Pronunciation:

hye-droe-KOE-done bye-TAR-trate, klor-fen-IR-a-meen MAL-ee-ate, soo-doe-e-FED-rin hye-droe-KLOR-ide

Brand Names:

• Hydron PSC
• Hyphed
• Notuss-Forte
• Zutripro
• Vasofrinic Dh

Dosage Forms:

• Solution

Warnings:

Warning: Addiction, abuse, and misuse; life-threatening respiratory depression; accidental ingestion; medication errors; cytochrome P450 3A4 interaction; concomitant use with benzodiazepines or other CNS depressants; interaction with alcohol; neonatal opioid withdrawal syndromeAddiction, Abuse, and MisuseHydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Reserve hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made. Assess each patient’s risk prior to prescribing hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride, prescribe hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride for the shortest duration that is consistent with individual patient treatment goals, monitor all patients regularly for the development of addiction or abuse, and refill only after reevaluation of the need for continued treatment.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride. Monitor for respiratory depression, especially during initiation of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride or when used in patients at higher risk.Accidental IngestionAccidental ingestion of even one dose of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride, especially by children, can result in a fatal overdose of hydrocodone.Risk of Medication ErrorsEnsure accuracy when prescribing, dispensing, and administering hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride. Dosing errors can result in accidental overdose and death. Always use an accurate milliliter measuring device when measuring and administering hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride.Cytochrome P450 3A4 InteractionThe concomitant use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Avoid the use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride in patients taking a CYP3A4 inhibitor or inducer.Risk from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Avoid the use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride in patients taking benzodiazepines, other CNS depressants, or alcohol.Interaction with AlcoholInstruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride. The co-ingestion of alcohol with hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride may result in increased plasma levels and a potentially fatal overdose of hydrocodone.Neonatal Opioid Withdrawal SyndromeHydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride is not recommended for use in pregnant women. Prolonged use of hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If hydrocodone bitartrate/chlorpheniramine maleate/pseudoephedrine hydrochloride 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:

Therapeutic—

Antitussive, Opioid/Antihistamine/Decongestant Combination

Pharmacologic—

Chlorpheniramine

Chemical—

Hydrocodone

Uses of This Medicine:

Hydrocodone, chlorpheniramine, and pseudoephedrine combination is used to relieve cough and nasal congestion associated with the common cold allergy.

Hydrocodone is a narcotic antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough. Chlorpheniramine is an antihistamine, which is used to relieve or prevent symptoms of an allergy. Pseudoephedrine is a decongestant, which decreases nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passage.

When hydrocodone 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.

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 of hydrocodone, chlorpheniramine, and pseudoephedrine combination is not indicated in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone, chlorpheniramine, and pseudoephedrine combination in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

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.

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.

• Dihydroergotamine
• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nalmefene
• Naltrexone
• Nialamide
• Phenelzine
• Potassium Citrate
• Procarbazine
• Rasagiline
• Safinamide
• Samidorphan
• Selegiline
• 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
• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amantadine
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Daridorexant
• Darunavir
• Dasabuvir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Fexinidazole
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Furazolidone
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Granisetron
• Guanethidine
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Iobenguane I 123
• Iobenguane I 131
• Iproniazid
• Isocarboxazid
• Isoflurane
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Lenacapavir
• Levocetirizine
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Mavacamten
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methacholine
• Methadone
• Methamphetamine
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methyldopa
• Methylene Blue
• Metoclopramide
• Mibefradil
• Midazolam
• Midodrine
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Moclobemide
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Netupitant
• Nevirapine
• Nialamide
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paritaprevir
• Paroxetine
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenelzine
• Phenobarbital
• Phenytoin
• Piperacetazine
• Pipotiazine
• Piritramide
• Pitolisant
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Procarbazine
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Ranitidine
• Ranolazine
• Rasagiline
• Remifentanil
• Remimazolam
• Remoxipride
• Revefenacin
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Secretin Human
• Selegiline
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Tranylcypromine
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Zavegepant
• 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 is usually not recommended, 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
• Grapefruit Juice

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's disease (adrenal gland problem) or
• Alcohol abuse, history of or
• Brain tumor or
• Chronic obstructive pulmonary disease (COPD) or
• Diabetes or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Enlarged prostate (eg, BPH, prostatic hypertrophy) or
• Gallbladder disease or
• Head injury, history of or
• Increased pressure in the head or
• Pancreatitis, acute (swelling of the pancreas) or
• Seizures, history of or
• Thyroid disease—Use with caution. May increase risk for more serious side effects.

• Asthma, acute or severe or
• Heart disease (eg, coronary artery disease), severe or
• Hypertension (high blood pressure), severe or
• Narrow-angle glaucoma or
• Respiratory depression (very slow breathing) or
• Stomach or bowel problems (eg, paralytic ileus), known or suspected or
• Urinary retention (problems with passing urine)—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 should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

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 (solution):
  • For relief of cough, sneezing, or runny or stuffy nose:
    • Adults—5 milliliters (mL) every 4 to 6 hours as needed. However, the dose is usually not more than 4 doses (20 mL) in 24 hours.
    • Children—Use is not recommended.

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 have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

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. In case of an overdose, call your doctor right away.

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.

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

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.

Using narcotics for a long time 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.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal 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.

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 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. This medicine may affect the results of certain medical tests.

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:

More common

Fainting

lightheadedness

shakiness in the legs, arms, hands, or feet

trembling or shaking of the hands or feet

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

Incidence not known

Bloating

blurred vision

bulging soft spot on the head of an infant

change in the ability to see colors, especially blue or yellow

confusion

constipation

decrease in the frequency of urination

decrease in the urine volume

diarrhea

difficult or troubled breathing

difficulty in passing urine (dribbling)

dizziness

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

drowsiness

fast, slow, or irregular heartbeat

headache

hives or welts, itching, skin rash

irregular, fast or slow, or shallow breathing

loss of appetite

loss of consciousness

nervousness

painful urination

pale or blue lips, fingernails, or skin

pounding in the ears

seizures

sore throat

spasm of the throat

stomach cramps or pain

sweating

tightness of the chest

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:

More common

Deep or fast breathing with dizziness

disturbed color perception

double vision

dry mouth

false or unusual sense of well-being

fear or nervousness

halos around lights

nausea

night blindness

numbness of the feet, hands, and around the mouth

overbright appearance of lights

relaxed and calm feeling

restlessness

sleepiness or unusual drowsiness

trouble sleeping

tunnel vision

Incidence not known

Belching

bigger, dilated, or enlarged pupils (black part of the eye)

bloating

change in color vision

chills

cold sweats

continuing ringing or buzzing or other unexplained noise in the ears

cool, pale skin

darkened urine

depression

difficulty seeing at night

feeling of constant movement of self or surroundings

fever

flushing or redness of the skin

full feeling

hearing loss

heartburn

increased appetite

increased hunger

increased in sexual ability, desire, drive, or performance

increased interest in sexual intercourse

increased sensitivity of the eyes to sunlight

increased sweating

indigestion

nightmares

pains in the stomach, side, or abdomen, possibly radiating to the back

pressure in the stomach

sensation of spinning

slurred speech

stomach discomfort or upset

sugar in the urine

swelling of the abdominal or stomach area

swelling of the breasts or breast soreness in both females and males

unusually warm skin

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.