Alyacen 7/7/7 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 may be given to you for other reasons. Talk with the doctor.
Drug Class
Contraceptive
Pharmacologic Class
Estrogen and Progestin Combination
Pregnancy Category
Category X
FDA Approved
Sep 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Alyacen 7/7/7 is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone). It works by preventing your body from releasing an egg (ovulation), thickening the fluid around your cervix to block sperm, and changing the lining of your uterus to prevent pregnancy. It's a triphasic pill, meaning the dose of one hormone changes throughout the month to mimic your natural cycle.
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 your medication at the same time every day.
You can take it with or without food, but if it causes stomach upset, take it with food.
If you are also taking colesevelam, 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-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's instructions regarding the use of non-hormone birth control methods.
Do not skip doses, even if you do not have sex frequently.
* If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy. If this happens within 3 to 4 hours after taking an active tablet, take another tablet 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 periods in a row, take a pregnancy test before starting a new cycle of medication.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Do not store 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 are taking this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a certain period 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 your medication at the same time every day.
You can take it with or without food, but if it causes stomach upset, take it with food.
If you are also taking colesevelam, 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-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's instructions regarding the use of non-hormone birth control methods.
Do not skip doses, even if you do not have sex frequently.
* If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy. If this happens within 3 to 4 hours after taking an active tablet, take another tablet 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 periods in a row, take a pregnancy test before starting a new cycle of medication.
Storing and Disposing of Your Medication
Keep your medication at room temperature, away from light and moisture. Do not store 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 are taking this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a certain period to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
- Take one pill at the same time every day to ensure maximum effectiveness.
- Use a backup method of contraception (like condoms) for the first 7 days when starting the pill, or if you miss pills.
- Be aware of potential drug interactions with other medications, including herbal supplements like St. John's Wort, and discuss all medications with your doctor.
- 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 tablet orally daily, starting on the first Sunday after the onset of menstruation or on Day 1 of the menstrual cycle. Follow the specific triphasic regimen: 7 days of light yellow tablets (0.5 mg norethindrone/35 mcg ethinyl estradiol), followed by 7 days of orange tablets (0.75 mg norethindrone/35 mcg ethinyl estradiol), followed by 7 days of white tablets (1 mg norethindrone/35 mcg ethinyl estradiol), followed by 7 days of green inert tablets.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missed_dose_1_active:
Take as soon as remembered, take next pill at usual time. No backup method needed.
missed_dose_2_active_weeks_1_2:
Take 2 pills the day remembered and 2 pills the next day. Use backup contraception for 7 days.
missed_dose_2_active_week_3_or_3_plus_active_any_week:
Discard current pack and start a new pack immediately. Use backup contraception for 7 days. If Day 1 starter, do not take placebo pills. If Sunday starter, continue taking pills until Sunday, then discard pack and start new pack. Use backup contraception for 7 days.
missed_placebo_pills:
Discard missed pills and continue taking one pill per day until the pack is finished. No backup method needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Dosing is the same as for adults once menstruation has begun and contraception is desired.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Use with caution; monitor for fluid retention. Not extensively studied.
Dialysis:
Use with caution; monitor for fluid retention. Not extensively studied.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Contraindicated.
Severe:
Contraindicated.
Pharmacology
Mechanism of Action
Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins, which in turn inhibits ovulation. They also induce changes in the cervical mucus, increasing its viscosity and making it more difficult for sperm to penetrate, and alter the endometrium, making it less receptive to implantation.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: 40-60%; Norethindrone: 60-100%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect:
Food may slightly decrease Cmax for ethinyl estradiol but does not significantly affect bioavailability. Food may slightly increase Cmax for norethindrone.
Distribution:
Vd:
Ethinyl Estradiol: 2-4 L/kg; Norethindrone: 2-4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: ~96-99% (to albumin and SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~10-20 hours; Norethindrone: ~5-14 hours
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4 L/hr/kg
ExcretionRoute:
Renal (primarily as glucuronide and sulfate conjugates) and Fecal (primarily as unconjugated metabolites)
Unchanged:
Ethinyl Estradiol: <5% (urine); Norethindrone: <1% (urine)
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically achieved after 7 consecutive days of active pill use.
PeakEffect:
Steady-state concentrations reached within 3-4 days for both components.
DurationOfAction:
Daily dosing maintains contraceptive effect.
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 Alyacen 7/7/7, 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, 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 high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ 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
Blurred eyesight
Depression or other mood changes
Breast changes, such as:
+ A lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal itching or discharge
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Fluid retention, which may cause swelling, weight gain, or trouble breathing
If you experience any of these symptoms, contact your doctor right away. Additionally, be aware of the signs of a blood clot, which may include:
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. 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 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
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
+ 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 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 high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Yellow skin or eyes
+ Fever with chills
+ Bloating
+ 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
Blurred eyesight
Depression or other mood changes
Breast changes, such as:
+ A lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal itching or discharge
Eyesight changes or loss
Bulging eyes
Changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Fluid retention, which may cause swelling, weight gain, or trouble breathing
If you experience any of these symptoms, contact your doctor right away. Additionally, be aware of the signs of a blood clot, which may include:
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. 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 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
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
+ 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:
- A - Abdominal pain (severe)
- C - Chest pain (severe), cough, shortness of breath
- H - Headaches (severe, sudden, or worse than usual)
- E - Eye problems (blurred vision, flashing lights, partial or complete loss of vision)
- S - Severe leg pain (calf or thigh), swelling, warmth, or redness
- Yellowing of skin or eyes (jaundice)
- Dark urine or light-colored stools
- Sudden numbness or weakness on one side of the body
- Slurred speech
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed.
A history of jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or change the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, 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
+ Chest pain caused by angina
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical cancer, vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
Breastfeeding or plans to breastfeed.
A history of jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing products, such as hormonal birth control.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health status. Never start, stop, or change the dosage 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 instruct you 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 as directed by your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor. Additionally, this medication may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as recommended.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab workers that you are taking this medication.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the need for additional non-hormonal birth control methods, such as condoms.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. 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.
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, consult your doctor. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not. If you have concerns, discuss them with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
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 instruct you 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 as directed by your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor. Additionally, this medication may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor and have your blood work and other lab tests checked as recommended.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab workers that you are taking this medication.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, and discuss the need for additional non-hormonal birth control methods, such as condoms.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. 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.
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, consult your doctor. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not. If you have concerns, discuss them with your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (vaginal bleeding may occur in females)
What to Do:
Seek medical attention or call Poison Control at 1-800-222-1222. Treatment is generally supportive; there is no specific antidote.
Drug Interactions
Contraindicated Interactions
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (increased ALT levels)
- Certain strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) due to potential for contraceptive failure.
Major Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole) - COCs may decrease their efficacy.
- CYP3A4 inducers (e.g., bosentan, griseofulvin, modafinil, topiramate, rufinamide) - may decrease COC efficacy.
- Certain antibiotics (e.g., rifampin, possibly others like ampicillin, tetracycline, though evidence is less robust for non-rifamycin antibiotics, backup method often recommended).
- Lamotrigine (COCs can significantly decrease lamotrigine levels, leading to loss of seizure control).
Moderate Interactions
- CYP3A4 inhibitors (e.g., azole antifungals like ketoconazole, itraconazole; macrolide antibiotics like erythromycin, clarithromycin; grapefruit juice) - may increase COC plasma concentrations, potentially increasing side effects.
- Thyroid hormone replacement therapy (COCs can increase thyroid binding globulin, requiring increased thyroid hormone dose).
- Cyclosporine (COCs may increase cyclosporine levels, increasing toxicity risk).
- Theophylline (COCs may increase theophylline levels).
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels slightly).
- Ascorbic acid (Vitamin C) (may increase ethinyl estradiol levels slightly).
Monitoring
Baseline Monitoring
Complete medical history (including family history)
Rationale: To identify contraindications, risk factors for cardiovascular disease, thromboembolism, and certain cancers.
Timing: Prior to initiation of therapy.
Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To establish baseline health status and screen for conditions that may be exacerbated by or contraindicate COC use.
Timing: Prior to initiation of therapy, or as clinically indicated per current guidelines.
Routine Monitoring
Blood Pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <140/90 mmHg (ideally <120/80 mmHg)
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may necessitate discontinuation or change in contraceptive method.
Annual physical examination (including breast and pelvic exam, Pap test)
Frequency: Annually, or as per national screening guidelines.
Target: Normal findings
Action Threshold: Abnormal findings require further investigation and potential discontinuation of COC.
Weight/BMI
Frequency: Annually
Target: Healthy range
Action Threshold: Significant weight gain may increase cardiovascular risk.
Symptom Monitoring
- Severe abdominal pain (A)
- Severe chest pain, shortness of breath, or coughing up blood (C)
- Severe headaches (H)
- Eye problems (blurred vision, loss of vision) (E)
- Severe leg pain (calf or thigh), swelling, warmth, or redness (S)
- Jaundice (yellowing of skin or eyes)
- Dark urine, light-colored stools
- Mood changes, depression
- New or worsening migraines
- Unusual vaginal bleeding or spotting
Special Patient Groups
Pregnancy
Contraindicated. Alyacen 7/7/7 should not be used during pregnancy. If pregnancy occurs during use, discontinue immediately.
Trimester-Specific Risks:
First Trimester:
No evidence of increased risk of birth defects from inadvertent exposure to COCs early in pregnancy.
Second Trimester:
Not applicable, contraindicated.
Third Trimester:
Not applicable, contraindicated.
Lactation
Use is generally not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of steroids are excreted in breast milk.
Infant Risk:
L3 (Moderately Safe). Potential for decreased milk supply and minor adverse effects on the infant (e.g., jaundice, breast enlargement). Non-hormonal methods or progestin-only pills are generally preferred for breastfeeding mothers.
Pediatric Use
Not indicated for use before menarche. For adolescents who have begun menstruation, dosing is the same as for adults.
Geriatric Use
Not indicated for contraception in post-menopausal women. No data available for use in geriatric populations for contraception.
Clinical Information
Clinical Pearls
- Adherence is key: Taking the pill at the same time every day significantly improves efficacy. Consider linking it to a daily routine (e.g., brushing teeth, mealtime).
- Missed pills: Provide clear instructions on what to do for missed pills, emphasizing the need for backup contraception if multiple pills are missed or if pills are missed in the critical first week or last week of active pills.
- Drug interactions: Always ask patients about all medications, including over-the-counter drugs, herbal supplements (especially St. John's Wort), and new prescriptions, due to potential for reduced contraceptive efficacy.
- Emergency contraception: Advise patients on the availability and proper use of emergency contraception in case of missed pills or contraceptive failure.
- Non-contraceptive benefits: Inform patients about potential non-contraceptive benefits, such as regulation of menstrual cycles, reduction of dysmenorrhea, and decreased risk of ovarian and endometrial cancers.
- Risk of VTE: Emphasize the increased risk of venous thromboembolism (VTE), especially in smokers and those with other risk factors. Counsel on symptoms of VTE (ACHES).
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 and non-hormonal)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$20 - $50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered with low or no co-pay under ACA)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.