How does this medication work? What will it do for me?
This medication contains 3 active ingredients: etafedrine, doxylamine, and hydrocodone. It helps to control cough associated with inflammation of the mouth and throat that is not helped by cough medications that are less strong.
Hydrocodone is a narcotic medication that is an antitussive (cough suppressant). It helps to reduce cough by affecting the cough centre in the brain. Etafedrine belongs to the family of medications called decongestants. It works by narrowing blood vessels in the nasal passages, helping to relieve nasal stuffiness. Doxylamine belongs to the family of medications called antihistamines. It works by drying up the excess fluid that causes a runny nose and watery eyes.
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?
Each mL contains 0.33 mg of hydrocodone bitartrate, 3.33 mg of etafedrine HCl, 40 mg of sodium citrate, and 1.2 mg of doxylamine succinate. Nonmedicinal ingredients: alcohol, aromate, FD&C Yellow No. 6, glycerin, propylparaben, sorbitol, and sucrose.
How should I use this medication?
For adults, the recommended dose is 5 mL (1 teaspoonful) every 3 to 5 hours as needed, but not more than 30 mL in any 24-hour period.
Use an oral syringe to measure each dose of the liquid, as it gives a more accurate measurement than household teaspoons.
Many things can affect the dose of a 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 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 take etafedrine - doxylamine - hydrocodone if you:
- are allergic to hydrocodone, etafedrine, doxylamine, sodium citrate, or any of the ingredients of the medication
- are allergic to any other "opioid" type medications
- are pregnant or breast-feeding
- are currently taking a monoamine oxidase (MAO) inhibitor (e.g., phenelzine, tranylcypromine) or have taken within the last 14 days
- are experiencing slowed, shallow breathing (respiratory depression)
- are having difficulty breathing
- have a blockage of the intestines or a condition that slows down passage of material through the digestive tract
- have active alcoholism or are experiencing alcohol withdrawal
- have acute asthma or other obstructive airway diseases (e.g., chronic bronchitis, emphysema), or a chronic cough
- have a decreased level of consciousness
- have a head injury or increased pressure inside the head or spinal cord
- have a seizure disorder
- have or may have appendicitis or pancreatitis
Do not give this medication to children under the age of 18 years.
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.
- decreased appetite
- decreased sexual ability or interest in sexual activity
- dry mouth
- trouble sleeping
- unusual tiredness or weakness
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- fast, slow, or pounding heartbeat
- hallucinations (seeing, hearing, or feeling things that are not there)
- hives, itching, or skin rash
- increased sweating
- irregular breathing
- mental depression or other mood or mental changes
- new or worsening constipation
- shortness of breath, wheezing, or troubled breathing
- symptoms of low blood pressure (e.g., dizziness, fainting, lightheadedness, particularly when rising from a lying or sitting position)
- uncoordinated muscle movements
- vision changes
Stop taking the medication and seek immediate medical attention if any of the following occur:
- cold, clammy skin
- headache (severe or continuing)
- pinpoint pupils of eyes
- severe confusion or disorientation
- severe drowsiness
- severe nausea or vomiting
- severe nervousness or restlessness
- severe stomach pain
- severe weakness
- shortness of breath or troubled breathing (severe or continuing)
- signs of a severe allergic reaction (e.g., hives; difficulty breathing; swelling of the tongue, face, mouth, or throat)
- slow heartbeat
- symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, 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
August 24, 2020
Health Canada has issued new restrictions concerning the use of etafedrine - doxylamine - hydrocodone. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Previous advisories on etafedrine - doxylamine - hydrocodone were issued on February 18, 2019.
Accidental use: When this medication is used by anyone other than the person for whom it was prescribed, the effects of the medication may be fatal. Children are particularly 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 should avoid combining it with other medications, such as narcotic pain relievers, sedatives or anxiety medications that cause drowsiness. Doing so can cause additive drowsiness and reduced breathing as well as other side effects, which can be dangerous and possibly fatal.
Breathing: Hydrocodone can suppress breathing. If you are at risk for breathing difficulties, such as 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: Hydrocodone may worsen the condition of people with chronic constipation. People with chronic constipation should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether the potential benefits outweigh the risks.
Drowsiness/reduced alertness: Hydrocodone may impair the mental or physical abilities required to perform certain tasks such as driving a car or operating machinery. Do not undertake such activities until you have made sure that it does not affect you in this way.
Drug dependence: Hydrocodone can produce drug dependence and has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop if this medication is used regularly for a prolonged period of time. Talk to your doctor if you have any concerns.
Head injury: If you have a head injury or increased pressure in the head, you 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.
Seizure disorders: People with seizure disorders or a history of seizures should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Serotonin syndrome: Although rare, 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. These combinations should be avoided if possible. 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.
Withdrawal effects: As with other narcotic medications, hydrocodone can produce physical dependence, with or without psychological dependence, if it is taken regularly for a period of time. If this medication is stopped suddenly, it may produce withdrawal symptoms such as body aches, diarrhea, decreased appetite, runny nose, sneezing, tremors, shivering nausea, sweating, yawning, and weakness. Talk to your doctor before stopping this medication if you have been taking it routinely.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Babies born to mothers who have been taking this medication for long periods of time may experience serious breathing difficulties and withdrawal symptoms.
Breast-feeding: This medication may pass 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: Children are particularly at risk for serious side effects and potential overdose from this medication. This medication should not be used for children under the age of 18 years.
What other drugs could interact with this medication?
There may be an interaction between etafedrine - doxylamine - hydrocodone and any of the following:
- alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- anticholinergic medications (e.g., atropine, scopolamine)
- "azole" antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
- antihistamines (e.g., bilastine, chlorpheniramine, hydroxyzine, diphenhydramine, rupatadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- barbiturates (e.g., phenobarbital, butalbital)
- benzodiazepines (e.g., diazepam, lorazepam, oxazepam)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- chloral hydrate
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- ergot alkaloids (e.g., ergotamine, dihydroergotamine, disopyramide)
- general anesthetics (medications used to put people to sleep before surgery)
- grapefruit juice
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- monoamine oxidase (MAO) inhibitors (e.g., phenelzine, rasagiline, selegiline, tranylcypromine)
- muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
- other narcotic pain relievers (e.g., codeine, fentanyl, morphine)
- protein kinase inhibitors (e.g., ceritinib, crizotinib, imatinib, nilotinib)
- St. John's wort
- seizure medications (e.g., carbamazepine, clobazam, levetiracetam, phenobarbital, phenytoin, primidone, topiramate, valproic acid)
- serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- tetrahydrocannabinol (THC)
- tricyclic antidepressants (e.g., clomipramine, desipramine, imipramine)
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 – 2023. 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/Dalmacol