ranitidine (Discontinued)

Brand and Other Names:Zantac, Zantac 150 Maximum Strength, more...Zantac 75
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection solution

  • 25mg/mL

syrup

  • 15mg/mL

tablet

  • 75mg
  • 150mg
  • 300mg

capsule

  • 150mg
  • 300mg

FDA Safety Communication

On April 1, 2020, FDA requests removal of all ranitidine products (Zantac) from the market

For more information, see FDA Drug Safety Communication (link https://www.fda.gov/news-events/press-announcements/fda-requests-removal-all-ranitidine-products-zantac-market)

Health care professionals should stop prescribing and dispensing ranitidine to patients

Contact patients currently taking ranitidine, inform them of the reported contaminant N-Nitrosodimethylamine (NDMA) found in several ranitidine products, and request to discontinue medication

Discuss alternative medications approved for the same or similar uses as ranitidine that do not carry the same risks as NDMA

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 intermittent 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 intermittent 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 intermittent 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 necessary

Dosage Forms & Strengths

injection solution

  • 25mg/mL

syrup

  • 15mg/mL

tablet/capsule

  • 75mg
  • 150mg
  • 300mg

capsule

  • 150mg
  • 300mg

Active Duodenal/Gastric Ulcer

Treatment: 4-8 mg/kg PO q12hr; not to exceed 300 mg/day  

Maintenance: 2-4 mg/kg PO once daily; not to exceed 150 mg/day

Parenteral: 2-4 mg/kg/day IV divided q6-8hr; not to exceed 50 mg/dose or 200 mg/day

Gastroesophageal Reflux Disease

1 month - 16 years

5-10 mg/kg/day PO divided q12hr; not to exceed 300 mg/day  

Parenteral (Off-label): 2-4 mg/kg/day IV divided q6-8hr; not to exceed 50 mg/dose or 200 mg/day; alternatively, infusion at 1mg/kg/dose once followed by continuous infusion of 0.08-0.17 mg/kg/hr or 2-4 mg/kg/day

Erosive Esophagitis

1 month - 16 years

5-10 mg/kg/day PO divided q12hr; not to exceed 300 mg/day  

Parenteral (Off-label): 2-4 mg/kg/day IV divided q6-8hr; not to exceed 200 mg/day; alternatively, 1mg/kg/dose once followed by continuous infusion of 0.08-0.17 mg/kg/hr or 2-4 mg/kg/day

Neonates (Off-label)

Term Neonates (<29 days)

  • 2-4 mg/kg/day PO divided q8-12hr or 2 mg/kg/day IV divided q8hr  
  • Prophylaxis against dexamethasone associated ulceration: 0.031-1.25 mg/kg/hr during dexamethasone therapy to maintain gastric pH >4
  • Prophylaxis against stress ulceration: 2 mg/kg q12hr or 1.5 mg/kg IV q8hr; alternatively, 2 mg/kg over 10 min, followed by continuous infusion of 0.083 mg/kg/hr
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Interactions

Interaction Checker

and ranitidine

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (4)

              • infigratinib

                ranitidine will decrease the level or effect of infigratinib by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer infigratinib 2 hr before or 10 hr after administration of a H2-antagonist.

              • lonafarnib

                ranitidine will increase the level or effect of lonafarnib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If coadministration of lonafarnib (a sensitive CYP3A substrate) with weak CYP3A inhibitors is unavoidable, reduce to, or continue lonafarnib at starting dose. Closely monitor for arrhythmias and events (eg, syncope, heart palpitations) since lonafarnib effect on QT interval is unknown.

              • sotorasib

                ranitidine will decrease the level or effect of sotorasib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. If use with an acid-reducing agent cannot be avoided, administer sotorasib 4 hr before or 10 hr after administration of a locally-acting antacid.

              • trilaciclib

                trilaciclib will decrease the level or effect of ranitidine by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with substrates where minimal increased concentration in kidney or blood may lead to serious or life-threatening toxicities.

              Monitor Closely (3)

              • atogepant

                ranitidine will increase the level or effect of atogepant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              • finerenone

                ranitidine will increase the level or effect of finerenone by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Monitor serum potassium during initiation and dosage adjustment of either finererone or weak CYP3A4 inhibitors. Adjust finererone dosage as needed.

              • isavuconazonium sulfate

                ranitidine will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

              Minor (0)

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                Adverse Effects

                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)

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                Warnings

                Contraindications

                Hypersensitivity to ranitidine or components of the formulation

                Cautions

                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 confusional state reported with use (linked to age >50 years and renal or hepatic impairment); clears within 3-4 days after discontinuation

                If patient taking a prescription drug, the patient should ask a doctor or a pharmacist whether acid reducers can be taken concomitantly with it

                Patients with kidney disease should ask doctor before use

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                Pregnancy & Lactation

                Pregnancy category: B

                Lactation: Drug crosses into breast milk; discontinue drug, use caution

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                H2-receptor antagonist; blocks H2 receptors of gastric parietal cells, leading to inhibition of gastric secretions

                Absorption

                Bioavailability: 50% (PO); 90-100% (IM)

                Onset: 1 hr (IV/PO)

                Duration: 4-5 hr (IV/IM); 4-6 hr (PO)

                Peak serum time: 15 min (IM); 2-3 hr (PO)

                Distribution

                Protein bound: 10-19%

                Vd: 1.4 L/kg (normal renal function)

                Metabolism

                Metabolized in liver

                Metabolites: Ranitidine N-oxide, desmethylranitidine, ranitidine S-oxide (inactive)

                Enzymes inhibited: Unlike cimetidine, ranitidine does not inhibit microsomal enzymes

                Elimination

                Half-life: 2.5-3 hr (PO; increases to 4.8 hr with CrCl 25-35 mL/min); 2-2.5 hr (IV)

                Dialyzable: Yes (HD, PD)

                Renal clearance: 25 L/hr

                Total body clearance: 1.29-1.44 L/hr/kg

                Excretion: Urine (30% PO; 70% IV)

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                Administration

                IV Compatibilities

                Solution: Compatible with most common solvents

                Additive (partial list): Ampicillin(?), ciprofloxacin, dexamethasone, dobutamine, dopamine, epinephrine, erythromycin, floxacillin, fluconazole with ondansetron, furosemide, gentamicin, heparin, lidocaine, midazolam, norepinephrine (incompatible at 2 g), penicillin G potassium/sodium, potassium chloride, protamine sulfate, sodium nitroprusside, vancomycin

                Syringe (partial list): Atropine, dexamethasone, dimenhydrinate, diphenhydramine, dobutamine, dopamine, fentanyl, glycopyrrolate, heparin, hydromorphone, metoclopramide, morphine hydrochloride/sulfate, prochlorperazine, promethazine

                Y-site (partial list): Acyclovir, allopurinol, ceftazidime, ciprofloxacin, diltiazem, dobutamine, dopamine, epinephrine, esmolol, fentanyl, furosemide, heparin, linezolid, lorazepam, midazolam, morphine sulfate, nitroglycerin, norepinephrine, ondansetron, propofol, vecuronium, warfarin, zidovudine

                IV Incompatibilities

                Solution: D5W in LR(?)

                Additive: Amphotericin B, atracurium, cefamandole, cefazolin, cefoxitin, ceftazidime, cefuroxime, clindamycin(?), ethacrynate, insulin(?), phytonadione

                Syringe: Chlorpromazine(?), diazepam(?), hydroxyzine, lorazepam(?), methotrimeprazine, midazolam, papaveretum, pentobarbital, phenobarbital

                Y-site: Amphotericin B cholesteryl sulfate, hetastarch, insulin

                IV Administration

                Direct injection: 50 mg diluted to ≥20 mL with compatible IV infusion fluid and given over ≥5 minutes (4 mL/min)

                Intermittent infusion: 50 mg added to ≥100 mL of compatible IV solution and infused over 15-20 minutes

                Continuous infusion: 150 mg diluted in 250 mL of IV fluid and infused at 6.25 mg/hr for 24 hours

                IM Administration

                Administer undiluted

                Storage

                Store at 4-30°C (39-86°F)

                Protect from light and excessive heat

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                Images

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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.