Joyeaux 0.1/20 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. If you have been given this drug for some other reason, talk with your doctor for more information.
Drug Class
Contraceptive, Oral; Iron Supplement
Pharmacologic Class
Estrogen; Progestin; Iron Preparation
Pregnancy Category
Category X
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Joyeaux is a birth control pill that contains two female hormones, ethinyl estradiol and levonorgestrel, to prevent pregnancy. It works by stopping your body from releasing an egg and by changing the mucus in your cervix and the lining of your uterus. It also contains iron to help prevent or treat iron deficiency, which can be common in women.
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 as directed, with or without food. If you experience stomach upset, taking it with food may help. Establish a routine by taking your medication at the same time every day. It's essential to take your medication consistently, even if you don't have sex frequently.
If you're also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication. After starting this medication, your doctor may advise you to use a non-hormone form of birth control, such as condoms, for a period to prevent pregnancy. Follow your doctor's guidance on using additional birth control methods.
If you vomit or have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If you vomit or have diarrhea within 3 to 4 hours of taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you're unsure about what to do, don't hesitate to call your doctor.
Monitoring Your Menstrual Cycle
If your menstrual cycle is typically 28 days and you miss two consecutive periods, take a pregnancy test before starting a new cycle of medication. For cycles longer than 91 days, if you miss one period, take a pregnancy test before starting a new cycle.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or contact your doctor for guidance. 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 to prevent pregnancy.
To use this medication effectively, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. If you experience stomach upset, taking it with food may help. Establish a routine by taking your medication at the same time every day. It's essential to take your medication consistently, even if you don't have sex frequently.
If you're also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication. After starting this medication, your doctor may advise you to use a non-hormone form of birth control, such as condoms, for a period to prevent pregnancy. Follow your doctor's guidance on using additional birth control methods.
If you vomit or have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If you vomit or have diarrhea within 3 to 4 hours of taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you're unsure about what to do, don't hesitate to call your doctor.
Monitoring Your Menstrual Cycle
If your menstrual cycle is typically 28 days and you miss two consecutive periods, take a pregnancy test before starting a new cycle of medication. For cycles longer than 91 days, if you miss one period, take a pregnancy test before starting a new cycle.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Avoid storing it in a bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or contact your doctor for guidance. 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 to prevent pregnancy.
Lifestyle & Tips
- Take one pill at the same time every day to ensure effectiveness.
- Do not smoke, especially if you are over 35, due to increased risk of serious side effects.
- Use a backup method of birth control (like condoms) if you miss pills, have vomiting or severe diarrhea, or are taking certain medications that can reduce effectiveness.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
- Maintain regular follow-up appointments with your healthcare provider for blood pressure checks and annual exams.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One active tablet (0.1 mg Levonorgestrel / 20 mcg Ethinyl Estradiol) orally once daily for 21 consecutive days, followed by one inactive/iron tablet (Ferrous Bisglycinate) orally once daily for 7 consecutive days. Begin new pack on day 29.
Condition-Specific Dosing:
missedDose:
Refer to package insert for specific instructions based on number of missed pills and week in cycle. Generally, take missed pill as soon as remembered, and continue with remaining pills. May require backup contraception.
initialStart:
Start on the first day of menstrual period or the first Sunday after period begins.
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 adjustment needed for hormonal components. Iron component may need monitoring in severe cases.
Moderate:
No adjustment needed for hormonal components. Iron component may need monitoring in severe cases.
Severe:
Contraindicated for hormonal components due to potential for fluid retention and hyperkalemia (theoretical). Iron component should be used with caution and monitored due to risk of iron overload in patients on dialysis.
Dialysis:
Contraindicated for hormonal components. Iron component should be used with caution and monitored due to risk of iron overload.
Hepatic Impairment:
Mild:
No adjustment needed for hormonal components. Iron component may need monitoring.
Moderate:
Use with caution for hormonal components; consider alternative methods. Iron component may need monitoring.
Severe:
Contraindicated for hormonal components due to impaired steroid metabolism. Iron component should be used with caution.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Levonorgestrel act primarily by suppressing gonadotropins, 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 Bisglycinate provides elemental iron, which is an essential component of hemoglobin, myoglobin, and various enzymes, used to prevent or treat iron deficiency anemia.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Levonorgestrel: ~100%; Ferrous Bisglycinate: Varies, generally good (higher than inorganic iron salts).
Tmax:
Ethinyl Estradiol: ~1-2 hours; Levonorgestrel: ~1-2 hours; Ferrous Bisglycinate: Not directly applicable for Tmax of elemental iron, absorption is continuous.
FoodEffect:
Ethinyl Estradiol: May slightly decrease Cmax; Levonorgestrel: No significant effect; Ferrous Bisglycinate: Absorption may be reduced by food, but bisglycinate form is less affected and causes less GI upset, often taken with food to minimize GI side effects.
Distribution:
Vd:
Ethinyl Estradiol: ~2-4 L/kg; Levonorgestrel: ~1.8 L/kg; Ferrous Bisglycinate: Iron is distributed throughout the body, primarily bound to transferrin.
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin); Levonorgestrel: ~97-99% (to albumin and sex hormone-binding globulin); Ferrous Bisglycinate: Iron is bound to transferrin in plasma.
CnssPenetration:
Limited for hormonal components; Iron does not readily cross the intact blood-brain barrier.
Elimination:
HalfLife:
Ethinyl Estradiol: ~13-20 hours; Levonorgestrel: ~24-45 hours; Ferrous Bisglycinate: Iron has no specific half-life, as it is conserved and recycled in the body.
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Levonorgestrel: ~1.0 mL/min/kg; Ferrous Bisglycinate: Not applicable for elemental iron.
ExcretionRoute:
Ethinyl Estradiol: Renal (60%) and Fecal (40%); Levonorgestrel: Renal (40-50%) and Fecal (30-40%); Ferrous Bisglycinate: Primarily fecal (unabsorbed iron), small amounts lost via desquamation of cells, sweat, urine, and menstruation.
Unchanged:
Ethinyl Estradiol: <5%; Levonorgestrel: <1%; Ferrous Bisglycinate: Not applicable (iron is absorbed and utilized).
Pharmacodynamics
OnsetOfAction:
Contraceptive effect: Within 7 days of consistent use (if started on Day 1 of menses, immediate protection; if started on Sunday, protection after 7 days). Iron effect: Gradual, over weeks to months for correction of anemia.
PeakEffect:
Contraceptive effect: Achieved after 7 consecutive days of active pill use. Iron effect: Hemoglobin levels begin to rise in 1-2 weeks, normalize in 1-2 months.
DurationOfAction:
Contraceptive effect: Maintained with continuous daily use. Iron effect: As long as iron stores are maintained.
Confidence:
Medium
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 Joyeaux, are contraindicated in women who are over 35 years of age and smoke.
Side Effects
Serious 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, such as:
+ Rash or 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Change in stools
+ Dark urine or yellow skin or eyes
+ Fever with chills
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
New or worsening migraines
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Changes in eyesight or loss of eyesight
Bulging eyes
Changes in how contact lenses feel
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Changes in menstrual periods, including spotting or bleeding between cycles
Back pain
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
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 medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash or 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Change in stools
+ Dark urine or yellow skin or eyes
+ Fever with chills
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
New or worsening migraines
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Changes in eyesight or loss of eyesight
Bulging eyes
Changes in how contact lenses feel
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Changes in menstrual periods, including spotting or bleeding between cycles
Back pain
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
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:
- Severe abdominal pain
- Severe chest pain, shortness of breath, or coughing up blood
- Severe headaches, especially if sudden or with vision changes
- Eye problems such as blurred vision or loss of vision
- Severe leg pain, swelling, or redness in the calf or thigh
- Yellowing of the skin or eyes (jaundice)
- Dark urine or pale stools
- Unexplained vaginal bleeding or spotting that is heavy or lasts longer than usual
- Symptoms of depression or severe mood changes
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
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
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you experienced jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control
If you have taken ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
If you are currently taking glecaprevir and pibrentasvir
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
If you are breast-feeding or plan to breast-feed
This is not an exhaustive list of all potential interactions. 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 use. Do not start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
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
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you experienced jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control
If you have taken ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
If you are currently taking glecaprevir and pibrentasvir
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
If you are breast-feeding or plan to breast-feed
This is not an exhaustive list of all potential interactions. 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 use. Do not 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 medication before certain types of surgery, and will instruct you on when to resume taking it after the procedure.
Blood Clots, Stroke, and Heart Attack Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this may further increase your risk of blood clots.
Diabetes and Blood Sugar Control
If you have diabetes, inform your doctor, as this medication may raise your blood sugar levels. Monitor your blood sugar levels as directed by your doctor.
Blood Pressure Monitoring
Drugs like this one may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked, as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this medication.
Breast Health and Gynecology
Regular breast exams and gynecology check-ups are essential. Perform breast self-exams as instructed by your doctor.
Interactions with Other Medications and Health Problems
Certain medications, herbal products, or health problems may reduce the effectiveness of hormone-based birth control. Inform your doctor about all your medications and health problems, and discuss the need for additional non-hormone birth control methods, such as condoms.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Cholesterol and Triglyceride Levels
This medication may cause high cholesterol and triglyceride levels. Discuss this risk with your doctor.
Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use a latex or polyurethane condom during sex to reduce the risk of transmission. If you have questions, consult your doctor.
Accidental Overdose and Child Safety
Accidental overdose of iron-containing medications is a leading cause of fatal poisoning in children under 6 years old. Keep this medication out of reach of children. If accidentally ingested, call a doctor or poison control center immediately.
Cervical Cancer Risk
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. Discuss any concerns with your doctor.
Breast Cancer Risk
Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, consult your doctor.
Pediatric Use
This medication is not intended for use in children who have not had their first menstrual period.
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 medication before certain types of surgery, and will instruct you on when to resume taking it after the procedure.
Blood Clots, Stroke, and Heart Attack Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, inform your doctor, as this may further increase your risk of blood clots.
Diabetes and Blood Sugar Control
If you have diabetes, inform your doctor, as this medication may raise your blood sugar levels. Monitor your blood sugar levels as directed by your doctor.
Blood Pressure Monitoring
Drugs like this one may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked, as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this medication.
Breast Health and Gynecology
Regular breast exams and gynecology check-ups are essential. Perform breast self-exams as instructed by your doctor.
Interactions with Other Medications and Health Problems
Certain medications, herbal products, or health problems may reduce the effectiveness of hormone-based birth control. Inform your doctor about all your medications and health problems, and discuss the need for additional non-hormone birth control methods, such as condoms.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Cholesterol and Triglyceride Levels
This medication may cause high cholesterol and triglyceride levels. Discuss this risk with your doctor.
Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use a latex or polyurethane condom during sex to reduce the risk of transmission. If you have questions, consult your doctor.
Accidental Overdose and Child Safety
Accidental overdose of iron-containing medications is a leading cause of fatal poisoning in children under 6 years old. Keep this medication out of reach of children. If accidentally ingested, call a doctor or poison control center immediately.
Cervical Cancer Risk
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. Discuss any concerns with your doctor.
Breast Cancer Risk
Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, consult your doctor.
Pediatric Use
This medication is not intended for use in children who have not had their first menstrual period.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Vaginal bleeding (withdrawal bleeding may occur in females)
What to Do:
There is no specific antidote for overdose. Treatment is symptomatic and supportive. In case of suspected overdose, especially with iron, contact a poison control center immediately. Call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir (increased ALT)
- Tranexamic acid (increased risk of thrombosis)
Major Interactions
- CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Barbiturates, Topiramate, Oxcarbazepine, Griseofulvin, St. John's Wort) - decreased contraceptive efficacy
- CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Voriconazole, Clarithromycin, Grapefruit juice) - increased estrogen/progestin levels
- Lamotrigine (decreased lamotrigine levels, loss of seizure control)
- Thyroid hormones (Levothyroxine) - iron can decrease absorption of thyroid hormones
- Tetracyclines, Fluoroquinolones (iron can chelate and decrease absorption of these antibiotics)
- Bisphosphonates (iron can decrease absorption of bisphosphonates)
Moderate Interactions
- Colesevelam (decreased absorption of ethinyl estradiol)
- Cyclosporine (increased cyclosporine levels)
- Theophylline (increased theophylline levels)
- Corticosteroids (increased corticosteroid levels)
- Warfarin (variable effect on INR, monitor closely)
- Antacids, Proton Pump Inhibitors, H2 Blockers (can decrease iron absorption)
- Calcium supplements (can decrease iron absorption)
Minor Interactions
- Acetaminophen (increased ethinyl estradiol levels)
- Ascorbic acid (can enhance iron absorption)
Monitoring
Baseline Monitoring
Complete Medical History (including family history of thrombosis)
Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by hormonal contraception.
Timing: Prior to initiation
Physical Examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To assess overall health, identify contraindications, and establish baseline for ongoing monitoring.
Timing: Prior to initiation
Lipid Panel
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation (optional, based on risk factors)
Hemoglobin/Hematocrit, Ferritin, Iron studies
Rationale: To assess baseline iron status and confirm need for iron supplementation.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure
Frequency: Annually, or more frequently if elevated
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may require discontinuation or change in contraception.
Annual Physical Examination (including breast exam, Pap test as per guidelines)
Frequency: Annually
Target: N/A
Action Threshold: Abnormal findings require further investigation.
Hemoglobin/Hematocrit
Frequency: Every 3-6 months initially, then annually or as needed
Target: Normal range for age/sex (e.g., Hb >12 g/dL)
Action Threshold: Failure to improve or decline indicates need for further investigation of iron deficiency or other causes.
Ferritin
Frequency: Every 6-12 months or as needed to assess iron stores
Target: >30 ng/mL
Action Threshold: Persistent low levels indicate inadequate iron repletion.
Symptom Monitoring
- ACHES: Abdominal pain (severe)
- Chest pain (severe), shortness of breath, coughing blood
- Headaches (severe, sudden, or worse than usual, especially with visual changes)
- Eye problems (blurred vision, loss of vision, flashing lights)
- Severe leg pain (calf or thigh), swelling, redness, warmth
- Signs of depression or mood changes
- Jaundice or severe abdominal pain (liver problems)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Symptoms of iron overload (fatigue, joint pain, abdominal pain, heart problems, liver problems) - rare with therapeutic doses.
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. Oral contraceptives should not be used during pregnancy to prevent pregnancy or for any other reason. If pregnancy occurs while taking Joyeaux, discontinue immediately.
Trimester-Specific Risks:
First Trimester:
No evidence of teratogenicity from inadvertent exposure during early pregnancy.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Use with caution. Estrogens can decrease the quantity and quality of breast milk. Small amounts of hormonal steroids and/or their metabolites are excreted in breast milk. Iron is excreted in breast milk and is generally considered safe for the infant.
Infant Risk:
Low risk of adverse effects to the infant from hormonal components, but potential for decreased milk supply. Iron component is beneficial if infant is iron deficient, otherwise generally safe.
Pediatric Use
Not indicated for use before menarche. Safety and efficacy in pre-menarcheal females have not been established. Post-menarcheal adolescents can use adult dosing.
Geriatric Use
Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, especially in women over 35. Generally not used in geriatric population for contraception.
Clinical Information
Clinical Pearls
- Emphasize the importance of taking the pill at the same time every day for maximum effectiveness.
- Counsel patients on the Black Box Warning regarding smoking and cardiovascular risk, especially for women over 35.
- Advise patients about potential drug interactions, particularly with antibiotics, anticonvulsants, and St. John's Wort, which can reduce contraceptive efficacy.
- Explain the ACHES warning signs for serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
- Inform patients that the iron component is for iron supplementation and does not affect contraceptive efficacy.
- Remind patients that oral contraceptives do not protect against STIs.
Alternative Therapies
- Progestin-only pills (mini-pill)
- 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
- Sterilization (tubal ligation, vasectomy)
- Other iron supplements (e.g., Ferrous Sulfate, Ferrous Gluconate)
Cost & Coverage
Average Cost:
$25 - $75 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often covered by most insurance plans, especially generics, due to ACA mandate for contraception)
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 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.