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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (C's) » Carbamazepine



WARNING

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.

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.

CATEGORIES, BRAND NAMES

CATEGORIES: Convulsions; Epilepsy; Neuralgia; Seizures, Tonic-clonic; Seizures; Pregnancy Category C; FDA Approved 1968 Mar; WHO Formulary

FDA Drug Class: Antiarthritics; Anticonvulsants; Central Pain Syndromes

BRAND NAMES: Apo-Carbamazepine; Atretol; Camapine; Carbadac; Carbagamma; Carbatol; Carbazene; Carbazep; Carbazina; Carbazine; Carmaz; Carmine; Carmine CR; Carpaz; Carzepin; Carzepine; Convuline; Degranol; Eleptin; Epileptol; Epileptol CR; Epitol; Foxalepsin; Foxalepsin Retard; Hermolepsin; Karbamazepin; Kodapan; Lexin; Macrepan; Mazepine; Mazetol; Neugeron; Neurotol; Neurotop; Neurotop Retard; Nordotol; Panitol; Sirtal; Tardotol; Taver; Tegol; Tegretal; Tegretol; Tegretol CR; Tegretol-S; Telesmin; Temporol; Temporal Slow; Teril; Timonil; Timonil Retard; Zeptol

COST OF THERAPY: $186.15 (Epilepsy; Tablet; 200 mg; 4/day; 365 days)





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