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Tuxarin Er Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—30, 100
Manufacturer
Generic Availability
NO
Mechanism of Action
Codeine is an opioid agonist relatively selective for the mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic and antitussive properties of codeine have been speculated to come from its conversion to morphine. Although the exact mechanism of analgesic action remains unknown, codeine is believed to act centrally on the cough center.
Chlorpheniramine is a propylamine derivative H1-receptor antagonist of the alkylamine class that also possesses anticholinergic and sedative activity. It prevents released histamine from dilating capillaries and causing edema of the respiratory mucosa.
Tuxarin Er Indications
Indications
Temporary relief of cough and upper respiratory symptoms associated with allergy or the common cold.
Limitations of Use
Due to risks of addiction, abuse, and misuse with opioids (even at recommended), reserve for use in adults for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
Tuxarin Er Dosage and Administration
Adult
Use lowest effective dose for shortest duration. Swallow whole. ≥18yrs: 1 tab every 12hrs as needed; max 2 tabs/24hrs. Withdraw gradually by 25–50% every 2–4 days in those physically-dependent.
Children
<18yrs: not indicated.
Tuxarin Er Contraindications
Contraindications
Children <12yrs. Post-op management in children <18yrs following tonsillectomy and/or adenoidectomy. Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. During or within 14 days of MAOIs.
Tuxarin Er Boxed Warnings
Boxed Warning
Addiction, abuse, and misuse. Life-threatening respiratory depression. Accidental ingestion. Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children. Risk of medication errors. Cytochrome P450 interactions. Risks from concomitant use with benzodiazepines or other CNS depressants. Neonatal opioid withdrawal syndrome.
Tuxarin Er Warnings/Precautions
Warnings/Precautions
Abuse potential (monitor). Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy or when used in higher-risk patients. Accidental exposure may cause fatal overdose (esp. in children). Avoid in adolescents 12–18yrs with conditions associated with hypoventilation (eg, post-op status, obstructive sleep apnea, obesity, severe pulmonary disease, neuromuscular disease, concomitant drugs that cause respiratory depression). Avoid in chronic respiratory disease, acute febrile illness with productive cough. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Underlying intestinal motility disorders. Ultra-rapid metabolizers (due to CYP2D6 genotype): avoid. Reevaluate periodically. Avoid abrupt cessation. Severe renal or hepatic impairment: monitor. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery. Nursing mothers: not recommended.
Tuxarin Er Pharmacokinetics
Distribution
Volume of distribution: ~3–6 L/kg (codeine); ~3.2 L/kg (chlorpheniramine). Plasma protein bound: 7–25% (codeine); ~70% (chlorpheniramine).
Elimination
Codeine: renal (90%). Half-life: ~4 hours (codeine); 21 hours (chlorpheniramine).
Tuxarin Er Interactions
Interactions
See Contraindications. Increased risk of hypotension, respiratory depression, sedation, coma, and death with benzodiazepines or other CNS depressants (eg, sedatives/hypnotics, anxiolytics, general anesthetics, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists); monitor and discontinue if suspected. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May be affected by CYP2D6 inhibitors (eg, amiodarone, paroxetine, fluoxetine, bupropion, quinidine). Avoid concomitant phenytoin. May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May increase serum amylase.
Tuxarin Er Adverse Reactions
Adverse Reactions
Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, constipation, shortness of breath, sweating; respiratory depression, orthostatic hypotension, syncope.
Tuxarin Er Clinical Trials
See Literature
Tuxarin Er Note
Not Applicable
Tuxarin Er Patient Counseling
See Literature
