INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
LOMOTIL (Tablets)

SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

LOMOTIL (Tablets)

COMPOSITION:
Each tablet contains 2,5 mg diphenoxylate hydrochloride and 0,025 mg atropine sulphate.

PHARMACOLOGICAL CLASSIFICATION:
A 11.9 Antidiarrhoeals.

PHARMACOLOGICAL ACTION:
Diphenoxylate is a piperidine opioid that is structurally related to meperidine. It increases gastrointestinal contractions but disrupts aboral peristaltic motility, thereby increasing the transit time of intestinal contents. The prolonged transit time facilitates absorption of fluid and solutes throughout the intestinal tract.

INDICATIONS:
For the short-term use in the management of mild to moderate diarrhoea.

CONTRA-INDICATIONS:

•	Diarrhoea associated with antibiotic induced pseudomembranous entero-colitis.
•	Fever
•	Sensitivity to the substance.
•	Should not be administered to children younger than four years, because of their susceptibility to the effects of overdosage.
•	Safety in pregnancy has not been established.
•	The use of LOMOTIL in lactation is not recommended.
•	Prostatic enlargement, paralytic ileus or pyloric stenosis, ulcerative colitis, closed angle glaucoma, angle closure.

WARNINGS:

•	Patients with inflammatory bowel disease should be carefully observed for signs of toxic megacolon.
•	Hyperthyroidism, adrenocortical insufficiency, impaired kidney or liver function, prostatic hypertrophy, shock or obstructive bowel disorders.
•	Myasthenia gravis.
•	Acute attack of bronchial asthma or in heart failure secondary to lung disease.
•	Respiratory depression, especially in the presence of acute alcoholism, cyanosis and excessive bronchial secretion, head injuries and conditions in which intracranial pressure is raised, may occur.

DOSAGE AND DIRECTIONS FOR USE:
If the symptoms persist for longer than 48 hours or the condition of the patient deteriorates, the product must be discontinued, and a doctor consulted.
In the treatment of diarrhoea, it is important that hydration be maintained by administering adequate fluids and electrolytes.
Adults
For patients with acute diarrhoea the recommended starting dose is four tablets followed by two tablets every 6 hours. Not to exceed 25 mg daily (ten tablets).
Children
LOMOTIL is not recommended for use in children under 4 years of age.
The recommended dosage is 0,3 to 0,4 mg/kg diphenoxylate hydrochloride daily, administered in divided doses. The following table is a guideline for attainment of this dosage schedule:

Age	Approximate Body Weight	Dosage
4 to 8 years	20 - 27 kg	1 tablet 3 times daily.
9 to 12 years	27 - 36 kg	1 tablet 4 times daily.
13 years & above		2 tablets 4 times daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
PRECAUTIONS:
Lactation:
See contra-indications.
Interactions:
Diphenoxylate may potentiate the effects of other central nervous system depressants such as alcohol, barbiturates and tranquilisers. May interact with monoamine oxidase inhibitors.
SIDE-EFFECTS:
Diphenoxylate hydrochloride
At therapeutic doses, the following have been reported:
Nervous system: malaise/lethargy, confusion, sedation/drowsiness, dizziness, restlessness, depression, euphoria, headache and paraesthesia, insomnia, numbness of extremeties.
Allergic: anaphylaxis, angioneurotic oedema, urticaria, pruritus, swelling of gums.
Gastro-intestinal system: toxic megacolon, paralytic ileus, pancreatitis, vomiting, nausea, anorexia, abdominal discomfort.
Atropine Sulphate
In susceptible individuals or in cases of overdosage, subtherapeutic doses of atropine sulphate in preparations containing diphenoxylate may cause the following side-effects: dryness of the mouth, thirst, dilatation of the pupils, photophobia, flushing and dryness of the skin, transient bradycardia followed by tachycardia, with palpitations and arrhythmias, urinary urgency, difficulty and retention, constipation. Occasionally vomiting, giddiness, and staggering may occur. Retrosternal pain may occur.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
In acute poisoning the stomach should be emptied by aspiration and lavage. Overdosage may result in narcosis with respiratory depression, particularly in children. Signs of atropine poisoning may be present. When respiratory depression occurs, naloxone hydrochloride should be administered.Treatment is symptomatic and supportive.

IDENTIFICATION:
LOMOTIL tablets are white, unscored tablets, stamped with "SEARLE" on one side.

PRESENTATION:
Lomotil tablets are packed in blister strips of 10 tablets.

STORAGE INSTRUCTIONS:
Store in a dry place below 30°C.
Keep out of reach of children.

REGISTRATION NUMBER:
E/11.9/0918

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Pharmacia South Africa (Pty) Ltd.
Alphen West G
George St
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
22 April 1997

Updated on this site: January 2005
Source: Pharmaceutical Industry
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