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.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. 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?
Each 5 mL of neutral-tasting, gold-coloured suspension contains hydrocodone 5 mg and phenyltoloxamine 10 mg. 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.
Each light brown tablet, scored on one side and marked "0894" on the other, contains hydrocodone 5 mg and phenyltoloxamine 10 mg. Nonmedicinal ingredients: calcium phosphate dibasic, colloidal silicon dioxide, cornstarch, lactose, magnesium stearate, polacrilin potassium, and sucrose.
How should I use this medication?
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 1 to 5 years of age, the recommended dose is 2.5 mL every 12 hours, with a maximum daily dose of 5 mL. For children over 5 years, the recommended dose is 5 mL every 12 hours, with a maximum daily dose of 10 mL. This medication is not recommended for children under one year of age weighing less than 9 kg.
Shake 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 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 lesions inside the head causing increased pressure inside the head (intracranial pressure)
- 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
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)
- dry mouth
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:
- clumsiness or unsteadiness
- convulsions (seizures)
- drowsiness (severe)
- dryness of mouth, nose, or throat (severe)
- flushing or redness of face
- restlessness (severe)
- shortness of breath or troubled breathing
- slow or fast heartbeat
Stop taking the medication and seek immediate medical attention if any of the following occur:
- 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)
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
July 28, 2016
Health Canada has issued new restrictions concerning the use of prescription hydrocodone. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Addiction potential: This medication contains hydrocodone and therefore may be habit-forming.
Constipation: This medication may cause constipation or worsen existing constipation. If 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.
Drowsiness and reduced alertness: Because this medication may cause drowsiness, avoid driving or other tasks requiring alertness and physical coordination until you determine that the medication does not affect you in this way.
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 are additive to those of other sedating medications. 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 during treatment with this medication.
Pregnancy: This medication is not recommended for pregnant women. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: This medication 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.
What other drugs could interact with this medication?
There may be an interaction between phenyltoloxamine - hydrocodone and any of the following:
- antihistamines that cause drowsiness (e.g., chlorpheniramine)
- barbiturates (e.g., phenobarbital, secobarbital)
- benzodiazepines (e.g., diazepam, lorazepam)
- MAO inhibitors (e.g., phenelzine, tranylcypromine)
- medications for high blood pressure (e.g., hydrochlorothiazide)
- other narcotic medications (e.g., codeine, morphine)
- phenothiazines (e.g., chlorpromazine)
- tricyclic antidepressants (e.g., amitriptyline, desipramine)
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.