What you need to know about drugs

Vistaril

Hydroxyzine Pamoate(hydroxyzine pamoate) – Various

OTHER BRAND NAMES

Vistaril (Pfizer)

THERAPEUTIC CLASS

Piperazine antihistamine

INDICATIONS

Symptomatic relief of anxiety and tension associated with psychoneurosis and adjunct in organic disease states in which anxiety is manifested. Sedative when used as premedication and following general anesthesia. Management of pruritus due to allergic conditions (eg, chronic urticaria, atopic/contact dermatoses) and in histamine-mediated pruritus.

ADULT DOSAGE

Adults: Anxiety/Tension: 50-100mg qid. Pruritus: 25mg tid or qid. Sedation: 50-100mg. Adjust dose according to response to therapy. When treatment is initiated by IM route, subsequent doses may be administered PO. Elderly: Start at lower end of dosing range.

PEDIATRIC DOSAGE

Pediatrics: Anxiety/Tension/Pruritus: >6 yrs: 50-100mg/day in divided doses. <6 yrs: 50mg/day in divided doses. Sedation: 0.6mg/kg. Adjust dose according to response to therapy. When treatment is initiated by IM route, subsequent doses may be administered PO.

HOW SUPPLIED

Cap: 100mg; (Vistaril) 25mg, 50mg

CONTRAINDICATIONS

Early pregnancy.

WARNINGS/PRECAUTIONS

Drowsiness may occur. May impair mental/physical abilities. Effectiveness as an antianxiety agent for long-term use (>4 months) has not been established. Caution in elderly.

ADVERSE REACTIONS

Dry mouth, drowsiness, involuntary motor activity.

DRUG INTERACTIONS

Potentiated by CNS depressants (eg, narcotics, non-narcotic analgesics, barbiturates); reduce dose of CNS depressants when administered concomitantly. Effect of alcohol may be increased when used concomitantly. Modify use of meperidine and barbiturates, on an individualized basis, when used in preanesthetic adjunctive therapy.

PREGNANCY

Contraindicated in early pregnancy, not for use in nursing.

MECHANISM OF ACTION

Piperazine antihistamine; believed to suppress activity in certain key regions of the subcortical area of the CNS and shown to have primary skeletal muscle relaxation, bronchodilator activity, antihistaminic, antiemetic, and analgesic effects.

PHARMACOKINETICS

Absorption: Rapid.

ASSESSMENT

Assess for hypersensitivity to the drug, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor for response to treatment. Monitor for drowsiness and other adverse reactions.

PATIENT COUNSELING

Inform about risks/benefits of therapy. Advise against simultaneous use of other CNS depressants and caution that the effect of alcohol may be increased. Advise that drowsiness may occur; instruct to use caution against driving or operating heavy machinery.

ADMINISTRATION/STORAGE

Administration: Oral route. Storage: 20-25oC (68-77oF). (Vistaril) Below 30°C (86°F).


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    Vistaril

    Vistaril

    Pronunciation Generic Name: hydroxyzine (hye-DROX-i-zeen)

    Brand Name: Examples include Atarax and Vistaril

    OverviewSide EffectsInteractionsFor ProfessionalsMore…

    Vistaril is used for:

    Treating anxiety, for sedation before and after general anesthesia, and to treat itching due to certain allergic conditions, including hives and contact dermatitis (eg, poison ivy). It also may be used for other conditions as determined by your doctor.

    Vistaril is an antihistamine. It works by affecting the brain to reduce anxiety. It also has other activities, including opening breathing tubes, relieving pain or allergy symptoms, and preventing or treating nausea and vomiting caused by motion sickness.

    Do NOT use Vistaril if:

    • you are allergic to any ingredient in Vistaril
    • you are taking sodium oxybate (GHB)
    • you are in your first 3 months of pregnancy

    Contact your doctor or health care provider right away if any of these apply to you.

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    Before using Vistaril:

    Some medical conditions may interact with Vistaril. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have asthma, glaucoma, difficulty urinating, urinary or intestinal blockage, a prostate disease, or a blood disease
    • if you drink alcoholic beverages

    Some MEDICINES MAY INTERACT with Vistaril. Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Sodium oxybate (GHB) because side effects such as an increase in sleep duration and slowed breathing may occur

    This may not be a complete list of all interactions that may occur. Ask your health care provider if Vistaril may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Vistaril:

    Use Vistaril as directed by your doctor. Check the label on the medicine for exact dosing instructions.

    • Take Vistaril by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
    • If you miss a dose of Vistaril and you are using it regularly, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

    Ask your health care provider any questions you may have about how to use Vistaril.

    Important safety information:

    • Vistaril may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Vistaril with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
    • Avoid drinking alcohol or using medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Vistaril; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
    • The effectiveness of Vistaril as anxiety treatment for longer than 4 months is not known.
    • Use Vistaril with caution in the ELDERLY; they may be more sensitive to its effects.
    • Vistaril should not be used in NEWBORNS; safety and effectiveness in newborns have not been confirmed.
    • PREGNANCY and BREAST-FEEDING: Do not use Vistaril if you are in your first 3 months of pregnancy. If you think you may be pregnant, contact your doctor right away. It is not known if Vistaril is found in breast milk. Do not breast-feed while taking Vistaril.

    Possible side effects of Vistaril:

    All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

    Drowsiness; dry mouth.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); involuntary movements.

    This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include unusual drowsiness and dizziness.

    Proper storage of Vistaril: Store Vistaril at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do not freeze. Store away from heat, moisture, and light in a tightly closed container. Do not store in the bathroom. Keep Vistaril out of the reach of children and away from pets.

    General information:

    • If you have any questions about Vistaril, please talk with your doctor, pharmacist, or other health care provider.
    • Vistaril is to be used only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your doctor.
    • Check with your pharmacist about how to dispose of unused medicine.

    This information should not be used to decide whether or not to take Vistaril or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Vistaril. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vistaril. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Vistaril.

    Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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    Vistaril

    Vistaril

    Pronunciation Generic Name: hydroxyzine pamoate

    Dosage Form: capsules and oral suspension

    For ProfessionalsSide EffectsDosageInteractionsMore…

    Vistaril®

    (hydroxyzine pamoate)

    Capsules and

    Oral Suspension

    Vistaril Description

    Hydroxyzine pamoate is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-hydroxyethoxy) ethyl] diethylenediamine salt of 1,1′-methylene bis (2 hydroxy-3-naphthalene carboxylic acid).

    Inert ingredients for the capsule formulations are: hard gelatin capsules (which may contain Yellow 10, Green 3, Yellow 6, Red 33, and other inert ingredients); magnesium stearate; sodium lauryl sulfate; starch; sucrose.

    Inert ingredients for the oral suspension formulation are: carboxymethylcellulose sodium; lemon flavor; propylene glycol; sorbic acid; sorbitol solution; water.

    Vistaril – Clinical Pharmacology

    Vistaril® (hydroxyzine pamoate) is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines.

    Vistaril is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation has been demonstrated experimentally. Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically. An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases has mild antisecretory activity. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and Vistaril’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

    INDICATIONS

    For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

    Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

    As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

    The effectiveness of hydroxyzine as an antianxiety agent for long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

    Contraindications

    Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat and mouse at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

    Hydroxyzine pamoate is contraindicated for patients who have shown a previous hypersensitivity to any component of this medication.

    Warnings

    Nursing Mothers

    It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

    Precautions

    THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, NON-NARCOTIC ANALGESICS AND BARBITURATES. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. Since drowsiness may occur with use of the drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Vistaril (hydroxyzine pamoate). Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

    Geriatric Use

    A determination has not been made whether controlled clinical studies of Vistaril included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant disease or other drug therapy.

    The extent of renal excretion of Vistaril has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

    Sedating drugs may cause confusion and over sedation in the elderly; elderly patients generally should be started on low doses of Vistaril and observed closely.

    Adverse Reactions

    Side effects reported with the administration of Vistaril are usually mild and transitory in nature.

    Anticholinergic: Dry mouth.

    Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

    In post-marketing experience, the following additional undesirable effects have been reported: Body as a Whole: allergic reaction, Nervous System: headache, Psychiatric: hallucination, Skin and Appendages: pruritus, rash, urticaria.

    Overdosage

    The most common manifestation of overdosage of Vistaril is hypersedation. Other reported signs and symptoms were convulsions, stupor, nausea and vomiting. As in the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.

    If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended. General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated. Hypotension, though unlikely, may be controlled with intravenous fluids and vasopressors (do not use epinephrine as hydroxyzine counteracts its pressor action.) Caffeine and Sodium Benzoate Injection, USP, may be used to counteract central nervous system depressant effects.

    There is no specific antidote. It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydroxyzine. However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated. There is no practical method to quantitate hydroxyzine in body fluids or tissue after its ingestion or administration.

    DOSAGE

    For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50–100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50–100 mg daily in divided doses.

    For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; and over 6 years, 50–100 mg daily in divided doses.

    As a sedative when used as a premedication and following general anesthesia: 50–100 mg in adults, and 0.6 mg/kg in children.

    When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

    As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

    How is Vistaril Supplied

    Vistaril® Capsules (hydroxyzine pamoate equivalent to hydroxyzine hydrochloride)

          25 mg:  100′s (NDC 0069-5410-66), two-tone green capsules

          50 mg:  100′s (NDC 0069-5420-66), green and white capsules

    Vistaril® Oral Suspension (hydroxyzine pamoate equivalent to 25 mg hydroxyzine hydrochloride per teaspoonful-5 mL): 1 pint (473 mL) bottles (NDC 0069-5440-93) and

    4 ounce (120 mL) bottles (NDC 0069-5440-97) in packages of 4.

    Shake vigorously until product is completely resuspended.

    BIBLIOGRAPHY

    Available on request.

    Rx only

    LAB-0126-2.0

    Revised April 2004

    PRINCIPAL DISPLAY PANEL – 25 mg 100 Capsule Bottle Label

    NDC 0069-5410-66

    100 Capsules

    Vistaril®

    (hydroxyzine pamoate)

    25 mg*

    Pfizer

    Distributed by

    Pfizer Labs

    Division of Pfizer Inc, NY, NY 10017

    Vistaril 

    hydroxyzine pamoate capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0069-5410
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    hydroxyzine pamoate (hydroxyzine) hydroxyzine hydrochloride 25 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C Yellow No. 10  
    FD&C Green No. 3  
    FD&C Yellow No. 6  
    D&C Red No. 33  
    magnesium stearate  
    sodium lauryl sulfate  
    sucrose  
    Product Characteristics
    Color GREEN (two-tone green) Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code Vistaril;Pfizer;541
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0069-5410-66 100 CAPSULE (CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA011459 11/28/1994
    Vistaril 

    hydroxyzine pamoate capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0069-5420
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    hydroxyzine pamoate (hydroxyzine) hydroxyzine hydrochloride 50 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C Yellow No. 10  
    FD&C Green No. 3  
    FD&C Yellow No. 6  
    D&C Red No. 33  
    magnesium stearate  
    sodium lauryl sulfate  
    sucrose  
    Product Characteristics
    Color GREEN, WHITE Score no score
    Shape CAPSULE Size 14mm
    Flavor Imprint Code Vistaril;Pfizer;542
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0069-5420-66 100 CAPSULE (CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA011459 11/15/1968
    Vistaril 

    hydroxyzine pamoate capsule

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0069-5430
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    hydroxyzine pamoate (hydroxyzine) hydroxyzine hydrochloride 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    D&C Yellow No. 10  
    FD&C Green No. 3  
    FD&C Yellow No. 6  
    D&C Red No. 33  
    magnesium stearate  
    sodium lauryl sulfate  
    sucrose  
    Product Characteristics
    Color GREEN, GRAY Score no score
    Shape CAPSULE Size 18mm
    Flavor Imprint Code Vistaril;Pfizer;543
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0069-5430-66 100 CAPSULE (CAPSULE) in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA011459 11/15/1968
    Vistaril 

    hydroxyzine pamoate suspension

    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0069-5440
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    hydroxyzine pamoate (hydroxyzine) hydroxyzine hydrochloride 25 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    carboxymethylcellulose sodium  
    propylene glycol  
    sorbic acid  
    sorbitol  
    water  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor LEMON Imprint Code
    Contains         
    Packaging
    # Item Code Package Description
    1 NDC:0069-5440-93 473 mL in 1 BOTTLE
    2 NDC:0069-5440-97 4 BOTTLE (BOTTLE) in 1 PACKAGE
    2 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA011795 06/03/1959
    Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)
    Establishment
    Name Address ID/FEI Operations
    Pfizer Pharmaceuticals LLC 193684656 MANUFACTURE
    Establishment
    Name Address ID/FEI Operations
    Uniion Quimico Famaceutica S.A. 460940868 MANUFACTURE

    Revised: 02/2010   Pfizer Laboratories Div Pfizer Inc

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