INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MAXOLON T (tablets)
MAXOLON S (syrup)
MAXOLON D (paediatric drops)
MAXOLON I (injection)
MAXOLON S5 (suppositories)
MAXOLON S10 (suppositories)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MAXOLON T (tablets)
MAXOLON S (syrup)
MAXOLON D (paediatric drops)
MAXOLON I (injection)
MAXOLON S5 (suppositories)
MAXOLON S10 (suppositories)

COMPOSITION:
MAXOLON T
: Tablets each containing the equivalent of 10 mg anhydrous
metoclopramide monohydrochloride.
MAXOLON S : Syrup containing the equivalent of 5 mg anhydrous metoclopramide monohydrochloride per 5 mL with methyl p-hydroxybenzoate B.P. 0,08% m/v and propyl p-hydroxybenzoate B.P. 0,02% m/v as preservatives.
MAXOLON D : Paediatric drops containing the equivalent of 1 mg anhydrous metoclopramide monohydrochloride per 1 mL, with methyl p-hydroxybenzoate B.P. 0,08% m/v and propyl p-hydroxybenzoate B.P. 0,02% m/v as preservatives
MAXOLON I : Injection containing the equivalent of 10 mg anhydrous metoclopramide monohydrochloride per 2 mL, with sodium metabisulphite B.P. 0,148% m/v as antioxidant.
MAXOLON S5 : Suppositories containing 5 mg metoclopramide free base.
MAXOLON S10 : Suppositories containing 10 mg metoclopramide free base.

PHARMACOLOGICAL CLASSIFICATION:
A.5.7.2 Anti-emetics and antivertigo preparations.

PHARMACOLOGICAL ACTION:
MAXOLON
belongs to the orthopramide series of synthetic compounds.
MAXOLON is well absorbed by oral, subcutaneous, intramuscular or rectal routes. Approximately 30% of MAXOLON is excreted unchanged in the urine.
Gastro-intestinal Action:
MAXOLON seems to sensitise tissues to the action of acetylcholine. MAXOLON increases the number, strength and activity of gastric antral contractions and also producing an increase in the strength of duodenal contractions. These changes increase the speed of gastric emptying and reduce reflux from the duodenum and the stomach into the oesophagus. which has been observed radiologically and by other methods MAXOLON simultaneously increases the motor :action of the small intestine which results in a decrease in the small bowel transit time. MAXOLON has no effect on gastric secretion MAXOLON has an effect on the gastro-oesophageal junction of the stomach. producing an increase in cardiac sphincter pressure .
Anti-Emetic Action:
MAXOLON
acts on the chemoreceptor trigger zone to produce a central anti-emetic effect

INDICATIONS:
Adults (20 years and over):
Digestive Disorders:
MAXOLON
is of value in conditions associated with gastric stasis or hypomotility.
Nausea and Vomiting:
MAXOLON
is an effective anti-emetic agent in the control of nausea and vomiting associated with the following conditions: intolerance to essential drugs possessing emetic properties, uraemic conditions, malignant disease, gastro-intestinal disorders and post-anaesthetic vomiting.
Diagnostic Radiology:
In patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine.
Duodenal Intubation:
The action of MAXOLON in promoting stomach emptying, combined with its anti-emetic effect, has proved a useful aid to gastro-intestinal 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.
        As an aid to gastro-intestinal intubation and diagnostic radiology.

CONTRA-INDICATIONS:
Animal tests in several mammalian species have shown no teratogenic effects but MAXOLON is not recommended during pregnancy.
Cases of hypertensive crises have reportedly been associated with metoclopramide after administration to patients with phaeochromocytoma.
MAXOLON should not be given to patients with suspected or confirmed phaeochromocytoma.
Where stimulation of muscular contractions might adversely affect gastro-intestinal conditions such as gastro-intestinal obstruction or immediately after surgery.
Hypersensitivity to any of the ingredients.
Patients with convulsive disorders.

WARNINGS:
Care should be exercised in patients being treated with other centrally active drugs e.g. in epilepsy
Tardive dyskinesia has been reported during prolonged therapy and long term treatment should be regularly reviewed. especially when used m elderly patients for long periods.
In patients with clinically significant degrees of renal or hepatic Impairment. therapy should be at a reduced dosage.
Care should be taken when medication causing extrapyramidal side-effects such as phenothiazines, are taken concomitantly. The neuroleptic malignant syndrome has been reported with metoclopramide in combination with neuroleptics as well as with metoclopramide monotherapy (see Side-Effects and Special Precautions).

DOSAGE AND DIRECTIONS FOR USE:
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 0,5 mg/kg body mass.
MAXOLON should only be used after careful examination to avoid masking an underlying disorder, e.g. cerebral irritation.
In the treatment of young adults and children attention should be given primarily to body mass and treatment should commence at the lower dosage where stated.

Oral
A liquid presentation should be used in the younger age groups as this facilitates accurate dosage and administration.
Adults 15 years and over, with a mass of 60 kg or more:
10 mg (1 x 10 mg tablet or 10 mL of 5 mg/5 mL syrup) 3 times daily.
Adults 15 years and over, with a mass of less than 60 kg:
5 mg (0,5 x 10 mg tablet or 5 mL of 5 mg/5 mL syrup) 3 times daily.
Children 9 - 14 years (30 kg and over):
5 mg (0,5 x 10 mg tablet or 5 mL of 5 mg/5 mL syrup) 3 times daily.
Children 5 - 9 years (20 - 29 kg):
2,5 mg (2,5 mL of 5 mg/5 mL syrup) 3 times daily.
Children 3 - 5 years (15 - 19 kg):
2 mg (2 mL of 1 mg/1 mL drops) 2 - 3 times daily.
Children 1 - 3 years (10 - 14 kg):
1 mg (1 mL of 1 mg/1 mL drops) 2 - 3 times daily.
Children under 1 year (up to 10 kg):
1 mg (1 mL of 1 mg/1 mL drops) twice daily.

Per Rectum:
Adults 15 years and over, with a mass of 60 kg or more:
10 mg (1 x 10 mg suppository) 1 - 3 times daily.
Adults 15 years and over, with a mass of less than 60 kg:
5 mg (1 x 5 mg suppository) 1 - 3 times daily.
Children 9 - 14 years (30 kg and over):
5 mg (1 x 5 mg suppository) 1 - 3 times daily.
Children under 9 years:
No suitable preparation available.

Parenteral:
On no account should MAXOLON ampoules be diluted for injection since this will upset the isotonicity and stability of the drug.
Adults 15 years and over, with a mass of 60 kg or more:
10 mg (1 ampoule) 1 - 3 times daily I.V. or I.M. depending on the severity of the condition.
Adults 15 years and over, with a mass of less than 60 kg:
5 mg (1,0 mL of a 10 mg/2 mL ampoule) I.V. or I.M. 1 - 3 times daily.
Children 5 - 14 years:
2,5 mg (0,5 mL of 10 mg/2 mL ampoule) I.V. or I.M. twice daily in a tuberculin syringe.
Children 3 - 5 years:
1 mg (0,2 mL of 10 mg/2 mL ampoule) I.V. or I.M. twice daily in a tuberculin syringe.
Children 1- 3 years:
0,5 mg (0,1 mL of 10 mg/2 mL ampoule) I.V. or I.M. twice daily in a tuberculin syringe.

Dosage for Diagnostic Radiology:
Intravenous:
10 - 20 mg (1 - 2 ampoules) 5 - 15 minutes before the barium meal.
Intramuscular: 10 - 20 mg (1 - 2 ampoules) 10 - 15 minutes before the barium meal.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Subjective feelings of restlessness have been reported. Anxiety, agitation may occur, especially after rapid injection. Rare cases of acute depression have been reported. Drowsiness has been reported less frequently. Headache and dizziness may also occur.
There have been reports of abnormalities of cardiac conduction (such as bradycardia and heart block) in association with intravenous metoclopramide.
Various extrapyramidal dystonic-like reactions could occur. especially in children and young adults. The findings include spasm of facial and/or extra ocular muscles, trismus, a bulbar type of speech and unnatural positioning of the head and shoulders. There may be a general increase in muscle tone.
Hypotension, hypertension may occur and there are isolated reports of blood disorders, hypersensitivity reactions, and urinary incontinence.
Parkinsonism has been reported during prolonged therapy and long-term treatment should be regularly reviewed.
Less frequent 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 Creatinine phosphokinase and must be treated urgently (recognised treatments include dantrolene and bromocriptine).
Metoclopramide should be stopped immediately if this syndrome occurs.
Diarrhoea or constipation have been reported. MAXOLON stimulates serum prolactin levels, and may cause breast engorgement, galactorrhoea, lactorrhoea or related disorders.
The conditions return to normal after withdrawal of the drug.
Transient increases in plasma aldosterone concentrations have been observed.
Lactation:
Since metoclopramide is found in breast milk, the risk-benefit must be considered.
Interactions:
Anticholinergic agents and opioid analgesics may antagonise the gastro-intestinal effects of metoclopramide. The effects of central nervous system depressants may be enhanced.
Metoclopramide may affect the absorption of other medicines by either diminishing absorption from the stomach or by enhancing absorption from the small intestine.
As both MAXOLON and the phenothiazines may cause dystonia, care should be exercised in the event of both drugs being prescribed concomitantly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage of MAXOLON could give rise to the dyskinetic reactions manifested as motor restlessness, agitation, irritability, spasm of facial and neck muscles and the muscles of the tongue. In severe cases opisthotonus can result. Very seldomly AV block has been observed. Overdosage should be treated by gastric lavage with appropriate supportive measures. Should active therapy be required for a dystonic reaction, an anti-Parkinson drug may be used. Further treatment is symptomatic and supportive.

IDENTIFICATION:
MAXOLON T :
White to ivory white, circular biconvex tablet, scored on one side and engraved MAXOLON on the reverse side.
MAXOLON S : Clear, colourless, viscous liquid with a sweet citrus flavour and odour.
MAXOLON D : Clear, colourless, viscous liquid with a sweet citrus flavour and odour.
MAXOLON I : Clear, colourless liquid in well marked snap ampoules.
MAXOLON S5; MAXOLON S10 : Off white, torpedo-shaped suppositories.

PRESENTATIONS:
MAXOLON T :
Securitainer containing 500 tablets.
Blister strips containing 10 tablets packed in cartons of 2 or 10 strips.
MAXOLON S : Bottles containing 50 mL and l00 mL syrup.
MAXOLON D : Bottle containing 15 mL paediatric drops. Calibrated pipette provided.
MAXOLON I : Packs of 10 glass ampoules each containing 10 mg/2 mL.
MAXOLON S5 : Cartons containing 5 suppositories of 5 mg.
MAXOLON S10 : Cartons containing 5 suppositories of 10 mg.

STORAGE INSTRUCTIONS:
MAXOLON T :
Keep tightly closed and store in a cool (below 25°C), dry place.
MAXOLON S : Keep tightly closed and store in a cool place (below 25°C). Protect from light.
MAXOLON D : Keep tightly closed and store in a cool place (below 25°C) Protect from light.
MAXOLON I : Store in a cool place (below 25°C). Protect from light. Should inadvertent exposure occur, reject any ampoules showing a yellow discolouration.
MAXOLON S5; MAXOLON S10 : Store in a cool (below 25°C) dry place.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBERS:
MAXOLON I:         C.919 (Act 101/1965)

REGISTRATION NUMBERS:
MAXOLON S:         C/5.7.2/918
MAXOLON S5:         H/5.7.2/200
MAXOLON S10:         H/5.7.2/201
MAXOLON T:         C/5.7.2/0920
MAXOLON D:         C/5.7.2/1014

NAME AND ADDRESS OF THE APPLICANT:
SmithKline Beecham Pharmaceuticals (Pty) Limited
39 Hawkins Avenue, Epping Industria 1,
Cape Town, 7460

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
04.03.1994

P2371

Updated on this site: November 1999

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