INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
GASTRON TABLETS
GASTRON SYRUP

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

GASTRON TABLETS
GASTRON SYRUP

COMPOSITION:
Each tablet contains 2 mg loperamide hydrochloride.
Each 5 mL of syrup contains 1 mg loperamide hydrochloride.
Preservatives:

Methylparaben	0,072% m/v
Propylparaben	0,008% m/v

PHARMACOLOGICAL CLASSIFICATION:
A 11.9 Medicines acting on gastro-intestinal tract: Antidiarrhoeals.

PHARMACOLOGICAL ACTION:
GASTRON is a piperidine derivative. It slows gastro-intestinal motility by effects on the circular and longitudinal muscles of the intestine.
It normalises the stool in both chronic and acute diarrhoea.
GASTRON is partially absorbed in the gastro-intestinal tract. It undergoes considerable first-pass metabolism in the liver and is excreted mainly in the faeces.

INDICATIONS:
GASTRON is indicated for the control of acute and chronic diarrhoea.
GASTRON controls intestinal transit time in patients with ileostomies, colostomies and other intestinal resections.

CONTRA-INDICATIONS:
GASTRON should not be used in the treatment of acute infective diarrhoea, and should also not be used when hepatic dysfunction exists, which may result in relative overdosing.
GASTRON should not be administered to children under 2 years. It is contra-indicated in patients hypersensitive to the active ingredient and in those in whom inhibition of peristalsis must be avoided, in particular where constipation is present or in patients with inflammatory bowel disease.
Safety in pregnancy has not been established.

WARNING:
Patients with inflammatory bowel disease receiving GASTRON should be carefully observed for signs of toxic megacolon.
Patients should be told not to continue medication if no response is obtained within 48 hours; medical advice should then be sought.
Discontinue use immediately if constipation, abdominal distension or subileus develop.
Do not use in patients with acute ulcerative colitis or pseudomembranous colitis associated with broad spectrum antibiotics.

DOSAGE AND DIRECTIONS FOR USE:
GASTRON should not be administered to children under 2 years.
Acute Diarrhoea
ADULTS
The usual initial dose of GASTRON is two tablets (4 mg) followed by one tablet (2 mg) after each loose stool, up to a total of 8 tablets (16 mg) daily.
CHILDREN 2-5 YEARS (13-20 kg body mass)
One medicine measure (5 mL) three times a day for the first day, followed by one medicine measure (5 mL) per 10.0 kg body mass after each loose stool. The total daily dose should not exceed 3 medicine measures (15 mL).
CHILDREN 5-8 YEARS (20-30 kg body mass)
One medicine measure (5 mL) four times a day for the first day, followed by one medicine measure (5 mL) per 10.0 kg body mass after each loose stool. The total daily dose should not exceed 4 medicine measures (20 mL).
CHILDREN 8-12 YEARS (over30 kg)
Two medicine measures (10 mL) three to four times a day for the first day, followed by one medicine measure (5 mL) per 10.0 kg body mass after each loose stool. The total daily dose should not exceed 8 medicine measures (40 mL).

Chronic Diarrhoea
TABLETS
The initial dosage is 2-4 tablets daily in divided doses for adults.

SIDE EFFECTS AND SPECIAL PRECAUTIONS'
Abdominal pain and other gastrointestinal disturbances, dry mouth, dizziness, and fatigue have occurred. Skin rash has also been reported. Reversible paralytic ileus may occur at a high dose level.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may result in constipation.
Depression of the central nervous system may be seen in overdosage.
Excessive inhibition of peristalsis with nausea and dryness of the mouth.
Children may be more sensitive to central nervous system depressant effects of loperamide than adults.
Convulsions have been reported in children under the age of 2 years.
Treatment is symptomatic and supportive.

IDENTIFICATION:

Tablets	A flat, white, bevelled edged tablet bisected on one side.
Syrup	A clear red liquid.

PRESENTATION:

Tablets	Blister packs of 6 tablets and 300 tablets.
Syrup	Amber PVC bottles of 50 mL.

STORAGE INSTRUCTIONS:
Store below 25°C
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:

GASTRON Tablets:	V/11.9/213
GASTRON Syrup:	V/11.9/214

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
Port Elizabeth
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
10/03/1988
        G566C
KOHLER C&P P.E

Updated on this site: February 2003
Current: March 2005
Source: Hospital Pharmacy
SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2005