Ranitidine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Benign gastric and duodenal ulceration Initial: 150 mg bid or 300 mg at bedtime for at least 4 weeks, may increase up to 300 mg bid, as necessary. Maintenance: 150 mg/day at bedtime. NSAID-associated ulceration 150 mg bid or 300 mg at bedtime for 8 weeks. Duodenal ulcers associated with H. pylori infection 300 mg at bedtime or 150 mg bid given with oral amoxicillin and metronidazole for 2 weeks. Continue therapy without antibiotics for another 2 weeks. GERD 150 mg bid or 300 mg at bedtime for up to 8 weeks or if necessary, up to 12 weeks. Hypersecretory conditions Initial: 150 mg bid or tid. Max: 6000 mg/day. Dyspepsia 150 mg bid for up to 6 weeks. Prophylaxis of gastrointestinal haemorrhage from stress ulceration 150 mg bid as a substitute for IV inj once oral therapy is possible. Prophylaxis of acid aspiration during general anaesthesia 150 mg given 2 hours prior to induction of anaesthesia and, preferably 150 mg on the previous evening. IV/IM Benign gastric and duodenal ulceration 50 mg IM or IV inj or 25 mg/hr via intermittent infusion 6-8 hourly. Prophylaxis of acid aspiration during general anaesthesia 50 mg via IM or slow IV inj 45-60 minutes prior to induction of anaesthesia. IV Hypersecretory conditions Initial: 1 mg/kg/hr via infusion, may increase rate at increments of 0.5 mg/kg/hr after 4 hours, as necessary. Prophylaxis of gastrointestinal haemorrhage from stress ulceration 50 mg via slow IV as priming dose, followed by 0.125-0.25 mg/kg/hr continuous infusion. Substitute oral therapy as soon as possible.
Dosage Details
Intravenous
Hypersecretory conditions
Adult: Initially, 1 mg/kg/hr via infusion, may increase rate at increments of 0.5 mg/kg/hr after 4 hours, as necessary. Doses up to 2.5 mg/kg/hr and infusion rates up to 220 mg/hr may be given.

Intravenous
Prophylaxis of gastrointestinal haemorrhage from stress ulceration
Adult: 50 mg via slow IV inj as priming dose, followed by 0.125-0.25 mg/kg/hr via continuous infusion. Substitute oral therapy as soon as possible.

Oral
NSAID-associated ulceration
Adult: 150 mg bid or 300 mg at bedtime for 8 weeks.

Oral
Dyspepsia
Adult: 150 mg bid for up to 6 weeks. For short-term symptomatic relief: 75 mg repeated up to Max 4 doses daily, as necessary. Treatment duration: Up to 2 weeks of continuous use at one time.

Oral
Gastro-oesophageal reflux disease
Adult: 150 mg bid or 300 mg at bedtime for up to 8 weeks or if necessary, up to 12 weeks. Alternatively, 75 mg daily, as needed, no additional dose within 24 hours. For erosive esophagitis: May increase usual dose to 150 mg 4 times daily for up to 12 weeks; maintenance: 150 mg bid.
Child: As tab or oral solution: 3-11 years 5-10 mg/kg daily as in 2 divided doses up to Max of 600 mg daily; ≥12 years Same as adult dose.

Oral
Duodenal ulcers associated with H. pylori infection
Adult: 300 mg at bedtime or 150 mg bid given with oral amoxicillin and metronidazole for 2 weeks. Continue therapy without antibiotics for another 2 weeks. For patient with history of recurrent ulcer and have responded to short-term therapy, reduce dose to 150 mg at bedtime.

Oral
Prophylaxis of gastrointestinal haemorrhage from stress ulceration
Adult: 150 mg bid as a substitute for IV inj once oral therapy is possible.

Oral
Prophylaxis of acid aspiration during general anaesthesia
Adult: 150 mg given 2 hours prior to induction of anaesthesia and, and preferably, a 150 mg dose on the previous evening. In obstetric patients, 150 mg may be given at the start of labour and may be repeated at 6-hour intervals, as necessary.

Oral
Benign gastric and duodenal ulceration
Adult: Initially, 150 mg bid or 300 mg at bedtime for at least 4 weeks. May increase dose up to 300 mg bid, as necessary. Maintenance: 150 mg daily at bedtime.
Child: As tab or oral solution: 3-11 years 4-8 mg/kg daily in 2 divided doses to a Max of 300 mg daily for 4 weeks or up to 8 weeks if needed; ≥12 years Same as adult dose.

Oral
Hypersecretory conditions
Adult: Initially, 150 mg bid or tid, may be increased if necessary, up to 6,000 mg daily.

Parenteral
Benign gastric and duodenal ulceration
Adult: Up to 50 mg via IM or IV inj over 2 minutes or 25 mg/hour via intermittent IV infusion. Dose may be repeated 6-8 hourly.
Child: 6 months-11 years Initially, 2 or 2.5 mg/kg (Max 50 mg) via slow IV inj over 2 minutes. Maintenance of pH>4: 1.5 mg/kg via intermittent infusion 6-8 hourly. Alternatively, 0.45 mg/kg as loading dose via slow IV inj over 2 minutes followed by 0.15 mg/kg/hr via continuous infusion.  ≥12 years Same as adult dose.

Parenteral
Prophylaxis of acid aspiration during general anaesthesia
Adult: 50 mg via IM or slow IV inj 45-60 minutes prior to induction of anaesthesia.
Renal Impairment
Oral:
CrCl (mL/min) Dosage
<50 150 mg at night for 4-8 weeks. For patient with inadequate response, may adjust dose to 150 mg bid and may reduce back to maintenance treatment of 150 mg at night.
Parenteral:
CrCl (mL/min)
Dosage
<50
May reduce dose to 25 mg. 
Administration
May be taken with or without food.
Reconstitution
Intermittent bolus injection: Dilute 50 mg in 0.9% NaCl or other compatible IV solution to a max concentration of 2.5 mg/mL (20 mL). Intermittent IV infusion: Dilute 50 mg in dextrose 5% or other compatible IV solution to a max concentration of 0.5 mg/mL (100 mL).
Contraindications
History of acute porphyria.
Special Precautions
Patient with chronic lung disease, diabetes, factors predisposing to cardiac rhythm disturbances. Immunocompromised or severely ill patient. Rule out gastric malignancy or possibility of malignancy prior to initiation of therapy. Renal and hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Rarely, mental confusion, depression, hallucinations.
Blood and lymphatic system disorders: Rarely, agranulocytosis, aplastic anaemia, granulocytopenia, haemolytic anaemia, leucopenia, pancytopenia (sometimes with marrow hypoplasia or marrow aplasia), thrombocytopenia.
Cardiac disorders: Dyspnoea, rarely, asystole, atrioventricular block, bradycardia (rapid IV administration), tachycardia, ventricular premature contractions.
Eye disorders: Rarely, reversible blurred vision.
Gastrointestinal disorders: Abdominal pain, constipation, nausea, abdominal distress, diarrhoea, vomiting.
General disorders and admin site conditions: Rarely, malaise.
Hepatobiliary disorders: Rarely, pancreatitis, cholestatic hepatitis, hepatic failure, hepatitis, jaundice.
Immune system disorders: Hypersensitivity reactions (e.g. fever, rash, bronchospasm, eosinophilia), anaphylaxis, angioneurotic oedema). Rarely, erythema multiforme.
Infections and infestations: Pneumonia.
Injury, poisoning and procedural complications: Pain, burning sensation, pruritus at injection site (IV/IM inj).
Investigations: Reversible changes in LFTs, elevated plasma creatinine, increased serum prolactin.
Metabolism and nutrition disorders: Rarely, acute porphyria.
Musculoskeletal and connective tissue disorders: Rarely, arthralgia, myalgia.
Nervous system disorders: Headache (sometimes severe), rarely, involuntary motor activity, dizziness, drowsiness, vertigo, agitation.
Psychiatric disorders: Rarely, insomnia.
Renal and urinary disorders: Rarely, acute interstitial nephritis.
Reproductive system and breast disorders: Rarely, reversible impotence.
Skin and subcutaneous tissue disorders: Rash, rarely, alopecia.
Vascular disorders: Rarely, vasculitis.
IM/IV/Parenteral/PO: B
Patient Counseling Information
This drug may cause dizziness, drowsiness or blurred vision, if affected, do not drive or operate machinery.
MonitoringParameters
Monitor liver and kidney (e.g. serum creatinine) functions, occult blood with gastrointestinal bleeding, and signs of confusion.
Overdosage
Symptoms: Transient adverse effects similar to those experienced with normal doses, additionally, abnormalities of gait and hypotension. Management: Symptomatic and supportive treatment with removal of unabsorbed drugs from the gastrointestinal tract.
Drug Interactions
Altered prothrombin time and increased serum concentration with coumarin anticoagulants (e.g. warfarin). May reduce the excretion and increase plasma concentrations of procainamide and N-acetylprocainamide (high dose ranitidine). May alter the absorption of pH-dependent drugs which may result in either an increase in absorption (e.g. triazolam, glipizide, midazolam) or decrease in absorption (e.g. atazanavir, gefitnib, ketoconazole, delaviridine). Decreased absorption with co-administration of high dose sucralfate.
Lab Interference
False-positive result for urine protein tests with Multistix.
Action
Description: Ranitidine competitively and reversibly inhibits histamine at H2-receptors of the gastric parietal cells thereby inhibiting gastric acid secretion, gastric volume and reducing hydrogen ion concentration.
Pharmacokinetics:
Absorption: 50% of the administered dose is absorbed from the gastrointestinal tract (oral); rapidly absorbed (IM). Time to peak plasma concentration: 2-3 hours (oral); within 15 minutes (IM). Bioavailability: Approx 50% (oral); 90-100% (IM).
Distribution: Minimally penetrates the blood-brain barrier, crosses placenta and enters breast milk. Volume of distribution: Approx: 1.4 L/kg. Plasma protein binding: Approx 15%.
Metabolism: Metabolised in the liver to N-oxide (principal metabolite), S-oxide, and N-desmethyl metabolites.
Excretion: Mainly via urine (oral: 30%; IV: 70% as unchanged drug), faeces (as metabolites). Elimination half-life: 2.5-3 hours (oral); 2-2.5 hours (IV).
Chemical Structure

Click on icon to see table/diagram/image
Storage
Store below 25°C. Protect from light and moisture.
ATC Classification
A02BA02 - ranitidine ; Belongs to the class of H2-receptor antagonists. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Disclaimer: This information is independently developed by MIMS based on Ranitidine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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