Gemmily 1/20 Capsules 28s
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age. @ COMMON USES: It is used to prevent pregnancy.It is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Contraceptive, Oral; Iron Supplement
Pharmacologic Class
Estrogen/Progestin Combination; Iron Salt
Pregnancy Category
Category X
FDA Approved
Oct 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gemmily 1/20 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) and changing the cervical mucus and uterine lining to prevent pregnancy. The iron helps prevent or treat iron deficiency anemia, which can be common with menstrual bleeding.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from this medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take this medication at the same time every day. You can take it with or without food, but if it causes stomach upset, take it with food. If you are also taking colesevelam, take it at least 4 hours before or after you take 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. Be sure to follow your doctor's advice on using non-hormone birth control. Do not skip doses, even if you do not have sex frequently. If you vomit or have diarrhea, this medication may not work as well to prevent pregnancy. If this happens within 3 to 4 hours after taking an active tablet, take another tablet. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and contact your doctor. If you are unsure what to do, call your doctor.
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 this medication at room temperature, away from light and moisture. Do not store it in a bathroom.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or contact your doctor for guidance. 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 while to prevent pregnancy.
To get the most benefit from this medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take this medication at the same time every day. You can take it with or without food, but if it causes stomach upset, take it with food. If you are also taking colesevelam, take it at least 4 hours before or after you take 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. Be sure to follow your doctor's advice on using non-hormone birth control. Do not skip doses, even if you do not have sex frequently. If you vomit or have diarrhea, this medication may not work as well to prevent pregnancy. If this happens within 3 to 4 hours after taking an active tablet, take another tablet. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and contact your doctor. If you are unsure what to do, call your doctor.
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 this medication at room temperature, away from light and moisture. Do not store it in a bathroom.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or contact your doctor for guidance. 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 while to prevent pregnancy.
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 minimize breakthrough bleeding.
- Use a backup method of birth control (like condoms) for the first 7 days of your first pack, or if you miss pills.
- Be aware that this medication does not protect against sexually transmitted infections (STIs).
- Maintain regular physical activity and a healthy diet to support overall cardiovascular health.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. Take tablets in the order directed on the blister pack. Each pack contains 24 active tablets (Ethinyl Estradiol/Norethindrone) and 4 inactive tablets (Ferrous Fumarate).
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missedDose:
Refer to package insert for specific instructions based on number of missed active pills. Generally, take missed pill as soon as remembered, and continue with remaining pills. Backup contraception may be needed.
postpartum:
Do not use until 4 weeks postpartum if not breastfeeding, or 6 weeks postpartum if breastfeeding (due to VTE risk).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Dosing is the same as for adults once menstruation has begun and contraception is desired.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; monitor for fluid retention. Not extensively studied.
Dialysis:
Not recommended due to potential for fluid retention and lack of data.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Contraindicated.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone act primarily by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), thereby inhibiting ovulation. They also induce changes in the cervical mucus (making it less permeable to sperm) and the endometrium (making it less receptive to implantation). Ferrous Fumarate provides elemental iron, which is an essential component of hemoglobin, myoglobin, and various enzymes. It is used to prevent or treat iron deficiency anemia, often associated with menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-100%; Ferrous Fumarate: ~10-30% (variable, depends on iron stores and dietary factors)
Tmax:
Ethinyl Estradiol: ~1-2 hours; Norethindrone: ~1-2 hours; Ferrous Fumarate: ~2-4 hours
FoodEffect:
Food may slightly decrease the absorption of ethinyl estradiol and norethindrone but is generally not clinically significant for efficacy. Food can decrease gastrointestinal upset from ferrous fumarate, but may also slightly reduce its absorption.
Distribution:
Vd:
Ethinyl Estradiol: ~5-15 L/kg; Norethindrone: ~2-4 L/kg; Ferrous Fumarate: Not readily quantifiable as it's incorporated into body stores.
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin); Norethindrone: ~96-97% (to albumin and sex hormone-binding globulin); Ferrous Fumarate: Binds to transferrin.
CnssPenetration:
Limited for steroid hormones; Iron does not readily cross the blood-brain barrier in significant amounts.
Elimination:
HalfLife:
Ethinyl Estradiol: Terminal half-life ~10-20 hours; Norethindrone: Terminal half-life ~5-14 hours; Ferrous Fumarate: Iron is primarily conserved and recycled, not excreted in significant amounts.
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4-0.8 L/hr/kg
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50-80%) and Fecal (20-50%); Ferrous Fumarate: Primarily fecal (unabsorbed iron), minimal renal excretion.
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <10%; Ferrous Fumarate: Not applicable, as iron is absorbed and utilized.
Pharmacodynamics
OnsetOfAction:
Contraceptive effect typically achieved after 7 consecutive days of active pill use. Iron supplementation effect is gradual, over weeks to months.
PeakEffect:
Contraceptive effect maintained with consistent daily use. Iron effect on hemoglobin levels peaks after several weeks of consistent supplementation.
DurationOfAction:
Contraceptive effect lasts as long as pills are taken consistently. Iron effect persists as long as stores are maintained.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, oral contraceptives, including Gemmily 1/20, should not be used by women who are over 35 years of age and smoke. Additionally, Gemmily 1/20 is contraindicated in patients receiving ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations.
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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin or eyes, fever with chills, bloating, or severe stomach upset or vomiting
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Depression or other mood changes
Breast lump, breast pain or tenderness, or nipple discharge
Vaginal itching or discharge
Vision 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 difficulty breathing
Additionally, be aware of the following serious condition:
Blood clots: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty 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 mild 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 attention if they bother you or persist:
Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark skin patches on the face (avoid sun exposure, use sunscreen, and protective clothing)
* Menstrual changes, 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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin or eyes, fever with chills, bloating, or severe stomach upset or vomiting
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
Depression or other mood changes
Breast lump, breast pain or tenderness, or nipple discharge
Vaginal itching or discharge
Vision 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 difficulty breathing
Additionally, be aware of the following serious condition:
Blood clots: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty 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 mild 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 attention if they bother you or persist:
Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark skin patches on the face (avoid sun exposure, use sunscreen, and protective clothing)
* Menstrual changes, 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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- ACHES: Abdominal pain (severe)
- CHEST pain (severe), shortness of breath, coughing up blood
- HEADACHES (severe, sudden, or worse than usual), dizziness, weakness, numbness
- EYE problems (sudden partial or complete loss of vision, double vision)
- SEVERE leg pain (calf or thigh), swelling, redness, warmth
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, such as:
+ 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, or abnormal heart rhythms like 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 while using estrogen-containing products, 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 dosage of any medication without consulting 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, such as:
+ 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, or abnormal heart rhythms like 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 while using estrogen-containing products, 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 dosage of any medication without consulting your doctor.
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, consult with your doctor. Prolonged inactivity may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), discuss this 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. 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, inform 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, and to 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, discuss with your doctor if you consume grapefruit juice or eat grapefruit regularly.
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, and discuss the potential need for additional non-hormonal birth control methods, such as condoms.
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 concerns, discuss them with your doctor.
Research on the link between hormone-based birth control and breast cancer risk has yielded conflicting results. If you have questions or 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.
If you anticipate being inactive for extended periods, such as during long trips, bedrest after surgery, or illness, consult with your doctor. Prolonged inactivity may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), discuss this 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. 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, inform 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, and to 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, discuss with your doctor if you consume grapefruit juice or eat grapefruit regularly.
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, and discuss the potential need for additional non-hormonal birth control methods, such as condoms.
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 concerns, discuss them with your doctor.
Research on the link between hormone-based birth control and breast cancer risk has yielded conflicting results. If you have questions or 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.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Dizziness
- Abdominal pain
- Drowsiness
- Fatigue
- Withdrawal bleeding (in females)
- For iron overdose: severe abdominal pain, vomiting, diarrhea (possibly bloody), lethargy, pallor, cyanosis, shock, metabolic acidosis, liver damage, coma.
What to Do:
Seek immediate medical attention. For suspected iron overdose, call a poison control center (1-800-222-1222) or emergency services immediately. Management may include gastric lavage, chelation therapy (e.g., deferoxamine) for iron, and supportive care.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir (used for Hepatitis C): Significant increase in ALT levels.
- Tranexamic Acid: Increased risk of thrombosis.
Major Interactions
- CYP3A4 Inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, Griseofulvin, St. John's Wort): Can decrease contraceptive efficacy and increase breakthrough bleeding.
- CYP3A4 Inhibitors (e.g., Azole antifungals like Ketoconazole, Macrolide antibiotics like Erythromycin, Grapefruit juice): Can increase plasma concentrations of ethinyl estradiol and norethindrone, potentially increasing side effects.
- Lamotrigine: Oral contraceptives can decrease lamotrigine levels, leading to loss of seizure control.
- Warfarin and other anticoagulants: Oral contraceptives can decrease the anticoagulant effect; monitor INR.
- Thyroid hormones (e.g., Levothyroxine): Oral contraceptives can increase thyroid-binding globulin, leading to increased thyroid hormone requirements.
- Tetracyclines, Fluoroquinolones, Penicillamine, Levodopa, Mycophenolate Mofetil: Iron absorption can be significantly reduced or chelated by these agents.
Moderate Interactions
- Ascorbic Acid (Vitamin C): Can enhance iron absorption, potentially leading to iron overload in susceptible individuals.
- Antacids, Proton Pump Inhibitors, H2 Blockers: Can decrease iron absorption by increasing gastric pH.
- Colestyramine: Can interfere with enterohepatic recirculation of estrogens.
- Bosentan: May reduce contraceptive efficacy.
- Ritonavir-boosted protease inhibitors (HIV): Variable effects on contraceptive levels; may require alternative contraception.
Minor Interactions
- Acetaminophen: May increase ethinyl estradiol levels.
- Corticosteroids: Oral contraceptives may increase corticosteroid levels.
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To establish baseline and identify hypertension, a contraindication or risk factor for COC use.
Timing: Prior to initiation
Physical Examination (including breast and pelvic exam)
Rationale: To rule out contraindications (e.g., undiagnosed vaginal bleeding, breast cancer) and establish baseline.
Timing: Prior to initiation
Lipid Profile
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation (optional, but recommended for high-risk individuals)
Liver Function Tests (LFTs)
Rationale: To rule out hepatic impairment, a contraindication.
Timing: Prior to initiation (if clinically indicated)
Pregnancy Test
Rationale: To ensure patient is not pregnant, as COCs are contraindicated in pregnancy.
Timing: Prior to initiation
Hemoglobin/Hematocrit, Ferritin (if iron deficiency suspected)
Rationale: To assess baseline iron status.
Timing: Prior to initiation (if clinically indicated)
Routine Monitoring
Blood Pressure
Frequency: Annually or more frequently if risk factors present.
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: Any new or worsening conditions, especially those that are contraindications to COC use.
Hemoglobin/Hematocrit (if treating iron deficiency)
Frequency: Every 3-6 months until levels normalize, then annually.
Target: Normal range for age/sex
Action Threshold: Failure to improve or worsening anemia may indicate poor adherence, malabsorption, or other underlying cause.
Symptom Monitoring
- Severe abdominal pain (may indicate liver tumor, blood clot, or ectopic pregnancy)
- Chest pain, shortness of breath, coughing up blood (may indicate pulmonary embolism or myocardial infarction)
- Severe headache, sudden vision changes, speech disturbance, weakness/numbness in an arm or leg (may indicate stroke)
- Leg pain, swelling, redness (may indicate deep vein thrombosis)
- Jaundice (yellowing of skin or eyes), dark urine, light-colored stools (may indicate liver problems)
- Unexplained vaginal bleeding or spotting (may indicate contraceptive failure, uterine pathology)
- Symptoms of iron overload (if taking additional iron supplements and not iron deficient): fatigue, joint pain, abdominal pain, heart problems.
Special Patient Groups
Pregnancy
Contraindicated. There is no indication for oral contraceptives in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
First Trimester:
Exposure during early pregnancy has not been shown to cause an increased risk of birth defects.
Second Trimester:
Not applicable, as contraception should be discontinued upon confirmed pregnancy.
Third Trimester:
Not applicable, as contraception should be discontinued upon confirmed pregnancy.
Lactation
Not recommended. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be transferred to the infant via breast milk. Progestin-only methods are generally preferred for breastfeeding mothers.
Infant Risk:
Small amounts of steroid hormones and/or metabolites are excreted in breast milk. No serious adverse effects have been reported in breastfed infants, but potential for effects on infant growth or development cannot be excluded. Iron is naturally present in breast milk; supplemental iron from the pill is unlikely to cause harm to the infant.
Pediatric Use
Not indicated before menarche. Once menstruation has begun, dosing is the same as for adults. Safety and efficacy have been established in females of reproductive age.
Geriatric Use
Not indicated for postmenopausal women. Contraception is not needed in this population. Risk of cardiovascular events increases with age.
Clinical Information
Clinical Pearls
- Adherence is key: Missing pills, especially active pills, significantly increases the risk of pregnancy. Use backup contraception if pills are missed.
- Smoking cessation is crucial: Emphasize the increased risk of serious cardiovascular events, especially for women over 35 who smoke.
- Drug interactions: Counsel patients on potential interactions with antibiotics, anticonvulsants, St. John's Wort, and certain HIV/HCV medications.
- Breakthrough bleeding: Common, especially during the first few cycles. Usually resolves. If persistent or heavy, evaluate for other causes.
- Iron component: The ferrous fumarate is for iron supplementation during the inactive pill days, helping to prevent iron deficiency anemia often associated with menstrual blood loss. It is not intended to treat severe iron deficiency anemia alone.
- Emergency contraception: Advise patients on options for emergency contraception if pills are missed or contraception fails.
Alternative Therapies
- Progestin-only pills (mini-pill)
- Contraceptive patch
- Contraceptive vaginal ring
- Contraceptive injection (Depo-Provera)
- Contraceptive implant (Nexplanon)
- Intrauterine devices (IUDs - hormonal and non-hormonal)
- Barrier methods (condoms, diaphragm, cervical cap)
- Surgical sterilization (tubal ligation, vasectomy)
- Other iron supplements (e.g., ferrous sulfate, ferrous gluconate) if iron deficiency is the primary concern.
Cost & Coverage
Average Cost:
Varies, typically $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 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 for more information. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.