Atarax (hydroxyzine hydrochloride) Product Information | Study Guides, Projects, Research Marketing

AT ARAX- hydroxyzine hydrochloride tablet

AT ARAX- hydroxyzine hydrochloride s yrup

Roerig

----------

ATARAX®

hydroxyzine hydrochloride

TABLET S AND SYRUP

DESCRIPTION

Hydroxyzine hydroc hlo ride is designated chemically as 1-(p-chl orobenzhydryl) 4- [2-(2-

hydro xyethoxy)-ethyl] piper azine dihydroc hlo ride.

Inert ingredie nts for the table ts are : acacia; carnauba wax; dibasic calc ium phosphate; gelatin; lactos e;

magnes ium stearate; prec ipitated c alcium carbonate; shellac; suc rose; talc; white wax. The 10 mg tablets

also contain: sodium hydroxide; starch; titanium dioxide; Yellow 6 Lake. The 25 mg tablets also co ntain:

starc h; velo dark gree n. The 50 mg tablets also contain: starc h; velo yello w. T he 10 0 mg table ts als o

co ntain: alginic acid; Blue 1; polyethylene g lycol; Re d 3.

The inert ingredients fo r the syrup are: alcohol; menthol; peppermint oil; sodium benzoate; spearmint

oil; sucrose; water.

CLINICAL PHARMACOLOGY

Atarax is unrelated chemically to the phenothiazines , re serpine, meprobamate, or the benzodiazepines .

Atarax is not a co rtic al depressant, but its action may be due to a suppression of activity in certain key

regions of the subco rtical are a of the central nervous system. Primary skeletal muscle relaxation has

bee n demonstrated experimentally. Bronchodilator ac tivity, and anti- histaminic and analgesic effects

have be en demonstrated experimentally and confirmed clinically. An antiemetic e ffect, both by the

apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies

indicate that hydroxyzine in therapeutic do sag e do es not incre ase gas tric secretion or acidity and in

mos t cases has mild antisecreto ry activity. Hydroxyzine is rapidly absorbe d from the gastrointestinal

tract and Atarax's clinical e ffects are usually noted within 15 to 30 minutes after oral administratio n.

INDICATIONS

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in

organic dise ase states in which anxiety is manife sted.

Useful in the management of pruritus due to alle rg ic conditio ns such as chronic urtic aria and atopic and

co ntact dermatos es, and in histamine-mediated pruritus.

As a sedative whe n used as premedication and following g eneral anesthesia, Hydroxyz ine may

pote ntiate me peridine (De merol®) and barbiturates , so their us e in pre -anesthetic adjunctive therapy

sho uld be modifie d on an individual basis. Atropine and other belladonna alkaloids ar e not affec ted by

the drug. Hydroxyzi ne is not known to interfere with the actio n of digitalis in any way and it may be used

co ncurrently with this age nt.

The effective ness of hydroxyzine as an antianxiety agent for lo ng term use, that is more than 4 months,

has not been assess ed by s ystematic clinical studies. T he physician sho uld reass es s perio dic ally the

use fulnes s o f the drug for the individual patient.

CONTRAINDICATIONS

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ATARAX- hydroxyzine hydrochloride tablet

ATARAX- hydroxyzine hydrochloride s yrup

Roerig

ATARAX®

hydroxyzine hydrochloride

TABLETS AND SYRUP

DESCRIPTION

Hydroxyzine hydrochloride is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-

hydroxyethoxy)-ethyl] piperazine dihydrochloride.

Inert ingredients for the tablets are: acacia; carnauba wax; dibasic calcium phosphate; gelatin; lactose;

magnesium stearate; precipitated calcium carbonate; shellac; sucrose; talc; white wax. The 10 mg tablets

also contain: sodium hydroxide; starch; titanium dioxide; Yellow 6 Lake. The 25 mg tablets also contain:

starch; velo dark green. The 50 mg tablets also contain: starch; velo yellow. The 100 mg tablets also

contain: alginic acid; Blue 1; polyethylene glycol; Red 3.

The inert ingredients for the syrup are: alcohol; menthol; peppermint oil; sodium benzoate; spearmint

oil; sucrose; water.

CLINICAL PHARMACOLOGY

Atarax is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines.

Atarax 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 anti- histaminic 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 Atarax's clinical effects are usually noted within 15 to 30 minutes after oral administration.

INDICATIONS

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.

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.

WARNINGS

Nurs ing Mothers

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.

For Tablets Only

This product is manufactured with 1,1,1-trichloroethane, a substance which harms public health and the

environment by destroying ozone in the upper atmosphere.

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 Atarax. Patients should

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

alcohol may be increased.

Geriatric Us e

A determination has not been made whether controlled clinical studies of ATARAX 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 ATARAX 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 over sedation in the elderly; elderly patients generally should

be started on low doses of ATARAX and observed closely.

ADVERSE REACTIONS

Side effects reported with the administration of Atarax (hydroxyzine hydrochloride) are usually mild

and transitory in nature.

Anticholinergic

Dry mouth.

Central Nervous Sys tem

Available on request.

Rx only

LAB-0122-2.

June 2006

ATARAX

hydroxyzine hydrochloride tablet

Product Information

Prod uct T yp e HUMAN PRESCRIPTIO N DRUG^ Ite m Cod e (S ource ) NDC:0 0 49 -56 0 0

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th

hydro xyz ine hydro c hlo ride (UNII: 76 755771U3) (hydro xyz ine - UNII:30 S50 YM8 O G) 10 mg

Inactive Ing redients

Ing redient Name Streng th

a c a c ia () c a rna uba wa x () diba sic c a lc ium pho spha te () g e la tin () la c to se () ma g ne sium ste a ra te (UNII: 70 0 9 7M6 I30 ) pre c ipita te d c a lc ium c a rbo na te () she lla c () suc ro se (UNII: C151H8 M554) ta lc (UNII: 7SEV7J4R1U) white wa x () so dium hydro xide (UNII: 55X0 4Q C32I) sta rc h () tita nium dio xide (UNII: 15FIX9 V2JP) Ye llo w 6 La ke ()

Product Characteristics

Color O RANGE (O RANGE)^ S core no sc o re

S hap e TRIANGLE (TRIANGLE)^ S iz e 7mm

Flavor Imp rint Cod e Ata ra x;

Contains

Coating fa lse^ S ymb ol fa lse

Packag ing

# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date

1 NDC:0 0 49 -56 0 0 -6 6 10 0 in 1 BO TTLE

ATARAX

hydroxyzine hydrochloride tablet

Product Information

Prod uct T yp e HUMAN PRESCRIPTIO N DRUG Ite m Cod e (S ource ) NDC:0 0 49 -56 10

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th

hydro xyz ine hydro c hlo ride (UNII: 76 755771U3) (hydro xyz ine - UNII:30 S50 YM8 O G) 25 mg

Inactive Ing redients

Ing redient Name Streng th

Product Characteristics

Color GREEN (GREEN)^ S core no sc o re

S hap e TRIANGLE (TRIANGLE)^ S iz e 7mm

Flavor Imp rint Cod e Ata ra x;

Contains

Coating fa lse^ S ymb ol fa lse

Packag ing

# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date

1 NDC:0 0 49 -56 20 -6 6 10 0 in 1 BO TTLE

ATARAX

hydroxyzine hydrochloride tablet

Product Information

Prod uct T yp e HUMAN PRESCRIPTIO N DRUG^ Ite m Cod e (S ource ) NDC:0 0 49 -56 30

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th

hydro xyz ine hydro c hlo ride (UNII: 76 755771U3) (hydro xyz ine - UNII:30 S50 YM8 O G) 10 0 mg

Inactive Ing redients

Ing redient Name Streng th

a c a c ia () c a rna uba wa x () diba sic c a lc ium pho spha te () g e la tin () la c to se () ma g ne sium ste a ra te (UNII: 70 0 9 7M6 I30 ) pre c ipita te d c a lc ium c a rbo na te () she lla c () suc ro se (UNII: C151H8 M554) ta lc (UNII: 7SEV7J4R1U) white wa x () a lg inic a c id () Blue 1 () po lye thyle ne g lyc o l () Re d 3 ()

Product Characteristics

Color RED (RED)^ S core no sc o re

S hap e TRIANGLE (TRIANGLE)^ S iz e 12mm

Flavor Imp rint Cod e Ata ra x;10 0

Contains

Coating fa lse^ S ymb ol fa lse

Packag ing

Roerig

# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date

1 NDC:0 0 49 -56 30 -6 6 10 0 in 1 BO TTLE

ATARAX

hydroxyzine hydrochloride syrup

Product Information

Prod uct T yp e HUMAN PRESCRIPTIO N DRUG Ite m Cod e (S ource ) NDC:0 0 49 -559 0

Route of Ad minis tration O RAL

Active Ing redient/Active Moiety

Ing redient Name Basis o f Streng th Streng th

hydro xyz ine hydro c hlo ride (UNII: 76 755771U3) (hydro xyz ine - UNII:30 S50 YM8 O G) 10 mg in 5 mL

Inactive Ing redients

Ing redient Name Streng th

a lc o ho l (UNII: 3K9 9 58 V9 0 M) me ntho l (UNII: 8 0 R520 6 4AQ ) pe ppe rmint o il () so dium be nz o a te (UNII: O J245FE5EU) spe a rmint o il () suc ro se (UNII: C151H8 M554) wa te r (UNII: 0 59 Q F0 KO 0 R)

Packag ing

# Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date

1 NDC:0 0 49 -559 0 -9 3 473 mL in 1 BO TTLE

Atarax (hydroxyzine hydrochloride) Product Information, Study Guides, Projects, Research of Marketing

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Partial preview of the text

Download Atarax (hydroxyzine hydrochloride) Product Information and more Study Guides, Projects, Research Marketing in PDF only on Docsity!

ATARAX- hydroxyzine hydrochloride tablet

ATARAX- hydroxyzine hydrochloride s yrup

Roerig

ATARAX®

hydroxyzine hydrochloride

TABLETS AND SYRUP

DESCRIPTION

Hydroxyzine hydrochloride is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2-

hydroxyethoxy)-ethyl] piperazine dihydrochloride.

Inert ingredients for the tablets are: acacia; carnauba wax; dibasic calcium phosphate; gelatin; lactose;

magnesium stearate; precipitated calcium carbonate; shellac; sucrose; talc; white wax. The 10 mg tablets

also contain: sodium hydroxide; starch; titanium dioxide; Yellow 6 Lake. The 25 mg tablets also contain:

starch; velo dark green. The 50 mg tablets also contain: starch; velo yellow. The 100 mg tablets also

contain: alginic acid; Blue 1; polyethylene glycol; Red 3.

The inert ingredients for the syrup are: alcohol; menthol; peppermint oil; sodium benzoate; spearmint

oil; sucrose; water.

CLINICAL PHARMACOLOGY

Atarax is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines.

Atarax 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 anti- histaminic 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 Atarax's clinical effects are usually noted within 15 to 30 minutes after oral administration.

INDICATIONS

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.

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.

WARNINGS

Nurs ing Mothers

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.

For Tablets Only

This product is manufactured with 1,1,1-trichloroethane, a substance which harms public health and the

environment by destroying ozone in the upper atmosphere.

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 Atarax. Patients should

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

alcohol may be increased.

Geriatric Us e

A determination has not been made whether controlled clinical studies of ATARAX 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 ATARAX 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 over sedation in the elderly; elderly patients generally should

be started on low doses of ATARAX and observed closely.

ADVERSE REACTIONS

Side effects reported with the administration of Atarax (hydroxyzine hydrochloride) are usually mild

and transitory in nature.