Each film coated tablet contains 400 mg cimetidine
Excipient: each tablet contains 18.5 mg of Lactose monohydrate
Plane green coloured, capsule-shaped, biconvex, film coated tablet, debossed “CD” on one side and plain on other side.
Cimetidine is a histamine H2-receptor antagonist which rapidly inhibits both basal and stimulated gastric secretion of acid and reduces pepsin output.
Cimetidine is indicated in the treatment of duodenal and benign gastric ulceration, including that associated with non-steroidal anti-inflammatory agents, recurrent and stomal ulceration , oesophageal reflux disease and other conditions where reduction of gastric acid by Cimetidine has been shown to be beneficial: persistent dyspeptic symptoms with or without ulceration, particularly meal-related upper abdominal pain, including such symptoms associated with non-steroidal anti-inflammatory agents; the prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients ; before general anaesthesia in patients thought to be at risk of acid aspiration (Mendelson's Syndrome), particularly obstetric patients during labour ; to reduce malabsorption and fluid loss in the short bowel syndrome; and in pancreatic insufficiency to reduce degradation of enzyme supplements. Cimetidine is also recommended in the management of the Zollinger-Ellison syndrome.
Posology and method of administration
For oral administration.
The total daily dose by any route should not normally exceed 2.4g. Dosage should be reduced in patients with impaired renal function (see Special warnings and precautions for use)
Oral: The usual dosage is 400mg twice a day, with breakfast and at bedtime. For patients with duodenal or benign gastric ulceration, a single daily dose of 800mg at bedtime is recommended. Other effective regimens are 200mg three times a day with meals and 400mg at bedtime (1.0g/day) and, if inadequate, 400mg four times a day (1.6g/day), also with meals and at bedtime.
Symptomatic relief is usually rapid. Treatment should be given initially for at least four weeks (six weeks in benign gastric ulcer, eight weeks in ulcer associated with continued non-steroidal anti-inflammatory agents) even if symptomatic relief has been achieved sooner. Most ulcers will have healed by that stage, but those which have not will usually do so after a further course of treatment.
Treatment may be continued for longer periods in those patients who may benefit from reduction of gastric secretion and the dosage may be reduced as appropriate to 400mg at bedtime or 400mg in the morning and at bedtime. In patients with benign peptic ulcer disease who have responded to the initial course, relapse may be prevented by continued treatment, usually with 400mg at bedtime; 400mg in the morning and at bedtime has also been used.
In oesophageal reflux disease, 400 mg four times a day, with meals and at bedtime, for four to eight weeks is recommended to heal oesophagitis and relieve associated symptoms. In patients with very high gastric acid secretion (e.g. Zollinger-Ellison syndrome) it may be necessary to increase the dose to 400mg four times a day or in occasional cases further. Since Cimetidine may not give immediate symptomatic relief, antacids can be made available to all patients until symptoms disappear.
In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients, doses of 200 - 400mg can be given every four to six hours by the oral route.
In patients thought to be at risk of acid aspiration syndrome, an oral dose of 400mg can be given 90-120 minutes before induction of general anaesthesia or, in obstetric practice, at the start of labour. While such a risk persists, a dose of up to 400mg may be repeated (parenterally if appropriate) at four hourly intervals as required up to the usual daily maximum of 2.4g.
Cimetidine syrup should not be used. The usual precautions to avoid acid aspiration should be taken.
In the short bowel-syndrome e.g. following substantial resection for Crohn's disease, the usual dosage range (see above) can be used according to individual response.
To reduce degradation of pancreatic enzyme supplements, 800-1600mg a day may be given, according to response, in four divided doses, one to one and a half hours before meals.
The normal adult dosage may be used unless renal function is markedly impaired. (see section 4.4).
Experience in children is less than that in adults. In children more than one year old, Cimetidine 25-30mg/kg body weight per day in divided doses may be administered by oral route.
The use of Cimetidine in infants under one year old is not fully evaluated, 20mg/kg body weight per day in divided doses has been used.
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