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Indications and Dosage
Oral
Allergic conditions Adult: As anhydrous substance: 30 mg bid.
Child: As anhydrous substance: Initially, 0.5 mg/kg bid. Optimal dose: 0.5-1 mg/kg bid. |
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Hepatic Impairment
Initiate at 50% of the normal dose.
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Administration
Should be taken with food.
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Contraindications
Premature infants or full-term neonates. Pregnancy and lactation.
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Special Precautions
May impair ability to drive and operate machinery. Angle-closure glaucoma, urinary retention, prostatic hyperplasia or pyloroduodenal obstruction; hepatic impairment. Elderly. Not for acute asthma. Children <6 yr.
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Adverse Reactions
Sedation, inability to concentrate, lassitude, dizziness, hypotension, muscular weakness, incoordination. Nausea, vomiting, diarrhoea or constipation, epigastric pain. Headache, blurred vision, tinnitus, elation or depression, irritability, nightmares, anorexia, urinary retention, dry mouth, chest tightness, dysuria and tingling. Rash, urticaria. Agranulocytosis, haemolytic anaemia. Increased appetite, wt gain. Convulsions, increased transaminase, hepatitis. Dyskinetic neurological reactions (infants and young children).
Potentially Fatal: Anaphylactoid reactions, angioedema. |
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Overdosage
Symptoms: Somnolence, stupor, dyskinesia, torticollis, oculogyria, dystonia, hypertonia, hyperexcitability, agitation, mydriasis, tachycardia, bradycardia, generalised muscle spasms. Excitement, hallucinations, muscle tremors, ataxia, convulsions, dry mouth, flushed face, mydriasis, hyperpyrexia in infants and children. Coma and cardiorespiratory collapse (terminal events). Management: Symptomatic and supportive. Extrapyramidal symptoms have been successfully treated with anticholinergic agents; no specific antidote.
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Drug Interactions
May enhance effects of CNS depressants e.g. alcohol, barbiturates, hypnotics, opioid analgesics, anxiolytic sedatives and tranquillizers. Anticholinergic effects of atropine, TCAs, MAOIs may be enhanced. May mask signs of ototoxicity caused by aminoglycosides.
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Lab Interference
May interfere with skin testing.
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Action
Description: Oxatomide is a piperazine derivative sedating antihistamine. It also has mast-cell stabilising properties.
Pharmacokinetics: Absorption: Almost completely absorbed from the GI tract. Peak plasma levels within 2 hr. Distribution: Protein-binding: 98%. Metabolism: Hepatic via aromatic hydroxylation, oxidative N-dealkylation and conjugation. Excretion: Mainly via faeces (60%) from the bile; via urine. Half-life: 14 hr. |
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Storage
Store below 25°C. Protect from light.
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MIMS Class
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