Drug Description

Presentation

Indications

Adult Dosage

Route of Administration

Oral

Dosage

Adults (Including The Elderly) and children 16 years of age and older:

Swallow one Zantac 75 tablet whole, with a drink of water, as soon as you have symptoms. If symptoms persist for more than one hour or return, take another tablet. Do not take more than four tablets in 24 hours.

For prevention of acid indigestion, indigestion, hyperacidity and heartburn associated with consuming food and drink, swallow one tablet with water, half to one hour beforehand.

Patients will be advised not to take the tablets for more than 2 weeks continuously and to consult their doctor if symptoms get worse or persist after 2 weeks treatment.

Child Dosage

Children under 16 years

Not recommended for children under 16 years of age.

Contra Indications

Ranitidine is contraindicated for patients known to be hypersensitive to the drug or any of the ingredients of Zantac 75 tablets.

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.

Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. Zantac 75 are not suitable for these patients.

Patients who are taking non-steroidal anti-inflammatory drugs especially in the elderly should be referred to their doctor before taking Zantac 75. Current evidence shows that ranitidine protects against NSAID associated ulceration in the duodenum and not in the stomach.

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.

The Patient Information Leaflet and Label advises the patient not to take the maximum daily dose for more than 14 consecutive days unless advised by their doctor.

Interactions

Ranitidine does not inhibit the hepatic Cytochrome P450-linked mixed function oxygenase system. Accordingly, ranitidine does not potentiate the actions of drugs which are inactivated by this enzyme; these include diazepam, lidocaine, phenytoin, propranolol, theophylline and warfarin.

Adverse Reactions

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

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 and elderly patients.

Nervous System Disorders

Very Rare: Headache (sometimes severe),dizziness and reversible involuntary movement disorders.

Cardiac Disorders

Very Rare: As with other H₂ receptor antagonists bradycardia and A-V Block.

Vascular Disorders

Very Rare: Vasculitis.

Gastrointestinal Disorders

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

Very rare: Acute interstitial nephritis.

Reproductive System and Breast Disorders

Very Rare: Reversible impotence. Breast symptoms in men.

Manufacturer

Updated