Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 23 February 2017
CONTRAINDICATIONS Carbamazepine should not be used in patients with a history of previous bone marrow
Likewise, on theoretical grounds its use with monoamine oxidase (MAO)
Before administration of carbamazepine,
Coadministration of carbamazepine and nefazodone may result in
Coadministration of carbamazepine with nefazodone is contraindicated.
PRECAUTIONS Before initiating therapy, a
Carbamazepine should be used with
Therapy should be prescribed only after
This occurred generally, but not solely, in
Hepatic effects, ranging from slight elevations in liver enzymes to
In some cases, hepatic effects may progress despite discontinuation of the drug.
This syndrome consists of a cholestatic process with a variable clinical course ranging from fulminant to
Some, but not all, cases are associated with features that overlap with other immunoallergenic syndromes such as multiorgan hypersensitivity (DRESS syndrome) and serious dermatologic reactions.
As an example there has been a report of vanishing bile duct syndrome associated with Stevens-Johnson syndrome and in another case an association with fever and eosinophilia.
Carbamazepine suspension contains sorbitol and, therefore, should not be administered to patients with
Patients should be informed of the availability of a Medication Guide and they should be instructed to read the Medication Guide before taking carbamazepine.
Patients should be made
These symptoms may include, but are not
The patient should be advised that, because these signs and symptoms may signal a
In addition, the patient should be advised that these signs and symptoms should be reported even if
Patients should be advised that serious skin reactions have been reported in association with carbamazepine.
In the event a skin reaction should occur while taking carbamazepine, patients should consult with their physician immediately (see WARNINGS).
Patients, their caregivers, and families should be counseled that AEDs, including carbamazepine, may increase the risk of
Carbamazepine may interact with some drugs.
Therefore, patients should be advised to report to their doctors the use of any other prescription or nonprescription medications or herbal products.
Since dizziness and drowsiness may occur,
This registry is collecting information about the
To enroll, patients can call
For genetically at-risk patients (see WARNINGS), high-resolution ' HLA -B * 1502 typing ' is
If a patient in
Discontinuation of the drug should be considered if any evidence of
Baseline and periodic evaluations of liver function, particularly in patients with a history of liver disease, must be performed during treatment with this drug since
Baseline and periodic eye examinations, including slit-lamp, funduscopy, and tonometry, are
Thyroid function tests have been reported to show decreased values with carbamazepine administered alone.
Hyponatremia has been reported in association with carbamazepine use, either alone or in combination with other drugs.
Interference with some pregnancy tests has been reported.
There has been a report of a patient who passed an orange
Thorazine ®* solution.
Subsequent testing has shown that mixing carbamazepine suspension and chlorpromazine solution (both generic and brand name) as well as carbamazepine suspension and liquid Mellaril ®, resulted in the occurrence of this precipitate.
Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medicinal agents or diluents (see DOSAGE AND ADMINISTRATION).
Drugs that have been shown, or would be expected, to
Drugs that have been shown, or that would be expected, to
Carbamazepine causes, or would be expected to cause, decreased levels of the following: acetaminophen, albendazole, alprazolam, aprepitant, buprenorphone, bupropion, citalopram, clonazepam, clozapine, corticosteroids (e.g. prednisolone, dexamethasone), cyclosporine, dicumarol, dihydropyridine calcium channel blockers (e.g. felodipine), doxycycline, ethosuximide, everolimus, haloperidol, imatinib, itraconazole, lamotrigine, levothyroxine, methadone, methsuximide, mianserin, midazolam, olanzapine, oral and other hormonal contraceptives, oxcarbazepine, paliperidone, phensuximide, phenytoin, praziquantel, protease inhibitors, risperidone, sertraline, sirolimus, tadalafil, theophylline, tiagabine, topiramate, tramadol, trazodone, tricyclic antidepressants (e.g. imipramine
amitriptyline, nortriptyline), valproate, warfarin, ziprasidone, zonisamide.
In concomitant use with carbamazepine, monitoring of concentrations or dosage
There is a
When carbamazepine is added to aripiprazole therapy,
When carbamazepine is withdrawn from the combination therapy,
When carbamazepine is used with tacrolimus, monitoring of
The use of concomitant strong CYP3A4 inducers such as
Based on pharmacokinetic studies, if patients must be coadministered carbamazepine with temsirolimus, an
If carbamazepine is started in a patient already taking lapatinib, the dose of lapatinib should be gradually titrated up.
Coadministration of carbamazepine with nefazodone results in
Coadministration of carbamazepine with nefazodone is contraindicated (see CONTRAINDICATIONS).
Concomitant administration of carbamazepine and lithium may increase the risk of neurotoxic side effects.
Concomitant medication with carbamazepine and some diuretics (hydrochlorothiazide, furosemide) may lead to symptomatic hyponatremia.
Alterations of thyroid function have been reported in combination therapy with other anticonvulsant medications.
Concomitant use of carbamazepine with hormonal contraceptive products (e.g. oral, and levonorgestrel subdermal implant contraceptives) may render
Alternative or back-up methods of contraception should be considered.
Resistance to the neuromuscular
Whether or not carbamazepine has the same effect on other non-depolarizing agents is unknown.
Carbamazepine, when administered to Sprague-Dawley
Carbamazepine must, therefore, be considered to be carcinogenic in Sprague-Dawley
Bacterial and mammalian mutagenicity studies using carbamazepine produced
The significance of these findings relative to the use of carbamazepine in humans is, at present, unknown.
Pregnancy Category D (see WARNINGS).
The effect of carbamazepine on human labor and delivery is unknown.
Carbamazepine and its epoxide metabolite are transferred to breast milk.
The ratio of the concentration in breast milk to that in maternal plasma is about 0.4 for carbamazepine and about 0.5 for the epoxide.
The estimated doses given to the newborn during breastfeeding are in the range of 2 to 5 mg daily for carbamazepine and 1 to 2 mg daily for the epoxide.
Because of the
Taken as a whole,
The evidence assembled was primarily obtained from
The most frequently observed
To minimize the possibility of such reactions, therapy should be initiated at
The following additional
In certain cases, discontinuation of therapy may be necessary.
Isolated cases of hirsutism have been reported, but
Some of these cardiovascular
Myocardial infarction has been associated with other tricyclic compounds.
Respiratory System: Pulmonary hypersensitivity characterized by fever, dyspnea, pneumonitis, or pneumonia.
Genitourinary System: Urinary frequency,
There have been
In dogs, it produced a brownish
Relevance of these findings to humans is unknown.
There have been reports of associated
Isolated cases of neuroleptic
Eyes: Scattered punctate cortical lens opacities,
Although a direct causal relationship has not been
Metabolism: Fever and chills.
Decreased levels of plasma calcium leading to osteoporosis have been reported.
Isolated cases of a lupus erythematosus-like syndrome have been reported.
There have been occasional reports of
A case of aseptic meningitis, accompanied by myoclonus and peripheral eosinophilia, has been reported in a patient taking carbamazepine in combination with other medications.
DOSAGE & ADMINISTRATION Carbamazepine suspension in combination with liquid chlorpromazine or thioridazine results in precipitate formation, and, in the case of chlorpromazine, there has been a report of a patient passing an orange
Because the extent to which this occurs with other liquid medications is not known, carbamazepine suspension should not be administered simultaneously with other liquid medications or diluents.
As soon as
Medication should be taken with meals.
Conversion of patients from oral carbamazepine tablets to carbamazepine suspension: Patients should be converted by administering the same number of mg per day in smaller, more frequent doses (i.e. b.i.d. tablets to t.i.d. suspension).
Carbamazepine extended-release is an extended-release formulation for twice-a-day administration.
When converting patients from carbamazepine conventional tablets to carbamazepine extended-release, the same total daily mg dose of carbamazepine extended-release should be administered.
Carbamazepine extended-release tablets must be swallowed whole and never
Carbamazepine extended-release tablets should be inspected for chips or
Carbamazepine extended-release tablet coating is not absorbed and is excreted in the feces; these coatings may be noticeable in the stool.
Epilepsy (SEE INDICATIONS AND USAGE) Adults and children over 12 years of age - Initial: Either 200 mg b.i.d. for tablets and extended-release tablets, or 1 teaspoon q.i.d. for suspension (400 mg/day).
Doses up to 1600 mg daily have been used in adults in
Children 6 to 12 years of age - Initial: Either 100 mg b.i.d. for tablets or extended-release tablets, or 1/2 teaspoon q.i.d. for suspension (200 mg/day).
Children under 6 years of age - Initial: 10 to 20 mg/kg/day b.i.d. or t.i.d. as tablets, or q.i.d. as suspension.
Combination Therapy: Carbamazepine may be used alone or with other anticonvulsants.
When added to existing anticonvulsant therapy,
Trigeminal Neuralgia (SEE INDICATIONS AND USAGE) Initial: On the first day, either 100 mg b.i.d. for tablets or extended-release tablets, or 1/2 teaspoon q.i.d. for suspension, for a total daily dose of 200 mg.
Maintenance: Control of
However, some patients may be maintained on as little as 200 mg daily, while
At least once every 3 months throughout the treatment period, attempts should be made to reduce the dose to the minimum
Dosage Information Initial Dose Subsequent Dose Maximum Daily Dose Indication Tablet * Extended-Release Tablets Suspension Tablet * Extended-Release Tablets Suspension Tablet * Extended-Release Tablets Suspension Epilepsy Under 6 yr 10-20 mg/kg/day b.i.d. or t.i.d. 10-20 mg/kg/
tsp q.i.d. (200 mg/day) Add up to 100 mg/day at weekly intervals, t.i.d. or q.i.d. Add 100 mg/day at weekly intervals, b.i.d. Add up to 1 tsp (100 mg)/day at weekly intervals, t.i.d. or q.i.d. 1000 mg/24
tsp q.i.d. (200 mg/day) Add up to 200 mg/day in increments of 100 mg every 12
tsp) q.i.d. 1200 mg/24
|Agency product number||33CM23913M|
|Date Last Revised||07-01-2016|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||REMEDYREPACK INC.|
These Reactions Are Estimated To Occur In 1 To 6 Per 10,000 New Users In Countries With Mainly Caucasian Populations, But
Studies In Patients Of Chinese Ancestry Have Found A
Hla-B * 1502 Is
Patients With Ancestry In Genetically At-Risk Populations Should Be Screened For The Presence Of Hla-B * 1502 Prior To Initiating Treatment With Carbamazepine.
Clearly Outweighs The Risk (See Warnings And Precautions, Laboratory Tests).
Aplastic Anemia And Agranulocytosis Aplastic Anemia And Agranulocytosis Have Been Reported In Association With The Use Of Carbamazepine.
Data From A Population-Based Case Control Study Demonstrate That The Risk Of Developing These Reactions Is 5 To
However, The Overall Risk Of
Although Reports Of Transient Or
However, The Vast Majority Of The Cases Of Leukopenia Have Not Progressed To The More
Nonetheless, Complete Pretreatment Hematological Testing Should Be Obtained As A Baseline.
If A Patient In
Discontinuation Of The Drug Should Be Considered If Any Evidence Of