Heather 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
Aug 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Heather 0.35mg is a birth control pill that contains only one hormone, norethindrone. It works mainly by making the mucus in your cervix thicker, which blocks sperm from reaching an egg. It also thins the lining of your uterus and can sometimes stop ovulation. You must take it at the exact same time every day 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 one 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 the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications 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. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember and return to 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 one 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 the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications 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. You may also want to explore drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember and return to 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 one tablet at the same time every day, without interruption, even during your period.
- If you miss a pill by more than 3 hours, take it as soon as you remember and use a backup birth control method (like condoms) for the next 48 hours.
- This pill does not protect against sexually transmitted infections (STIs). Always use condoms to prevent STIs.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking, especially St. John's Wort, as they can reduce the effectiveness of the pill.
- Keep all appointments for follow-up care and annual exams.
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
Condition-Specific Dosing:
missedDose:
If a dose is missed by more than 3 hours, use backup contraception for the next 48 hours. Continue taking one tablet daily.
postpartum:
Can be started immediately postpartum, including in breastfeeding women.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
0.35 mg orally once daily, continuously (same as adult dosing).
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:
No adjustment needed
Moderate:
Use with caution
Severe:
Contraindicated
Pharmacology
Mechanism of Action
Norethindrone, a progestin, primarily exerts its contraceptive effect by thickening cervical mucus, which inhibits sperm penetration. It also thins the endometrium, making it less receptive to implantation, and suppresses ovulation in approximately 50% of cycles.
Pharmacokinetics
Absorption:
Bioavailability:
60-100%
Tmax:
1-2 hours
FoodEffect:
Minimal effect on absorption.
Distribution:
Vd:
Approximately 4 L/kg
ProteinBinding:
Approximately 90% (primarily to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration:
Limited
Elimination:
HalfLife:
5-12 hours
Clearance:
Not readily available for specific dose
ExcretionRoute:
Approximately 50% renal (urine) and 50% fecal (bile)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Contraceptive effect begins within 24-48 hours, but backup contraception is recommended for the first 7 days of use.
PeakEffect:
Steady-state plasma concentrations are generally reached within 2-3 days of continuous dosing.
DurationOfAction:
Requires daily administration due to short half-life; contraceptive effect is maintained with continuous daily dosing.
Safety & Warnings
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 immediately or seek emergency medical attention:
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 or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance or coordination
+ Drooping on one side of the face or blurred vision
Severe stomach pain
Extreme dizziness or fainting
Vision changes or loss, bulging eyes, or changes in how contact lenses feel
Breast-related symptoms, such as:
+ 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, color change, or pain in a leg or arm
+ Difficulty speaking or swallowing
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms and they bother you or persist, contact your doctor:
Dizziness or headache
Upset stomach or vomiting
Cramps or bloating
Tender breasts
Difficulty sleeping
Acne (pimples)
Weight gain
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
Changes in menstrual cycle, including spotting or bleeding between periods
Reporting Side Effects
This is not an exhaustive list of possible 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 immediately or seek emergency medical attention:
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 or decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools or vomiting
+ Yellow skin or eyes
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance or coordination
+ Drooping on one side of the face or blurred vision
Severe stomach pain
Extreme dizziness or fainting
Vision changes or loss, bulging eyes, or changes in how contact lenses feel
Breast-related symptoms, such as:
+ 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, color change, or pain in a leg or arm
+ Difficulty speaking or swallowing
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms and they bother you or persist, contact your doctor:
Dizziness or headache
Upset stomach or vomiting
Cramps or bloating
Tender breasts
Difficulty sleeping
Acne (pimples)
Weight gain
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
Changes in menstrual cycle, including spotting or bleeding between periods
Reporting Side Effects
This is not an exhaustive list of possible 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:
- Severe abdominal pain (especially with missed period, may indicate ectopic pregnancy)
- Sudden, severe headache or vision changes
- Chest pain, shortness of breath, or coughing up blood
- Severe pain, swelling, or redness in one leg
- Yellowing of the skin or eyes (jaundice)
- Unexplained heavy or prolonged vaginal bleeding
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 symptoms you experienced.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you have a history of certain health 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
If you have a history of other specific health conditions, 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 symptoms you experienced.
If you are pregnant or think you may be pregnant. Do not take this medication if you are pregnant.
If you have a history of certain health 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
If you have a history of other specific health conditions, 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 developing blood clots, having a stroke, or experiencing a heart attack, so it's crucial to discuss these potential risks with your doctor.
If you have diabetes (high blood sugar), you will need to closely monitor your blood sugar levels while taking this medication. Regular breast exams and gynecology check-ups are also vital, 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 be sure to inform all your healthcare providers and laboratory personnel that you are taking this drug. If you suspect you may be pregnant or have a positive pregnancy test, contact your doctor immediately.
The effectiveness of hormone-based birth control may be reduced by certain medications, herbal products, or health conditions. Therefore, it's essential to inform your doctor about all your medications and health issues to determine if you need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
It's crucial to remember that this medication does not protect against sexually transmitted diseases like HIV or hepatitis. To reduce the risk of transmission, always use a latex or polyurethane condom during sexual activity. If you have questions or concerns, discuss them with your doctor.
Some studies have suggested a potential link between the use of birth control pills and an increased risk of breast cancer, particularly in younger women and those who have taken the pills for an extended period. Another study found that the risk may still be elevated in women who have taken birth control pills within the past 10 years.
Additionally, research has shown that women taking hormone-based birth control may have a higher risk of developing cervical cancer, although this may be attributed to other factors. If you have concerns or questions, discuss them with your doctor.
There may also be an increased risk of ectopic pregnancy (pregnancy outside the uterus) in some women taking this medication. If you experience symptoms such as vaginal bleeding, nausea or vomiting, 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 to discuss any potential risks to your baby.
If you have diabetes (high blood sugar), you will need to closely monitor your blood sugar levels while taking this medication. Regular breast exams and gynecology check-ups are also vital, 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 be sure to inform all your healthcare providers and laboratory personnel that you are taking this drug. If you suspect you may be pregnant or have a positive pregnancy test, contact your doctor immediately.
The effectiveness of hormone-based birth control may be reduced by certain medications, herbal products, or health conditions. Therefore, it's essential to inform your doctor about all your medications and health issues to determine if you need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
It's crucial to remember that this medication does not protect against sexually transmitted diseases like HIV or hepatitis. To reduce the risk of transmission, always use a latex or polyurethane condom during sexual activity. If you have questions or concerns, discuss them with your doctor.
Some studies have suggested a potential link between the use of birth control pills and an increased risk of breast cancer, particularly in younger women and those who have taken the pills for an extended period. Another study found that the risk may still be elevated in women who have taken birth control pills within the past 10 years.
Additionally, research has shown that women taking hormone-based birth control may have a higher risk of developing cervical cancer, although this may be attributed to other factors. If you have concerns or questions, discuss them with your doctor.
There may also be an increased risk of ectopic pregnancy (pregnancy outside the uterus) in some women taking this medication. If you experience symptoms such as vaginal bleeding, nausea or vomiting, 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 to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Vaginal bleeding (in females)
What to Do:
Overdose is generally not life-threatening. Treatment is supportive. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Major Interactions
- CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, barbiturates, topiramate, St. John's Wort, bosentan, felbamate, griseofulvin, modafinil, oxcarbazepine, rufinamide)
- Protease inhibitors (e.g., ritonavir, nelfinavir, lopinavir/ritonavir)
Moderate Interactions
- Broad-spectrum antibiotics (e.g., ampicillin, tetracycline) - theoretical risk of reduced efficacy, backup method often advised
- Aromatase inhibitors (e.g., anastrozole, letrozole) - concurrent use may reduce efficacy of both agents
- Thyroid hormones - may increase binding globulin levels, requiring increased thyroid hormone dose
Minor Interactions
- Acetaminophen (may increase norethindrone levels slightly)
- Ascorbic acid (may increase norethindrone levels slightly)
Monitoring
Baseline Monitoring
Medical history (including family history of cardiovascular disease, personal history of liver disease, undiagnosed vaginal bleeding)
Rationale: To identify contraindications or risk factors for adverse events.
Timing: Prior to initiation
Blood pressure
Rationale: To establish baseline and monitor for hypertension.
Timing: Prior to initiation
Weight/BMI
Rationale: To establish baseline and monitor for changes.
Timing: Prior to initiation
Physical examination (including breast and pelvic exam, Pap test)
Rationale: As per standard gynecological care, to rule out contraindications like pregnancy or malignancy.
Timing: Prior to initiation (as clinically indicated)
Routine Monitoring
Blood pressure
Frequency: Annually or as clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or alternative contraception.
Weight/BMI
Frequency: Annually
Target: Stable
Action Threshold: Significant, unexplained weight gain may warrant investigation.
Assessment of bleeding patterns
Frequency: At each visit or as patient reports concerns
Target: Acceptable for patient (irregular bleeding is common)
Action Threshold: Persistent, heavy, or prolonged bleeding, or amenorrhea with pregnancy concerns, requires investigation.
Review of side effects and adherence
Frequency: At each visit
Target: Patient tolerates medication and adheres to daily dosing
Action Threshold: Intolerable side effects or poor adherence may necessitate change in contraceptive method.
Symptom Monitoring
- Severe abdominal pain (especially with missed period, signs of ectopic pregnancy)
- Chest pain, shortness of breath, coughing up blood (signs of pulmonary embolism)
- Severe headache, sudden vision changes, numbness/weakness (signs of stroke)
- Severe leg pain, swelling, redness (signs of deep vein thrombosis)
- Yellowing of skin or eyes (jaundice, signs of liver problems)
- Changes in mood, depression
- Persistent irregular bleeding or amenorrhea
Special Patient Groups
Pregnancy
Norethindrone is contraindicated during pregnancy. If pregnancy occurs while taking this medication, discontinue use immediately. There is no evidence of teratogenicity with inadvertent exposure.
Trimester-Specific Risks:
First Trimester:
Contraindicated; no evidence of increased risk of birth defects with inadvertent exposure.
Second Trimester:
Contraindicated; no evidence of increased risk of birth defects with inadvertent exposure.
Third Trimester:
Contraindicated; no evidence of increased risk of birth defects with inadvertent exposure.
Lactation
Norethindrone is considered a preferred contraceptive option for breastfeeding women. It has minimal impact on milk production or composition and very low levels are excreted into breast milk, with no known adverse effects on the infant.
Infant Risk:
Low risk (L2)
Pediatric Use
Norethindrone 0.35mg is indicated for contraception in post-menarcheal adolescents. Dosing is the same as for adults. Safety and efficacy have not been established in pre-pubertal children.
Geriatric Use
Norethindrone 0.35mg is not indicated for contraception in postmenopausal women. No specific dose adjustments are provided for geriatric patients for other indications, but caution should be exercised due to potential comorbidities and polypharmacy.
Clinical Information
Clinical Pearls
- Progestin-only pills (POPs) like Heather are often chosen for women who cannot take estrogen (e.g., due to history of blood clots, migraines with aura, uncontrolled hypertension, or during breastfeeding).
- Strict adherence to the daily dosing time (within a 3-hour window) is critical for efficacy due to the short half-life of norethindrone.
- Irregular bleeding (spotting, breakthrough bleeding, or amenorrhea) is a common and expected side effect with POPs and does not necessarily indicate a lack of efficacy, but persistent or heavy bleeding should be evaluated.
- Counsel patients that POPs do not protect against STIs.
- Always advise backup contraception for 7 days when starting the pill or if a dose is missed by more than 3 hours.
Alternative Therapies
- Combined oral contraceptives (estrogen and progestin)
- Intrauterine devices (IUDs - hormonal or copper)
- Contraceptive implant (e.g., etonogestrel implant)
- Contraceptive injection (e.g., depot medroxyprogesterone acetate)
- Contraceptive patch
- Vaginal ring
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Sterilization (tubal ligation, vasectomy)
- Natural family planning 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)
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 this 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.