'Maxolon' speeds up the passage of a barium meal by increasing the rate of gastric emptying, co-ordinating peristalsis and dilating the duodenal bulb. Careful monitoring of cyclosporine plasma concentration is required. This information is intended for use by health professionalsEach tablet contains Metoclopramide Hydrochloride BP 10mg equivalent to 10mg of the anhydrous substance.White to ivory-white circular double convex tablet with a single break bar on one side.- Prevention of delayed chemotherapy induced nausea and vomiting (CINV)- Prevention of radiotherapy induced nausea and vomiting (RINV).- Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting. Also, it was very affordable. Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in new born cannot be excluded.Metoclopramide should be avoided at the end of pregnancy.
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Maxolon should be used with care with other drugs affecting cardiac conduction.Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism (see section 4.3).Alcohol potentiates the sedative effect of metoclopramide.Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified.Anticholinergics and morphine derivatives may have both a mutual antagonism with metoclopramide on the digestive tract motility.Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.Metoclopramide may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders.The use of metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.Metoclopramide may decrease digoxin bioavailability. If metoclopramide is used, neonatal monitoring should be undertaken.Metoclopramide is excreted in breast milk at low level. 'Maxolon' may reduce plasma concentrations of atovaquone.A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity. The rules for apostrophes vary with the type of word. Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs (see section 4.3)Symptoms of Parkinson's disease may also be exacerbated by metoclopramide.Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. Treatment must be discontinued if clinical signs of tardive dyskinesia appear.Neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8). Frequencies are defined using the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to<1/100), rare (≥1/10000 to<1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).Methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency, particularly in neonates (see section 4.4); Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulphur-releasing medicinal productsBradycardia, particularly with intravenous formulationCardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4);Atrioventricular block, Sinus arrest particularly with intravenous formulation;Electrocardiogram QT prolonged; Torsade de Pointes;General disorders and administration site conditionsAnaphylactic reaction (including anaphylactic shock particularly with intravenous formulationExtrapyramidal disorders (particularly in children and young adults and/or when the recommended dose is exceeded, even following administration of a single dose of the drug) (see section 4.4), Parkinsonism, AkathisiaDystonia including oculogyric crisis, Dyskinesia, Depressed level of consciousnessTardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4), Neuroleptic malignant syndrome (see section 4.4)Hypotension, particularly with intravenous formulationShock, syncope after injectable use, Acute hypertension in patients with phaeochromocytoma (see section 4.3) Transient increase in blood pressure* Endocrine disorders during prolonged treatment in relation with hyperprolactinaemia (amenorrhoea, galactorrhoea, gynaecomastia).The following reactions, sometimes associated, occur more frequently when high doses are used:- Extrapyramidal symptoms: acute dystonia and dyskinesia, parkinsonian syndrome, akathisia, even following administration of a single dose of the medicinal product, particularly in children and young adults (see section 4.4).- Drowsiness, decreased level of consciousness, confusion and hallucination.Reporting suspected adverse reactions after authorisation of the medicinal product is important. Given that this work is arguably his most commercially successful and The time interval of at least 6 hours specified in the section 4.2 should be respected between each metoclopramide administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly.
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