CIMETINE
-
Chemical Name:
Cimetidine -
Therapeutic Category:
Gastro-intestinal drugs -
Pharmacologic Category:
Histamine H2 Antagonist -
Pharmaceutical Form:
Ampoule -
Composition:
Cimetidine 200mg/2ml
CIMETINE
F.C. Tablet & Syrup & Ampoule
Cimetidine
Anti-ulcer
1-PROPERTIES:
Cimetidine is a histamine H2 -receptor antagonist. It inhibits gastric acid secretion and reduces pepsin output, and it has also inhibits other actions of histamine mediated by H2 -receptors.
2-INDICATIONS:
CIMETINE is used in the treatment of:
Peptic ulcers (gastric and duodenal).
Oesophageal reflux,
Selected cases of dyspepsia,
Zollinger-Ellison syndrome.
3-CONTRA – INDICATIONS:
Hypersensitivity to the Cimetidine
4-SIDE EFFECTS:
Cimetidine may cause: diarrhoea, dizziness, arthralgia, skin rashes, hepatotoxicity, agranulocytosis, and impotence.
5-DRUG-INTERACTIONS:
Cimetidine inhibits the metabolism of phenytoin, warfarin and theophylline.
Metoclopramide decreases the bioavailability of Cimetidine.
6-PRECAUTIONS:
Before giving Cimetidine to patients with gastric ulcers, the possibility of malignancy should be excluded.
The dosage of Cimetidine should be reduced in patients with impaired renal function and the doses suggested according to creatinine clearance.
Intravenous infusion of Cimetidine is recommended in patients with cardiovascular disorders.
Intravenous injection of Cimetidine should be given slowly.
7-PREGNANCY AND LACTATION:
Pregnancy Category (B): This drug should be used during pregnancy only if clearly needed.
Caution should be exercised when it is administered to nursing women.
8-DOSAGE & ADMINISTRATION:
ORAL ADMINISTRATION:
Duodenal Ulcer: The dose of choice for most patients is 800 mg at bedtime, as it provides a high healing rate, maximal pain relief, a decreased potential for drug interactions and maximal patient convenience. Patients unhealed at 4 weeks, or those with persistent symptoms, have been shown to benefit from 2-4 weeks of continued therapy.
It has been shown that patient who both have an endoscopically demonstrated ulcer larger than 1 cm and are also heavy smokers (i.e. smoke 20 cigarettes or more per day) are more difficult to heal, where a dose of 1600 mg at bedtime provides an appropriate alternative when it is important to ensure healing within 4 weeks for this subpopulation.
Other CIMETINE regimens which have been shown to be effective are:
- 300 mg four times daily, with meals and at bedtime or
- 400 mg twice daily, in the morning and at bedtime.
While healing with CIMETINE often occurs during the first week or two, treatment should be continued for 4 to 6 weeks unless healing has been demonstrated by endoscopic examination.
Maintenance Therapy for Duodenal Ulcer: In those patients requiring maintenance therapy the recommended adult oral dose is 400 mg at bedtime.
Active Benign Gastric Ulcer:
The recommended adult oral dosage for short-term treatment of active benign gastric ulcer is 800 mg at bedtime or 300 mg four times a day with meals and at bed time, but a dose of 800 mg at bedtime is the preferred regimen for most patients based upon convenience and reduced potential for drug interactions.
Erosive Gastroesophageal Reflux Disease (GERD): The recommended adult oral dosage for the treatment of erosive esophagitis that has been diagnosed by endoscopy is 1600 mg daily in divided doses (800 mg two times daily or 400 mg four times daily) for 12 weeks. The use of CIMETINE for more than 12 weeks has not been established.
Pathological Hypersecretory Conditions (such as Zollinger-Ellison Syndrome): The recommended adult oral dosage is 300 mg four times a day with meals and at bedtime. In some patients, it may be necessary to administer higher doses more frequently. Doses should be adjusted to individual patient needs, but should not usually exceed 2400 mg per day and should continue as long as clinically indicated.
PARENTERAL ADMINISTRATION:
CIMETINE may be given by intravenous or intramuscular injection.
Total daily dose should not exceed 2.4 g.
Adults:
I.M. injection: One ampoule (200 mg) may be repeated every 4-6 hours.
I.V. injection: One ampoule should be given slowly and may be repeated every 4-6 hours. If larger dose is required, intravenous infusion is recommended.
(400 mg in 100 ml of sodium chloride 0.9 %) given over 30 minutes to 1 hour and repeated every 4-6 hours if necessary.
Children:
25-30 mg per kg body weight daily in divided doses.
9-PACKING & COMPOSITION:
- Film Coated Tablet:
CIMETIDINE-200
Pack of 20 Tablets
Each tablet contains 200 mg Cimetidine.
CIMETIDINE-300
Pack of 20 Tablets
Each tablet contains 300 mg Cimetidine.
CIMETIDINE-400
Pack of 20 Tablets
Each tablet contains 400 mg Cimetidine.
-Syrup:
CIMETIDINE
Bottle of 100 ml
Each 5 ml contains 300 mg Cimetidine.
-Ampoule:
CIMETIDINE
Packs of 5 or 25 Ampoules
Each ampoule (2 ml) contains 200 mg Cimetidine (HCl).