Brand Name

    US Brand Name

    Atarax

    Vistaril


    Description

    Hydroxyzine is used to help control anxiety and tension caused by nervous and emotional conditions. It can also be used to help control anxiety and produce sleep before surgery. This medicine is also used to relieve symptoms of allergic conditions (eg, chronic urticaria and atopic and contact dermatoses).

    Hydroxyzine is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body.

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Tablet
    • Syrup
    • Capsule

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydroxyzine in children.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hydroxyzine in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, confusion, drowsiness) and age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving hydroxyzine.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

    • Bepridil
    • Calcium Oxybate
    • Cisapride
    • Dronedarone
    • Levoketoconazole
    • Magnesium Oxybate
    • Mesoridazine
    • Pimozide
    • Piperaquine
    • Potassium Citrate
    • Potassium Oxybate
    • Saquinavir
    • Sodium Oxybate
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Tranylcypromine
    • Ziprasidone

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Adagrasib
    • Alfentanil
    • Alfuzosin
    • Alprazolam
    • Amantadine
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Anagrelide
    • Apomorphine
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Asenapine
    • Astemizole
    • Atazanavir
    • Azithromycin
    • Bedaquiline
    • Benzhydrocodone
    • Bromazepam
    • Bromopride
    • Buprenorphine
    • Bupropion
    • Buserelin
    • Butalbital
    • Butorphanol
    • Cannabidiol
    • Cannabis
    • Carbinoxamine
    • Ceritinib
    • Cetirizine
    • Chloroquine
    • Chlorpromazine
    • Ciprofloxacin
    • Citalopram
    • Clarithromycin
    • Clofazimine
    • Clomipramine
    • Clonazepam
    • Clothiapine

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Electrolyte imbalance or
    • Heart attack or
    • Heart disease or
    • Heart failure, uncompensated or
    • Heart rhythm problems (eg, long QT syndrome, slow heartbeat), or family history of—Use with caution. May cause side effects to become worse.
    • Heart rhythm problem (eg, prolonged QT interval)—Should not be used in patients with this condition.
    • Skin problems—Use with caution. May make these conditions worse.

    Proper Use

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

    Shake the Vistaril® oral liquid well before using.

    Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For oral dosage form (capsules, tablets, or solution):
      • For anxiety and tension:
        • Adults—50 to 100 milligrams (mg) 4 times a day.
        • Children 6 years of age and older—50 to 100 mg per day given in divided doses.
        • Children younger than 6 years of age—50 mg per day given in divided doses.
      • For management of allergic reactions:
        • Adults—25 milligrams (mg) 3 or 4 times a day.
        • Children 6 years of age and older—50 to 100 mg per day given in divided doses.
        • Children younger than 6 years of age—50 mg per day given in divided doses.
      • For controlling anxiety and produce sleep before surgery:
        • Adults—50 to 100 milligrams (mg) per day.
        • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.6 milligram (mg) per kilogram (kg) of body weight per day.
    • For oral dosage forms (Vistaril® capsules or suspension):
      • For anxiety and tension:
        • Adults—50 to 100 milligrams (mg) 4 times a day.
        • Children 6 years of age and older—50 to 100 mg per day given in divided doses.
        • Children younger than 6 years of age—50 mg per day given in divided doses.
      • For management of allergic reactions:
        • Adults—50 to 100 milligrams (mg) 4 times a day.
        • Children 6 years of age and older—50 to 100 mg per day given in divided doses.
        • Children younger than 6 years of age—50 mg per day given in divided doses.
      • For controlling anxiety and produce sleep before surgery:
        • Adults—50 to 100 milligrams (mg) per day.
        • Children—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.6 milligram (mg) per kilogram (kg) of body weight per day.

    Missed Dose

    If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

    Call your doctor if your symptoms do not improve or if they get worse.

    Make sure your doctor knows if you are pregnant. Do not use this medicine during the early part of a pregnancy unless your doctor tells you to.

    This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

    Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation.

    This medicine may cause a serious skin condition called acute generalized exanthematous pustulosis (AGEP). Tell your doctor if you have a fever, skin rash, or worsening of skin problems after using this medicine.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Incidence not known

    • Chest pain, discomfort, or tightness
    • cough
    • difficulty with swallowing
    • dizziness
    • fainting
    • fast heartbeat
    • hives, itching, or skin rash
    • irregular or slow heart rate
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • trouble breathing
    • unusual tiredness or weakness

    Get emergency help immediately if any of the following symptoms of overdose occur:

    Symptoms of overdose

    • Decreased awareness or responsiveness
    • drowsiness
    • nausea
    • seizures
    • severe sleepiness
    • vomiting

    Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    Rare

    • Shakiness in the legs, arms, hands, or feet
    • trembling or shaking of the hands or feet

    Incidence not known

    • Dry mouth
    • headache
    • seeing, hearing, or feeling things that are not there

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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