EPITOL- carbamazepine tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Teva Pharmaceuticals USA, Inc.

INN (International namn):

CARBAMAZEPINE

Sammansättning:

CARBAMAZEPINE 200 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Epitol (carbamazepine tablets) is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of Epitol (carbamazepine tablets) 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 Epitol (carbamazepine tablets) (see PRECAUTIONS, General ). Epitol (carbamazepine tablets) 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. Epitol should not be used in pa

Produktsammanfattning:

Epitol® (carbamazepine tablets, USP) 200 mg is available as round, white, single-scored tablets, debossed “93” above the score line,  “93” below the score line and “EPITOL” on the unscored side of the tablet. Supplied in bottles of 100. NDC 0093-0090-01. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture. Store in a dry place. Dispense in a tight container, preferably glass, as defined in the USP. Dispense in a container labeled: Store in a dry place. Protect from moisture. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Kfar Saba, 4410202, Israel Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. AO 3/2022

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

EPITOL- carbamazepine tablet
Teva Pharmaceuticals USA, Inc.
----------
MEDICATION GUIDE
Dispense with Medication Guide available at: www.tevausa.com/medguides
Epitol® (EP-ih-tall)
(carbamazepine tablets)
(kar″ ba maz′ e peen)
Rx only
Read this Medication Guide before you start taking Epitol 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 Epitol?
Do not stop taking Epitol without first talking to your healthcare
provider.
Stopping Epitol suddenly can cause serious problems.
Epitol can cause serious side effects, including:
1. Epitol 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 Epitol 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
Epitol 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. Epitol 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. Epitol 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 rash
•
painful sores in the mouth or around your eyes
•
unusual bruising or bleeding
•
frequent infections o

Produktens egenskaper

EPITOL- CARBAMAZEPINE TABLET
TEVA PHARMACEUTICALS USA, INC.
----------
EPITOL
(CARBAMAZEPINE TABLETS, USP)
200 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 CARBAMAZEPINE. 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 CARBAMAZEPINE. PATIENTS TESTING
POSITIVE FOR THE ALLELE SHOULD NOT BE TREATED WITH
CARBAMAZEPINE 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 CARBAMAZEPINE. 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 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 VAST MAJORITY OF THE CASES OF LEUKOPENIA HAVE
NOT