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Hydroxyzine Syrup

Hydroxyzine Syrup

Pronunciation Generic Name: hydroxyzine hydrochloride

Dosage Form: syrup

For ProfessionalsSide EffectsInteractionsMore…

HYDROXYZINE HYDROCHLORIDE SYRUP, USP

10 mg/5 mL

Rx only

Hydroxyzine Syrup Description

Hydroxyzine hydrochloride is designated chemically as (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride. Its structural formula is as follows:

Inactive Ingredients for Hydroxyzine Hydrochloride Syrup are: alcohol 0.5%; liquid sugar; methylparaben; peppermint oil; propylene glycol; propylparaben; purified water and spearmint oil. It may also contain citric acid anhydrous or sodium citrate dihydrate for pH adjustment. The pH range is between 2.0 and 4.3.

Hydroxyzine Syrup – 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.

Indications and Usage for Hydroxyzine Syrup

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 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

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.

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.

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 oversedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine and observed closely.

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 the 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.

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 Syrup 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: 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.

How is Hydroxyzine Syrup Supplied

Hydroxyzine Hydrochloride Syrup, USP 10 mg per 5 mL (teaspoonful) is a colorless, peppermint-flavored syrup, supplied in 4 fl oz (118 mL) and Pint (473 mL) bottles.

RECOMMENDED STORAGE

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

PROTECT FROM FREEZING

PROTECT FROM LIGHT

Dispense in a tight, light-resistant container as defined in the USP, with child-resistant closure.

Rx Only

Product No.: 8150

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8150-16

REV. 01-10

PRINCIPAL DISPLAY PANEL – 473 mL Bottle Label

MGP

NDC 60432-150-16

HydrOXYzine

HYDROCHLORIDE

SYRUP, USP

10 mg/5 mL

Alcohol 0.5%

DO NOT USE IF INNER FOIL SEAL PRINTED “SEALED

FOR YOUR PROTECTION” IS BROKEN OR MISSING.

BULK CONTAINER —

NOT FOR HOUSEHOLD USE

Rx Only

NET: 1 Pint (473 mL)

HYDROXYZINE HYDROCHLORIDE 

hydroxyzine hydrochloride syrup

Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60432-150
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydroxyzine Hydrochloride (Hydroxyzine) Hydroxyzine Hydrochloride 10 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
water  
alcohol  
peppermint oil  
spearmint oil  
propylene glycol  
methylparaben  
propylparaben  
Anhydrous Citric Acid  
Trisodium Citrate Dihydrate  
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:60432-150-04 118 mL in 1 BOTTLE, PLASTIC
2 NDC:60432-150-16 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087294 03/09/1995
Labeler - Morton Grove Pharmaceuticals, Inc. (801897505)

Revised: 11/2010   Morton Grove Pharmaceuticals, Inc.

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Hydroxyzine syrup

Hydroxyzine syrup

Pronunciation Generic Name: hydroxyzine (hye-DROX-i-zeen)

Brand Name: Atarax

OverviewSide EffectsInteractionsFor ProfessionalsMore…

Hydroxyzine syrup is used for:

Treating anxiety, causing sedation before and after general anesthesia, and treating itching due to certain allergic conditions, including hives and contact dermatitis (eg, poison ivy). It also may be used for other conditions as determined by your doctor.

Hydroxyzine syrup is an antihistamine. It works by affecting the brain to reduce anxiety. It also has other activities, including opening breathing tubes, relieving pain or allergy symptoms, and preventing or treating nausea and vomiting caused by motion sickness.

Do NOT use hydroxyzine syrup if:

  • you are allergic to any ingredient in hydroxyzine syrup
  • you are taking sodium oxybate (GHB)
  • you are in your first 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

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Before using hydroxyzine syrup:

Some medical conditions may interact with hydroxyzine syrup. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have asthma, glaucoma, difficulty urinating, a urinary or intestinal blockage, a prostate disease, or a blood disease
  • if you drink alcoholic beverages

Some MEDICINES MAY INTERACT with hydroxyzine syrup. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Sodium oxybate (GHB) because side effects, such as an increase in sleep duration and slowed breathing, may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if hydroxyzine syrup may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use hydroxyzine syrup:

Use hydroxyzine syrup as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take hydroxyzine syrup by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
  • If you miss a dose of hydroxyzine syrup and you are using it regularly, take it as soon as possible. If it is almost time for you next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use hydroxyzine syrup.

Important safety information:

  • Hydroxyzine syrup may cause drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use hydroxyzine syrup with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Avoid drinking alcohol or using medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using hydroxyzine syrup; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • The effectiveness of hydroxyzine syrup as anxiety treatment for longer than 4 months is not known.
  • Use hydroxyzine syrup with caution in the ELDERLY; they may be more sensitive to its effects.
  • Hydroxyzine syrup should not be used in NEWBORNS; safety and effectiveness in newborns have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use hydroxyzine syrup if you are in your first 3 months of pregnancy. If you think you may be pregnant, contact your doctor right away. It is not known if hydroxyzine syrup is found in breast milk. Do not breast-feed while taking hydroxyzine syrup.

Possible side effects of hydroxyzine syrup:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Drowsiness; dry mouth.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); involuntary movements.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include unusual drowsiness and dizziness.

Proper storage of hydroxyzine syrup: Store hydroxyzine syrup at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep hydroxyzine syrup out of the reach of children and away from pets.

General information:

  • If you have any questions about hydroxyzine syrup, please talk with your doctor, pharmacist, or other health care provider.
  • Hydroxyzine syrup is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take hydroxyzine syrup or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about hydroxyzine syrup. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to hydroxyzine syrup. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using hydroxyzine syrup.

Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

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