Zantac

Zantac Dosage/Direction for Use

ranitidine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
General Information: Syrup: ZANTAC syrup contains approximately 7.5% w/v ethanol (alcohol), i.e. up to 405 mg per 5ml spoonful (approximately a teaspoonful) which is equivalent to about 11 ml of beer or 5 ml of wine.
Populations: Adults/Adolescents (12 years and over): Oral Formulations: Duodenal Ulcer and Benign Gastric Ulcer: Acute treatment: The standard dosage regimen for duodenal or benign gastric ulcer is 150 mg twice daily or 300 mg once nightly. In most cases of duodenal ulcer, or benign gastric ulcer healing occurs within 4 weeks. Healing usually occurs after a further 4 weeks in those not fully healed after the initial 4 weeks.
In duodenal ulcer 300 mg twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with ZANTAC 150 mg twice daily or 300 mg once nightly. The increased dose has not been associated with an increased incidence of unwanted effects.
Long-term management: For the long-term management of duodenal or benign gastric ulcer the usual dosage regimen is 150 mg once nightly.
Smoking is associated with a higher rate of duodenal ulcer relapse, and such patients should be advised to stop smoking. In those who fail to comply with such advice a dose of 300 mg once nightly provides additional therapeutic benefit over the 150 mg dosage regimen.
NSAID Associated Peptic Ulceration: Acute treatment: In ulcers following non-steroidal anti-inflammatory drug therapy, or associated with continued non-steroidal anti-inflammatory drugs, 8 to 12 weeks treatment may be necessary with 150 mg twice daily or 300 mg once nightly.
Prophylaxis: For the prevention of non-steroidal anti-inflammatory drug associated duodenal ulcers ZANTAC 150 mg twice daily may be given concomitantly with non-steroidal anti-inflammatory drug therapy.
Duodenal Ulcer Associated with Helicobacter Pylori Infection: ZANTAC 300 mg once nightly or 150 mg twice daily may be given with oral amoxicillin 750 mg 3 times daily and metronidazole 500 mg 3 times daily for 2 weeks. Therapy with ZANTAC only should continue for a further 2 weeks. This dose regimen significantly reduces the frequency of duodenal ulcer recurrence.
Post-Operative Ulcer: The standard dosage regimen for post-operative ulcer is 150 mg twice daily.
Most cases heal within 4 weeks. Those not fully healed after the initial 4 weeks usually do so after a further 4 weeks.
Gastro-Oesophageal Reflux Disease: Acute treatment: In reflux oesophagitis 150 mg twice daily or 300 mg once nightly is administered for up to a period of 8, or if necessary, 12 weeks.
In patients with moderate to severe oesophagitis, the dosage of ZANTAC may be increased to 150 mg 4 times daily for up to 12 weeks.
Long-term management: For the long-term management of reflux oesophagitis the recommended adult oral dose is 150 mg twice daily.
Symptom relief: For the relief of symptoms associated with oesophageal acid reflux, the recommended regimen is 150 mg twice daily for 2 weeks. This regimen may be continued for a further 2 weeks in those patients in whom the initial response is inadequate.
Zollinger-Ellison Syndrome: The initial dosage regimen for Zollinger-Ellison syndrome is 150 mg 3 times daily, but this may be increased as necessary. Doses up to 6 g per day have been well tolerated.
Chronic Episodic Dyspepsia: The standard dosage regimen for patients with chronic episodic dyspepsia is 150 mg twice daily for up to 6 weeks. Anyone not responding or relapsing shortly afterwards should be investigated.
Prophylaxis of Mendelson's Syndrome: 150 mg 2 hours before anaesthesia, and preferably 150 mg the previous evening. Alternatively, the injection is also available. In obstetric patients in labour 150 mg every 6 hours, but if general anaesthesia is required it is recommended that a non-particulate antacid (e.g. sodium citrate) be given in addition.
Prophylaxis of Haemorrhage from Stress Ulceration in Seriously Ill Patients or Prophylaxis of Recurrent Haemorrhage in Patients Bleeding from Peptic Ulceration: 150 mg twice daily may be substituted for the injection once oral feeding commences.
Injection: ZANTAC Injection may be given as: A slow (over 2 minutes) intravenous (i.v.) injection of 50 mg, diluted to a volume of 20 ml, every 6 to 8 hours.
An intermittent i.v. infusion at 25 mg/h for 2 hours, repeated at 6 to 8 hours intervals.
An intramuscular (i.m.) injection of 50 mg every 6 to 8 hours.
Prophylaxis of Mendelson's Syndrome: For prophylaxis of Mendelson's syndrome 50 mg by i.m. or slow i.v. injection 45 to 60 minutes before induction of general anaesthesia.
Prophylaxis of Haemorrhage from Stress Ulceration in Seriously Ill Patients or Prophylaxis of Recurrent Haemorrhage in Patients Bleeding from Peptic Ulceration: In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences. Patients considered to be still at risk may then be treated with ZANTAC tablets 150 mg twice daily.
In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients, a priming dose of 50 mg as a slow i.v. injection followed by a continuous i.v. infusion of 0.125-0.250 mg/kg/h may be preferred.
Prophylaxis of Stress Ulceration in Seriously Ill Patients: Patients over 50 years of age: (see Pharmacology: Pharmacokinetics: Special Patient Populations: Patients over 50 years of age under Actions)
Renal Impairment: Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with renal impairment (creatinine clearance less than 50 ml/min). It is recommended that the daily dose of oral ZANTAC in such patients should be 150 mg, and that ZANTAC injection be administered in doses of 25 mg.
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