Ranitidine

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Gastroesophageal Reflux Disease


150 mg PO q12hr or 50 mg IM/IV q6-8hr Gastric Ulcer, Benign


Treatment: 150 mg PO q12hr or 300 mg PO at bedtime


Maintenance of healing: 150 mg PO at bedtime Erosive Esophagitis


Treatment: 150 mg PO q6hr or 50 mg IM/IV q6-8hr intermitent bolus or infusion; alternatively, 6.25 mg/hr IV by continuous infusion


Maintenance of healing: 150 mg PO q12hr Hypersecretory Conditions


150 mg PO q12hr; up to 6 g/day used


Parenteral: 50 mg (2 mL) IM or intermitent IV bolus or infusion q6-8hr; not to exceed 400 mg/day; alternatively, 6.25 mg/hr continuous infusion Dosing considerations More frequent doses may be necessary; individualize dosage, and continue as long as indicated; dosages up to 6 g/day have been used for severe disease Zollinger-Ellison syndrome: Start IV infusion at 1 mg/kg/hr, then adjust upward in 0.5 mg/kg/hr increments according to gastric acid output (not to exceed 2.5 mg/kg/hr or 220 mg/hr) Stress Ulcer Prophylaxis (Off-label)


150 mg PO or NG q12hr


50 mg (2 mL) IM or intermitent IV bolus or infusion q6-8hr; not to exceed 400 mg/day; alternatively, 6.25 mg/hr continuous infusion Dosing Modifications


Renal impairment (CrCl <50 mL/min): 50 mg IV/IM q18-24hr or 150 mg PO once daily


Hepatic impairment: Dosage adjustment not necessaryAdministrationMay be taken with or without food.

OverdosageSeizures, ventricular arrhythmias, bradycardia, gait abnormalities, hypotension. Management: Should perform gastric lavage or induce emesis. Diazepam may be given for seizure, atropine for bradycardia and lidocaine for ventricular arrhythmias. Haemodialysis may enhance elimination.Contraindications Hypersensitivity to ranitidine or components of the formulationSpecial Precautions If gastroesophageal reflux disease does not respond adequately in 6-8 weeks, do not increase dosage; prescribe proton pump inhibitor instead


Prolonged treatment may lead to B12 malabsorption and subsequent vitamin B12 deficiency; degree of deficiency is dose-related and association stronger in females and younger in age (<30 years)


Use caution in renal impairment; adjust dosage


Use caution in hepatic impairment


Elevation of ALT levels reported with higher doses (≥100 mg) or prolonged IV therapy (≥5 days); monitor for ALT levels for the remainder of treatment


Avoid in patients with acute porphyria; may precipitate attack


Symptom relieve does not rule out presence of gastric malignancy


Reversible comfusional state reported with use (linked to age >50 years and renal or hepatic impairment); clears within 3-4 days after discontinuationAdverse Drug Reactions 1-10%


Headache (3%) <1%


Abdominal pain, Agitation, Alopecia, Confusion, Constipation, Diarrhea, Dizziness, Hypersensitivity reaction, Nausea, Vomiting Frequency Not Defined


Anemia, Necrotizing enterocolitis in fetus or newborn, Pancreatitis (rare), Thrombocytopenia (rare), Pancytopenia (rare), Agranulocytosis (rare), Acquired immune hemolytic anemia (rare), Arthralgia (rare), Myalgia (rare) Potentially Fatal: Hepatotoxicity.Drug InteractionsDelayed absorption and increased peak serum concentration w/ propantheline bromide. Ranitidine minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability w/ antacids.Food InteractionMay cause gastric mucosal irritation with alcohol.Lab InterferenceFalse-positive results in urine protein determination using Multistix.Pregnancy Category (US FDA)Category BStorageIntravenous: Store between 4-25°C. Protect from light. Oral: Tab: Store between 15-30°C. Oral soln: Store between 4-25°C. Protect from light. Parenteral: Store between 4-25°C. Protect from light.Mechanism of ActionRanitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.

Absorption: Readily absorbed from the GI tract. Bioavailability: Approx 50%. Time to peak plasma concentration: Approx 2-3 hr (oral); approx 15 min (IM).

Distribution: Widely distributed; enters breast milk, crosses the placental barrier. Volume of distribution: Approx 1.4 L/kg. Plasma protein binding: Approx 15%.

Metabolism: Hepatically metabolised. Small portion is converted to N-oxide (major metabolite, approx 4-6% of a dose), S-oxide and desmethylranitidine.

Excretion: Via urine (oral: Approx 30%, IV: 70%) as unchanged drug and in the faeces. Elimination half-life: Approx 2-3 hr.

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