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Ranitidine

Pronunciation

Pronunciation

(ra NI ti deen)

Index Terms

  • Ranitidine Hydrochloride

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Generic: 150 mg, 300 mg

Solution, Injection:

Zantac: 50 mg/2 mL (2 mL); 150 mg/6 mL (6 mL); 1000 mg/40 mL (40 mL) [contains phenol]

Generic: 50 mg/2 mL (2 mL); 150 mg/6 mL (6 mL); 1000 mg/40 mL (40 mL)

Solution, Intravenous [preservative free]:

Zantac in NaCl: 50 mg (50 mL [DSC])

Suspension Reconstituted, Oral:

Deprizine FusePaq: 22.4 mg/mL (250 mL) [contains sodium benzoate]

Syrup, Oral:

Zantac: 15 mg/mL (480 mL [DSC]) [contains alcohol, usp, butylparaben, propylparaben, saccharin sodium; peppermint flavor]

Generic: 15 mg/mL (10 mL, 473 mL, 474 mL, 480 mL); 75 mg/5 mL (473 mL, 480 mL [DSC]); 150 mg/10 mL (10 mL)

Tablet, Oral:

Acid Reducer: 75 mg, 150 mg

Acid Reducer: 150 mg [sodium free, sugar free]

Acid Reducer: 75 mg [DSC] [sugar free]

Acid Reducer Maximum Strength: 150 mg [DSC] [sugar free; contains fd&c yellow #6 (sunset yellow)]

GoodSense Acid Reducer: 75 mg [gluten free]

Ranitidine Acid Reducer: 75 mg

Zantac 75: 75 mg

Zantac: 150 mg, 300 mg

Zantac 150 Maximum Strength: 150 mg

Zantac 150 Maximum Strength: 150 mg [sodium free, sugar free; contains brilliant blue fcf (fd&c blue #1); mint flavor]

Generic: 75 mg, 150 mg, 300 mg

Tablet Effervescent, Oral:

Zantac EFFERdose: 25 mg [DSC] [contains aspartame, sodium benzoate]

Brand Names: U.S.

  • Acid Reducer Maximum Strength [OTC] [DSC]
  • Acid Reducer [OTC]
  • Deprizine FusePaq
  • GoodSense Acid Reducer [OTC]
  • Ranitidine Acid Reducer [OTC]
  • Zantac
  • Zantac 150 Maximum Strength [OTC]
  • Zantac 75 [OTC]
  • Zantac EFFERdose [DSC]
  • Zantac in NaCl [DSC]

Pharmacologic Category

  • Histamine H2 Antagonist

Pharmacology

Competitive inhibition of histamine at H2-receptors of the gastric parietal cells, which inhibits gastric acid secretion, gastric volume, and hydrogen ion concentration are reduced. Does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion, or serum gastrin.

Absorption

Oral: 50%; IM: Rapid

Distribution

Vd: ~1.4 L/kg in patients with normal renal function; 1.76 L/kg in patients with CrCl 25 to 35 mL/minute

Metabolism

Hepatic (minor) to N-oxide, S-oxide, and N-desmethyl metabolites

Excretion

Urine (as unchanged drug): Oral: 30%, IV: 70%; feces (as metabolites)

Time to Peak

Serum: Oral: 2 to 3 hours; IM: ≤15 minutes

Half-Life Elimination

Oral: Normal renal function: 2.5 to 3 hours

IV: Normal renal function: 2 to 2.5 hours; CrCl 25 to 35 mL/minute: 4.8 hours

Protein Binding

~15%

Special Populations: Renal Function Impairment

Plasma half-life, clearance, and volume of distribution are all altered in proportion to creatinine clearance.

Special Populations: Hepatic Function Impairment

Alterations in half-life, distribution, clearance, and bioavailability are minor but clinically insignificant.

Special Populations: Elderly

Plasma half-life is prolonged (to 3 to 4 hours [oral] and 3.1 hours [IV]) and total clearance is lowered.

Use: Labeled Indications

Oral:

Duodenal ulcer: Short-term treatment of active duodenal ulcer and maintenance therapy after the healing of acute ulcers.

Erosive esophagitis: Treatment of endoscopically diagnosed erosive esophagitis; for the maintenance of healing of erosive esophagitis.

Gastric ulcer: Short-term treatment of active, benign gastric ulcer and maintenance therapy after the healing of acute ulcer.

Gastroesophageal reflux disease: Treatment of gastroesophageal reflux disease (GERD).

Pathological hypersecretory conditions: Treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome, systemic mastocytosis).

Heartburn (OTC only): Relief and prevention of heartburn associated with acid indigestion and sour stomach.

Injection:

Duodenal ulcers: Indicated in some hospitalized patients with intractable duodenal ulcers.

Pathological hypersecretory conditions: Indicated in some hospitalized patients with pathological hypersecretory conditions (eg, Zollinger-Ellison).

Patients not able to take oral medication: As an alternative to the oral dosage form for short-term use in patients who are unable to take oral medication.

Use: Unlabeled

Recurrent postoperative ulcer, upper GI bleeding, and prevention of stress-induced ulcers

Contraindications

Hypersensitivity to ranitidine or any component of the formulation

OTC labeling: When used for self-medication (OTC), do not use if trouble or pain when swallowing food, vomiting with blood, or bloody or black stools, allergic to ranitidine or other acid reducers. Do not use with other acid reducers. Do not use 150 mg tablet with kidney disease without medical advice.

Documentation of allergenic cross-reactivity for histamine H2 antagonists is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosage

Children:

Duodenal ulcer:

Oral:

Treatment:

Infants, Children, and Adolescents ≤16 years: 4 to 8 mg/kg/day divided twice daily; maximum: 300 mg/day

Adolescents >16 years: Refer to adult dosing.

Maintenance of healing:

Infants, Children, and Adolescents ≤16 years: 2 to 4 mg/kg once daily; maximum: 150 mg/day

Adolescents >16 years: Refer to adult dosing.

IM: Adolescents >16 years: 50 mg every 6 to 8 hours

IV:

Infants, Children, and Adolescents ≤16 years: 2 to 4 mg/kg/day divided every 6 to 8 hours; maximum dose: 50 mg/dose

Adolescents >16 years: Refer to adult dosing.

Continuous infusion: 6.25 mg/hour

Intermittent bolus or infusion: 50 mg every 6 to 8 hours

Gastric ulcer: Oral:

Treatment:

Infants, Children, and Adolescents ≤16 years: 4 to 8 mg/kg/day divided twice daily; maximum: 300 mg/day

Adolescents >16 years: Refer to adult dosing.

Maintenance of healing:

Infants, Children, and Adolescents ≤16 years: 2 to 4 mg/kg once daily; maximum: 150 mg/day

Adolescents >16 years: Refer to adult dosing.

Gastroesophageal reflux disease (GERD) or erosive esophagitis: Oral:

Infants, Children, and Adolescents ≤16 years: 5 to 10 mg/kg/day divided twice daily; maximum: 300 mg/day

Adolescents >16 years: Refer to adult dosing.

Heartburn prevention or relief (OTC labeling):

Prevention: Children ≥12 years and Adolescents: Oral: 75 mg to 150 mg 30 to 60 minutes before eating food or drinking beverages which cause heartburn (maximum: 2 doses/day); do not use for more than 14 days

Relief of symptoms: Children ≥12 years and Adolescents: Oral: 75 mg to 150 mg up to twice daily (maximum: 2 doses/day); do not use for more than 14 days

Patients not able to take oral medications:

Infants, Children, and Adolescents <16 years: IV: 2 to 4 mg/kg/day divided every 6 to 8 hours; maximum dose: 50 mg/dose

Adolescents ≥16 years: Refer to adult dosing.

Pathological hypersecretory conditions: Adolescents >16 years: Refer to adult dosing.

Anaphylaxis, adjunct therapy (off-label use): Infants, Children, and Adolescents: IV: 1 mg/kg/dose; maximum dose: 50 mg/dose; should not be used as monotherapy or as first line therapy (AAAAI/ACAAI [Lieberman 2010])

Adults:

Duodenal ulcer:

Oral: Treatment: 150 mg twice daily or 300 mg once daily after the evening meal or at bedtime; maintenance of healing: 150 mg once daily at bedtime

IM: 50 mg every 6 to 8 hours

IV:

Intermittent bolus or infusion: 50 mg every 6 to 8 hours (if increased doses are necessary utilize more frequent administration up to a maximum of 400 mg/day)

Continuous infusion: 6.25 mg/hour

Erosive esophagitis: Oral: Treatment: 150 mg 4 times daily; maintenance of healing: 150 mg twice daily

Gastric ulcer, benign: Oral: 150 mg twice daily; maintenance of healing: 150 mg once daily at bedtime

Gastroesophageal reflux disease (GERD): Oral: 150 mg twice daily

Pathological hypersecretory conditions:

Oral: 150 mg twice daily; adjust dose or frequency as clinically indicated; doses of up to 6 g/day have been used in patients with severe disease

IM: 50 mg every 6 to 8 hours

IV:

Continuous IV infusion: 6.25 mg/hour

Continuous infusion for Zollinger-Ellison: Initial: 1 mg/kg/hour; measure gastric acid output at 4 hours, if >10 mEq or if patient is symptomatic, increase dose in increments of 0.5 mg/kg/hour; doses of up to 2.5 mg/kg/hour (or 220 mg/hour) have been used

Intermittent bolus or infusion: 50 mg every 6 to 8 hours (if increased doses are necessary utilize more frequent administration up to a maximum of 400 mg/day).

Patients not able to take oral medication:

IM: 50 mg every 6 to 8 hours

IV: Intermittent bolus or infusion: 50 mg every 6 to 8 hours

Continuous IV infusion: 6.25 mg/hour

Heartburn prevention or relief (OTC labeling): Oral:

Prevention: 75 to 150 mg 30 to 60 minutes before eating food or drinking beverages that cause heartburn (maximum: 2 doses/day); do not use for more than 14 days

Relief of symptoms: 75 mg to 150 mg up to twice daily (maximum: 2 doses/day); do not use for more than 14 days

Premedication to prevent taxane hypersensitivity (off-label use): IV: 50 mg 30 minutes prior to paclitaxel administration (along with dexamethasone and diphenhydramine) (Lee 2009)

Stress ulcer prophylaxis, ICU patients (off-label use) (ASHP 1999): Note: Intended for patients with associated risk factors (eg, coagulopathy, mechanical ventilation for >48 hours, severe sepsis); discontinue use once risk factors have resolved. The Surviving Sepsis Campaign guidelines suggest the use of proton pump inhibitors rather than H2 antagonist therapy (Dellinger 2013).

Oral, nasogastric (NG) tube: 150 mg twice daily; may administer a 300 mg loading dose prior to maintenance dosing (Pemberton, 1993)

IV: Intermittent bolus: 50 mg every 6-8 hours (Cook 1998; Geus 1993)

Anaphylaxis, adjunct therapy (off-label use): IV: 50 mg/dose; should not be used as monotherapy or as first line therapy (AAAAI/ACAAI [Lieberman 2010]).

Elderly: Refer to adult dosing.

Dosage adjustment in renal impairment:

Pediatrics (Aronoff 2007):

Oral: Based on a usual dose of 2 to 6 mg/kg/day divided every 8 to 12 hours

GFR >50 mL/minute/1.73 m2: No dosage adjustment necessary.

GFR 30 to 50 mL/minute/1.73 m2: 2 mg/kg/dose every 12 hours

GFR 10 to 29 mL/minute/1.73 m2: 1 mg/kg/dose every 12 hours

GFR <10 mL/minute/1.73 m2: 1 mg/kg/dose every 24 hours

Hemodialysis: 1 mg/kg/dose every 24 hours

Peritoneal dialysis: 1 mg/kg/dose every 24 hours

Continuous renal replacement therapy: 2 mg/kg/dose every 12 hours

Parenteral (IV): Based on a usual dose of 2 to 4 mg/kg/day divided every 6 to 24 hours

GFR >50 mL/minute/1.73 m2: No dosage adjustment necessary.

GFR 30 to 50 mL/minute/1.73 m2: 1 mg/kg/dose every 12 hours

GFR 10 to 29 mL/minute/1.73 m2: 0.5 mg/kg/dose every 12 hours

GFR <10 mL/minute/1.73 m2: 0.5 mg/kg/dose every 24 hours

Hemodialysis: 0.5 mg/kg/dose every 24 hours

Peritoneal dialysis: 0.5 mg/kg/dose every 24 hours

Continuous renal replacement therapy: 1 mg/kg/dose every 12 hours

Adults:

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl <50 mL/minute:

Oral: 150 mg every 24 hours; adjust dose cautiously if needed

IV: 50 mg every 18 to 24 hours; adjust dose cautiously if needed

Hemodialysis: Adjust dosing schedule so that dose is scheduled to coincide with the end of hemodialysis

Stress ulcer prophylaxis (ASHP 1999): CrCl <50 mL/minute:

Oral, nasogastric (NG) tube: 150 mg 1 to 2 times daily

IV: Intermittent bolus: 50 mg every 12 to 24 hours

Dosage adjustment in hepatic disease: There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.

Reconstitution

Continuous infusion: Dilute in D5W or other compatible IV solution; for Zollinger-Ellison patients, dilute in D5W or other compatible IV solution to a maximum concentration of 2.5 mg/mL.

Intermittent bolus injection: Dilute in NS or other compatible IV solution to a maximum concentration of 2.5 mg/mL (20 mL).

Intermittent infusion: Dilute in D5W or other compatible IV solution to a maximum concentration of 0.5 mg/mL (100 mL).

IM: No dilution necessary.

Administration

Injection may be administered IM or IV:

IM: Injection is administered undiluted

IV: Must be diluted; may be administered intermittent bolus, intermittent IV infusion, or continuous IV infusion

Intermittent bolus: Manufacturer recommends a maximum rate of administration of 10 mg/minute (infuse over at least 5 minutes); however, in adults may also be administered at a maximum rate of 25 mg/minute (or over 2 minutes) if necessary (Coursin 1988; Goelzer 1988; Smith 1987).

Intermittent IV infusion: Administer over a maximum rate of 2.5 to 3.5 mg/minute (infuse over at least 15 to 20 minutes)

Continuous IV infusion: Administer at a rate of 6.25 mg/hour; for Zollinger-Ellison patients, administer at a rate of 1 mg/kg/hour (infusion rates as high as 220 mg/hour have been used).

Dietary Considerations

Some products may contain phenylalanine and/or sodium. Oral dosage forms may be taken with or without food.

Compatibility

Stable in D51/2NS, D5W, D10W, fat emulsion 10%, LR, NS, sodium bicarbonate 5%; for injection, do not add other medications to premixed bag.

Y-site administration: Incompatible with amphotericin B cholesteryl sulfate complex, hetastarch in sodium chloride 0.9%, insulin (regular), pantoprazole.

Storage

Capsules, tablets: Store between 20°C and 25°C (68°F and 77°F). Protect from light. Protect from moisture.

Injection: Store intact vials between 4°C and 25°C (39°F to 77°F); excursion permitted to 30°C (86°F). Protect from light; do not freeze. Avoid excessive heat (brief exposure up to 40°C does not affect the product). Undiluted solution is a clear, colorless to yellow color; slight darkening does not affect potency. Stable for 48 hours at room temperature when diluted for infusion in commonly used IV solutions (eg, NS, D5W, D10W, Ringer's lactate injection, sodium bicarbonate 5% injection).

Suspension (Deprizine FusePaq): Store unused kit between 15°C and 30°C (59°F and 86°F); store reconstituted suspension between 2°C and 8°C (36°F and 46°F). The final suspension is stable for 8 weeks.

Syrup: Store between 4°C and 25°C (39°F and 77°F). Protect from light.

Drug Interactions

ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy

Atazanavir: H2-Antagonists may decrease the serum concentration of Atazanavir. Management: Specific dose limitations and administration guidelines exist; consult full interaction monograph or atazanavir prescribing information. Consider therapy modification

Bosutinib: H2-Antagonists may decrease the serum concentration of Bosutinib. Management: Administer histamine H2 receptor antagonists more than 2 hours before or after bosutinib. Consider therapy modification

BuPROPion: May increase the serum concentration of OCT2 Substrates. Monitor therapy

Cefditoren: H2-Antagonists may decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with H2-antagonists and antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of H2-antagonists can not be avoided. Consider therapy modification

Cefpodoxime: H2-Antagonists may decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. Monitor therapy

Cefuroxime: H2-Antagonists may decrease the absorption of Cefuroxime. Separate oral doses by at least 2 hours. Monitor therapy

Cysteamine (Systemic): H2-Antagonists may diminish the therapeutic effect of Cysteamine (Systemic). Monitor therapy

Dabrafenib: H2-Antagonists may decrease the serum concentration of Dabrafenib. Monitor therapy

Dasatinib: H2-Antagonists may decrease the absorption of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of H2-antagonists if some acid-reducing therapy is needed. Avoid combination

Delavirdine: H2-Antagonists may decrease the serum concentration of Delavirdine. Management: Chronic therapy with H2-antagonists should be avoided in patients who are being treated with delavirdine. The clinical significance of short-term H2-antagonist therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Avoid combination

Dexmethylphenidate: H2-Antagonists may increase the absorption of Dexmethylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Doxofylline: Ranitidine may increase the serum concentration of Doxofylline. Monitor therapy

Erlotinib: H2-Antagonists may decrease the serum concentration of Erlotinib. Management: Avoid H2-antagonists in patients receiving erlotinib when possible. If concomitant treatment cannot be avoided, erlotinib should be dosed once daily, 10 hours after and at least 2 hours before H2-antagonist dosing. Consider therapy modification

Fosamprenavir: H2-Antagonists may decrease the serum concentration of Fosamprenavir. Cimetidine may also inhibit the metabolism of the active metabolite amprenavir, making its effects on fosamprenavir/amprenavir concentrations difficult to predict. Monitor therapy

Gefitinib: H2-Antagonists may decrease the serum concentration of Gefitinib. Management: Administer gefitinib at least 6 hours before or after administration of a histamine H2-antagonist, and closely monitor clinical response to gefitinib. Consider therapy modification

Indinavir: H2-Antagonists may decrease the serum concentration of Indinavir. Monitor therapy

Iron Salts: H2-Antagonists may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Monitor therapy

Itraconazole: H2-Antagonists may decrease the serum concentration of Itraconazole. Management: When this combination is used, the itraconazole should be administered with a cola beverage (8 ounces). Itraconazole oral suspension may be less sensitive to this interaction. Monitor patient response to itraconazole closely. Consider therapy modification

Ketoconazole (Systemic): H2-Antagonists may decrease the serum concentration of Ketoconazole (Systemic). Management: Administer oral ketoconazole at least 2 hours prior to use of any H2-receptor antagonist. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Consider therapy modification

Ledipasvir: H2-Antagonists may decrease the serum concentration of Ledipasvir. Consider therapy modification

Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Mesalamine: H2-Antagonists may diminish the therapeutic effect of Mesalamine. Histamine H2-Antagonist-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose histamine H2-receptor antagonists with sustained-release mesalamine products. Consider therapy modification

Methylphenidate: H2-Antagonists may increase the absorption of Methylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): H2-Antagonists may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be impaired by H2-antagonists. Monitor therapy

Nelfinavir: H2-Antagonists may decrease the serum concentration of Nelfinavir. Concentrations of the active M8 metabolite may also be reduced. Monitor therapy

Nilotinib: H2-Antagonists may decrease the serum concentration of Nilotinib. Management: The nilotinib dose should be given 10 hours after or 2 hours before the H2 receptor antagonist in order to minimize the risk of a significant interaction. Consider therapy modification

PAZOPanib: H2-Antagonists may decrease the serum concentration of PAZOPanib. Management: Avoid the use of histamine H2-antagonists in combination with pazopanib. Strategies to minimize the expected interaction between these agents (eg, dose separation) have not been investigated. Avoid combination

P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy

Posaconazole: H2-Antagonists may decrease the serum concentration of Posaconazole. Management: Avoid concurrent use of oral suspension with H2-antagonists whenever possible. Monitor patients closely for decreased antifungal effects if this combination is used. Delayed-release posaconazole tablets may be less likely to interact. Consider therapy modification

Prasugrel: Ranitidine may decrease serum concentrations of the active metabolite(s) of Prasugrel. Monitor therapy

Procainamide: Ranitidine may increase the serum concentration of Procainamide. Ranitidine may also increase the concentration of the active N-acetyl-procainamide (NAPA) metabolite. Monitor therapy

Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy

Rilpivirine: H2-Antagonists may decrease the serum concentration of Rilpivirine. Management: Administer histamine H2 receptor antagonists at least 12 hours before or 4 hours after rilpivirine. Consider therapy modification

Risedronate: H2-Antagonists may increase the serum concentration of Risedronate. This applies specifically to delayed-release risedronate. Avoid combination

Saquinavir: H2-Antagonists may increase the serum concentration of Saquinavir. Monitor therapy

Sulfonylureas: Ranitidine may increase the serum concentration of Sulfonylureas. Monitor therapy

TiZANidine: CYP1A2 Inhibitors (Weak) may increase the serum concentration of TiZANidine. Management: Avoid these combinations when possible. If combined use cannot be avoided, initiate tizanidine at an adult dose of 2 mg and increase in 2-4 mg increments based on patient response. Monitor for increased effects of tizanidine, including adverse reactions. Consider therapy modification

Varenicline: H2-Antagonists may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concomitant use of cimetidine or other H2-antagonists, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. Monitor therapy

Warfarin: Ranitidine may increase the serum concentration of Warfarin. Monitor therapy

Test Interactions

False-positive urine protein using Multistix.

Adverse Reactions

Frequency not defined.

Cardiovascular: Asystole, atrioventricular block, bradycardia (with rapid IV administration), premature ventricular beats, tachycardia, vasculitis

Central nervous system: Agitation, dizziness, depression, hallucinations, headache, insomnia, malaise, mental confusion, somnolence, vertigo

Dermatologic: Alopecia, erythema multiforme, rash

Endocrine & metabolic: Prolactin levels increased

Gastrointestinal: Abdominal discomfort/pain, constipation, diarrhea, nausea, necrotizing enterocolitis (VLBW neonates; Guillet, 2006), pancreatitis, vomiting

Hematologic: Acquired immune hemolytic anemia, acute porphyritic attack, agranulocytosis, aplastic anemia, granulocytopenia, leukopenia, pancytopenia, thrombocytopenia

Hepatic: Cholestatic hepatitis, hepatic failure, hepatitis, jaundice

Local: Transient pain, burning or itching at the injection site

Neuromuscular & skeletal: Arthralgia, involuntary motor disturbance, myalgia

Ocular: Blurred vision

Renal: Acute interstitial nephritis, serum creatinine increased

Respiratory: Pneumonia (causal relationship not established)

Miscellaneous: Anaphylaxis, angioneurotic edema, hypersensitivity reactions (eg, bronchospasm, fever, eosinophilia)

Warnings/Precautions

Concerns related to adverse effects:

• Confusion: Rare cases of reversible confusion have been associated with ranitidine; usually elderly or severely ill patients, or in patients with renal or hepatic impairment.

• Hepatic effects: Elevation in ALT levels has occurred with higher doses (≥100 mg) or prolonged IV therapy (≥5 days); monitor ALT levels daily for the remainder of treatment.

• Vitamin B12 deficiency: Prolonged treatment (≥2 years) may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years); prevalence is decreased after discontinuation of therapy (Lam 2013).

Disease-related concerns:

• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.

• Hepatic impairment: Use with caution in patients with hepatic impairment (ranitidine undergoes hepatic metabolism).

• Porphyria: Avoid use in patients with a history of acute porphyria; may precipitate attacks.

• Renal impairment: Ranitidine is primarily excreted renally; dosage adjustment is recommended in patients with renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Children: Use of gastric acid inhibitors, including proton pump inhibitors and H2 blockers, has been associated with an increased risk for development of acute gastroenteritis and community-acquired pneumonia in pediatric patients (Canani 2006).

Dosage form specific issues:

• Injection: Rapid administration has been associated with bradycardia (rare), usually in patients with predisposing risk factors for cardiac rhythm disorders. Do not exceed the recommended IV administration rate(s).

• Syrup: May contain up to 7.5% alcohol.

Other warnings/precautions:

• OTC labeling: When used for self-medication (OTC), notify health care provider before use if any of the following are present: Frequent chest pain; frequent wheezing particularly with heartburn; nausea/vomiting; unexplained weight loss; stomach pain; heartburn longer than 3 months; heartburn with light-headedness, sweating, or dizziness; chest pain or shoulder pain with shortness of breath; sweating or pain that spreads to arms, neck, or shoulders; light-headedness. Stop use and notify health care provider if heartburn continues, worsens, or lasts longer than 14 days.

Monitoring Parameters

AST, ALT, serum creatinine; occult blood with GI bleeding, signs/symptoms of peptic ulcer disease; when used to prevent stress-related GI bleeding, measure the intragastric pH and try to maintain pH >4; when used for Zollinger-Ellison syndrome, monitor gastric acid secretion (goal: <10 mEq/hour); signs of confusion

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Ranitidine crosses the placenta (Armentano, 1989). Histamine H2 antagonists have been evaluated for the treatment of gastroesophageal reflux disease (GERD) as well as gastric and duodenal ulcers during pregnancy. If needed, ranitidine is the agent of choice (Cappell 2003; Richter 2003). Histamine H2 antagonists may be used for aspiration prophylaxis prior to cesarean delivery (ASA 2007).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, constipation, diarrhea, or injection site irritation. Have patient report immediately to prescriber severe dizziness, syncope, illogical thinking, angina, tachycardia, arrhythmia, significant headache, urinary retention, ecchymosis, hemorrhaging, or signs of hepatic impairment (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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