Carbamazepine 100mg/5ml Shake Well
WARNING: Blood cell problems have happened, like aplastic anemia and a type of low white blood cell count. Tell your doctor right away if you feel very tired or weak or have a fever, chills, shortness of breath, any unexplained bruising or bleeding, or purple "splotches" on your skin.Call your doctor right away if you have any signs of infection like fever, chills, flu-like signs, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or a wound that will not heal.A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause severe health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.People with a certain gene (HLA-B*1502) have a higher chance of severe and sometimes deadly skin reactions with this drug. This gene is more common in Asian people, including South Asian Indian people. If you have questions, talk with the doctor.People with a certain gene (HLA-A*3101) may have a higher chance of severe allergic reactions with this drug. Allergic reactions can be deadly. If you have questions, talk with the doctor. @ COMMON USES: It is used to treat seizures.It is used to treat pain caused by a problem with a nerve in the face.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticonvulsant, Mood Stabilizer, Trigeminal Neuralgia Agent
Pharmacologic Class
Iminostilbene derivative, Sodium Channel Blocker
Pregnancy Category
D
FDA Approved
Apr 1968
DEA Schedule
Not Controlled
Overview
What is this medicine?
Carbamazepine is a medication used to treat certain types of seizures (epilepsy), nerve pain (like trigeminal neuralgia), and bipolar disorder. It works by calming overactive nerve signals in the brain.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food to help your body absorb it properly.
Before using, shake the medication well to mix the ingredients evenly.
If you're taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If you don't have one, ask your pharmacist for a device to measure your medication.
Do not mix your medication with any other liquid medications.
Avoid taking your medication at the same time as other liquid medications.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store your medication at room temperature, away from direct light.
Keep your medication in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom, as the moisture can affect its potency.
Keep all medications in a safe and secure location, 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 by your pharmacist.
Check with your pharmacist for guidance on disposing of medications, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
To ensure you get the most benefit from your medication, follow these steps:
Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication with food to help your body absorb it properly.
Before using, shake the medication well to mix the ingredients evenly.
If you're taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If you don't have one, ask your pharmacist for a device to measure your medication.
Do not mix your medication with any other liquid medications.
Avoid taking your medication at the same time as other liquid medications.
Storing and Disposing of Your Medication
To keep your medication effective and safe:
Store your medication at room temperature, away from direct light.
Keep your medication in a dry place, such as a closet or drawer.
Do not store your medication in a bathroom, as the moisture can affect its potency.
Keep all medications in a safe and secure location, 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 by your pharmacist.
Check with your pharmacist for guidance on disposing of medications, and consider participating in a drug take-back program in your area.
What to Do If You Miss a Dose
If you miss a dose of your medication:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Shake the oral suspension well before each use.
- Take with food to reduce stomach upset and improve absorption.
- Avoid grapefruit and grapefruit juice as it can increase carbamazepine levels.
- Do not stop taking this medication suddenly, as it can cause seizures or withdrawal symptoms. Always consult your doctor.
- Avoid alcohol and other CNS depressants, as they can increase drowsiness and dizziness.
- Use effective birth control methods, as carbamazepine can make hormonal contraceptives less effective.
- Be aware of potential sun sensitivity; use sunscreen and protective clothing.
- Carry identification stating you are taking carbamazepine, especially if you have epilepsy.
Available Forms & Alternatives
Available Strengths:
- Carbamazepine 100mg/5ml Shake Well
- Carbamazepine 200mg Tablets
- Carbamazepine 200mg Tablets
- Carbamazepine 100mg Chewable Tabs
- Carbamazepine ER 200mg Tablets
- Carbamazepine ER 400mg Tablets
- Carbamazepine 200mg ER Capsules
- Carbamazepine 100mg ER Capsules
- Carbamazepine 100mg ER Capsules
- Carbamazepine 300mg ER Capsules
- Carbamazepine 200mg ER Capsules
- Carbamazepine ER 100mg Tablets
- Carbamazepine ER 100mg Tablets
- Carbamazepine ER 200mg Tablets
- Carbamazepine ER 400mg Tablets
- Carbamazepine 200mg Chw Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 200 mg orally twice daily (or 100 mg four times daily for suspension). Maintenance: 800-1200 mg/day in divided doses.
Dose Range:
200 - 1600 mg
Condition-Specific Dosing:
epilepsy:
Initial: 200 mg orally twice daily (or 100 mg four times daily for suspension). Increase by up to 200 mg/day at weekly intervals. Maintenance: 800-1200 mg/day in divided doses. Max: 1600 mg/day.
trigeminalNeuralgia:
Initial: 100 mg orally twice daily (or 50 mg four times daily for suspension). Increase by up to 100 mg every 12 hours as needed. Maintenance: 200-400 mg twice daily. Max: 1200 mg/day.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Initial (6-12 years): 100 mg orally twice daily (or 50 mg four times daily for suspension) or 10-20 mg/kg/day in 2-3 divided doses. Increase by 100 mg/day at weekly intervals. Maintenance: 400-800 mg/day. Max: 1000 mg/day (6-12 years), 1200 mg/day (>12 years).
Adolescent:
Initial: 100 mg orally twice daily (or 50 mg four times daily for suspension). Increase by 100 mg/day at weekly intervals. Maintenance: 800-1200 mg/day in divided doses. Max: 1600 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for adverse effects.
Moderate:
No specific adjustment recommended, monitor for adverse effects.
Severe:
Use with caution, monitor closely for adverse effects and carbamazepine levels. Consider lower initial doses and slower titration.
Dialysis:
Carbamazepine is not significantly dialyzable. Supplementation after dialysis is generally not needed, but monitor levels.
Hepatic Impairment:
Mild:
No specific adjustment recommended, monitor LFTs.
Moderate:
Use with caution, monitor LFTs and carbamazepine levels closely. Consider lower initial doses and slower titration.
Severe:
Contraindicated in severe hepatic impairment due to risk of hepatotoxicity.
Pharmacology
Mechanism of Action
Carbamazepine stabilizes inactivated voltage-gated sodium channels, thereby inhibiting repetitive neuronal firing and reducing synaptic transmission. It also has effects on potassium channels, calcium channels, and neurotransmitter systems (e.g., adenosine, GABA). Its mood-stabilizing effects are thought to involve modulation of central noradrenergic and serotonergic systems.
Pharmacokinetics
Absorption:
Bioavailability:
75-85%
Tmax:
Oral suspension: 1.5 hours (range 0.5-6 hours); Tablets: 4-5 hours (range 2-12 hours)
FoodEffect:
Food can increase absorption and reduce peak concentrations, leading to more consistent plasma levels.
Distribution:
Vd:
0.8-1.9 L/kg
ProteinBinding:
75-80%
CnssPenetration:
Yes
Elimination:
HalfLife:
Initial: 25-65 hours; Chronic (autoinduction): 12-17 hours
Clearance:
Not available (highly variable due to autoinduction)
ExcretionRoute:
Renal (72%), Fecal (28%)
Unchanged:
2-3% (renal)
Pharmacodynamics
OnsetOfAction:
Variable, typically within hours to days for seizure control; weeks for mood stabilization.
PeakEffect:
Correlates with Tmax, but clinical effect may take longer due to autoinduction and need for steady state.
DurationOfAction:
Dependent on half-life, typically requires twice to four times daily dosing.
Safety & Warnings
BLACK BOX WARNING
SERIOUS DERMATOLOGIC REACTIONS AND HLA-B*1502 ALLELE: Serious and sometimes fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), have been reported with CARBAMAZEPINE. These reactions are estimated to occur in 1 to 6 per 10,000 new users in countries with mainly Caucasian populations, but the risk in some Asian countries is about 10 times higher. Studies in patients of Chinese ancestry have shown a strong association between the risk of developing SJS/TEN and the presence of the HLA-B*1502 allele. Prior to initiating CARBAMAZEPINE, test patients of Asian ancestry for the presence of HLA-B*1502 allele. Aplastic Anemia and Agranulocytosis: Aplastic anemia and agranulocytosis have been reported in association with the use of CARBAMAZEPINE. Patients should be advised of the early toxic signs and symptoms of a potential hematologic problem and the need to consult their physician immediately if such signs or symptoms appear. Complete pretreatment blood counts (including platelet count and reticulocyte count) should be obtained and should be repeated at regular intervals during therapy.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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 low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Changes in speech
Hallucinations (seeing or hearing things that are not there)
Changes in eyesight
Trouble walking
A severe and potentially life-threatening condition has occurred in people taking seizure medications like this one. Seek medical help immediately if you experience:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in the amount of urine passed
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
A rare but serious condition called neuroleptic malignant syndrome (NMS) may occur. Seek medical help immediately if you experience:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Change in thinking
Fast heartbeat
Abnormal heartbeat
Excessive sweating
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:
Feeling dizzy, sleepy, tired, or weak
Upset stomach or vomiting
Dry mouth
Constipation
This is not a complete 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 or seek immediate medical attention:
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 low sodium levels, including:
+ Headache
+ Trouble focusing
+ Memory problems
+ Feeling confused
+ Weakness
+ Seizures
+ Change in balance
Changes in speech
Hallucinations (seeing or hearing things that are not there)
Changes in eyesight
Trouble walking
A severe and potentially life-threatening condition has occurred in people taking seizure medications like this one. Seek medical help immediately if you experience:
Swollen glands
Fever
Rash
Painful sores in the mouth or around the eyes
Chest pain
Signs of kidney problems, such as:
+ Unable to pass urine
+ Change in the amount of urine passed
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
A rare but serious condition called neuroleptic malignant syndrome (NMS) may occur. Seek medical help immediately if you experience:
Fever
Muscle cramps or stiffness
Dizziness
Severe headache
Confusion
Change in thinking
Fast heartbeat
Abnormal heartbeat
Excessive sweating
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical help:
Feeling dizzy, sleepy, tired, or weak
Upset stomach or vomiting
Dry mouth
Constipation
This is not a complete 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:
- New or worsening skin rash, especially if it's severe, blistering, or involves mucous membranes (mouth, eyes, genitals).
- Fever, sore throat, mouth sores, easy bruising, or unusual bleeding (signs of blood problems).
- Yellowing of the skin or eyes, dark urine, severe stomach pain, or persistent nausea/vomiting (signs of liver problems).
- Swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing (signs of a severe allergic reaction).
- Confusion, dizziness, unsteadiness, or problems with coordination.
- New or worsening thoughts about suicide or self-harm.
- Changes in vision (e.g., blurred vision, double vision).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions and circumstances to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Kidney disease, as this may affect how your body processes the medication.
A history of bone marrow problems or porphyria, as these conditions may be exacerbated by the medication.
Fructose intolerance, as this medication may contain fructose or affect your body's ability to break it down.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat hepatitis C, HIV, infections, and other conditions, may interact with this medication and should be avoided.
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, health problems, and allergies. This will help them determine whether it is safe for you to take this medication and identify potential interactions. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions and circumstances to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Kidney disease, as this may affect how your body processes the medication.
A history of bone marrow problems or porphyria, as these conditions may be exacerbated by the medication.
Fructose intolerance, as this medication may contain fructose or affect your body's ability to break it down.
Any medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because certain medications, such as those used to treat hepatitis C, HIV, infections, and other conditions, may interact with this medication and should be avoided.
If you have taken specific medications for depression or Parkinson's disease within the last 14 days, including isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this may increase the risk of very high blood pressure.
To ensure your safety, it is crucial to provide your doctor and pharmacist with a comprehensive list of all your medications, health problems, and allergies. This will help them determine whether it is safe for you to take this medication and identify potential interactions. Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Monitoring and Follow-up
Regular blood tests will be necessary, as directed by your doctor. Additionally, schedule an eye exam as recommended by your doctor.
Interference with Lab Tests
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Pregnancy Testing
This medication may cause false results in some pregnancy tests. Discuss this with your doctor if you are concerned.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor.
Grapefruit Interaction
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with this medication.
Stopping the Medication
Do not suddenly stop taking this medication without consulting your doctor, as this may increase the risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually discontinue it.
Seizure Management
If your seizures change or worsen after starting this medication, inform your doctor promptly.
Mental Health
Like other seizure medications, this medication may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. If you have suicidal thoughts or actions, seek help right away.
Cardiovascular Risks
This medication may cause heart problems, including heart failure and abnormal heart rhythms, which can be fatal. Seek immediate medical attention if you experience a rapid, slow, or irregular heartbeat, severe dizziness, fainting, shortness of breath, significant weight gain, or swelling in your arms or legs.
Angioedema
A rare but potentially life-threatening reaction called angioedema can occur with this medication. Symptoms include swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing, or unusual hoarseness. Seek medical help immediately if you experience any of these symptoms.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility in men. Discuss this with your doctor.
Birth control pills and other hormone-based contraceptives may be less effective while taking this medication. Use an additional form of birth control, such as a condom.
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.
* If you are breastfeeding, consult your doctor to discuss potential risks to your baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Monitoring and Follow-up
Regular blood tests will be necessary, as directed by your doctor. Additionally, schedule an eye exam as recommended by your doctor.
Interference with Lab Tests
This medication may affect certain laboratory test results. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Pregnancy Testing
This medication may cause false results in some pregnancy tests. Discuss this with your doctor if you are concerned.
Interactions with Other Substances
Before consuming alcohol, marijuana, or other forms of cannabis, or taking prescription or over-the-counter medications that may cause drowsiness, consult your doctor.
Grapefruit Interaction
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with this medication.
Stopping the Medication
Do not suddenly stop taking this medication without consulting your doctor, as this may increase the risk of seizures. If you need to stop taking this medication, your doctor will guide you on how to gradually discontinue it.
Seizure Management
If your seizures change or worsen after starting this medication, inform your doctor promptly.
Mental Health
Like other seizure medications, this medication may rarely increase the risk of suicidal thoughts or actions, particularly in individuals with a history of suicidal behavior. Immediately contact your doctor if you experience new or worsening symptoms such as depression, anxiety, restlessness, irritability, panic attacks, or mood changes. If you have suicidal thoughts or actions, seek help right away.
Cardiovascular Risks
This medication may cause heart problems, including heart failure and abnormal heart rhythms, which can be fatal. Seek immediate medical attention if you experience a rapid, slow, or irregular heartbeat, severe dizziness, fainting, shortness of breath, significant weight gain, or swelling in your arms or legs.
Angioedema
A rare but potentially life-threatening reaction called angioedema can occur with this medication. Symptoms include swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing, or unusual hoarseness. Seek medical help immediately if you experience any of these symptoms.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
This medication may affect fertility in men. Discuss this with your doctor.
Birth control pills and other hormone-based contraceptives may be less effective while taking this medication. Use an additional form of birth control, such as a condom.
If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.
* If you are breastfeeding, consult your doctor to discuss potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Dizziness
- Drowsiness
- Nausea
- Vomiting
- Unsteady gait (ataxia)
- Nystagmus (involuntary eye movements)
- Dilated pupils
- Slurred speech
- Tremor
- Agitation
- Confusion
- Coma
- Seizures
- Respiratory depression
- Cardiac conduction disturbances (e.g., bradycardia, AV block)
- Hypotension
What to Do:
Call 911 or Poison Control (1-800-222-1222) immediately. Seek emergency medical attention. Treatment is supportive and may include gastric lavage, activated charcoal, and monitoring of vital signs and cardiac function.
Drug Interactions
Contraindicated Interactions
- MAO inhibitors (within 14 days)
- Nefazodone
- Delavirdine
- Boceprevir
- Telaprevir
- Voriconazole
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - significantly increase carbamazepine levels.
- Strong CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital) - significantly decrease carbamazepine levels.
- Other CNS depressants (e.g., alcohol, benzodiazepines, opioids) - increased sedation.
- Oral contraceptives - decreased efficacy of contraceptives.
- Warfarin - decreased anticoagulant effect.
- Lamotrigine, Valproic acid - altered levels of both drugs, increased risk of toxicity (especially lamotrigine rash).
- Clozapine - increased risk of agranulocytosis.
- Lithium - increased neurotoxicity.
Moderate Interactions
- Calcium channel blockers (e.g., felodipine, verapamil, diltiazem) - altered levels of both drugs.
- Tricyclic antidepressants (TCAs) - decreased TCA levels.
- SSRIs (e.g., fluoxetine, fluvoxamine) - increased carbamazepine levels.
- Theophylline - decreased theophylline levels.
- Cyclosporine, Tacrolimus - decreased immunosuppressant levels.
- Quetiapine - decreased quetiapine levels.
Minor Interactions
- Acetaminophen - increased risk of hepatotoxicity with chronic carbamazepine use.
- Diuretics (e.g., hydrochlorothiazide, furosemide) - increased risk of hyponatremia.
Monitoring
Baseline Monitoring
Complete Blood Count (CBC) with differential and platelet count
Rationale: Risk of aplastic anemia and agranulocytosis (Black Box Warning).
Timing: Prior to initiation
Liver Function Tests (LFTs)
Rationale: Risk of hepatotoxicity.
Timing: Prior to initiation
Renal Function Tests (BUN, Creatinine)
Rationale: Assess baseline kidney function.
Timing: Prior to initiation
Electrolytes (Sodium)
Rationale: Risk of hyponatremia.
Timing: Prior to initiation
HLA-B*1502 allele testing (for patients of Asian ancestry)
Rationale: Strong association with increased risk of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
Timing: Prior to initiation
Thyroid Function Tests (TFTs)
Rationale: Can cause asymptomatic decreases in thyroid hormones.
Timing: Prior to initiation
Ophthalmologic exam
Rationale: Rare reports of lens opacities and retinal changes.
Timing: Prior to initiation
Routine Monitoring
Complete Blood Count (CBC) with differential and platelet count
Frequency: Weekly for the first month, then monthly for 2-3 months, then quarterly or as clinically indicated.
Target: WBC >3000/mm³, ANC >1500/mm³, Platelets >100,000/mm³
Action Threshold: Discontinue if WBC <3000/mm³ or ANC <1000/mm³ or Platelets <100,000/mm³.
Liver Function Tests (LFTs)
Frequency: Monthly for the first few months, then quarterly or as clinically indicated.
Target: Within normal limits
Action Threshold: Discontinue if significant elevations (e.g., >3x ULN) or signs of liver injury.
Electrolytes (Sodium)
Frequency: Monthly for the first few months, then quarterly or as clinically indicated.
Target: 135-145 mEq/L
Action Threshold: Monitor closely if <135 mEq/L; consider dose reduction or discontinuation if symptomatic hyponatremia.
Carbamazepine plasma levels
Frequency: After 3-5 days of therapy, then periodically to guide dosing, especially during titration, with drug interactions, or if toxicity/lack of efficacy suspected.
Target: 4-12 mcg/mL (therapeutic range)
Action Threshold: Adjust dose to maintain levels within range or based on clinical response/toxicity.
Renal Function Tests (BUN, Creatinine)
Frequency: Annually or as clinically indicated.
Target: Within normal limits
Action Threshold: Not available
Thyroid Function Tests (TFTs)
Frequency: Annually or as clinically indicated.
Target: Within normal limits
Action Threshold: Not available
Symptom Monitoring
- Fever
- Sore throat
- Rash (especially severe, blistering, or widespread)
- Unusual bruising or bleeding
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Persistent nausea/vomiting
- Severe fatigue
- Swelling of face, lips, or tongue
- Difficulty breathing
- Changes in vision
- Confusion
- Dizziness
- Ataxia
- New or worsening suicidal thoughts or behavior
Special Patient Groups
Pregnancy
Carbamazepine is classified as Pregnancy Category D due to evidence of human fetal risk. It is associated with an increased risk of major congenital malformations, particularly neural tube defects (e.g., spina bifida), craniofacial defects (e.g., cleft lip/palate), and developmental delays. Use only if the potential benefit outweighs the potential risk to the fetus. Folic acid supplementation is recommended for women of childbearing potential.
Trimester-Specific Risks:
First Trimester:
Highest risk for neural tube defects and other major congenital malformations.
Second Trimester:
Continued risk of developmental effects; potential for growth restriction.
Third Trimester:
Risk of withdrawal symptoms in the neonate (e.g., irritability, tremor, feeding difficulties) if exposed late in pregnancy. Potential for coagulation defects in the neonate (vitamin K deficiency).
Lactation
Carbamazepine and its active metabolite are excreted into breast milk. While generally considered compatible with breastfeeding, monitor the infant for adverse effects such as drowsiness, poor feeding, weight gain, and signs of liver dysfunction (e.g., jaundice). Infant serum levels can be measured if concerns arise.
Infant Risk:
L3 (Moderately Safe) - Monitor infant for sedation, poor feeding, and weight gain. Potential for mild adverse effects.
Pediatric Use
Dosing is weight-based and age-dependent. Children may metabolize carbamazepine faster than adults, requiring higher mg/kg doses or more frequent dosing. Close monitoring of drug levels and adverse effects is crucial. Risk of dermatologic reactions (SJS/TEN) is higher in Asian children with HLA-B*1502 allele.
Geriatric Use
Start with lower doses and titrate slowly due to increased sensitivity to adverse effects (e.g., dizziness, ataxia, hyponatremia). Monitor closely for falls, cognitive changes, and electrolyte imbalances. Increased risk of hyponatremia.
Clinical Information
Clinical Pearls
- Always shake the oral suspension well before administering to ensure uniform dosing.
- Carbamazepine is a potent enzyme inducer, leading to numerous drug-drug interactions, including autoinduction of its own metabolism.
- Therapeutic drug monitoring (TDM) is essential, especially during initiation, dose adjustments, or when drug interactions are suspected.
- Patients of Asian ancestry should be screened for the HLA-B*1502 allele due to the significantly increased risk of SJS/TEN.
- Educate patients on the signs and symptoms of serious dermatologic and hematologic reactions and to seek immediate medical attention if they occur.
- Hyponatremia is a common side effect, especially in the elderly or those on diuretics; monitor sodium levels regularly.
- Consider folic acid supplementation for women of childbearing potential due to the risk of neural tube defects.
Alternative Therapies
- For Epilepsy: Valproic acid, Lamotrigine, Levetiracetam, Phenytoin, Oxcarbazepine, Topiramate, Gabapentin, Pregabalin.
- For Trigeminal Neuralgia: Oxcarbazepine, Gabapentin, Pregabalin, Baclofen.
- For Bipolar Disorder: Lithium, Valproic acid, Lamotrigine, Atypical antipsychotics (e.g., Quetiapine, Olanzapine).
Cost & Coverage
Average Cost:
$20 - $100+ per 450 mL (100mg/5mL)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.
This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.