1. Name Of The Medicinal Product
Maxolon® SR
2. Qualitative And Quantitative Composition
Each capsule contains Metoclopramide Hydrochloride BP equivalent to 15 mg of the anhydrous substance.
3. Pharmaceutical Form
Colourless, transparent capsules, overprinted 'Maxolon SR 15', containing white sustained release microgranules.
Maxolon SR does not contain tartrazine or any other azo dyes.
4. Clinical Particulars
4.1 Therapeutic Indications
Digestive disorders:
Maxolon SR restores normal co-ordination and tone to the upper digestive tract. Maxolon SR relieves symptoms of gastro-duodenal dysfunction.
Including: dyspepsia, heartburn, flatulence, sickness, pain, regurgitation of bile. These symptoms may be associated with such conditions as: reflux oesophagitis, hiatus hernia, gastritis, duodenitis, peptic ulcer, cholelithiasis and post-cholecystectomy dyspepsia.
Nausea and vomiting:
Maxolon SR is indicated for the treatment of the nausea and vomiting associated with gastro-intestinal disorders and intolerance to cytotoxic drugs.
4.2 Posology And Method Of Administration
Adults
In adults 20 years and over: 1 capsule (15 mg) twice daily, swallowed whole. Total daily dosage of Maxolon SR should not normally exceed 0.5 mg/kg body weight.
Elderly:
As for adults. To avoid adverse reactions adhere strictly to dosage recommendations and where prolonged therapy is considered necessary, patients should be regularly reviewed.
The interval between doses may need to be extended in patients with clinically significant degrees of renal or hepatic impairment. The predominant route of elimination is via the kidney.
Children and young adults:
A presentation of Maxolon SR suitable for patients under 20 years of age is not available.
4.3 Contraindications
'Maxolon' SR is contra-indicated in patients under 20 years since the dose level cannot be reduced.
'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' SR 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.
1PL 20072/0047-0007; 27/07/2009
4.8 Undesirable Effects
Various extrapyramidal reactions to metoclopramide, usually of the dystonic type, have been reported. The incidence of these reactions may be increased if daily dosages higher than 0.5 mg 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.
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. 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
The following pharmacokinetic parameters for MAXOLON SR after a single administration have been established.
Cmax | 102.5 nmol/l |
Tmax | 4.5 hours |
AUC | 1514.25 nmol.hr/l |
t ½ (elim) | 7.04 hours |
C12 hrs | 54.75 nmol/l |
On repeated administration the following parameters have been established.
Cmax | 188 nmol/l |
Cmin | 109 nmol/l |
5.3 Preclinical Safety Data
No relevant information available.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sucrose
Maize starch
Dibutyl phthalate
Talc
Polymethacrylates
Gelatin
Black iron oxide
6.2 Incompatibilities
Not applicable.
6.3 Shelf Life
See under 6.5.
6.4 Special Precautions For Storage
Protect from direct light.
6.5 Nature And Contents Of Container
All pack sizes (8,14 or 56 capsules) are available in the following packs:
PVC blister (300 microns) backed with aluminium foil (20 microns). The underside of the foil is coated with vinyl based lacquer. Shelf life 24 months.
PVC (200 microns)/PVDC (60gsm) blister. Shelf life 24 months.
Polypropylene containers with polyethylene caps. Shelf life 36 months.
6.6 Special Precautions For Disposal And Other Handling
None.
7. Marketing Authorisation Holder
Amdipharm PLC
Regency House
Miles Gray Road
Basildon
Essex
SS14 3AF
United Kingdom
8. Marketing Authorisation Number(S)
PL 20072/0047
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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