Atarax: Uses, Side Effects and Dosage

What is ATARAX used for?

ATARAX is used:

In Adults:

• to help manage anxiety

In Adults and children:

• as a pre-surgery medication (such as in preparation for a dental procedure)
• in the treatment of itching with rash or eczema that is caused by an allergic reaction
• in the treatment of nausea and vomiting (such as from chemotherapy or after surgery)

How does ATARAX work?

ATARAX works by:

• blocking a substance called histamine. Your body produces this when you have an allergic reaction.
• affecting how certain chemicals work in your brain, such as serotonin.

What are the ingredients in ATARAX ?

Medicinal ingredients: hydroxyzine hydrochloride

Non-medicinal ingredients: alcohol, menthol, peppermint oil, sodium benzoate, spearmint oil, sucrose, water.

Sodium hydroxide or hydrochloric acid (for pH adjustment).

Tartrazine-free.

ATARAX comes in the following dosage forms:

Syrup, 2 mg/mL

Do not use ATARAX if:

• you are allergic to:

  • hydroxyzine hydrochloride
  • cetirizine
  • other piperazine derivatives
  • aminophylline
  • ethylenediamine
• you are allergic to any of the non-medicinal ingredients in ATARAX , or component of the container (see: “What are the ingredients in ATARAX ?”)
• you have had an ECG (electrocardiogram) that showed that you have or had a heart rhythm problem called “QT interval prolongation’’ or other problems with you heart rhythm.
• you are taking other medicines that have an effect on heart rhythm.
• you have or had heart disease
• you have or had a heart rate that is very slow
• you have had anyone in your family die suddenly from heart problems
• you have a low levels of potassium or magnesium in your blood
• you have asthma and have had an allergic reaction to another antihistamine in the past
• you have porphyria (a rare inherited disease where there is a problem with proteins in the blood).

• you are pregnant or planning to become pregnant

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ATARAX . Talk about any health conditions or problems you may have, including if you:

• have kidney problems or are on dialysis
• have liver problems or liver failure.
• have glaucoma or an increased pressure in the eye
• have digestive system or stomach problems, such as ulcers or inflammation of the stomach or esophagus, pyloroduodenal obstruction, or decreased gastrointestinal motility.
• have myasthenia gravis (a muscle weakness disorder)
• have dementia
• Have seizure disorders including epilepsy

• have lung or breathing problems such as:

  • emphysema
  • chronic bronchitis
• have trouble emptying your bladder
• have prostate problems
• have thyroid problems or an “overactive thyroid”
• have high blood pressure (hypertension)
• are dehydrated, suffer from excessive vomiting or diarrhea or have an eating disorder
• have recently had a stroke, bleeding in your brain or any other head trauma
• have diabetes
• are breast-feeding
• have autonomic neuropathy (a dysfunction of the nerves)
• if you are 65 years or older

Other warnings you should know about:

Serious heart problems: Taking ATARAX may cause serious heart problems, such as worsening of the health of your heart, heart rhythm disorders (QT prolongation), cardiac arrest and sudden death.

If you have any of the following symptoms while you are taking ATARAX , stop taking ATARAX and get immediate medical help :

• dizziness
• heart palpitations (feeling of rapid pounding or skipped heartbeat or “fluttering”)
• fainting
• seizures

See the Serious side effects and what to do about them table below for information on this and other serious side effects.

Test results: ATARAX may affect the test results of an allergy and asthma tests. If you are scheduled to have allergy or asthma tests, stop taking ATARAX :

• 1 week before a skin test for allergies
• 96 hours before a methacholine test (a test to diagnose asthma)

Driving and Using Machines: ATARAX may make you drowsy. Avoid driving or operating machinery or doing tasks that require special attention.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with ATARAX :

Serious Drug Interactions

Do not take ATARAX with medicines/foods that can:

• affect your heart rhythm
• increase your blood levels of ATARAX SYRUP 2MG/mL

as this may cause:

• worsening of the health of your heart
• heart rhythm disorders (QT prolongation)
• cardiac arrest
• death

Examples of these medicines/foods include, but are not limited to:

• heart medicines used to treat abnormal heart rhythm (e.g. quinidine, amiodarone)
• medicines used to treat schizophrenia and other mental health problems (e.g. haloperidol)
• antidepressants (e.g. citalopram) and tricyclic antidepressants (e.g. amitriptyline)
• opioids (e.g. methadone)
• antibiotics used to treat bacterial infections (e.g. erythromycin, ciprofloxacin)
• antimalarial medicines (e.g. quinine, chloroquine)
• medicines used to treat fungal infections (e.g. ketoconazole)
• domperidone, used to speed up the movements of the stomach and bowel
• other medicines used to treat nausea and vomiting (e.g. ondansetron)
• medicines used to treat cancer (e.g. arsenic trioxide, sunitinib)
• medicines used to treat breathing problems like asthma and COPD (e.g. salmeterol, formoterol)
• medicines used to treat HIV/AIDS (protease inhibitors)
• grapefruit, grapefruit juice and grapefruit-containing products

• Medications that can cause low levels of electrolytes in your blood such as:

  • medicines used to relieve constipation (laxatives and enemas)
  • high dose corticosteroids, used to treat swelling and inflammation
  • medicines used to help your body get rid of water (diuretics), also called “water pills”, used to treat high blood pressure
• Alcohol. Do not drink alcohol while you are taking ATARAX . It may increase the sedative effects of the alcohol.
• Medicines used to treat seizures or epilepsy (anticonvulsants)
• Sedatives used to treat anxiety and sleeping problems
• Sedative antihistamines, used to treat allergies
• Drugs of recreational use

How to take ATARAX :

• Always take ATARAX exactly as your healthcare professional tells you to. Do not change your dose without talking to your healthcare professional.
• Your healthcare professional will ensure the lowest effective dose of ATARAX is used for the shortest amount of time.

Usual dose:

Adults: the maximum daily dose is 100 mg (50 mL), given in divided doses throughout the day.

Children and Adolescents who are over 40 kg in weight: the maximum daily dose is 100 mg (50 mL), given in divided doses throughout the day.

Children and Adolescents up to 40 kg in weight: the maximum daily dose is 2 mg/kg, given in divided doses throughout the day. Your healthcare professional will decide on the correct dose based on your child’s weight.

Geriatric patients (> 65 years of age)

ATARAX should generally be avoided in the geriatric population. If ATARAX has been recommended by your healthcare professional, the maximum daily dose for the elderly is 50 mg (25 mL), given in divided doses throughout the day.

Patients with liver problems

Your healthcare professional will reduce your dose by about 1/3 if you have liver problems.

Patients with kidney problems

Your healthcare professional will reduce your dose by about 1/2 if you have kidney problems.

Overdose:

If you think you, or a person you are caring for, have taken too much ATARAX , contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

If you forget to take a dose, you should take it as soon as you remember. If it is close to the time of your next dose when you remember, skip the missed dose and take your next dose at the usual time. DO NOT take a double dose.

What are possible side effects from using ATARAX ?

These are not all the possible side effects you may have when taking ATARAX . If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

• dry mouth
• flushing
• drowsiness
• headache
• itching
• rash

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store at controlled room temperature (15°C – 30°C). Protect from freezing.

Keep out of reach and sight of children.

If you want more information about ATARAX :

• Talk to your healthcare professional

• Find the full product monograph that is prepared for healthcare professionals and includes this

  Patient Medication Information by visiting the Health Canada website:

  (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.searchlightpharma.com, or by calling 1-647-945-9762.

Last Revised OCT 11, 2022.