Tuzistra XR

Tuzistra XR is used for the treatment of respiratory symptoms induced by cold or allergy.

Codeine polistirex acts directly on the cough center in the brain to prevent a cough while chlorpheniramine polistirex treats or prevents the symptoms of hypersensitivity.

You can develop dependence to codeine polistirex if usage is prolonged. Unwanted withdrawal effects may happen if codeine is stopped suddenly.

Consult with your healthcare professional if you have questions regarding this drug combination. This drug combination requires a prescription.

Before using Tuzistra XR, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals.

Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications. Studies on the relationship of age to the effects of codeine and chlorpheniramine in the pediatric population have not been performed while safety and efficacy of this drug are yet to be established.

Codeine is associated with severe breathing problems and deaths in some children who had tonsil or adenoid surgery.

No studies indicate geriatric-specific problems that would limit the usefulness of chlorothiazide in the elderly. Elderly patients may require an adjustment to their dosage due to increased likelihood of having age-related liver, kidney, or heart problems.

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women or animal studies. Infant risk is still undetermined when using this drug combination during breastfeeding due to inadequacy studies.

Consult your healthcare provider about the benefits and risks of this drug while breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

• Alfentanil
• Almotriptan
• Alprazolam
• Amitriptyline
• Amoxapine
• Anileridine
• Baclofen
• Bromazepam
• Buprenorphine
• Bupropion
• Butalbital
• Butorphanol
• Carbinoxamine
• Carisoprodol
• Chloral Hydrate
• Chlordiazepoxide
• Chlorzoxazone
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Darunavir
• Desvenlafaxine
• Dezocine
• Diazepam
• Dolasetron
• Donepezil
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Flunitrazepam
• Fluoxetine
• Flurazepam
• Granisetron
• Halazepam
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Ketazolam
• Levomilnacipran
• Levorphanol
• Lorazepam
• Lorcaserin
• Lormetazepam
• Meclizine
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Meptazinol
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Midazolam
• Mirtazapine
• Morphine
• Morphine Sulfate
• Liposome
• Nalbuphine
• Naltrexone
• Nitrazepam
• Opium
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Palonosetron
• Paroxetine
• Pentazocine
• Prazepam
• Propoxyphene
• Quazepam
• Remifentanil
• Safinamide
• Sodium Oxybate
• Sufentanil
• Suvorexant
• Tapentadol
• Temazepam
• Tizanidine
• Tramadol
• Trazodone
• Triazolam
• Vilazodone
• Vortioxetine
• Ziprasidone

Intake of specific food or using alcohol or tobacco with codeine and chlorpheniramine is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare provider for any other medical problems especially Addison disease, asthma, enlarged prostate, head injury, hypothyroidism, increased intracranial pressure or trouble urinating. Alcohol abuse, or drug dependence, especially with narcotics, lung or breathing or bowel problems may cause side effects to worsen.

For patients with kidney or liver disease, the effects of this drug may be potentiated due to slower excretion of the drug from the body.

Proper usage of Tuzistra XR requires strict adherence to your doctor’s orders. Additional or prolonged doses could increase the chance of side effects. The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. A patient information leaflet is provided with this drug. Ask your healthcare professional if you have any questions.

Shake well before taking this drug, and drink it accurately using a marked measuring spoon, oral syringe, or medicine cup with or without food. Shake the medicine well before you use it.

Adults with a cough and cold or allergy are usually prescribed with an extended-release suspension of 10 milliliters every 12 hours. Do not take more than 20 mL in 24 hours. Use and dose for children must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

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. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

Before using Tuzistra XR, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug.

Do not use more than your prescribed dose as dependence has been associated with this drug.

Your healthcare professional may advise you to take laxatives, drink a lot of fluids,increase the amount of fiber in your diet to prevent severe constipation associated with this drug.

This drug may also cause confusion, dizziness, or drowsiness. Do not do dangerous if you experience such symptoms. Inform any healthcare professional that you are using this drug.

This drug potentiates the effects of alcohol and other CNS depressants such as 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

Consult with your healthcare professional before taking any of these drugs while you are using this codeine.

Contact emergency medical services immediately if someone has signs of an overdose such as 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.

Consult with your healthcare professional before taking prescription or non-prescription drugs, and herbal or vitamin supplements.

As with many medications, there are several potential side effects associated with Tuzistra XR.

Side effects may vary for each individual and prompt medical attention should be given if they occur:

• symptoms of acid or sour stomach
• anxiety
• belching
• bloating
• blurred or loss of vision
• chills
• cold
• clammy skin
• cold sweats
• confusion
• dark colored urine
• depression
• diarrhea
• 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
• the feeling of constant movement of self or surroundings
• fever halos around lights
• headache
• heartburn
• increased hunger
• indigestion
• irregular
• fast or slow or shallow breathing
• loss of appetite
• nausea
• nervousness
• night blindness
• nightmares
• the 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
• seizures
• the sensation of spinning
• shakiness
• sleepiness or unusual drowsiness
• slow, fast or irregular heartbeat,
• slurred speech
• stomach discomfort
• upset or pain sweating
• tunnel vision
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin have unknown incidence

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional.

• anxiety 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
• the face is warm or hot to touch
• the false or unusual sense of well-being
• the general feeling of discomfort or illness,
• hearing loss
• hiccups
• increased appetite
• increased in sexual ability, desire, drive or performance
• increased interest in sexual intercourse
• irritability, lack or loss of strength
• redness of the face
• restlessness
• skin rash, itching, redness, hives
• 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 have been reported but have an unknown incidence

Report any side effects to the FDA hotline at 1-800-FDA-1088.