Tuzistra XR (Oral)

Codeine polistirex and chlorpheniramine polistirex combination is used to treat cough and respiratory symptoms related to a cold or allergy.

Codeine polistirex is a narcotic cough suppressant. It works directly on the cough center in the brain to stop a cough. Chlorpheniramine polistirex is an antihistamine that treats or prevents allergy symptoms.

Using codeine polistirex for a long time may lead to habit-forming behavior. This can cause mental or physical dependence. If you become physically dependent and suddenly stop taking codeine, you may experience unwanted withdrawal effects. However, severe withdrawal side effects can usually be avoided by gradually lowering the dose over time before stopping completely. Talk to your doctor if you have questions.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to monitor your progress while you are taking this medicine. This will help your doctor see if the medicine is effective and decide if you should keep using it. If your cough does not improve or worsens within 5 days, contact your doctor.

Do not use this medicine if you have taken an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] within the last 14 days.

This medicine can be habit-forming. If you think the medicine is not working as well, do not take more than your prescribed dose. Contact your doctor for guidance.

Do not change your dose or suddenly stop using this medicine without first consulting your doctor. Your doctor may advise you to gradually reduce your dose before stopping completely. This can help prevent your condition from worsening and decrease the chance of withdrawal symptoms, which may include abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Codeine is converted to morphine in the body. Some people convert codeine to morphine faster than others. These individuals are known as "ultra-rapid metabolizers of codeine." Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of codeine," leading to excess morphine in your body and more side effects than usual. Children may be especially vulnerable to this effect (for example, serious breathing problems or death). Do not give this medicine to children aged 12 to 18 years who have had tonsil or adenoid surgery.

If a nursing mother is an ultra-rapid metabolizer of codeine, it may lead to a morphine overdose in the nursing baby, resulting in very serious side effects.

For nursing mothers taking this medicine:

• Talk to your doctor if you have any questions about using codeine or how this medicine may affect your baby.
• Call your doctor if you feel extremely tired and struggle to care for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
• Contact your doctor, a hospital emergency room, or local emergency services (for example, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, trouble breathing, or limpness. These may be signs of an overdose and require immediate medical attention.

Using this medicine during pregnancy may cause serious unwanted effects, including neonatal opioid withdrawal syndrome in your newborn baby. Inform your doctor right away if you think you might be pregnant or if you plan to become pregnant while using this medicine.

This medicine can cause severe constipation. To help prevent this, your doctor may suggest taking laxatives, drinking plenty of fluids, or increasing fiber in your diet. Be sure to follow these instructions carefully, as ongoing constipation can lead to more serious issues.

This medicine may cause confusion, dizziness, or drowsiness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Dizziness, lightheadedness, or fainting may occur if you get up suddenly from a lying or sitting position. Getting up slowly may help reduce this issue. Additionally, lying down for a while may alleviate dizziness or lightheadedness.

This medicine will enhance the effects of alcohol and other CNS depressants (medicines that can cause drowsiness or reduced alertness). Examples of CNS depressants include antihistamines or allergy/cold medications, sedatives, tranquilizers, sleeping aids, other prescription pain medications or narcotics, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Consult your doctor before taking any of these medicines while using this medicine.

If you think you or someone else may have taken an overdose of this medicine, seek emergency help immediately. Signs of an overdose include pale or blue lips, fingernails, or skin, confusion, difficulty breathing, irregular, fast, slow, or shallow breathing, extreme sleepiness or drowsiness, cold and clammy skin, or lightheadedness or fainting.

This medicine may cause adrenal insufficiency. Contact your doctor immediately if you experience darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

If you are particularly sensitive to the effects of this medicine, do not suddenly stop using it without first consulting your doctor. Your doctor may want you to gradually decrease your dose before stopping completely. This can help reduce the likelihood of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Using too much of this medicine may cause infertility (the inability to have children). Talk to your doctor before using this medicine if you plan to have children.

Ensure that any doctor or dentist who treats you knows that you are using this medicine.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this drug, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this drug or any other drugs. Also inform 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.

Pediatric

Use is not advised in children. Safety and efficacy have not been established.

It should not be used to ease pain following the surgical removal of tonsils or adenoids in children. Serious breathing problems and deaths have been reported in some children who received codeine following tonsil or adenoid surgery.

Geriatric

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 issues, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medication.

Interactions with Medications

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 physician may want to change the dose, or other precautions may be necessary. When you are taking this drug, it is especially essential that your healthcare professional know if you are using 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 drug with any of the following medications is not advised. Your doctor may decide not to treat you with this medication or change some of the other medications you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nalmefene
• Naltrexone
• Nialamide
• Ozanimod
• Phenelzine
• Potassium Citrate
• Procarbazine
• Rasagiline
• Safinamide
• Samidorphan
• Selegiline
• Toloxatone
• Tranylcypromine

Using this drug with any of the following medicines is typically not recommended, but may be required in some cases. If both medications are prescribed together, your clinician may change the dose or how often you use one or both of the medicines.

• Abametapir
• Abiraterone Acetate
• Acepromazine
• Aclidinium
• Alfentanil
• Almotriptan
• Alosetron
• Alprazolam
• Amantadine
• Amifampridine
• Amiloride
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Apalutamide
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Armodafinil
• Asenapine
• Atazanavir
• Atropine
• Baclofen
• Belladonna
• Bemetizide
• Bendroflumethiazide
• Benperidol
• Bentazepam
• Benzhydrocodone
• Benzphetamine
• Benzthiazide
• Benztropine
• Biperiden
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Bumetanide
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Canrenoate
• Canrenone
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cenobamate
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorothiazide
• Chlorpheniramine
• Chlorpromazine
• Chlorthalidone
• Chlorzoxazone
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clemastine
• Clidinium
• Clobazam
• Clomipramine
• Clonazepam
• Clopamide
• Clopidogrel
• Clorazepate
• Cloxazolam
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclopenthiazide
• Cyclopentolate
• Cyclosporine
• Cyclothiazide
• Cyproheptadine
• Daridorexant
• Darifenacin
• Darunavir
• Delavirdine
• Delorazepam
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diacetylmorphine
• Diazepam
• Diazoxide
• Dibenzepin
• Dichloralphenazone
• Dicyclomine
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Dimenhydrinate
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Elagolix
• Eletriptan
• Enflurane
• Enzalutamide
• Eplerenone
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethacrynic Acid
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etozolin
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fesoterodine
• Fexinidazole
• Flavoxate
• Flibanserin
• Fluconazole
• Flunitrazepam
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furosemide
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Homatropine
• Hydrochlorothiazide
• Hydrocodone
• Hydroflumethiazide
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Hyoscyamine
• Idelalisib
• Imatinib
• Imipramine
• Indapamide
• Indinavir
• Ipratropium
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Larotrectinib
• Lasmiditan
• Lemborexant
• Lenacapavir
• Letermovir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Loprazolam
• Lorazepam
• Lorcaserin
• Lorlatinib
• Lormetazepam
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Medazepam
• Melitracen
• Melperone
• Mepenzolate
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaclazepam
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyclothiazide
• Methylene Blue
• Metoclopramide
• Metolazone
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nordazepam
• Nortriptyline
• Olanzapine
• Omaveloxolone
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxitropium Bromide
• Oxybutynin
• Oxycodone
• Oxymorphone
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pinazepam
• Pipenzolate Bromide
• Piperacetazine
• Pipotiazine
• Pirenzepine
• Piretanide
• Piritramide
• Pitolisant
• Polythiazide
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Prochlorperazine
• Procyclidine
• Promazine
• Promethazine
• Propantheline
• Propiverine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinethazone
• Quinidine
• Quinine
• Ramelteon
• Ranitidine
• Ranolazine
• Remifentanil
• Remimazolam
• Remoxipride
• Revefenacin
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Secretin Human
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• Solifenacin
• Spironolactone
• St John's Wort
• Stramonium
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Terbinafine
• Terodiline
• Tetrazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Thiothixene
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tocilizumab
• Tolonium Chloride
• Tolterodine
• Topiramate
• Torsemide
• Tramadol
• Trazodone
• Triamterene
• Triazolam
• Trichlormethiazide
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trihexyphenidyl
• Trimeprazine
• Trimipramine
• Tropicamide
• Trospium
• Tryptophan
• Umeclidinium
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Voxelotor
• Xipamide
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Interactions with Food/Tobacco/Alcohol

Certain medications 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 medications may as well 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 clinician may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

The presence of other medical problems may affect the use of this medicine. Make sure you inform your doctor if you have any other medical issues, especially:

• Acute pancreatitis (swelling of the pancreas) or
• Alcohol abuse, or history of or
• Addison's disease (adrenal gland issue) or
• Brain tumor, history of or
• Drug dependence, especially with narcotics, or history of or
• Enlarged prostate (BPH, prostatic hypertrophy) or
• Gallbladder disease or
• Head injury, history of or
• Hypothyroidism (underactive thyroid), severe or
• Increased pressure in the head or
• Lung or breathing issues (eg, COPD) or
• Trouble urinating—May cause adverse effects to become worse.

• Asthma, acute or serious or
• Paralytic ileus (stomach or bowel blockage), known or suspected or
• Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.

• Hypotension (low blood pressure)—Use with caution. May make this condition worse.

• Kidney disease, severe or
• Liver disease, serious—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

• Anxiety
• belching
• bloating
• blurred or loss of vision
• chills
• cold, clammy skin
• cold sweat
• confusion
• dark 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
• 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
• overbright appearance of lights
• pain in the stomach, side, or abdomen, possibly radiating to the back
• pain or discomfort in the chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• pressure in the stomach
• pounding in the ears
• seizures
• 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

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

• 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
• face is warm or hot to touch
• false or unusual sense of well-being
• 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
• 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 the 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.

In the U.S.

• Tuzistra XR

Pharmacologic Class: Chlorpheniramine

Chemical Class: Codeine

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 Medication Guide. 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.

Dosing

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 as needed. Do not take more than 20 mL in 24 hours. Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

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.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm