A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Tegretol Online, Description, Chemistry, Ingredients - Carbamazepine
Tegretol Online, Description, Chemistry, Ingredients - Carbamazepine
WARNING
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APLASTIC ANEMIA AND AGRANULOCYTOSIS HAVE BEEN
REPORTED IN ASSOCIATION WITH THE USE OF CARBAMAZEPINE. DATA
FROM A POPULATION-BASED CASE CONTROL STUDY DEMONSTRATE T.A.
THE RISK OF DEVELOPING THESE REACTIONS IS 5-8 TIMES GREATER
T.A. IN THE GENERAL
POPULATION. HOWEVER, THE OVERALL RISK OF THESE REACTIONS IN
THE UNTREATED GENERAL POPULATION IS LOW, APPROXIMATELY SIX
PATIENTS PER ONE MILLION POPULATION PER YEAR FOR AGRANULOCYTOSIS
AND TWO PATIENTS PER ONE MILLION POPULATION PER YEAR FOR APLASTIC
ANEMIA.
ALTHOUGH REPORTS OF TRANSIENT OR
PERSISTENT DECREASED PLATELET OR
WHITE BLOOD CELL COUNTS ARE NOT UNCOMMON IN ASSOCIATION WITH
THE USE OF CARBAMAZEPINE, DATA ARE NOT AVAILABLE TO
ESTIMATE ACCURATELY THEIR INCIDENCE OR
OUTCOME. HOWEVER, THE V.S.
MAJORITY OF THE CASES OF LEUKOPENIA HAVE NOT PROGRESSED TO
THE MORE SERIOUS CONDITIONS OF APLASTIC ANEMIA OR
AGRANULOCYTOSIS.
BECAUSE OF THE VERY
LOW INCIDENCE OF AGRANULOCYTOSIS AND APLASTIC ANEMIA, THE
V.S. MAJORITY OF
MINOR HEMATOLOGIC CHANGES OBSERVED IN MONITORING OF PATIENTS
ON CARBAMAZEPINE ARE
UNLIKELY TO SIGNAL
THE OCCURRENCE OF EITHER ABNORMALITY. NONETHELESS, COMPLETE
PRETREATMENT HEMATOLOGICAL TESTING SHOULD BE OBTAINED AS
BASELINE. IF A PATIENT IN THE COURSE OF TREATMENT EXHIBITS
LOW OR DECREASED WHITE
BLOOD CELL OR PLATELET
COUNTS, THE PATIENT SHOULD BE MONITORED CLOSELY. DISCONTINUATION
OF THE DRUG SHOULD BE CONSIDERED IF ANY EVIDENCE OF SIGNIFICANT
BONE MARROW DEPRESSION DEVELOPS.
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DESCRIPTION
Before prescribing carbamazepine, the physician
should be thoroughly familiar with the details of this prescribing
information, particularly regarding use with other drugs, especially
those which accentuate toxicity potential.
Carbamazepine USP is an anticonvulsant
and specific analgesic
for trigeminal neuralgia, available for oral
administration
as chewable tablets of 100 mg, tablets of 200 mg, XR tablets of
100, 200, and 400 mg, and as a suspension of 100 mg/5 ml
(teaspoon). Its chemical
name is 5H-dibenz(b,f)azepine-5-carboxamide.
Carbamazepine USP is a white
to off-white powder, practically insoluble in water
and soluble in alcohol
and in acetone. It molecular weight
is 236.27.
Inactive Ingredients
Tablets: Colloidal silicon
dioxide, FD&C Red No. 30 (chewable tablets only), FD&C Red
No. 40 (200-mg tablets only), flavoring (chewable tablets only),
gelatin, glycerin, magnesium
stearate, sodium starch
glycolate (chewable tablets only), starch,
stearic acid, and sucrose
(chewable tablets only).
XR Tablets: cellulose
compounds, dextrates, iron
oxides, magnesium stearate, mannitol, polyethylene
glycol, sodium lauryl
sulfate, titanium dioxide (200-mg tablets only).
Suspension: Citric acid,
FD&C Yellow No. 6, flavoring, polymer, potassium sorbate, propylene
glycol, purified water, sorbitol, sucrose, and xanthan gum.
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