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

Logo ADCO-LOPERAMIDE 1 mg/5 mL

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

ADCO-LOPERAMIDE 1 mg/5 mL
Syrup

COMPOSITION:
Each 5 mL contains:
Loperamide Hydrochloride 1 mg with Methyl Hydroxybenzoate 0,07% and Propyl Hydroxybenzoate 0,008% as preservatives.

PHARMACOLOGICAL CLASSIFICATION:
A.11.9 Medicines Acting on Gastro-intestinal Tract, Antidiarrhoeals.

PHARMACOLOGICAL ACTION:
ADCO-LOPERAMIDE 1 mg/5 mL
inhibits gastro-intestinal motility by direct action on the circular and longitudinal muscles of the intestine. Part of its antidiarrhoeal effect may be due to a reduction of gastro-intestinal secretion produced by actions at opioid receptors in the intestinal mucosa.
ADCO-LOPERAMIDE 1 mg/5 mL normalises the stool in both acute and chronic diarrhoea.
ADCO-LOPERAMIDE 1 mg/5 mL is incompletely absorbed after oral administration. It undergoes considerable first-pass metabolism in the liver and is excreted mainly in the faeces. Elimination half-life is about ten hours.

INDICATIONS:
Children 2 - 5 years:
Loperamide is not indicated for acute and chronic nonspecific diarrhoea but for inhibition of peristalses and slowing of intestinal transit time.
Adults and children 6 years and older:
Loperamide is indicated for the symptomatic relief of acute and chronic nonspecific diarrhoea and to inhibit peristalsis and slow intestinal transit time in patients with ileostomies, colostomies and other intestinal resections.

CONTRA-INDICATIONS:
ADCO-LOPERAMIDE 1 mg/5 mL
is contra-indicated in patients with a known sensitivity to the medicine, in colitis and in diarrhoea associated with pseudomembranous colitis. Do not use as primary therapy in acute dysentery, which is characterised by blood in the stools and high fever.
Safety in pregnancy and lactation has not been established.
ADCO-LOPERAMIDE 1 mg/5 mL is contra-indicated in children under 2 years of age.

WARNINGS:
ADCO-LOPERAMIDE 1 mg/5 mL
should be used with caution in conditions where constipation must be avoided and in patients with hepatic dysfunction, because of its considerable first-pass metabolism in the liver. Patients with inflammatory bowel disease should be carefully observed for signs of toxic megacolon as loperamide may precipitate this condition in these patients.

DOSAGE AND DIRECTIONS FOR USE:
Do not administer ADCO-LOPERAMIDE 1 mg/5 mL Syrup to infants under 2 years of age.

For inhibition of peristalses and slowing of the intestinal transit time:
For children 2 - 5 years:
One medicine measureful (5 mL) per 12,5 kg body mass eight hourly.

Acute Diarrhoea:
For adults and children 6 years and older:
One medicine measureful (5 mL) per 12,5 kg body mass followed by ½ a medicine measureful (2,5 mL) per 12,5 kg after each subsequent loose stool.
Daily dosage should not exceed three medicine measurefuls (15 mL)/12,5 kg body mass.
In acute diarrhoea, if clinical improvement is not observed within forty-eight hours of administration of ADCO-LOPERAMIDE 1 mg/5 mL this medication should be discontinued and a doctor should be consulted.

Chronic Diarrhoea:
For adults and children 6 years and older:
With individually adjusted dosage, it is usually possible to obtain a virtually normal bowel movement.
The initial dose is one medicine measureful (5 mL)/12,5 kg body mass daily for children.
The initial dose should be adjusted until one to two solid stools per day are obtained. This is usually achieved on a maintenance dose of ½ to 2 medicine measurefuls (2,5 mL - 10 mL) daily.
If constipation occurs, treatment should be discontinued.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Abdominal pain and other gastro-intestinal disturbances including toxic megacolon, dry mouth, dizziness, fatigue and skin rash may occur.
In patients with diarrhoea, especially in children, fluid and electrolyte depletion may occur. In such cases administration of appropriate fluid and electrolyte replacement is essential.
Adco-loperamide syrup is not recommended for routine use in acute or chronic diarrhoea in children under the age of 6 years. Adco-loperamide syrup should not be given to children less than 6 years of age, without medical prescription and supervision.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may lead to constipation and depression of the central nervous system. Children are especially sensitive to the latter. Convulsions have been reported in children under the age of two years. Excessive inhibition of peristalsis with nausea and dryness of the mouth may occur.
Naloxone can be given as antidote. Since the duration of action of Adco-loperamide syrup is longer than that of naloxone (1-3 hours) repeated treatment of naloxone may be indicated.
Therefore the patient should be monitored closely for at least 48 hours in order to detect possible central nervous system depression.
Treatment is symptomatic and supportive.

IDENTIFICATION:
Clear red syrup with a fruity raspberry flavour.

PRESENTATION:
Amber glass bottles containing 50 mL and 500 mL of syrup.

STORAGE INSTRUCTIONS:
Store below 25°C in well closed containers. Keep out of reach of children.

REGISTRATION NUMBER:
28/11.9/0003

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston
Private Bag X69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12 November 1993

New addition to this site: April 2004
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004