Hydroxyzine Information
Hydroxyzine () Description
Hydroxyzine () hydrochloride has the chemical name of 2-[2-[4-(-Chloro-α-phenylbenzyl)- 1-piperazinyl]ethoxy] ethanol dihydrochloride. C21H27CIN2O2•2HCl M.W. 447.83 Hydroxyzine () hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg Hydroxyzine () hydrochloride. Inactive ingredients include carnauba wax, colloidal silicon dioxide, crospovidone, lactose monohydrate, macrogol/polyethylene glycol 3350, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol - part. hydrolyzed, talc and titanium dioxide.
Hydroxyzine () 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 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.
Hydroxyzine () 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 a premedication and following general anesthesia, 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.
Hydroxyzine () 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 () is contraindicated for patients who have shown a previous hypersensitivity to it.
Hydroxyzine () Warnings
Hydroxyzine () 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 this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking Hydroxyzine () . Patients should also be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effects of alcohol may be increased.
Hydroxyzine () Adverse Reactions
Side effects reported with the administration of Hydroxyzine () hydrochloride are usually mild and transitory in nature. Dry mouth. Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of 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.
Hydroxyzine () Overdosage
The most common manifestation of Hydroxyzine () overdosage is hypersedation. 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 levarterenol or metaraminol. Do not use epinephrine as Hydroxyzine () counteracts its pressor action. 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.
Hydroxyzine () Dosage And Administration
For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: Adults, 50 to100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 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: adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50 to 100 mg daily in divided doses. As a sedative when used as a premedication and following general anesthesia: 50 to 100 mg for adults and 0.6 mg/kg of body weight in children. When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally. As with all potent medication, the dosage should be adjusted according to the patient’s response to therapy.
Hydroxyzine () How Supplied
Hydroxyzine () hydrochloride tablets, USP are available as follows: Hydroxyzine () hydrochloride tablets, USP 10 mg are supplied as white, round, film coated, biconvex tablets debossed “K10” on one side and plain on the other side. Blisterpacks of 30, NDC 0615-1525-39. Hydroxyzine () hydrochloride tablets, USP 25 mg are supplied as white, round, film coated, biconvex tablets debossed “K11” on one side and plain on the other side. Blisterpacks of 30, NDC 0615-1526-39. Hydroxyzine () hydrochloride tablets, USP 50 mg are supplied as white, round, film coated, biconvex tablets debossed “K12” on one side and plain on the other side. Blisterpacks of 30, NDC 0615-1527-39.
Hydroxyzine () References
Manufactured by: KVK-TECH, INC. 110 Terry Dr. Suite 200 Newtown, PA 18940 Item ID # 6015/00 05-06 Manufacturer’s Code: 10702
Hydroxyzine () Principal Display Panel
Hydroxyzine () Hydrochloride Tablets,
USP 10mg
Hydroxyzine () Package Label Principal Display Panel
Hydroxyzine () Hydrochloride Tablets,
USP 25mg
Hydroxyzine () Principal Display Panel
Hydroxyzine () Hydrochloride Tablets,
USP 50mg
