Triprolidine, pseudoephedrine, and codeine

Generic name: Triprolidine, Pseudoephedrine, And Codeine
Drug class: Upper respiratory combinations

Usage of Triprolidine, pseudoephedrine, and codeine

Triprolidine, pseudoephedrine, and codeine combination is used to relieve cough, sneezing, itchy or runny nose, and nasal congestion (stuffy nose) caused by allergies or the common cold.

Triprolidine is an antihistamine that works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Pseudoephedrine is a decongestant, which decreases nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passage. Codeine is a narcotic antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough.

When codeine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing cough and nasal congestion should not let the fear of dependence keep them from using narcotics to relieve their cough. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment 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.

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

Triprolidine, pseudoephedrine, and codeine 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

Anxiety

back, leg, or stomach pain

black, tarry stools

bleeding gums

blood in the urine or stools

blurred vision

cold, clammy skin

confusion

cough

dark urine

decrease in how much or how often you urinate

difficulty breathing

difficulty sleeping

difficulty urinating

disturbed coordination

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

double vision

drowsiness to profound loss of consciousness

excessive sweating and chills

excitation

false or unusual sense of well-being

fast, irregular, pounding, or racing heartbeat or pulse

feeling of constant movement of self or surroundings

fever with or without chills

general body swelling

general feeling of tiredness or weakness

headache

hoarseness

irritability

loss of appetite

lower back or side pain

mood or other mental changes

nausea

nervousness

nosebleed

painful or difficult urination

pinpoint red spots on the skin

relaxed and calm feeling

restlessness

seeing double

seeing, hearing, or feeling things that are not there

seizures

sensation of spinning

sleepiness

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stuffy nose

thickening of bronchial secretions

tightness of the chest

tremor

unusual bleeding or bruising

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

vomiting

yellowing of the 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

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

dry mouth, throat, or nose

increased sensitivity of the skin to sunlight

itching, skin rash

redness or other discoloration of the skin

severe sunburn

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.

Before taking Triprolidine, pseudoephedrine, and codeine

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of triprolidine, pseudoephedrine, and codeine combination in children.

Triprolidine, pseudoephedrine, and codeine combination should not be used to relieve pain after surgery 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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triprolidine, pseudoephedrine, and codeine combination in the elderly.

Breast Feeding

Codeine

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.

Pseudoephedrine

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.

Triprolidine

Studies in women suggest that this medication poses minimal risk to the infant when used during 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.

Dihydroergotamine

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Methylene Blue

Moclobemide

Nalmefene

Naltrexone

Nialamide

Ozanimod

Phenelzine

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

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

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

Glycopyrrolate

Glycopyrronium Tosylate

Granisetron

Guanethidine

Halazepam

Haloperidol

Halothane

Hexobarbital

Homatropine

Hydrochlorothiazide

Hydrocodone

Hydroflumethiazide

Hydromorphone

Hydroxytryptophan

Hydroxyzine

Hyoscyamine

Idelalisib

Imatinib

Imipramine

Indapamide

Indinavir

Iobenguane I 123

Iobenguane I 131

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

Methadone

Methamphetamine

Methdilazine

Methocarbamol

Methohexital

Methotrimeprazine

Methyclothiazide

Methyldopa

Metoclopramide

Metolazone

Mibefradil

Midazolam

Midodrine

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

Rifabutin

Rifampin

Rifapentine

Ritonavir

Rizatriptan

Rolapitant

Ropeginterferon Alfa-2b-njft

Saquinavir

Scopolamine

Secobarbital

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

Zavegepant

Ziprasidone

Zolmitriptan

Zolpidem

Zopiclone

Zotepine

Zuranolone

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.

Ethanol

Relate drugs

How to use Triprolidine, pseudoephedrine, and 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.

Measure the oral liquid correctly using the marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid. Ask your pharmacist for instructions for measuring the correct dose of this medicine.

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 (syrup):

For relief of cough, sneezing, or runny or stuffy nose:

Adults and children 12 years of age and older—10 milliliters (mL) every 4 to 6 hours. Do not take more than 4 doses (40 mL) in 24 hours.

Children 6 to 11 years of age—5 mL every 4 to 6 hours. Do not take more than 4 doses (20 mL) in 24 hours.

Children 2 to 5 years of age—2.5 mL every 4 to 6 hours. Do not take more than 4 doses (10 mL).

Children younger than 2 years of age—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 website 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

Warnings

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 use it. If your symptoms do not improve or if they get worse, call your doctor.

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.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Symptoms of an overdose include: extreme dizziness or weakness, trouble breathing, slow heartbeat or breathing, seizures, and cold, clammy skin.

This medicine may make you dizzy or drowsy. Do not drive or do anything else until you know how this medicine affects you.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that effect the CNS with triprolidine, pseudoephedrine, and codeine combination may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

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. Do not give this medicine to children with obstructive sleep apnea (breathing problem) 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 effect 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 for more than 4 hours at a time.

Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") right away 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.

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.

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