General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Tuxarin
CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE
1 INDICATIONS AND USAGE TUXARIN ER 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. TUXARIN ER is a combination of codeine, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist, 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. ( 1 ) Important Limitatio...
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Brand names:Tuxarin
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE
- Medicine class
- General Medicine
- Brand names
- Tuxarin
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- Half life (h) 4 (1) 21 (7) Not determined Not determined Food Effect The presence of a high-fat, hig
- FDA approved
- Yes
What Is Tuxarin?
1 INDICATIONS AND USAGE TUXARIN ER 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. TUXARIN ER is a combination of codeine, an opioid agonist; and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist, 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. ( 1 ) Important Limitatio...
Tuxarin (CODEINE PHOSPHATE AND CHLORPHENIRAMINE MALEATE) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Tuxarin. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Tuxarin with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Tuxarin is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE TUXARIN ER 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.
TUXARIN ER is a combination of codeine, an opioid agonist;
and chlorpheniramine, a histamine-1 (H 1 ) receptor antagonist, 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.
( 1 ) Important Limitations of Use ( 1 ) Not indicated for pediatric patients under 18 years of age.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve TUXARIN ER for use in adult patients 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.
Important Limitations of Use Not indicated for pediatric patients under 18 years of age [see Use in Specific Population (8.4) ].
Contraindicated in pediatric patients under 12 years of age [ see Contraindications (4) , Use in Specific Populations (8.4) ].
Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4) , Use in Specific Populations (8.4) ].
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION Adults 18 years of age and older : 1 tablet every 12 hours as needed, not to exceed 2 tablets in 24 hours. ( 2.2 ) Do not increase the dose or dosing frequency. ( 2.1 ) Prescribe for the shortest duration consistent with treatment goals. ( 2.3 ) Reevaluate patients with unresponsive cough in 5 days or sooner for possible underlying pathology. ( 2.3 ) Reevaluate patient prior to refilling. ( 2.3 ) 2.1 Important Dosage and Administration Instructions Administer TUXARIN ER by the oral route only. Advise patients not to increase the dose or dosing frequency of TUXARIN ER because serious adverse events such as respiratory depression may occur with overdosage [ see Warnings and Precautions (5.2) , Overdosage (10) ]. The dosage of TUXARIN ER should not be increased if cough fails to respond; an unresponsive cough should be reevaluated for possible underlying pathology [ see Dosage and Administration (2.3) , Warnings and Precautions (5.5) ]. 2.2 Recommended Dosage A
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, abuse, and misuse [ see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.3) ] Life-threatening respiratory depression [ see Warnings and Precautions (5.2 , 5.3 , 5.4 , 5.5 , 5.9) , Overdosage (10) ] Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children [ see Warnings and Precautions (5.3) ] Accidental overdose and death due to medication errors [ see Warnings and Precautions (5.6) ] Decreased mental alertness with impaired mental and/or physical abilities [ see Warnings and Precautions (5.7) ] Interactions with benzodiazepines and other CNS depressants [ see Warnings and Precautions (5.9) ] Paralytic ileus, gastrointestinal adverse reactions [ see Warnings and Precautions (5.10) ] Increased intracranial pressure [ see Warnings and Precautions (5.11) ] Obscured clinical course in patients with head injuries [ see Warnings and Precautions (5.11) ] Seizures [ see Warnings and Precautions (5.12) ] Interactions with MAOI [ see Warnings and Precautions (5.13) ] Severe hypotension [ see Warnings and Precautions (5.14) ] Neonatal Opioid Withdrawal Syndrome [ see Warnings and Precautions (5.15) ] Adrenal insufficiency [ see Warnings and Precautions (5.16) ] The following adverse reactions have been identified during clinical studies, 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 TUXARIN ER 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 TUXARIN ER.
- 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.
Serious
- 5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy.
- ( 5.5 ) Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery.
- ( 5.7 ) Risks of use in patients with head injury, impaired consciousness, increased intracranial pressure, or brain tumors: Avoid use.
- May increase intracranial pressure and obscure the clinical course of head injuries.
- ( 5.11 ) Seizures in patients with seizure disorders: Monitor during therapy.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS See Boxed WARNINGS Life-threatening respiratory depression in patients with chronic pulmonary disease or in elderly, cachectic, or debilitated patients: Monitor closely, particularly during initiation of therapy. ( 5.5 ) Activities requiring mental alertness: Avoid engaging in hazardous tasks requiring mental alertness such as driving or operating machinery. ( 5.7 ) Risk
How Tuxarin Works
12.1 Mechanism of Action Codeine 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. 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. Chlorpheniramine Chlorpheniramine is a propylamine derivative antihistamine (H 1 -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.
Pharmacokinetics
Absorption
Absorption Pharmacokinetic (PK) parameters (Mean ± SD) for TUXARIN ER in fasting, healthy volunteers are shown in the table below
Half-Life
Half life (h) 4 (1) 21 (7) Not determined Not determined Food Effect The presence of a high-fat, hig
Metabolism
metabolite, morphine, are transferred to human breast milk
Excretion
Excretion Approximately 90% of the total dose of codeine is excreted through the kidneys, of which approximately 10% is unchanged codeine
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Tuxarinwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure. Keep this and all medicine out of reach of children.
Frequently Asked Questions
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Adult, pediatric, renal, and hepatic dosing for Tuxarin
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Tuxarin side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Tuxarin
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.