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Cimetidine

Composition and Description
Cimetidine 200 mg/tablet Round, pale yellow film-coated tablet, bevel-edged, shallow convex faces.
Cimetidine 400 mg/tablet Oblong, pale yellow film-coated tablet, deep convex faces and break-bar embossed on one face.
Cimetidine 800 mg/tablet Oblong, pale yellow film-coated tablet with shallow convex faces, bevel-edged and break-bar embossed on one face.


Actions and Pharmacology
Cimetidine inhibits basal and nocturnal gastric acid secretion by competitive inhibition of the action of histamine at the histamine H2-receptors. It also inhibits gastric acid secretion stimulated by food, betasole, pentagastrin, caffeine, insulin and physiological vagal reflex. Cimetidine is well absorbed from the gastrointestinal tract and is weakly bound to plasma proteins. It is partially metabolised in the liver and most of an oral dose of cimetidine is excreted unchanged in the urine.


Indications
Cimetidine is indicated in the :
- prophylaxis and treatment of duodenal ulcer.
- short-term treatment of active benign gastric ulcer.
- treatment of pathological gastric hypersecretion states, such as Zollinger-Ellison syndrome.

- treatment of acute gastroesophageal reflux disease.
- treatment of upper gastrointestinal bleeding.


Contraindications
- Avoid in patients known to be hypersensitive to histamine H2-receptors antagonists.

- It should not be used in nursing mothers.


Precautions
- Caution in patients with cirrhosis, history of portal systemic encephalopathy, hepatic and renal function impairment.

- Safety for use in pregnancy has not been established.
- Dosage should be reduced in patients with impaired renal function.
- Care should be taken in patients with a history of peptic ulcer, particularly the elderly.


Main Side/Adverse Effects
Diarrhoea, dizziness, tiredness, rashes. Reversible confusional states, especially in the elderly or in seriously ill patients such as those with renal failure, gynaecomastia and impotence have occasionally occurred.


Drug Interactions
Concurrent use with the following drugs requires careful monitoring :
- Theophylline, phenytoin, lidocaine, anti-arrhythmias, benzodiazepines, some beta-blockers and some vasodilators.


Adjustment to anti-coagulant medications may be necessary during and after cimetidine therapy to prevent bleeding due to anti-coagulant potentiation.


Overdosage
Clinical features : Allergic reaction, bradycardia or tachycardia, bronchospasm, confusion, neutropenia or other blood dyscrasias and fever may occur.


Treat overdosage by emesis or gastric lavage; artificial respiration in the event of respiratory failure and administration of beta-blocker to control tachycardia.


Dosage and Administration
Adults (Oral) :
Duodenal or benign gastric ulcer :

  A single daily dose of 800 mg at bedtime, or

  400 mg twice a day with breakfast and at bedtime, or
  200. mg three times a day with meals and 400 mg at bedtime (1.0 g/day), or

  400 mg four times a day with meals and at bedtime (1.6 g/day).


Treatment should be given initially for at least four weeks (six weeks in benign gastric ulcer).


Oesophageal reflux disease : 400 mg four times a day, with meals and at bedtime, for 4 to 8 weeks.

 

Gastric hypersecretion states (eg Zollinger-Ellison Syndrome) : 400 mg four times a day.


The total daily dose should not exceed 2.4 g. Dosage should be reduced in patients with impaired renal function. Antacids can be made available to all patients until symptoms disappear.


Children (more than one year old) : Oral, 25 - 30 mg/kg of body weight per day in divided doses.


Shelf-life

3 years from the date of manufacture.


Storage

Store below 25C. Protect from light and moisture.


Presentation/Packing

Film-Coated Tablet 200 mg x 100's, 500's, 1000's, Blisters of 10 x 10's.
Film-Coated Tablet 400 mg x 100's, 500's, 1000's, Blisters of 10 x 10's.
Film-Coated Tablet 800 mg x 100's, 500's, 1000's, Blisters of 10 x 10's.

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