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RANITIDINE is a brand name for Ranitidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Duodenal ulcer and benign gastric ulcer, including that associated with non- steroidal anti-inflammatory agents. Prevention of NSAID associated duodenal ulcers. Treatment of duodenal ulcers associated with Helicobacter pylori infection. Post-operative ulcer. Oesophageal reflux disease including long term…
Verbatim from this product's MHRA label. Tap a section to expand.
For oral administration.
Adults (including the elderly) / Adolescent (12 years and over):
The usual dosage is 150mg twice daily, taken in the morning and evening.
Duodenal ulcer, gastric ulcer:
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 in 4 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. Ulcers following NSAID therapy or associated with continued NSAIDs: 8 weeks’ treatment may be necessary.
Prevention of NSAID associated duodenal ulcers: 150 mg twice daily may be given concomitantly with NSAID therapy. In duodenal ulcer 300mg twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with ranitidine 150mg twice daily or 300mg at night.
The increased dose has not been associated with an increased incidence of unwanted effects.
Duodenal ulcers associated with Helicobacter pylori infection:
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.
Gastro-oesophageal reflux disease:
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.
The following convention has been utilised for the classification of undesirable effects: Very common (> 1/10), Common > 1/100 to < 1/10), Uncommon >1/1,000 to < 1/100) Rare (> 1/10,000 to < 1/1,000), Very rare (< 1/10,000), not known (frequency cannot be estimated from the available data).
Adverse event frequencies have been estimated from spontaneous reports from post-marketing data.
Blood & Lymphatic System Disorders Very Rare:
Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.
Immune System Disorders Rare:
Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).
Very Rare:
Anaphylactic shock Unknown: dyspnoea These events have been reported after a single dose.
Psychiatric Disorders Very Rare:
Reversible mental confusion, depression and hallucinations. These have been reported predominantly in severely ill patients, in elderly and in nephropatic patients.
Nervous System Disorders Very Rare:
Headache (sometimes severe), dizziness and reversible involuntary movement disorders.
Eye Disorders Very Rare:
Reversible blurred vision. There have been reports of blurred vision, which is suggestive of a change in accommodation.
Cardiac Disorders Very Rare:
The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer [and if indications include dyspepsia; patients of middle age and over with new or recently changed dyspeptic symptoms must be included] as treatment with ranitidine may mask symptoms of gastric carcinoma.
Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with renal impairment. 2 in Renal impairment. Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria.
In patients such as the elderly, persons with chronic lung disease, diabetes or the immuno-compromised, there may be an increased risk of developing community acquired pneumonia. 64). 8). Regular supervision of patients who are taking non-steroidal anti- inflammatory drugs concomitantly with ranitidine is recommended, especially in the elderly and in those with a history of peptic ulcer.
Ranitidine products are contraindicated in patients known to have hypersensitivity to any component of the preparation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ranitidine in United Kingdom.
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Oesophageal reflux disease 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 150mg four times daily for up to 12 weeks.
The increased dose has not been associated with an increased incidence of unwanted effects.
Healed oesophagitis:
For long term treatment, the recommended adult oral dose is 150mg twice daily. Long-term treatment is not indicated in the management of patients with unhealed oesophagitis, with or without Barrett’s epithelium. Zollinger-Ellison syndrome In patients with Zollinger-Ellison syndrome, the starting dose is 150mg three times daily and this may be increased as necessary.
Patients with this syndrome have been given increasing doses up to 6 g daily and these doses have been well tolerated.
Chronic episodic dyspepsia:
For patients with chronic episodic dyspepsia the recommended course of treatment is 150mg twice daily for up to 6 weeks. Anyone not responding or relapsing shortly afterwards should be investigated. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration.
Prophylaxis of acid aspiration (Mendelson's syndrome):
In patients thought to be at risk of acid aspiration (Mendelson’s) syndrome an oral dose of 150mg can be given 2 hours before induction of general anaesthesia, and preferably also 150mg the previous evening. In obstetric patients at commencement of labour, an oral dose of 150mg may be given followed by 150mg at 6 hourly intervals.
It is recommended that since gastric emptying and drug absorption are delayed during labour, any patient requiring emergency general anaesthesia should be given, in addition, a non-particulate antacid (eg sodium citrate) prior to induction of anaesthesia.
The usual precautions to avoid acid aspiration should also be taken. Children 12 years and over For children 12 years and over the adult dosage is given. 2 Pharmacokinetic Properties - Special Patient Populations. Peptic Ulcer Acute Treatment The recommended oral dose for the treatment of peptic ulcer in children is 4mg/kg/day to 8mg/kg/day administered as two divided doses to a maximum of 300mg ranitidine per day for a duration of 4 weeks.
For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment. Gastro-Oesophageal Reflux The recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5mg/kg/day to 10mg/kg/day administered as two divided doses to a maximum dose of 600mg (the maximum dose is likely to apply to heavier children or adolescents with severe symptoms).
Neonates Safety and efficacy in new-born patients has not been established. 2 Pharmacokinetic Properties (Special Patient Populations, Patients over 50 years of age) Renal Impairment: 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.
As with other H2 receptor antagonists bradycardia, A-V block and tachycardia (for all formulations).
Vascular Disorders Very Rare:
Vasculitis.
Gastrointestinal Disorders Very Rare:
Acute pancreatitis, diarrhoea Uncommon: abdominal pain, , constipation, nausea (these symptoms mostly improved during continued treatment).
Hepatobiliary Disorders Rare:
Transient and reversible changes in liver function tests.
Very Rare:
Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.
Skin and Subcutaneous Tissue Disorders Rare:
Skin rash.
Very Rare:
Erythema multiforme, alopecia.
Musculoskeletal and Connective Tissue Disorders Very Rare:
Musculoskeletal symptoms such as arthralgia and myalgia.
Renal and Urinary Disorders Very rare:
Acute interstitial nephritis. Rare: elevation of plasma creatinine (usually slight; normalised during continued treatment) Reproductive System and Breast Disorders Very Rare: Reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea) Paediatric population: The safety of ranitidine has been established in children aged 0-16 years with gastric acid-related disease and was generally well tolerated with an adverse event profile resembling that in adults.
There are limited safety data available on long-term use, in particular in relation to growth and development. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. uk/yellowcard.