MYGDALON/METOCLOPRAMIDE

Posology Adult patients The recommended single dose is 10 mg, repeated up to three times daily. 5mg/kg body weight. The maximum recommended treatment duration is 5 days. 15 mg/kg body weight, repeated up to three times daily by oral route.

5mg/kg body weight. 5 mg Up to 3 times daily 9-18 years 30-60 kg 5 mg Up to 3 times daily 15-18 years Over 60kg 10 mg Up to 3 times daily The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).

Tablets are not suitable for use in children weighing less than 61 kg. Other pharmaceutical forms/strengths may be more appropriate for administration to this population. Special population Elderly In elderly patients a dose reduction should be considered, based on renal and hepatic function and overall frailty.

Renal impairment In patients with end stage renal disease (Creatinine clearance ≤ 15 ml/min), the daily dose should be reduced by 75%. 2). 2). Other pharmaceutical forms/strengths may be more appropriate for administration to these populations.

3). Diagnostic indications A single dose of Metoclopramide may be given 5-10 minutes before the examination, subject to body weight consideration, (see above). Method of administration Oral. 4).

). These reactions occur usually at the beginning of the treatment and can occur after a single administration. Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms. These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti-Parkinsonian medicinal products in adults).

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.

8). Treatment must be discontinued if clinical signs of tardive dyskinesia appear. Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.

3). Symptoms of Parkinson's disease may also be exacerbated by metoclopramide. Methaemoglobinemia Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).

8). Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.

g. hypotension, akathisia). 2). Metoclopramide may cause elevation of serum prolactin levels. Patients with rare hereditary problems of lactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Care should be exercised when using Metoclopramide in patients with a history of atopy (including asthma) or porphyria. Metoclopramide should not be used in the immediate post-operative period (up to 3-4 days) following pyloroplasty or gut anastomosis, as vigorous gastrointestinal contractions may adversely affect healing.

3). Combination to be avoided Alcohol potentiates the sedative effect of metoclopramide. Combination to be taken into account Due to the prokinetic effect of metoclopramide, the absorption of certain drugs may be modified. Anticholinergics and morphine derivatives Anticholinergics and morphine derivatives may have both a mutual antagonism with metoclopramide on the digestive tract motility.

Central nervous system depressants (morphine derivatives, anxiolytics, sedative H1 antihistamines, sedative antidepressants, barbiturates, clonidine and related) Sedative effects of Central Nervous System depressants and metoclopramide are potentiated.

Neuroleptics Metoclopramide may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders. Serotonergic drugs The use of Metoclopramide with serotonergic drugs such as SSRIs may increase the risk of serotonin syndrome.

Digoxin Metoclopramide may decrease digoxin bioavailability. Careful monitoring of digoxin plasma concentration is required. Cyclosporine Metoclopramide increases cyclosporine bioavailability (Cmax by 46% and exposure by 22%). Careful monitoring of cyclosporine plasma concentration is required.

The clinical consequence is uncertain. Mivacurium and suxamethonium Metoclopramide injection may prolong the duration of neuromuscular block (through inhibition of plasma cholinesterase). Strong CYP2D6 inhibitors Metoclopramide exposure levels are increased when co-administered with strong CYP2D6 inhibitors such as fluoxetine and paroxetine.

Although the clinical significance is uncertain, patients should be monitored for adverse reactions. Metoclopramide may reduce the plasma concentration of atovaquone. 6 Fertility, pregnancy and lactation Pregnancy A large amount of data on pregnant women (more than 1000 exposed outcomes) indicates no malformative toxicity nor foetotoxicity.

Metoclopramide can be used during pregnancy if clinically needed. Due to pharmacological properties (as other neuroleptics), in case of metoclopramide administration at the end of pregnancy, extrapyramidal syndrome in newborn cannot be excluded.

Metoclopramide should be avoided at the end of pregnancy. If metoclopramide is used, neonatal monitoring should be undertaken. Breastfeeding Metoclopramide is excreted in breast milk at low level. Adverse reactions in the breast-fed baby cannot be excluded.

Therefore metoclopramide is not recommended during breastfeeding. Discontinuation of metoclopramide in breastfeeding women should be considered. 7 […]

g. cerebral irritation. 8 Undesirable effects). These reactions occur usually at the beginning of the treatment and can occur after a single administration. Metoclopramide should be discontinued immediately in the event of extrapyramidal symptoms.

These effects are generally completely reversible after treatment discontinuation, but may require a symptomatic treatment (benzodiazepines in children and/or anticholinergic anti-Parkinsonian medicinal products in adults). 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. 8). Treatment must be discontinued if clinical signs of tardive dyskinesia appear. Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.

3). Symptoms of Parkinson's disease may also be exacerbated by metoclopramide. Methaemoglobinemia Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, metoclopramide should be immediately and permanently discontinued and appropriate measures initiated (such as treatment with methylene blue).

8). Special care should be taken when administering metoclopramide, particularly via the intravenous route to the elderly population, to patients with cardiac conduction disturbances (including QT prolongation), patients with uncorrected electrolyte imbalance, bradycardia and those taking other drugs known to prolong QT interval.

g. hypotension, akathisia). 2). Metoclopramide may cause elevation of serum prolactin levels. Patients with rare hereditary problems of lactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Care should be exercised when using Metoclopramide in patients with a history of atopy (including asthma) or porphyria. Metoclopramide should not be used in the immediate post-operative period (up to 3-4 days) following pyloroplasty or gut anastomosis, as vigorous gastrointestinal contractions may adversely affect healing.

5) - Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency. 4) Metoclopramide is contraindicated in neonates. Metoclopramide should not be used during the first three to four days following operations such as pyloroplasty or gut anastomosis as vigorous muscular contractions may not help healing.