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Cimulcer

COMPOSITION
CIMULCER TABLETS 200 mg
Each tablet contains : Cimetidine 200 mg
CIMULCER TABLETS 400 mg
Each tablet contains : Cimetidine 400 mg

DOSAGE FORM AVAILABLE
TABLET

PRODUCT DESCRIPTION
CIMULCER TABLETS 200 mg
Round, biconvex, green film-coated tablet, impressed BIOLAB's logo on one face.
CIMULCER TABLETS 400 mg
Oblong, biconvex, green film-coated tablet, impressed "BIOLAB" on one face and "400" on the other face.

ACTIONS
Pharmacological actions:

CIMULCER (Cimetidine) is a histamine H2-receptor antagonist.

 

Mechanism of action:

Cimetidine competitively inhibits the action of histamine on the H2-receptors of parietal cells, reducing gastric output and concentration under basal conditions and also stimulated by food, insulin, histamine, pentagastrin and caffeine.

Pharmacokinetics :
Absorption : Cimetidine is rapidly and well absorbed following oral administration.

A small portion of orally administered is metabolized during first pass through the liver, resulting in an average bioavailability of 60-70% when compared to IV route.

Distribution : Cimetidine is widely distributed throughout the body and is 15-20% bound to plasma proteins. It is distributed into milk.

Elimination : Cimetidine is metabolized in the liver to sulfoxide and 5-hydroxy methyl derivatives. It has a plasma half life about 2 hours in patients with normal renal function, 2.9 hours in patients with creatinine clearance of 20-50 ml per minute, 3.7 hours in patients with creatinine clearances of less than 20 ml per minute and 5 hours in anephric patients. It is excreted in urine within 24 hours.

INDICATIONS
For the treatment of gastric and duodenal ulcers. Other conditions associated with gastric hyperacidity i.e. Zollinger-Ellison syndrome.

DOSAGE AND ADMINISTRATIONS
Gastric and Duodenal Ulcer :
Adults : 200 mg 3 time daily after meals and 400 mg at bedtime or 400 mg twice daily at breakfast and at bedtime or 800 mg once daily at bedtime for 4-6 weeks or as directed by the physician.

Zollinger-Ellison Syndrome :
Adults : 200-400 mg, 3-4 times a day after meals and 400 mg at bedtime.

OVERDOSAGE
A patient who took about 12 g of Cimetidine had slurred speech, high pulse-rate, and dilated pupils. Five hours after gastric lavage he was confused, agitated, disorientated and making staccato nonsensical conversation. He recovered from these mental symptoms the next day. There were no changed in ECG,
blood indexes, liver or kidney.

CONTRAINDICATIONS
Cimetidine is contraindicated in the patients who are known to have hypersensitivity to the drug.

PRECAUTIONS AND WARNINGS
CIMULCER should not be used in pregnancy and lactation. It should be given with care and in reduced dosage to patients with impaired renal function.

SIDE EFFECTS/ADVERSE REACTIONS
Mild diarrhoea, muscle pain, dizziness, and skin rash may occasionally occur.

DRUG INTERACTIONS
Cimetidine, as enzyme inhibitor of hepatic microsomal enzyme system, reduces the hepatic metabolism of some drugs including coumarin anticoagulant, phenytoin, propranolol, some benzodia-zepines, lidocaine, theophylline, metronidazole, and triamterene, thereby decreasing elimination and increasing plasma concentration of these drugs bioavailability of drugs with high hepatic extraction ratios.

STORAGE
Store at temperature not exceeding 30C.
Keep medicine out of reach of children.

The shelf-life period is 5 years

SUPPLY
CIMULCER TABLETS 200 mg
Blister pack in printing box of 50x10's.
Bottle of 1,000's.

CIMULCER TABLETS 400 mg
Blister pack in printing box of 10x10's.
Bottle of 500's.

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