INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ADCO-CIMETIDINE 200 mg TABLETS
ADCO-CIMETIDINE 400 mg TABLETS
ADCO-CIMETIDINE 800 mg TABLETS
SCHEDULING STATUS:
S3

PROPRIETARY NAME:
(and dosage form)

ADCO-CIMETIDINE 200 mg TABLETS
ADCO-CIMETIDINE 400 mg TABLETS
ADCO-CIMETIDINE 800 mg TABLETS

COMPOSITION:
Each ADCO-CIMETIDINE 200 mg Tablet (green, round tablet) contains 200 mg cimetidine.
Each ADCO-CIMETIDINE 400 mg Tablet (green, oblong tablet) contains 400 mg cimetidine.
Each ADCO-CIMETIDINE 800 mg Tablet (green, elliptical tablet) contains 800 mg cimetidine.

PHARMACOLOGICAL CLASSIFICATION:
A 11.4.3 Antacids : Other.

PHARMACOLOGICAL ACTION:
ADCO-CIMETIDINE inhibits basal (fasting) and nocturnal gastric acid secretion and reduces pepsin output by competitive inhibition of the action of histamine at the histamine H2-receptors of the parietal cells. ADCO-CIMETIDINE also inhibits gastric secretion elicited by muscarinic agonists or by gastrin, although this effect is not always complete. It reduces both the volume of gastric juice secreted and its hydrogen ion concentration.
After oral administration, peak plasma concentrations are obtained in about 1 to 2 hours. The bioavailability of cimetidine following oral administration is about 60% due to first pass metabolism. ADCO-CIMETIDINE is eliminated primarily by the kidneys.

INDICATIONS:
Duodenal ulcer
Gastric ulcer
Reflux oesophagitis
Upper gastrointestinal bleeding
Hypersecretory states associated with systemic mastocytosis or basophilic leukemia with hyperhistaminemia or Zollinger - Ellison syndrome.

CONTRA-INDICATIONS:
Sensitivity to cimetidine or related agents.
Should not be administered to pregnant or lactating patients.

DOSAGE AND DIRECTIONS FOR USE:
Since ADCO-CIMETIDINE may not always give immediate symptomatic relief, antacids should be made available to patients as needed for relief of pain.
Duodenal Ulcer:
Usual dose:        200 mg, or if necessary 400 mg three times a day with meals and 400 mg at bedtime.
Other regimens: 400 mg twice daily, with breakfast and at bedtime or
  800 mg at bedtime.
Treatment should be continued for at least four weeks.
Maintenance Treatment: 400 mg at bedtime
  Some patients may require 400 mg twice a day.
Gastric Ulcer:
Usual dose:        200 mg, or if necessary 400 mg three times a day
  with meals and 400 mg at bedtime.
Other regimens: 400 mg twice daily, with breakfast and at bedtime or
  800 mg at bedtime.
Treatment should be continued for at least six weeks.
Zollinger-Ellison syndrome and other cases of high gastric secretion:
Usual dose: 200 mg, or if necessary 400 mg three times a day with meals and 400 mg at bedtime.
In some patients, it may be necessary to administer ADCO-CIMETIDINE more frequently. Doses should be adjusted to individual needs and should continue as long as clinically indicated.
Reflux Oesophagitis:
400 mg four times a day, taken with meals and at bedtime for up to 12 weeks.
Upper Gastrointestinal Bleeding:
200 mg, or if necessary 400 mg three times a day with meals and 400 mg at bedtime.
Dosage in impaired renal function:
The dosage of ADCO-CIMETIDINE should be reduced in patients with impaired renal function, suggested doses according to creatinine clearance are:
Creatinine clearance Dose
0 - 15 mL/minute 200 mg twice daily
15 - 30 mL/minute 200 mg three times daily
30 - 50 mL/minute 200 mg four times daily
>50 mL/minute normal dosage
Children:
Clinical experience with ADCO-CIMETIDINE in children is limited. Not recommended for use in children.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-Effects:
Diarrhoea, dizziness, tiredness, headache and rashes have been reported.
Reversible confusional states, especially in the elderly or in seriously ill patients such as those with renal failure, have occurred.
Adco-Cimetidine has an anti-androgenic effect and gynaecomastia and impotence have occurred in men receiving relatively high doses for conditions such as the Zollinger - Ellison syndrome.
Allergic reactions, arthralgia and myalgia, blood disorders including agranulocytosis or granulocytopenia and thrombocytopenia, interstitial nephritis, hepatotoxicity and pancreatitis have been reported.
Special Precautions:
Before giving Adco-Cimetidine to patients with gastric ulcers the possibility of malignancy should be excluded since cimetidine may mask symptoms and delay diagnosis.
Adco-Cimetidine should be given in reduced dosage to patients with impaired renal function. See "Dosage and Directions for Use".
Adco-Cimetidine should not be administered to pregnant or lactating patients.

INTERACTIONS:
Adco-Cimetidine binds to cytochrome P-450 and thereby diminishes the activity of the hepatic microsomal mixed-function oxidases. As a result other therapeutic agents may accumulate during treatment with Adco-Cimetidine. Medicines whose metabolism is affected include warfarin, phenytoin, theophylline, phenobarbital, diazepam (or other benzodiazepines), propranolol (or other beta-blockers) and imipramine.
Adco-Cimetidine reduces hepatic blood flow which slows the clearance of drugs such as lignocaine.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions".
Treatment is symptomatic and supportive.

IDENTIFICATION:
ADCO-CIMETIDINE 200 mg - green, round tablet, embossed with ADCO on one side.
ADCO-CIMETIDINE 400 mg - green, oblong tablet
ADCO-CIMETIDINE 800 mg - green, elliptical tablet

PRESENTATION:
ADCO-CIMETIDINE is available as:
200 mg tablets in securitainers of 60, 150 and 250 and in amber glass bottles of 250
400 mg tablets in securitainers of 60
800 mg tablets in securitainers of 30

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light. Keep tightly closed, out of reach of children.

REGISTRATION NUMBER:
ADCO-CIMETIDINE 200 mg Tablets: Y/11.4.3/426
ADCO-CIMETIDINE 400 mg Tablets: Y/11.4.3/427
ADCO-CIMETIDINE 800 mg Tablets: Y/11.4.3/428

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Adcock Ingram Limited
Adcock Ingram Park
17 Harrison Avenue
Bryanston, 2021
Private Bag X 69, Bryanston, 2021

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13 December 1991

New addition to this site: April 2004
Source: Pharmaceutical Industry

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