TEGRETOL- carbamazepine suspension TEGRETOL- carbamazepine tablet TEGRETOL XR- carbamazepine tablet, extended release

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

CARBAMAZEPINE (UNII: 33CM23913M) (CARBAMAZEPINE - UNII:33CM23913M)

Disponível em:

Novartis Pharmaceuticals Corporation

DCI (Denominação Comum Internacional):

CARBAMAZEPINE

Composição:

CARBAMAZEPINE 100 mg in 5 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Tegretol is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Tegretol as an anticonvulsant was derived from active drug-controlled studies that enrolled patients with the following seizure types: - Partial seizures with complex symptomatology (psychomotor, temporal lobe). Patients with these seizures appear to show greater improvement than those with other types. - Generalized tonic-clonic seizures (grand mal). - Mixed seizure patterns which include the above, or other partial or generalized seizures. Absence seizures (petit mal) do not appear to be controlled by Tegretol (see PRECAUTIONS, General). Tegretol is indicated in the treatment of the pain associated with true trigeminal neuralgia. Beneficial results have also been reported in glossopharyngeal neuralgia. This drug is not a simple analgesic and should not be used for the relief of trivial aches or pains. Tegretol should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug,

Resumo do produto:

Chewable Tablets 100 mg  - round, red-speckled, pink, single-scored (imprinted Tegretol on one side and 52 twice on the scored side) Bottles of 100………………………………………………………………………………….NDC 0078-0492-05 Unit Dose (blister pack) Box of 100 (strips of 10)……………………………………………………………………....NDC 0078-0492-35 Do not store above 30°C (86°F). Protect from light and moisture. Dispense in tight, light-resistant container (USP). Meets USP Dissolution Test 1. Tablets 200 mg  - capsule-shaped, pink, single-scored (imprinted Tegretol on one side and 27 twice on the partially scored side) Bottles of 100.............................................................................................................................NDC 0078-0509-05 Bottles of 60...............................................................................................................................NDC 0078-0509-20 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Meets USP Dissolution Test 2.       XR Tablets 100 mg - round, yellow, coated (imprinted “T” on one side and 100 mg on the other), release portal on one side Bottles of 100.............................................................................................................................NDC 0078-0510-05 XR Tablets 200 mg  - round, pink, coated (imprinted “T” on one side and 200 mg on the other), release portal on one side Bottles of 100.............................................................................................................................NDC 0078-0511-05 XR Tablets 400 mg - round, brown, coated (imprinted “T” on one side and 400 mg on the other), release portal on one side Bottles of 100.............................................................................................................................NDC 0078-0512-05 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Suspension 100 mg/5 mL (teaspoon) –  yellow-orange, citrus-vanilla flavored Bottles of 450 mL.......................................................................................................................................NDC 0078-0508-83 Shake well before using. Do not store above 30°C (86°F). Dispense in tight, light -resistant container (USP). *Thorazine® is a registered trademark of GlaxoSmithKline. T2023-61 September 2023

Status de autorização:

New Drug Application

Folheto informativo - Bula

TEGRETOL- CARBAMAZEPINE SUSPENSION
TEGRETOL- CARBAMAZEPINE TABLET
TEGRETOL XR- CARBAMAZEPINE TABLET, EXTENDED RELEASE
Novartis Pharmaceuticals Corporation
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MEDICATION GUIDE
TEGRETOL® and TEGRETOL®-XR (Teg-ret-ol)
(carbamazepine)
Tablets, Suspension, Chewable Tablets, Extended-Release Tablets
Read this Medication Guide before you start taking Tegretol or
Tegretol–XR (TEGRETOL) and each
time you get a refill. There may be new information. This information
does not take the place of talking to
your healthcare provider about your medical condition or treatment.
What is the most important information I should know about TEGRETOL?
Do not stop taking TEGRETOL without first talking to your healthcare
provider.
Stopping TEGRETOL suddenly can cause serious problems.
TEGRETOL can cause serious side effects, including:
1.
TEGRETOL may cause rare but serious skin rashes that may lead to
death. These serious skin
reactions are more likely to happen when you begin taking TEGRETOL
within the first four
months of treatment but may occur at later times. These reactions can
happen in anyone, but are
more likely in people of Asian descent. If you are of Asian descent,
you may need a genetic blood
test before you take TEGRETOL to see if you are at a higher risk for
serious skin reactions with
this medicine. Symptoms may include:
•
skin rash
•
hives
•
sores in your mouth
•
blistering or peeling of the skin
2.
TEGRETOL may cause rare but serious blood problems. Symptoms may
include:
•
fever, sore throat, or other infections that come and go or do not go
away
•
easy bruising
•
red or purple spots on your body
•
bleeding gums or nose bleeds
•
severe fatigue or weakness
3.
TEGRETOL may cause allergic reactions or serious problems, which may
affect organs and other
parts of your body like the liver or blood cells. You may or may not
have a rash with these types
of reactions.
Call your healthcare provider right away if you have any of the
following:
•
swelling of your face, eyes, lips, or tongue
•
a skin

Características técnicas

TEGRETOL- CARBAMAZEPINE SUSPENSION
TEGRETOL- CARBAMAZEPINE TABLET
TEGRETOL XR- CARBAMAZEPINE TABLET, EXTENDED RELEASE
NOVARTIS PHARMACEUTICALS CORPORATION
----------
TEGRETOL
TEGRETOL
CARBAMAZEPINE USP
CHEWABLE TABLETS OF 100 MG - RED-SPECKLED, PINK
TABLETS OF 200 MG – PINK
SUSPENSION OF 100 MG/5 ML
TEGRETOL
-XR
(CARBAMAZEPINE EXTENDED-RELEASE TABLETS)
100 MG, 200 MG, 400 MG
RX ONLY
PRESCRIBING INFORMATION
WARNINGS
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 DURING TREATMENT WITH TEGRETOL. 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
ESTIMATED TO BE ABOUT 10 TIMES HIGHER. STUDIES IN PATIENTS OF CHINESE
ANCESTRY HAVE FOUND A STRONG ASSOCIATION BETWEEN THE RISK OF
DEVELOPING SJS/TEN AND THE PRESENCE OF HLA-B*1502, AN INHERITED
ALLELIC VARIANT OF THE HLA-B GENE. HLA-B*1502 IS FOUND ALMOST
EXCLUSIVELY IN PATIENTS WITH ANCESTRY ACROSS BROAD AREAS OF ASIA.
PATIENTS WITH ANCESTRY IN GENETICALLY AT-RISK POPULATIONS SHOULD BE
SCREENED FOR THE PRESENCE OF HLA-B*1502 PRIOR TO INITIATING TREATMENT
WITH TEGRETOL. PATIENTS TESTING POSITIVE FOR THE ALLELE SHOULD NOT BE
TREATED WITH TEGRETOL UNLESS THE BENEFIT 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 TEGRETOL. DATA FROM A POPULATION-BASED
CASE CONTROL STUDY DEMONSTRATE THAT THE RISK OF DEVELOPING THESE
REACTIONS IS 5 TO 8 TIMES GREATER THAN 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 DEC