• Important Safety Information
  • Full Prescribing Information
  • Medication Guide
  • For Patients
Tuzistra® XR

Site Map

  • TUZISTRA XR Patient
  • TUZISTRA XR HCP
    • Site Map
    • Contact Us
  • Medication Guide
  • Full Prescribing Information
  • Site Map
  • Contact Us

TUZISTRA® XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, CIII

WARNING

ULTRA-RAPID METABOLISM OF CODEINE AND OTHER RISK FACTORS FOR LIFE-THREATENING RESPIRATORY DEPRESSION IN CHILDREN

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.

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. 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.

RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid use of opioid cough medications in patients taking benzodiazepines, other CNS depressants, or alcohol.

INDICATIONS AND USAGE

TUZISTRA XR is a combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 (H1) receptor antagonist indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold.

Important Limitations of Use

Not indicated for pediatric patients under 18 years of age.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • Children less than 12 years of age
  • Postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.
  • Patients with known hypersensitivity to codeine, chlorpheniramine, or any of the product components of TUZISTRA XR.

WARNINGS AND PRECAUTIONS

  • Risk of death in ultra-rapid metabolizers: Conversion of codeine into its active metabolite, morphine, may occur more rapidly and completely resulting in higher than expected morphine levels and respiratory depression or death.
  • Risks from concomitant use with benzodiazepines or other CNS depressants: Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
  • Dose-related respiratory depression: Use with caution.
  • Drug dependence: Prescribe with caution that is appropriate to the use of other opioids.
  • Head injury and increased intracranial pressure: Avoid in patients with head injury, intra-cranial lesions, or increased intracranial pressure.
  • Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring complete mental alertness such as driving or operating heavy machinery. Avoid concurrent use of alcohol or other central nervous system depressants.
  • Acute abdominal conditions: Use with caution in patients with acute abdominal conditions.
  • Special risk patients: Caution in elderly patients and those with asthma, hypothyroidism, Addison’s disease, prostatic hypertrophy or urethral stricture.

ADVERSE REACTIONS:

  • Common adverse reactions of TUZISTRA XR include: nausea and vomiting, constipation, abdominal distension, abdominal pain, blurred vision, diplopia, visual disturbances, confusion, dizziness, depression, drowsiness, sedation, headache, euphoria, facial dyskinesia, feeling faint, light-headedness, general feeling of discomfort or illness, excitability, nervousness, agitation, restlessness, somnolence, insomnia, dyskinesia, irritability, tremor.
  • To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, at 1-732-940-0358 (U.S. only) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 


Please see full Prescribing Information, including Boxed Warning.

  • Tris Pharma
  • Privacy Policy
  • Online Terms of Use
  • Site Map
  • Contact Us
TUZISTRA XR is a licensed trademark of Tris Pharma, Inc.
  • If you are a US healthcare professional, send us your email to receive future communications from Vernalis Therapeutics, Inc.

    Review our Privacy Policy and Terms of Use

  • This field is for validation purposes and should be left unchanged.
×
OK Cancel
×

This site contains information for licensed healthcare professionals in the United States. By entering this website, you acknowledge that you are a licensed healthcare professional practicing in the United States.

OK CANCEL
×
Amerisource 10192387
Anda 202175
Cardinal 5493556
H.D. Smith 57748223
McKesson 3546645
Morris and Dickson 494039
Mutual 327866
Smith 870360
TUZISTRA XR IS A CIII COUGH MEDICATION1
×

*PHARMACY SAVINGS CARD PROGRAM TERMS AND CONDITIONS

  • You must be 18 years of age or older to redeem the Pharmacy Savings Card.
  • Patient is responsible for the first $25 of their out-of-pocket cost.
  • The Pharmacy Savings Card benefit is either based on the number of ounces dispensed or the actual out-of-pocket cost over $25, whichever is less. Benefit is limited to a maximum amount. The Pharmacy Savings Card is valid for one use. No other purchase is necessary.
  • The Pharmacy Savings Card is not transferable. No substitutions are permitted. The offer cannot be combined with any other coupon, free trial, discount, prescription savings card, or other offer.
  • The Pharmacy Savings Card is not insurance.
  • Patient is not eligible if prescriptions are paid in part or full by any state or federally funded programs, including but not limited to Medicare or Medicaid, Medigap, VA, DOD or TriCare, or where prohibited by law.
  • The Pharmacy Savings Card can be used only by eligible residents of the United States at participating eligible retail pharmacies in the United States.
  • It is illegal to sell, purchase, trade, or counterfeit, or offer to sell, purchase, trade, or counterfeit the Pharmacy Savings Card. Void if reproduced. Void where prohibited by law, taxed, or restricted.
  • Aytu BioPharma, Inc. reserves the right to terminate, rescind, revoke, or amend the offer at any time without notice.