Tri-Lo- Marzia Tablets 28s
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.
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.
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.
Available Forms & Alternatives
Available Strengths:
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, 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.
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
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
+ 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.
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 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.
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
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (used for Hepatitis C)
- Glecaprevir/pibrentasvir (used for Hepatitis C)
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.
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.
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
Baseline Monitoring
Rationale: To identify contraindications, risk factors for cardiovascular disease, VTE, and other conditions.
Timing: Prior to initiation
Rationale: To screen for hypertension, a contraindication or risk factor for COC use.
Timing: Prior to initiation
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)
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: N/A
Action Threshold: N/A
Frequency: At each visit or annually
Target: N/A
Action Threshold: Identify potential drug interactions or new contraindications.
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
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:
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.
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.
Geriatric Use
Not indicated for use in postmenopausal women. Contraception is not required in this population.
Clinical Information
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.
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)