TUZISTRA XR- codeine polistirex and chlorpheniramine polistirex suspension, extended release

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

CODEINE PHOSPHATE ANHYDROUS (UNII: 2X585M1M3T) (CODEINE - UNII:Q830PW7520), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)

থেকে পাওয়া:

Aytu BioPharma, Inc.

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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.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 [ ]. 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 [ ]. 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 pedi

পণ্য সারাংশ:

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 69654-480-01. 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.

অনুমোদন অবস্থা:

New Drug Application

তথ্য লিফলেট

Aytu BioPharma, 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 not for children under 18 years of age.
TUZISTRA XR can cause serious side effects, including:
•
Addiction, abuse and misuse. Taking TUZISTRA XR or other medicines
that contain an opioid
can cause addiction, abuse, and misuse, which can lead to overdose and
death. This can happen
even if you take TUZISTRA XR exactly as prescribed by your healthcare
provider. Your risk of
addiction, abuse, and misuse is increased if you or a family member
has a history of drug or
alcohol abuse or addiction, or mental health problems.
•
Do not share your TUZISTRA XR with other people.
•
Keep TUZISTRA XR in a safe place away from children.
•
Life-threatening breathing problems (respiratory depression). TUZISTRA
XR can cause
breathing problems (respiratory depression) that can happen at any
time during treatment and can
lead to death. Your risk of breathing problems is greatest when you
first start taking TUZISTRA
XR, are taking other medicines that can cause breathing problems, have
certain lung problems,
are elderly or have certain other health problems. Children are at
higher risk for respiratory
depression. Breathing problems can happen even if you take TUZISTRA XR
exactly as
prescribed by your healthcare provider.
Call your healthcare provider or get emergency medical help right away
if anyone taking TUZISTRA
XR has any of the symptoms below:
•
increased sleepiness
•
confusion
•
difficulty breathing
•
shallow breathing
•
limpness
Keep TUZISTRA XR in a safe place away from children. Accidental use of
even 1 dose of TUZISTRA
XR, especially by a child, is a medical emergency and can cause
breathing problems (respiratory
depression) which can lead to death. If a child accidentally takes
TUZISTRA XR, get emergency help
right away.
•
Overdose and death due to med

পণ্য বৈশিষ্ট্য

TUZISTRA XR- CODEINE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
SUSPENSION,
EXTENDED RELEASE
AYTU BIOPHARMA, INC.
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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,