Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 22 February 2017
CONTRAINDICATIONS Tegretol 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 Tegretol,
Coadministration of carbamazepine and nefazodone may result in
Coadministration of carbamazepine with nefazodone is contraindicated.
PRECAUTIONS Before initiating therapy, a
Tegretol 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.
Tegretol suspension contains sorbitol and, therefore, should not be administered to patients with
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.
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
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.
Hyponatremia (see WARNINGS, General).
Decreased levels of plasma calcium have been reported.
Osteoporosis has 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 Tegretol 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, Tegretol suspension should not be administered simultaneously with other liquid medications or diluents.
As soon as
Medication should be taken with meals.
teaspoon q.i.d.) and to
Conversion of patients from oral Tegretol tablets to Tegretol 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).
Tegretol-XR is an extended-release formulation for twice-a-day administration.
When converting patients from Tegretol conventional tablets to Tegretol-XR, the same total daily mg dose of Tegretol-XR should be administered.
Tegretol -XR tablets must be swallowed whole and never
Tegretol-XR tablets should be inspected for chips or
Tegretol-XR tablet coating is not absorbed and is excreted in the feces; these coatings may be noticeable in the stool.
INDICATIONS AND USAGE) Adults and children over 12 years of age-Initial: Either 200 mg b.i.d. for tablets and XR 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 XR tablets, or?
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: Tegretol may be used alone or with other anticonvulsants.
When added to existing anticonvulsant therapy,
Interactions, and Pregnancy Category D).
Trigeminal Neuralgia (SEE INDICATIONS AND USAGE) Initial: On the first day, either 100 mg b.i.d. for tablets or XR tablets, or?
teaspoon q.i.d. for suspension, for a total daily dose of 200 mg.
teaspoon) q.i.d. for suspension, only as
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 * XR† Suspension Tablet * XR†
Suspension Tablet * XR†
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
NURSING MOTHERS Tegretol 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 Tegretol 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 Tegretol and 1 to 2 mg daily for the epoxide.
Because of the
|Agency product number||33CM23913M|
|Date Last Revised||19-10-2015|
|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 Tegretol.
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 Tegretol.
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
Because Of The Very
Agranulocytosis And Aplastic Anemia, The Vast Majority Of Minor Hematologic Changes Observed In Monitoring Of Patients On Tegretol Are Unlikely To Signal The Occurrence Of Either
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