Trade Names:Zantac- Injection 1 mg (as base)/mL- Injection 25 mg (as base)/mL- Syrup 15 mg (as base)/mL- Tablets 150 mg (as base)- Tablets 300 mg (as base)
Trade Names:Zantac 75- Tablets 75 mg (as base)
Trade Names:Zantac 150- Tablets 150 mg (as base)
Trade Names:Zantac EFFERdose- Tablets, effervescent 25 mg (as base)- Tablets, effervescent 150 mg (as base)Apo-Ranitidine (Canada)CO Ranitidine (Canada)Gen-Ranitidine (Canada)Novo-Ranidine (Canada)Nu-Ranit (Canada)PMS-Ranitidine (Canada)ratio-Ranitidine (Canada)Sandoz Ranitidine (Canada)Zantac Maximum Strength Non-Prescription (Canada)
Reversibly and competitively blocks histamine at H 2 receptors, particularly those in gastric parietal cells, leading to inhibition of gastric acid secretion.
Absorbed rapidly (IV and IM), 50% absorbed orally. C max is 576 ng/mL (IM) or 440 to 545 ng/mL (oral). T max is 15 min (IM) or 2 to 3 h (oral). Bioavailability is 90% to 100% (IV) or 50% (oral).
Protein binding is 15%. Vd is 1.4 L/kg.
Hepatic to N-oxide (main metabolite), s-oxide and desmethyl ranitidine.
Excreted in urine (70% unchanged when given IV, 30% unchanged when given orally), main metabolite is N-oxide (less than 4%), also S-oxide (1%), desmethyl ranitidine (1%), remainder found in feces. Renal Cl is 530 mL/min (IM), 410 mL/min (oral). Total Cl is 760 mL/min. Elimination t ½ is 2 to 2.5 h (IM) or 2.5 to 3 h (oral).
Plasma t ½ , Cl, Vd are all altered in proportion to creatinine Cl.Hepatic Function Impairment
Alterations in t ½ , distribution, Cl, and bioavailability are minor but clinically insignificant.Elderly
Plasma t ½ is prolonged and total Cl is lowered.
Treatment and maintenance therapy of duodenal ulcer; management of gastroesophageal reflux disease (GERD; including erosive or ulcerative disease); short-term treatment of benign gastric ulcer; treatment of pathologic hypersecretory conditions (Zollinger-Ellison); maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers; treatment of endoscopically diagnosed erosive esophagitis; maintenance of healing of erosive esophagitis.OTC
Treatment and prevention of heartburn.
Prevention of upper GI bleeding; treatment of aspiration pneumonia; stress ulcer; and gastric NSAID damage. Used as a part of a multi-drug regimen to eradicate Helicobacter pylori in the treatment of peptic ulcer; protection against aspiration of acid during anesthesia; prevention of gastroduodenal mucosal damage that may be associated with long-term NSAIDs; control of acute upper GI bleeding; prevention of stress ulcers.
PO 150 mg twice daily or 300 mg at bedtime. Maintenance dose is 150 mg at bedtime. IM/IV/Intermittent IV 50 mg every 6 to 8 h.Treatment of Duodenal and Gastric UlcersChildren 1 mo to 16 yr of age
PO 2 to 4 mg/kg twice daily (max, 300 mg/day).Maintenance of Healing of Duodenal and Gastric UlcersChildren 1 mo to 16 yr of age
PO 2 to 4 mg/kg daily (max, 150 mg/day).Acute Benign Gastric Ulcer and GERDAdults
PO 150 mg twice daily. IM/IV/Intermittent IV 50 mg every 6 to 8 h.Treatment of GERD and Erosive EsophagitisChildren 1 mo to 16 yr of age
PO 5 to 10 mg/kg daily usually given in 2 divided doses.Pathologic Hypersecretory ConditionsAdults
PO 150 mg twice daily. Individualize.Erosive EsophagitisAdults
PO 150 mg 4 times daily. IM/IV/Intermittent IV 50 mg every 6 to 8 h. Continuous IV 6.25 mg/h. For patients with Zollinger-Ellison, start infusion at rate of 1 mg/kg/h and adjust upward in 0.5 mg/kg/h increments according to gastric acid output (max, 2.5 mg/kg/h; infusion rate 220 mg/h).Maintenance of Healing of Erosive EsophagitisAdults
PO 150 mg at bedtime.Heartburn (OTC)Adults
PO Treatment: 75 to 150 mg with a glass of water. Prevention: 75 to 150 mg with a glass of water 30 to 60 min before eating food or drinking beverages that cause heartburn. Maintenance: Up to 150 mg twice daily.Renal Insufficiency (Ccr less than 50 mL/min)Adults
PO 150 mg every 24 h. IM/IV 50 mg every 18 to 24 h.
Store tablets at controlled room temperature (59° to 86°F). Protect from moisture and light. Replace cap securely after each opening. Store effervescent tablets in refrigerator or at controlled room temperature. Store syrup between 39° and 77°F. Store premixed injection between 36° and 77°F. Store injection between 39° and 86°F. Protect from light. Ranitidine injection is stable for 24 h at room temperature when added to, or diluted with, compatible IV solutions.
Pharmacologic effects may be increased or decreased because of decreased GI absorption by ranitidine. Staggering administration times may avoid this reaction.Ethanol
May increase plasma ethanol levels.Glipizide
Possible increased hypoglycemia effect.Ketoconazole
May decrease effects of ketoconazole.Lidocaine
May cause increased lidocaine levels.Warfarin
Ranitidine may interfere with warfarin Cl. Hypoprothrombinemic effects may increase; may need adjustment.
False-positive test results for urine protein with Multistix may occur during ranitidine therapy; testing with sulfosalicylic acid is recommended.
AV block; bradycardia; cardiac arrhythmias; premature ventricular beats.
Agitation; confusion; depression; dizziness; fatigue; hallucinations; headache; insomnia; malaise; motor disturbances; somnolence; vertigo.
Alopecia; erythema multiforme; rash; vasculitis.
Abdominal discomfort; constipation; diarrhea; nausea; pancreatitis; vomiting.
Acquired immune hemolytic anemia; agranulocytosis; autoimmune hemolytic or aplastic anemia; granulocytopenia; leukopenia; pancytopenia; thrombocytopenia.
Cholestatic or hepatocellular effects.
Anaphylaxis; angioneurotic edema; hypersensitivity reactions.
Category B .
Excreted in breast milk.
Safety and efficacy of ranitidine have been established in children 1 mo to 16 yr of age for the treatment of duodenal and gastric ulcers, GERD and erosive esophagitis, and the maintenance of healed duodenal and gastric ulcer. Safety and efficacy have not been established for the treatment of pathological hypersecretory conditions or the maintenance of healing of erosive esophagitis in children or in neonates less than 1 mo of age.
May have reduced renal function; therefore, decreased drug Cl may be more common.
Rare cases of anaphylaxis have occurred as well as rare episodes of hypersensitivity.
Decreased Cl may occur; dosage reduction may be needed. Hemodialysis reduces level of ranitidine-dosage; timing must be adjusted so that scheduled dose coincides with end of hemodialysis.
Use drug with caution; decreased Cl may occur.
May occur, manifested as reversible hepatitis, hepatocellular or hepatocanalicular or mixed, with or without jaundice.
May rarely result in bradycardia, tachycardia, or premature ventricular beats, usually in patients predisposed to cardiac rhythm disturbances.
Collapse, diarrhea, hypotension, lacrimation, miosis, muscle tremors, pallor of mucous membranes, rapid redness of mouth and ears, respiration, respiratory failure, restlessness, salivation, tachycardia, vomiting.
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