Medication Guide

TUXARIN^® ER (Tuks-a-ren)

(codeine phosphate and chlorpheniramine maleate)
extended-release tablets, C-III

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

TUXARIN ER is not for children under 18 years of age.

TUXARIN ER can cause serious side effects, including:

• Addiction, abuse and misuse. Taking TUXARIN ER or other medications that contain an opioid can cause addiction, abuse, and misuse, which can lead to overdose and death.  This can happen even if you take TUXARIN ER exactly as prescribed by your healthcare provider.  Your risk of addiction, abuse, and misuse is increased if you or a family member has a history of drug or alcohol abuse or addiction, or mental health problems.
  • Do not share your TUXARIN ER with other people.
  • Keep TUXARIN ER in a safe place away from children.
• Life-threatening breathing problems (respiratory depression).  TUXARIN ER can cause breathing problems (respiratory depression) that can happen at any time during treatment and can lead to death.  Your risk of breathing problems is greatest when you first start taking TUXARIN ER, are taking other medicines that can cause breathing problems, have certain lung problems, are elderly or have certain other health problems.  Children are at higher risk for respiratory depression.  Breathing problems can happen even if you take TUXARIN ER exactly as prescribed by your healthcare provider.

Call your healthcare provider or get emergency medical help right away if anyone taking TUXARIN ER has any of the symptoms below:

o    increased sleepiness o    confusion o    difficulty breathing

o    shallow breathing o    limpness

Keep TUXARIN ER in a safe place away from children.  Accidental use of even 1 dose of TUXARIN ER, especially by a child, is a medical emergency and can cause breathing problems (respiratory depression) which can lead to death.  If a child accidentally takes TUXARIN ER, get emergency help right away.

• Overdose and death due to medicine dosing errors. Overdose and death can happen if you take the wrong dose of TUXARIN ER.  Do not increase the dose or dosing frequency of TUXARIN ER. See “How should I take TUXARIN ER?”
• Breathing problems (respiratory depression) that can lead to death and opioid withdrawal can happen if you start taking or stop taking other medicines while taking TUXARIN ER, including:
  • certain antibiotics
  • certain medicines to treat a fungal infection
  • certain medicines to treat Human Immunodeficiency Virus (HIV)-1 infection, Acquired Immune Deficiency Syndrome (AIDS), or Hepatitis C
  • rifampin
  • carbamazepine
  • phenytoin
• Severe drowsiness, breathing problems (respiratory depression), coma, and death can happen in adults and children who take TUXARIN ER with benzodiazepines, or other central nervous system depressants, including alcohol.
  • Do not take any benzodiazepines or medicines that can cause drowsiness or sleepiness during treatment with TUXARIN ER.  Ask your healthcare provider for a list of these medicines if you are not sure.
  • Do not drink alcohol during treatment with TUXARIN ER.
• Opioid withdrawal in a newborn.  Use of TUXARIN ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.  You should not take TUXARIN ER if you are pregnant.  Tell your healthcare provider right away if you are pregnant or think you may be pregnant.

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 contains 2 medicines, codeine and chlorpheniramine. Codeine is an opioid (narcotic) cough suppressant. Chlorpheniramine is an antihistamine.
• TUXARIN ER is a federal controlled substance (C-III) 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.  Tell your healthcare provider if you have abused or been dependent on alcohol, prescription medicines or street drugs.

Who should not take TUXARIN ER?

TUXARIN ER is not for children under 18 years of age.  See “What is the most important information I should know about TUXARIN ER?”

Do not take TUXARIN ER if you:

• have severe breathing problems (respiratory depression).  See “What is the most important information I should know about TUXARIN ER?”
• have a blockage (obstruction) in your bowel such as a paralytic ileus.
• take a medicine for depression called a Monoamine Oxidase Inhibitor (MAOI).
  • Do not take an MAOI within 14 days after you stop taking TUXARIN ER.
  • Do not start taking TUXARIN ER if you stopped taking an MAOI in the last 14 days.
• are allergic to codeine, chlorpheniramine, or 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.

Ask your healthcare provider if you have any questions about this information.

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

• have a drug addiction                                             
• have bile duct or pancreas problems
• have lung or breathing problems                         
• have prostate problems
• have a fever and are coughing up mucus
• have problems with your urinary tract or difficulty urinating
• have had a recent head injury                             
• have kidney or liver problems
• have had a brain tumor or other brain problems
• have adrenal gland problems
• have or have had seizures       
• have low blood pressure (hypotension)
• have pain in your stomach-area (abdomen) 
• plan to have surgery
• have constipation or other bowel problems
• are pregnant or plan to become pregnant. TUXARIN ER can harm your unborn baby.  See “What is the most important information I should know about TUXARIN ER?” 
• are breastfeeding or plan to breastfeed.  Codeine and chlorpheniramine pass into your breast milk and can cause serious side effects in your baby including increased sleepiness, breathing problems (respiratory depression) and death.  You and your healthcare provider should decide if you will take TUXARIN ER or breastfeed.  You should not do both.  See “What should I avoid while taking TUXARIN ER?”
• plan to have children.  TUXARIN ER may affect the ability to have a child in females and males (fertility problems).  It is not known if these fertility problems will be reversible, even after you stop taking TUXARIN ER.

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

Taking TUXARIN ER with certain other medicines can cause side effects or affect how well TUXARIN ER or the other medicines work.  Do not start or stop taking other medicines without talking to your healthcare provider.

Especially tell your healthcare provider if you:

• See “What is the most important information I should know about TUXARIN ER?”
• take pain medicines such as opioids (narcotics).
• take cold or allergy medicines that contain antihistamines or cough suppressants.
• drink alcohol.
• take muscle relaxants.
• take certain medicines used to treat mood, anxiety, psychotic or thought disorders, or depression, including monoamine oxidase inhibitors (MAOIs), tricyclics, selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), or antipsychotics.
• take medicines to lower your blood pressure.
• water pills (diuretics).
• take medicines called “anticholinergics” used to treat health problems such as asthma, chronic obstructive pulmonary disease (COPD), or stomach problems.
• take a medicine called “phenytoin” used to treat seizures or epilepsy.

Ask your healthcare provider if you are not sure if you take one of these medicines.

How should I take TUXARIN ER?

• See “What is the most important information I should know about TUXARIN ER?”
• Take TUXARIN ER exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
• Take TUXARIN ER by mouth only.  TUXARIN ER is usually taken every 12 hours.  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.
• Tell your healthcare provider if your cough does not get better within 5 days of treatment with TUXARIN ER.

What should I avoid doing while taking TUXARIN ER?

• Avoid driving a car or operating machinery during treatment with TUXARIN ER. TUXARIN ER can cause you to be drowsy, slow your thinking and motor skills, and affect your vision.
• Do not drink alcohol during treatment with TUXARIN ER. Drinking alcohol with TUXARIN ER can increase your chances of having serious side effects.

Avoid the use of TUXARIN ER if you:

• are pregnant.  Use of TUXARIN ER during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.  Tell your healthcare provider right away if you are pregnant or think you may be pregnant.
• are breastfeeding.  Use of TUXARIN ER while breastfeeding can cause severe breathing problems (respiratory depression) in your breastfed infant that could be life-threatening.

What are the possible side effects of TUXARIN ER?

TUXARIN ER can cause serious side effects, including:

• See “What is the most important information I should know about TUXARIN ER?”
• Bowel problems including severe constipation or stomach pain. See, “Who should not takeTUXARIN ER?”
• Increased pressure in your head (intracranial).  Avoid the use of TUXARIN ER if you have a head injury or have been told that you have changes in the tissue of your brain (brain lesions) or increased pressure in your head.
• Increased risk of seizures in people with seizure disorders.  If you have a seizure disorder, TUXARIN ER may increase how often you have seizures.
• Low blood pressure.  A sudden drop in blood pressure can happen in some people during treatment with TUXARIN ER and this may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension).  Your risk of having this problem may be increased if you take TUXARIN ER with certain other medicines that lower blood pressure.  If you have any of these symptoms while taking TUXARIN ER, sit or lie down.  Do not change your body position too fast.  Get up slowly from sitting or lying down.
• Adrenal gland problems.  TUXARIN ER can cause serious and life-threatening adrenal gland problems.  Your healthcare provider may do blood tests to check for adrenal gland problems. Call your healthcare provider right away if you have any of these symptoms:
  • nausea
  • vomiting
  • not wanting to eat (anorexia)
  • fatigue
  • weakness
  • dizziness
  • low blood pressure

The most common side effects of TUXARIN ER include:

sleepiness confusion coordination problems decrease in mental and physical performance lack of energy lightheadedness dizziness

headache dry mouth sweating nausea vomiting constipation

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 at room temperature between 68oF to 77oF (20oC to 25oC).
• Keep TUXARIN ER in a tightly closed container, in a dry, cool place away from heat or direct sunlight.
• Keep TUXARIN ER and all medicines out of the reach of children.

How should I dispose of TUXARIN ER?

Remove unused TUXARIN ER from the container and mix it with an undesirable, non-toxic substance such as cat litter or used coffee grounds to make it less appealing to children and pets.  Place the mixture in a container such as a sealed plastic bag and throw it away in the household trash.  You can also follow your state or local guidelines on how to safely throw away TUXARIN ER.

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 TUXARINER for a condition for which it was not prescribed. Do not give TUXARIN ER to other people, even if they have thesame 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 healthprofessionals.

What are the ingredients in TUXARIN ER?

Active ingredients: codeine phosphate and chlorpheniramine maleate

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