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Tussionex

Common Name

phenyltoloxamine - hydrocodone

How does this medication work? What will it do for me?

This medication contains two medicinal ingredients: hydrocodone and phenyltoloxamine. Hydrocodone belongs to the class of medications called antitussives (cough suppressants). Phenyltoloxamine belongs to the class of medications called antihistamines.

These two ingredients work together for the treatment of exhausting or non-productive cough that is associated with cold or with upper respiratory allergic conditions. Relief from the symptoms of coughing usually lasts between 8 to 12 hours. Hydrocodone is a narcotic medication. This medication is normally prescribed only after non-narcotic medications have been found ineffective.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Suspension

Each 5 mL of neutral-tasting, gold-coloured suspension contains 5 mg of hydrocodone and 10 mg of phenyltoloxamine. Nonmedicinal ingredients: alcohol 95%, FD&C Yellow No. 10, FD&C Yellow No. 6, glycerin, methylparaben, natural and artificial pineapple flavour, natural peach flavour, polacrilin potassium, propylene glycol, propylparaben, purified water, sorbitol, and xanthan gum.

Tablets

Each light brown tablet, scored on one side and marked "0894" on the other, contains 5 mg of hydrocodone and 10 mg of phenyltoloxamine. Nonmedicinal ingredients: calcium phosphate dibasic, colloidal silicon dioxide, cornstarch, lactose, magnesium stearate, polacrilin potassium, and sucrose.

How should I use this medication?

Note: A cough is a symptom. Before taking a cough suppressant, it is important to assess the underlying cause of the cough.

Adults: The usual adult dose is 5 mL or 1 tablet every 8 to 12 hours. The maximum daily dose is 10 mL or 2 tablets.

Children (suspension):  For children 6 years and older, the recommended dose is 5 mL every 12 hours, with a maximum daily dose of 10 mL. This medication is not recommended for children weighing less than 9 kg.

Shake the suspension form of this preparation well. Do not dilute with fluids or mix with other medication.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If your doctor has told you to take this medication regularly and you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

  • are allergic to phenyltoloxamine, hydrocodone, or any ingredients of the medication
  • have severe CNS depression or increased pressure inside the head (intracranial pressure) or spinal column
  • have pre-existing respiratory depression (breathing rate that is too slow)
  • have very high blood pressure
  • take MAO inhibitors such as phenelzine or tranylcypromine, or have taken them within the past 14 days
  • are experiencing acute alcoholism or delirium tremens
  • have acute or severe asthma or another obstructive airway disease
  • have a blockage of the gastrointestinal tract, particularly paralytic ileus
  • have or may have a surgical abdomen (e.g., acute appendicitis, pancreatitis)
  • have cor pulmonale
  • have a seizure disorder

Do not give this medication to children less than 6 years of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation (mild)
  • decreased appetite
  • decreased interest in sexual activity
  • decreased sexual ability
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • itching
  • nausea
  • sweating
  • trouble sleeping
  • vision problems
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • bowel blockage (e.g., abdominal pain, severe constipation, nausea)
  • difficulty urinating
  • dizziness when rising from a sitting or lying position
  • drowsiness
  • fainting
  • hallucinations (seeing or hearing things that aren’t there)
  • mild mental stimulation
  • reduced coordination
  • shortness of breath or troubled breathing
  • slow, fast, or irregular heartbeat

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • seizures
  • signs of overdose
    • cold, clammy skin
    • confusion (severe)
    • convulsions (seizures)
    • drowsiness or dizziness (severe)
    • nervousness or restlessness (severe)
    • pinpoint-sized pupils of eyes
    • slow heartbeat
    • slow or troubled breathing
    • weakness (severe)
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)
  • withdrawal symptoms (e.g., nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

HEALTH CANADA ADVISORY

February 18, 2019

Health Canada has issued new restrictions concerning the use of hydrocodone. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Abdominal (stomach) conditions: Hydrocodone and other narcotic medications may make the diagnosis of abdominal conditions more difficult or it may worsen these conditions. If you have abdominal or stomach problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Accidental use: Accidental ingestion of hydrocodone by someone for whom it has not been prescribed can lead to a fatal overdose. Children are especially at risk. Keep this medication out of sight and reach of children.

Alcohol and other medications that cause drowsiness: People taking this medication should not combine it with alcohol and avoid combining it with other medications, such as narcotic pain relievers or sedatives, that cause drowsiness. Doing so can cause additional drowsiness and reduced breathing as well as other side effects, which can be dangerous and possibly even fatal.

Breathing: Hydrocodone can suppress breathing. If you are at risk for breathing difficulties – for example, if you have asthma – discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Constipation: This medication may cause constipation or worsen existing constipation. Eating a high-fibre diet and following good bowel habits will help to minimize this effect. If you develop constipation easily or you have chronic constipation, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Dependence and withdrawal: This medication contains hydrocodone and may be habit-forming. Physical dependence, psychological dependence, and abuse have occurred with the use of hydrocodone. People with a history of past or current substance use problems may be at greater risk of developing abuse or addiction while taking this medication. If you have been taking this medication for a while, it should be stopped gradually as directed by your doctor.

Drowsiness and reduced alertness: Because this medication may cause drowsiness, avoid driving or other tasks requiring alertness and physical coordination until you determine how this medication affects you.

Head injury: People with head injuries or increased pressure in the head may have a higher risk of experiencing side effects (breathing problems) or worsening of their condition while taking this medication. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood pressure: Hydrocodone can cause low blood pressure, resulting in symptoms such as weakness or dizziness, particularly when rising suddenly from a sitting or lying position. People who are prone to low blood pressure (e.g., those taking diuretics) should be cautious when using this medication.

Medical conditions: If you have high blood pressure, diabetes, overactive thyroid, glaucoma, heart disease, or blood vessel disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Sedation: The sedating effects of this medication will add to those of other sedating medications. Alcohol increases the risk of severe side effects from hydrocodone.

Avoid drinking alcohol or taking hypnotics/sedatives (e.g., barbiturates such as phenobarbital or benzodiazepines such as diazepam), tricyclic antidepressants (e.g., amitriptyline, desipramine), benzodiazepines, or other narcotic medications while you are on this medication. Doing so can cause additional drowsiness and reduced breathing as well as other side effects, which can be dangerous and possibly even fatal.

Serotonin syndrome: Severe reactions are possible when hydrocodone is combined with other medications that act on serotonin, such as tricyclic antidepressants and serotonin reuptake inhibitors; medications used to treat depression. Symptoms of a reaction may include muscle rigidity and spasms, difficulty moving, changes in mental state including delirium and agitation. Coma and death are possible.

If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. Hydrocodone crosses into the placenta, where it can affect the developing baby. Babies born to mothers who have been taking this medication regularly prior to delivery are likely to be physically dependent on the medication. Withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever.

Breast-feeding: It is not known if hydrocodone passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: This medication is not recommended for children less than 18 years of age. Children are at increased risk of experiencing serious side effects such as breathing problems.

What other drugs could interact with this medication?

There may be an interaction between phenyltoloxamine - hydrocodone and any of the following:

  • abiraterone
  • aclidinium
  • alcohol
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • apalutamide
  • aprepitant
  • atorvastatin
  • atropine
  • azelastine
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital, secobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam)
  • belladonna
  • benztropine
  • betahistine
  • bicalutamide
  • bosentan
  • brimonidine
  • bupropion
  • buspirone
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • chloral hydrate
  • clonidine
  • cobicistat
  • conivaptan
  • darifenacin
  • deferasirox
  • desmopressin
  • disopyramide
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • domperidone
  • donepezil
  • dronedarone
  • eluxadoline
  • entacapone
  • enzalutamide
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • flavoxate
  • flibanserin
  • galantamine
  • general anesthetics (medications used to put people to sleep before surgery)
  • glucagon
  • glycopyrrolate
  • grapefruit juice
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • hyaluronidase
  • idelalisib
  • ipratropium
  • ketotifen
  • linezolid
  • lithium
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • methadone
  • metoclopramide
  • mifepristone
  • mirabegron
  • mirtazapine
  • mitotane
  • modafinil
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • nabilone
  • naltrexone
  • other narcotic medications (e.g., codeine, fentanyl, morphine, oxycodone)
  • nitroglycerine
  • octreotide
  • oxybutynin
  • pegvisomant
  • pramipexole
  • protein kinase inhibitors (e.g., ceritinib, crizotinib, dasatinib, imatinib, lapatinib)
  • potassium chloride
  • rifabutin
  • rifampin
  • rivastigmine
  • ropinirole
  • rotigotine
  • quinidine
  • St. John's wort
  • scopolamine
  • seizure medications (e.g., carbamazepine, clobazam,  levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid, zonisamide)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
  • siltuximab
  • solifenacin
  • suvorexant
  • tapentadol
  • tiotropium
  • tocilizumab
  • tolcapone
  • tolterodine
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine)
  • tryptophan
  • umeclidinium
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Tussionex

All material © 1996-2020 MediResource Inc. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.