País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
HYDROXYZINE DIHYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)
Aurobindo Pharma Limited
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 a 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. Oral hydroxyzine hydrochloride
Hydroxyzine Hydrochloride Tablets USP, 10 mg are lavender, round, biconvex, film- coated tablets debossed with "1" on one side and plain on other side. They are supplied as follows: Bottles of 100 NDC 59651-499-01 Bottles of 500 NDC 59651-499-05 Bottles of 1,000 NDC 59651-499-99 Blister of 10x10 Unit-Dose Tablets NDC 59651-499-78 Hydroxyzine Hydrochloride Tablets USP, 25 mg are lavender, round, biconvex, film- coated tablets debossed with "2" on one side and plain on other side. They are supplied as follows: Bottles of 100 NDC 59651-500-01 Bottles of 500 NDC 59651-500-05 Bottles of 1,000 NDC 59651-500-99 Hydroxyzine Hydrochloride Tablets USP, 50 mg are purple, round, biconvex, film-coated tablets debossed with "7" on one side and plain on other side. They are supplied as follows: Bottles of 100 NDC 59651-501-01 Bottles of 500 NDC 59651-501-05 Bottles of 1,000 NDC 59651-501-99 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 10/2021
Abbreviated New Drug Application
HYDROXYZINE HYDROCHLORIDE - HYDROXYZINE HYDROCHLORIDE TABLET, FILM COATED AUROBINDO PHARMA LIMITED ---------- HYDROXYZINE HYDROCHLORIDE TABLETS, USP RX ONLY DESCRIPTION Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-(_p_-Chloro-α-phenylbenzyl)- 1-piperazinyl] ethoxy] ethanol dihydrochloride. C H CLN O •2HCL MOLECULAR WEIGHT 447.83 Hydroxyzine hydrochloride USP occurs as a white powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride USP. Inactive ingredients include FD&C blue #2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch (corn), and titanium dioxide. In addition, 10 mg contains D&C red #30 aluminum lake, 25 mg and 50 mg contains D&C red #7 calcium lake. CLINICAL PHARMACOLOGY Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines. Hydroxyzine 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 21 27 2 2 does not increase gastric secretion or acidity and in most cases has mild antisecretory activity. Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine’s 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 o Llegiu el document complet