CARBAMAZEPINE suspension

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

CARBAMAZEPINE

구성:

CARBAMAZEPINE 100 mg in 5 mL

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Carbamazepine is indicated for use as an anticonvulsant drug. Evidence supporting efficacy of carbamazepine 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 carbamazepine (see PRECAUTIONS, General). Carbamazepine 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. Carbamazepine should not be used in patients with a history of previous bone marrow depression, hype

제품 요약:

Carbamazepine Oral Suspension, USP 100 mg/5 mL (teaspoonful) is a yellow-orange, citrus-vanilla flavored suspension, supplied as follows: 450 mL amber plastic bottles (NDC 60432-129-16). Shake well before using. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. 1Thorazine® is a registered trademark of GlaxoSmithKline. 2Mellaril® is a registered trademark of Novartis Consumer Health, Inc. Rx Only Prod. No.: 8129 Manufactured For: Wockhardt USA, LLC Parsippany, NJ 07054 Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053 B50-8129-16 REV. 07-18

승인 상태:

Abbreviated New Drug Application

환자 정보 전단

CARBAMAZEPINE- CARBAMAZEPINE SUSPENSION
Morton Grove Pharmaceuticals, Inc.
----------
MEDICATION GUIDE
Carbamazepine Oral Suspension, USP
100 mg/5 mL
(Carbamazepine)
Read this Medication Guide before you start taking Carbamazepine 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
Carbamazepine?
Do not stop taking Carbamazepine without first talking to your
healthcare provider.
Stopping Carbamazepine suddenly can cause serious problems.
Carbamazepine can cause serious side effects, including:
1. Carbamazepine 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
Carbamazepine 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
Carbamazepine 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. Carbamazepine 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. Carbamazepine 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:
1.
swelling of your face, eyes, lips, or tongue
2.
a skin rash
3.
painful sores in the mouth or around your eyes
4.
unusual bruising or bleeding
5.
frequent infections or infect

제품 특성 요약

CARBAMAZEPINE- CARBAMAZEPINE SUSPENSION
MORTON GROVE PHARMACEUTICALS, INC.
----------
CARBAMAZEPINE - CARBAMAZEPINE SUSPENSION
MORTON GROVE PHARMACEUTICALS, INC.
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