COMPOSITION: Each ampoule contains hydroxyzine hydrochloride 100 mg/2 mL with benzyl alcohol 0,9% v/v.
PHARMACOLOGICAL CLASSIFICATION: A 2.6.3 Tranquillisers: Diphenylmethane and its derivatives.
PHARMACOLOGICAL ACTION: Hydroxyzine is a long-acting antihistamine or receptor H1 -antagonist classified as a piperazine derivative.
Hydroxyzine has sedative, anticholinergic and antiemetic effects. The duration of action is 6 to 24 hours with an elimination half-life of 20 hours.
INDICATIONS: To be used intramuscularly as a pre-and post-operative sedative, for control of nausea and vomiting as well as for symptomatic treatment of vertigo, nausea and vomiting of Ménière's disease and related disorders.
CONTRA-INDICATIONS: It should not be given to premature infants or neonates. Antihistamine's should not be used to control blood transfusion reactions caused by ABO incompatibility. Patients with a known hypersensitivity to hydroxyzine or any other piperazine derivative. Patients with porphyria. Safety in pregnancy and lactation has not been established.
WARNINGS: Due to hydroxyzine's central - depressant activity it may lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol, barbiturates, hypnotics, opoid analgesics, anxiolytic sedatives and neuroleptics. Affected patients should not drive or operate machinery. Mono amine oxidase inhibitors may enhance the antimuscarinic effects of antihistamines, and antihistamines have an additive antimuscarinic action with agents such as atropine and tricyclic antidepressants.
DOSAGE AND DIRECTIONS FOR USE: Only for deep intramuscular injection.
25 mg to 100 mg
1,1 mg per kg body weight.
H1 -receptor antagonists are eliminated more rapidly by children than by adults.
Do not administer intravenously as haemolysis may result.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: The most common side-effect is sedation, varying from slight drowsiness to deep sleep, and including lassitude, dizziness, and inco-ordination. Paradoxical central nervous system (CNS) stimulation may occur in children.
Hydroxyzine may also produce antimuscarinic effects including dry mouth; thickened respiratory-tract secretions and tightness of the chest; blurred vision; urinary difficulty and retention; a reduction in and motility of the gastro-intestinal tract resulting in constipation and increased gastric reflux; in high doses, transient bradycardia followed by tachycardia with palpitations and arrhythmias; also in high doses, central nervous system stimulation. In addition to constipation, gastro-intestinal disturbances such as nausea, vomiting, diarrhoea, or epigastric pain has occurred.
Blood disorders, including agranulocytosis, leucopenia, haemolytic anameia, and thrombocytopenia, have been reported. Other adverse effects include hypotension, tinnitus, headache, and paraesthesias.
A decreased dosage frequency is necessary in patients with primary biliary cirrhosis.
Use with care in conditions such as closed-angle glaucoma, urinary retention, prostatic hypertrophy, or pyloroduodenal obstruction. It should be given with caution to patients with epilepsy and severe cardiovascular disorders.
Warning signs of damage caused by ototoxic agents could be masked and hydroxyzine may interfere with skin allergy test results.
KNOWN SYMPTOMS OF OVERDOSAGE AND ITS TREATMENT: Overdosage may be fatal especially in infants and children in whom the main symptoms are central nervous system and antimuscarinic effects, including ataxia, excitement, hallucinations, tremors, psychoses, convulsions and hyperpyrexia. Deepening coma and cardiorespiratory collapse may follow.
In adults, central nervous system depression is more common with drowsiness, coma and convulsions, progressing to respiratory failure or possibly cardiovascular collapse. Convulsions may be controlled with diazepam. Other treatment is supportive and symptomatic and may include artificial respiration, external cooling for hyperpyrexia, and intravenous fluids.
IDENTIFICATION: Clear, colourless solution in clear, colourless glass ampoules.
PRESENTATION: 2 mL Clear, colourless glass ampoules in packs of 10.
STORAGE INSTRUCTIONS: Store below 25°C.
Keep out of reach of children.
Protect from light.
REGISTRATION NUMBER: 31/2.6.3/0070
NAME AND BUSINESS ADDRESS OF THE APPLICANT: Quatromed Limited
10 Lindley Street
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 7 November 1996 Pro-Print PHY0131/1-97