Tuzistra XR

What is Tuzistra XR?

• Tuzistra XR is a prescription medicine used in adults to treat cough and upper respiratory symptoms that you can have with allergies or a common cold. Tuzistra XR contains 2 medicines, codeine and chlorpheniramine. Codeine is an opioid (narcotic) cough suppressant. Chlorpheniramine is an antihistamine.
• Tuzistra XR is a federal controlled substance (C-III) because it contains codeine that can be abused or lead to dependence. Keep Tuzistra XR in a safe place to prevent misuse and abuse. Selling or giving away Tuzistra XR 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.

What is the most important information I should know about Tuzistra XR?

Tuzistra XR is not for children under 18 years of age.

Tuzistra XR can cause serious side effects, including:

• Addiction, abuse and misuse. Taking Tuzistra XR or other medicines that contain an opioid can cause addiction, abuse, and misuse, which can lead to overdose and death. This can happen even if you take Tuzistra XR 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 Tuzistra XR with other people.
  • Keep Tuzistra XR in a safe place away from children.
• Life-threatening breathing problems (respiratory depression). Tuzistra XR 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 Tuzistra XR, 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 Tuzistra XR exactly as prescribed by your healthcare provider.
  
  Call your healthcare provider or get emergency medical help right away if anyone taking Tuzistra XR has any of the symptoms below:
  • increased sleepiness
  • confusion
  • difficulty breathing
  • shallow breathing
  • limpness

Keep Tuzistra XR in a safe place away from children. Accidental use of even 1 dose of Tuzistra XR, 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 Tuzistra XR, get emergency help right away.

• Overdose and death due to medicine dosing errors. Overdose and death can happen if you measure the wrong dose of Tuzistra XR. Always use an accurate milliliter (mL) measuring device to measure the correct amount of Tuzistra XR. Do not use a household teaspoon to measure your medicine. You may accidentally take too much. You can ask your pharmacist for the measuring device you should use and how to measure the correct dose.
• 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 Tuzistra XR, 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 Tuzistra XR 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 Tuzistra XR. Ask your healthcare provider for a list of these medicines if you are not sure.
  • Do not drink alcohol during treatment with Tuzistra XR.
• Opioid withdrawal in a newborn. Use of Tuzistra XR during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. You should not take Tuzistra XR if you are pregnant. Tell your healthcare provider right away if you are pregnant or think you may be pregnant.

Who should not take Tuzistra XR?

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

Do not take Tuzistra XR if you:

• have severe breathing problems (respiratory depression). See “What is the most important information I should know about Tuzistra XR?”
• 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 Tuzistra XR.
  • Do not start taking Tuzistra XR if you stopped taking an MAOI in the last 14 days.
• are allergic to codeine, chlorpheniramine, or any of the ingredients in Tuzistra XR. See the end of this Medication Guide for a complete list of ingredients in Tuzistra XR. You may have an increased risk of an allergic reaction to Tuzistra XR if you are allergic to certain other opioid medicines.

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

What should I tell my healthcare provider before taking Tuzistra XR?

Before you take Tuzistra XR, tell your healthcare provider about all your medical conditions, including if you:

• have a drug addiction
• have lung or breathing problems
• have a fever and are coughing up mucus
• have had a recent head injury
• have had brain tumor or other brain problems
• have or have had seizures
• have pain in your stomach-area (abdomen)
• have constipation or other bowel problems
• have bile duct or pancreas problems
• have prostate problems
• have problems with your urinary tract or difficulty urinating
• have kidney or liver problems
• have adrenal gland problems
• have low blood pressure (hypotension)
• plan to have surgery
• are pregnant or plan to become pregnant. Tuzistra XR can harm your unborn baby. See “What is the most important information I should know about Tuzistra XR?”
• 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 Tuzistra XR or breastfeed. You should not do both. See “What should I avoid while taking Tuzistra XR?”
• plan to have children. Tuzistra XR 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 Tuzistra XR. Talk to your healthcare provider if this is a concern for you.

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

Taking Tuzistra XR with certain other medicines can cause side effects or affect how well Tuzistra XR 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 Tuzistra XR?”
• 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 Tuzistra XR?

• See “What is the most important information I should know about Tuzistra XR?”
• Take Tuzistra XR exactly as your healthcare provider tells you to take it. Do not change your dose without talking to your healthcare provider.
• Take Tuzistra XR by mouth only. Tuzistra XR is usually taken every 12 hours. Do not take more than 20 mL of Tuzistra XR in 24 hours.
• Do not mix Tuzistra XR with other fluids or medicines.
• Take Tuzistra XR using an accurate milliliter (mL) measuring device. If you do not have one, ask your pharmacist to give you a measuring device to measure the correct amount of Tuzistra XR. Do not use a household teaspoon to measure your medicine. You may accidently take too much.
• Do not overfill the measuring device.
• Rinse the measuring device with water after each use.
• If you take too much Tuzistra XR, 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 Tuzistra XR.

What should I avoid while taking Tuzistra XR?

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

Avoid the use of Tuzistra XR if you:

• are pregnant. Use of Tuzistra XR 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 Tuzistra XR 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 Tuzistra XR?

Tuzistra XR can cause serious side effects, including:

• See “What is the most important information I should know about Tuzistra XR?”
• Bowel problems including severe constipation or stomach pain. See “Who should not take Tuzistra XR?”
• Increased pressure in your head (intracranial). Avoid the use of Tuzistra XR 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, Tuzistra XR may increase how often you have seizures.
• Low blood pressure. A sudden drop in blood pressure can happen in some people during treatment with Tuzistra XR 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 Tuzistra XR with certain other medicines that lower blood pressure. If you have any of these symptoms while taking Tuzistra XR, sit or lie down. Do not change your body position too fast. Get up slowly from sitting or lying down.
• Adrenal gland problems. Tuzistra XR 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 Tuzistra XR 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 Tuzistra XR.

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

General information about the safe and effective use of Tuzistra XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Tuzistra XR for a condition for which it was not prescribed. Do not give Tuzistra XR 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 Tuzistra XR that is written for health professionals.

How should I store Tuzistra XR?

• Store Tuzistra XR at room temperature between 68°F to 77°F (20°C to 25°C).
• Store Tuzistra XR in a tightly closed container, in a dry, cool place away from heat or direct sunlight.
• Keep Tuzistra XR and all medicines out of the reach of children.

How should I dispose of Tuzistra XR?

Remove unused Tuzistra 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 Tuzistra XR.

What are the ingredients in Tuzistra XR?

Active ingredients: codeine polistirex and chlorpheniramine polistirex

Inactive ingredients: cherry flavor, citric acid, D&C Red No. 30, ethyl maltol, glycerin, methylparaben, polysorbate 80, polyvinyl acetate, povidone, propyl gallate, propylparaben, purified water, sodium citrate, sodium polystyrene sulfonate, starch, sucrose, triacetin, xanthan gum.

For more information call 1-855-AYTU BIO (1-855-298-8246)