Tri-Norinyl Tablets 28
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 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
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tri-Norinyl is a birth control pill that contains two female hormones, ethinyl estradiol (an estrogen) and norethindrone (a progestin). It works by preventing your body from releasing an egg (ovulation) and by changing your cervical mucus and the lining of your uterus to make it harder for sperm to reach an egg or for a fertilized egg to implant. It is taken daily to prevent pregnancy.
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.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication. After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. 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 a day, use an additional form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.
If you miss two periods in a row, 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 call your doctor for instructions. If you're using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a certain period 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.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication. After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. 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 a day, use an additional form of birth control and consult your doctor. If you're unsure what to do, call your doctor for guidance.
If you miss two periods in a row, 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 call your doctor for instructions. If you're using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a certain period 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 the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
- Use a backup method of birth control (like condoms) for the first 7 days when starting the pill or after missing pills.
- Attend all scheduled doctor's appointments for blood pressure checks and other health screenings.
- Inform your doctor about all medications, supplements, and herbal products you are taking, as they can interact with birth control pills.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally once daily, taken at the same time each day, for 28 consecutive days. The 28-day regimen consists of 21 active tablets followed by 7 inactive (placebo) tablets.
Condition-Specific Dosing:
first_start:
Start on the first day of menstruation or the first Sunday after menstruation begins.
missed_dose:
If one active tablet is missed, take it as soon as remembered. If two consecutive active tablets are missed in Week 1 or 2, take two tablets on the day remembered and two tablets the next day, then continue with one tablet daily. Use backup contraception for 7 days. If two consecutive active tablets are missed in Week 3, or three or more consecutive active tablets are missed anytime, discard the rest of the pack and start a new pack immediately (Day 1 start) or on the next Sunday (Sunday start). Use backup contraception for 7 days. If any inactive tablets are missed, discard them and continue with the next tablet as scheduled.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Dosing is the same as for adults once menarche has occurred and contraception is desired.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required.
Moderate:
No specific dose adjustment required.
Severe:
Use with caution due to potential for fluid retention; monitor blood pressure and fluid status.
Dialysis:
Considerations: Not specifically studied, but caution advised due to fluid retention.
Hepatic Impairment:
Mild:
Use with caution; monitor liver function.
Moderate:
Contraindicated due to impaired steroid metabolism.
Severe:
Contraindicated due to impaired steroid metabolism and risk of 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. They also cause changes in the cervical mucus, making it less permeable to sperm, and alter the endometrium, reducing its receptivity to implantation.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-45%; Norethindrone: Approximately 60-80%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours
FoodEffect:
Food may slightly decrease the rate but not the extent of absorption for both components.
Distribution:
Vd:
Ethinyl Estradiol: 2-4 L/kg; Norethindrone: 2-4 L/kg
ProteinBinding:
Ethinyl Estradiol: ~98% (primarily to albumin); Norethindrone: ~96-98% (primarily to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: Biphasic, terminal half-life ~10-20 hours; Norethindrone: ~5-14 hours
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone: ~0.4 L/hr/kg
ExcretionRoute:
Both primarily excreted in urine and feces as glucuronide and sulfate conjugates.
Unchanged:
Less than 5% of either drug is excreted unchanged.
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically achieved after 7 consecutive days of active tablet use.
PeakEffect:
Peak hormone levels reached within 1-2 hours after dosing.
DurationOfAction:
Daily dosing maintains consistent hormone levels for 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 Tri-Norinyl, 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out or 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 or severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
If you experience any of these symptoms, contact your doctor right away.
Blood Clots: Seek Medical Help Immediately
This medication may increase the risk of blood clots. If you notice any of the following symptoms, seek medical attention immediately:
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 may cause side effects in some people. While many individuals may not experience any side effects or only minor 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:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Signs of high blood pressure, such as:
+ Severe headache or dizziness
+ Passing out or 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 or severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
If you experience any of these symptoms, contact your doctor right away.
Blood Clots: Seek Medical Help Immediately
This medication may increase the risk of blood clots. If you notice any of the following symptoms, seek medical attention immediately:
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 may cause side effects in some people. While many individuals may not experience any side effects or only minor 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:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
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 unusual)
- E: Eye problems (sudden vision loss, blurred vision, bulging eyes)
- 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 and situations to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
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, or abnormal heart rhythms like atrial fibrillation
+ Chest pain caused by angina, heart attack, or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication should not be taken during pregnancy.
Breast-feeding or plans to breast-feed.
Previous experiences of jaundice during pregnancy or with estrogen use, such as hormonal birth control.
This list is not exhaustive, and 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 use of this medication. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances, and describe the symptoms you experienced.
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, or abnormal heart rhythms like atrial fibrillation
+ Chest pain caused by angina, heart attack, or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to sunlight or radiation.
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication should not be taken during pregnancy.
Breast-feeding or plans to breast-feed.
Previous experiences of jaundice during pregnancy or with estrogen use, such as hormonal birth control.
This list is not exhaustive, and 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 use of this medication. Do not initiate, stop, or adjust the dosage 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.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing blood clots.
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.
This medication 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. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as directed by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab workers that you are taking this 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.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
Taking this medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor.
The risk of blood clots is highest during the first year of using this medication and when restarting hormone-based birth control after a break of 4 weeks or more. Consult your doctor to discuss this risk.
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. If you have questions, discuss this with your doctor.
Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you experience any signs of pregnancy 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.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as it may increase your risk of developing blood clots.
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.
This medication 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. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as directed by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you consume grapefruit juice or eat grapefruit frequently, discuss this with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab workers that you are taking this 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.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
Taking this medication may increase the risk of blood clots, stroke, or heart attack. Discuss this with your doctor.
The risk of blood clots is highest during the first year of using this medication and when restarting hormone-based birth control after a break of 4 weeks or more. Consult your doctor to discuss this risk.
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. If you have questions, discuss this with your doctor.
Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
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)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevation)
- Glecaprevir/pibrentasvir (risk of ALT elevation)
Major Interactions
- Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Barbiturates, Topiramate, Oxcarbazepine, Felbamate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- Protease inhibitors (e.g., Ritonavir, Nelfinavir) - may alter COC metabolism.
- Non-nucleoside reverse transcriptase inhibitors (e.g., Efavirenz, Nevirapine) - may alter COC metabolism.
- Lamotrigine (COCs may decrease lamotrigine levels, leading to loss of seizure control).
Moderate Interactions
- Antibiotics (e.g., Ampicillin, Tetracycline) - theoretical risk of reduced efficacy due to altered gut flora, though clinical evidence is limited. Backup contraception often recommended.
- CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Voriconazole, Grapefruit juice) - may increase COC levels, potentially increasing side effects.
- Thyroid hormone replacement (COCs may increase thyroid-binding globulin, requiring increased thyroid hormone dose).
- Cyclosporine (COCs may increase cyclosporine levels, increasing toxicity risk).
- Theophylline (COCs may increase theophylline levels).
- Corticosteroids (COCs may decrease corticosteroid clearance, increasing effects).
Minor Interactions
- Acetaminophen (may increase ethinyl estradiol levels)
- Ascorbic acid (may increase ethinyl estradiol levels)
Monitoring
Baseline Monitoring
Complete medical history (including family history of cardiovascular disease, breast cancer, thromboembolism)
Rationale: To identify contraindications and risk factors for adverse events.
Timing: Prior to initiation of therapy.
Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To assess overall health, identify pre-existing conditions, and establish baseline values.
Timing: Prior to initiation of therapy.
Lipid profile (optional, based on risk factors)
Rationale: To assess cardiovascular risk, as COCs can affect lipid metabolism.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if hypertension develops or worsens.
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or change in contraception.
Weight
Frequency: Annually
Target: Maintain healthy BMI
Action Threshold: Significant weight gain may warrant discussion of alternative contraception or lifestyle changes.
Breast exam
Frequency: Annually
Target: Normal findings
Action Threshold: New lumps or changes require further investigation.
Cervical cancer screening (Pap test)
Frequency: As per national guidelines (e.g., every 3-5 years)
Target: Normal findings
Action Threshold: Abnormal results require follow-up.
Symptom Monitoring
- Severe abdominal pain (especially sudden, sharp, or radiating)
- Severe chest pain (sudden, crushing, or radiating to arm/jaw)
- Sudden shortness of breath or coughing up blood
- Severe headaches (sudden, worst ever, or associated with neurological symptoms)
- Sudden partial or complete loss of vision, double vision, or bulging eyes
- Severe leg pain, swelling, warmth, or redness (especially in one leg)
- Jaundice (yellowing of skin or eyes)
- Dark urine or light-colored stools
- Mood changes, depression
- Unusual vaginal bleeding or spotting
Special Patient Groups
Pregnancy
Tri-Norinyl is contraindicated during pregnancy. If pregnancy occurs while taking this drug, discontinue immediately. There is no evidence of teratogenicity from inadvertent exposure to COCs early in pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects has been found in women who inadvertently used COCs during early pregnancy.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Use is generally not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of steroids are excreted in breast milk and may affect the infant.
Infant Risk:
L4 (Possibly Hazardous): Potential for decreased milk supply and possible adverse effects on the infant (e.g., jaundice, breast enlargement). Non-hormonal methods or progestin-only methods are preferred during breastfeeding.
Pediatric Use
Safety and efficacy have been established for post-menarcheal adolescents. Use is not indicated before menarche.
Geriatric Use
Not indicated for use in postmenopausal women for contraception. Risks of cardiovascular events increase with age, especially in smokers.
Clinical Information
Clinical Pearls
- Tri-Norinyl is a triphasic oral contraceptive, meaning the hormone doses change throughout the cycle to mimic natural hormone fluctuations. This may help reduce side effects for some users.
- Consistency is key: Taking the pill at the exact same time every day significantly improves efficacy.
- Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves. If persistent or heavy, consult a healthcare provider.
- COCs do not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs). Use condoms for STI protection.
- Inform all healthcare providers (including dentists) that you are taking oral contraceptives, as they can interact with other medications or affect certain medical procedures.
Alternative Therapies
- Progestin-only pills (POPs)
- 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 or copper)
- Barrier methods (e.g., condoms, diaphragm, cervical cap)
- Spermicides
- Fertility awareness methods
- Permanent contraception (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
Not available (brand likely discontinued) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (for generics); often covered by most insurance plans under preventive care.
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 check with your pharmacist for more information. If you have any questions or concerns about your 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 details about the medication taken, the amount, and the time it was taken.