(and dosage form):
Each tablet contains
A11.9-Medicines acting on gastro-intestinal tract. Antidiarrhoeals.
Betaperamide inhibits hypermotility by direct action on the bowel wall. Its inhibition of peristalsis is the result of decreasing the activity of both the longitudinal muscles (preparatory and reflex phases) and the circular muscle (reflex phase).
Betaperamide is readily absorbed from the gut, but it is almost completely metabolised in the liver where it is conjugated and excreted via the bile. Betaperamide is mainly eliminated via the faeces.
Adults and children 6 years of age and older:
Loperamide is indicated for symptomatic relief of acute and chronic nonspecific diarrhea and to inhibit peristalsis and slow intestinal transit time in patients with ileostomies colostomies and other intestinal resections.
For children 2-5 years of age:
Loperamide is indicated for inhibition of peristalsis and slowing of intestinal transit time.
Betaperamide is contra-indicated in patients with a known hypersensitivity to the medicine. Patients in whom inhibition of peristalsis must be avaoided (e.g. partial obstruction due to tumour). Patients with liver impairment. Infants under two years of age. Safety in pregnancy and nursing mothers has not been established.
Patients with inflammatory bowel receiving Betaperamide should be carefully observed for signs of toxic megacolon.
DOSAGE AND DIRECTIONS FOR USE:
For adults and children 6 years of age and older: 2 tablets (adults) or 1 tablets (children) as an initial dose followed by 1 tablet after each subsequent loose stool. Dosage should not exceed 8 tablets per day for adults, or depending on age, 4 to 6 tablets per day for children.
For adults and children 6 years of age and older: With individually adjusted dosage it is usually possible to obtain a virtually normal bowel movement. The initial dose is 2 tablets daily for adults and 1 tablets daily for children 6 years and over. The initial dose should be adjusted until 1-2 solid stools per day are obtained. This is usually achieved on a maintenance dose of 1-6 tablets daily. If constipation occurs, treatment should be discontinued.
For children 2-5 years of age: Loperamide is not indicated for acute and chronic nonspecific diarrhea, but for inibition of peristalsis and slowing of intestinal transit time. Dosage: Half a tablet eight hourly.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Abdominal pain and other gastro-intestinal disturbances, including toxic megacolon, dry mouth, dizziness, fatigue and skin rashes may occur.
Betaperamide should be used with caution in patients with hepatic dysfunction because of its considerable first-pass metabolism in the liver. It should also be used with caution in young children because of a greater variability of response in such an age group. Betaperamide is not recommended for routine use in acute or chronic diarrhea in children under the age of 6 years. Betaperamide 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. Depression of the central nervous system, especially in children. Treatment is symtomatic and supportive. Naloxone can be given as antidote. Since the duration of Betaperamide 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.
Round, white normal convex bisected tablet, 6,35 mm in diameter.
10 tablets packed in white Securitainers
Store in well-closed containers below 30°C.
KEEP OUT OF REACH OF CHILDREN.
NAME AND BUSINESS ADDRESS OF APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrosin Avenue
Bryanston Ext 77
Private Bag X69, Bryanston, 2021
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
New addition to this site: April 2004
Source: Pharmaceutical Industry
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