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hydrocodone, pseudoephedrine, and guaifenesin (Oral route)

hye-droe-KOE-done bye-TAR-trate, soo-doe-e-FED-rin hye-droe-KLOR-ide, gwye-FEN-e-sin

Commonly used brand name(s)

In the U.S.

  • Hycofenix

Available Dosage Forms:

  • Syrup
  • Liquid
  • Solution
  • Elixir
  • Tablet

Therapeutic Class: Antitussive, Opioid/Decongestant/Expectorant Combination

Pharmacologic Class: Pseudoephedrine

Chemical Class: Hydrocodone

Uses For hydrocodone, pseudoephedrine, and guaifenesin

Hydrocodone, pseudoephedrine, and guaifenesin combination is used to relieve cough and nasal congestion (stuffy nose) caused by the common cold.

Hydrocodone is a narcotic cough suppressant. It acts directly on the cough center in the brain to relieve cough. Pseudoephedrine is a decongestant, which decreases nasal congestion by narrowing the blood vessels and reducing blood flow to the nasal passage. Guaifenesin is used to help clear mucus or phlegm from the chest when you have congestion from a cold or flu. It works by thinning the mucus or phlegm in the lungs.

When hydrocodone 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 treatment is stopped suddenly. Talk to your doctor if you have questions.

hydrocodone, pseudoephedrine, and guaifenesin is available only with your doctor's prescription.

Before Using hydrocodone, pseudoephedrine, and guaifenesin

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 hydrocodone, pseudoephedrine, and guaifenesin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hydrocodone, pseudoephedrine, and guaifenesin 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

Use of hydrocodone and pseudoephedrine combination is not indicated in children younger than 18 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydrocodone, pseudoephedrine, and guaifenesin 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 hydrocodone, pseudoephedrine, and guaifenesin.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

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 hydrocodone, pseudoephedrine, and guaifenesin, 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 hydrocodone, pseudoephedrine, and guaifenesin 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
  • Naltrexone
  • Nialamide
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Safinamide
  • Selegiline
  • Tranylcypromine

Using hydrocodone, pseudoephedrine, and guaifenesin 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.

  • Acetophenazine
  • Alfentanil
  • Alprazolam
  • Amobarbital
  • Anileridine
  • Aprepitant
  • Aripiprazole
  • Asenapine
  • Atazanavir
  • Baclofen
  • Boceprevir
  • Bosentan
  • Bromazepam
  • Bromopride
  • Brotizolam
  • Buprenorphine
  • Buspirone
  • Butabarbital
  • Butalbital
  • Butorphanol
  • Carbamazepine
  • Carbinoxamine
  • Cariprazine
  • Carisoprodol
  • Ceritinib
  • Chloral Hydrate
  • Chlordiazepoxide
  • Chlorpromazine
  • Chlorzoxazone
  • Clarithromycin
  • Clobazam
  • Clonazepam
  • Clorazepate
  • Clozapine
  • Codeine
  • Conivaptan
  • Cyclobenzaprine
  • Dantrolene
  • Dasabuvir
  • Dexmedetomidine
  • Dezocine
  • Diacetylmorphine
  • Diazepam
  • Dichloralphenazone
  • Difenoxin
  • Dihydrocodeine
  • Diltiazem
  • Diphenhydramine
  • Diphenoxylate
  • Dixyrazine
  • Donepezil
  • Doxylamine
  • Dronedarone
  • Droperidol
  • Efavirenz
  • Enflurane
  • Erythromycin
  • Estazolam
  • Eszopiclone
  • Ethchlorvynol
  • Ethopropazine
  • Ethylmorphine
  • Fentanyl
  • Fentanyl Citrate
  • Flibanserin
  • Fluconazole
  • Flunitrazepam
  • Fluphenazine
  • Flurazepam
  • Fluspirilene
  • Fosaprepitant
  • Fosphenytoin
  • Fospropofol
  • Furazolidone
  • Guanethidine
  • Halazepam
  • Haloperidol
  • Halothane
  • Hexobarbital
  • Hydromorphone
  • Hydroxyzine
  • Idelalisib
  • Iloperidone
  • Imatinib
  • Indinavir
  • Iobenguane I 123
  • Iproniazid
  • Isocarboxazid
  • Isoflurane
  • Itraconazole
  • Ketamine
  • Ketazolam
  • Ketobemidone
  • Ketoconazole
  • Levorphanol
  • Linezolid
  • Lopinavir
  • Lorazepam
  • Lormetazepam
  • Loxapine
  • Lurasidone
  • Meclizine
  • Medazepam
  • Melperone
  • Meperidine
  • Mephenesin
  • Mephobarbital
  • Meprobamate
  • Meptazinol
  • Mesoridazine
  • Metaxalone
  • Methadone
  • Methdilazine
  • Methocarbamol
  • Methohexital
  • Methotrimeprazine
  • Methyldopa
  • Methylene Blue
  • Metopimazine
  • Midazolam
  • Midodrine
  • Moclobemide
  • Modafinil
  • Molindone
  • Moricizine
  • Morphine
  • Morphine Sulfate Liposome
  • Nalbuphine
  • Nefazodone
  • Nelfinavir
  • Nicomorphine
  • Nitrazepam
  • Olanzapine
  • Ombitasvir
  • Opium
  • Opium Alkaloids
  • Orphenadrine
  • Oxazepam
  • Oxycodone
  • Oxymorphone
  • Paliperidone
  • Papaveretum
  • Paregoric
  • Paritaprevir
  • Pentazocine
  • Pentobarbital
  • Perampanel
  • Perazine
  • Periciazine
  • Perphenazine
  • Phenelzine
  • Phenobarbital
  • Phenytoin
  • Pimavanserin
  • Pimozide
  • Pipotiazine
  • Piritramide
  • Posaconazole
  • Prazepam
  • Primidone
  • Procarbazine
  • Prochlorperazine
  • Promazine
  • Promethazine
  • Propiomazine
  • Propofol
  • Quazepam
  • Quetiapine
  • Ramelteon
  • Rasagiline
  • Remifentanil
  • Remoxipride
  • Rifampin
  • Risperidone
  • Ritonavir
  • Saquinavir
  • Secobarbital
  • Selegiline
  • Sertindole
  • Sodium Oxybate
  • St John's Wort
  • Sufentanil
  • Sulpiride
  • Suvorexant
  • Tapentadol
  • Telaprevir
  • Telithromycin
  • Temazepam
  • Thiethylperazine
  • Thiopental
  • Thiopropazate
  • Thioproperazine
  • Thioridazine
  • Thiothixene
  • Tilidine
  • Tizanidine
  • Tolonium Chloride
  • Topiramate
  • Tramadol
  • Tranylcypromine
  • Triazolam
  • Trifluoperazine
  • Trifluperidol
  • Triflupromazine
  • Trimeprazine
  • Verapamil
  • Voriconazole
  • Zaleplon
  • Ziprasidone
  • Zolpidem
  • Zopiclone
  • Zotepine

Using hydrocodone, pseudoephedrine, and guaifenesin with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Escitalopram

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 hydrocodone, pseudoephedrine, and guaifenesin 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 hydrocodone, pseudoephedrine, and guaifenesin, 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 hydrocodone, pseudoephedrine, and guaifenesin. Make sure you tell your doctor if you have any other medical problems, especially:

  • Addison's disease (adrenal gland problem) or
  • Asthma or
  • Diabetes or
  • Drug dependence, especially narcotic abuse or dependence, or history of or
  • Enlarged prostate (BPH, prostatic hypertrophy) or
  • Head injury, history of or
  • Problems with passing urine or
  • Thyroid disease—Use with caution. May increase risk for more serious side effects.
  • Glaucoma, narrow angle or
  • Hypertension (high blood pressure), severe or
  • Heart disease (eg, coronary artery disease), severe or
  • Problems with passing urine—Should not be used in patients with these conditions.
  • 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 hydrocodone, pseudoephedrine, and guaifenesin

Take hydrocodone, pseudoephedrine, and guaifenesin 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 hydrocodone, pseudoephedrine, and guaifenesin 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 hydrocodone, pseudoephedrine, and guaifenesin.

Dosing

The dose of hydrocodone, pseudoephedrine, and guaifenesin 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 hydrocodone, pseudoephedrine, and guaifenesin. 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—10 milliliters (mL) every 4 to 6 hours as needed. Do not take more than 4 doses (40 mL) in 24 hours.
      • Children—Use is not recommended.

Missed Dose

If you miss a dose of hydrocodone, pseudoephedrine, and guaifenesin, 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.

Precautions While Using hydrocodone, pseudoephedrine, and guaifenesin

It is very important that your doctor check your progress while you are using hydrocodone, pseudoephedrine, and guaifenesin. 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 symptoms do not improve or if they get worse, call your doctor.

Do not use hydrocodone, pseudoephedrine, and guaifenesin if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days.

hydrocodone, pseudoephedrine, and guaifenesin 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 hydrocodone, pseudoephedrine, and guaifenesin, get emergency help at once. Signs of an overdose include dark urine, difficult or troubled breathing, irregular, fast or slow, or shallow breathing, nausea or vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

hydrocodone, pseudoephedrine, and guaifenesin may make you dizzy or drowsy. Make sure you know how you react to hydrocodone, pseudoephedrine, and guaifenesin before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

hydrocodone, pseudoephedrine, and guaifenesin 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 hydrocodone, pseudoephedrine, and guaifenesin.

Using this medication 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.

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.

hydrocodone, pseudoephedrine, and guaifenesin 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
  • Abdominal or stomach cramps or pain
  • bloating
  • blurred vision
  • chest pain or discomfort
  • cold, clammy, pale skin
  • confusion
  • constipation
  • convulsions
  • diarrhea
  • difficult or troubled breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • fast, slow, or irregular heartbeat
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • shakiness in the legs, arms, hands, or feet
  • slow heart rate
  • sweating
  • trembling or shaking of the hands or feet
  • unusual tiredness or weakness
  • vomiting

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
  • Diarrhea
  • drowsiness
  • feeling of warmth
  • headache
  • nausea
  • redness of the face, neck, arms, and occasionally, upper chest
  • relaxed and calm
  • sleepiness
  • sudden sweating
Incidence not known
  • Trouble sleeping

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.

See also: Side effects (in more detail)

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