Metoclopramide Injection

Metoclopramide Injection

Product Name:Metoclopramide injection

Nombre del Producto: Metoclopramida solución Inyectable

Specification: 10mg/2ml

Package: 10amps/box, 50amps/box, 100amps/box

Standard: USP & BP& CP

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Details

Metoclopramide injection

Therapeutic indications

Paediatric population:

Metoclopramide 10 mg/2ml Injection is indicated in children (1 – 18 years) for:

• Prevention of delayed chemotherapy induced nausea and vomiting (CINV) as a second line option

• Treatment of established post-operative nausea and vomiting (PONV) as a second line option

For other indications, the use in the paediatric population is not recommended.

Adult population:

Metoclopramide 10mg/2ml Injection is indicated in adults for:

• Prevention of post-operative nausea and vomiting (PONV)

• Symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting

• Prevention of radiotherapy induced nausea and vomiting (RINV)

 

Posology and method of administration

The solution can be administered intravenously or intramuscularly.

Intravenous doses should be administered as a slow bolus (at least over 3 minutes).

All indications (paediatric patients aged 1-18 years)

The recommended dose is 0.1 to 0.15 mg/kg body weight, repeated up to three times daily by intravenous route. The maximum dose in 24 hours is 0.5 mg/kg body weight.

A minimal interval of 6 hours between two administrations is to be respected, even in case of vomiting or rejection of the dose.

Dosing table

Age Body Weight Dose Frequency

1-3 years 10-14kg 1 mg Up to 3 times daily

3-5 years 15-19 kg 2 mg Up to 3 times daily

5-9 years 20-29 kg 2.5 mg Up to 3 times daily

9-18 years 30-60 kg 5 mg Up to 3 times daily

15-18 years Over 60 kg 10 mg Up to 3 times daily

The maximum treatment duration is 48 hours for treatment of established post-operative nausea and vomiting (PONV).

The maximum treatment duration is 5 days for prevention of delayed chemotherapy induced nausea and vomiting (CINV).

All indications (adult patients)

For prevention of PONV a single dose of 10mg is recommended.For the symptomatic treatment of nausea and vomiting, including acute migraine induced nausea and vomiting and for the prevention of radiotherapy induced nausea and vomiting (RINV): the recommended single dose is 10 mg, repeated up to three times daily

The maximum recommended daily dose is 30 mg or 0.5mg/kg body weight.

The injectable treatment duration should be as short as possible and transfer to oral or rectal treatment should be made as soon as possible.

The maximum recommended treatment duration is 5 days.

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%.

In patients with moderate to severe renal impairment (Creatinine clearance 15-60 ml/min), the dose should be reduced by 50% (see section 5.2).

Hepatic impairment

In patients with severe hepatic impairment, the dose should be reduced by 50%.

Paediatric population

Metoclopramide is contraindicated in children aged less than 1 year .

 

Contraindications

• Gastrointestinal haemorrhage, mechanical obstruction or gastro-intestinal perforation for which the stimulation of gastrointestinal motility constitutes a risk

• Confirmed or suspected phaeochromocytoma, due to the risk of severe hypertension episodes

• History of neuroleptic or metoclopramide-induced tardive dyskinesia

• Epilepsy (increased crises frequency and intensity)

• Parkinson's disease

• Combination with levodopa or dopaminergic agonists

• Known history of methaemoglobinaemia with metoclopramide or of NADH cytochrome-b5 deficiency.

• Use in children less than 1 year of age due to an increased risk of extrapyramidal disorders

 

Special warnings and precautions for use

Neurological Disorders

Extrapyramidal disorders may occur, particularly in children and young adults, and/or when high doses are used. 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).

Prolonged treatment with metoclopramide may cause tardive dyskinesia, potentially irreversible, especially in the elderly. Treatment should not exceed 3 months because of the risk of tardive dyskinesia. 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. Metoclopramide should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome and appropriate treatment should be initiated.

Special care should be exercised in patients with underlying neurological conditions and in patients being treated with other centrally-acting drugs

Symptoms of Parkinson's disease may also be exacerbated by metoclopramide.

Methaemoglobinaemia

Methaemoglobinaemia 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).

Cardiac Disorders

There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT prolongation following administration of metoclopramide by injection, particularly via the intravenous route .

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.

Intravenous doses should be administered as a slow bolus (at least over 3 minutes) in order to reduce the risk of adverse effects (e.g. hypotension, akathisia).

Renal and Hepatic Impairment

In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended.

 

Interaction with other medicinal products and other forms of interaction

Contraindicated combination

Levodopa or dopaminergic agonists and metoclopramide have a mutual antagonism.

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 both have 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.


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