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ZANTAC is a brand name for Ranitidine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Zantac Tablets are indicated for: • treatment of duodenal ulcer and benign gastric ulcer, including that associated with non- steroidal anti-inflammatory agents. • treatment of duodenal ulcers associated with Helicobacter pylori infection. • treatment of post-operative ulcer • Zollinger-Ellison syndrome •…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults (including the elderly) The usual dosage is 150 mg twice daily, taken in the morning and evening. Patients with duodenal ulceration, gastric ulceration or oesophageal reflux disease may be treated with a single bedtime dose of 300 mg.
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 four 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, eight weeks treatment may be necessary. 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 nocte.
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 2 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.
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 if necessary 12 weeks. 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 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 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:
Malignancy The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer and in patients of middle age and over with new or recently changed dyspeptic symptoms) as treatment with ranitidine may mask symptoms of gastric carcinoma.
Renal Disease Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with renal impairment. 2 Patients with renal impairment. Regular supervision of patients who are taking non-steroidal anti- inflammatory drugs concomitantly with ranitidine is recommended, especially in the elderly.
Current evidence shows that ranitidine protects against NSAID associated ulceration in the duodenum and not in the stomach. 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 immunocompromised, there may be an increased risk of developing community acquired pneumonia. 64). 8). Important information about excipients This medicinal product contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially 'sodium-free'.
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 three times daily and this may be increased as necessary. Patients with this syndrome have been given increasing doses up to 6 g 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 twice daily for up to six 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, treatment with Zantac Tablets 150 mg twice daily may be substituted for Zantac Injection (see separate SPC) once oral feeding commences in patients considered to be still at risk from these conditions.
Prophylaxis of acid aspiration (Mendleson’s syndrome):
In patients thought to be at risk of acid aspiration syndrome an oral dose of 150 mg can be given 2 hours before induction of general anaesthesia, and preferably also 150 mg the previous evening. In obstetric patients at commencement of labour, an oral dose of 150 mg may be given followed by 150 mg at six hourly intervals.
g. 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 (Other special Populations ) Peptic Ulcer Acute Treatment The recommended oral dose for 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 to a maximum of 600 mg (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 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.
Method of administration For oral administration.
As with other H2 receptor antagonists bradycardia, A-V block and tachycardia.
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 ages 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 data 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.
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