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Components:
Metoclopramide
Method of action:
Antiemetic, Anti-Icicle, Drugs For Functional Gastrointestinal Disorders, Stimulating Tone And Motility Of The Gastrointestinal Tract
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Medically reviewed by Oliinyk Elizabeth Ivanovna, Pharmacy. Last updated on 2019.12.15

Name of the medicinal product

Klopra SR

Qualitative and quantitative composition

Metoclopramide

Therapeutic indications

The information provided in Therapeutic indications of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Therapeutic indications in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

Adult population

Metoclopramide is indicated in adults for:

- 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. Metoclopramide can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.

Paediatric population

Metoclopramide is indicated in children (aged 1-18 years) for:

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

Adult population

Klopra SR is indicated in adults for:

- 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. Klopra SR can be used in combination with oral analgesics to improve the absorption of analgesics in acute migraine.

Paediatric population

Klopra SR 10mg tablets are indicated in children (aged 15-18 years) for:

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

Dosage (Posology) and method of administration

The information provided in Dosage (Posology) and method of administration of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Dosage (Posology) and method of administration in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

Posology

Adult population

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 maximum recommended treatment duration is 5 days.

Prevention of delayed chemotherapy induced nausea and vomiting (CINV) (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 oral route. The maximum dose in 24 hours is 0.5 mg/kg body weight.

Dosing table

Age

Body Weight

Dose

Frequency

1-3 years

10-14 kg

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 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 30 kg.

Other pharmaceutical forms/strengths may be more appropriate for administration to this population.

Method of administration:

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

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%.

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.

All indications (adult patients)

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 maximum recommended treatment duration is 5 days.

Paediatric patients aged 15-18 years

Prevention of delayed chemotherapy induced nausea and vomiting (CINV)

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

Dosing table

Age

Body Weight

Dose

Frequency

15-18 years

Over 60kg

10mg

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 61kg.

Other pharmaceutical forms/strengths may be more appropriate for administration to this population.

Method of administration:

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

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%.

Hepatic impairment:

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

Paediatric population

Klopra SR is contraindicated in children aged less than 1 year.

Contraindications

The information provided in Contraindications of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Contraindications in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

- Hypersensitivity to the active substance or any of the excipients listed in 6.1.

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

- A history of neuroleptic or metoclopramide-induced tardive dyskinesia.

- Epilepsy (increased crises frequency and intensity)

- Parkinson's disease

- Confirmed or suspected phaeochromocytoma due to the risk of severe hypertension episode.

- 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

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

- Confirmed or suspected pheochromocytoma, due to the risk of severe hypertension episodes

- History of neuroleptic or Klopra SR-induced tardive dyskinesia

- Epilepsy (increased crises frequency and intensity)

- Parkinson's disease

- Combination with levodopa or dopaminergic agonists

- Known history of methaemoglobinaemia with Klopra SR 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

The information provided in Special warnings and precautions for use of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Special warnings and precautions for use in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

Special warnings

Neurological Disorders

Extrapyramidal disorders may occur, particular 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.

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).

Cardiac Disorders

There have been reports of serious cardiovascular undesirable effects including cases of circulatory collapse, severe bradycardia, cardiac arrest and QT prolongation following dministration 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.

Klopra SRe tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicine.

Neurological Disorders

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

Prolonged treatment with Klopra SR 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 Klopra SR in combination with neuroleptics as well as with Klopra SR monotherapy. Klopra SR 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 Klopra SR.

Methaemoglobinemia

Methemoglobinemia which could be related to NADH cytochrome b5 reductase deficiency has been reported. In such cases, Klopra SR 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 Klopra SR by injection, particularly via the intravenous route.

Special care should be taken when administering Klopra SR, 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.

Contains lactose:

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Effects on ability to drive and use machines

The information provided in Effects on ability to drive and use machines of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Effects on ability to drive and use machines in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

Metoclopramide may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

Klopra SR may cause drowsiness, dizziness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.

Undesirable effects

The information provided in Undesirable effects of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Undesirable effects in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

Systeme Organ Class

Frequency

Adverse reactions

Blood and lymphatic system disorders

Not known

Methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency, particularly in neonates

Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulphur-releasing medicinal products

Cardiac disorders

Uncommon

Bradycardia, particularly with intravenous Formulation

Not known

Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia ;

Atrioventricular block, Sinus arrest particularly with intravenous formulation;

Electrocardiogram QT prolonged; Torsade de Pointes;

Endocrine disorders*

Uncommon

Amenorrhoea, Hyperprolactinaemia,

Rare

Galactorrhoea

Not known

Gynaecomastia

Gastrointestinal disorders

Common

Diarrhoea

General disorders and administration site conditions

Common

Asthenia

Immune system disorders

Uncommon

Hypersensitivity

Not known

Anaphylactic reaction (including anaphylactic shock particularly with intravenous formulation

Nervous system disorders

Nervous system disorders

Very Common

Somnolence

Common

Extrapyramidal 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) , Parkinsonism, Akathisia

Uncommon

Dystonia, Dyskinesia, Depressed level of Consciousness

Rare

Convulsion especially in epileptic patients

Not known

Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients , Neuroleptic malignant syndrome

Psychiatric disorders

Common

Depression

Uncommon

Hallucination

Rare

Confusional state

Vascular disorder

Common

Hypotension, particularly with intravenous Formulation

Not known

Shock, syncope after injectable use Acute hypertension in patients with phaeochromocytoma , 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.

- Drowsiness, decreased level of consciousness, confusion, hallucination.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Adverse reactions listed by System Organ Class. Frequencies are defined using the following convention: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare (>1/10000, <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data).

System Organ Class

Frequency

Adverse reactions

Blood and lymphatic system disorders

Not known

Methaemoglobinaemia, which could be related to NADH cytochrome b5 reductase deficiency, particularly in neonates Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulfur-releasing medicinal products

Cardiac disorders

Uncommon

Bradycardia, particularly with intravenous formulation

Not known

Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia ; Atrioventricular block, Sinus arrest particularly with intravenous formulation; Electrocardiogram QT prolonged; Torsade de Pointes;

Endocrine disorders*

Uncommon

Amenorrhoea, Hyperprolactinaemia,

Rare

Galactorrhoea

Not known

Gynaecomastia

Gastrointestinal disorders

Common

Diarrhoea

General disorders and administration site conditions

Common

Asthenia

Immune system disorders

Uncommon

Hypersensitivity

Not known

Anaphylactic reaction (including anaphylactic shock particularly with intravenous formulation

Nervous system disorders

Very common

Somnolence

Common

Extrapyramidal 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) , Parkinsonism, Akathisia

Uncommon

Dystonia, Dyskinesia, Depressed level of consciousness

Rare

Convulsion especially in epileptic patients

Not known

Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients , Neuroleptic malignant syndrome

Psychiatric disorders

Common

Depression

Uncommon

Hallucination

Rare

Confusional state

Vascular disorder

Common

Hypotension, particularly with intravenous formulation

Not known

Shock, syncope after injectable use Acute hypertension in patients with phaeochromocytoma

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.

- Drowsiness, decreased level of consciousness, confusion, hallucination.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme; website: www.mhra.gov.uk/yellowcard

Overdose

The information provided in Overdose of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Overdose in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

Symptoms

Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.

Management

In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults).

A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.

Symptoms

Extrapyramidal disorders, drowsiness, decreased level of consciousness, confusion, hallucination, and cardio-respiratory arrest may occur.

Management

In case of extrapyramidal symptoms related or not to overdose, the treatment is only symptomatic (benzodiazepines in children and/or anticholinergic anti-parkinsonian medicinal products in adults). A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.

Pharmacodynamic properties

The information provided in Pharmacodynamic properties of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Pharmacodynamic properties in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

Metoclopramide is a substituted benzamide. It is used among other things because of its anti-emetic properties. The anti-emetic effect is the result of two mechanisms of action involving the central nervous system:

- antagonism of the dopaminergic D2 receptors in the chemoreceptor trigger zone and in the vomiting centre of the medulla which is affected in apomorphine-induced vomiting;

- antagonism of the serotoninergic 5HT3 receptors and agonist effect on the 5HT4 receptors which are affected in chemotherapy-induced vomiting.

In addition to the central action, metoclopramide has a stimulant effect on gastrointestinal motility via a peripheral mechanism of action. There is an antidopaminergic effect and potentiation of the effect of acetylcholine. This causes accelerated emptying of the stomach and there is an increase in the pressure exerted by the lower oesophageal sphincter. Metoclopramide has no effect on gastric secretions.

Klopra SR hydrochloride is an anti-emetic and an accelerator of gastric emptying.

Pharmacokinetic properties

The information provided in Pharmacokinetic properties of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Pharmacokinetic properties in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

Following oral administration the relative bioavailability compared with intravenous administration is 60 to 100%. Peak plasma concentrations are reached within 0.5 to 2 hours.

The distribution volume is 2-3 l/kg; 13-22% is bound to plasma proteins. Metoclopramide is excreted primarily in the urine, both in unchanged form and in sulfate or glucuronide conjugate form. The principal metabolite is an N-4 sulphur conjugate.

The plasma elimination half-life is 5 to 6 hours, irrespective of the route of administration.

Special patient populations

Renal impairment

The clearance of metoclopramide is reduced by up to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15 hours for a creatinine clearance <10 mL/minute).

Hepatic impairment

In patients with cirrhosis of the liver, accumulation of metoclopramide has been observed, associated with a 50% reduction in plasma clearance.

Renal impairment

The clearance of Klopra SR is reduced by up to 70% in patients with severe renal impairment, while the plasma elimination half-life is increased (approximately 10 hours for a creatinine clearance of 10-50 mL/minute and 15 hours for a creatinine clearance <10 mL/minute).

Hepatic impairment

In patients with cirrhosis of the liver, accumulation of Klopra SR has been observed, associated with a 50% reduction in plasma clearance.

Pharmacotherapeutic group

The information provided in Pharmacotherapeutic group of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Pharmacotherapeutic group in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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preparations to combat nausea/vomiting.

Preclinical safety data

The information provided in Preclinical safety data of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Preclinical safety data in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

No abnormalities have been found in animal studies to indicate a safety risk in humans. This is based on data from pharmacological studies relating to safety, and data on toxicity following repeated administration, genotoxicity, carcinogenicity and reproductive toxicity.

Not applicable.

Incompatibilities

The information provided in Incompatibilities of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Incompatibilities in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

No particulars.

None known.

Special precautions for disposal and other handling

The information provided in Special precautions for disposal and other handling of Klopra SR is based on data of another medicine with exactly the same composition as the Klopra SR of the medicine (Metoclopramide). Be careful and be sure to specify the information on the section Special precautions for disposal and other handling in the instructions to the drug Klopra SR directly from the package or from the pharmacist at the pharmacy.
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Substance; Substance-powder
Pills; Solution for intravenous and intramuscular injection

No special requirements.

Not applicable.

Administrative data
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