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Peptacid

Afrab-Chem Ltd
No. 22, Abimbola Street, Isolo Industrial Estate, Isolo, P.O. Box 1647, Lagos, Nigeria.
Email: info@afrabchem.com
Tel: 234-1-2700057
Fax: 234-1-4520328
Website: http://afrabchem.com/

Brand Name

Peptacid

Manufacturer

Joswe Medicals, Na'ur Jordan

Therapeutic Class

Antiulcerants, H2-receptor antagonists (H2RA)

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Effervescent tablet (NRN:04-0760): Each tablet contains: Ranitidine 150 mg (as HCl).

Effervescent tablet (NRN:04-8902): Each tablet contains: Ranitidine 75 mg (as HCl).

Pharmacology

Ranitidine is a specific, rapidly acting histamine H2 antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of the secretion. Ranitidine has a relatively long duration of action and so a single 150 mg dose effectively suppresses gastric acid secretion for twelve hours.

Pharmacokinetics:

Absorption of ranitidine after oral administration is rapid and peak plasma concentrations are usually achieved within two hours of administration. Absorption is not significantly impaired by food or antacids. The elimination half-life of ranitidine is approximately two hours. Ranitidine is excreted via the kidneys mainly as the free drug and in minor amounts as metabolites. Its major metabolite is N-oxide and there are smaller quantities of S-oxide and desmethyl ranitidine. The 24-hour urinary recovery of free ranitidine and its metabolites is about 40% with orally administered drug.

Use in renal transplants: Ranitidine has been used without adverse effects in patients with renal transplants.

Indications

Peptacid 150 effervescent tablets are indicated for the treatment of duodenal ulcers, benign gastric ulcer, post-operative ulcer, reflux oesophagitis, Zollinger-Ellison syndrome, and the following conditions where reduction of gastric secretion and acid output is desirable:

Prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients; Prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers and before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's syndrome), particulary obstetric patients during labor.

Contra-indications

Hypersensitivity to ranitidine.

This product contains aspartame as sweetener, not to be used by phenylketonurics.

Precautions/Warnings

Treatment with a histamine H2-antagonist may mask symptoms associated with carcinoma of the stomach and may therefore delay diagnosis of the condition. Accordingly, where gastric ulcer is suspected, the possibility of malignancy should be excluded before therapy with Ranitidine is instituted.

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal failure. Accordingly, it is recommended that the therapeutic regimen for Ranitidine in such patients be 150 mg at night for 4 to 8 weeks. The same dose should be used for maintenance treatment should this be deemed necessary. If an ulcer has not healed after treatment, the standard dosage regimen of 150 mg twice daily should be instituted and followed, if need be, by maintenance treatment of 150 mg at night.

Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without any adverse effect on labour, delivery or subsequent neonatal progress. Ranitidine is also excreted in human milk. Like other drugs, Ranitidine should only be used during pregnancy and nursing if considered essential.

Interactions

Ranitidine does not inhibit the hepatic cytochrome P450 linked mixed function oxygenase system. Accordingly, ranitidine does not potentiate the actions of drugs, which are inactivated by this enzyme. These include diazepam, lignocaine, phenyton, propranolol, theophylline and warfarin.

Adverse Effects

The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to ranitidine therapy has not been established in many cases. Transient and reversible changes in liver function tests can occur.

There have been occasional reports of reversible hepatitis (hepatocellular, hepatocanicular or mixed) with or without jaundice. Reversible leucopenia and thrombocytopenia have occurred rarely in patients on ranitidine. Hypersensitivity reactions (urticaria, angioneurotic oedema, bronchospasm hypotension) have been seen rarely following the parenteral and oral administration of ranitidine. These reactions have occasionally occurred after a single dose.

Rare reports have occurred of bradycardia. Headache, sometimes severe, and dizziness have been reported in a very small proportion of patients. Rare cases of reversible mental confusion have been reported, predominantly in severely ill and elderly patients. Skin rash has been rarely reported.

No clinically significant interference with endocrine or gonadal function has been reported. There have been a few reports of breast symptoms in men taking ranitidine.

Use in elderly patients: Rates of healing of ulcers in clinical trial patients aged 65 and over have not been found to differ from those in younger patients. Additionally, the incidence of adverse events was not different in elderly and younger patients.

Dosage & Administration

Adult: The usual dosage is one 150 mg effervescent tablet twice daily, taken in the morning and evening. Alternatively, patients with duodenal or gastric ulcerations may be treated with a single bedtime dose of 300 mg. It is not necessary to time the dose in relation to meals. In most cases of duodenal ulcer, benign gastric ulcer and post-operative ulcer, healing occurs in four weeks. Healing usually occurs after a further 4 weeks of treatment in those patients whose ulcers have not fully healed after the initial course of therapy.

Maintenance treatment at a reduced dosage of one 150 mg effervescent tablet at bedtime is recommended for patients who have responded to short-term therapy, particularly those with a history of recurrent ulcer. In the management of reflux oesophagitis, the recommended course of treatment is one 150 mg effervescent tablet twice daily for up to 8 weeks. In patients with Zollinger-Ellison syndrome, the starting dose is 150 mg three times daily and this may be increased as necessary. Patients with this syndrome have been given increasing doses up to 6 g per day and these doses have been well tolerated.

In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, treatment with Ranitidine effervescent tablets 150 mg twice daily may be substituted for Ranitidine injection once oral feeding commences in patients considered to be still at risk from these conditions.

In patients thought to be at risk of acid aspiration syndrome, an oral dose of 150 mg can be given 2 hours before induction of general anaesthesia, and preferably also a 150 mg effervescent tablet the previous evening.

In obstetric patients at commencement of labor, an oral dose of 150 mg may be given followed by 150 mg at six hourly intervals. It is recommended that since gastric emptying and drug absorption are delayed during labor, any patient requiring emergency general anaesthesia should be given, in addition, a non-particulate antacid (e.g sodium citrate) prior to induction of anaesthesia. The usual precaution to avoid aspiration should also be taken.

Children: Experience with Ranitidine in children is limited and such use has not been fully evaluated in clinical studies. It has, however, been used successfully in children aged 8-18 years in doses up to 150 mg twice daily without adverse effects.

Preparation of Peptacid Effervescent tablets: Dissolve each dose in approximately 200 mL of water before drinking.

Overdosage:

Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If need be, the drug may be removed from the plasma by haemodialysis.

Storage/Handling Recommendations

Store in a dry place below 30ºC.

Keep out of the reach of children.

Review Date

2015-08-19 10:27:23