Chemical Waste

Western Medicine CIMETIDINE Tablets B.P. 400mg. (20TABLETS , Aluminum , A white round tablets )

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DESCRIPTION: Cimetidine is 2-Cyano-1-methyl-3[2-(5-methyl-IH-imidazol-4-Methyl)sulphani]etgtk]guanidine.Used as a HistamineH2-receptor antagomist.

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COMPOSITIONl:

Each uncoated tablet contains:Cimetidine B.P. 200/400mg.

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CLINICAL PHARMACOLOGY:Targment competitively inhibits the active histamine at The H2receptor.

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Antisecretory Activity:

1. Acid Secretion: Noctumal Cimetidine 200/400mg. at bed time reduces mean hourly H+activity by greater than 85% over an eight hour period in duodenal ulcer patients, With no effect on daytime acid secretion,.

2. Pepsin:Oral Cimetidine 200/400mg reduces total pepsin output as a result of the Decrease in volume of gastricjuice.

3. Intrinsic Factor: Intrinsic factor secretion was studied with betazole as a stimulant. Oral Cimetidine 200/400mg.inhibits the rise in intrinsic factor concentration produced By betazole but some intrinsic factor was secreted at all times.

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Cimetidine is rapidly absorbed after oral administration and peak levels occur in 45-90 minutes. The half life is approximately 2hours. The principal route of excretion is throughurin.Following a single oral dose 48% of the drug is recovered from the urine after 24 hours as the parent compound.

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INDICATIONS:Treatment and maintenance therapy of active duodenal ulcer.Treatment of benign gastic ulcers.Treatment of reflux oesophagitis.Treatment of pathological hyper secreory conditions(Zollinger-Ellison Syndrome)

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PRECAUTIONS:Before giving cimetidine to patients with glastic ulcers the possibility of malignancy should be considered sine cimetidine may mask symptoms and dely diagnois. It should be givenin reduced dosage to patients with imparired renll function.Intravenous injection of cimetidine should be given slowly and intravenous infusion is recommended in patients with cardiovascular impairment.

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Dosage:Cimetidine should be administered preferably after meals or at bedtime.

Doses should be adjusted to individual patients need & should continue as long as clinically indicated.

Active duodenal ulcer:200/400mg thrice daily for 4-5 weeks.

Maintenance therapy for duodenal ulcer:400mg once or twice daily foe 6 months

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Active duodenal ulcer:200/400ma four times a day.

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Reflux oesophagitis:400mg t.i.d.for 4-8 weeks.

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Pathological hypersecretory conditions(such as Zollinger Ellison syndrome):

200/400mg four times a day or as diected by the physician.

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USES AND ADMINISTRATION:Cimetidine is a histamine H2-receptor antagonist.

Accordingly,it inhibits gastic acid secretion and reduces pepsin out put; it has also been shown to inhibit other actions of histamine mediated by H2-receptors. It is used in conditions where inhibitions of gsatic acid secretion amy be beneficial.Such conditions include peptic ulcer disease,gastrooesophageal reflux disease,selected cases of persistent dyspepsia,pathological hypersecretor stares such as the Zollinger-Ellison syndrome,stress ulceration,and in patients at risk of acid aspiration during general anaesthesia.Cimetidine may also be used to reduce malabsorption and fluid loss in patients with the short bowel syndrome and to reduce the degradation of enzme supplements given to patients with pancreatic insullciency.

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ADVERSE EFFECTS:Adverse reactions to cimetidine are generally infrequent and are usually reversible foolwing a reduction of dosage or withdrawal of therapy.The commonest side-effects reported have been altered bowel habit,dizziness,tiredness,headache and rashes.

Reversible confusional state,especially in the elderly or in seriously ill patients such as those with renal failure, have occasionally occurred. Cimetidine has a week antiandrogenic iffect and gynaecomastia and impotence have also occasionally occurred un men receiving relatively high doses for conditions such as the Zollinger-Ellison syndrome.

Other adverse effects which have been reported rarely are hypersensitivity reactions and fever,arthralgia and myalgia,blood disorders including agranlocytosis and thrombocytopenia,interstitial nephritis,hepatotoxicity and cardiovascular disorders including bardycardia and heart block.

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DRUG INTERACTIONS:Cimetidine may inhibit the hepatic metabolism of may drugs by binding to Cytochrome Althougt may such interactions have been demonstrated,a few are considered clinically significant,notably those with phenytoin,hteopylline,lignocanie and other antiarrhythmica and oral anticoagulants.Reduction in the dosage of some drugs may be required.

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OVERDOSAGE:Overdosage with cimetidine 5.2 ti 20gm including one patient who tookabout 12g daily for 5 days, has not produced serious toxic effects,despite plasma concentration ? of up to 57ug.per mL(peak concentraction after a 200mg dose is reported to be 1ug per mL.) However, an overdose of about 12g produced high pulse rate,dilated pupils,speech disturbances,agitation and disorientation in one patients and respiratory depression in another patient who had chronic shizophremia and was also taking trifluoperazine and hydroxyzine. Also,fatal bradycardia has been reported after overdosage with an unknown amount of cimetidine an diazepam.

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PACKING:Blister strip

20 tablets/box 1000boxes/carton

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Store in a cool,dry & dark place.

Keep away from children.

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