Mili Tablets 28s
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 and Progestin Combination
Pregnancy Category
Category X
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mili is a daily birth control pill that uses two hormones, an estrogen (ethinyl estradiol) and a progestin (norgestimate), to prevent pregnancy. It works mainly by stopping your body from releasing an egg each month (ovulation). It also changes the mucus in your cervix, making it harder for sperm to reach an egg, and changes the lining of your uterus, making it less likely for a fertilized egg to implant.
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 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.
Missing 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 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.
Missing 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
- Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
- Take one pill at the same time every day to ensure maximum effectiveness. If you miss pills, follow the instructions in the package insert carefully and use a backup birth control method (like condoms).
- Attend all scheduled follow-up appointments with your healthcare provider for blood pressure checks and annual exams.
- This medication does not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally daily for 28 consecutive days, starting on the first day of menstruation (Day 1 Start) or the first Sunday after menstruation begins (Sunday Start). The 28-day regimen typically consists of 21 active tablets (varying doses of norgestimate and ethinyl estradiol in a triphasic regimen) followed by 7 inactive/placebo tablets.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missedDose:
If one active tablet is missed, take it as soon as remembered and the next tablet at the usual time. If two or more active tablets are missed, refer to package insert for specific instructions, often requiring taking the last missed tablet, discarding others, continuing daily, and using backup contraception.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for post-menarcheal adolescents requiring contraception.
Prepubertal:
Not indicated for prepubertal girls.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Use with caution; close monitoring advised due to potential fluid retention.
Dialysis:
Not specifically studied; use with caution.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution; consider alternative methods.
Severe:
Contraindicated in severe hepatic dysfunction, liver tumors, or acute viral hepatitis.
Pharmacology
Mechanism of Action
Mili (norgestimate/ethinyl estradiol) acts primarily by suppressing gonadotropins (luteinizing hormone [LH] and follicle-stimulating hormone [FSH]), thereby inhibiting ovulation. Additional contraceptive effects 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 40-45% (due to first-pass metabolism); Norgestimate: Rapidly and extensively absorbed, then 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 2.8-8.6 L/kg; Norelgestromin: Approximately 1.6 L/kg.
ProteinBinding:
Ethinyl Estradiol: Approximately 98% (to albumin and sex hormone-binding globulin [SHBG]); Norelgestromin: Approximately 97% (to albumin and SHBG); Norgestrel: Approximately 99% (to SHBG).
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: Approximately 18-24 hours; Norelgestromin: Approximately 24-30 hours; Norgestrel: Approximately 36-45 hours.
Clearance:
Ethinyl Estradiol: Approximately 5-13 mL/min/kg.
ExcretionRoute:
Renal (approximately 40%) and fecal (approximately 60%) for both ethinyl estradiol and norgestimate metabolites.
Unchanged:
Minimal unchanged drug excreted.
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically begins after 7 consecutive days of active pill use, if started on Day 1 of menstruation, immediate protection is often assumed.
PeakEffect:
Steady-state concentrations are generally reached within 3-4 days of daily dosing.
DurationOfAction:
Requires daily administration for continuous contraceptive effect.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from 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, oral contraceptives, including 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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder, or between the shoulder blades
+ Yellow skin or eyes (jaundice)
+ Fever with chills
+ Bloating or severe upset stomach
+ Vomiting
Weakness on one side of the body
Difficulty speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Depression or other mood changes
Swelling
Urination problems (inability to pass urine or changes in urine output)
Breast changes, such as:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Severe or persistent spotting or vaginal bleeding
Vision changes, including:
+ Eyesight loss
+ Bulging eyes
+ Changes in how contact lenses feel
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Difficulty speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Weight gain
Headache
Upset stomach or vomiting
Gas
Feeling nervous or excitable
Stomach pain
Bloating
Fatigue or weakness
Breast changes, such as:
+ Enlarged breasts
+ Tender breasts
Menstrual changes, including:
+ Spotting or bleeding between cycles
* Dark patches of skin on the face (avoid sun exposure and use protective measures)
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 or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Fainting or changes in vision
Signs of gallbladder problems, including:
+ Pain in the upper right belly area, right shoulder, or between the shoulder blades
+ Yellow skin or eyes (jaundice)
+ Fever with chills
+ Bloating or severe upset stomach
+ Vomiting
Weakness on one side of the body
Difficulty speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred vision
Depression or other mood changes
Swelling
Urination problems (inability to pass urine or changes in urine output)
Breast changes, such as:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Severe or persistent spotting or vaginal bleeding
Vision changes, including:
+ Eyesight loss
+ Bulging eyes
+ Changes in how contact lenses feel
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, color changes, or pain in a leg or arm
+ Difficulty speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Weight gain
Headache
Upset stomach or vomiting
Gas
Feeling nervous or excitable
Stomach pain
Bloating
Fatigue or weakness
Breast changes, such as:
+ Enlarged breasts
+ Tender breasts
Menstrual changes, including:
+ Spotting or bleeding between cycles
* Dark patches of skin on the face (avoid sun exposure and use protective measures)
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)
- E: Eye problems (blurred vision, flashing lights, partial or complete loss of vision)
- S: Severe leg pain (calf or thigh), swelling, warmth, or redness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other health conditions, 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. Therefore, it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Ensure that it is safe to take this medication with your other medications and health conditions. Do not 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. Describe the allergic reaction and its symptoms.
A history of certain health conditions, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems
+ Heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other health conditions, 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. Therefore, it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Ensure that it is safe to take this medication with your other medications and health conditions. Do not 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 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 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 Tests and Allergies
This medication may affect certain lab tests. Inform all your healthcare providers and lab workers that you are taking this drug. If you are allergic to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some products contain this ingredient.
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
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. Discuss any concerns with your doctor. Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, talk to your doctor.
Pediatric Use
This medication should not be used in children who have not had their first menstrual period.
Pregnancy
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 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 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 Tests and Allergies
This medication may affect certain lab tests. Inform all your healthcare providers and lab workers that you are taking this drug. If you are allergic to tartrazine (FD&C Yellow No. 5), discuss this with your doctor, as some products contain this ingredient.
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
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. Discuss any concerns with your doctor. Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, talk to your doctor.
Pediatric Use
This medication should not be used in children who have not had their first menstrual period.
Pregnancy
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. Treatment is symptomatic. In case of suspected overdose, 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): Concomitant use can significantly increase ALT levels.
- Glecaprevir/pibrentasvir (used for Hepatitis C): Concomitant use can significantly increase ALT levels.
Major Interactions
- CYP3A4 Inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, Oxcarbazepine, Felbamate, Griseofulvin, St. John's Wort): Can significantly decrease plasma concentrations of ethinyl estradiol and norgestimate/norelgestromin, leading to reduced contraceptive efficacy and increased risk of breakthrough bleeding. Advise alternative or backup contraception.
- Certain Antibiotics (e.g., Ampicillin, Tetracycline): While clinical significance is debated, some reports suggest reduced efficacy due to interference with enterohepatic recirculation. Advise backup contraception during and for 7 days after antibiotic use.
- Lamotrigine: Oral contraceptives can significantly decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control. Dose adjustment of lamotrigine may be necessary.
Moderate Interactions
- CYP3A4 Inhibitors (e.g., Itraconazole, Ketoconazole, Voriconazole, Grapefruit Juice, Clarithromycin, Erythromycin): Can increase plasma concentrations of ethinyl estradiol and norgestimate/norelgestromin, potentially increasing side effects.
- Ascorbic Acid (Vitamin C): Can increase ethinyl estradiol levels.
- Acetaminophen: Can increase ethinyl estradiol levels.
- Atorvastatin: Can increase ethinyl estradiol levels.
- Thyroid Hormone Replacement Therapy: Oral contraceptives can increase thyroid-binding globulin, leading to increased total thyroid hormone levels but unchanged free hormone levels. Patients on thyroid hormone replacement may need increased doses.
Minor Interactions
- Corticosteroids: Oral contraceptives can decrease the clearance of corticosteroids, leading to increased plasma concentrations and potential for increased side effects.
- Theophylline: Oral contraceptives may decrease the clearance of theophylline.
Monitoring
Baseline Monitoring
Complete Medical History and Physical Examination
Rationale: To identify contraindications, risk factors for cardiovascular disease (e.g., smoking, hypertension, dyslipidemia, diabetes), and other conditions that may be affected by or contraindicate oral contraceptive use.
Timing: Prior to initiation of therapy.
Blood Pressure
Rationale: To establish baseline and identify hypertension, a risk factor for cardiovascular events.
Timing: Prior to initiation of therapy.
Breast and Pelvic Examination, Pap Smear
Rationale: Standard gynecological care; to screen for cervical cancer and breast abnormalities.
Timing: Prior to initiation of therapy, as clinically indicated.
Routine Monitoring
Blood Pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <120/80 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may necessitate discontinuation or change in contraceptive method.
Annual Physical Examination
Frequency: Annually.
Target: N/A
Action Threshold: Identification of new or worsening risk factors or contraindications.
Weight/BMI
Frequency: Annually.
Target: Healthy BMI (18.5-24.9 kg/m²)
Action Threshold: Significant weight gain may increase cardiovascular risk.
Symptom Monitoring
- Severe abdominal pain (possible liver tumor, blood clot)
- Severe chest pain, shortness of breath, coughing up blood (possible pulmonary embolism, myocardial infarction)
- Severe headaches, sudden partial or complete loss of vision, speech disturbances, weakness or numbness in an arm or leg (possible stroke)
- Severe leg pain, swelling, warmth, or redness (possible deep vein thrombosis)
- Jaundice (yellowing of skin or eyes), dark urine, light-colored stools (possible liver problems)
- Changes in vision (e.g., blurred vision, loss of vision)
- Depression or mood changes (especially if severe or persistent)
Special Patient Groups
Pregnancy
Mili is contraindicated during pregnancy. If pregnancy occurs while taking this drug, discontinue immediately. There is no evidence of increased risk of birth defects from inadvertent exposure to oral contraceptives early in pregnancy.
Trimester-Specific Risks:
First Trimester:
No evidence of increased risk of birth defects.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended during the immediate postpartum period or while breastfeeding. 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 infant.
Infant Risk:
Low risk of adverse effects on the infant, but potential for reduced milk supply and possible hormonal effects on the infant (e.g., jaundice, breast enlargement).
Pediatric Use
Not indicated for use in prepubertal girls. For post-menarcheal adolescents, the safety and efficacy are expected to be similar to adults.
Geriatric Use
Not indicated for use in postmenopausal women. Contraception is not required in this population.
Clinical Information
Clinical Pearls
- Mili is a triphasic oral contraceptive, meaning the dose of hormones changes throughout the 21 active pills. It's crucial to take the pills in the correct order as indicated on the blister pack.
- Non-contraceptive benefits of combined oral contraceptives include improvement of acne, regulation of menstrual cycles, reduction of menstrual pain (dysmenorrhea) and blood loss (menorrhagia), and a potential reduction in the risk of ovarian and endometrial cancers.
- Always advise patients to use a backup method of contraception (e.g., condoms) for the first 7 days when starting the pill, or if pills are missed, or when taking medications that may reduce efficacy.
- Counsel patients on the importance of not smoking while on oral contraceptives, especially if they are over 35 years old, due to the significantly increased risk of serious cardiovascular events.
Alternative Therapies
- Progestin-only pills (mini-pill)
- Contraceptive implant (e.g., Nexplanon)
- Injectable contraceptives (e.g., Depo-Provera)
- Intrauterine devices (IUDs - hormonal like Mirena, Skyla, Kyleena, Liletta; or non-hormonal like Paragard)
- Barrier methods (e.g., condoms, diaphragm, cervical cap)
- Spermicides
- Permanent sterilization (tubal ligation, vasectomy)
- Natural family planning/fertility awareness methods
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered with no or low co-pay under ACA mandates for contraception)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.