Norethindrone 0.35mg 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. @ 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
Progestin
Pregnancy Category
Category X
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Norethindrone 0.35mg is a 'mini-pill' or progestin-only birth control pill. It works primarily by making the mucus in your cervix thicker to block sperm and by changing the lining of your uterus to prevent pregnancy. It may also stop ovulation in some cycles. It's crucial to take one pill every day at the exact same time, without any breaks between packs, to ensure it works effectively.
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 the tablet with or without food, but consider taking it with food if you experience stomach upset. If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy, so use an additional form of birth control, such as condoms, until you consult with your doctor.
It's essential to take your medication as directed, even if you're spotting, bleeding, or feeling nauseous. Do not skip doses, as this can reduce the medication's effectiveness. If you miss two periods in a row, take a pregnancy test before starting a new cycle.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets can access it. Keep all medications in a safe location and dispose of unused or expired drugs properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist, who may be aware of local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. However, if you miss a dose by more than 3 hours, you'll need to use an additional form of birth control, such as a condom or spermicide, for the next 48 hours. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
To use this medication effectively, follow your doctor's instructions and read all the information provided. Take the tablet with or without food, but consider taking it with food if you experience stomach upset. If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy, so use an additional form of birth control, such as condoms, until you consult with your doctor.
It's essential to take your medication as directed, even if you're spotting, bleeding, or feeling nauseous. Do not skip doses, as this can reduce the medication's effectiveness. If you miss two periods in a row, take a pregnancy test before starting a new cycle.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms and areas where children and pets can access it. Keep all medications in a safe location and dispose of unused or expired drugs properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult your pharmacist, who may be aware of local drug take-back programs.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember and resume your regular schedule. However, if you miss a dose by more than 3 hours, you'll need to use an additional form of birth control, such as a condom or spermicide, for the next 48 hours. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
Lifestyle & Tips
- Take the pill at the exact same time every day, without fail. Missing a dose by even a few hours can reduce effectiveness.
- Use a backup method of contraception (e.g., condoms) for the first 7 days after starting the pill, or if you miss a pill, or if you start taking medications that can interfere with its effectiveness.
- Norethindrone does not protect against sexually transmitted infections (STIs). Use condoms for STI prevention.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking, especially St. John's Wort, rifampin, and certain seizure medications, as they can reduce the effectiveness of norethindrone.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.35 mg orally once daily, continuously, at the same time each day.
Dose Range:
0.35 - 0.35 mg
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
For post-menarcheal adolescents, same as adult dosing (0.35 mg orally once daily).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Dialysis:
No specific considerations; not significantly dialyzable.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution.
Severe:
Contraindicated in severe hepatic impairment or liver tumors.
Pharmacology
Mechanism of Action
Norethindrone, a progestin, primarily exerts its contraceptive effect by thickening cervical mucus, which inhibits sperm penetration. It also alters the endometrial lining, making it less receptive to implantation. Additionally, it may suppress ovulation in some cycles, though less consistently than combined oral contraceptives.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-100%
Tmax:
1-2 hours
FoodEffect:
Minimal or no significant effect.
Distribution:
Vd:
Relatively large (e.g., ~4 L/kg)
ProteinBinding:
Highly protein bound (~80% to albumin and sex hormone-binding globulin (SHBG)).
CnssPenetration:
Limited, but hormonal effects can occur.
Elimination:
HalfLife:
5-14 hours (variable)
Clearance:
Not readily available as a single rate; primarily hepatic clearance.
ExcretionRoute:
Urine (primarily as metabolites) and feces (primarily as metabolites).
Unchanged:
<1% (very little unchanged drug excreted).
Pharmacodynamics
OnsetOfAction:
Contraceptive effect begins after 48 hours (2 days) of consistent use. Backup contraception recommended for the first 7 days.
PeakEffect:
Peak plasma levels at 1-2 hours; contraceptive effect is continuous with daily dosing.
DurationOfAction:
24 hours (requires daily dosing to maintain contraceptive efficacy).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Stomach pain
Severe dizziness or fainting
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Breast-related symptoms, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Depression or other mood changes
Swelling
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Most people do not experience serious side effects, and some may only have minor side effects. However, if you notice any of the following symptoms and they bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache
Upset stomach or vomiting
Cramps
Bloating
Tender breasts
Trouble sleeping
Pimples (acne)
Weight gain
Dark patches of skin on the face (avoid sun exposure and use sunscreen)
* Period (menstrual) changes, including spotting or bleeding between cycles
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 right away:
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
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Stomach pain
Severe dizziness or fainting
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Breast-related symptoms, including:
+ Lump in the breast
+ Breast pain or soreness
+ Nipple discharge
Vaginal symptoms, including:
+ Itching or discharge
+ Abnormal vaginal bleeding
Depression or other mood changes
Swelling
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Other Possible Side Effects
Most people do not experience serious side effects, and some may only have minor side effects. However, if you notice any of the following symptoms and they bother you or do not go away, contact your doctor or seek medical attention:
Dizziness or headache
Upset stomach or vomiting
Cramps
Bloating
Tender breasts
Trouble sleeping
Pimples (acne)
Weight gain
Dark patches of skin on the face (avoid sun exposure and use sunscreen)
* Period (menstrual) changes, including spotting or bleeding between cycles
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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:
- Severe abdominal pain
- Chest pain, shortness of breath, or coughing up blood
- Severe headaches, especially if new or worse than usual
- Eye problems (e.g., sudden blurred vision, partial or complete loss of vision, flashing lights)
- Severe leg pain, swelling, or warmth in one leg
- Unexplained vaginal bleeding that is heavy or prolonged
- Sudden numbness or weakness on one side of the body
- Yellowing of the skin or eyes (jaundice)
- Lump in the breast
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:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
Certain medical conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver disease or liver tumors
+ Recent heart attack
+ Recent stroke
A history of specific health issues, such as:
+ Cancer of the uterus, ovary, cervix, or vagina
+ Vaginal bleeding with an unknown cause
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. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
Certain medical conditions, including:
+ Bleeding disorders
+ Blood clots or an increased risk of blood clots
+ Breast cancer
+ Liver disease or liver tumors
+ Recent heart attack
+ Recent stroke
A history of specific health issues, such as:
+ Cancer of the uterus, ovary, cervix, or vagina
+ Vaginal bleeding with an unknown cause
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. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may increase the risk of blood clots, stroke, or heart attack, so it is crucial to discuss this with your doctor.
If you have diabetes, you will need to closely monitor your blood sugar levels. Additionally, regular breast exams and gynecology check-ups are necessary, and you should continue to perform breast self-exams as instructed by your healthcare provider.
This medication may affect the results of certain laboratory tests, so it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug. If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Therefore, it is essential to inform your doctor about all your medications and health conditions. You may need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. To reduce the risk of transmission, use a latex or polyurethane condom during sexual activity. If you have questions or concerns, discuss them with your doctor.
Some studies have shown that taking birth control pills, especially at a younger age, may increase the risk of breast cancer. The risk may also be linked to the duration of use. One study found that the risk was higher in women who took birth control pills within the past 10 years.
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have questions or concerns, discuss them with your doctor.
The risk of ectopic pregnancy (pregnancy outside the uterus) may be higher in some individuals. If you experience symptoms such as vaginal bleeding, nausea, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale or sweaty skin, or confusion, seek medical attention immediately.
This medication is not intended for use in children who have not yet had their first menstrual period. If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
If you have diabetes, you will need to closely monitor your blood sugar levels. Additionally, regular breast exams and gynecology check-ups are necessary, and you should continue to perform breast self-exams as instructed by your healthcare provider.
This medication may affect the results of certain laboratory tests, so it is vital to inform all your healthcare providers and laboratory personnel that you are taking this drug. If you suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Therefore, it is essential to inform your doctor about all your medications and health conditions. You may need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. To reduce the risk of transmission, use a latex or polyurethane condom during sexual activity. If you have questions or concerns, discuss them with your doctor.
Some studies have shown that taking birth control pills, especially at a younger age, may increase the risk of breast cancer. The risk may also be linked to the duration of use. One study found that the risk was higher in women who took birth control pills within the past 10 years.
The risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have questions or concerns, discuss them with your doctor.
The risk of ectopic pregnancy (pregnancy outside the uterus) may be higher in some individuals. If you experience symptoms such as vaginal bleeding, nausea, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale or sweaty skin, or confusion, seek medical attention immediately.
This medication is not intended for use in children who have not yet had their first menstrual period. If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Vaginal bleeding (withdrawal bleeding)
What to Do:
Treatment is symptomatic and supportive. There is no specific antidote. Contact a poison control center or seek medical attention. Call 1-800-222-1222.
Drug Interactions
Major Interactions
- CYP3A4 inducers (e.g., rifampin, rifabutin, barbiturates, carbamazepine, phenytoin, oxcarbazepine, topiramate, St. John's Wort) - significantly reduce contraceptive efficacy.
- Certain antiretrovirals (e.g., efavirenz, nevirapine, ritonavir-boosted regimens) - may reduce efficacy.
Moderate Interactions
- Broad-spectrum antibiotics (e.g., ampicillin, tetracycline) - theoretical risk of reduced efficacy due to altered enterohepatic circulation, though evidence is less robust for progestin-only pills than combined OCs. Backup method often recommended.
- Griseofulvin - may reduce efficacy.
Monitoring
Baseline Monitoring
Complete medical history (including family history of VTE, breast cancer), physical examination (including blood pressure, breast and pelvic exam if indicated).
Rationale: To identify contraindications, assess suitability for hormonal contraception, and establish baseline health status.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood pressure, weight, general well-being, assessment of side effects (e.g., bleeding patterns).
Frequency: Annually or as clinically indicated.
Target: Normal for patient; stable weight.
Action Threshold: Significant changes in blood pressure, unexplained weight gain, persistent or severe adverse effects, or concerns about contraceptive efficacy.
Symptom Monitoring
- Irregular vaginal bleeding (spotting, breakthrough bleeding)
- Amenorrhea (prolonged absence of periods)
- Severe abdominal pain
- Severe headaches or migraines
- Vision changes (e.g., blurred vision, loss of vision, flashing lights)
- Leg pain or swelling (especially unilateral)
- Chest pain or shortness of breath
- Breast lumps
- Mood changes or depression
Special Patient Groups
Pregnancy
Norethindrone 0.35mg is contraindicated for use during pregnancy. If pregnancy occurs while taking norethindrone, the drug should be discontinued immediately.
Trimester-Specific Risks:
First Trimester:
Contraindicated for contraceptive use.
Second Trimester:
Contraindicated for contraceptive use.
Third Trimester:
Contraindicated for contraceptive use.
Lactation
Generally considered compatible with breastfeeding. Progestin-only pills are often preferred for breastfeeding mothers as they are less likely to affect milk supply compared to combined oral contraceptives. Small amounts of norethindrone pass into breast milk, but no adverse effects on infant development or growth have been reported in studies.
Infant Risk:
Low.
Pediatric Use
Not indicated for contraception in pre-menarcheal females. For post-menarcheal adolescents, dosing is the same as adults. Safety and efficacy are expected to be similar to adults.
Geriatric Use
Not indicated for contraception in post-menopausal women. No specific studies in geriatric populations for contraceptive use.
Clinical Information
Clinical Pearls
- The most critical instruction for norethindrone 0.35mg is to take it at the *exact same time* every single day. Missing a dose by even 3 hours can significantly reduce its contraceptive efficacy.
- Norethindrone-only pills are often a suitable option for women who have contraindications to estrogen (e.g., history of DVT/PE, migraine with aura, uncontrolled hypertension, breastfeeding, or those over 35 who smoke).
- Irregular bleeding (spotting, breakthrough bleeding) is a very common side effect, especially during the first few months of use. Patients should be counseled on this to improve adherence.
- Unlike combined oral contraceptives, norethindrone 0.35mg does not consistently suppress ovulation; its primary mechanisms are cervical mucus thickening and endometrial changes.
- Patients should be advised to use a backup method of contraception (e.g., condoms) for 7 days if they miss a pill or if they start taking medications known to interact (e.g., CYP3A4 inducers).
- There are no placebo pills in a pack of norethindrone 0.35mg; all pills contain active drug and are taken continuously.
Alternative Therapies
- Combined oral contraceptives (estrogen and progestin)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing, Annovera)
- Injectable progestins (e.g., Depo-Provera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs) - hormonal (e.g., Mirena, Skyla, Kyleena, Liletta) or copper (e.g., Paragard)
- Barrier methods (e.g., condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning/fertility awareness methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$10 - $50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations) under most insurance plans.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.