TUZISTRA XR- codeine polistirex and chlorpheniramine polistirex suspension, extended release
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Patient Information leaflet
(PIL)
27-08-2018
Summary of Product characteristics
(SPC)
27-08-2018
Active ingredient:
CODEINE PHOSPHATE ANHYDROUS (UNII: 2X585M1M3T) (CODEINE - UNII:Q830PW7520)
Available from:
Vernalis Therapeutics, Inc.
INN (International Name):
CODEINE PHOSPHATE ANHYDROUS
Composition:
CODEINE PHOSPHATE ANHYDROUS 14.7 mg in 5 mL
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
TUZISTRA XR is indicated for the temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older. Important Limitations of Use - Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]. Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4) ]. - Contraindicated in pediatric patients under 12 years of age [see Contraindications (4),Use in Specific Populations (8.4) ]. Contraindicated in pediatric patients under 12 years of age [see Contraindications (4),Use in Specific Populations (8.4) ]. - Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), Use in Specific Populations (8.4 ) ].
Product summary:
TUZISTRA XR is supplied as a pink to reddish pink, cherry-flavored liquid oral suspension containing codeine polistirex, providing 14.7 mg of codeine (equivalent to 20 mg codeine phosphate), and chlorpheniramine polistirex, providing 2.8 mg chlorpheniramine (equivalent to 4 mg chlorpheniramine maleate) per 5 mL. It is available in bottles of 16 fluid oz. (473 mL) NDC 69442-480-01. Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Shake well. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Ensure that patients have an oral dosing dispenser that measures the appropriate volume in milliliters. Counsel patients on how to utilize an oral dosing dispenser and correctly measure the oral suspension as prescribed.
Authorization status:
New Drug Application
Patient Information leaflet
These highlights do not include all the information needed
to use TUZISTRA XR® safely and effectively. See full
prescribing information for
TUZISTRA XR
.
TUZISTRA XR (codeine polistirex and chlorpheniramine
polistirex) extended-release oral suspension, CIII
Initial U.S. Approval: 1985
TUZISTRA XR- codeine
polistirex and chlorpheniramine polistirex suspension,
extended release
Vernalis Therapeutics,
Inc.
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Medication Guide
TUZISTRA® XR (Two-zis-
tra)
(codeine polistirex and
chlorpheniramine polistirex)
extended-release oral suspension, C-III
What is the most important information I should know
about TUZISTRA XR? TUZISTRA XR is no
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Summary of Product characteristics
TUZISTRA XR- CODEINE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
SUSPENSION, EXTENDED
RELEASE
VERNALIS THERAPEUTICS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TUZISTRA XR SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR TUZISTRA XR.
TUZISTRA XR (CODEINE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX)
EXTENDED-RELEASE ORAL SUSPENSION, CIII
INITIAL U.S. APPROVAL: 1985
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION;
ACCIDENTAL INGESTION; ULTRA-RAPID METABOLIS OF CODEINE AND OTHER RISK
FACTORS
FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN; MEDICATION
ERRORS;
INTERACTIONS WITH DRUGS AFFECTING CYTOCHROME P450 ISOENZYMES;
CONCOMITANT USE
WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS; NEONATAL OPIOID
WITHDRAWAL
SYNDROME
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
TUZISTRA XR EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE,
WHICH CAN LEAD TO OVERDOSE
AND DEATH. ASSESS PATIENT’S RISK BEFORE PRESCRIBING AND MONITOR
CLOSELY FOR THESE BEHAVIORS AND
CONDITIONS. (5.1)
SERIOUS, LIFE-THREATENING, OR FATAL RESPIRATORY DEPRESSION MAY OCCUR.
MONITOR CLOSELY, ESPECIALLY UPON
INITIATION OR WHEN USED IN PATIENTS AT HIGHER RISK. (5.2)
ACCIDENTAL INGESTION OF TUZISTRA XR, ESPECIALLY BY CHILDREN, CAN
RESULT IN A FATAL OVERDOSE OF
CODEINE. (5.2)
LIFE-THREATENING RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN
CHILDREN WHO RECEIVED CODEINE;
MOST CASES FOLLOWED TONSILLECTOMY AND/OR ADENOIDECTOMY, AND MANY OF
THE CHILDREN HAD EVIDENCE OF
BEING AN ULTRA-RAPID METABOLIZER OF CODEINE DUE TO A CYP2D6
POLYMORPHISM. (5.3) TUZISTRA XR IS
CONTRAINDICATED IN CHILDREN YOUNGER THAN 12 YEARS OF AGE AND IN
CHILDREN YOUNGER THAN 18 YEARS OF AGE
FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY. (4) AVOID THE USE OF
TUZISTRA XR IN ADOLESCENTS 12
TO 18 YEARS OF AGE WHO HAVE OTHER RISK FACTORS THAT MAY INCREASE THEIR
SENSITIVITY TO THE RESPIRATORY
DEPRESSANT EFFECTS OF CODEINE. ENSURE ACCURACY WHEN PRESCRIBING
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