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Logo ADCO-LOPERAMIDE TABLETS

SCHEDULING STATUS:
S2

PROPRIETARY NAME:
(and dosage form)

ADCO-LOPERAMIDE TABLETS

COMPOSITION:
Each tablet contains
Loperamide Hydrochloride 2 mg.

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

PHARMACOLOGICAL ACTION:
ADCO-LOPERAMIDE
inhibits gastro-intestinal motility by effects on the circular and longitudianl 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 normalises the stool in both acute and chronic diarrhoea.
ADCO-LOPERAMIDE 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
is contra-indicated in patients with a known hypersensitivity to the medicine, in colitis and in diarrhoea associated with pseudomembranous colitis.
The safety of use during pregnancy has not been established.

WARNINGS:
ADCO-LOPERAMIDE
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.

DOSAGE AND DIRECTIONS FOR USE:
Dosage should not exceed four to six tablets per day.
ADCO-LOPERAMIDE is contra-indicated in children under 2 years of age.

For inhibition of peristalses and slowing of the intestinal transit time:
For children 2 - 5 years:
½ a tablet eight hourly.

Acute Diarrhoea:
Adults
: Two tablets initially, followed by one tablet after each loose stool.
Children of 6 years and older: One tablet initially, followed by one tablet after each loose stool.
The initial dose should be adjusted until solid stools are obtained. This is usually achieved on a maintenance dose of one to six tablets.

Chronic Diarrhoea:
The dosage should be adjusted individually.
Adults: The initial dose is two tablets daily.
Children of 6 years and older: The initial dose is one tablet daily.
The inital dose should be adjusted until solid stools are obtained. This is usually achieved on a maintenance dose of one to six tablets.
If constipation occurs, treatment should be stopped.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Abdominal pain and other gastro-intestinal disturbances including toxic megacolon, dry mouth, dizziness, fatigue and skin rash may occur.
Adco-Loperamide is not recommended for routine use in acute and chronic diarrhoea in children under the age of 6 years. Adco-Loperamide 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. Excessive inhibition of peristalsis with nausea and dryness of the mouth. Treatment is symptomatic and supportive.
Naloxone can be given as antidote. Since the duration of action of Adco-Loperamide 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.

IDENTIFICATION:
White round tablet.

PRESENTATION:
Cartons containing foil strips of 6 tablets and securitainers containing 60 and 300 tablets.

STORAGE INSTRUCTIONS:
Store in well closed containers, below 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
Y/11.9/5

NAME AND BUSINESS 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:
November 1990

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

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