Zylam Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Midazolam HCl

Indications/Uses

Adult & childn: Conscious sedation before & during diagnostic or therapeutic procedures w/ or w/o local anaesth; premed before induction of anaesth; sedation in ICU. Induction of anaesth; as sedative component in combined anaesth in adult.

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Dosage/Direction for Use

Conscious sedation Adult <60 yr IV Initial dose: 2-2.5 mg; titration dose: 1 mg; total dose: 3.5-7.5 mg. Adult ≥60 yr/debilitated chronically ill Initial dose: 0.5-1 mg; titration dose: 0.5-1 mg; total dose: <3.5 mg. Childn 6-12 yr IV Initial dose: 0.025-0.05 mg/kg; total dose: <10 mg; 6 mth-5 yr Initial dose: 0.05-01 mg/kg; total dose: <6 mg; IM 1-15 yr 0.05-0.15 mg/kg. Anesth premed Adult <60 yr IM 0.07-0.1 mg/kg. Adult ≥60 yr/debilitated chronically ill 0.025-0.05 mg/kg. Childn 1-15 yr IM 0.08-0.2 mg/kg. Rectal: >6 mth 0.3-0.5 mg/kg. Anesth induction Adult <60 yr IV 0.15-0.2 mg/kg (0.3-0.35 w/o premed). Adult ≥60 yr/debilitated chronically ill IV 0.1-0.2 mg/kg (0.15-0.3 w/o premed). Sedative component in combined anaesth Adult <60 yr IV Intermittent doses of 0.03-0.1 mg/kg or continuous infusion of 0.03-0.1 mg/kg/hr. Adult ≥60 yr/debilitated chronically ill IV Lower doses than recommended for adult <60 yr. Sedation in ICU Adult <60 yr & ≥60 yr/debilitated chronically ill IV Loading dose: 0.03-0.3 mg/kg in increments of 1-2.5 mg. Maintenance dose: 0.03-0.2 mg/kg/hr. Childn >6 mth Loading dose: 0.05-0.2 mg/kg. Maintenance dose: 0.06-0.12 mg/kg/hr; neonates <32 wk 0.03 mg/kg/hr; >32 wk & childn up to 6 mth 0.06 mg/kg/hr.

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Overdosage

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Contraindications

Hypersensitivity to benzodiazepines.

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Special Precautions

May depress the myocardial contractility & cause apnea; severe cardiorespiratory adverse events. Adult <60 yr, chronically ill or debilitated patients, patients w/ chronic resp insufficiency, chronic renal failure, impaired hepatic function or impaired cardiac function ped patients especially those w/ CV instability. Patients w/ history of alcohol or drug abuse. Myasthenia gravis. Loss of efficacy in long-term sedation ICU. Risk of dependence & w/drawal symptoms. Anterograde amnesia. Paradoxical reactions eg, agitation, involuntary movements (including tonic/clonic convulsions & muscle tremor), hyperactivity, hostility, rage reaction, aggressiveness, paroxysmal excitement & assault. Altered elimination in patients w/ liver dysfunction, low cardiac output & in neonates. Pregnancy & lactation. Premature infants & neonates.

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Use In Pregnancy & Lactation

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Adverse Reactions

Skin rash, urticaria, pruritus; somnolence & prolonged sedation, alertness decreased, confusional state, euphoric mood, hallucinations, fatigue, headache, dizziness, ataxia, post-op sedation & anterograde amnesia, paradoxical reactions eg, agitation, involuntary movements (including tonic/clonic seizures & muscle tremor), hyperactivity, hostility, rage reaction, aggressiveness, paroxysmal excitement & assault in childn & elderly; seizures; may enhance physical dependence, w/drawal symptoms; nausea, vomiting, constipation, hiccup & dry mouth; severe cardiorespiratory adverse events; resp depression, apnea, resp arrest or cardiac arrest, hypotension, heart rate disorder, vasodilator effects, dyspnea & glottis spasm; skin reactions, CV reactions, bronchospasm, anaphylactic shock; erythema & pain on inj site, thrombophlebitis & thrombosis.

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Drug Interactions

Itraconazole, fluconazole & ketoconazole; verapamil & diltiazem; erythromycin & clarithromycin; reduced elimination w/ saquinavir; ritonavir, indinavir, nelfinavir & amprenavir; may increase effects w/ CNS depressants, additional sedation w/ other sedatives, increase of resp depression w/ opiates, phenobarb or benzodiazepines, alcohol; decrease minimum alveolar conc of inhalations anesth.

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Storage

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Description

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Action

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MIMS Class

Hypnotics & Sedatives

ATC Classification

N05CD08 - midazolam ; Belongs to the class of benzodiazepine derivatives. Used as hypnotics and sedatives.

Regulatory Classification

Presentation/Packing

Form

Zylam soln for inj 1 mg/mL

Packing/Price

5 mL x 10 × 1's

Zylam

midazolam

Manufacturer:

Laboratorios Normon

Distributor:

Cathay Drug