Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)
Physicians Total Care, Inc.
HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE 10 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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. Hydroxyzin
Hydroxyzine Hydrochloride Oral Solution, USP 10 mg per 5 mL (teaspoonful) NDC 54868-2032-0 is a slightly yellow peppermint flavored liquid supplied in 1 pint amber plastic bottles. Alcohol content: alcohol 0.5% v/v. Store at controlled room temperature 15° - 30°C (59° - 86°F). Dispense in tight, light-resistant containers as defined in the USP. Manufactured by: HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev. 796:03 8/09 Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK 74146
Abbreviated New Drug Application
HYDROXYZINE HYDROCHLORIDE - HYDROXYZINE HYDROCHLORIDE SOLUTION PHYSICIANS TOTAL CARE, INC. ---------- DESCRIPTION Hydroxyzine hydrochloride is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2- hydroxyethoxy)-ethyl] piperazine dihydrochloride, with the following structure: Each 5 mL (teaspoonful), for oral administration, contains 10 mg of hydroxyzine hydrochloride. The inactive ingredients for the oral solution are alcohol 0.5% v/v, corn syrup, methylparaben, peppermint flavor, propylene glycol, purified water, sodium benzoate, and sucrose. Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH when necessary. CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine hydrochloride 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 its clinical effects are usually noted within 15 to 30 minutes after oral administration. 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 potenti read_full_document