Alyacen 1/35 Tablets 28s

Manufacturer GLENMARK Active Ingredient Ethinyl Estradiol and Norethindrone Tablets(ETH in il es tra DYE ole & nor eth IN drone) Pronunciation AL-uh-sen (Ethinyl Estradiol: ETH-in-il es-tra-DYE-ol; Norethindrone: nor-ETH-in-drone)
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.
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Drug Class
Contraceptive, Hormonal
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Pharmacologic Class
Estrogen/Progestin Combination
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Pregnancy Category
Category X
FDA Approved
Mar 1982
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Alyacen 1/35 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) and by making it harder for sperm to reach the egg or for a fertilized egg to implant in the womb. It is taken daily to prevent pregnancy.
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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 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 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.

What to Do If You Miss a Dose

If you miss a dose, refer to the package insert or call your doctor for instructions. 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.
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Lifestyle & Tips

  • Take one pill at the same time every day to maximize effectiveness and minimize breakthrough bleeding.
  • Do not smoke, especially if you are over 35 years old, due to increased risk of serious side effects like blood clots.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
  • If you miss a pill, follow the specific instructions in the package insert immediately. A backup birth control method (like condoms) may be needed.
  • Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as some can reduce the effectiveness of birth control pills.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet daily, taken at the same time each day, for 28 consecutive days per cycle (21 active tablets followed by 7 inactive tablets).
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

initiation: Start on the first day of menstruation or the first Sunday after menstruation begins. Use a backup method for the first 7 days of the first cycle if not starting on Day 1.
missed_dose: Refer to package insert for specific instructions based on number of missed pills and week in cycle.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: Use with caution; monitor for fluid retention. Not extensively studied.
Dialysis: Not extensively studied; use with caution.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Use with caution; monitor liver function. May be contraindicated in some cases.
Severe: Contraindicated due to impaired steroid metabolism and potential for exacerbation of liver disease.

Pharmacology

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Mechanism of Action

Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone). This suppression inhibits ovulation. Additional mechanisms include changes in the cervical mucus, which increases the difficulty of sperm penetration, and changes in the endometrium, which reduce the likelihood of implantation.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-80%
Tmax: Ethinyl Estradiol: ~1-2 hours; Norethindrone: ~0.5-4 hours
FoodEffect: Food may slightly decrease Cmax for ethinyl estradiol but generally does not significantly affect overall bioavailability or efficacy.

Distribution:

Vd: Ethinyl Estradiol: ~2-4 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Norethindrone: ~61% (primarily to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~5-14 hours
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4-0.8 L/hr/kg
ExcretionRoute: Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50-80%) and Fecal (20-50%)
Unchanged: Ethinyl Estradiol: <5%; Norethindrone: <1%
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically achieved after 7 consecutive days of active pill use. Full protection usually after the first full cycle.
PeakEffect: Peak hormonal levels reached within hours of administration; contraceptive effect is sustained with daily dosing.
DurationOfAction: 24 hours (requires daily dosing for continuous effect)

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives should be strongly advised not to smoke.
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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Changes in eyesight or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing

If you experience any of these symptoms, contact your doctor right away. Additionally, be aware of the signs of a blood clot, such as:

Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, changes in color, or pain in a leg or arm
Trouble speaking or swallowing

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. While many individuals may not experience any side effects or only mild 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 persist:

Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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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, loss of vision, flashing lights)
  • S: Severe leg pain (calf or thigh), swelling, warmth, or redness
  • Yellowing of skin or eyes (jaundice)
  • Dark urine or light-colored stools
  • Unexplained vaginal bleeding or spotting that is heavy or lasts for several days
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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 or situations 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
+ 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 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
Previous experiences 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 to ensure safe treatment. Do not initiate, stop, or modify any medication without consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will provide guidance on when to resume taking it after the surgery or procedure.

If you 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 drug 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 personnel that you are taking this drug.

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. Use latex or polyurethane condoms during sexual activity, and consult your doctor if you have questions.

Taking this medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor, as the risk is highest during the first year of use 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. Additionally, there is conflicting evidence regarding the risk of breast cancer associated with long-term use of this medication. 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.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Withdrawal bleeding (in females)

What to Do:

Overdose is generally not life-threatening. Treatment is symptomatic and supportive. Call 911 or Poison Control (1-800-222-1222) for advice.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir (Viekira Pak, Technivie) - risk of ALT elevations
  • Glecaprevir/Pibrentasvir (Mavyret) - risk of ALT elevations
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Oxcarbazepine, Griseofulvin, Bosentan, Efavirenz, Nevirapine, Ritonavir-boosted protease inhibitors) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • St. John's Wort - may decrease contraceptive efficacy.
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Moderate Interactions

  • Broad-spectrum antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic recirculation, though clinical significance is debated. Backup method often recommended.
  • Grapefruit juice - may increase ethinyl estradiol levels, but clinical significance is generally minor for efficacy.
  • Lamotrigine - COCs can decrease lamotrigine levels, potentially leading to loss of seizure control.
  • Thyroid hormones (e.g., Levothyroxine) - COCs can increase thyroid-binding globulin, requiring increased thyroid hormone dose.
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Minor Interactions

  • Acetaminophen - may increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To identify pre-existing hypertension and monitor for drug-induced hypertension, a known risk factor for cardiovascular events.

Timing: Prior to initiation and annually.

Physical Examination (including breast and pelvic exam)

Rationale: To assess overall health, rule out contraindications, and establish baseline for future monitoring.

Timing: Prior to initiation and annually (as per clinical guidelines).

Lipid Profile (if risk factors present)

Rationale: To assess cardiovascular risk, as COCs can affect lipid metabolism.

Timing: Prior to initiation if indicated by patient history/risk factors.

Liver Function Tests (if history of liver disease)

Rationale: To assess hepatic function, as COCs are metabolized by the liver and contraindicated in severe impairment.

Timing: Prior to initiation if indicated.

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Routine Monitoring

Blood Pressure

Frequency: Annually, or more frequently if hypertension develops or is a concern.

Target: <120/80 mmHg (or individualized target)

Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or change in contraceptive method.

Weight/BMI

Frequency: Annually

Target: Healthy BMI (18.5-24.9 kg/m²)

Action Threshold: Significant weight gain may warrant counseling or re-evaluation of method.

Discussion of side effects and adherence

Frequency: At each follow-up visit (e.g., annually)

Target: N/A

Action Threshold: Persistent or severe side effects, or poor adherence, warrant counseling or method change.

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Symptom Monitoring

  • Severe abdominal pain (A)
  • Severe chest pain, shortness of breath, or coughing up blood (C)
  • Severe headaches (H)
  • Eye problems (e.g., blurred vision, loss of vision, flashing lights) (E)
  • Severe leg pain (e.g., calf or thigh), swelling, warmth, or redness (S)
  • Jaundice (yellowing of skin or eyes)
  • Mood changes, depression
  • Unusual vaginal bleeding or spotting

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. There is no indication for COC use in pregnancy, and there is evidence of fetal harm (Category X).

Trimester-Specific Risks:

First Trimester: Contraindicated. Studies suggest an association between intrauterine exposure to female sex hormones and congenital anomalies, though data are conflicting.
Second Trimester: Contraindicated.
Third Trimester: Contraindicated.
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Lactation

Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk and are excreted in breast milk. Progestins are also excreted in breast milk. Use should be avoided until the infant is weaned or at least 6 weeks postpartum, and only if non-hormonal methods are not suitable.

Infant Risk: L3 (Moderate risk). Potential for decreased milk supply, and small amounts of hormones are transferred to the infant. Monitor for potential effects on infant (e.g., jaundice, breast enlargement).
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Pediatric Use

Indicated for post-menarcheal adolescents for contraception. Safety and efficacy are expected to be similar to adults. Not indicated for prepubertal children.

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Geriatric Use

Not indicated for post-menopausal women. Risks of cardiovascular events increase with age, and COCs are generally not used in women over 35 who smoke or over 40-50 years of age due to increased risks.

Clinical Information

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Clinical Pearls

  • Consistent daily use at the same time is crucial for efficacy. Missing pills, especially active pills, significantly increases the risk of pregnancy.
  • Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves. If persistent or heavy, evaluate for other causes.
  • Non-contraceptive benefits include regulation of menstrual cycles, reduction of menstrual pain and blood loss, and reduced risk of ovarian and endometrial cancers.
  • Counsel patients on the importance of a backup contraceptive method (e.g., condoms) when starting the pill, if pills are missed, or when taking interacting medications.
  • Advise patients to report any signs of serious side effects immediately, particularly those related to blood clots (ACHES symptoms).
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Alternative Therapies

  • Progestin-only pills (POPs)
  • Progestin implants (e.g., Nexplanon)
  • Intrauterine devices (IUDs) - hormonal (e.g., Mirena, Kyleena) or non-hormonal (e.g., Paragard)
  • Injectable contraceptives (e.g., Depo-Provera)
  • Barrier methods (e.g., condoms, diaphragm, cervical cap)
  • Spermicides
  • Natural family planning methods
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $15 - $50 per 28 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often covered with no or low co-pay under ACA)
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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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.