Trade Name: Hydroxyzine Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals, Inc.

Presentation: TABLET, FILM COATED, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/1

Storage and handling

HYDROXYZINE HYDROCHLORIDE Antihistamine [EPC],Histamine Receptor Antagonists [MoA]

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  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
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  • No data
  • HydrOXYzine hydrochlorideu00a0 has the chemical name of 2-[2-[4-u00a0 (p-Chloro-u03b1-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride.
  • 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 HCl.u00a0 Inactive ingredients include: lactose monohydrate, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, stearic acid, polyethylene glycol, polysorbate 80, and titanium dioxide.
  • HydrOXYzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate or the benzodiazepines.u00a0 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.u00a0 Bronchodilator activity, and antihistaminic and analgesic effects have been demonstrated experimentally and confirmed clinically.u00a0 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 hydrOXYzineu2019s clinical effects are usually noted within 15 to 30 minutes after oral administration.
  • 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, n n n , so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis.u00a0 Atropine and other belladonna alkaloids are not affected by the drug.u00a0 HydrOXYzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.n nn
  • 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.u00a0 The physician should reassess periodically the usefulness of the drug for the individual patient.
  • Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.
  • 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.u00a0 Clinical data in human beings are inadequate to establish safety in early pregnancy.u00a0 Until such data are available, hydrOXYzine is contraindicated in early pregnancy.
  • HydrOXYzine is contraindicated for patients who have shown a previous hypersensitivity to it.
  • WARNINGS:u00a0 Nursing Mothers:
  • 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.u00a0 Patients should also be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effects of alcohol may be increased.
  • Geriatric Use:
  • The extent of renal excretion of hydrOXYzine has not been determined.u00a0 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 hydrOXYzine and observed closely.
  • Side effects reported with the administration of hydrOXYzine hydrochloride are usually mild and transitory in nature.
  • Anticholinergic:
  • Central Nervous System:
  • In post-marketing experience, the following additional undesirable effects have
  • been reported:
  • Body as a Whole:
  • Nervous System:
  • Psychiatric:
  • Skin and Appendages:
  • The most common manifestation of hydrOXYzine overdosage is hypersedation.u00a0 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.u00a0 Immediate gastric lavage is also recommended.u00a0 General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.u00a0 Hypotension, though unlikely, may be controlled with intravenous fluids and levarterenol or metaraminol.u00a0 Do not use epinephrine as hydrOXYzine counteracts its pressor action.
  • There is no specific antidote.u00a0 It is doubtful that hemodialysis would be of any value in the treatment of overdosage with hydrOXYzine.u00a0 However, if other agents such as barbiturates have been ingested concomitantly, hemodialysis may be indicated.u00a0 There is no practical method to quantitate hydrOXYzine in body fluids or tissue after its ingestion or administration.
  • For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested:u00a0 Adults, 50-100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses; children 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:u00a0 adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses; children over 6 years, 50-100 mg daily in divided doses.
  • As a sedative when used as a premedication and following general anesthesia: 50-100 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 patientu2019s response to therapy.
  • HydrOXYzine Hydrochloride Tablets, USP,
  • 10 mg - Round, white, film-coated tablet, debossed u201cH 500u201d, supplied in bottles of 15.
  • Bottles of 15 n 66267-112-15n
  • Dispense in a tight container as defined in the USP.
  • Store at controlled room temperature 20u00b0-25u00b0C (68u00b0-77u00b0F); [see USP Controlled Room Temperature].
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Manufactured for:
  • Heritage Pharmaceuticals Inc.
  • Eatontown, NJ 07724
  • 1-866-901-DRUG (3784)
  • Iss.06/14
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) which is also known as Hydroxyzine Hydrochloride and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 10 mg/1.

Hydroxyzine Hydrochloride (Hydroxyzine Hydrochloride) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.

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