Monograph Details
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Gastrointestinal Tract
> Hyperacidity, GERD, and ulcers
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ZANTAC EFFERDOSE |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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H2 blocker. |
| Generic Name |
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Ranitidine (as HCl) 25mg; effervescent tabs; contains phenylalanine, sodium (30.52mg per tab). |
| Also |
• ZANTAC
• ZANTAC INJECTION
• ZANTAC INJECTION PREMIXED
• ZANTAC SYRUP
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| Indications |
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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. |
| Children |
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Efferdose: dissolve 1 tab in 5mL of water. <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 literature. |
| Adults |
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Efferdose: dissolve 1 tab in 5mL of water. >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. |
| Precautions |
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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. |
| Interactions |
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May increase triazolam, midazolam, glipizide, procainamide levels. May decrease ketoconazole, atazanavir, delaviridine, gefitnib levels. Monitor anticoagulants. May cause false (+) urine protein test with Multistix. |
| Adverse Reactions |
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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 literature). |
| How Supplied |
Tabs 150mg—60, 180, 500
300mg—30
EFFERdose tabs—60
Syrup—pt
Inj single dose 2mL—10
Multidose 6mL—1
Premixed 50mL—24 |
| Additional Resources |
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• Related Prescribing Note |
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