Information

💎

Clinical Pearls

  • Missed pills: If one active pill is missed, take it as soon as remembered and the next pill at the regular time. If two or more active pills are missed, refer to the package insert for specific instructions, as backup contraception may be needed.
  • Non-contraceptive benefits: May improve acne, reduce menstrual cramps, decrease menstrual blood loss, and reduce the risk of ovarian and endometrial cancers.
  • Starting methods: Can be started on the first day of menstruation (Day 1 start) or the first Sunday after menstruation begins (Sunday start). A Sunday start requires backup contraception for the first 7 days.
  • Vomiting/Diarrhea: Severe vomiting or diarrhea can reduce absorption and efficacy; use backup contraception.
  • Drug interactions are common; always review concomitant medications with the patient.
🔄

Alternative Therapies

  • Progestin-only pills (POPs)
  • Contraceptive patch (Ethinyl Estradiol/Norelgestromin)
  • Vaginal ring (Ethinyl Estradiol/Etonogestrel)
  • Contraceptive injection (Depot Medroxyprogesterone Acetate)
  • Contraceptive implant (Etonogestrel)
  • Intrauterine devices (IUDs - hormonal or copper)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
💰

Cost & Coverage

Average Cost: $20 - $50 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered with no or low co-pay under ACA)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.