Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Glaxo Wellcome UK Limited, Trading as GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT
Duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents.
Prevention of non-steroidal anti-inflammatory drug (NSAID) (including aspirin) associated duodenal ulcers, especially in patients with a history of peptic ulcer disease.
Treatment of duodenal ulcers associated with Helicobacter pylori infection.
Post-operative ulcer.
Oesophageal reflux disease including long term management of healed oesophagitis.
Symptomatic relief in gastro-oesophageal reflux disease.
Zollinger-Ellison Syndrome.
Chronic episodic dyspepsia, characterised by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but not associated with the above conditions.
Prophylaxis of gastrointestinal haemorrhage from stress ulceration in seriously ill patients
Prophylaxis of recurrent haemorrhage with bleeding peptic ulcers.
Before general anaesthesia in patients at risk of acid aspiration (Mendelson’s syndrome), particularly obstetric patients during labour.
For appropriate cases, Zantac injection is also available (see separate SPC).
Short term treatment of peptic ulcer
Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.
Usual dosage is 150 mg twice daily, taken in the morning and evening.
The standard dosage regimen is 150 mg twice daily or 300 mg at night. 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 within 4 weeks. Healing usually occurs after a further 4 weeks of treatment in those not fully healed after the initial course of therapy.
8 weeks treatment may be necessary
150 mg twice daily may be given concomitantly with NSAID therapy.
In duodenal ulcer, 300 mg twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with ranitidine 150 mg twice daily or 300 mg at night. The increased dose has not been associated with an increased incidence of unwanted effects.
For duodenal ulcers associated with Helicobacter pylori infection, ranitidine 300 mg at bedtime or 150 mg twice daily may be given with oral amoxicillin 750 mg three times daily and metronidazole 500 mg three times daily for two weeks. Therapy with ranitidine should continue for a further two weeks. This dose regimen significantly reduces the frequency of duodenal ulcer recurrence.
Maintenance treatment at a reduced dosage of 150 mg at bedtime is recommended for patients who have responded to short term therapy, particularly those with a history of recurrent ulcer.
Symptom relief in gastro-oesophageal reflux disease. In patients with gastro-oesophageal reflux disease, a dose regimen of 150 mg twice daily for 2 weeks is recommended and this can be repeated in patients in whom the initial symptomatic response is inadequate
In the management of oesophageal reflux disease, the recommended course of treatment is either 150 mg twice daily or 300 mg at bedtime for up to 8 weeks or 12 weeks if necessary.
In patients with moderate to severe oesophagitis, the dosage of ranitidine may be increased to 150 mg 4 times daily for up to 12 weeks. The increased dose has not been associated with an increased incidence of unwanted effects.
For long term treatment, recommended adult dose is 150 mg twice daily. Long term treatment is not indicated in management of patients with unhealed oesophagitis with or without Barrett’s epithelium.
The starting dose for Zollinger-Ellison syndrome is 150 mg three times daily, and this may be increased as necessary. Doses up to 6 grams per day have been well tolerated.
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 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.
150 mg oral dose can be given 2 hours before anaesthesia, and preferably also 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. The usual precautions to avoid acid aspiration should also be taken.
For children 12 years and over the adult dosage is given.
See section 5.2 Pharmacokinetic properties (Other special Populations)
See section 5.2 Pharmacokinetic properties (Other special populations)
The recommended oral dose for the treatment of peptic ulcer in children is 4 mg/kg/day to 8 mg/kg/day administered as two divided doses to a maximum of 300 mg ranitidine per day for a duration of 4 weeks. For those patients with complete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment.
The recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5 mg/kg/day to 10 mg/kg/day administered as two divided doses to a maximum of 600 mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms).
Safety and efficacy in new-born patients has not been established.
Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with renal impairment (creatinine clearance less than 50 ml/min). Accordingly, it is recommended that the daily dose of ranitidine in such patients should be 150 mg at night for 4-8 weeks. The same dose should be used for maintenance treatment, if necessary. If an ulcer has not healed after treatment, 150 mg twice daily dosage should be instituted followed, if need be, by maintenance treatment of 150 mg at night.
For oral administration.
Ranitidine is very specific in action and accordingly no particular problems are expected following overdosage.
Symptomatic and supportive therapy should be given as appropriate.
Shelf life: 36 months.
Store below 25°C. Store in the original package in order to protect from moisture.
Cartons of 30, 60 or 90 tablets, in aluminium foil strips or push through double foil blister packs.
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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