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codeine polistirex and chlorpheniramine polistirex
Overview
What is TUZISTRA XR?
TUZISTRA XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension is a pink to reddish pink, cherry-flavored liquid suspension that contains an opiate agonist antitussive codeine and a histamine-1 (H) receptor antagonist (antihistamine) chlorpheniramine. Each 5 mL of TUZISTRA XR contains 14.7 mg of codeine (equivalent to 20 mg of codeine phosphate) and 2.8 mg of chlorpheniramine (equivalent to 4 mg of chlorpheniramine maleate) bound to sulfonated styrene-divinylbenzene copolymer (polistirex).
TUZISTRA XR contains the following inactive ingredients: cherry flavor, citric acid, D&C Red No. 30, ethyl maltol, glycerin, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propyl gallate, propylparaben, purified water, sodium citrate, sodium polystyrene sulfonate, starch, sucrose, triacetin, xanthan gum.
Codeine is (5α,6α)-7,8-didehydro-4,5-epoxy-3-methoxy-17-methylmorphinan-6-ol, has the following molecular formula, CHNO, and a molecular weight of 299.36. Codeine polistirex is a complex of codeine with sulfonated styrene-divinylbenzene copolymer, having the following structural formula:
Chlorpheniramine is γ-(4-chlorophenyl)-, -dimethyl-2-pyridinepropanamine, has the following molecular formula, CHClN, and a molecular weight of 274.80. Chlorpheniramine polistirex is a complex of chlorpheniramine with sulfonated styrene-divinylbenzene copolymer, having the following structural formula:
What does TUZISTRA XR look like?
What are the available doses of TUZISTRA XR?
Extended-release oral suspension contains: an antitussive – codeine polistirex, which contains 14.7 mg of codeine (equivalent to 20 mg codeine phosphate), and an antihistamine – chlorpheniramine polistirex, which contains 2.8 mg of chlorpheniramine (equivalent to 4 mg chlorpheniramine maleate) per 5 mL. ()
What should I talk to my health care provider before I take TUZISTRA XR?
How should I use TUZISTRA XR?
TUZISTRA XR is a combination of codeine, an opiate agonist antitussive, and chlorpheniramine, a histamine-1 (H) receptor antagonist indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold. ()
Limitation of Use
Not indicated for pediatric patients under 18 years of age. ()
TUZISTRA XR should be orally administered in a dose of 10 mL every 12 hours, not to exceed 2 doses (20 mL) in 24 hours.
What interacts with TUZISTRA XR?
Sorry No Records found
What are the warnings of TUZISTRA XR?
Sorry No Records found
What are the precautions of TUZISTRA XR?
Sorry No Records found
What are the side effects of TUZISTRA XR?
Sorry No records found
What should I look out for while using TUZISTRA XR?
TUZISTRA XR is contraindicated for:
What might happen if I take too much TUZISTRA XR?
No human overdosage data are available for TUZISTRA XR.
Codeine:
Overdosage with codeine is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.
Codeine may cause miosis, even in total darkness. Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origin may produce similar findings). Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Chlorpheniramine
Manifestations of chlorpheniramine overdosage may vary from central nervous system depression to stimulation. Central toxic effects are characterized by agitation, anxiety, delirium, disorientation, hallucinations, hyperactivity, sedation, and seizures. Severe overdosage may produce coma, medullary paralysis, and death. Peripheral toxicity includes hypertension, tachycardia, dysrhythmias, vasodilation, hyperpyrexia, mydriasis, urinary retention, and diminished gastrointestinal motility. Dry mouth, pharynx, bronchi, and nasal passages may be observed. Impaired secretion from sweat glands following toxic doses of drugs with anticholinergic side effects may predispose to hyperthermia.
An adult ingested 400 mg chlorpheniramine with no reported serious adverse effects. Toxic psychosis, a possible class effect from overdose of sedating antihistamines, has been reported with accidental overdose of chlorpheniramine.
Treatment of overdosage consists of discontinuation of TUZISTRA XR together with institution of appropriate therapy.
Give primary attention to re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. The opioid antagonist naloxone hydrochloride is a specific antidote for respiratory depression that may result from overdosage or unusual sensitivity to opioids including codeine. Therefore, an appropriate dose of naloxone hydrochloride should be administered, preferably by the intravenous route, simultaneously with efforts at respiratory resuscitation. For further information, see full prescribing information for naloxone hydrochloride. An antagonist should not be administered in the absence of clinically significant respiratory or circulatory depression. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug.
Hemodialysis is not routinely used to enhance the elimination of codeine or chlorpheniramine from the body. Urinary excretion of chlorpheniramine is increased when the pH of the urine is acidic; however, acid diuresis is NOT recommended to enhance elimination in overdose, as the risks of acidemia and acute tubular necrosis in patients with rhabdomyolysis far outweigh any potential benefits.
How should I store and handle TUZISTRA XR?
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. How SuppliedTUZISTRA 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.Storage and HandlingStore 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.How SuppliedTUZISTRA 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.Storage and HandlingStore 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.How SuppliedTUZISTRA 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.Storage and HandlingStore 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.How SuppliedTUZISTRA 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.Storage and HandlingStore 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.How SuppliedTUZISTRA 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.Storage and HandlingStore 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.How SuppliedTUZISTRA 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.Storage and HandlingStore 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.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Codeine is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of morphine. The precise mechanism of action of codeine and other opiates is not known; however, codeine is believed to act centrally on the cough center. In excessive doses, codeine will depress respiration. Codeine can produce miosis, euphoria, and physical and psychological dependence.
Chlorpheniramine is a propylamine derivative antihistamine drug (H receptor antagonist) that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.
Non-Clinical Toxicology
TUZISTRA XR is contraindicated for:Warfarin and other Oral Anticoagulants
Lithium
In patients stabilized on relatively high doses of lithium, short-term metronidazole therapy has been associated with elevation of serum lithium and, in a few cases, signs of lithium toxicity. Serum lithium and serum creatinine levels should be obtained several days after beginning metronidazole to detect any increase that may precede clinical symptoms of lithium intoxication.
Busulfan
Drugs that Inhibit CYP450 Enzymes
Drugs that Induce CYP450 Enzymes
Life-threatening respiratory depression and death have occurred in children who received codeine. Codeine is subject to variability in metabolism based upon CYP2D6 genotype (described below), which can lead to an increased exposure to the active metabolite morphine. Based upon post-marketing reports, children younger than 12 years old appear to be more susceptible to the respiratory depressant effects of codeine, particularly if there are risk factors for respiratory depression. For example, many reported cases of death occurred in the post-operative period following tonsillectomy and/or adenoidectomy, and many of the children had evidence of being ultra-rapid metabolizers of codeine. Furthermore, children with obstructive sleep apnea who are treated with codeine for post-tonsillectomy and/or adenoidectomy pain may be particularly sensitive to its respiratory depressant effect. Because of the risk of life-threatening respiratory depression and death:
Nursing Mothers
At least one death was reported in a nursing infant who was exposed to high levels of morphine in breast milk because the mother was an ultra-rapid metabolizer of codeine. Breastfeeding is not recommended during treatment with TUZISTRA XR .
CYP2D6 Genetic Variability: Ultra-rapid metabolizer
Some individuals may be ultra-rapid metabolizers because of a specific CYP2D6 genotype (e.g., gene duplications denoted as *1/*1xN or *1/*2xN). The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 1 to 10% for Whites (European, North American), 3 to 4% for Blacks (African Americans), 1 to 2% for East Asians (Chinese, Japanese, Korean), and may be greater than 10% in certain ethnic groups (i.e., Oceanian, Northern African, Middle Eastern, Ashkenazi Jews, Puerto Rican).
These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regimens, individuals who are ultra-rapid metabolizers may have life-threatening or fatal respiratory depression or experience of signs of overdose (such as extreme sleepiness, confusion, or shallow breathing)
Use of codeine, a semisynthetic opioid, may result in the following:
Use of chlorpheniramine, an antihistamine, may result in:
Adverse reactions listed below have been reported in the literature for codeine and chlorpheniramine and may be expected to occur with TUZISTRA XR. Also included are events that occurred during clinical pharmacokinetic studies (in a total of 66 healthy adult volunteers with either single or multiple dose exposure) with TUZISTRA XR and judged by the investigator to be related to study treatment. 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.
Allergic
Body as a whole
Cardiovascular
Dermatological System
Endocrine System
Gastrointestinal System
Genitourinary System
Nervous System
Respiratory
Special Senses
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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