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Shintamet

Shintamet, the brand of Cimetidine, is a histamine H2-receptor antagonist.


Ingredient(s)
Each tablet contains: Cimetidine ..... 400mg


Action(s)
1. Cimetidine competitively inhibits the action of histamine at the histamine H2-receptor of the parietal cells and thus represents a new class of pharmacological agents, the histamine H2-receptor antagonist.


2. Studies have shown that Cimetidine inhibits both daytime and nocturnal basal gastric acid secretion. It also inhibits gastric acid secretion stimulated by food, histamine, pentagastrin, caffeine and insulin.


3. Cimetidine is used in condition where inhibition of gastric acid secretion may be beneficial; such conditions include duodenal and gastric ulcers, esophageal reflux, selected cases of persistent dyspepsia, and pathological hypersecretory states, such as Zollinger-Ellison Syndrome.


4. Cimetidine's ability to inhibit acid secretion also means that Cimetidine may be used for the prophylaxis of gastrointestinal hemorrhage as a consequence of stress ulceration and in patients at risk of acid aspiration ( Mendelson's Syndrome ) during general anesthesia.


5. Cimetidine may also be used to reduce malabsorption and fluid loss in patients with the short bowel syndrome and to reduce the degradation of enzyme supplements given to patients with pancreatic insufficiency.


6. Cimetidine is not an anticholinergic agent.


Indication(s)
Treatment of duodenal and gastric ulcer, esophageal reflux disease ( including heartburn and peptic esophagitis ), selected cases of persistent dyspepsia, and pathological hypersecretory states, such as the Zollinger-Ellison Syndrome.


Dosage and Administration
The total daily dose by any route should not normally exceed 2.4g. The usual dose by mouth is 400mg twice daily ( in the morning and at bedtime ). Day-time doses should generally be taken with meals. Other regimens are 200mg, or if necessary 400mg, three times daily with 400mg at bedtime. In the management of duodenal and gastric ulcer, a single daily dose of 800mg by mouth at bedtime is recommended which should be given initially for at least 4 weeks in the case of duodenal and for at least 6 weeks in the case of gastric ulcers.


In reflux esophagitis the recommended dose is 400mg four times daily ( with meals and at bedtime ) for 4 to 8 weeks, and in pathological hypersecretory conditions, such as Zollinger-Ellison Syndrome, a dose of 400mg four times daily may also be required, occasionally increased to a total of 2.4g daily. The dosage of Cimetidine should be reduced in patients with impaired renal function; suggested doses according to creatinine clearance are: creatinine clearance of 0 to 15mL per minute, 200mg twice daily; creatinine clearance of 15 to 30mL per minute, 200mg three times daily, creatinine clearance of over 50mL per minute, normal dosage. A suggested dose of Cimetidine for children over one year of age is 25 to 30mg per kg body weight daily by mouth or parenterally.


Precaution(s) / Warning(s)
Before giving Cimetidine to patients with gastric ulcers, the possibility of malignancy should be excluded since Cimetidine may mask symptoms and delay diagnosis.

 

Cimetidine should be given in reduced dosage to patients with impaired renal function. Cimetidine has been reported to interact with many other drugs but the full clinical significance of some of these interactions has yet to be established since many of the studies have involved healthy subjects given single or subtherapeutic doses. Those interactions which are generally considered to be of clinical importance are with Lignocaine, Phenytoin, Theophylline and Warfarin where the blood concentrations of these drugs may be increased to such a degree that a reduction in their dosage may be necessary. Increased blood concentrations of some antiarrhythmics, some benzodiazepines, some betablockers, and some vasodilators have also been reported.


Use in Pregnancy and Lactation:
Pregnancy: Although studies in humans have not been done, risk-benefit must be considered since animal studies have shown that Cimetidine crosses the placenta. Also, a study in rats exposed to Cimetidine during intrauterine life and the immediate neonatal period showed a hypoandrogenization in adult life with decreased weights of androgen-dependent tissues and decreased concentrations of testosterone.


Lactation: Problems in humans have not been documented; however, Cimetidine is excreted in breast milk and could possibly suppress gastric acidity, inhibit drug metabolism, and cause central nervous system (CNS) stimulation in the nursing infant. It has been found that very high acute and chronic milk/plasma ratios occur with the use of Cimetidine; therefore, the Committee on Drugs of the American Academy of Pediatrics has recommended that Cimetidine not be taken by mothers while they are breast-feeding.


Side Effect(s) / Adverse Reaction(s)
Adverse reactions of Cimetidine are generally infrequent and are usually reversible following a reduction of dosage or withdrawal of therapy. The most common side effects reported are diarrhea, dizziness, tiredness, and rashes.


Contraindication(s)
Contraindicated in patients known to have hypersensitivity to the product.


Symptoms and Treatment for Overdosage, and Antidote(s)
In view of apparent lack of toxicity of Cimetidine in overdosage, it is recommended that treatment should consist of gastric lavage or administration of syrup of ipecacuanha, provided that not more than 4 hours have elapsed since ingestion of the drug, followed by supportive measures and symptomatic treatment only. Forced diuresis is not recommended and, moreover, there appears to be no evidence that it enhances the excretion of Cimetidine from the body.


Storage Condition(s)
Keep in a tight container. Store at temperature below 30C. Protect from light and moisture.


Shelf-Life
4 years from the date of manufacture.


Packing(s)
Plastic bottle of 500's, 1000's and 1500's(for export only).

Plastic bottle of 100's.
Blister packing of 10's x 10, 10's x 50 and 10's x 100.

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