Tuzistra XR (Oral)
Generic Name: chlorpheniramine and codeine polistirex (Oral route)
KOE-deen pol-ee-STYE-rex, klor-fen-IR-a-meen pol-ee-STYE-rex
Respiratory depression and death have been reported in children who received codeine after a tonsillectomy or adenoidectomy and who were ultra-rapid metabolizers of codeine due to CYP2D6 polymorphism .
Commonly used brand name(s)
In the U.S.
- Tuzistra XR
Available Dosage Forms:
- Suspension, Extended Release
Therapeutic Class: Antitussive, Opioid/Antihistamine Combination
Pharmacologic Class: Chlorpheniramine
Chemical Class: Codeine
Uses For Tuzistra XR
Codeine polistirex and chlorpheniramine polistirex combination is used to treat cough and respiratory symptoms associated with a cold or allergy.
Codeine polistirex is a narcotic cough suppressant. It acts directly on the cough center in the brain to prevent a cough. Chlorpheniramine polistirex is an antihistamine that treats or prevents the symptoms of an allergy.
When codeine polistirex is used for a long time, it may become habit-forming. This could cause mental or physical dependence. Physical dependence may lead to unwanted withdrawal effects if codeine is stopped suddenly. Talk to your doctor if you have questions.
This medicine is available only with your doctor's prescription.
Before Using Tuzistra XR
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of codeine and chlorpheniramine combination in the pediatric population. Safety and efficacy have not been established. It should not be used to relieve pain after the surgical removal of tonsils and/or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.
Although appropriate studies on the relationship of age to the effects of codeine and chlorpheniramine combination have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to develop age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Chloral Hydrate
- Methylene Blue
- Morphine Sulfate Liposome
- Nitrous Oxide
- Opium Alkaloids
- Sodium Oxybate
- Tolonium Chloride
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Addison disease (adrenal gland problem) or
- Asthma or
- Enlarged prostate (BPH, prostatic hypertrophy) or
- Head injury, history of or
- Hypothyroidism (underactive thyroid), severe or
- Increased pressure in the head or
- Trouble urinating—May cause side effects to become worse.
- Alcohol abuse, or history of or
- Drug dependence, especially with narcotics, or history of or
- Lung or breathing problems (eg, sleep apnea, respiratory depression) or
- Stomach or bowel problems—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use of Tuzistra XR
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose.
This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.
You may take this medicine with or without food.
Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Shake the medicine well before you use it.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (extended-release suspension):
- For relief of cough and cold or allergy symptoms:
- Adults—10 milliliters (mL) every 12 hours. Do not take more than 20 mL in 24 hours.
- Children—Use and dose must be determined by your doctor.
- For relief of cough and cold or allergy symptoms:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Tuzistra XR
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.
This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.
Using this medicine can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.
This medicine may make you confused, dizzy, or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.
Make sure any doctor or dentist who treats you knows that you are using this medicine.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.
If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: pale or blue lips, fingernails, or skin, confusion, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, extreme sleepiness or drowsiness, cold and clammy skin, or lightheadedness or fainting.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Tuzistra XR Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:Incidence not known
- Acid or sour stomach
- blurred or loss of vision
- cold clammy skin
- cold sweats
- dark colored urine
- difficult or painful urination
- disturbed color perception
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- dryness or spasm of the throat
- feeling of constant movement of self or surroundings
- halos around lights
- increased hunger
- irregular, fast or slow, or shallow breathing
- loss of appetite
- night blindness
- overbright appearance of lights
- pain or discomfort in the chest, upper stomach, or throat
- pain in the stomach, side, or abdomen, possibly radiating to the back
- pale or blue lips, fingernails, or skin
- pressure in the stomach
- pounding in the ears
- sensation of spinning
- sleepiness or unusual drowsiness
- slow, fast, or irregular heartbeat
- slurred speech
- stomach discomfort, upset, or pain
- tunnel vision
- unusual tiredness or weakness
- yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Incidence not known
- blistering, crusting, or irritation of the skin
- continuing ringing or buzzing or other unexplained noise in the ears
- cracked, dry, scaly skin
- dry mouth
- early menstrual periods
- face is warm or hot to touch
- false or unusual sense of well-being
- general feeling of discomfort or illness
- hearing loss
- increased appetite
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- lack or loss of strength
- redness of the face
- skin rash, itching, redness, hives, swelling
- swelling of the breasts or breast soreness in both females and males
- trouble sleeping
- twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
- watering of eyes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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