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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 Ranitidine Oral Solution is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. In addition, Ranitidine Oral Solution is indicated for the prevention of NSAID associated duodenal ulcers. Ranitidine Oral Solution is also…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults (including the elderly) The usual dosage is 150 mg (5 ml) twice daily, taken in the morning and evening. Alternatively, patients with duodenal ulceration, gastric ulceration or oesophageal reflux disease may be treated with a single bedtime dose of 300mg (10ml).
It is not necessary to time the dose in relation to meals.
Duodenal ulcer, benign gastric ulcer and post-operative ulcer:
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.
NSAID associated peptic ulceration, including prophylaxis of duodenal ulcers:
In ulcers following non-steroidal anti-inflammatory drug therapy or associated with continued non-steroidal anti-inflammatory drugs, 8 weeks treatment may be necessary. For the prevention of non-steroidal anti-inflammatory drug associated duodenal ulcers ranitidine 150 mg (5ml) twice daily may be given concomitantly with non- steroidal anti-inflammatory drug therapy.
In duodenal ulcer 300mg (10ml) twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with ranitidine 150 mg (5ml) twice daily or 300mg (10 ml) nocte. The increased dose has not been associated with an increased incidence of unwanted effects.
Maintenance treatment at a reduced dosage of 150 mg (5ml) 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:
In the management of oesophageal reflux disease, the recommended course of treatment is either 150 mg (5ml) twice daily or 300mg (10ml) at bedtime for up to 8 weeks or if necessary 12 weeks. In patients with moderate to severe oesophagitis, the dosage of ranitidine may be increased to 150 mg (5ml) four times daily for up to twelve weeks.
The increased dose has not been associated with an incidence of unwanted effects. For the long-term management of oesophagitis the recommended adult oral dose is 150 mg (5ml) twice daily. Long-term treatment is not indicated in the management of patients with unhealed oesophagitis with or without Barrett’s epithelium.
The following convention has been utilised for the classification of undesirable effects: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, ≤1/100), rare (≥1/10,000, ≤1/1000), very rare (≤1/10,000). 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 Not known: 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 nephropathic 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:
As with other H2 receptor antagonists bradycardia, A-V block and tachycardia.
2 Posology and method of administration Posology Adults (including the elderly) The usual dosage is 150 mg (5 ml) twice daily, taken in the morning and evening. Alternatively, patients with duodenal ulceration, gastric ulceration or oesophageal reflux disease may be treated with a single bedtime dose of 300mg (10ml).
It is not necessary to time the dose in relation to meals.
Duodenal ulcer, benign gastric ulcer and post-operative ulcer:
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.
NSAID associated peptic ulceration, including prophylaxis of duodenal ulcers:
In ulcers following non-steroidal anti-inflammatory drug therapy or associated with continued non-steroidal anti-inflammatory drugs, 8 weeks treatment may be necessary. For the prevention of non-steroidal anti-inflammatory drug associated duodenal ulcers ranitidine 150 mg (5ml) twice daily may be given concomitantly with non- steroidal anti-inflammatory drug therapy.
In duodenal ulcer 300mg (10ml) twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with ranitidine 150 mg (5ml) twice daily or 300mg (10 ml) nocte. The increased dose has not been associated with an increased incidence of unwanted effects.
Maintenance treatment at a reduced dosage of 150 mg (5ml) 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:
In the management of oesophageal reflux disease, the recommended course of treatment is either 150 mg (5ml) twice daily or 300mg (10ml) at bedtime for up to 8 weeks or if necessary 12 weeks. In patients with moderate to severe oesophagitis, the dosage of ranitidine may be increased to 150 mg (5ml) four times daily for up to twelve weeks.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Zollinger-Ellison syndrome:
In patients with Zollinger-Ellison Syndrome, the starting dose is 150 mg (5ml) three times daily and this may be increased as necessary. Patients with this syndrome have been given increasing doses up to 6 g (200 ml) per day and these doses have been well tolerated.
Chronic episodic dyspepsia:
For patients with chronic episodic dyspepsia the recommended course of treatment is 150 mg (5ml) twice daily for up to six weeks. Anyone not responding or relapsing shortly afterwards should be investigated.
Prophylaxis of haemorrhage from stress ulceration or recurrent haemorrhage:
In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or in the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, treatment with ranitidine tablets 150 mgs twice daily may be substituted for ranitidine injection once oral feeding commences in patients considered to be still at risk from these conditions.
Prophylaxis of Mendelson’s syndrome:
In patients thought to be at risk of acid aspiration syndrome an oral dose of 150mg (5ml) can be given 2 hours before induction of general anaesthesia, and preferably also 150 mg (5ml) the previous evening. In obstetric patients at commencement of labour, an oral dose of 150 mg (5ml) may be given followed by 150 mg (5ml) at six 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 dose is given. 5% w/v ethanol. Therefore an alternative formulation of ranitidine may be considered necessary for at-risk groups, including children (see section
Vascular Disorders Very Rare:
Vasculitis.
Gastrointestinal Disorders Uncommon:
Abdominal pain, constipation, nausea (these symptoms mostly improved during continued treatment).
Very Rare:
Acute pancreatitis, diarrhoea 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 Rare:
Elevation of plasma creatinine (usually slight; normalised during continued treatment) Very Rare: Acute interstitial nephritis.
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 assessed in children aged 0 to 16 years with acid- related disease and was generally well tolerated with an adverse event profile resembling that in adults.
There are limited long term safety available, in particular regarding 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.
uk/yellowcard.
The increased dose has not been associated with an incidence of unwanted effects. For the long-term management of oesophagitis the recommended adult oral dose is 150 mg (5ml) 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 150 mg (5ml) three times daily and this may be increased as necessary. Patients with this syndrome have been given increasing doses up to 6 g (200 ml) per day and these doses have been well tolerated.
Chronic episodic dyspepsia:
For patients with chronic episodic dyspepsia the recommended course of treatment is 150 mg (5ml) twice daily for up to six weeks. Anyone not responding or relapsing shortly afterwards should be investigated.
Prophylaxis of haemorrhage from stress ulceration or recurrent haemorrhage:
In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or in the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, treatment with ranitidine tablets 150 mgs twice daily may be substituted for ranitidine injection once oral feeding commences in patients considered to be still at risk from these conditions.
Prophylaxis of Mendelson’s syndrome:
In patients thought to be at risk of acid aspiration syndrome an oral dose of 150mg (5ml) can be given 2 hours before induction of general anaesthesia, and preferably also 150 mg (5ml) the previous evening. In obstetric patients at commencement of labour, an oral dose of 150 mg (5ml) may be given followed by 150 mg (5ml) at six 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 dose is given. 5% w/v ethanol. 4 Special warnings and precautions for use). 2 Pharmacokinetic properties (Other special populations) Peptic Ulcer Acute Treatment 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 300mg (10ml) 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 of 600mg (20ml) (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.
Patients with renal impairment:
Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with renal impairment (creatinine clearance less than 50ml/min). Accordingly, it is recommended that the daily dose of ranitidine in such patients be 150 mg (5ml) at night for 4 to 8 weeks.
The same dose should be used for maintenance treatment if necessary. If an ulcer has not healed after treatment, the standard dosage regimen of 150mg (5ml) twice daily should be instituted, followed, if need be, by maintenance treatment at 150 mg (5ml) at night.
3 Contraindications Hypersensitivity to the active substance or to any of the […]