Hydroxyzine Hydrochloride

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Overview

What is Hydroxyzine Hydrochloride?

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What does Hydroxyzine Hydrochloride look like?

What are the available doses of Hydroxyzine Hydrochloride?

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What should I talk to my health care provider before I take Hydroxyzine Hydrochloride?

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How should I use Hydroxyzine Hydrochloride?

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, , 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.

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested: in adults, 50 to 100 mg q.i.d.; children under 6 years, 50 mg daily in divided doses and 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: in adults, 25 mg t.i.d. or q.i.d.; children under 6 years, 50 mg daily in divided doses and 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 in adults, and 0.6 mg/kg in children.

When treatment is initiated by the intramuscular route of administration, subsequent doses may be administered orally.

As with all medications, the dosage should be adjusted according to the patient's response to therapy.

What interacts with Hydroxyzine 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. 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.

What are the warnings of Hydroxyzine Hydrochloride?

Safe use of nortriptyline hydrochloride during pregnancy and lactation has not been established; therefore, when the drug is administered to pregnant patients, nursing mothers, or women of childbearing potential, the potential benefits must be weighed against the possible hazards. Animal reproduction studies have yielded inconclusive results.

What are the precautions of Hydroxyzine Hydrochloride?

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 be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and oversedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.

What are the side effects of Hydroxyzine Hydrochloride?

Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature.

Anticholinergic:

Central Nervous System:

What should I look out for while using Hydroxyzine 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. 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.

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.

What might happen if I take too much Hydroxyzine Hydrochloride?

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.

How should I store and handle Hydroxyzine Hydrochloride?

Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Store at 20° to 25ºC (68° to 77°F).[See USP Controlled Room Temperature]Dispense in a tight container as defined in the USP.Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146 Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) bottles (, and Pint (473 mL) bottles (.Store at controlled room temperature, 15 °–30 °C (59 °–86 °F) [see USP].PROTECT FROM FREEZINGPROTECT FROM LIGHTDispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.Rx OnlyProduct No.: 8150Manufactured By:Morton Grove Pharmaceuticals, Inc.Morton Grove, IL 60053A50-8150-16REV. 7-04Relabeling of "Additional Barcode" by:Physicians Total Care, Inc.Tulsa, OK 74146

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Clinical Information

Chemical Structure

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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 its clinical effects are usually noted within 15 to 30 minutes after oral administration.

Non-Clinical Toxicology

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.

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.

(Seeand Clinically or potentially significant drug interactions between fluconazole and the following agents/classes have been observed. These are described in greater detail below:

Oral hypoglycemicsCoumarin-type anticoagulantsPhenytoinCyclosporineRifampinTheophyllineTerfenadineCisaprideAstemizoleRifabutinTacrolimusShort-term benzodiazepines

Astemizole:

Fluconazole tablets coadministered with ethinyl estradiol- and levonorgestrel-containing oral contraceptives produced an overall mean increase in ethinyl estradiol and levonorgestrel levels; however, in some patients there were decreases up to 47% and 33% of ethinyl estradiol and levonorgestrel levels. (See .) The data presently available indicate that the decreases in some individual ethinyl estradiol and levonorgestrel AUC values with fluconazole treatment are likely the result of random variation. While there is evidence that fluconazole can inhibit the metabolism of ethinyl estradiol and levonorgestrel, there is no evidence that fluconazole is a net inducer of ethinyl estradiol or levonorgestrel metabolism. The clinical significance of these effects is presently unknown.

Physicians should be aware that interaction studies with medications other than those listed in the section have not been conducted, but such interactions may occur.

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 be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

A determination has not been made whether controlled clinical studies of hydroxyzine included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

Sedating drugs may cause confusion and oversedation 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:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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