Hailey 1.5/30 Tablets 21

Manufacturer GLENMARK Active Ingredient Ethinyl Estradiol and Norethindrone Tablets(ETH in il es tra DYE ole & nor eth IN drone) Pronunciation ETH-in-il ES-tra-dye-ole & 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.
đŸˇī¸
Drug Class
Contraceptive
đŸ§Ŧ
Pharmacologic Class
Estrogen and Progestin Combination
🤰
Pregnancy Category
Category X
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Hailey 1.5/30 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 changing the lining of your uterus and cervical mucus to make it harder for sperm to reach an egg or for a fertilized egg to implant. It is used to prevent pregnancy.
📋

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, to prevent pregnancy for a certain period. 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.

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 to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a certain period to prevent pregnancy.
💡

Lifestyle & Tips

  • Take the 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, as this significantly increases the risk of serious side effects like blood clots.
  • Use a backup method of birth control (like condoms) if you miss pills, have vomiting or severe diarrhea, or are taking medications that can reduce the effectiveness of the pill.
  • Be aware that oral contraceptives do not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: One active tablet orally once daily for 21 consecutive days, followed by 7 days of inactive tablets (or no tablets), then begin a new cycle.
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

first_dose: Take the first tablet on the first day of menstrual bleeding (Day 1 Start) or on the first Sunday after menstrual bleeding begins (Sunday Start).
missed_dose: 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; if multiple pills missed, use backup contraception.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Same as adult dosing for post-menarcheal adolescents requiring contraception.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed

Hepatic Impairment:

Mild: Use with caution
Moderate: Contraindicated
Severe: Contraindicated

Pharmacology

đŸ”Ŧ

Mechanism of Action

Combined oral contraceptives (COCs) primarily act by suppressing gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]). This suppression inhibits ovulation. Additionally, they cause changes in the cervical mucus (making it thicker and less permeable to sperm) and the endometrium (making it less receptive to implantation).
📊

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 norethindrone but does not significantly affect bioavailability.

Distribution:

Vd: Ethinyl Estradiol: ~4-15 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: ~61% (to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~10-20 hours; Norethindrone: ~5-14 hours
Clearance: Not readily available as a single value, highly variable due to first-pass metabolism.
ExcretionRoute: Renal (conjugates) and Fecal (conjugates)
Unchanged: Ethinyl Estradiol: <5%; Norethindrone: <1%
âąī¸

Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically begins after 7 consecutive days of active pill use, if started correctly.
PeakEffect: Steady-state hormone levels achieved within 3-4 days of continuous dosing.
DurationOfAction: Daily dosing maintains contraceptive effect; effects wane rapidly upon discontinuation.

Safety & Warnings

âš ī¸

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 Hailey 1.5/30, are contraindicated in women who are over 35 years of age and smoke.
âš ī¸

Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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

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

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or 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. If you have questions or concerns, 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**bdominal pain (severe)
  • **C**hest pain (severe), cough, shortness of breath
  • **H**eadaches (severe, sudden, or worse than usual)
  • **E**ye problems (e.g., blurred vision, flashing lights, partial or complete loss of vision)
  • **S**evere leg pain (calf or thigh), swelling, warmth, or redness
  • Yellowing of skin or eyes (jaundice)
  • Lump in the breast
  • Severe mood changes or depression
📋

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 or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, or vaginal cancer
+ Unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
If you have experienced dark skin patches (chloasma) or increased sensitivity to the sun or radiation
If you have taken certain medications, such as 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 may be pregnant. Do not take this medication if you are pregnant.
If you are breastfeeding or plan to breastfeed
* If you experienced jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products, such as hormonal birth control

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 treatment. Do not start, stop, or change the dosage of any medication without consulting your doctor.
âš ī¸

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 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 levels as directed by your doctor.

This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.

High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests, as recommended by your doctor.

It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as instructed by your doctor.

If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.

This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this medication.

Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.

This medication does not protect against sexually transmitted diseases, including HIV and 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.

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, consult 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, discuss this 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 (in females)

What to Do:

There is no specific antidote. Treatment is symptomatic and supportive. Call 911 or Poison Control (1-800-222-1222) immediately if a large overdose is suspected.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir and dasabuvir (Viekira Pak)
  • Glecaprevir/pibrentasvir (Mavyret)
🔴

Major Interactions

  • CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, St. John's Wort): May decrease contraceptive efficacy and increase breakthrough bleeding.
  • Protease inhibitors (e.g., Ritonavir, Nelfinavir): May alter COC levels, requiring dose adjustment or alternative contraception.
  • Aromatase inhibitors (e.g., Anastrozole, Letrozole): Concurrent use is not recommended as COCs may interfere with their therapeutic effect.
🟡

Moderate Interactions

  • Lamotrigine: COCs may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
  • Thyroid hormone replacement (e.g., Levothyroxine): COCs may increase thyroid-binding globulin, leading to increased thyroid hormone requirements.
  • Cyclosporine: COCs may increase cyclosporine plasma concentrations, requiring monitoring and dose adjustment.
  • Theophylline: COCs may increase theophylline plasma concentrations.
  • Corticosteroids (e.g., Prednisolone): COCs may increase corticosteroid plasma concentrations.
đŸŸĸ

Minor Interactions

  • Acetaminophen: May increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C): May increase ethinyl estradiol levels.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Complete medical history (including family history)

Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by COC use.

Timing: Prior to initiation

Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)

Rationale: To establish baseline health status and rule out existing conditions.

Timing: Prior to initiation (as clinically indicated)

Lipid profile, Glucose

Rationale: To assess baseline metabolic risk factors, especially in patients with pre-existing conditions or family history.

Timing: Prior to initiation (as clinically indicated)

📊

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 examination (including breast exam, pelvic exam, Pap test)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation.

Review of medical history and current medications

Frequency: Annually

Target: No new contraindications or significant drug interactions

Action Threshold: Identify new risks or interacting medications.

đŸ‘ī¸

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) (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

🤰

Pregnancy

Contraindicated in pregnancy. There is no evidence that COCs taken inadvertently during early pregnancy harm the fetus.

Trimester-Specific Risks:

First Trimester: No increased risk of birth defects reported with inadvertent exposure.
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
🤱

Lactation

Not recommended during the immediate postpartum period (first 4-6 weeks) in breastfeeding women due to potential for decreased milk production and changes in milk composition. Small amounts of steroids may pass into breast milk.

Infant Risk: Low risk of adverse effects in the infant, but potential for decreased milk supply is the primary concern.
đŸ‘ļ

Pediatric Use

Not indicated before menarche. For post-menarcheal adolescents, dosing is the same as adults. Safety and efficacy are expected to be similar to adults.

👴

Geriatric Use

Not indicated for postmenopausal women. Risk of cardiovascular events increases with age, and COCs are generally not used in this population.

Clinical Information

💎

Clinical Pearls

  • Strict adherence to the daily dosing schedule is crucial for contraceptive efficacy. Missed pills are a common cause of contraceptive failure.
  • Counsel patients on the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and to seek immediate medical attention if experienced.
  • Smoking cessation is strongly advised for all COC users, especially those over 35, due to significantly increased cardiovascular risk.
  • Inform patients about potential drug interactions, particularly with enzyme-inducing medications, and advise them to use backup contraception if necessary.
  • Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves. Persistent or heavy bleeding should be evaluated.
🔄

Alternative Therapies

  • Progestin-only pills (POPs)
  • Contraceptive patch (Xulane)
  • Vaginal ring (NuvaRing, Annovera)
  • Contraceptive implant (Nexplanon)
  • Intrauterine devices (IUDs - hormonal and non-hormonal)
  • Contraceptive injection (Depo-Provera)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
💰

Cost & Coverage

Average Cost: $15 - $50 per 28 tablets (1 cycle)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered under Affordable Care Act as preventive care)
📚

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. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.