Ziltem/Ziltem IM Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Hydroxyzine HCl

Indications/Uses

Anxiolytic. Adjunct to pre & post-op medication & in the management of pruritus & urticaria. Adjunct to opioid analgesia in the management of cancer pain.

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Dosage/Direction for Use

Ziltem Adult Short-term management of anxiety 50-100 mg qid. Pruritus Initially 25 mg at night, increased if necessary to 25 tid-qid. Pre/post-op sedation 50-100 mg. Childn >6 yr Pruritus Initially 15-25 mg daily, increased if necessary to 50 mg daily in divided doses. Max: 2 mg/kg, 1-6 yr 1 mg/kg in divided doses. Max: 2.5 mg/kg. Pre/post-op sedation 600 mcg/kg. Ziltem IM Pre & postpartum adjunctive therapy 25-100 mg. Adult Psychiatric & emotional emergencies including acute alcoholism 50-100 mg immediately & every 4-6 hr as needed. Nausea & vomiting excluding nausea & vomiting of pregnancy 25-200 mg. Pre & post-op adjunctive medication 25-200 mg. Childn Pre- or post-op sedative dose 600 mcg/kg. Nausea & vomiting 0.5 mg/lb. Pre & post-op adjunctive medication 0.5 mg/lb.

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Administration

May be taken with or without food.

Adverse Reactions

CNS depression, w/ effects varying from slight drowsiness to deep sleep, & including lassitude, dizziness, incoordination. Headache, psychomotor impairment & antimuscarinic effects eg, dry mouth, thickened resp-tract secretions, blurred vision, urinary difficulty/retention, constipation & increased gastric reflux.

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Drug Interactions

May enhance sedative effects of CNS depressants including alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytics, sedatives & antipsychotics. Additive antimuscarinic action w/ other antimuscarinic drugs eg, atropine & some antidepressants (both tricyclics & MAOIs). May mask warning signs of damage caused by ototoxic drugs eg, aminoglycosides. May suppress cutaneous histamine response to allergen extracts & should be stopped several days before skin testing.

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Storage

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Description

View Ziltem/Ziltem IM description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Anxiolytics

ATC Classification

N05BB01 - hydroxyzine ; Belongs to the class of diphenylmethane derivatives anxiolytics. Used in the management of anxiety, agitation or tension.

Regulatory Classification

Presentation/Packing

Form

Ziltem IM soln for inj 50 mg/mL

Packing/Price

1 mL x 10 × 1's

Form

Ziltem tab 25 mg

Packing/Price

100's

Ziltem/Ziltem IM

hydroxyzine

Manufacturer:

Alvita Pharma

Distributor:

Emcure Pharma

Marketer:

MedEthix