gical Hypersecretory Conditions (such as Zollinger-Ellison syndrome)
ZANTAC inhibits gastric acid secretion and reduces occurrence of diarrhea, anorexia, and pain in patients with pathological hypersecretion associated with Zollinger-Ellison syndrome, systemic mastocytosis, and other pathological hypersecretory conditions (e.g., postoperative, "short-gut" syndrome, idiopathic). Use of oral ZANTAC was followed by healing of ulcers in 8 of 19 (42%) patients who were intractable to previous therapy.
In a retrospective review of 52 Zollinger-Ellison patients given ZANTAC as a continuous IV infusion for up to 15 days, no patients developed complications of acid-peptic disease such as bleeding or perforation. Acid output was controlled to ≤10 mEq/h.
INDICATIONS AND USAGE
ZANTAC Injection and ZANTAC Injection Premixed are indicated in some hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.
CONTRAINDICATIONS
ZANTAC Injection and ZANTAC Injection Premixed are contraindicated for patients known to have hypersensitivity to the drug.
PRECAUTIONS
General
Symptomatic response to therapy with ZANTAC does not preclude the presence of gastric malignancy.
Since ZANTAC is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function (see DOSAGE AND ADMINISTRATION). Caution should be observed in patients with hepatic dysfunction since ZANTAC is metabolized in the liver.
In controlled studies in normal volunteers, elevations in SGPT have been observed when H2-antagonists have been administered intravenously at greater-than-recommended dosages for 5 days or longer. Therefore, it seems prudent in patients receiving IV ranitidine at dosages ≥100 mg 4 times daily for periods of 5 days or longer to monitor SGPT daily (from day 5) for the remainder of IV therapy.
Bradycardia in association with rapid administration of ZANTAC Injection has been reported rarely, usually in patients with factors predisposing to cardiac rhythm disturbances. Recommended rates of administration should not be exceeded (see DOSAGE AND ADMINISTRATION).
Rare reports suggest that ZANTAC may precipitate acute porphyric attacks in patients with acute porphyria. ZANTAC should therefore be avoided in patients with a history of acute porphyria.
Laboratory Tests
False-positive tests for urine protein with MULTISTIX® may occur during therapy with ZANTAC, and therefore testing with sulfosalicylic acid is recommended.
Drug Interactions
Ranitidine has been reported to affect the bioavailability of other drugs through several different mechanisms such as competition for renal tubular secretion, alteration of gastric pH, and inhibition of cytochrome P450 enzymes.
Procainamide: Ranitidine, a substrate of the renal organic cation transport system, may affect the clearance of other drugs eliminated by this route. High doses of ranitidine (e.g., such as those used in the treatment of Zollinger-Ellison syndrome) have been shown to reduce the renal excretion of procainamide and N-acetylprocainamide resulting in increased plasma levels of these drugs. Although this interaction is unlikely to be clinically relevant at usual ranitidine doses, it may be prudent to monitor for procainamide toxicity when adm