Clopamon 10 Mg/2 Ml Injection

CLOPAMON INJECTION 10 mg/2 ml is indicated for:

• Digestive disorders:CLOPAMON INJECTION 10 mg/2 ml is of value in any condition associated with gastric status or hypomotility. It is, therefore, useful in the management of post-vagotomy syndrome.
• Nausea and vomiting: CLOPAMON INJECTION 10 mg/2 ml is an effective anti- emetic medicine in the control of nausea and vomiting associated with the following conditions: intolerance to essential medicines possessing emetic properties , uraemic conditions, malignant disease, gastrointestinal disorders and post-anaesthetic vomiting.
• Diagnostic radiology: CLOPAMON INJECTION 10 mg/2 ml is effective in patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine.
• Duodenal intubation: The action of CLOPAMON INJECTION 10 mg/2 ml in promoting stomach emptying, combined with its anti-emetic effect, has proved a very useful aid to gastrointestinal intubation procedures.
• Young adults and children: The use of CLOPAMON INJECTION 10 mg/2 ml in patients under 20 years should be restricted to the following: Severe intractable vomiting of known cause. As an aid to gastrointestinal intubation and diagnostic radiology.

Posology CLOPAMON INJECTION 10 mg/2 ml ampoules should not be diluted for injection since this will upset the isotonicity and stability of the medicine.

Adults: 10 mg (1 ampoule) 1 to 3 times daily IV or IM depending on the severity of the condition.

Dosage for diagnostic radiology

Intravenous: 10 to 20 mg (1 to 2 ampoules) 5 to 15 minutes before the barium meal.

Intramuscular: 10 to 20 mg (1 to 2 ampoules) 10 to 15 minutes before the barium meal.

Special populations

Renal Impairment and hepatic impairment Care should also be taken when CLOPAMON INJECTION 10 mg/2 ml is administered to patients with renal impairment or to those at risk of fluid retention as in hepatic impairment. Therapy should be at a reduced dosage.

Paediatric population Children over 14 years: 10 mg (1 ampoule) 1 to 3 times daily IV or IM depending on the severity of the condition. Children 5 to 14 years: 2,5 mg (0,5 ml of a 10 mg/2 ml ampoule) I.V. or I.M. twice daily in a tuberculin syringe. Children 3 to 5 years: 1 mg (0,2 ml of a 10 mg/2 ml ampoule) I.V. or I.M. twice daily in a tuberculin syringe. Children 1 to 3 years: 0,5 mg (0,1 ml of a 10 mg/2 ml ampoule) I.V. or I.M. in a tuberculin syringe twice daily.

Method of administration For intravenous or intramuscular administration.

CLOPAMON INJECTION 10 mg/2 ml is contraindicated in :

• Patients with hypersensitivity to metoclopramide or to any excipients in CLOPAMON INJECTION 10 mg/2 ml (see section 6.1).
• Patients being treated with phenothiazines.
• Patients where stimulation of muscular contractions might adversely affect gastrointestinal conditions, such as in gastrointestinal haemorrhage, obstruction or perforation or immediately after surgery.
• Patients with phaechromocytoma as hypertensive crises have been reported. CLOPAMON INJECTION 10 mg/2 ml should not be given to patients with suspected or confirmed phaeochromocytoma.
• Patients with convulsive disorders (epileptic patients, due to risk of increased frequency and severity of seizures.
• Porphyria.
• CLOPAMON INJECTION 10 mg/2ml is not recommended in pregnancy.

• There should be at least a 6 hour time interval between each CLOPAMON INJECTION 10 mg/2 ml administration, even in case of vomiting and rejection of the dose, in order to avoid overdose.
• If vomiting persists the patient should be re-assessed to exclude the possibility of an underlying disorder, e.g. cerebral irritation.
• Neurological disorders The elderly should be treated with care as they are at increased risk of extrapyramidal reactions usually at the beginning of the treatment and can occur after a single administration. CLOPAMON INJECTION 10 mg/2 ml 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 (anticholinergic anti-Parkinsonian medicines in adults).
• Care should be exercised in patients being treated with other centrally active medicines e.g. in epilepsy (see section 4.3).
• Prolonged treatment with CLOPAMON INJECTION 10 mg/2 ml may cause tardive dyskinesia, potentially irreversible, especially in the elderly. Treatment should not exceed 3 months because of the risk of tardive dyskinesia (see section 4.8). Patients on prolonged therapy and long-term treatment should be reviewed regularly. Treatment must be discontinued if clinical signs of tardive dyskinesia appear.
• Neuroleptic malignant syndrome (NMS) has been reported with CLOPAMON INJECTION 10 mg/2 ml in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8). CLOPAMON INJECTION 10 mg/2 ml should be discontinued immediately in the event of symptoms of neuroleptic malignant syndrome (NMS) and appropriate treatment should be initiated.
• Hypertension CLOPAMON INJECTION 10 mg/2 ml should be used with caution in patients with hypertension, since there is limited evidence that the CLOPAMON INJECTION 10 mg/2 ml may increase circulating catecholamines in such patients.
• Parkinson's disease Symptoms of Parkinson's disease may also be exacerbated by CLOPAMON INJECTION 10 mg/2 ml.
• Methaemoglobinaemia Methaemoglobinaemia which could be related to NADH cytochrome b 5 reductase deficiency has been reported. In such cases, CLOPAMON INJECTION 10 mg/2 ml 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 CLOPAMON INJECTION 10 mg/2 ml by injection, particularly via the intravenous route (see section 4.8). Special care should be taken when administering CLOPAMON INJECTION 10 mg/2 ml, 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 medicines 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).
• Special care should be taken when administering CLOPAMON INJECTION 10 mg/2 ml intravenously to patients with u201csick sinus syndromeu201d or other cardiac conduction disturbances.
• Renal and hepatic impairment In patients with renal impairment or with severe hepatic impairment, a dose reduction is recommended.
• Reproductive system CLOPAMON INJECTION 10 mg/2 ml may cause elevation of serum prolactin levels.
• Atopy and porphyria Care should be exercised when using CLOPAMON INJECTION 10 mg/2 ml in patients with a history of atopy (including asthma) or porphyria (see section 4.3).
• Post-surgery Following operations such as pyloroplasty or gut anastomosis CLOPAMON INJECTION 10 mg/2 ml should be withheld for three or four days as vigorous muscular contractions may not help healing.
• Sodium CLOPAMON INJECTION 10 mg/2 ml contains less than 1 mmol sodium (23 mg) per 2 ml, essentially u2018sodium-freeu2019.
• Paediatric population Children and young patients should be treated with care as they are at increased risk of extrapyramidal reactions usually at the beginning of the treatment and can occur after a single administration. CLOPAMON INJECTION 10 mg/2 ml 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).

• Levodopa or dopaminergic agonists and CLOPAMON INJECTION 10 mg/2 ml have a mutual antagonism.
• Alcohol potentiates the sedative effect of CLOPAMON INJECTION 10 mg/2 ml.
• Due to the prokinetic effect of CLOPAMON INJECTION 10 mg/2 ml, the absorption of other medicine may be modified.
• Anticholinergics and morphine derivatives Anticholinergics and morphine derivatives may both have a mutual antagonism with CLOPAMON INJECTION 10 mg/2 ml on the digestive tract motility.
• Central nervous system depressants (morphine derivatives, anxiolytics, sedative H 1 antihistamines, sedative antidepressants, barbiturates, clonidine and related). Sedative effects of central nervous system (CNS)depressants and CLOPAMON INJECTION 10 mg/2 ml are potentiated.
• Neuroleptics CLOPAMON INJECTION 10 mg/2 ml may have an additive effect with other neuroleptics on the occurrence of extrapyramidal disorders. Caution should be observed when using CLOPAMON INJECTION 10 mg/2 ml in patients taking other medicine that can also cause extrapyramidal reactions, such as the phenothiazines (see section 4.3).
• Serotonergic medicines The use of CLOPAMON INJECTION 10 mg/2 ml with serotonergic medicines such as SSRIs may increase the risk of serotonin syndrome.
• Digoxin CLOPAMON INJECTION 10 mg/2 ml may decrease digoxin bioavailability. Careful monitoring of digoxin plasma concentration is required.
• Cyclosporine CLOPAMON INJECTION 10 mg/2 ml increases cyclosporine bioavailability (C max by 46 % and exposure by 22 %). Careful monitoring of cyclosporine plasma concentration is required. The clinical consequence is uncertain.
• Mivacurium and suxamethonium CLOPAMON INJECTION 10 mg/2 ml may prolong suxamethonium-induced neuromuscular blockade (through inhibition of plasma cholinesterase).
• Strong CYP2D6 inhibitors CLOPAMON INJECTION 10 mg/2 ml 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.
• The effects of certain medicines with potential central stimulant effects, e.g. monoamine oxidase inhibitors and sympathomimetics, may be modified when prescribed with CLOPAMON INJECTION 10 mg/2 ml and their dosage may need to be adjusted accordingly.
• Aspirin, paracetamol The effect of CLOPAMON INJECTION 10 mg/2 ml on gastric motility may modify the absorption of other concurrently administered oral medicines from the gastrointestinal tract either by diminishing absorption from the stomach or by enhancing the absorption from the small intestine (e.g. the effects of paracetamol and aspirin are enhanced).
• Atovaquone CLOPAMON INJECTION 10 mg/2 ml may reduce plasma concentrations of atovaquone.
• Lithium Increased toxicity may occur in patients receiving lithium.
• Hyperprolactinaemic medicines CLOPAMON INJECTION 10 mg/2 ml may also increase prolactin blood-concentrations and therefore interfere with medicines which have a hypoprolactinaemic effect e.g. bromocriptine.

Safety in pregnancy has not been established (see section 4.3)

Pregnancy Animal tests in several mammalian species have shown no teratogenic effects but CLOPAMON INJECTION 10 mg/2 ml is not recommended during pregnancy.

Breastfeeding CLOPAMON INJECTION 10 mg/2 ml is excreted in breast milk at low levels. Adverse reactions in the breastfed baby cannot be excluded. Discontinuation of metoclopramide, as in CLOPAMON INJECTION 10 mg/2 ml in breastfeeding women should be considered.

Fertility There are no fertility data.

CLOPAMON INJECTION 10 mg/2 ml has a minor influence on the ability to drive and use machines. Since adverse reactions such as dizziness, drowsiness have been reported in patients receiving CLOPAMON INJECTION 10 mg/2 ml, patients should not drive, use machinery or perform any tasks that require concentration, until they are certain that CLOPAMON INJECTION 10 mg/2 ml does not adversely affect their ability to do so (see sections 4.4 and 4.8).

a) Summary of the safety profile CLOPAMON INJECTION 10 mg/2 ml is a dopamine antagonist and may cause extrapyramidal symptoms which usually occur as acute dystonic reactions, especially in young female patients. Parkinsonism and tardive dyskinesia have occasionally occurred, usually during prolonged treatment in elderly patients.

b) Tabulated list of adverse reactions

System organ class Frequent Less frequent Frequency unknown (cannot be estimated from the available data) Blood and the lymphatic system disorders Methaemoglobinaemia, sulfhaemoglobinaemia Immune system disorders Hypersensitivity Anaphylactic reaction (including anaphylactic shock) Endocrine disorders Amenorrhoea, hyperprolactinaemia, galactorrhoea Transient increases in plasma aldosterone concentrations, gynaecomastia Psychiatric disorders Depression, Hallucination, confusional state Nervous system disorders Drowsiness, dizziness, headache, restlessness, Dystonia (including visual disturbances and oculogyric crisis), dyskinesia, depressed level of consciousness, convulsion Tardive dyskinesia, neuroleptic malignant syndrome Cardiac disorders Bradycardia Cardiac arrest, atrioventricular block, sinus arrest, electrocardiogram qt prolonged, Torsade de Pointes Vascular disorders Hypotension, Acute hypertension, shock, transient increase in blood pressure Gastrointestinal disorders Diarrhoea, constipation Renal and urinary disorders Urinary incontinence Reproductive system and breast disorders Stimulate serum prolactin levels, breast engorgement, galactorrhoea, lactorrhea Skin and subcutaneous tissue disorders Rash, pruritus, angioedema, urticaria General disorders and administrative site conditions Asthenia Inflammation at injection site, local phlebitis

c) Description of selected adverse reactions 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 medicine, particularly in children and young adults (see section 4.4). - Drowsiness, decreased level of consciousness, confusion, hallucination.

Blood and lymphatic system disorders: Methaemoglobinaemia, which could be related to NADH cytochrome b 5 reductase deficiency, particularly in neonates (see section 4.4). Sulfhaemoglobinaemia, mainly with concomitant administration of high doses of sulphur-releasing medicines. Nervous system disorders: Parkinsonism has been reported during prolonged and long-term treatment should be regularly reviewed. Less frequent occurrences of the neuroleptic malignant syndrome (NMS) have been reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of Creatinine phosphokinase and must be treated urgently (recognised treatments include dantrolene and bromocriptine). CLOPAMON INJECTION 10 mg/2 ml should be stopped immediately if this syndrome occurs. 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 medicine) (see section 4.4). Convulsions especially in epileptic patients. Tardive dyskinesia which may be persistent, during or after prolonged treatment, particularly in elderly patients (see section 4.4). Cardiac disorders Bradycardia, particularly with intravenous formulation. Cardiac arrest, occurring shortly after injectable use, and which can be subsequent to bradycardia (see section 4.4). Sinus arrest particularly with intravenous formulation. Vascular disorders Hypotension, particularly with intravenous formulation. Shock, syncope after injectable use. Acute hypertension in patients with phaeochromocytoma (see section 4.3). Reproductive system and breast disorders CLOPAMON INJECTION 10 mg/2 ml stimulates serum prolactin levels, and may cause breast engorgement, galactorrhoea, lactorrhea or related disorders. The conditions return to normal after withdrawal of the medicines. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to:

Symptoms Overdosage of CLOPAMON INJECTION 10 mg/2 ml could give rise to dyskinetic reactions manifested as motor restlessness, agitation, irritability, spasm of facial and neck muscles and the muscles of the tongue. In severe cases opisthotonos can result. Extrapyramidal disorders, drowsiness, a decreased level of consciousness, confusion, hallucination and cardio-respiratory arrest may occur.

Treatment Anticholinergic anti-Parkinson medications, e.g. procyclidine, will usually control these symptomatic reactions in adults and benzodiazepines in children. A symptomatic treatment and a continuous monitoring of the cardiovascular and respiratory functions should be carried out according to clinical status.