Tri-Lo- Marzia Tablets 28s

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Ethinyl Estradiol and Norgestimate(ETH in il es tra DYE ole & nor JES ti mate) Pronunciation TRY-low-MAR-zee-uh (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
Sep 2002
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tri-Lo-Marzia 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 making it harder for sperm to reach the egg. It's 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.

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 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 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 the pill at the same time every day to maximize effectiveness and minimize breakthrough bleeding.
  • Do not smoke, especially if you are over 35, as smoking significantly increases the 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.
  • Inform your doctor 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 orally once daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. Follow the 21 active tablets (light blue, blue, dark blue) with 7 inactive tablets (white).

Condition-Specific Dosing:

missedDose: If one active tablet is missed, take it as soon as remembered. If two or more active tablets are missed, refer to package insert for specific instructions, which may include taking two tablets daily until caught up and using back-up contraception.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Dosing is the same as for adults once menstruation has begun and contraception is desired.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Contraindicated
Severe: Contraindicated

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) like Tri-Lo-Marzia primarily act by suppressing gonadotropins, which in turn inhibits ovulation. Other mechanisms include changes in the cervical mucus (increasing its viscosity to impede sperm penetration) and alterations in the endometrium (rendering it unfavorable for implantation). The estrogen component (Ethinyl Estradiol) suppresses FSH release, while the progestin component (Norgestimate) suppresses LH release and contributes to cervical mucus and endometrial changes.
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-45%; Norgestimate: Not directly available (prodrug), but active metabolite norelgestromin ~90%
Tmax: Ethinyl Estradiol: ~1.5 hours; Norelgestromin (active metabolite of Norgestimate): ~1.5 hours
FoodEffect: Food does not significantly affect the extent of absorption of norgestimate or ethinyl estradiol.

Distribution:

Vd: Ethinyl Estradiol: ~4-13 L/kg; Norelgestromin: ~1.6 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (to albumin and SHBG); Norelgestromin: >97% (to albumin and SHBG)
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~10-20 hours; Norelgestromin: ~28 hours
Clearance: Not available
ExcretionRoute: Renal (urine) and Fecal (bile)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Contraceptive effect typically begins after 7 consecutive days of active tablet use, assuming the first tablet was taken on the first day of menstruation or the first Sunday after menstruation begins.
PeakEffect: Not directly applicable for contraceptive effect, but steady-state plasma concentrations are reached within 7 days for both components.
DurationOfAction: Daily dosing maintains contraceptive effect; protection is lost if pills are missed.
Confidence: Medium

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-Marzia, are contraindicated in women who are over 35 years of age and 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, 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, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent vaginal bleeding or spotting
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, changes in color, or pain in a leg or arm
+ 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 mild ones, it's essential to contact your doctor if you notice any of the following:

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

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

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**bdominal pain (severe)
  • **C**hest pain (severe), cough, shortness of breath
  • **H**eadaches (severe, sudden, or worse than usual)
  • **E**ye problems (blurred vision, flashing lights, partial or complete loss of vision)
  • **S**evere leg pain (calf or thigh), swelling, redness, or warmth
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine or light-colored stools
  • Unexplained swelling of hands, ankles, or feet
  • Depressed mood or changes in mood
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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 cancer, vaginal cancer, or unexplained vaginal bleeding
If you experienced jaundice (yellowing of the skin and eyes) during pregnancy or while taking estrogen-based 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 existing treatments and health status. 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. 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 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 also 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 risk with your doctor and have your blood work checked as directed.

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

Birth Control and Hormone Interactions
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.

Cancer Risks
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, some studies have shown a potential increased risk of breast cancer with long-term use, while others have not. 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
  • Withdrawal bleeding (vaginal bleeding that may occur a few days after stopping the pills)

What to Do:

Overdose is generally not life-threatening. Treatment is supportive. If a large overdose is suspected, contact a poison control center (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

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Contraindicated Interactions

  • Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used for Hepatitis C)
  • Glecaprevir/pibrentasvir (used for Hepatitis C)
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Major Interactions

  • Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Topiramate, Griseofulvin, Oxcarbazepine, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
  • Certain HIV protease inhibitors (e.g., Ritonavir, Nelfinavir) and non-nucleoside reverse transcriptase inhibitors (e.g., Nevirapine, Efavirenz) - may alter COC levels.
  • Lamotrigine - COCs may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
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Moderate Interactions

  • Antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of decreased efficacy due to altered gut flora, though clinical significance is debated. Use back-up contraception.
  • Grapefruit juice - may increase ethinyl estradiol levels, potentially increasing adverse effects.
  • Atorvastatin, Rosuvastatin - may increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
  • Acetaminophen - may increase ethinyl estradiol levels.
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Minor Interactions

  • Thyroid hormone replacement therapy - COCs may increase thyroid-binding globulin, requiring increased thyroid hormone dose.
  • Corticosteroids - COCs may increase plasma concentrations of corticosteroids.

Monitoring

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Baseline Monitoring

Complete medical history (including family history)

Rationale: To identify contraindications, risk factors for cardiovascular disease, VTE, and other conditions.

Timing: Prior to initiation

Blood pressure measurement

Rationale: To screen for hypertension, a contraindication or risk factor for COC use.

Timing: Prior to initiation

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

Rationale: To assess overall health and screen for gynecological conditions. Note: Pelvic exam and Pap test are not required before initiating COCs but are part of routine women's health care.

Timing: Prior to initiation (as per routine care guidelines)

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Routine Monitoring

Blood pressure measurement

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

Frequency: Annually

Target: N/A

Action Threshold: N/A

Review of medication list and health changes

Frequency: At each visit or annually

Target: N/A

Action Threshold: Identify potential drug interactions or new contraindications.

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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 (blurred vision, loss of vision) (E)
  • Severe leg pain (calf or thigh), swelling, redness, or warmth (S)
  • Jaundice (yellowing of skin or eyes)
  • Mood changes, depression
  • Unusual vaginal bleeding or spotting
  • Lump in breast

Special Patient Groups

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Pregnancy

Tri-Lo-Marzia is contraindicated during pregnancy. There is no indication for use of COCs in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure to COCs during early pregnancy.

Trimester-Specific Risks:

First Trimester: Contraindicated. No increased risk of birth defects observed with inadvertent exposure.
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. Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk, potentially affecting the infant.

Infant Risk: Potential for decreased milk supply and possible adverse effects on the infant (e.g., jaundice, breast enlargement). Progestin-only methods are generally preferred for breastfeeding women.
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Pediatric Use

Safety and efficacy are established for women of reproductive age. Use is not indicated before menarche. Dosing for post-menarcheal adolescents is the same as for adults.

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Geriatric Use

Not indicated for use in postmenopausal women. Contraception is not required in this population.

Clinical Information

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Clinical Pearls

  • Emphasize strict adherence to the daily dosing schedule for optimal contraceptive efficacy.
  • Counsel patients on the importance of using back-up contraception (e.g., condoms) during the first 7 days of the first cycle, or if pills are missed.
  • Educate patients about the 'ACHES' mnemonic for recognizing serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain).
  • Reinforce the contraindication for smoking, especially in women over 35, due to increased cardiovascular risk.
  • Be aware of potential drug interactions, particularly with enzyme-inducing medications, which can reduce contraceptive effectiveness.
  • Breakthrough bleeding and spotting are common, especially during the first few cycles, and usually resolve with continued use. Counsel patients not to discontinue due to this unless severe or persistent.
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Alternative Therapies

  • Progestin-only pills (mini-pills)
  • Progestin injections (e.g., Depo-Provera)
  • Progestin implants (e.g., Nexplanon)
  • Intrauterine devices (IUDs - hormonal and non-hormonal)
  • Barrier methods (e.g., condoms, diaphragm)
  • Spermicides
  • Natural family planning methods
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $20 - $60 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 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 is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.