Indications
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; 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.
Dosage and Administration
Usage: Oral
Dosage:The total daily dose by any route should not normally exceed 2.4g.
Dosage should be reduced in patients with impaired renal function.
The usual dosage is 400mg twice a day, with breakfast and at bedtime.
Elderly: The normal adult dosage may be used unless renal function is markedly impaired.
Paediatric population: 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.
Contraindications
Hypersensitivity to Cimetidine or to any other of the tablet ingredients listed.
Precautions & Warning:
1.Dosage should be reduced in patients with impaired renal function according to creatinine clearance.
2.Cimetidine is removed by haemodialysis, but not to any significant extent by peritoneal dialysis.
3.Clinical trials over six years' continuous treatment and more than 15 years' widespread use have not revealed unexpected adverse reactions related to long-term therapy.
4.Due to possible interaction with coumarins, close monitoring of prothrombin time is recommended when cimetidine is concurrently used.
5.Co-administration of therapeutic agents with a narrow therapeutic index, such as phenytoin or theophylline, may require dosage adjustment when starting or stopping concomitantly administered cimetidine.
6.Lactose: This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Adverse Reactions:
1.Blood and Lymphatic system disorders: Leukopenia,Thrombocytopenia, aplastic anaemia,Pancytopenia, agranulocytosis
2.Immune system disorders: Anaphylaxis. Anaphylaxis is usually cleared on withdrawal of the drug.
3.Psychiatric disorders: Depression, confusional states, hallucinations.
4.Nervous system disorders:Headache, dizziness
5.Cardiac disorders:Tachycardia,Sinus bradycardia,Heart block
6.Gastrointestinal disorders:Diarrhoea,Pancreatitis.
7.Hepatobiliary disorders:Hepatitis,Increased serum transaminase levels.
8.Skin and subcutaneous tissue disorders:Skin rashes,Reversible alopecia and hypersensitivity vasculitis.
9.Musculoskeletal and connective tissue disorders:Myalgia
10.Renal and urinary disorders
Storage instructions:
Blister: Do not store above 30°C. Store in the original package.