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Pacidine

Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name

Pacidine

Manufacturer

Baroque Pharmaceuticals Pvt. Ltd, Sokhada-388 620, Ta. Khambhat, Gujarat, India. Mfg. Lic. No G/1217.

Therapeutic Class

Antiulcerants, H2-receptor antagonists (H2RA)

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: 04-3714): Cimetidine 400 mg.

How to Identify the Product: White, oblong film coated tablet.

Pharmacology

Pacidine 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.

Pacidine 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 bioavaliability of cimetidine following oral administration is about 60% due to first pass metabolism.

Pacidine is eliminated primarily by the kidneys.

Indications

Treatment of duodenal and gastric ulcers, oesophageal reflux, selected cases of persistent dyspepsia and pathological hypersecretory states, e.g. Zollinger-Ellison syndrome.

Cimetidine is also used for the prevention of stress ulcer in patients at risk of gastrointestinal haemorrhage, reducing the risk of pulmonary damage caused by aspirating gastric contents in patients during general anaesthesia.

It may also be used to reduce malabsorption and fluid loss in patients with the short bowel syndrome and as an adjunct to enzyme supplement therapy to patients with pancreatic insufficiency to reduce the degradation of the enzyme.

It is also used for the treatment of NSAID-induced lesions (ulcer erosions) and prevention of their recurrence in patients needing continued NSAID therapy.

Contra-indications

Known hypersensitivity to cimetidine.

Should not be administred to pregnant or lactating patients.

Precautions/Warnings

Cimetidine treatment may mask the symptoms and allow transient healing of gastric cancer and delay diagnosis.

It should be given in reduced dosage to patients with impaired renal function.

Use in pregnancy & lactation:

Avoid use of Pacidine during pregnancy and lactation, unless the benefits outweighs the risks.

Interactions

Cimetidine has been reported to interact with many drugs but few of these interactions are considered to be of clinical significance. Reduction in the dosage of some drugs, e.g. Cyclosporin, Lignocaine, Nifedipine, Phenytoin, Suxamethonium, Theophylline and Warfarin may be needed.

Adverse Effects

Adverse effects of cimetidine are generally infrequent and are usually reversible following a reduction of dosage or withdrawal of therapy. The common side effects which have been reported are diarrhea, dizziness, tiredness, headache and rashes.

Confusional states, reversible within a few days of withdrawing cimetidine, have been reported rarely, usually in elderly or seriously ill patients.

Gynecomastia has been reported in some male patients receiving relatively high dosage for conditions, e.g. Zollinger-Ellison syndrome.

Other adverse effects which have been reported rarely are impotence in men, blood disorders, e.g. agranulocytosis or neutropenia and thrombocytopenia, interstitial nephritis, hepatotoxicity and cardiovascular disorders.

Dosage & Administration

Adults:

Treatment of duodenal and generic ulcers: 800 mg daily at bedtime for at least 4 weeks in the case of duodenal and at least 6 weeks for gastric ulcers. A maintenance dose of 400 mg may be given once at bedtime or both in the morning and at bedtime.

Oesophageal reflux disease: 400 mg 4 times daily with meals and at bedtime for 4-8 weeks.

Pathological hypersecretion: 400 mg 4 times daily may be required, occasionally increased to the total of 2.4 g daily

Management of patients at risk from stress-related ulceration of upper gastrointestinal tract: 200 mg or 400 mg every 4-6 hours.

In patients at risk of developing the acid aspiration syndrome during general anaesthesia: 400 mg may be given 90-120 min before the induction of anaesthesia or at the start of labour.

As an adjunct to enzyme supplement therapy in patients with pancreatic insufficiency: 0.8-1.6 g daily in 4 divided doses, 60-90 min before meals.

Treatment of NSAID-induced lesions: 800 mg at bedtime or 400 mg twice daily.

Treatment should be given for at least 4 weeks. Recurrence of lesion may be prevented by Cimetidine 400 mg at bedtime for patients needing continued NSAID therapy.

Children (>1 year):

25-30 mg/kg body weight daily in divided doses

In patients with impaired renal function, dosage should be reduced according to creatinine clearance:

 Creatinine clearance (mL/min)    Dosage 
0-15  200 mg twice daily
15-30 200 mg 3 times daily
30-50 200 mg 4 times daily 
>50 Normal dosage

Storage/Handling Recommendations

Store below 25ºC. Protect from light and out of reach of children.

Review Date

2016-12-02 19:17:04