Hydroxyzine Hydrochloride
Generic: HYDROXYZINE HYDROCHLORIDE
Basic Information
Manufacturer
Proficient Rx LP
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
bcddc5ce-6cfb-4a09-8e6c-c956b65e3188
Indications & Usage
INDICATIONS AND USAGE 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 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.
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 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.
Warnings
WARNINGS Keep out of the reach of children.
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.
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.
Adverse Reactions
ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Wockhardt USA, LLC at 1-800-445-4290.
Skin and Appendages: Oral hydroxyzine hydrochloride is associated with fixed drug eruptions in postmarketing reports.
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 have been reported, usually with doses considerably higher than those recommended.
Clinically significant respiratory depression has not been reported at recommended doses.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Wockhardt USA, LLC at 1-800-445-4290.
Skin and Appendages: Oral hydroxyzine hydrochloride is associated with fixed drug eruptions in postmarketing reports.
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 have been reported, usually with doses considerably higher than those recommended.
Clinically significant respiratory depression has not been reported at recommended doses.