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The following reactions occur more frequently when high doses are used. Nervous system and psychiatric disorders Extrapyramidal symptoms: acute dystonia and dyskinesia, Parkinsonian syndrome, akathisia may occur even following administration of a single dose of the drug particularly in young adults and the elderly. Extrapyramidal reactions include spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of extraocular muscles including oculogyric crises, unnatural positioning of the head and shoulders and opisthotonos. There may be a generalised increase in muscle tone. The majority of reactions occur within 36 hours of starting treatment and the effects usually disappear within 24 hours of withdrawal of the drug. Should treatment of a dystonic reaction be required, a benzodazepine or an anticholinergic anti-Parkinsonian drug may be used. Drowsiness, decreased level of consciousness, confusion, hallucination. Other reactions may occur: Tardive dyskinesia, particularly in elderly patients and during or after prolonged treatment; Depression; Restlessness, anxiety; Seizures; Neuroleptic malignant syndrome. Metoclopramide may cause lethargy, insomnia, dizziness. Endocrine disorders Hyperprolactinaemia with amenorrhea, galactorrhea, gynaecomastia. Blood and Lymphatic system disorders Metoclopramide may cause methaemoglobinaemia which could be related to NADH cytochrome b5 reductase deficiency. Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulfur-releasing drugs. Aspirin may increase bleeding time, decrease platelet adhesiveness, and in large doses cause hypothrombinaemia. It may cause other blood disorders, including thrombocytopenia, iron deficiency or haemolytic anaemia and rarely agranulocytosis. Cardiac and Vascular disorders Bradycardia and heart block have been reported with metoclopramide, particularly the intravenous formulation. Gastrointestinal disorders The most common side effects occurring with therapeutic doses of salicylates are gastrointestinal disturbances such as gastric irritation with blood loss, nausea, dyspepsia, vomiting and gastric ulceration. The gastrointestinal haemorrhaging is occasionally severe but in most cases blood loss is not significant. Diarrhoea, flatulence may also occur. General disorders and administration site conditions Very rarely hypersensitivity, including anaphylaxis has been reported. Salicylates may induce hypersensitivity especially in those individuals with asthma or rhinitis, and a history of atopy or nasal polyps. The observed hypersensitivity reactions include anaphylaxis, urticara and bronchospasm. Asthenia may also occur. Ear and labyrinth disorders Tinnitus Renal and urinary disorders Other reported effects of salicylates include urate kidney stones. |
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