Camila 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?
Camila is a birth control pill that contains only one hormone, norethindrone. It works mainly by making the fluid in your cervix thicker, which helps block sperm from reaching an egg. It also changes the lining of your uterus to make it harder for a fertilized egg to implant. You must take this pill at the exact same time every single 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 accompanying information carefully. You can take the tablet with or without food, but if it causes stomach upset, take it with food. If you experience vomiting or 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 consecutive periods, 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 medications 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 with 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 accompanying information carefully. You can take the tablet with or without food, but if it causes stomach upset, take it with food. If you experience vomiting or 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 consecutive periods, 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 medications 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 with 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 one tablet at the same time every day, without missing any doses. Consistency is crucial for effectiveness.
- If you miss a dose 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.
- If you experience vomiting or severe diarrhea within 4 hours of taking a pill, treat it as a missed dose and use a backup method for 48 hours.
- This medication 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 supplements, and over-the-counter drugs you are taking, as some can reduce the effectiveness of Camila.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One 0.35 mg tablet orally once daily, at the same time each day, continuously without interruption.
Dose Range:
0.35 - 0.35 mg
Condition-Specific Dosing:
missedDose:
If a dose is missed by more than 3 hours, use a backup contraceptive method for the next 48 hours. If vomiting or severe diarrhea occurs within 4 hours of taking a tablet, use a backup method for 48 hours.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Adolescents who have reached menarche should follow adult dosing.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific adjustment, but monitor for fluid retention.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Use with caution; monitor for adverse effects.
Severe:
Contraindicated in acute liver disease or hepatic adenomas/carcinoma.
Pharmacology
Mechanism of Action
Norethindrone, a progestin, primarily exerts its contraceptive effect by thickening cervical mucus, which inhibits sperm penetration. It also alters the endometrium, making it unfavorable for implantation. While it may suppress ovulation in some cycles, this is not its primary mechanism of action as consistently as with combined oral contraceptives.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 60-70%
Tmax:
Approximately 1-2 hours
FoodEffect:
Minimal effect on absorption.
Distribution:
Vd:
Approximately 4 L/kg
ProteinBinding:
Approximately 80% (primarily to albumin and sex hormone-binding globulin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 5-14 hours
Clearance:
Approximately 0.4 L/hr/kg
ExcretionRoute:
Primarily renal (50-80%) and fecal (20-40%) as metabolites.
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically begins 48 hours after the first tablet if started correctly on the first day of menstruation. If started at other times, a backup method is needed for 48 hours.
PeakEffect:
Peak progestational effects (e.g., cervical mucus thickening) occur within hours of dosing.
DurationOfAction:
Requires daily administration due to relatively short half-life; contraceptive effect diminishes rapidly if doses are missed.
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, such as:
+ Itching or discharge
+ Abnormal vaginal bleeding
Depression or other mood changes
Swelling
Signs of a blood clot, including:
+ 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 no side effects or only mild 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 about side effects or experience any symptoms that concern you, contact your doctor for medical advice. 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, such as:
+ Itching or discharge
+ Abnormal vaginal bleeding
Depression or other mood changes
Swelling
Signs of a blood clot, including:
+ 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 no side effects or only mild 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 about side effects or experience any symptoms that concern you, contact your doctor for medical advice. 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 chest pain or shortness of breath
- Sudden, severe headache or migraine with aura
- Sudden vision changes (e.g., blurred vision, loss of vision)
- Severe leg pain, swelling, or redness (especially in one leg)
- Yellowing of skin or eyes (jaundice)
- Unexplained heavy 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 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.
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 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.
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 blood clots, stroke, or heart attack, so it's crucial to discuss this with your doctor.
If you have diabetes, you will need to monitor your blood sugar levels closely 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 lab 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's essential to inform your doctor about all your medications and health issues. 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, always 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 young 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 monitor your blood sugar levels closely 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 lab 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's essential to inform your doctor about all your medications and health issues. 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, always 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 young 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:
Overdose is generally not life-threatening. Treatment is supportive. Contact your poison control center (1-800-222-1222) or seek medical attention if symptoms are severe or concerning.
Drug Interactions
Major Interactions
- Strong CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, St. John's Wort, Topiramate, Oxcarbazepine, Griseofulvin, Ritonavir, Efavirenz): May significantly decrease norethindrone levels, leading to contraceptive failure.
- Certain HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors (NNRTIs): May alter norethindrone metabolism.
Moderate Interactions
- Moderate CYP3A4 inducers (e.g., Bosentan, Modafinil): May reduce norethindrone efficacy.
- Antibiotics (e.g., Ampicillin, Tetracycline): While less evidence for POPs than COCs, some sources suggest potential for reduced efficacy due to altered gut flora; backup method often recommended during and for 7 days after antibiotic use.
- Lamotrigine: Norethindrone may decrease lamotrigine levels, potentially leading to loss of seizure control.
Minor Interactions
- Ascorbic acid (Vitamin C): May increase norethindrone levels slightly.
- Acetaminophen: May increase norethindrone levels slightly.
Monitoring
Baseline Monitoring
Medical history and physical examination
Rationale: To identify contraindications or risk factors for hormonal contraceptive use.
Timing: Prior to initiation
Blood pressure
Rationale: To establish baseline and identify hypertension.
Timing: Prior to initiation
Pregnancy test
Rationale: To rule out existing pregnancy.
Timing: Prior to initiation
Routine Monitoring
Blood pressure
Frequency: Annually
Target: <140/90 mmHg
Action Threshold: Sustained elevation requiring evaluation or change in contraception.
Weight
Frequency: Annually
Target: Stable or within healthy BMI range
Action Threshold: Significant, unexplained weight gain or loss.
Annual physical exam (including breast and pelvic exam as indicated)
Frequency: Annually
Target: N/A
Action Threshold: Abnormal findings requiring further investigation.
Symptom Monitoring
- Irregular vaginal bleeding (spotting, breakthrough bleeding)
- Amenorrhea (absence of periods)
- Headaches (new onset or worsening)
- Abdominal pain (especially severe or persistent)
- Leg pain, swelling, or redness (signs of DVT)
- Chest pain or shortness of breath (signs of PE)
- Vision changes (blurred vision, loss of vision)
- Jaundice or severe itching (signs of liver problems)
- Mood changes, depression
Special Patient Groups
Pregnancy
Norethindrone is contraindicated during pregnancy. If pregnancy occurs while taking Camila, discontinue the medication immediately. There is no evidence of teratogenicity with inadvertent exposure during early pregnancy.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects reported with inadvertent exposure.
Second Trimester:
Not applicable, as contraception should be discontinued.
Third Trimester:
Not applicable, as contraception should be discontinued.
Lactation
Norethindrone is considered a preferred contraceptive option for breastfeeding women. Small amounts of norethindrone pass into breast milk, but studies have shown no adverse effects on infant health, growth, or milk production/quality.
Infant Risk:
Low risk to the infant. Considered compatible with breastfeeding.
Pediatric Use
Safety and efficacy have been established for post-menarcheal adolescents. Not indicated for use in pre-pubertal children.
Geriatric Use
Norethindrone is not indicated for contraception in postmenopausal women. No specific dosing adjustments are needed for elderly women if used for other indications (e.g., hormone therapy), but age-related decline in hepatic function should be considered.
Clinical Information
Clinical Pearls
- Progestin-only pills (POPs) are less forgiving than combined oral contraceptives (COCs) regarding missed doses. Strict adherence to the daily dosing time (within a 3-hour window) is critical for efficacy.
- POPs are a good option for women who cannot take estrogen, such as those with a history of DVT/PE, stroke, certain migraines with aura, uncontrolled hypertension, or who are breastfeeding.
- Irregular bleeding (spotting, breakthrough bleeding) is a common side effect, especially during the first few months of use. This usually improves over time.
- POPs may be associated with a slightly higher risk of ectopic pregnancy compared to no contraception, but the overall risk is still very low.
- Counsel patients on the importance of using a backup method if doses are missed or if they are taking interacting medications.
Alternative Therapies
- Other progestin-only pills (e.g., Slynd - drospirenone POP)
- Combined oral contraceptives (estrogen and progestin)
- Progestin-only injectable (Depo-Provera)
- Progestin-only implant (Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Vaginal ring (NuvaRing)
- Contraceptive patch (Xulane)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic) on most commercial and Medicaid plans, often covered without cost-sharing under the Affordable Care Act.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.