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Dalmacol

(etafedrine - doxylamine - hydrocodone)

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.

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.

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.

For children 6 to 12 years of age, the recommended dose is 2.5 mL to 5 mL every 3 to 5 hours as needed, but not more than 15 mL in any 24-hour period.

For children 1 to 6 years of age, the recommended dose is 1.25 mL to 2.5 mL every 3 to 5 hours as needed, but not more than 3 doses 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.

What form(s) does this medication come in?

Each mL contains hydrocodone bitartrate 0.33 mg, etafedrine HCl 3.33 mg, sodium citrate 40 mg, and doxylamine succinate 1.2 mg. Nonmedicinal ingredients: alcohol, aromate, FD&C Yellow No. 6, glycerin, propylparaben, sorbitol, and sucrose.

Who should NOT take this medication?

Etafedrine - doxylamine - hydrocodone should not be taken by anyone who:

  • is allergic to hydrocodone, etafedrine, doxylamine, sodium citrate, or to any of the ingredients of the medication
  • is allergic to any other "opioid" type medications
  • is currently taking monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine)
  • is having difficulty breathing
  • has a head injury or increased pressure inside the head or spinal cord

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
  • dizziness
  • drowsiness
  • lightheadedness or feeling faint
  • nausea
  • nervousness or restlessness
  • increased blood pressure
  • 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
  • redness or flushing of face
  • ringing or buzzing in the ears
  • shortness of breath, wheezing, or troubled breathing
  • swelling of face
  • trembling or uncontrolled muscle movements
  • unusual excitement or restlessness (especially in children)

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

  • cold, clammy skin
  • headache (severe or continuing)
  • low blood pressure
  • pinpoint pupils of eyes
  • seizures
  • severe confusion or disorientation
  • severe dizziness
  • severe drowsiness
  • severe nausea or vomiting
  • severe nervousness or restlessness
  • 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

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.

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.

Diabetes: People with diabetes should discuss with their doctor how this medication may affect their medical condition and whether any special monitoring is needed. You may need to test your blood glucose levels more frequently while you are taking this medication.

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.

Glaucoma: People with glaucoma should discuss with their doctor how this medication may affect their medical condition and whether any special monitoring is needed. Discuss with your doctor whether the potential benefits outweigh the risks of using this medication.

High blood pressure and heart disease: People with high blood pressure or heart disease 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. You may need to check your blood pressure more frequently while you are taking this medication.

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.

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.

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: Hydrocodone has the potential to produce dose-related respiratory depression (difficulty in breathing) by directly acting on the brain stem respiratory centres. In young children, the respiratory centre is especially susceptible to the depressant action of narcotic cough suppressants. Do not give this medication to a child without first discussing with your doctor whether the potential benefits outweigh the risks to the child.

What other drugs could interact with this medication?

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

  • alcohol
  • amphetamines
  • anesthetics
  • anticholinergic medications (e.g., atropine, scopolamine)
  • antidiabetes medications (e.g., glyburide, insulin, metformin)
  • antifungal medications (e.g., fluconazole, itraconazole, ketoconazole)
  • antiglaucoma medications (e.g., levobunolol, latanoprost, dorzolamide)
  • antihistamines that cause drowsiness (e.g., chlorpheniramine, diphenhydramine)
  • barbiturates (e.g., phenobarbital, butalbital)
  • benzodiazepines (e.g., diazepam, lorazepam, oxazepam)
  • beta-blockers (e.g., atenolol, propranolol)
  • blood pressure medications
  • butorphanol
  • carbamazepine
  • chloral hydrate
  • cimetidine
  • erythromycin
  • isoniazid
  • monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine)
  • methocarbamol
  • nalbuphine
  • naltrexone
  • other narcotic pain relievers (e.g., codeine, fentanyl, morphine)
  • pentazocine
  • phenothiazines (e.g., chlorpromazine, prochlorperazine)
  • phenytoin
  • quinidine
  • rifampin
  • selegiline
  • SSRIs (e.g., fluvoxamine, paroxetine, sertraline)
  • thiopental
  • thyroid medications
  • tramadol
  • tricyclic antidepressants (e.g., amitriptyline, desipramine, nortriptyline)
  • warfarin

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 – 2017. 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

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