HYDROXYZINE HYDROCHLORIDE- hydroxyzine tablet, film coated

Egyesült Államok - angol - NLM (National Library of Medicine)

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Termékjellemzők Termékjellemzők (SPC)

24-11-2020

Aktív összetevők:
HYDROXYZINE HYDROCHLORIDE (UNII: 76755771U3) (HYDROXYZINE - UNII:30S50YM8OG)
Beszerezhető a:
Amneal Pharmaceuticals LLC
Az alkalmazás módja:
ORAL
Recept típusa:
PRESCRIPTION DRUG
Terápiás javallatok:
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 i
Termék összefoglaló:
Hydroxyzine Hydrochloride Tablets, USP are white, round, film-coated, biconvex tablets containing 10 mg, 25 mg, or 50 mg of Hydroxyzine Hydrochloride, and supplied as: 10 mg Tablets: Debossed ‘75’ on one side and ‘A’ on the other NDC 65162-575-10                Bottles of 100 NDC 65162-575-50                Bottles of 500 NDC 65162-575-11                Bottles of 1000 25 mg Tablets: Debossed ‘71’ on one side and ‘AN’ on the other NDC 65162-671-10                Bottles of 100 NDC 65162-671-50                Bottles of 500 NDC 65162-671-11                Bottles of 1000 50 mg Tablets: Debossed ‘77’ on one side and ‘AN’ on the other NDC 65162-577-10                Bottles of 100 NDC 65162-577-50                Bottles of 500 NDC 65162-577-11                Bottles of 1000 STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents with a child-resistant closure (if required) and in a tight container as defined in the USP. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev: 10-2016-00
Engedélyezési státusz:
Abbreviated New Drug Application
Engedély száma:
65162-575-10, 65162-575-11, 65162-575-50, 65162-577-10, 65162-577-11, 65162-577-50, 65162-671-10, 65162-671-11, 65162-671-50

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HYDROXYZINE HYDROCHLORIDE- hydroxyzine tablet, film coated

Amneal Pharmaceuticals LLC

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HYDROXYZINE HYDROCHLORIDE TABLETS, USPRx only

DESCRIPTION

Hydroxyzine hydrochloride, USP has the chemical name of 2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-

piperazinyl]ethoxy] ethanol dihydrochloride.

C H ClN 0 2HCI M.W. 447.83

Hydroxyzine hydrochloride, USP 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, USP. Inactive

ingredients include anhydrous lactose, carnauba wax, colloidal silicon dioxide, crospovidone,

hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol,

sodium starch glycolate, titanium dioxide and triacetin.

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

21

27

2

2

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 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.

CONTRAINDICATIONS

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 is contraindicated in patients with a prolonged QT interval.

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

Nursing 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.

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.

QT Prolongation/Torsade de Pointes (TdP): Cases of QT prolongation and Torsade de

Pointes have been reported during post-marketing use of hydroxyzine. The majority of reports occurred

in patients with other risk factors for QT prolongation/TdP (pre-existing heart disease, electrolyte

imbalances or concomitant arrhythmogenic drug use). Therefore, hydroxyzine should be used with

caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history

of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia,

as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias.

Caution is recommended during the concomitant use of drugs known to prolong the QT interval. These

include Class 1A (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmics,

certain antipsychotics (e.g., ziprasidone,

iloperidone, clozapine, quetiapine, chlorpromazine), certain antidepressants (e.g., citalopram,

fluoxetine), certain antibiotics (e.g., azithromycin, erythromycin, clarithromycin, gatifloxacin,

moxifloxacin); and others (e.g., pentamidine, methadone,

ondansetron, droperidol).

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.

Geriatric Use:

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 over sedation in the elderly; elderly patients generally should

be started on low doses of hydroxyzine and observed closely.

Acute Generalized Exanthematous Pustulosis (AGEP)

Hydroxyzine may rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin

reaction characterized by fever and numerous small, superficial, nonfollicular, sterile pustules, arising

within large areas of edematous erythema. Inform patients about the signs of AGEP, and discontinue

hydroxyzine at the first appearance of a skin rash, worsening of pre-existing skin reactions which

hydroxyzine may be used to treat, or any other sign of hypersensitivity. If signs or symptoms suggest

AGEP, use of hydroxyzine should not be resumed and alternative therapy should be considered. Avoid

cetirizine or levocetirizine in patients who have experienced AGEP or other hypersensitivity reactions

with hydroxyzine, due to the risk of cross-sensitivity.

ADVERSE REACTIONS

Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and

transitory in nature.

Anticholinergic: Dry mouth.

Central Nervous System: 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 has been reported, usually with doses considerably higher than those

recommended. Clinically significant respiratory depression has not been reported at recommended

doses.

Cardiac System: QT prolongation, Torsade de Pointes.

In postmarketing experience, the following additional undesirable effects have been reported:

Body as a Whole: Allergic reaction.

Nervous System: Headache.

Psychiatric: Hallucination.

Skin and Appendages: Oral hydroxyzine hydrochloride is associated with Acute Generalized

Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports.

Pruritus, rash, urticaria.

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Amneal Pharmaceuticals at

1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

Hydroxyzine overdose may cause QT prolongation and Torsade de Pointes. ECG

monitoring is recommended in cases of hydroxyzine overdose.

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.

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 to 100 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.

HOW SUPPLIED

Hydroxyzine Hydrochloride Tablets, USP are white, round, film-coated, biconvex tablets containing 10

mg, 25 mg, or 50 mg of Hydroxyzine Hydrochloride, and supplied as:

10 mg Tablets: Debossed ‘75’ on one side and ‘A’ on the other

NDC 65162-575-10 Bottles of 100

NDC 65162-575-50 Bottles of 500

NDC 65162-575-11 Bottles of 1000

25 mg Tablets: Debossed ‘71’ on one side and ‘AN’ on the other

NDC 65162-671-10 Bottles of 100

NDC 65162-671-50 Bottles of 500

NDC 65162-671-11 Bottles of 1000

50 mg Tablets: Debossed ‘77’ on one side and ‘AN’ on the other

NDC 65162-577-10 Bottles of 100

NDC 65162-577-50 Bottles of 500

NDC 65162-577-11 Bottles of 1000

STORAGE

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents with a

child-resistant closure (if required) and in a tight container as defined in the USP.

Distributed by:

Amneal Pharmaceuticals

Bridgewater, NJ 08807

Rev: 10-2016-00

PRINCIPAL DISPLAY PANEL

HYDROXYZINE HYDROCHLORIDE

hydroxyzine tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 516 2-575

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO XYZINE HYDRO CHLO RIDE (UNII: 76 755771U3) (HYDROXYZINE -

UNII:30 S50 YM8 OG)

HYDROXYZINE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

SO DIUM STARCH GLYCO LATE TYPE A (UNII: H8 AV0 SQX4D)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

WHITE (white)

S core

no sco re

S hap e

ROUND

S iz e

20 mm

Flavor

Imprint Code

75;A

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 516 2-575-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

2

NDC:6 516 2-575-11

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

3

NDC:6 516 2-575-50

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 8 0 8

0 9 /24/20 0 8

HYDROXYZINE HYDROCHLORIDE

hydroxyzine tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 516 2-6 71

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO XYZINE HYDRO CHLO RIDE (UNII: 76 755771U3) (HYDROXYZINE -

UNII:30 S50 YM8 OG)

HYDROXYZINE

HYDROCHLORIDE

25 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

SO DIUM STARCH GLYCO LATE TYPE A (UNII: H8 AV0 SQX4D)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

20 mm

Flavor

Imprint Code

71;AN

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 516 2-6 71-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

2

NDC:6 516 2-6 71-11

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

3

NDC:6 516 2-6 71-50

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 8 0 8

0 9 /24/20 0 8

HYDROXYZINE HYDROCHLORIDE

hydroxyzine tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 516 2-577

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HYDRO XYZINE HYDRO CHLO RIDE (UNII: 76 755771U3) (HYDROXYZINE -

UNII:30 S50 YM8 OG)

HYDROXYZINE

HYDROCHLORIDE

50 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

Amneal Pharmaceuticals LLC

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

CRO SPO VIDO NE (UNII: 2S78 30 E56 1)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYDEXTRO SE (UNII: VH2XOU12IE)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

SO DIUM STARCH GLYCO LATE TYPE A (UNII: H8 AV0 SQX4D)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

TRIACETIN (UNII: XHX3C3X6 73)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

20 mm

Flavor

Imprint Code

77;AN

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 516 2-577-10

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

2

NDC:6 516 2-577-11

10 0 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

3

NDC:6 516 2-577-50

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /24/20 0 8

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 8 0 8

0 9 /24/20 0 8

Labeler -

Amneal Pharmaceuticals LLC (123797875)

Revised: 11/2020

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