Hailey 1.5/30 Tablets 21
Overview
What is this medicine?
How to Use This Medicine
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).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
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
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.
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 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
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.
Minor Interactions
- Acetaminophen: May increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C): May increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors for cardiovascular disease, and other conditions that may be affected by COC use.
Timing: Prior to initiation
Rationale: To establish baseline health status and rule out existing conditions.
Timing: Prior to initiation (as clinically indicated)
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
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.
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Frequency: Annually
Target: No new contraindications or significant drug interactions
Action Threshold: Identify new risks or interacting medications.
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:
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.
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)