Tri-Lo Estarylla Tablets 28s

Manufacturer PERRIGO Active Ingredient Ethinyl Estradiol and Norgestimate(ETH in il es tra DYE ole & nor JES ti mate) Pronunciation ETH in il es tra DYE ole & nor JES ti mate
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 is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
đŸˇī¸
Drug Class
Contraceptive, Oral
đŸ§Ŧ
Pharmacologic Class
Estrogen and Progestin Combination
🤰
Pregnancy Category
Category X
✅
FDA Approved
Sep 2013
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Tri-Lo Estarylla is a birth control pill that contains two female hormones, ethinyl estradiol (an estrogen) and norgestimate (a progestin). It works by preventing ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. It is taken daily to prevent pregnancy.
📋

How to Use This Medicine

Taking Your Medication Correctly

To get the most out of your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food. If you experience an upset stomach, taking it with food may help.

After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a while. Be sure to follow your doctor's guidance on using a non-hormone form of birth control.

If you are also taking colesevelam, take it at least 4 hours after taking this medication. Do not skip doses, even if you do not have sex frequently. If you vomit or have diarrhea, this 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 extra form of birth control and contact your doctor for advice. If you are unsure what to do, call your doctor.

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. Store it in a dry place, avoiding the bathroom.

What to Do If You Miss a Dose

If you miss a dose, refer to the package insert or contact your doctor for guidance. If you are using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a while to prevent pregnancy.
💡

Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
  • Take the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
  • Use a backup birth control method (like condoms) for the first 7 days when starting the pill or if you miss pills.
  • Be aware that this medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
💊

Available Forms & Alternatives

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: One active tablet orally once daily for 21 consecutive days, followed by one inactive tablet orally once daily for 7 consecutive days. Begin new pack on day 29.

Condition-Specific Dosing:

first_start: Start on the first day of menstrual period or the first Sunday after the period begins.
missed_dose: Refer to package insert for specific missed dose instructions based on number of missed pills and week in cycle.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Dosing is the same as adults once menstruation has begun and contraception is desired.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No specific adjustment data; use with caution due to potential fluid retention.
Dialysis: No specific adjustment data; use with caution.

Hepatic Impairment:

Mild: No specific adjustment data; use with caution.
Moderate: Use with caution; monitor for adverse effects.
Severe: Contraindicated in women with acute or chronic liver disease or benign or malignant liver tumors.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins. Although the primary mechanism is inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm entry into the uterus) and changes in the endometrium (which reduce the likelihood of implantation). Norgestimate is a progestin that, along with ethinyl estradiol, provides contraceptive effects.
📊

Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: Approximately 43%; Norgestimate: Rapidly absorbed, bioavailability not directly stated for norgestimate itself but for its active metabolites.
Tmax: Ethinyl Estradiol: 1-2 hours; Norgestimate (as active metabolites norelgestromin and norgestrel): 1.5-2 hours.
FoodEffect: Food does not significantly affect the extent of absorption of ethinyl estradiol or norgestimate.

Distribution:

Vd: Ethinyl Estradiol: Approximately 4.3 L/kg; Norelgestromin: 1.64 L/kg; Norgestrel: 2.2 L/kg.
ProteinBinding: Ethinyl Estradiol: Approximately 98% (to albumin and sex hormone-binding globulin [SHBG]); Norelgestromin: Approximately 97% (to albumin); Norgestrel: Approximately 99% (to SHBG and albumin).
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: Approximately 10-20 hours; Norelgestromin: Approximately 24 hours; Norgestrel: Approximately 45 hours.
Clearance: Ethinyl Estradiol: Approximately 5-10 mL/min/kg.
ExcretionRoute: Renal (approximately 40%) and fecal (approximately 60%) for ethinyl estradiol metabolites. Norgestimate metabolites are also excreted renally and fecally.
Unchanged: Minimal
âąī¸

Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically achieved after 7 consecutive days of active pill use.
PeakEffect: Not directly applicable for contraceptive effect, but hormonal levels peak within hours of dosing.
DurationOfAction: Daily dosing required for continuous contraceptive effect.

Safety & Warnings

âš ī¸

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 Tri-Lo Estarylla, 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 immediate medical attention:

Signs of an allergic reaction, such as:
+ 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
+ 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
Swelling
Difficulty urinating or changes in urine output
Breast lump, pain, or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Changes in eyesight or loss of vision
Bulging eyes
Changes in how contact lenses feel
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Trouble speaking or swallowing

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Weight gain
Headache
Upset stomach or vomiting
Gas
Feeling nervous or excitable
Stomach pain
Bloating
Feeling tired or weak
Enlarged or tender breasts
Changes in menstrual periods, including spotting or bleeding between cycles
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)

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 (in calf or thigh), swelling, warmth, or redness in leg
  • Yellowing of skin or eyes (jaundice)
  • Dark urine, 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
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer
+ Cervical or vaginal cancer
+ Unexplained vaginal bleeding
If you experienced jaundice (yellowing of the skin and eyes) during pregnancy or while using estrogen-containing medications, such as hormonal birth control.
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy: Do not take this medication if you are pregnant.
* Breastfeeding or plans to breastfeed.

This is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or change the dose 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 drug before certain surgical procedures. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.

Blood Clots, Stroke, and Heart Attack Risk

This medication may increase your risk of developing blood clots, having a stroke, or experiencing a heart attack. Discuss these potential risks with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, talk to your doctor, as this can also increase your risk of blood clots.

Diabetes and Blood Sugar Monitoring

If you have high blood sugar (diabetes), inform your doctor, as this medication may raise your blood sugar levels. Monitor your blood sugar as directed by your doctor.

Blood Pressure and Cholesterol Monitoring

Drugs like this one may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor. Additionally, this medication may increase your cholesterol and triglyceride levels. Discuss this with your doctor and have your blood work checked as recommended.

Breast and Gynecological Health

Regular breast exams and gynecology check-ups are crucial while taking this medication. Perform breast self-exams as instructed by your doctor.

Grapefruit Juice and Medication Interactions

If you consume grapefruit juice or eat grapefruit frequently, inform your doctor, as this may interact with your medication.

Lab Tests and Allergies

This medication may affect certain lab tests. Inform all your healthcare providers and lab workers that you are taking this drug. If you are allergic to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some products contain this ingredient.

Hormone-Based Birth Control Effectiveness

Certain medications, herbal products, or health problems 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.

Sexually Transmitted Diseases

This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Always use a latex or polyurethane condom during sex. If you have questions, consult your doctor.

Cancer Risks

The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. Discuss any concerns with your doctor. Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, talk to your doctor.

Pediatric Use and Pregnancy

Do not use this medication 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 are no specific antidotes. Treatment is symptomatic and supportive. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
  • Certain aromatase inhibitors (e.g., anastrozole, letrozole) - theoretical interaction, not typically co-administered for contraception
🔴

Major Interactions

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, topiramate, primidone, oxcarbazepine, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Certain HIV protease inhibitors (e.g., nelfinavir, ritonavir, lopinavir/ritonavir) - may decrease or increase COC levels.
  • Certain non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, nevirapine) - may decrease COC levels.
  • Griseofulvin - may decrease contraceptive efficacy.
🟡

Moderate Interactions

  • Antibiotics (e.g., ampicillin, tetracycline) - historical concern, but current evidence suggests minimal impact on efficacy for most antibiotics, though some clinicians still advise backup methods.
  • Grapefruit juice - may increase ethinyl estradiol levels.
  • Atorvastatin, rosuvastatin - may increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
  • Acetaminophen - may increase ethinyl estradiol levels.
  • Lamotrigine - COCs may decrease lamotrigine levels, potentially leading to loss of seizure control.
đŸŸĸ

Minor Interactions

  • Thyroid hormone replacement therapy - COCs may increase thyroid binding globulin, leading to increased thyroid hormone requirements.
  • Corticosteroids - COCs may decrease clearance of corticosteroids, leading to increased effects.

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 of therapy

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

Rationale: To establish baseline health status and rule out contraindications.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Blood pressure

Frequency: Annually, or more frequently if clinically indicated

Target: <140/90 mmHg

Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may warrant discontinuation or change in contraceptive method.

Annual physical examination (including breast exam, pelvic exam, Pap test as per guidelines)

Frequency: Annually

Target: Normal findings

Action Threshold: Abnormal findings require further investigation.

đŸ‘ī¸

Symptom Monitoring

  • Severe abdominal pain (A)
  • 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) (S)
  • Jaundice (yellowing of skin or eyes)
  • Mood changes, depression
  • Unusual vaginal bleeding or spotting

Special Patient Groups

🤰

Pregnancy

Tri-Lo Estarylla is contraindicated during pregnancy. There is no indication for use of COCs in pregnancy, and there is no evidence of increased risk of birth defects in women who have inadvertently used COCs during early pregnancy.

Trimester-Specific Risks:

First Trimester: No evidence of increased risk of birth defects.
Second Trimester: Not indicated for use.
Third Trimester: Not indicated for use.
🤱

Lactation

Use is generally not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids and/or their metabolites may pass into breast milk.

Infant Risk: Potential for adverse effects on the infant (e.g., jaundice, breast enlargement) and reduction in milk supply. Non-hormonal or progestin-only methods are generally preferred during breastfeeding.
đŸ‘ļ

Pediatric Use

Safety and efficacy are established for women of reproductive age. Use is not indicated before menarche. Once menstruation has begun, dosing is the same as for adults.

👴

Geriatric Use

Tri-Lo Estarylla is not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age.

Clinical Information

💎

Clinical Pearls

  • Adherence is key for contraceptive efficacy. Missing pills, especially early or late in the cycle, increases the risk of pregnancy.
  • Breakthrough bleeding and spotting are common, especially during the first few cycles, and usually decrease over time. If persistent or heavy, consult a healthcare provider.
  • Vomiting or severe diarrhea within 3-4 hours of taking an active pill may reduce absorption; use a backup method for 7 days.
  • Consider potential drug interactions, especially with enzyme-inducing medications, and advise patients to use backup contraception if necessary.
  • Counsel patients on the ACHES warning signs for serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
🔄

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
  • Sterilization (tubal ligation, vasectomy)
  • Emergency contraception
💰

Cost & Coverage

Average Cost: $20 - $60 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered with low or no co-pay under Affordable Care Act)
📚

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.