Xarah FE Tablets
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; Mineral Supplement
Pregnancy Category
Category X
FDA Approved
Jul 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Xarah FE is a birth control pill that contains two female hormones (estrogen and progestin) to prevent pregnancy, and iron to help prevent iron deficiency anemia. It works by stopping your body from releasing an egg and by changing the lining of your womb and cervical mucus.
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, for a period of time to prevent pregnancy. Follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.
If you miss two periods in a row, take a pregnancy test before starting a new cycle of medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. If you're using this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy.
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, for a period of time to prevent pregnancy. Follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.
If you miss two periods in a row, take a pregnancy test before starting a new cycle of medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. If you're using this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a period of time 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 and heart attack.
- Take one pill at the same time every day to ensure maximum effectiveness.
- Use a backup method of birth control (like condoms) for the first 7 days of your first pack, or if you miss pills.
- Report any unusual or severe side effects to your doctor immediately.
- Maintain regular follow-up appointments with your healthcare provider for blood pressure checks and general health assessments.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily, starting on the first day of menstruation or the first Sunday after menstruation begins. Active tablets are taken for 21 days, followed by 7 days of 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 of cycle. Generally, take missed pill as soon as remembered; if multiple pills missed, use backup contraception.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
For post-menarcheal adolescents, adult dosing applies. Safety and efficacy are expected to be similar to adult women.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for hormonal components. Iron absorption may be altered in severe renal disease, but typically not a primary concern for this formulation.
Moderate:
No specific adjustment required for hormonal components. Use with caution in patients with chronic kidney disease due to potential for iron overload or altered iron metabolism.
Severe:
Not specifically studied for hormonal components, but generally not contraindicated. Use with caution in patients with severe renal impairment, especially if on dialysis, due to potential for iron accumulation. Monitor iron levels if prolonged use.
Dialysis:
Use with caution. Hormonal components are not significantly dialyzable. Iron accumulation can occur; monitor iron parameters.
Hepatic Impairment:
Mild:
Use with caution. Hormonal components are extensively metabolized by the liver.
Moderate:
Contraindicated in patients with acute or chronic hepatocellular disease or severe hepatic impairment.
Severe:
Contraindicated in patients with acute or chronic hepatocellular disease or severe hepatic impairment.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone act primarily by suppressing gonadotropins (follicle-stimulating hormone [FSH] and luteinizing hormone [LH]), 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 and myoglobin, necessary for oxygen transport and utilization.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45% (due to first-pass metabolism); Norethindrone: ~60-65% (due to first-pass metabolism); Ferrous Fumarate: Variable (5-35%), enhanced by acidic environment.
Tmax:
Ethinyl Estradiol: ~1-2 hours; Norethindrone: ~0.5-4 hours; Ferrous Fumarate: Not directly applicable for Tmax of iron absorption, but peak serum iron levels typically occur 2-4 hours post-dose.
FoodEffect:
Food may decrease the rate but not the extent of absorption for hormonal components. Food may decrease iron absorption but can reduce gastrointestinal side effects.
Distribution:
Vd:
Ethinyl Estradiol: ~5-18 L/kg; Norethindrone: ~2-4 L/kg; Ferrous Fumarate: Iron is primarily bound to transferrin in plasma and stored as ferritin or hemosiderin.
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: ~96-98% (to albumin and SHBG); Ferrous Fumarate: Iron is highly protein-bound (to transferrin).
CnssPenetration:
Limited for hormonal components; Not applicable for iron in this context.
Elimination:
HalfLife:
Ethinyl Estradiol: ~6-20 hours; Norethindrone: ~5-14 hours; Ferrous Fumarate: Iron is primarily conserved and recycled, with minimal daily excretion.
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4-0.8 L/hr/kg; Ferrous Fumarate: Not applicable for clearance in the traditional sense.
ExcretionRoute:
Ethinyl Estradiol: Renal and fecal (as metabolites); Norethindrone: Renal and fecal (as metabolites); Ferrous Fumarate: Minimal excretion (primarily through desquamation of cells, sweat, urine, feces).
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <10%; Ferrous Fumarate: Not applicable (absorbed as iron).
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically achieved after 7 consecutive days of active tablet use, assuming proper initiation. Iron component provides therapeutic effect as iron stores are replenished.
PeakEffect:
Contraceptive effect maintained with daily dosing. Iron effect is gradual, over weeks to months.
DurationOfAction:
Contraceptive effect requires continuous daily dosing. Iron effect persists as long as iron stores are maintained.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events 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 Xarah 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 immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 yellowing of the 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, yellowing of the 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 problems, 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.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Fluid retention, swelling, weight gain, or difficulty breathing.
Blood Clots: Seek Medical Help Right Away
If you experience any of the following symptoms, contact your doctor immediately, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor 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 (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 yellowing of the 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, yellowing of the 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 problems, 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.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
Fluid retention, swelling, weight gain, or difficulty breathing.
Blood Clots: Seek Medical Help Right Away
If you experience any of the following symptoms, contact your doctor immediately, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color changes, or pain in a leg or arm
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 minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor 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 (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- ACHES: Abdominal pain (severe)
- Chest pain (severe), shortness of breath, coughing up blood
- Headaches (severe), dizziness, weakness, numbness, vision changes
- Eye problems (blurred vision, loss of 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, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurrent 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, 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Do not initiate, stop, or modify 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, such as foods or drugs. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain) or a history of heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurrent 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, 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 discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Do not initiate, stop, or modify 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. If you need to stop taking this medication, your doctor will instruct you on when to resume taking it after your 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. Prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
This medication may cause high blood pressure. 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 directed 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 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. 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.
This medication may increase the 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 the risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have questions, discuss this with your doctor.
Long-term use of hormone-based birth control may be associated with an increased risk of breast cancer, although not all studies confirm this finding. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you experience any signs of pregnancy 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. If you need to stop taking this medication, your doctor will instruct you on when to resume taking it after your 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. Prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
This medication may cause high blood pressure. 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 directed 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 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. 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.
This medication may increase the 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 the risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have questions, discuss this with your doctor.
Long-term use of hormone-based birth control may be associated with an increased risk of breast cancer, although not all studies confirm this finding. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not 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
- Withdrawal bleeding (in females)
- For iron overdose: severe abdominal pain, vomiting, diarrhea, lethargy, pallor, cyanosis, shock, metabolic acidosis, liver damage (delayed)
What to Do:
Seek immediate medical attention. For iron overdose, call a poison control center (1-800-222-1222) or emergency services. Treatment may involve gastric lavage, chelation therapy (for iron), and supportive care.
Drug Interactions
Contraindicated Interactions
- Hepatitis C antiviral combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (increased ALT levels)
Major Interactions
- CYP3A4 inducers (e.g., rifampin, barbiturates, carbamazepine, oxcarbazepine, phenytoin, topiramate, felbamate, griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- Protease inhibitors (e.g., ritonavir, nelfinavir) - may alter hormone levels.
- Aromatase inhibitors (e.g., anastrozole, letrozole) - may reduce efficacy of aromatase inhibitors.
- Tranexamic acid (increased risk of thrombosis).
- Deferoxamine, Dimercaprol (increased toxicity with iron).
Moderate Interactions
- Broad-spectrum antibiotics (e.g., ampicillin, tetracycline) - theoretical reduction in efficacy due to altered enterohepatic recirculation, though clinical significance is debated.
- CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole; macrolide antibiotics like erythromycin, clarithromycin; grapefruit juice) - may increase hormone levels, potentially increasing side effects.
- Lamotrigine (decreased lamotrigine levels, loss of seizure control).
- Thyroid hormones (oral contraceptives can increase thyroid-binding globulin, leading to increased thyroid hormone requirements).
- Antacids, proton pump inhibitors, H2 blockers (decreased iron absorption).
- Tetracyclines, Fluoroquinolones (decreased absorption of both iron and antibiotic).
- Levothyroxine (decreased levothyroxine absorption).
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels).
- Ascorbic acid (may increase ethinyl estradiol levels and iron absorption).
- Corticosteroids (may increase corticosteroid levels).
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To identify pre-existing hypertension, which is a contraindication or risk factor for COC use.
Timing: Prior to initiation
Complete Medical History and Physical Exam
Rationale: To identify contraindications, risk factors (e.g., smoking, DVT/PE history, liver disease, migraines with aura), and assess overall health.
Timing: Prior to initiation
Lipid Profile (optional)
Rationale: To assess cardiovascular risk, especially in patients with family history of dyslipidemia or cardiovascular disease.
Timing: Prior to initiation
Liver Function Tests (optional)
Rationale: To assess baseline liver function, especially if there is a history of liver disease.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or change in contraception.
Annual Physical Exam
Frequency: Annually
Target: Not applicable
Action Threshold: Identification of new risk factors or contraindications.
Iron Status (e.g., Ferritin, CBC)
Frequency: Periodically, if there are concerns about iron deficiency or overload, or if patient has underlying conditions affecting iron metabolism.
Target: Normal ranges for age/sex
Action Threshold: Abnormal levels may require dose adjustment or investigation.
Symptom Monitoring
- Severe abdominal pain (possible liver tumor, DVT, pancreatitis)
- Chest pain, shortness of breath, coughing up blood (possible pulmonary embolism, myocardial infarction)
- Severe headaches, sudden partial or complete loss of vision, speech disturbances, weakness or numbness in an arm or leg (possible stroke, retinal thrombosis)
- Leg pain, swelling, warmth, redness (possible deep vein thrombosis)
- Jaundice, dark urine, light-colored stools (possible liver problems)
- Unusual vaginal bleeding or spotting
- Signs of depression
Special Patient Groups
Pregnancy
Xarah FE is contraindicated during pregnancy. There is no indication for use in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Studies suggest a potential association between intrauterine exposure to female sex hormones and congenital anomalies, though data are conflicting.
Second Trimester:
Contraindicated. No benefit for use.
Third Trimester:
Contraindicated. No benefit for use.
Lactation
Not recommended for use during lactation. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant.
Infant Risk:
L3 (Moderate risk). Potential for decreased milk supply, and small amounts of hormones may be transferred to the infant. Observe infant for potential adverse effects (e.g., jaundice, breast enlargement).
Pediatric Use
Safety and efficacy have been established for post-menarcheal adolescents. Use in prepubertal children is not indicated.
Geriatric Use
Not indicated for use in post-menopausal women. No data on use in geriatric population for contraception.
Clinical Information
Clinical Pearls
- Strict adherence to the daily dosing schedule is crucial for contraceptive efficacy. Missed pills, especially early in the cycle, significantly increase the risk of pregnancy.
- Counsel patients on the importance of not smoking, particularly if they are over 35, due to the increased risk of serious cardiovascular events.
- Inform patients about potential drug interactions, especially with enzyme-inducing medications, and advise them to use backup contraception if such interactions occur.
- Breakthrough bleeding and spotting are common, especially during the first few cycles, and usually resolve with continued use. Persistent or heavy bleeding should be evaluated.
- The ferrous fumarate component is included to prevent iron deficiency anemia, which can be common in women of reproductive age, especially with menstrual blood loss.
Alternative Therapies
- Progestin-only pills (POPs)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive injection (e.g., Depo-Provera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Surgical sterilization (tubal ligation, vasectomy)
- Emergency contraception
Cost & Coverage
Average Cost:
$20 - $60 per 28 tablets (1 cycle)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, including the amount and time of ingestion.