Tuxarin ER

Included as part of the PRECAUTIONS section.

No human overdosage data are available for TUXARIN ER.

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 TUXARIN ER 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.

TUXARIN ER™
(tuks a ren)
(codeine phosphate and chlorpheniramine maleate) Extended Release Tablets

What is the most important information I should know about TUXARIN ER?

• Taking TUXARIN ER with benzodiazepines, or other central nervous system depressants, including alcohol can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.
• TUXARIN ER can cause you to be drowsy. Avoid driving a car or operating machinery during treatment with TUXARIN ER.
• Do not give TUXARIN ER to a child to treat pain after tonsillectomy or adenoidectomy surgery.
  • When you take TUXARIN ER, some of it changes into morphine in your body.
  • In some children and adults this happens very quickly, and can cause you to stop breathing and cause death due to an overdose.
• Women who breastfeed should talk to their healthcare provider before taking TUXARIN ER
  • When you take TUXARIN ER, some of it changes into morphine in your body.
  • In some women, this happens very quickly. Codeine and morphine pass into your breast milk. A large amount of morphine can cause your baby to die.
• Call your healthcare provider or get emergency medical help right away if anyone taking TUXARIN ER, or your breastfeeding baby has any of the symptoms listed below:
  • increased sleepiness
  • confusion
  • difficulty breathing
  • shallow breathing
  • limpness
  • your baby has difficulty breastfeeding
• Keep TUXARIN ER in a safe place away from children. Accidental use by a child is a medical emergency and can cause death. If a child accidentally takes TUXARIN ER, get emergency help right away.
• TUXARIN ER can cause serious side effects, including death.
• Take TUXARIN ER exactly as prescribed by your healthcare provider. If you take the wrong dose of TUXARIN ER, you could overdose and die.
• It is especially important when you take TUXARIN ER that you know exactly what dose to take.

What is TUXARIN ER?

TUXARIN ER is a prescription medicine used to treat cough and upper respiratory symptoms that you can have with allergies or a common cold. TUXARIN ER is for adults 18 years and older. TUXARIN ER contains 2 medicines, codeine and chlorpheniramine. Codeine is a narcotic cough suppressant. Chlorpheniramine is an antihistamine.

TUXARIN ER is a federal controlled substance (CIII) because it contains codeine that can be abused or lead to dependence. Keep TUXARIN ER in a safe place to prevent misuse and abuse. Selling or giving away TUXARIN ER may harm others and is against the law.

TUXARIN ER is not for children under 18 years of age. It is not known if TUXARIN ER is safe and effective in children.

Who should not take TUXARIN ER?

Do not give TUXARIN ER to a child to treat pain after tonsillectomy or adenoidectomy surgery.

Do not take TUXARIN ER if you are allergic to any of the ingredients in TUXARIN ER. See the end of this Medication Guide for a complete list of ingredients in TUXARIN ER. You may have an increased risk of having an allergic reaction to TUXARIN ER if you are allergic to certain other opioid medicines.

Before taking TUXARIN ER, tell your healthcare provider about all of your medical conditions, including if you:

• have a drug dependence
• have lung or breathing problems
• have had a head injury
• have pain in your stomach (abdomen)
• have constipation or problems with your intestines
• have prostate problems
• have problems with your urinary tract (urethral stricture)
• plan to have surgery
• abuse alcohol
• have kidney or liver problems
• have thyroid problems, such as hypothyroidism
• have Addison's disease
• are pregnant or plan to become pregnant. It is not known if TUXARIN ER will harm your unborn baby. You and your healthcare provider should decide if you should take TUXARIN ER while you are pregnant.
• are breastfeeding or plan to breastfeed. Codeine and chlorpheniramine pass into your breast milk and may harm your baby. You and your healthcare provider should discuss whether you should take TUXARIN ER or breastfeed. You should not do both.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using TUXARIN ER with certain other medicines may affect each other. Using TUXARIN ER with other medicines can cause serious side effects.

Especially tell your healthcare provider if you:

• take pain medicines such as narcotics
• take cold or allergy medicines that contain antihistamines or cough suppressants
• take medicines for mental illness (anti-psychotics, anti-anxiety)
• drink alcohol
• take medicines for depression, other mental health problems, or Parkinson's disease, including monoamine oxidase inhibitors (MAOIs), or if you have taken an MAOI in the last 14 days
• take medicines for stomach or intestine problems Ask your healthcare provider if you are not sure if you take one of these medicines.

How should I take TUXARIN ER?

• Take TUXARIN ER exactly as your healthcare provider tells you.
• Do not take more than 2 TUXARIN ER tablets in 24 hours.
• If you take too much TUXARIN ER, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while taking TUXARIN ER?

• TUXARIN ER can cause you to be drowsy. Avoid driving a car or using machinery during treatment with TUXARIN ER.
• Do not drink alcohol during treatment with TUXARIN ER. Drinking alcohol can increase your chances of having serious side effects.

What are the possible side effects of TUXARIN ER?

TUXARIN ER may cause serious side effects, including:

• See “What is the most important information I should know about TUXARIN ER”
• Breathing problems (respiratory depression) which can lead to death. Call your healthcare provider or get emergency treatment right away if you have excessive sleepiness, shallow or slow breathing, or confusion.
• Physical dependence or abuse. Take TUXARIN ER exactly as your healthcare provider tells you to take it. Stopping TUXARIN ER suddenly could cause withdrawal symptoms.
• Increased intracranial pressure
• Bowel problems including constipation or stomach pain.

The most common side effects of TUXARIN ER include:

• nausea and vomiting
• constipation
• swelling or boating of your stomach-area
• stomach-area pain
• vision problems, including blurred vision and double vision
• confusion
• dizziness
• depression
• drowsiness
• headache
• feeling high (euphoria)
• feeling faint
• light-headedness
• general feeling of discomfort or illness
• excitability, nervousness
• agitation, restlessness, irritability
• sleepiness
• difficulty sleeping (insomnia)
• unable to control muscle movements
• tremor

These are not all the possible side effects of TUXARIN ER.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store TUXARIN ER?

• Store TUXARIN ER in a safe place between 68°F to 77°F (20°C to 25°C).
• Keep TUXARIN ER in a tightly closed, child-resistant container and out of the light.
• Safely throw away medicine that is out of date or no longer needed.
• Keep TUXARIN ER and all medicines out of the reach of children.

General information about the safe and effective use of TUXARIN ER.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TUXARIN ER for a condition for which it was not prescribed. Do not give TUXARIN ER to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TUXARIN ER that is written for health professionals.

What are the ingredients in TUXARIN ER?

Active ingredients: codeine and chlorpheniramine

Inactive ingredients: Hypromellose, lactose monohydrate, cellulose microcrystalline, polysorbate 80, magnesium stearate, and colloidal silicon dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration

• Denavir
• Robitussin Ac

• Zovirax

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

Tuxarin ER is part of the drug class:

• OTHER COLD PREPARATIONS