Tri-Lo-mili Tablets
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.
Drug Class
Contraceptive
Pharmacologic Class
Estrogen/Progestin Combination
Pregnancy Category
Category X
FDA Approved
Mar 2002
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tri-Lo-mili is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norgestimate). It works primarily by preventing the release of an egg from the ovary (ovulation). It also thickens the fluid around the cervix to make it harder for sperm to reach the egg and changes the lining of the uterus to prevent a fertilized egg from implanting.
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 sexual intercourse frequently.
If you vomit or have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If vomiting or diarrhea 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 on what to do. 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.
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 sexual intercourse frequently.
If you vomit or have diarrhea, the effectiveness of this medication in preventing pregnancy may be reduced. If vomiting or diarrhea 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 on what to do. 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 one tablet every day at the same time 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 vomiting or severe diarrhea within 3-4 hours of taking a pill, treat it as a missed pill and use a backup method of contraception for 7 days.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily at the same time each day for 28 consecutive days, starting with the first active tablet on the first day of menstruation or the first Sunday after menstruation begins. Follow with placebo tablets for 7 days, then begin a new pack.
Condition-Specific Dosing:
missedDose:
If one active tablet is missed, take it as soon as remembered and take the next tablet at the regular time. If two active tablets are missed in a row in Week 1 or 2, take two tablets the day remembered and two tablets the next day, then continue with one tablet daily. Use back-up contraception for 7 days. If two active tablets are missed in a row in Week 3, or three or more active tablets are missed in a row anytime, discard the rest of the pack and start a new pack immediately (Day 1 start) or on the next Sunday (Sunday start). Use back-up contraception for 7 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Adolescents (post-menarche) use adult dosing.
Prepubertal:
Not indicated for prepubertal females.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Use with caution; monitor for fluid retention and electrolyte disturbances. No specific dose adjustment guidelines available.
Dialysis:
Not specifically studied; use with caution.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; monitor for adverse effects. Consider lower dose or alternative if clinically indicated.
Severe:
Contraindicated due to impaired steroid metabolism and potential for cholestasis.
Pharmacology
Mechanism of Action
Combination oral contraceptives (COCs) primarily act by suppressing gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]), which in turn inhibits ovulation. Additional mechanisms include changes in the cervical mucus, which increase the difficulty of sperm penetration, and changes in the endometrium, which reduce the likelihood of implantation.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-60% (due to first-pass metabolism). Norgestimate: Rapidly absorbed and extensively metabolized to active metabolites (norelgestromin and norgestrel).
Tmax:
Ethinyl Estradiol: 1-2 hours. Norelgestromin: 1.5 hours. Norgestrel: 1.5 hours.
FoodEffect:
Food does not significantly affect the bioavailability of norgestimate or ethinyl estradiol.
Distribution:
Vd:
Ethinyl Estradiol: Approximately 4.3 L/kg. Norelgestromin: Approximately 1.64 L/kg. Norgestrel: Approximately 2.49 L/kg.
ProteinBinding:
Ethinyl Estradiol: Approximately 98% (primarily to albumin). Norelgestromin: Approximately 97% (primarily to albumin and sex hormone-binding globulin [SHBG]). Norgestrel: Approximately 97% (primarily 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 5-13 mL/min/kg. Norelgestromin: Approximately 0.81 mL/min/kg. Norgestrel: Approximately 0.53 mL/min/kg.
ExcretionRoute:
Renal (urine) and fecal (bile).
Unchanged:
Very little unchanged drug is excreted.
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically begins after 7 consecutive days of active tablet use in the first cycle. Immediate protection if started on Day 1 of menstruation.
PeakEffect:
Not directly applicable for contraceptive effect; refers to steady-state plasma concentrations achieved after approximately 7 days of daily dosing.
DurationOfAction:
Daily dosing required for continuous contraceptive effect.
Safety & Warnings
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-mili, are contraindicated in women who are over 35 years of age and smoke.
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, 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 discuss any concerns with your doctor. If you experience 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
Fatigue or weakness
Enlarged or tender breasts
* Changes in menstrual cycle, including spotting or bleeding between periods
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 outdoors.
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.
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, 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 discuss any concerns with your doctor. If you experience 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
Fatigue or weakness
Enlarged or tender breasts
* Changes in menstrual cycle, including spotting or bleeding between periods
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 outdoors.
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: Abdominal pain (severe)
- C: Chest pain (severe), cough, shortness of breath
- H: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- E: Eye problems (sudden vision loss or blurring)
- S: Severe leg pain (calf or thigh), swelling, redness, or warmth
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. Be sure to describe the allergic reaction and its symptoms.
A history of certain health problems, 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
+ Chest pain caused by angina
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health problems, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Vaginal bleeding with an unknown cause
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 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 problems with your doctor and pharmacist to ensure safe treatment. Never start, stop, or change the dose of any medication without consulting 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. Be sure to describe the allergic reaction and its symptoms.
A history of certain health problems, 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
+ Chest pain caused by angina
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health problems, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Vaginal bleeding with an unknown cause
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 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 problems with your doctor and pharmacist to ensure safe treatment. Never start, stop, or change the dose of any medication without consulting your doctor.
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 Monitoring
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect 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 cholesterol and triglyceride levels. Discuss this risk with your doctor and have regular blood work checked as directed.
Breast Health and Gynecology
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. 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, and discuss the potential need for non-hormone birth control methods, such as condoms.
Allergic Reactions and Lab Tests
If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some products contain this ingredient. Inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.
Sexually Transmitted Diseases and Birth Control
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use latex or polyurethane condoms 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 breast cancer, although other studies have not confirmed this association. Additionally, 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.
Contraindications
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.
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 Monitoring
If you have diabetes (high blood sugar), consult your doctor, as this medication may affect 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 cholesterol and triglyceride levels. Discuss this risk with your doctor and have regular blood work checked as directed.
Breast Health and Gynecology
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. 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, and discuss the potential need for non-hormone birth control methods, such as condoms.
Allergic Reactions and Lab Tests
If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some products contain this ingredient. Inform all your healthcare providers and lab personnel that you are taking this medication, as it may affect certain lab tests.
Sexually Transmitted Diseases and Birth Control
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use latex or polyurethane condoms 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 breast cancer, although other studies have not confirmed this association. Additionally, 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.
Contraindications
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 (vaginal bleeding)
What to Do:
There is no specific antidote for overdose. Treatment is symptomatic and supportive. Contact a poison control center (e.g., 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., Carbamazepine, Phenytoin, Rifampin, Barbiturates, Topiramate, St. John's Wort)
- Aromatase inhibitors (e.g., Anastrozole, Letrozole)
- Certain HIV protease inhibitors (e.g., Ritonavir-boosted regimens)
- Certain non-nucleoside reverse transcriptase inhibitors (e.g., Efavirenz)
Moderate Interactions
- Broad-spectrum antibiotics (e.g., Ampicillin, Tetracycline - theoretical risk of reduced efficacy due to altered enterohepatic recirculation, though clinical significance is debated)
- Griseofulvin
- Grapefruit juice (may increase ethinyl estradiol levels)
- Lamotrigine (reduced lamotrigine levels)
- Thyroid hormone replacement therapy (increased thyroid binding globulin, requiring increased thyroid hormone dose)
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels)
- Ascorbic acid (Vitamin C, may increase ethinyl estradiol levels)
Monitoring
Baseline Monitoring
Complete medical history (including family history of thromboembolic disorders)
Rationale: To identify contraindications and risk factors for adverse events (e.g., VTE, cardiovascular disease, liver disease, certain cancers).
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 existing conditions that may be contraindications or require monitoring.
Timing: Prior to initiation of therapy.
Lipid profile
Rationale: To assess baseline cardiovascular risk, especially in patients with pre-existing dyslipidemia.
Timing: Consider prior to initiation, especially if risk factors are present.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <140/90 mmHg (or individualized target)
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may necessitate 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 and potential discontinuation.
Weight
Frequency: Annually, or more frequently if clinically indicated.
Target: Stable or healthy range
Action Threshold: Significant or rapid weight gain may warrant investigation.
Symptom Monitoring
- Severe abdominal pain (possible liver problems, blood clot)
- Severe chest pain, shortness of breath, or coughing up blood (possible blood clot in lungs or heart attack)
- Severe headaches, sudden partial or complete loss of vision, or double vision (possible stroke or blood clot in eye)
- Severe leg pain, swelling, warmth, or redness (possible deep vein thrombosis)
- Yellowing of skin or eyes (jaundice), dark urine, light-colored stools (possible liver problems)
- Lump in breast
- Mood changes, including depression
Special Patient Groups
Pregnancy
Contraindicated. There is no indication for Tri-Lo-mili in pregnancy, and there is evidence of fetal harm. Discontinue immediately if pregnancy is confirmed.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on the fetus, though data on specific risks are limited and conflicting. Generally, not recommended.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
Not recommended. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids and/or their metabolites are excreted in breast milk, which may affect the breastfed infant. Non-hormonal methods or progestin-only methods are generally preferred during lactation.
Infant Risk:
Potential for decreased milk supply, and exposure of the infant to hormones. Monitor infant for jaundice and breast enlargement.
Pediatric Use
Not indicated for use before menarche. Adolescents (post-menarche) can use Tri-Lo-mili at the same dosage as adults.
Geriatric Use
Not indicated for use in post-menopausal women. Safety and efficacy have not been established in this population. Estrogen-containing products are generally not recommended for contraception in women over 65.
Clinical Information
Clinical Pearls
- Breakthrough bleeding and spotting are common, especially during the first few cycles of use, and usually decrease over time. This does not necessarily indicate reduced contraceptive efficacy if pills are taken correctly.
- Non-contraceptive benefits include improvement of acne, reduction of dysmenorrhea (painful periods), and reduction of menorrhagia (heavy periods).
- Advise patients to use a backup method of contraception (e.g., condoms) for the first 7 days of the first cycle of use, or if pills are missed.
- Inform patients about 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.
Alternative Therapies
- Progestin-only pills (mini-pill)
- 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 (e.g., condoms, diaphragm, cervical cap)
- Spermicides
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations), often covered without cost-sharing under the Affordable Care Act for contraception.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 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 details about the medication taken, the amount, and the time it happened.