Canges-XP

1 What is Canges-XP?

Brand: Canges-XP, CodiClear DH, ExeClear, ExeCof XP, Extendryl HC, FluTuss XP, Hydro-Tussin HG, Monte-G HC, Narcof, Pancof XP, Tussiclear DH, Tusso-HC, Kwelcof Solution

Generic: Guaifenesin and hydrocodone

Guaifenesin and hydrocodone combination is used to relieve cough and nasal congestion associated with the common cold.

Hydrocodone is a narcotic antitussive (cough suppressant). It acts directly on the cough center in the brain to relieve cough. 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.

This medicine is available only with your doctor's prescription. This product is available in the following dosage forms:

  • Syrup
  • Solution
  • Tablet, Extended Release
  • Capsule
  • Liquid
  • Tablet

2 What to Know Before Using

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:

1. 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.

2. Pediatric Population:

The use of hydrocodone in children younger than 6 years of age has caused serious breathing problems, sometimes causing death. Appropriate studies have not been performed on the relationship of age to the effects of guaifenesin and hydrocodone combination in the pediatric population. Safety and efficacy have not been established.

3. Geriatric Population:

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

4. Pregnancy

Category 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.

5. Breastfeeding

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.

6. Drug Interactions

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.

  • Naltrexone

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.

  • Acetophenazine Alfentanil Alprazolam Amobarbital Anileridine Aprepitant Aripiprazole Asenapine Atazanavir 
  • Baclofen Boceprevir Bosentan Bromazepam Brotizolam Buprenorphine Buspirone Butabarbital Butalbital Butorphanol 
  • Carbamazepine Carbinoxamine Carisoprodol Ceritinib Chloral Hydrate Chlordiazepoxide Chlorpromazine Chlorzoxazone Clarithromycin Clobazam Clonazepam Clorazepate Clozapine Codeine Conivaptan Cyclobenzaprine 
  • Dantrolene Dexmedetomidine Dezocine Diacetylmorphine Diazepam Dichloralphenazone Difenoxin Dihydrocodeine Diltiazem Diphenhydramine Diphenoxylate Dixyrazine Donepezil Doxylamine Dronedarone Droperidol 
  • Efavirenz Enflurane Erythromycin Estazolam Eszopiclone Ethchlorvynol Ethopropazine Ethylmorphine 
  • Fentanyl Flibanserin Fluconazole Flunitrazepam Fluphenazine Flurazepam Fluspirilene Fosaprepitant Fosphenytoin Fospropofol Furazolidone 
  • Halazepam Haloperidol Halothane Hexobarbital Hydromorphone Hydroxyzine 
  • Idelalisib Iloperidone Imatinib Indinavir 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 Methylene Blue Metopimazine Midazolam Moclobemide Modafinil Molindone Moricizine Morphine Morphine Sulfate Liposome 
  • Nalbuphine Nefazodone Nelfinavir Nicomorphine Nilotinib Nitrazepam 
  • Olanzapine Opium Opium Alkaloids Orphenadrine Oxazepam Oxycodone Oxymorphone 
  • Paliperidone Papaveretum Paregoric Pentazocine Pentobarbital Perampanel Perazine Periciazine Perphenazine Phenelzine Phenobarbital Phenytoin 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 Trifluperidol Triflupromazine Trimeprazine 
  • Verapamil Voriconazole 
  • Zaleplon Ziprasidone Zolpidem Zopiclone Zotepine

Using this medicine 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

7. 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

8. 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 problem) or
  • Asthma or
  • Diabetes or
  • Drug dependence, especially with narcotics, or history of or
  • Enlarged prostate or
  • Stomach problems or
  • Thyroid disease or
  • Trouble urinating—Use with caution. May increase risk for more serious side effects.
  • Brain tumor or
  • Head injuries or
  • ncreased pressure in the head—Hydrocodone can cause serious problems in people who have these medical problems.
  • Cough, chronic or persistent or
  • Paralytic ileus (intestine stops working and may be blocked), known or suspected or
  • Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.
  • Kidney disease, severe or
  • Liver disease, severe—Use with caution.

3 Proper Usage

General Instructions:

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.

How to administer:

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—10 milliliters (mL) every 4 to 6 hours as needed. Do not take more than 6 doses (60 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.

4 Precautions to Take

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 symptoms do not improve or if they get worse, 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.

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.

Overdose:

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 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.

Dizziness:

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

Other Medicines:

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.

Constipation:

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.

5 Potential 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

  • Difficult or troubled breathing
  • irregular, fast or slow, or shallow breathing
  • pale or blue lips, fingernails, or skin
  • shortness of breath

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
  • dizziness
  • feeling of warmth
  • headache
  • nausea
  • redness of the face, neck, arms, and occasionally, upper chest
  • sleepiness or unusual drowsiness
  • sudden sweating

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.

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