Tri-Lo-sprintec Tablets 28s

Manufacturer TEVA PHARMACEUTICALS USA Active Ingredient Ethinyl Estradiol and Norgestimate(ETH in il es tra DYE ole & nor JES ti mate) Pronunciation TRY-low-SPRIN-tek (Ethinyl Estradiol: ETH-in-il es-tra-DYE-ol; Norgestimate: 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.
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Drug Class
Contraceptive
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Pharmacologic Class
Estrogen/Progestin Combination
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Pregnancy Category
Category X
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FDA Approved
Aug 2002
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tri-Lo-sprintec is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norgestimate). It works by preventing your body from releasing an egg (ovulation) and by changing your cervical mucus and uterine lining to prevent pregnancy. It is taken daily to be effective.
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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.

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

If you vomit or have diarrhea, the medication may not be as effective in preventing pregnancy. 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 1 day, use an additional form of birth control and consult your doctor. If you are unsure what to do, call your doctor for guidance.

If you miss two consecutive periods, take a pregnancy test before starting a new dosing cycle.

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 consult your doctor for instructions. If you are using this medication for birth control, you may need to use a non-hormonal 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, without missing any doses, to ensure maximum effectiveness.
  • 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.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms to prevent STIs.
  • If you experience severe vomiting or diarrhea, the effectiveness of the pill may be reduced; use a backup method of contraception.
  • Discuss all other medications, including over-the-counter drugs, herbal products (especially St. John's Wort), and supplements, with your doctor or pharmacist, as they can interact with birth control pills.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily for 28 consecutive days, starting on Day 1 of menstrual cycle or first Sunday after onset of menstruation. Follow the 21 active tablets then 7 inert tablets regimen.

Condition-Specific Dosing:

contraception: One tablet daily at the same time each day.
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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 recommended, but use with caution.
Moderate: No specific adjustment recommended, but use with caution.
Severe: No specific adjustment recommended, but use with caution. Monitor for fluid retention.
Dialysis: Not specifically studied; use with caution and monitor for fluid retention.

Hepatic Impairment:

Mild: Use with caution; monitor liver function.
Moderate: Contraindicated due to impaired steroid metabolism.
Severe: Contraindicated due to impaired steroid metabolism.

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) like Tri-Lo-sprintec primarily act by suppressing gonadotropins (Luteinizing Hormone and Follicle-Stimulating Hormone), which in turn 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).
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norgestimate: Rapidly absorbed, prodrug to norelgestromin and norgestrel.
Tmax: Ethinyl Estradiol: ~1-2 hours; Norelgestromin: ~1.5 hours; Norgestrel: ~5 hours.
FoodEffect: Food does not significantly affect the extent of absorption of ethinyl estradiol or norgestimate.

Distribution:

Vd: Ethinyl Estradiol: ~2.8-8.6 L/kg; Norelgestromin: ~1.6 L/kg; Norgestrel: ~1.8 L/kg.
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Norelgestromin: ~97% (primarily to albumin and sex hormone-binding globulin [SHBG]); Norgestrel: ~92% (primarily to SHBG).
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~10-20 hours; Norelgestromin: ~28 hours; Norgestrel: ~45 hours.
Clearance: Ethinyl Estradiol: ~5-13 mL/min/kg.
ExcretionRoute: Renal (urine) and Fecal (bile).
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically achieved after 7 consecutive days of active pill use. Immediate if started on Day 1 of menstrual cycle.
PeakEffect: Not directly applicable for contraceptive effect; refers to steady-state plasma concentrations achieved after several days of dosing.
DurationOfAction: Daily dosing required to maintain contraceptive effect.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combined 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, combined oral contraceptives, including Tri-Lo-sprintec, are contraindicated in women who are over 35 years of age and smoke.
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Side Effects

Serious 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 vision
Depression or other mood changes
Swelling
Difficulty urinating or changes in urine output
Breast lump, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Changes in vision, bulging eyes, or changes in how contact lenses feel
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. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Weight gain
Headache
Upset stomach or vomiting
Gas
Feeling nervous or excitable
Stomach pain
Bloating
Feeling tired or weak
Enlarged breasts
Tender breasts
Changes in menstrual periods, including spotting or bleeding between cycles

Additional Information

This medication may cause dark patches of skin on your face. To minimize this risk, avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and wear protective clothing and eyewear when going outside.

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:

  • ACHES: Abdominal pain (severe)
  • Chest pain (severe), cough, shortness of breath
  • Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
  • Eye problems (sudden partial or complete loss of vision)
  • Severe leg pain (calf or thigh), swelling, redness, warmth
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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 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:
+ 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 potential pregnancy: Do not take this medication if you are pregnant.
* Breastfeeding or plans to breastfeed.

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 if it is safe to take this medication with your other treatments and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
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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 provide guidance on when to resume taking it after the surgery or procedure.

Blood Clots, Stroke, and Heart Attack Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk 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 may further increase your risk of blood clots.

Diabetes and Blood Sugar Control
If you have high blood sugar (diabetes), consult your doctor, as this medication may raise your blood sugar levels. Monitor your blood sugar levels 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 cholesterol and triglyceride levels. Discuss this with your doctor and have your blood work checked as recommended.

Regular Health Check-Ups
It is crucial to have regular breast exams and gynecology check-ups. 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 Test Interactions
This medication may affect certain lab tests. Inform all your healthcare providers and lab workers that you are taking this drug.

Tartrazine Allergy
If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some products contain this ingredient.

Hormone-Based Birth Control Effectiveness
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.

Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use a latex or polyurethane condom during sex to reduce the risk of transmission. If you have questions, consult your doctor.

Cervical Cancer and Breast Cancer Risk
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. Additionally, some studies suggest a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not found this association. Discuss any concerns with your doctor.

Pediatric Use
This medication should not be used in children who have not had their first menstrual period.

Pregnancy
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Vaginal bleeding (withdrawal bleeding may occur in females)

What to Do:

There is no specific antidote. Treatment is symptomatic. In case of suspected overdose, contact a poison control center immediately (Call 1-800-222-1222 in the US) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/Paritaprevir/Ritonavir
  • Dasabuvir
  • Glecaprevir/Pibrentasvir
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, Oxcarbazepine)
  • St. John's Wort
  • Griseofulvin
  • Certain HIV protease inhibitors (e.g., Ritonavir-boosted regimens)
  • Certain non-nucleoside reverse transcriptase inhibitors (e.g., Efavirenz, Nevirapine)
  • Bosentan
  • Modafinil
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Moderate Interactions

  • Certain antibiotics (e.g., Ampicillin, Tetracycline - theoretical risk, clinical significance debated)
  • CYP3A4 inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Clarithromycin, Erythromycin, Grapefruit juice)
  • Lamotrigine (reduced lamotrigine levels)
  • Cyclosporine (increased cyclosporine levels)
  • Theophylline (increased theophylline levels)
  • Corticosteroids (increased corticosteroid levels)
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Minor Interactions

  • Acetaminophen (may increase ethinyl estradiol levels)
  • Ascorbic acid (may increase ethinyl estradiol levels)

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To establish baseline and identify hypertension, a risk factor for cardiovascular events.

Timing: Prior to initiation

Physical Examination (including breast and pelvic exam)

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

Timing: Prior to initiation

Medical History (including family history of VTE, stroke, MI)

Rationale: To identify risk factors for adverse events.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure

Frequency: Annually

Target: <140/90 mmHg

Action Threshold: Sustained elevation requiring re-evaluation or discontinuation.

Annual Physical Examination

Frequency: Annually

Target: N/A

Action Threshold: Significant changes or new findings requiring intervention.

Weight/BMI

Frequency: Annually

Target: Healthy BMI range

Action Threshold: Significant weight gain/loss or obesity, which can increase VTE risk.

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Symptom Monitoring

  • Severe chest pain or shortness of breath (Pulmonary Embolism)
  • Sudden severe headache, weakness/numbness on one side of body, speech changes (Stroke)
  • Sudden loss of vision or blurred vision (Retinal Thrombosis)
  • Leg pain, swelling, warmth, redness (Deep Vein Thrombosis)
  • Abdominal pain, especially severe (Hepatic Adenoma/Thrombosis)
  • Jaundice, dark urine, light stools (Liver dysfunction)
  • Depressed mood, changes in mood
  • New or worsening migraines

Special Patient Groups

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Pregnancy

Contraindicated. There is no indication for Tri-Lo-sprintec in pregnancy, and it may cause fetal harm. Discontinue if pregnancy is confirmed.

Trimester-Specific Risks:

First Trimester: Potential for virilization of female fetus (though rare with low-dose COCs).
Second Trimester: Not applicable, as use is contraindicated.
Third Trimester: Not applicable, as use is contraindicated.
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Lactation

Not recommended. Estrogen-containing contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk. Non-hormonal or progestin-only methods are generally preferred for breastfeeding mothers.

Infant Risk: Low risk of adverse effects in the infant, but potential for decreased milk supply and transfer of hormones.
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Pediatric Use

Safety and efficacy are established for post-menarcheal adolescents. Use before menarche is not indicated.

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Geriatric Use

Not indicated for use in postmenopausal women. Risk of cardiovascular events increases with age, especially in smokers.

Clinical Information

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Clinical Pearls

  • Missed pills: If one active pill is missed, take it as soon as remembered and the next pill at the regular time (may mean taking two pills in one day). If two or more active pills are missed, refer to the package insert for specific instructions, as backup contraception may be needed.
  • Breakthrough bleeding: Common, especially during the first few cycles. Usually resolves with continued use. If persistent or heavy, consult a healthcare provider.
  • Non-contraceptive benefits: May improve acne, reduce menstrual cramps, regulate menstrual cycles, and decrease risk of ovarian and endometrial cancers.
  • Emergency contraception: Tri-Lo-sprintec is not for use as an emergency contraceptive.
  • Switching methods: Follow specific instructions when switching from other contraceptive methods to ensure continuous protection.
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Alternative Therapies

  • Progestin-only pills (mini-pills)
  • Progestin implants (e.g., Nexplanon)
  • Intrauterine devices (IUDs - hormonal or copper)
  • Depot medroxyprogesterone acetate (DMPA) injection (e.g., Depo-Provera)
  • Barrier methods (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 Available: Yes
Insurance Coverage: Tier 1 or 2 (often preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe and effective treatment, 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.