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Drug Details

Ranitidine 150mg/10ml Oral Solution

• Drug Class Description
  H2 -antagonists - ATC Code: A02 BA02
• Generic Name
  ranitidine hydrochloride
• Presentation
  Oral Solution A straw coloured liquid with odour of mint
• Description
  Ranitidine Hydrochloride 167.5mg/10ml (equivalent to Ranitidine 150mg/10ml) Ethanol = 810mg/10ml Sorbitol = 1.4g/10ml
• Indications
  

  Ranitidine is indicated for the treatment of duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti-inflammatory agents. In addition, ranitidine is indicated for the prevention of NSAID (including aspirin) associated duodenal ulcers.

  Ranitidine is also indicated for the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and treatment of oesophageal reflux disease including prevention of relapse.

  Ranitidine is indicated for the following conditions where reduction of gastric secretion and acid output is desirable;

  - the prophylaxis of gastro-intestinal haemorrhage from stress ulceration in seriously ill patients

  - the prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers

  - before general anaesthesia in patients considered to be at risk of acid aspiration (Mendelson's Syndrome), particularly obstetric patients during labour.

  Children (3 to 18 years)

  - Short term treatment of peptic ulcer

  - Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

• Adult Dosage
  

  Route of administration: Oral

  Adults (including the elderly):

  Treatment of duodenal and gastric ulcer:

  The usual dosage is 150mg twice daily, taken in the morning and evening or a single bedtime dose of 300mg. It is not necessary to time the dose in relation to meals. This may be increased to ranitidine 300mg twice daily without an increased incidence of unwanted effects.

  In most cases of duodenal ulcer, benign gastric ulcer and post operative ulcer, healing occurs in four weeks. Healing usually occurs after a further four 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 150mg at bedtime is recommended for patients who have responded to short term therapy, particularly those with a history of recurrent ulcer.

  Treatment of ulcers following NSAID therapy or associated with continuing NSAIDS

  In ulcers following non-steroidal anti-inflammatory drug therapy or associated with continued non-steroidal anti-inflammatory drugs, eight to twelve weeks treatment may be necessary with 150mg bd or 300mg nocte.

  Prevention of NSAID induced ulcers:

  For the prevention of non-steroidal anti-inflammatory drug associated duodenal ulcers, ranitidine 150mg twice daily may be given concomitantly with non-steroidal anti-inflammatory drug therapy.

  Treatment of oesophageal reflux disease including prevention of relapse:

  In the management of oesophageal reflux disease, the recommended course of treatment is either 150mg twice daily or 300mg at bedtime for up to eight weeks or if necessary twelve weeks.

  In patients with moderate to severe oesophagitis, the dosage of ranitidine may be increased to 150mg 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 150mg twice daily. Ranitidine is not indicated in patients with complications of reflux oesophagitis e.g. oesophageal stricture or Barrett's oesophagous.

  In keeping with the recommended clinical practice, it is advisable that patients on long term maintenance therapy receive regular routine assessments by their practitioner

  Treatment of 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 6g per day and these doses have been well tolerated.

  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 the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, treatment with Ranitidine 150mg/10ml Oral Solution b.d. may be substituted for Ranitidine Injection once oral feeding commences in patients considered to still be at risk from these conditions.

  Prophylaxis of acid aspiration (Mendelson's Syndrome)

  In patients thought to be at risk of acid aspiration syndrome an oral dose of 150mg can be given two 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 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 (e.g. sodium citrate) prior to induction of anaesthesia. The usual precautions to avoid acid aspiration should also be taken.

  Renal Insufficiency

  Accumulation of ranitidine with resulting elevated plasma concentration will occur in patients with severe renal impairment. Accordingly, it is recommended that the daily dose of ranitidine in such patients should be 150mg at night for 4 – 8 weeks. In patients with creatinine clearance of less than 50ml/min the usual dose is 150mg nightly. In patients on dialysis, dosage should be given on completion of dialysis.

  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 300 mg 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 5 mg/kg/day to 10 mg/kg/day administered as two divided doses in a maximum dose 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.

• Child Dosage
  

  Children (3 to 11 years)

  Ranitidine syrup contains 8%w/v ethanol. Therefore an alternative formulation of ranitidine may be considered necessary for at-risk groups, including children.

• Contra Indications
  

  Known hypersensitivity to ranitidine or any of the excipients in the formulation.

• Special Precautions
  

  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 has been diagnosed or in patients of middle age and over with new or recently changed dyspeptic symptoms the possibility of malignancy should be excluded by endoscopy and biopsy before therapy with ranitidine is instituted.

  In keeping with the recommended clinical practice, it is advisable that patients on long term maintenance therapy receive regular routine assessments by their practitioner

  Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment.

  Regular supervision of patients who are taking non-steroidal anti-inflammatory drugs concomitantly with ranitidine is recommended, especially in the elderly and those with a history of peptic ulcer.

  Patients on prolonged treatment (particularly more than one year) should be kept under regular surveillance.

  Although clinical reports of acute intermittent porphyria associated with ranitidine administration have been rare and inconclusive, ranitidine should be avoided in patients with a history of this condition.

  Rates of healing ulcers in clinical trial patients aged 65 and over have not been found to differ from those in younger patients. Additionally, there was no difference in the incidence of adverse effects.

  Physicians should be aware that on rare occasions immune system reactions (rash and hypereosinophilia) have been reported on reintroduction of ranitidine, even months or years after withdrawal.

  In patients such as the elderly, persons with chronic lung disease, diabetes or the immunocompromised, there may be an increased risk of developing community acquired pneumonia. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of ranitidine alone H₂ receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk increase of 1.82 (95% CI 1.26 – 2.64).

  Excipient Information

  Ethanol – This product contains 8%w/v ethanol (alcohol), i.e. up to 405mg per 5ml spoonful which is equivalent to about 11ml of beer or 5ml of wine.

  It is harmful for those suffering from alcoholism. It should be taken into account in pregnant or lactating women, children and high risk groups (those suffering from alcoholism, liver disease, epilepsy, brain injury or disease). It may modify or increase the effect of other medicines. The amount of alcohol in this medicinal product may impair the ability to drive or use machines.

  Alternative formulation of ranitidine may be considered preferential in these populations.

  Sorbitol – The product contains 700mg per 5ml spoonful of sorbitol which is a source of 175mg fructose. Patients with rare hereditary problems of fructose intolerance should not take this medicine. It can also cause stomach upset and diarrhoea in large amounts.

  Sodium –The product contains 11mg of sodium per 5ml spoonful.

• Interactions
  

  Ranitidine has the potential to affect the absorption, metabolism or renal excretion of other drugs. The altered pharmacokinetics may necessitate dosage adjustment of the affected drug or discontinuation of treatment.

  Interactions occur by several mechanisms including:

  1) Inhibition of cytochrome P450-linked mixed function oxygenase system: Ranitidine at usual therapeutic doses does not potentiate the action of drugs which are inactivated by this enzyme system such as diazepam, lidocaine, phenytoin, propranolol and theophylline.

  There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased or decreased prothrombin time is recommended during concurrent treatment with ranitidine.

  2) Competition for renal tubular secretion:

  Since ranitidine is partially eliminated by the cationic system, it may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g. such as those used in the treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs.

  3) Alteration of gastric pH

  The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide, raltegravir) or a decrease in absorption (e.g. ketoconazole, itraconazole, atazanavir, delavirdine, gefitinib, lapatinib, cefpodoxime).

  There is no evidence of an interaction between ranitidine and amoxicillin and metronidazole. If high doses (2g) of sucralfate are co-administered with ranitidine the absorption of the latter may be reduced. This effect is not seen if sucralfate is taken after an interval of 2 h.

• Adverse Drug Reactions
  

  System Organ Class	Common (>1/100, <1/10)	Uncommon (>1/1000,<1/100)	Rare (>1/10,000, <1/1000)	Very rare (<1/10,0000)	Unknown
  Blood and the lymphatic system				Blood count changes (leucopenia, thrombocytopenia) these are usually reversible, agranulocytosis, pancytopenia (sometimes with marrow hypoplasia) or marrow aplasia	acute porphyria.
  Immune system disorders			Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).	Anaphylactic shock. These events have been reported after a single dose.
  Psychiatric disorders				Reversible mental confusion, depression and hallucinations (especially in the elderly or severely ill)
  Nervous system disorders				Headache (sometimes severe), dizziness and reversible involuntary movement disorders
  Eye disorders				Reversible blurred vision. There have been reports of blurred vision which is suggestive of a change in accommodation.
  Cardiac disorders				As with other H2 receptor antagonists bradycardia, A-V block
  Vascular disorders				Vasculitis
  Gastrointestinal disorders		Abdominal pain, diarrhoea, constipation, nausea (these symptoms mostly improved during continued treatment).		Acute pancreatitis
  Hepatobiliary disorders			Transient and reversible changes in liver function tests	Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible
  Skin and subcutaneous tissue disorders			Skin rash	Erythema multiforme, alopecia
  Musculoskeletal, connective tissue and bone disorders				Musculoskeletal symptoms such as arthralgia, myalgia
  Renal and urinary disorders			Elevation of plasma creatinine (usually slight; normalised during continued treatment).	Acute interstitial nephritis
  Reproductive system and breast disorders				Reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea).

  In the case of breast symptoms in men, it may be necessary to discontinue treatment to establish the underlying cause; however some cases have been resolved on continued therapy.

  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 data available, in particular, regarding growth and development.