ranitidine hydrochloride: clinical use

Prescribing considerations

• Ranitidine is not currently available in the UK; confirm current product and regulatory status before prescribing or supplying.
• Exclude concerning pathology where indigestion is new or changing, or accompanied by dysphagia, persistent abdominal pain or unintended weight loss.
• Review severe renal or hepatic impairment, concurrent medicines, regular medical supervision or NSAID use before considering this product.
• H2-receptor antagonism can mask symptoms of gastric malignancy.

Contraindications and cautions

• Hypersensitivity to ranitidine or any product ingredient.
• Avoid in people with a history of porphyria.
• The selected product is unsuitable without medical supervision in severe renal impairment; severe hepatic impairment also requires assessment.

Monitoring

• Routine laboratory monitoring is not described for the selected self-care product.
• Monitor anticoagulation where warfarin or another coumarin anticoagulant is used concurrently.
• Consider renal function because exposure rises when renal clearance is impaired.
• Investigate persistent or changing symptoms rather than continuing symptomatic treatment.

Clinical pharmacology

Ranitidine is a competitive, surmountable H2-receptor antagonist that suppresses basal and stimulated gastric-acid secretion. Oral bioavailability is approximately 50–60%; metabolism is limited, protein binding is low and elimination is predominantly renal, including tubular secretion.

Formulation and product differences

• The selected product is a white, round, biconvex film-coated oral tablet.
• Listed excipients include microcrystalline cellulose, magnesium stearate, hypromellose and titanium dioxide.
• The SmPC describes blister packaging and storage in the original package, protected from light and below the stated storage limit.

Tablet

Route: Oral

Strengths: 75 mg