Tuxarin-ER

What Is Tuxarin ER?

Tuxarin ER (codeine phosphate and chlorpheniramine maleate) extended release tablets are a combination of an opiate agonist antitussive and a histamine-1 (H1) receptor antagonist indicated for the relief of cough and symptoms associated with upper respiratory allergies or a common cold. Tuxarin ER is available in generic form.

What Are Side Effects of Tuxarin ER?

Common side effects of Tuxarin ER include:

• nausea and vomiting,
• constipation,
• abdominal bloating,
• abdominal pain,
•  blurred vision,
• double vision,
• visual disturbances,
• confusion,
• dizziness,
• depression,
•  drowsiness,
•  sedation,
• headache,
•  euphoria,
•  facial dyskinesia,
• feeling faint,
• lightheadedness,
•  general feeling of discomfort or illness (malaise),
• excitability,
• nervousness,
• agitation,
• restlessness,
• drowsiness,
• insomnia,
• abnormal movement (dyskinesia),
•  irritability,
• or tremor.

Psychological dependence, physical dependence, and tolerance may develop upon repeated use of Tuxarin ER.

Dosage for Tuxarin ER

The dose of Tuxarin ER for adults and children 18 years of age and older is 1 tablet every 12 hours, not to exceed 2 doses in 24 hours.

What Drugs, Substances, or Supplements Interact with Tuxarin ER?

Tuxarin ER may interact with benzodiazepines, opioids, antihistamines, antipsychotics, anti-anxiety agents, other central nervous system depressants (including alcohol), monoamine oxidase inhibitors, tricyclic antidepressants, anticholinergics, and phenytoin. Tell your doctor all medications and supplements you use.

Tuxarin ER During Pregnancy and Breastfeeding

Tuxarin ER is not recommended for use during pregnancy; it may harm a fetus. Use of Tuxarin ER shortly before delivery may result in respiratory depression in a newborn. Tuxarin ER passes into breast milk and may have adverse effects on nursing infants. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop taking Tuxarin ER.

Additional Information

Our Tuxarin ER (codeine phosphate and chlorpheniramine maleate) Extended Release Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Tuxarin-ER 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.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

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.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops during sleep;
• chest pain, fast or pounding heartbeats, feeling light-headed, fainting;
• confusion, extreme drowsiness, unusual thoughts or behavior;
• painful or difficult urination;
• severe constipation;
• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

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 overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects include:

• dizziness, drowsiness, tiredness, headache;
• nausea, vomiting, stomach pain, constipation;
• sweating, itching; or
• skin rash.

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 Tuxarin-ER (Codeine Phosphate and Chlorpheniramine Maleate Extended Release Tablets, CIII)

 

Tuxarin-ER Professional Information

SIDE EFFECTS

Use of codeine, an opioid, may result in the following:

• Respiratory depression [see WARNINGS AND PRECAUTIONS and OVERDOSE]
• Drug dependence [see WARNINGS AND PRECAUTIONS]
• Increased intracranial pressure [see WARNINGS AND PRECAUTIONS]
• Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]
• Paralytic ileus [see WARNINGS AND PRECAUTIONS]

Use of chlorpheniramine, an antihistamine, may result in:

• Decreased mental alertness with impaired mental and/or physical abilities [see WARNINGS AND PRECAUTIONS]

Adverse reactions listed below have been reported in the literature for codeine and chlorpheniramine and may be expected to occur with TUXARIN ER. 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 TUXARIN ER 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: Allergic laryngospasm, nasal stuffiness, bronchospastic allergic reaction, hives, itching, swelling of face.

Body as a whole: Asthenia, feeling of relaxation, redness or flushing of the face, unusual tiredness, weakness.

Cardiovascular: Fast, or slow heartbeat, hypertension, hypotension, orthostatic hypotension, palpitations, shock-like state, syncope.

Dermatological System: Skin rash, pruritus, erythema, urticaria, excessive perspiration, dermatitis.

Endocrine System: Changes in glucose utilization, decreased lactation, early menses, glycosuria, gynecomastia, hypoglycemia, increased appetite, increased libido, pheochromocytoma stimulation.

Gastrointestinal System: Nausea and vomiting, constipation, abdominal distension, abdominal pain, acute pancreatitis, dry mouth, dyspepsia, epigastric distress, loss of appetite, diarrhea, gastro-esophageal reflux, gastrointestinal hypomotility.

Genitourinary System: Ureteral spasm, urinary retention, dysuria, urinary frequency, urinary hesitancy, irritative bladder symptom.

Nervous System: Blurred vision, diplopia, visual disturbances, confusion, dizziness, depression, drowsiness, sedation, headache, euphoria, facial dyskinesia, false sense of well-being, feeling faint, lightheadedness, general feeling of discomfort or illness, excitability nervousness, agitation, restlessness, somnolence, insomnia, dyskinesia, irritability, tremor.

Respiratory: Dryness of the pharynx and respiratory passages, laryngismus, atelectasis, wheezing, troubled breathing, respiratory depression, hiccups.

Special Senses: labyrinthitis, tinnitus, vertigo, hypermetropia, lacrimation increased, mydriasis, photophobia.

Read the entire FDA prescribing information for Tuxarin-ER (Codeine Phosphate and Chlorpheniramine Maleate Extended Release Tablets, CIII)