Tuzistra XR

Last updated on RxList: 2/1/2021
Tuzistra XR Side Effects Center

What Is Tuzistra XR?

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

What Are Side Effects of Tuzistra XR?

Common side effects of Tuzistra XR include:P

Dosage for Tuzistra XR

The adult dose of Tuzistra XR is 10 mL every 12 hours, not to exceed 2 doses (20 mL) in 24 hours.

What Drugs, Substances, or Supplements Interact with Tuzistra XR?

Tuzistra XR may interact with other opioids, antihistamines, antipsychotics, anti-anxiety agents, other CNS depressants, MAOIs, tricyclic antidepressants, anticholinergics, and phenytoin or other inhibitors or inducers of metabolic enzymes. Tell your doctor all medications and supplements you use.

Tuzistra XR During Pregnancy and Breastfeeding

Tuzistra XR is not recommended for use during pregnancy; it may harm a fetus. Codeine passes into breast milk and may cause undesirable side effects in a nursing infant. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Tuzistra XR.

Additional Information

Our Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Could I Be Allergic? Discover Your Allergy Triggers See Slideshow
Tuzistra XR Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Stop using this medicine and call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
  • confusion, severe drowsiness;
  • a light-headed feeling, like you might pass out;
  • severe constipation; or
  • adrenal gland problems--nausea, vomiting, loss of appetite, feeling very dizzy, weak, or tired.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious side effects may be more likely in older adults and those who are debilitated.

Common side effects may include:

  • dizziness, drowsiness, feeling light-headed;
  • feeling short of breath;
  • confusion, mood changes, lack of energy,
  • feeling nervous, irritable, agitated, or restless;
  • sleep problems;
  • headache, vision problems;
  • tremors, coordination problems;
  • dry mouth;
  • sweating; or
  • nausea, vomiting, constipation, stomach pain, bloating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tuzistra XR (Codeine Polistirex, Chlorpheniramine Polistirex Extended-release Oral Suspension)

QUESTION

Allergies can best be described as: See Answer
Tuzistra XR Professional Information

SIDE EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

  • Addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS, Drug Abuse And Dependence]
  • Life-threatening respiratory depression [see WARNINGS AND PRECAUTIONS, OVERDOSE]
  • Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children [see WARNINGS AND PRECAUTIONS]
  • Accidental overdose and death due to medication errors [see WARNINGS AND PRECAUTIONS]
  • Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
  • Interactions with benzodiazepines and other CNS depressants [see WARNINGS AND PRECAUTIONS]
  • Paralytic ileus, gastrointestinal adverse reactions [see WARNINGS AND PRECAUTIONS]
  • Increased intracranial pressure [see WARNINGS AND PRECAUTIONS]
  • Obscured clinical course in patients with head injuries [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Interactions with MAOI [see WARNINGS AND PRECAUTIONS]
  • Severe hypotension [see WARNINGS AND PRECAUTIONS]
  • Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Adrenal insufficiency [see WARNINGS AND PRECAUTIONS]

The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of codeine and/or chlorpheniramine. Because these reactions may be reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The most common adverse reactions to TUZISTRA XR include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, and sweating.

Other reactions include:

Anaphylaxis: Anaphylaxis has been reported with codeine, one of the ingredients in TUZISTRA XR.

Body as a whole: Coma, death, fatigue, falling injuries, lethargy.

Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush.

Central Nervous System: Ataxia, facial dyskinesia, insomnia, increased intracranial pressure, migraine, seizure, tremor, tinnitus, vertigo.

Dermatologic: Flushing, hyperhidrosis, pruritus, rash.

Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids [see CLINICAL PHARMACOLOGY].

Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi).

Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention.

Hematologic: Agranulocytosis, aplastic anemia, and thrombocytopenia have been reported.

Laboratory: Increases in serum amylase.

Musculoskeletal: Arthralgia, backache, muscle spasm.

Ophthalmic: Blurred vision, diplopia, miosis (constricted pupils), visual disturbances.

Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression, hallucinations.

Reproductive: Hypogonadism, infertility.

Respiratory: Bronchitis, cough, dry nose, dry throat, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, thickening of bronchial secretions, tightness of chest and wheezing, upper respiratory tract infection.

Other: Drug abuse, drug dependence, opioid withdrawal syndrome.

Read the entire FDA prescribing information for Tuzistra XR (Codeine Polistirex, Chlorpheniramine Polistirex Extended-release Oral Suspension)

© Tuzistra XR Patient Information is supplied by Cerner Multum, Inc. and Tuzistra XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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