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Ranitidine Syrup Generic Name & Formulations
Legal Class
Rx
General Description
Ranitidine (as HCl) 15mg/mL; peppermint flavor; contains alcohol 7.5%.
Pharmacological Class
H2 blocker.
How Supplied
Tabs, syrup—contact supplier; Inj single dose (2mL)—10; Multidose (6mL)—1; Premixed (50mL)—24
Manufacturer
Ranitidine Syrup Indications
Indications
Active duodenal or benign gastric ulcer. Maintenance of healing of duodenal or gastric ulcer. Pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome and systemic mastocytosis). GERD. Erosive esophagitis. Maintenance of healing of erosive esophagitis.
Ranitidine Syrup Dosage and Administration
Adult
>16yrs: Active duodenal ulcer: 150mg twice daily or 300mg once daily after evening meal or at bedtime for up to 8wks; maintenance: 150mg at bedtime. Active benign gastric ulcer, hypersecretory conditions or GERD: 150mg twice daily; max 6g daily in hypersecretory conditions. Maintenance of healing of gastric ulcer: 150mg at bedtime. Limit to 6wks in benign gastric ulcer. Esophagitis: 150mg 4 times daily; reevaluate after 12wks; maintenance of healing of erosive esophagitis: 150mg twice daily. Renal impairment (CrCl <50mL/min): 150mg every 24hrs or more often if needed. Coincide a dose for end of hemodialysis. May give antacids concomitantly.
Children
<1month: not recommended. ≥1month–16yrs: Treatment of duodenal or gastric ulcers: 2–4mg/kg per day in two divided doses; max 300mg/day. Maintenance of healing of duodenal or gastric ulcers: 2–4mg/kg per day once daily; max 150mg/day. GERD, erosive esophagitis: 5–10mg/kg per day usually in two divided doses. Renal impairment (CrCl <50mL/min): reduce dose; see full labeling.
Ranitidine Syrup Contraindications
Not Applicable
Ranitidine Syrup Boxed Warnings
Not Applicable
Ranitidine Syrup Warnings/Precautions
Warnings/Precautions
History of acute porphyria: not recommended. Renal impairment: reduce dose. Hepatic dysfunction. Discontinue if hepatic disorders occur. Monitor SGPT if on high-dose IV therapy for ≥5 days. Pregnancy (Cat.B). Nursing mothers.
Ranitidine Syrup Pharmacokinetics
See Literature
Ranitidine Syrup Interactions
Interactions
May increase triazolam, midazolam, glipizide, procainamide levels. May decrease ketoconazole, atazanavir, delaviridine, gefitnib levels. Monitor anticoagulants. May cause false (+) urine protein test with Multistix.
Ranitidine Syrup Adverse Reactions
Adverse Reactions
Headache, GI disturbances, jaundice, hepatitis, rash; rare: CNS disturbances, arrhythmias, blurred vision, arthralgia, myalgia, inj site reactions, blood dyscrasias, anaphylaxis, angioneurotic edema, acute interstitial nephritis, bradycardia with rapid administration (IV); increased risk of pneumonia (see full labeling).
Ranitidine Syrup Clinical Trials
See Literature
Ranitidine Syrup Note
Not Applicable
Ranitidine Syrup Patient Counseling
See Literature
