Meleya 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
X
FDA Approved
Aug 1973
DEA Schedule
Not Controlled
Overview
What is this medicine?
Meleya 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 helps prevent ovulation (the release of an egg) and changes the lining of your uterus to prevent pregnancy. You must take it at the exact same time every single day to be effective.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. You can take the tablet with or without food, but taking it with food may help if you experience stomach upset. However, if you vomit or have diarrhea, the medication may not work as well to prevent pregnancy, so be sure to 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 any doses. 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 in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of 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 check if there are 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 accompanying information carefully. You can take the tablet with or without food, but taking it with food may help if you experience stomach upset. However, if you vomit or have diarrhea, the medication may not work as well to prevent pregnancy, so be sure to 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 any doses. 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 in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of 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 check if there are 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 the pill at the same time every day, without missing any doses, even if you have bleeding or feel unwell. Consistency is key for effectiveness.
- If you miss a pill by more than 3 hours, use a backup method of birth control (like condoms) for the next 48 hours.
- Do not smoke, especially if you are over 35, as smoking increases the risk of serious cardiovascular side effects with hormonal contraceptives (though less so with progestin-only pills compared to combined pills).
- This pill does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms for STI protection.
- Inform your healthcare provider about all medications, herbal products, and supplements you are taking, as some can reduce the effectiveness of this birth control.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
0.35 mg orally once daily, taken at the same time each day, without interruption.
Dose Range:
0.35 - 0.35 mg
Condition-Specific Dosing:
contraception:
0.35 mg orally once daily, continuously.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
0.35 mg orally once daily, continuously (same as adult dose for post-menarcheal adolescents).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
No adjustment needed.
Dialysis:
No specific considerations; generally considered safe.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution; consider alternative methods.
Severe:
Contraindicated in severe liver disease 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 suppresses ovulation in a significant proportion of cycles (though less consistently than combined oral contraceptives) and thins the endometrium, making it less receptive to implantation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-70%
Tmax:
0.5-4 hours
FoodEffect:
Food may slightly increase absorption but is not clinically significant; can be taken with or without food.
Distribution:
Vd:
Approximately 4 L/kg
ProteinBinding:
Approximately 80% (to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 5-14 hours
Clearance:
Approximately 600 mL/min
ExcretionRoute:
Primarily urine (50-80%) and feces (20-40%) as metabolites.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy begins after 48 hours of consistent use; backup contraception recommended for the first 2 days.
PeakEffect:
Peak plasma concentrations reached within 0.5-4 hours.
DurationOfAction:
Requires daily dosing due to relatively short half-life; contraceptive effect is maintained with consistent daily administration.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
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, 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, change of color, or pain in a leg or arm
+ Trouble 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 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
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
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, 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, change of color, or pain in a leg or arm
+ Trouble 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 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
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
- Sudden, severe headache or migraine with aura
- Chest pain, shortness of breath, or coughing up blood
- Sudden vision changes (e.g., blurred vision, loss of vision)
- Weakness or numbness in an arm or leg
- Yellowing of the skin or eyes (jaundice)
- Lump in the breast
- Heavy or prolonged vaginal bleeding that is unusual for you
- Signs of depression (e.g., persistent sadness, loss of interest in activities)
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. Be sure to describe the allergic reaction and its symptoms.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
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
A history of specific female 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. Be sure to describe the allergic reaction and its symptoms.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
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
A history of specific female 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 is crucial to discuss these potential risks with your doctor.
If you have diabetes, it is vital to closely monitor your blood sugar levels while taking this medication. 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 essential 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.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Therefore, it is crucial to inform your doctor about all your medications and health conditions to determine if you need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
It is essential to note that 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 suggested that taking birth control pills, especially at a younger age, may increase the risk of developing breast cancer. The risk may also be linked to the duration of birth control pill 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 taking this medication. If you experience symptoms such as vaginal bleeding, nausea, 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, it is vital to closely monitor your blood sugar levels while taking this medication. 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 essential 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.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Therefore, it is crucial to inform your doctor about all your medications and health conditions to determine if you need to use a non-hormonal form of birth control, such as condoms, in addition to this medication.
It is essential to note that 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 suggested that taking birth control pills, especially at a younger age, may increase the risk of developing breast cancer. The risk may also be linked to the duration of birth control pill 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 taking this medication. If you experience symptoms such as vaginal bleeding, nausea, 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 (especially in females)
What to Do:
Overdose of norethindrone is generally not life-threatening. Treatment is supportive. Contact a poison control center or seek medical attention if symptoms are severe or concerning. Call 1-800-222-1222 for poison control.
Drug Interactions
Major Interactions
- Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, St. John's Wort): May significantly decrease norethindrone levels, leading to contraceptive failure.
- Certain HIV protease inhibitors (e.g., Ritonavir, Nelfinavir): May alter norethindrone metabolism.
Moderate Interactions
- Certain antibiotics (e.g., Ampicillin, Tetracycline): While the clinical significance is debated, some sources suggest reduced efficacy due to altered enterohepatic recirculation. Backup contraception is often recommended.
- Griseofulvin: May reduce contraceptive efficacy.
- Bosentan: May reduce contraceptive efficacy.
- Topiramate: May reduce contraceptive efficacy at higher doses.
- Modafinil: May reduce contraceptive efficacy.
Minor Interactions
- CYP3A4 inhibitors (e.g., Ketoconazole, Itraconazole, Erythromycin, Grapefruit juice): May increase norethindrone levels, potentially increasing side effects, but unlikely to be clinically significant for efficacy.
- Lamotrigine: Norethindrone may decrease lamotrigine levels, potentially reducing seizure control.
Monitoring
Baseline Monitoring
Complete medical history (including family history of VTE, breast cancer)
Rationale: To identify contraindications, risk factors, and inform contraceptive choice.
Timing: Prior to initiation
Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To assess overall health, rule out contraindications, and establish baseline for future monitoring. Pelvic exam and Pap test frequency should follow standard guidelines, not necessarily annually for contraception.
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 warrant discontinuation or change in contraception.
Weight/BMI
Frequency: Annually
Target: Healthy range
Action Threshold: Significant weight gain may warrant discussion of lifestyle or alternative contraception.
Review of side effects (e.g., irregular bleeding, mood changes, headache)
Frequency: At follow-up visits (e.g., 3 months, then annually)
Target: Patient comfort and adherence
Action Threshold: Persistent or severe side effects may require counseling or change in contraception.
Adherence to daily dosing
Frequency: At each visit
Target: Consistent daily use
Action Threshold: Frequent missed pills indicate need for counseling or alternative method.
Symptom Monitoring
- Unusual or severe abdominal pain
- Chest pain, shortness of breath, or coughing up blood (signs of pulmonary embolism)
- Severe headache or migraine with aura (though less common with POPs than COCs)
- Sudden partial or complete loss of vision
- Speech disturbances
- Weakness or numbness in an arm or leg
- Yellowing of skin or eyes (jaundice)
- Dark urine or light-colored stools
- Severe depression or mood changes
- Lump in the breast
- Unexplained vaginal bleeding (heavy or prolonged)
Special Patient Groups
Pregnancy
Norethindrone is contraindicated during pregnancy. If pregnancy occurs while taking norethindrone, the medication should be discontinued immediately. There is no evidence of teratogenicity with inadvertent exposure.
Trimester-Specific Risks:
First Trimester:
Contraindicated; discontinue if pregnancy is confirmed.
Second Trimester:
Contraindicated; discontinue if pregnancy is confirmed.
Third Trimester:
Contraindicated; discontinue if pregnancy is confirmed.
Lactation
Norethindrone is considered a preferred contraceptive option for breastfeeding women, especially after the immediate postpartum period (e.g., 6 weeks postpartum). Small amounts of norethindrone pass into breast milk, but no adverse effects on infant health or milk production have been consistently reported.
Infant Risk:
Low risk (L3 - compatible, but monitor for potential effects like changes in feeding patterns or weight gain, though rarely observed).
Pediatric Use
Norethindrone 0.35mg is indicated for contraception in post-menarcheal adolescents. Safety and efficacy are expected to be similar to adult women. Not indicated for pre-pubertal children.
Geriatric Use
Norethindrone 0.35mg is not indicated for contraception in postmenopausal women. However, norethindrone is used in higher doses for hormone therapy or management of gynecological conditions in older women. No specific dose adjustment is needed based on age alone, but contraindications (e.g., liver disease) should be considered.
Clinical Information
Clinical Pearls
- Progestin-only pills (POPs) are a good option for women who cannot take estrogen (e.g., breastfeeding, history of VTE, migraine with aura, uncontrolled hypertension).
- Strict adherence to the daily dosing time (within a 3-hour window) is crucial for effectiveness due to the short half-life of norethindrone.
- Irregular bleeding (spotting or breakthrough bleeding) is a common side effect, especially during the first few months of use, and should be counseled on.
- POPs do not have a hormone-free interval; all pills in the pack contain active drug.
- Efficacy may be reduced by certain medications, particularly CYP3A4 inducers. Always ask about all concomitant medications.
- Emergency contraception should be considered if pills are missed or if there is concern about reduced efficacy due to drug interactions.
Alternative Therapies
- Combined Oral Contraceptives (COCs)
- Depot Medroxyprogesterone Acetate (DMPA) injection (Depo-Provera)
- Etonogestrel implant (Nexplanon)
- Levonorgestrel Intrauterine System (IUS) (Mirena, Skyla, Kyleena, Liletta)
- Copper Intrauterine Device (IUD) (Paragard)
- Contraceptive patch (Xulane)
- Vaginal ring (NuvaRing, Annovera)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Fertility awareness methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (most generic formulations are covered by insurance plans, often with low or no co-pay under ACA)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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 overdose, including the medication taken, the amount, and the time it occurred.