Chlorpheniramine and codeine polistirex (Oral route)

Pronunciation:

KOE-deen pol-ee-STYE-rex, klor-fen-IR-a-meen pol-ee-STYE-rex

Brand Names:

Tuzistra XR

Warnings:

Oral route(Suspension, Extended Release)

Warning: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression, Accidental Ingestion, Ultra-Rapid Metabolism of Codeine and Other Risk Factors for Life-Threatening Respiratory Depression in Children; Medication Errors; Interactions with Drugs Affecting Cytochrome P450 3A4; Concomitant Use with Benzodiazepines or Other CNS Depressants; Neonatal Opioid Withdrawal SyndromeCodeine polistirex/chlorpheniramine polistirex exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor closely for these behaviors and conditions.Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or when used in patients at higher risk.Accidental ingestion of codeine polistirex/chlorpheniramine polistirex, especially by children, can result in a fatal overdose of codeine.Life-threatening respiratory depression and death have occurred in children who received codeine; most cases followed tonsillectomy and/or adenoidectomy, and many of the children had evidence of being an ultra-rapid metabolizer of codeine due to a CYP2D6 polymorphism. Codeine polistirex/chlorpheniramine polistirex is contraindicated in children younger than 12 years of age and in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid the use of codeine polistirex/chlorpheniramine polistirex in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of codeine.Ensure accuracy when prescribing, dispensing, and administering codeine polistirex/chlorpheniramine polistirex. Dosing errors can result in accidental overdose and death.The effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with codeine are complex, requiring careful consideration of the effects on the parent drug, codeine, and the active metabolite, morphine. Avoid the use of codeine polistirex/chlorpheniramine polistirex in patients who are taking a CYP3A4 inhibitor, CYP3A4 inducer, or 2D6 inhibitor.Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of codeine polistirex/chlorpheniramine polistirex in patients taking benzodiazepines, other CNS depressants, or alcohol. Codeine polistirex/chlorpheniramine polistirex is not recommended for use in pregnant women. Prolonged use of codeine polistirex/chlorpheniramine polistirex during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If codeine polistirex/chlorpheniramine polistirex is used for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available .

Classifications:

Pharmacologic—

Chlorpheniramine

Chemical—

Codeine

Uses of This Medicine:

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. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely. Talk to your doctor if you have questions.

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

Before Using This Medicine:

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:

Allergies—

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.

Children—

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

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

Older adults—

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.

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 medicine.

Other 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.

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

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.

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
Celecoxib
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
LetibotulinumtoxinA-wlbg
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
Oliceridine
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
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

Other interactions—

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.

Ethanol

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:

Acute pancreatitis (swelling of the pancreas) or
Alcohol abuse, or history of or
Addison's disease (adrenal gland problem) 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 problems (eg, COPD) or
Trouble urinating—May cause side effects to become worse.

Asthma, acute or severe 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, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

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

Precautions While Using This Medicine:

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. If your cough does not improve or if it gets worse within 5 days, call your doctor.

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

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.

Do not change your dose or suddenly stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.

Codeine is changed to morphine in the body. Some people change codeine to morphine more quickly than others. These individuals are called "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". As a result, there is too much morphine in the body and more side effects of morphine than usual. Children may be especially sensitive to this effect (eg, serious breathing problems, death). Do not give this medicine to children 12 to 18 years of age who have had surgery removal of tonsils or adenoids.

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

For nursing mothers taking this medicine:

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

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

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. 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 when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

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.

This medicine may cause adrenal insufficiency. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

If you are especially sensitive to the effects of this medicine, do not suddenly stop using it without first checking with your doctor Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help reduce the possibility 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 (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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

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.

Side Effects of This Medicine:

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.

Last Updated: 4/24/2024

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