1. Name Of The Medicinal Product
Maxolon® Injection
2. Qualitative And Quantitative Composition
Each 2ml ampoule contains Metoclopramide Hydrochloride BP equivalent to 10mg of the anhydrous substance.
3. Pharmaceutical Form
Clear colourless solution for intramuscular or intravenous administration.
4. Clinical Particulars
4.1 Therapeutic Indications
Adults (20 years and over)
Digestive disorders:
'Maxolon' restores normal co-ordination and tone to the upper digestive tract.
'Maxolon' relieves the symptoms of gastro-duodenal dysfunction including:
Dyspepsia, | Heartburn, |
Flatulence, | Sickness, |
Regurgitation of bile, | Pain |
These symptoms may be associated with such conditions as:
Peptic ulcer, | Duodenitis, |
Reflux oesophagitis, | Hiatus hernia, |
Gastritis, | Cholelithiasis and
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Nausea and vomiting:
'Maxolon' is indicated for the treatment of the nausea and vomiting associated with:
Gastro-intestinal disorders,
Cyclical vomiting,
Intolerance to cytotoxic drugs,
Congestive heart failure,
Deep x-ray or cobalt therapy,
Post-anaesthetic vomiting
Migraine:
'Maxolon' relieves symptoms of nausea and vomiting, and overcomes gastric stasis associated with attacks of migraine. This improvement in gastric emptying assists the absorption of concurrently administered oral anti-migraine therapy (e.g. paracetamol) which may otherwise be impaired in such patients.
Post-operative conditions:
Post-operative gastric hypotonia
Post-vagotomy syndrome
'Maxolon' promotes normal gastric emptying and restores motility in vagotomised patients, and where post-operative symptoms suggest gastro-duodenal dysfunction.
Diagnostic procedures:
Radiology,
Duodenal intubation
'Maxolon' speeds up the passage of a barium meal by decreasing gastric emptying time, co-ordinating peristalsis and dilating the duodenal bulb.
'Maxolon' also facilitates duodenal intubation procedures.
Young adults and children
The use of 'Maxolon' in patients under 20 years should be restricted to the following:
Severe intractable vomiting of known cause, vomiting associated with radiotherapy and intolerance to cytotoxic drugs, as an aid to gastro-intestinal intubation, and as part of the premedication before surgical procedures
4.2 Posology And Method Of Administration
Route of administration:
'Maxolon' injection may be administered either intramuscularly or by slow intravenous injection (1-2 minutes).
The dosage recommendations given below should be strictly adhered to if side effects of the dystonic type are to be avoided. It should be noted that total daily dosage of 'Maxolon', especially for children and young adults, should not normally exceed 0.5mg/kg body weight.
In patients with clinically significant degrees of renal or hepatic impairment, therapy should be at reduced dosage. Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney.
Medical indications:
Adults 20 years and over:
10mg three times daily.
For patients of less than 60kg see below.
Elderly patients:
As for adults. To avoid adverse reactions adhere strictly to dosage recommendations and where prolonged therapy is considered necessary, patients should be regularly reviewed.
Young adults and children:
'Maxolon' should only be used after careful examination to avoid masking an underlying disorder, e.g. cerebral irritation. In the treatment of this group attention should be given primarily to body weight and treatment should commence at the lower dosage where stated.
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Diagnostic indications:
A single dose of 'Maxolon' may be given 5-10 minutes before the examination.
Subject to body weight consideration, (see above), the following dosages are recommended.
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4.3 Contraindications
'Maxolon' should not be used in patients with phaeochromocytoma as it may induce an acute hypertensive response.
'Maxolon' 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.
'Maxolon' should not be administered to patients with gastrointestinal obstruction, perforation or haemorrhage.
'Maxolon' is contra-indicated in patients who have previously shown hypersensitivity to metoclopramide or any of its components.
4.4 Special Warnings And Precautions For Use
Precautions:
If vomiting persists the patient should be reassessed to exclude the possibility of an underlying disorder e.g. cerebral irritation.
Care should be exercised in epileptic patients and patients being treated with other centrally acting drugs.
Since extrapyramidal symptoms may occur with both metoclopramide and neuroleptics such as the phenothiazines, particular care should be exercised in the event of these drugs being prescribed concurrently.
The neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see section 4.8 Undesirable effects).
Maxolon should be used with care in combination with other serotonergic drugs including SSRIs.
Special care should be taken in cases of severe renal and hepatic insufficiency (see also section 4.2 Posology and method of administration).
Care should be exercised when using Maxolon in patients with a history of atopy (including asthma) or porphyria.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
The action of 'Maxolon' on the gastro-intestinal tract is antagonised by anticholinergics and opioid analgesics. The absorption of any concurrently administered oral medication may be modified by the effect of 'Maxolon' on gastric motility. Drugs known to be affected in this way include aspirin and paracetamol.
Since extrapyramidal reactions may occur with 'Maxolon', Phenothiazines and Tetrabenazine, care should be exercised in the event of co-administration of these drugs.
'Maxolon' should be used with care in association with other drugs acting at central dopamine receptors, such as levodopa, bromocriptine and pergolide.
The use of Maxolon with serotonergic drugs may increase the risk of serotonin syndrome.
'Maxolon' may reduce plasma concentrations of atovaquone.
4.6 Pregnancy And Lactation
Animal tests in several mammalian species and clinical experience have not indicated a teratogenic effect. Nevertheless 'Maxolon' should only be used when there are compelling reasons and is not advised during the first trimester.
During lactation metoclopramide is found in breast milk,therefore it should not be used during lactation.
4.7 Effects On Ability To Drive And Use Machines
[1]'Maxolon' may cause drowsiness, dyskinesia and dystonias which could affect the vision and also interfere with the ability to drive and operate machinery.
[1] PL 20072/0051-0007; 27/07/2009
4.8 Undesirable Effects
Various extrapyramidal reactions to 'Maxolon', usually of the dystonic type, have been reported.
The incidence of dystonic reactions, particularly in children and young adults, is increased if daily dosages higher than 0.5mg per kg body weight are administered. Dystonic reactions include: spasm of the facial muscles, trismus, rhythmic protrusion of the tongue, a bulbar type of speech, spasm of extra-ocular muscles including oculogyric crises, unnatural positioning of the head and shoulders and opisthotonos. There may be a generalised increase in muscle tone. The majority of reactions occur within 36 hours of starting treatment and the effects usually disappear within 24 hours of withdrawal of the drug. Should treatment of a dystonic reaction be required an anticholinergic anti-Parkinsonian drug, or a benzodiazepine may be used.
Very rare occurrences of the neuroleptic malignant syndrome have been reported. This syndrome is potentially fatal and comprises hyperpyrexia, altered consciousness, muscle rigidity, autonomic instability and elevated levels of creatine phosphokinase (CPK) and must be treated urgently (recognised treatments include dantrolene and bromocriptine). Metoclopramide should be stopped immediately if this syndrome occurs.
There have been very rare reports of abnormalities of cardiac conduction (such as bradycardia and heart block) in association with intravenous metoclopramide.
Tardive dyskinesia has been reported during prolonged treatment in a small number of mainly elderly patients. Patients on prolonged treatment should be regularly reviewed.
Very rarely hypersensitivity, including anaphylaxis, has been reported.
Rarely, drowsiness, restlessness, confusion, anxiety and diarrhoea have been reported in patients receiving metoclopramide therapy. Depression has been reported extremely rarely.
Raised serum prolactin levels have been observed during metoclopramide therapy: this may result in galactorrhoea, irregular periods and gynaecomastia.
Extremely rarely cases of red cell disorders such as methaemoglobinaemia and sulphaemoglobinaemia have been reported, particularly at high doses of metoclopramide. If this occurs the drug should be withdrawn. Methaemoglobinaemia may be treated using methylene blue.
A small number of skin reactions such as rashes, urticaria, pruritus and oedema have also been reported.
4.9 Overdose
In cases of overdosage, acute dystonic reactions have occurred. Very rarely AV block has been observed. Should treatment of a dystonic reaction be required, an anticholinergic anti-Parkinsonian drug or a benzodiazepine may be used.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
The action of metoclopramide is closely associated with parasympathetic nervous control of the upper gastro-intestinal tract, where it has the effect of encouraging normal peristaltic action. This provides for a fundamental approach to the control of those conditions where disturbed gastro-intestinal motility is a common underlying factor.
5.2 Pharmacokinetic Properties
Metoclopramide is metabolised in the liver and the predominant route of elimination of metoclopramide and its metabolites is via the kidney.
5.3 Preclinical Safety Data
No additional data available.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride
Sodium metabisulphite
Water for injection
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
Sixty months.
6.4 Special Precautions For Storage
Do not store above 25°C. If ampoules are removed from their carton, they should be stored away from light. If inadvertent exposure occurs, ampoules showing discolouration must be discarded.
6.5 Nature And Contents Of Container
Clear glass 2ml ampoules (Ph. Eur. Type I neutral glass) in packs of 1 or 12 ampoules or 1 ampoule plus 12 tablets in an aluminium canister as a home visit pack.
6.6 Special Precautions For Disposal And Other Handling
Protect from light.
7. Marketing Authorisation Holder
Amdipharm PLC
Regency House
Miles Gray Road
Basildon
Essex
SS14 3AF
United Kingdom
8. Marketing Authorisation Number(S)
PL 20072/0051
9. Date Of First Authorisation/Renewal Of The Authorisation
16 June 1995
10. Date Of Revision Of The Text
July 2009
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