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

Logo SETIN Tablets

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

SETIN Tablets

COMPOSITION:
Metoclopramide is chemically designated as the monohydrochloride of 4-amino-5-chloro-2-methoxy-N-diethyl-aminoethylbenzamide which has the approved name of Metoclopramide.
Each tablet contains 10 mg of
Metoclopramide monohydrochloride.

PHARMACOLOGICAL CLASSIFICATION:
A5.7.2 - Drugs affecting autonomic functions - Anti-emetics and Anti-vertigo preparations.

PHARMACOLOGICAL ACTION:
Metoclopramide acts peripherally to enhance the action of acetylcholine at the muscarinic synapses, thereby increasing the motility and tone of the stomach, accelerate emptying of gastric contents and reduce reflex from the duodenum and the stomach into the esophagus. Metoclopramide acts on the chemo-emetic trigger zone to produce a central anti-emetic effect. Metoclopramide does not affect gastric secretion.

INDICATIONS:
Anti-emetic:
Use in control of nausea and vomiting associated with the following conditions: medicine-induced post-operative nausea and vomiting, nausea and vomiting due to cancer chemotherapy and radiotherapy and gastro-intestinal disorders.
Digestive disorders:
Conditions associated with gastric stasis or hypomotility.
Diagnostic radiology examination:
In patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine.
Duodenal intubation:
An aid to gastro-intestinal intubation procedures.

CONTRA-INDICATIONS:
Sensitivity to metoclopramide.
Patients where stimulation of muscular contractions might adversely affect gastrointestinal conditions such as gastro-intestinal obstruction or immediately after surgery.
In patients with phaeochromocytoma, it may cause a hypertensive crisis.
Patients with convulsive disorders.
The use of metoclopramide throughout the duration of pregnancy is considered unsafe as teratogenicity has been demonstrated in animal studies.
Safety in lactation has not been established.

WARNINGS:
Tardive dyskinesia has been reported during prolonged therapy and long-term treatment should be regularly reviewed, especially when used in elderly patients for long periods.
Patients with significant renal impairment or to those at risk of fluid retention as in hepatic impairment.
Care should be taken when medication causing extrapyramidal side-effects such as phenothiazines, are taken concomitantly.

DOSAGE AND DIRECTIONS FOR USE:
Oral dosages:
Treatment of patients under 20 years of age should be limited to severe intractable vomiting of known cause.
The dosage recommendations should be strictly adhered to. Metoclopramide should only be used after careful examination to avoid masking of an underlying disorder, eg. cerebral irritation. In the treatment of young adults and children attention should be given primarily to body mass and treatment should commence at the lower dosage as stated. The total daily dosage of metoclopramide should not exceed 0,5 mg/kg body-weight daily.
Oral:
Adults: (60 kg and over) 10 mg three times daily.
Young adults 15 to 19 yrs: (less than 60 kg) 5 mg three times daily.
Children 9 to 14 yrs: (30 kg and over) 5 mg three times daily.
Children 5 to 9 yrs: 2,5 mg three times daily.
Children 3 to 5 yrs: 2 mg two to three times daily.
Children 1 to 3 yrs: 1 mg two to three times daily.
Children under 1 yrs: 0,1 mg/kg twice daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Anxiety or agitation may occur, especially after rapid infection. Cases of acute depression have been reported.
Dystonic reactions have been reported, especially in children and young adults where therapy must be limited to severe intractable vomiting.
Depression, lassitude, insomnia, headache, nausea, oedema of tongue, periorbital oedema, drowsiness, fatigue, dizziness, restlessness, and skin rashes may occur.
Other adverse effects include bowel upsets such as diarrhoea or constipation.
Metoclopramide stimulates prolactin secretion and may cause galactorrhoea, gynaecomastia, breast engorgement, amenorrhoea or impotence.
Metoclopramide may affect the absorption of other medicines by either diminishing absorption from the stomach or by enhancing absorption from the small intestine.
Parkinsonism and/or tardive dyskinesia may occur. Increases in plasma aldosterone concentrations have been observed.
INTERACTIONS:
Anticholinergic agents and narcotic analgesics may antagonise the effects of metoclopramide.
The effect of central nervous system depressants may be enhanced.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and special precautions ".
Treatment is symptomatic and supportive.

IDENTIFICATION:
Small, uncoated white tablets with a diameter of 5,5 mm.

PRESENTATION:
Containers of 20, 100 and 1000 tablets.

STORAGE INSTRUCTIONS:
Since metoclopramide monohydrochloride is affected by light, it is essential to protect tablets from direct sunlight.
Keep in a cool, dry place (below 25°C).
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
M/5.7.2/141

NAME AND BUSINESS ADDRESS OF APPLICANT:
Alliance Pharma (Pty) Limited
Co. Reg. No. 89/07635/07
17 Faraday Street
Village Main
Johannesburg 2001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
September 1980

                        PM 0572-7/99

Updated on this site: October 2000
Current: October 2005
Source: Hospital Pharmacy

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