Tilia FE Tablets 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; Iron Supplement
Pharmacologic Class
Estrogen/Progestin Combination; Iron Salt
Pregnancy Category
Category X
FDA Approved
Sep 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tilia FE is a birth control pill that contains two female hormones, estrogen (Ethinyl Estradiol) and progestin (Norethindrone), which work together to prevent pregnancy. It also includes iron (Ferrous Fumarate) to help prevent iron deficiency anemia, which can sometimes occur with menstrual bleeding.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from this medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Take this medication at the same time every day.
You can take it with or without food. If it causes 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.
Important Information for Women Taking This Medication for Birth Control
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy. Follow your doctor's instructions regarding the use of non-hormonal birth control methods.
Do not skip doses, even if you do not have sexual intercourse frequently.
If you vomit or have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If vomiting or diarrhea 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 contact your doctor for guidance. If you are unsure what to do, call your doctor.
What to Do If You Miss a Period
If you miss two consecutive periods, take a pregnancy test before starting a new cycle of this 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.
* Keep the medication in a dry place.
Missing a Dose
If you miss a dose, refer to the package insert or contact your doctor for instructions on what to do. If you are taking this medication for birth control, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy.
To get the most benefit from this medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Take this medication at the same time every day.
You can take it with or without food. If it causes 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.
Important Information for Women Taking This Medication for Birth Control
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy. Follow your doctor's instructions regarding the use of non-hormonal birth control methods.
Do not skip doses, even if you do not have sexual intercourse frequently.
If you vomit or have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If vomiting or diarrhea 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 contact your doctor for guidance. If you are unsure what to do, call your doctor.
What to Do If You Miss a Period
If you miss two consecutive periods, take a pregnancy test before starting a new cycle of this 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.
* Keep the medication in a dry place.
Missing a Dose
If you miss a dose, refer to the package insert or contact your doctor for instructions on what to do. If you are taking this medication for birth control, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time to prevent pregnancy.
Lifestyle & Tips
- Take one tablet at the same time every day to maximize effectiveness.
- Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
- Use a backup method of contraception (like condoms) for the first 7 days of your first pack, or if you miss pills.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
- Attend regular check-ups with your doctor, including blood pressure monitoring.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. The last 7 tablets (ferrous fumarate) are inert for contraception but provide iron supplementation.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missedDose:
Refer to package insert for specific instructions based on number of missed doses and week of cycle. Generally, take missed dose as soon as remembered; if multiple doses missed, use backup contraception.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for post-menarcheal adolescents requiring contraception.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for hormonal components. Use ferrous fumarate with caution in patients with severe renal impairment due to risk of iron accumulation.
Moderate:
No specific adjustment required for hormonal components. Use ferrous fumarate with caution in patients with severe renal impairment due to risk of iron accumulation.
Severe:
Contraindicated for hormonal components due to potential for fluid retention and electrolyte imbalance. Use ferrous fumarate with caution due to risk of iron accumulation.
Dialysis:
Contraindicated for hormonal components. Ferrous fumarate should be used with extreme caution and close monitoring of iron levels.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Contraindicated.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone primarily act by suppressing gonadotropins, which inhibits ovulation. They also cause changes in the cervical mucus (increasing viscosity to impede sperm penetration) and the endometrium (rendering it unfavorable for implantation). Ferrous Fumarate provides elemental iron, which is an essential component in the formation of hemoglobin and is necessary for oxygen transport and utilization.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~64-100%; Ferrous Fumarate: Variable, ~10-30% of elemental iron absorbed, depending on iron stores.
Tmax:
Ethinyl Estradiol: ~1-2 hours; Norethindrone: ~0.5-4 hours; Ferrous Fumarate: ~2-4 hours.
FoodEffect:
Ethinyl Estradiol/Norethindrone: Minimal effect. Ferrous Fumarate: Absorption decreased by food, but taking with food can reduce GI upset.
Distribution:
Vd:
Ethinyl Estradiol: ~5 L/kg; Norethindrone: ~4 L/kg; Ferrous Fumarate: Not applicable (incorporated into body stores).
ProteinBinding:
Ethinyl Estradiol: ~98% (primarily to albumin); Norethindrone: ~80% (primarily to albumin and sex hormone-binding globulin [SHBG]); Ferrous Fumarate: Binds to transferrin for transport.
CnssPenetration:
Ethinyl Estradiol/Norethindrone: Limited; Ferrous Fumarate: Limited.
Elimination:
HalfLife:
Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~5-14 hours; Ferrous Fumarate: Not applicable (iron is conserved and recycled in the body).
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4-0.8 L/hr/kg; Ferrous Fumarate: Minimal excretion.
ExcretionRoute:
Ethinyl Estradiol: Renal and fecal; Norethindrone: Renal and fecal; Ferrous Fumarate: Primarily fecal (unabsorbed iron), minimal renal/biliary excretion.
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%; Ferrous Fumarate: Not applicable (absorbed iron is utilized).
Pharmacodynamics
OnsetOfAction:
Contraceptive effect typically achieved after 7 consecutive days of active pill use, if started correctly. Iron supplementation effect is gradual.
PeakEffect:
Contraceptive effect maintained with consistent daily use. Iron effect seen with improvement in hemoglobin over weeks to months.
DurationOfAction:
Contraceptive effect lasts for 24 hours with daily dosing. Iron effect persists as long as supplementation continues and stores are replenished.
Safety & Warnings
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 Tilia FE, are contraindicated in women who are over 35 years of age and smoke.
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 not mentioned here. 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.
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 not mentioned here. 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.
Seek Immediate Medical Attention If You Experience:
- Severe abdominal pain
- Severe chest pain, shortness of breath, or coughing up blood
- Severe headaches, dizziness, weakness, or numbness
- Eye problems (vision loss or blurring)
- Severe leg pain (calf or thigh), swelling, or redness
- Yellowing of the skin or eyes (jaundice)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Symptoms of iron overdose: severe stomach pain, vomiting, diarrhea (possibly bloody), pale skin, blue lips, shallow breathing, weak pulse, drowsiness.
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 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, as this medication is contraindicated during pregnancy
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 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.
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 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, as this medication is contraindicated during pregnancy
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 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.
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.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests, as recommended by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
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 about 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 due to other factors. If you have questions, discuss this with your doctor.
Research on the link between hormone-based birth control and breast cancer risk has yielded conflicting results. If you have concerns, talk to 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.
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.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests, as recommended by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
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 about 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 due to other factors. If you have questions, discuss this with your doctor.
Research on the link between hormone-based birth control and breast cancer risk has yielded conflicting results. If you have concerns, talk to 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:
- Hormonal components: Nausea, vomiting, and withdrawal bleeding (in females).
- Ferrous Fumarate: Abdominal pain, vomiting, diarrhea (may be bloody), lethargy, pallor, shock, metabolic acidosis, liver damage, cardiovascular collapse.
What to Do:
Seek immediate medical attention. For iron overdose, chelation therapy (e.g., deferoxamine) may be necessary. Call 1-800-222-1222 (Poison Control Center).
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (risk of ALT elevation)
- Dasabuvir (risk of ALT elevation)
Major Interactions
- CYP3A4 inducers (e.g., Carbamazepine, Phenytoin, Rifampin, Barbiturates, Topiramate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy
- Lamotrigine (decreased lamotrigine levels, loss of seizure control)
- Warfarin (may alter anticoagulant effect, monitor INR)
- Thyroid hormones (may increase thyroid-binding globulin, requiring increased thyroid hormone dose)
- Tetracyclines, Fluoroquinolones (decreased iron absorption)
- Levothyroxine (decreased levothyroxine absorption by iron)
- Mycophenolate mofetil (decreased mycophenolate exposure)
Moderate Interactions
- CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin) - may increase estrogen/progestin levels
- Colesevelam (decreased absorption of hormonal components, administer 4 hours apart)
- Antacids, Proton Pump Inhibitors, H2 Blockers (decreased iron absorption)
- Bisphosphonates (decreased bisphosphonate absorption by iron)
- Zinc supplements (decreased iron absorption)
Minor Interactions
- Vitamin C (may enhance iron absorption, but not clinically significant for most)
- Caffeine (may increase caffeine levels due to reduced metabolism)
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To identify pre-existing hypertension and monitor for drug-induced hypertension.
Timing: Prior to initiation
Physical Examination (including breast and pelvic exam)
Rationale: To rule out contraindications and establish baseline health.
Timing: Prior to initiation
Pregnancy Test
Rationale: To ensure patient is not pregnant prior to starting contraception.
Timing: Prior to initiation
Lipid Profile
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation (optional, based on risk factors)
Liver Function Tests
Rationale: To assess hepatic function, especially if history of liver disease.
Timing: Prior to initiation (optional, based on history)
Routine Monitoring
Blood Pressure
Frequency: Annually
Target: <140/90 mmHg
Action Threshold: >140/90 mmHg or significant increase, consider alternative contraception.
Annual Physical Exam
Frequency: Annually
Target: N/A
Action Threshold: Identification of new contraindications or risk factors.
Hemoglobin/Hematocrit (for iron status)
Frequency: Periodically, especially if anemia persists or suspected iron overload.
Target: Normal range for age/sex
Action Threshold: Persistent anemia despite supplementation, or signs of iron overload.
Symptom Monitoring
- ACHES: 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
- Jaundice (yellowing of skin or eyes)
- Mood changes, depression
- Unusual vaginal bleeding
- Symptoms of iron overdose: severe abdominal pain, vomiting, diarrhea (may be bloody), lethargy, pallor, shock.
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for use of combination 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.
Lactation
Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant. Progestins are also excreted in breast milk. Iron is naturally present in breast milk and supplementation is generally safe for the infant.
Infant Risk:
Moderate risk (L3) due to hormonal components. Potential for decreased milk supply and possible adverse effects on the infant (e.g., jaundice, breast enlargement), though generally considered low risk for infant health.
Pediatric Use
Not indicated for prepubertal children. For post-menarcheal adolescents, dosing is the same as for adults. Safety and efficacy have been established in women of reproductive age.
Geriatric Use
Not indicated for post-menopausal women for contraception. Risk of cardiovascular events increases with age, and alternative methods of contraception or hormone therapy are typically used.
Clinical Information
Clinical Pearls
- Emphasize the importance of taking the pill at the same time every day to maintain contraceptive efficacy.
- Counsel patients on the missed dose instructions specific to their pill pack and the need for backup contraception if pills are missed.
- Highlight the Black Box Warning regarding smoking and cardiovascular risk, especially for women over 35.
- Inform patients that the last 7 tablets are iron supplements and do not contain hormones; they are important for maintaining iron levels but do not contribute to contraception.
- Advise patients about potential side effects, including breakthrough bleeding, nausea, breast tenderness, and mood changes, which often improve after the first few cycles.
- Discuss drug interactions, particularly with antibiotics, anticonvulsants, and St. John's Wort, which can reduce contraceptive effectiveness.
Alternative Therapies
- Progestin-only pills (POPs)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing)
- Contraceptive injection (e.g., Depo-Provera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Surgical sterilization (tubal ligation, vasectomy)
- For iron deficiency: other oral iron supplements (e.g., ferrous sulfate, ferrous gluconate) or intravenous iron.
Cost & Coverage
Average Cost:
$15 - $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 check 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.