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 Novo Hydroxyzin.
HEALTH CANADA ADVISORY
June 6, 2016
Health Canada has issued new restrictions concerning the use of Atarax (hydroxyzine) . To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Abnormal heart rhythms: Novo Hydroxyzin can cause abnormal heart rhythms. Certain medications (e.g., Sotalol, quinidine, thioridazine, Chlorpromazine, droperidol, Pimozide, moxifloxacin, Mefloquine, pentamidine, arsenic trioxide, probucol, Tacrolimus) can increase the risk of a type of abnormal heart rhythm called QT prolongation and should not be used in combination with hydroxyzine. You are more at risk for this type of abnormal heart rhythm and its complications if you:
- are female
- are older than 65 years of age
- have a family history of sudden cardiac death
- have a history of heart disease or abnormal heart rhythms
- have a slow heart rate
- have congenital prolongation of the QT interval
- have Diabetes
- have had a Stroke
- have low potassium, magnesium, or calcium levels
- have nutritional deficiencies
If you have heart disease and abnormal heart rhythms, or people are taking certain medications (e.g., Verapamil, atazanavir), discuss with your doctor how Novo Hydroxyzin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Hydroxyzin, and whether any special monitoring is needed.
Breathing problems: People with breathing problems such as asthma, emphysema, or chronic Bronchitis may find that hydroxyzine makes breathing more difficult. It can dry the mucus in the lungs, making it more difficult to clear the lungs. If you experience difficulty breathing, stop taking the medication and contact your doctor.
Digestive system problems: Antihistamines, such as hydroxyzine, cause the passage of food though the digestive system to slow down. If you have any condition that already slows down the movement of food through the stomach and intestines, hydroxyzine may make this worse.
Drowsiness/reduced alertness: Hydroxyzine may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by Novo Hydroxyzin.
Enlarged prostate and urinary difficulties: Hydroxyzine may worsen urinary difficulties. If you have an enlarged prostate or difficulty starting urination, including a blockage from the bladder, discuss with your doctor how Novo Hydroxyzin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Hydroxyzin, and whether any special monitoring is needed.
Epilepsy: Hydroxyzine should be used with caution by people with epilepsy, as it may increase the risk for seizures. If you have a history of seizures, discuss with your doctor how Novo Hydroxyzin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Hydroxyzin, and whether any special monitoring is needed.
Glaucoma: Novo Hydroxyzin may cause a slight increase in pressure in the eye and therefore should be used with caution by anyone with glaucoma. If you have glaucoma, discuss with your doctor how Novo Hydroxyzin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Hydroxyzin, and whether any special monitoring is needed.
If you notice vision changes while you are taking Novo Hydroxyzin, contact your doctor.
Kidney function: The kidneys are partially responsible for removing Novo Hydroxyzin from your body. Kidney Disease or reduced kidney function may cause Novo Hydroxyzin to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Novo Hydroxyzin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Hydroxyzin, and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause Novo Hydroxyzin to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Novo Hydroxyzin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Hydroxyzin, and whether any special monitoring is needed.
Myasthenia Gravis: Hydroxyzine may worsen the muscle weakness experienced by people with myasthenia gravis. Novo Hydroxyzin should be used with caution if you have myasthenia gravis.
Sedation: The sedating effect of hydroxyzine must be considered when the medication is used at the same time as other sedating medications such as narcotics, non-narcotic pain relievers, sleeping pills, sedatives, barbiturates, or alcohol.
Thyroid disease: Hydroxyzine may cause symptoms of an overactive thyroid gland (Hyperthyroidism). If you have thyroid problems, discuss with your doctor how Novo Hydroxyzin may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Novo Hydroxyzin, and whether any special monitoring is needed.
Pregnancy: Hydroxyzine should not be used during early pregnancy. It should be used during later pregnancy only if the potential benefits outweigh the risks.
Breast-feeding: It is not known if hydroxyzine passes into breast milk. If you are a breast-feeding mother and are taking Novo Hydroxyzin, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Seniors: Seniors may be at increased risk for the sedating and impaired coordination effects of Novo Hydroxyzin. Seniors should use extra caution, for example, when getting up during the night.
