INFORMATION FOR HEALTH PROFESSIONALS
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
Home | Consumers | Health Professionals | Regulatory | Other | Hot Topics | Search
ZANTAC Syrup: Each 10mL contains ranitidine 150mg (as the hydrochloride).
Syrup.
ZANTAC Syrup is indicated for:
ZANTAC Syrup is also indicated for the following conditions where reduction of gastric secretion and acid output is desirable:
For appropriate cases ZANTAC Injection is also available (see ZANTAC Injection Data Sheet).
Acute Treatment
The usual dosage is 150mg twice daily, taken in the morning and evening. Alternatively, patients with duodenal or gastric ulceration may be treated with a single bedtime dose of 300mg. It is not necessary to time the dose in relation to meals.
In most cases of duodenal ulcer or benign gastric 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.
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 bedtime. The increased dose has not been associated with an increased incidence of unwanted effects.
Long Term Management
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.
Smoking is associated with a higher rate of duodenal ulcer relapse, and such patients should be advised to stop smoking. In those who fail to comply with such advice a dose of 300mg at bedtime provides additional therapeutic benefit over the 150mg dosage regimen.
Acute Treatment
In ulcers following non-steroidal anti-inflammatory drug therapy, or associated with continued non-steroidal anti-inflammatory drugs, 8-12 weeks treatment may be necessary with 150mg twice daily or 300mg at bedtime.
Prophylaxis
For the prevention of non-steroidal anti-inflammatory drug associated duodenal ulcers, ZANTAC 150mg twice daily may be given concomitantly with non-steroidal anti-inflammatory therapy.
The standard dosage regimen for postoperative ulcer is 150mg twice daily. Most cases heal within 4 weeks. Those not fully healed after the initial 4 weeks usually do so after a further 4 weeks.
Acute reflux oesophagitis
In the management of oesophageal reflux disease, the recommended course of treatment is either 150mg twice daily or 300mg at bedtime for up to 8 weeks.
In patients with moderate to severe oesophageal reflux disease, the dosage or ranitidine may be increased to 150mg four times daily for up to twelve weeks.
Long-term management of reflux oesophagitis
For the long-term management of reflux oesophagitis the recommended adult oral dose is 150mg twice daily.
Symptom relief in gastro-oesophageal reflux disease
For the relief of symptoms associated with oesophageal acid reflux, the recommended regimen is 150mg twice daily for two weeks. This regimen may be continued for a further two weeks in those patients in whom the initial response is inadequate.
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.
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.
Treatment with ZANTAC syrup 150mg twice daily may be substituted for ZANTAC injection (see separate Data Sheet) once oral feeding commences in patients considered to be still at risk from these conditions.
In patients thought to be at risk of acid aspiration syndrome an oral dose of 150mg can be given 2 hours before induction of general anaesthesia, and preferably also 150mg orally the previous evening. Alternatively ZANTAC Injection for intravenous and intramuscular use is also available (see ZANTAC Injection Data Sheet).
In obstetric patients at commencement of labour, an oral dose of 150mg can be given followed by 150mg at 6 hourly intervals. It is recommended that since gastric emptying and medicine 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.
Experience with ZANTAC in children is limited and such use has not been fully evaluated in clinical studies. It has however been used successfully in children aged 8 to 18 years in doses up to 150mg twice daily.
Accumulation of ranitidine with resulting elevated plasma concentrations will occur in patients with severe renal impairment (creatinine clearance less than 50 mL/min). It is recommended that the daily dose of ranitidine in such patients should be 150mg.
ZANTAC is contra-indicated in patients known to have hypersensitivity to any component of the preparation.
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] 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 severe renal impairment.
The dosage should be adjusted as detailed above under Dosage in Renal Impairment.
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.
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. A large epidemiological study showed an increased risk of developing community acquired pneumonia in current users of H2 receptor antagonists versus those who had stopped treatment, with an observed adjusted relative risk of 1.63 (95% CI, 1.07-2,48).
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:
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 hours.
Ranitidine crosses the placenta and is excreted in human breast milk.
Like other drugs it should only be used during pregnancy and nursing if considered essential.
None reported.
The following have been reported as events in clinical trials or in the routine management of patients treated with ranitidine. The relationship to ranitidine therapy has not been established in many cases.
Blood count changes (leucopenia, thrombocytopenia) have occurred in a few patients. These are usually reversible. Rare cases of agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia have been reported.
As with other H2 receptor antagonists, there have been rare reports of bradycardia and A-V Block. Rare cases of vasculitis have been reported.
There have been a few reports of reversible blurred vision suggestive of a change in accommodation.
Very rare cases of diarrhoea have been reported.
Transient and reversible changes in liver function-tests can occur. There have been occasional reports of hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice. These were usually reversible. Acute pancreatitis has been rarely reported.
Musculoskeletal symptoms such as arthralgia and myalgia have been reported rarely.
Headache, sometimes severe and dizziness have been reported in a very small proportion of patients. Rare cases of reversible mental confusion, depression and hallucinations have been reported, predominantly in severely ill and elderly patients. In addition, reversible involuntary movement disorders have been reported rarely.
Skin rash has been reported, including rare cases of erythema multiforme. Rare cases of alopecia have been reported.
Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension, anaphylactic shock, chest pain) have been seen rarely after a single dose.
Very rare cases of acute interstitial nephritis have been reported.
Reversible impotence has been reported rarely. There have been a few reports of breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea).
Ranitidine is very specific in action and no particular problems are expected following overdosage with ZANTAC Syrup.
Zantac Syrup contains approximately 7.5% w/v ethanol (alcohol), i.e. up to 405 mg per 5 mL spoonful (approximately a teaspoonful) whic is equivalent to about 11 mL of beer or 5 mL of wine. This should be taken into account in children, pregnant or lactating women, or high risk groups (alcoholism, liver disease, epilepsy, brain injury or disease). It may modify or increase the effect of other medicines.
Symptomatic and supportive therapy should be given as appropriate.
ZANTAC is a specific, rapidly acting histamine H2-antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of the secretion. ZANTAC has a relatively long duration of action and so a single 150mg dose effectively suppresses gastric acid secretion for twelve hours. Clinical evidence has shown that ranitidine combined with amoxicillin and metronidazole eradicates Helicobacter pylori in approximately 90% of patients. This combination therapy has been shown to significantly reduce duodenal ulcer recurrence.
Helicobacter pylori infects about 95% of patients with duodenal ulcer and 80% of patients with gastric ulcer.
The bioavailability of ranitidine is consistently about 50%. Peak concentrations in plasma, normally in the range 300-550 ng/mL, occur 2-3 hours after oral administration of a 150mg dose. Concentrations of ranitidine in plasma are proportional to dose up to and including 300mg.
Ranitidine is not extensively metabolised. Elimination of the drug is primarily by tubular secretion. The elimination half-life is 2-3 hours.
In balance studies with 150mg 3H-ranitidine 93% of an intravenous dose was excreted in urine and 5% in faeces; 60-70% of an oral dose was excreted in urine and 26% in faeces. Analysis of urine excreted in the first 24 hours after dosing showed that 70% of the intravenous dose and 35% of the oral dose were eliminated unchanged. The metabolism of ranitidine is similar after both oral and intravenous dosing; about 6% of the dose being excreted in urine as the N-oxide, 2% as the S-oxide, 2% as desmethylranitidine and 1-2% as the furoic acid analogue.
No additional data of relevance.
Hydroxypropyl Methylcellulose 2906 or 2910.
Ethanol (96 percent).Propyl Hydroxybenzoate.
Butyl Hydroxybenzoate.
Potassium Dihydrogen Orthophosphate.
Disodium Hydrogen Orthophosphate Anhydrous.
Sodium Chloride.
Saccharin Sodium.
Sorbitol Solution BPC 1973 (Non-crystallising).
Mint Flavour IFF 17:42:3632.
Purified Water.
Dilution of ZANTAC Syrup with Syrup BP or sorbitol solution is not recommended as this may result in precipitation.
ZANTAC Syrup should not be diluted or admixed with other liquid preparations.
2 years when stored below 25°C.
ZANTAC Syrup should be stored below 25°C.
ZANTAC Syrup: 300mL presentation in a glass bottle.
None.
Prescription Only Medicine
GlaxoSmithKline NZ Limited
AMP Centre
Cnr Albert & Customs Streets
Private Bag 106600
Downtown
Auckland
NEW ZEALAND
Telephone: (09) 367 2900
Facsimile: (09) 367 2506
Issue date: 16 January 2008
Issue number: 26.
ZANTAC® is a registered trade mark of the GlaxoSmithKline group of companies