Carbamazepine description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Carbamazepine

Aidarex Pharmaceuticals LLC

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use carisoprodol safely and effectively. See full prescribing information for carisoprodol tablets, USP. Carisoprodol Tablets, USP for Oral use CIVInitial U.S. Approval: 1959INDICATIONS AND USAGE(1) Should only be used for acute treatment periods up to two or three weeks (1) Not recommended in pediatric patients less than 16 years of age (8.4) DOSAGE AND ADMINISTRATION Recommended dose is 350 mg three times a day and at bedtime. (2) DOSAGE FORMS AND STRENGTHS(3)CONTRAINDICATIONS Acute intermittent porphyria (4) Hypersensitivity reactions to a carbamate such as meprobamate (4) WARNINGS AND PRECAUTIONS Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery (5.1) Additive sedative effects when used with other CNS depressants including alcohol (5.1) Cases of Drug Dependence, Withdrawal, and Abuse (5.2) Seizures (5.3)  Side Effects(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.  DRUG INTERACTIONS CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) - additive sedative effects (5.1 and 7.1)  RECENT MAJOR CHANGES(5.1)(5.2)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE




see Dosage and Administration (2)

2 DOSAGE AND ADMINISTRATION


3 DOSAGE FORMS AND STRENGTHS


4 CONTRAINDICATIONS


5 WARNINGS AND PRECAUTIONS

5.1 Sedation


see ADVERSE REACTIONS (6.1)

5.2 Drug Dependence, Withdrawal, and Abuse




see Clinical Pharmacology (12.3)

5.3 Seizures


see Overdosage (10)

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience




see Clinical Studies (14)



Table 1. Patients with Adverse Reactions in Controlled Studies
Adverse
Reaction
Placebo (n=560)
n (%)
Carisoprodol 350 mg (n=279)
n (%)
    Drowsiness
 31 (6)
 47 (17)
    Dizziness
 11 (2)
 19 (7)
    Headache
 11 (2)
 9 (3)

6.2 Postmarketing Experience




Cardiovascular:
see Overdosage (10)

Central Nervous System:
see Overdosage (10)

Gastrointestinal:


Hematologic:

7 DRUG INTERACTIONS

7.1 CNS Depressants


see Warnings and Precautions (5.1)

7.2 CYP2C19 Inhibitors and Inducers


see Clinical Pharmacology (12.3)

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy: Pregnancy Category C.




Teratogenic effects:


Nonteratogenic effects:
in-uteroin-utero

8.2 Labor and Delivery


8.3 Nursing Mothers


8.4 Pediatric Use


8.5 Geriatric Use


8.6 Renal Impairment


8.7 Hepatic Impairment


8.8 Patients with Reduced CYP2C19 Activity


see Clinical Pharmacology (12.3)

9 DRUG ABUSE AND DEPENDENCE


see Warnings and Precautions (5.2)

In vitro

10 OVERDOSAGE




Treatment of Overdosage:


contact a Poison Control Center.

11 DESCRIPTION


122424
Carbamazepine

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action




12.2 Pharmacodynamics




12.3 Pharmacokinetics


maxmax
Table 2. Pharmacokinetic Parameters of Carisoprodol and Meprobamate (Mean ± SD, n=24)
350 mg Carisoprodol
 Carisoprodol
 Cmax (mcg/mL)
 1.8 ± 1
 AUCinf (mcg*hr/mL)
 7 ± 5
 Tmax (hr)
 1.7 ± 0.8
 T1/2 (hr)
 2 ± 0.5
 Meprobamate
 Cmax (mcg/mL)
 2.5 ± 0.5
 AUCinf (mcg*hr/mL)
 46 ± 9
 Tmax (hr)
 4.5 ± 1.9
 T1/2 (hr)
 9.6 ± 1.5

Absorption: max

Metabolism:
Patients with Reduced CYP2C19 Activity

Elimination:


Gender:


Patients with Reduced CYP2C19 Activity:

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility




in vitro in vitro S. typhimurium in vivo



14 CLINICAL STUDIES










Table 3. Results of the Primary Efficacy Endpointsa in Study 1
Study Parameter Placebo Carisoprodol 350 mg
 a The primary efficacy endpoints (Relief from Starting Backache and Global Impression of Change) were assessed by the patients on Study Day 3. These endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome).
b Mean is the least squared mean and SE is the standard error of the mean.
 


1
 Number of Patients
 n=269
 n=273
 
    Relief from Starting Backache, Mean (SE)b
 1.4 (0.1)
 1.8 (0.1)
 
    Difference between Carisoprodol and Placebo, Mean (SE)b (95% CI)
   0.4
(0.2, 0.6)
 
 
    Global Impression of Change, Mean (SE)b
 1.9 (0.1)
 2.2 (0.1)
 
    Difference between Carisoprodol and Placebo, Mean (SE)b (95% CI)
   0.3
(0.1, 0.4)
 

16 HOW SUPPLIED/STORAGE AND HANDLING

Carisoprodol Tablets USP, 350 mg are white colored, round shaped, biconvex, uncoated tablets, identified with ‘D’ debossed on one side and ‘31’ on the other side.
 
            Bottles of 60                 NDC 33261-676-60

            
Store at controlled room temperature 20º to 25ºC (68º to 77ºF).

 
Dispense in tight container.

17 PATIENT COUNSELING INFORMATION


17.1 Sedation


see Warnings and Precautions (5.1)

17.2 Avoidance of Alcohol and Other CNS Depressants


see Warnings and Precautions (5.1)

17.3 Carisoprodol Should Only Be Used for Short-Term Treatment




To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
 

Aurobindo Pharma USA, Inc.




Aurobindo Pharma Limited


Recent Major Changes

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 350 mg (100 Tablet Bottle)


Carbamazepine

Carbamazepine

Carbamazepine TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:33261-676(NDC:51672-4005)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMAZEPINE Carbamazepine 200 mg

Inactive Ingredients

Ingredient Name Strength
STARCH, CORN
CROSCARMELLOSE SODIUM
diethyl phthalate
MAGNESIUM STEARATE
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
WHITE 9 mm TARO;11 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33261-676-60 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074649 1996-10-03


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.