Ranitidine Hydrochloride

Histamine H2 receptor antagonist.1

Administration

Administered orally.1 118

Administered by IM or slow IV injection, or by intermittent or continuous IV infusion in hospitalized patients with pathologic GI hypersecretory conditions or intractable duodenal ulcer, or when oral therapy is not feasible.117 172

Administered by slow IV injection or intermittent IV infusion in children 1 month to 16 years of age for the treatment of duodenal ulcer.117 172 286

Administered by slow IV injection or intermittent or continuous IV infusion to decrease gastric pH in neonates <1 month of age receiving ECMO.117 172 286

Oral Administration

Administer antacids concomitantly as necessary for relief of pain.1

Dissolve each dose to be administered as 150-mg effervescent tablets in 180–240 mL (6–8 ounces) of water as directed prior to ingestion.1 Effervescent tablets should not be chewed, swallowed whole, or dissolved on the tongue.1

Dissolve each 25-mg effervescent tablet in ≥5 mL of water prior to administration.1 Allow tablet to completely dissolve before administering to the infant or child.1 May use a calibrated dropper or oral syringe to administer resultant solution in infants.1

Administer tablets for self-medication with a glass of water.287 288

IM Injection

May be administered undiluted.117

Intermittent Direct IV Injection

For solution and drug compatibility, see Compatibility under Stability.

Dilution

Dilute 50-mg dose to a concentration no greater than 2.5 mg/mL (i.e., total of 20 mL) with 0.9% sodium chloride injection or other compatible IV solution before direct IV injection.117 172

Rate of Administration

Inject the 20-mL diluted solution (containing 50 mg/20 mL) at rate ≤4 mL/minute (i.e., over at least 5 minutes).117 172

Intermittent IV Infusion

For solution and drug compatibility, see Compatibility under Stability.

Dilution

Dilute 50-mg dose to a concentration ≤0.5 mg/mL (i.e., 100 mL total) in 5% dextrose injection or other compatible IV solution.117 172

No additional dilution required for commercially available infusion solution (50 mg ranitidine in 50 mL of 0.45% sodium chloride).117

Rate of Administration

Infuse 50 mg/100 mL dilution at ≤5–7 mL/minute (i.e., over 15–20 minutes).117 172

Infuse commercially available infusion solution (50 mg in 50 mL of 0.45% sodium chloride) over 15–20 minutes.117

Continuous IV Infusion

For solution and drug compatibility, see Compatibility under Stability.

Dilution

Dilute 150 mg in 250 mL of 5% dextrose injection or other compatible IV solution.91 117 172

Dilute to concentration ≤2.5 mg/mL in 5% dextrose injection or other compatible IV solution for Zollinger-Ellison syndrome or other pathologic GI hypersecretory conditions.91 117 172

Rate of Administration

Infuse 150 mg/250 mL dilution at 6.25 mg/hour over 24 hours.91 117 172

Infuse dilution for Zollinger-Ellison syndrome or other pathologic GI hypersecretory conditions at initial rate of 1 mg/kg per hour; adjust subsequent rate to individual requirements.91 117 172

Dosage

Available as ranitidine hydrochloride; dosage expressed in terms of ranitidine.1 117 172

Pediatric Patients

Duodenal Ulcer Treatment of Active Duodenal Ulcer Oral

Children 1 month to 16 years of age: 2–4 mg/kg twice daily.1

Maximum 300 mg daily.1

IV

Children 1 month to 16 years of age: 2–4 mg/kg daily given as divided doses every 6–8 hours.117 172

Maximum 50 mg every 6–8 hours.117 172

Maintenance of Healing of Duodenal Ulcer Oral

Children 1 month to 16 years of age: 2–4 mg/kg once daily.1

Maximum 150 mg daily.1

Gastric Ulcer Treatment Oral

Children 1 month to 16 years of age: 2–4 mg/kg twice daily.1

Maximum 300 mg daily.1

Maintenance of Healing of Gastric Ulcer Oral

Children 1 month to 16 years of age: 2–4 mg/kg once daily.1

Maximum 150 mg daily.1

Gastroesophageal Reflux Treatment of GERD Oral

Children 1 month to 16 years of age: 5–10 mg/kg daily, usually administered as 2 equally divided doses.1

Treatment of Erosive Esophagitis Oral

Children 1 month to 16 years of age: 5–10 mg/kg daily, usually administered as 2 equally divided doses.1

Self-medication for Heartburn Oral

Children ≥12 years of age: 75 or 150 mg once or twice daily.287 288

Maximum 150 mg (as 75-mg tablets) or 300 mg (as 150-mg tablets) in 24 hours; maximum 2 weeks of continuous use as self-medication.287 288

Self-medication for Prevention of Heartburn Oral

Children ≥12 years of age: 75 or 150 mg once or twice daily; administer 30–60 minutes before ingestion of causative food or beverage.287 288

Maximum 150 mg (as 75-mg tablets) or 300 mg (as 150-mg tablets) in 24 hours; maximum 2 weeks of continuous use as self-medication.287 288

Increase Gastric pH in Neonates Undergoing ECMO IV

Neonates (<1 month of age) at risk for GI hemorrhage: Consider 2 mg/kg every 12–24 hours (or as continuous infusion).117 172

A dose of 2 mg/kg usually is sufficient to increase gastric pH to >4 for at least 15 hours.117 172

Adults

General Parenteral Dosage Hospitalized Patients with Pathologic Hypersecretory Conditions or Intractable Duodenal Ulcer, or Short-term Use When Oral Therapy is not Feasible IM

50 mg every 6–8 hours.117 172

Increase dosage when necessary by administering 50 mg more frequently.117 172

Maximum 400 mg daily.117 172

Intermittent Direct IV Injection

50 mg every 6–8 hours.117 172

Increase dosage when necessary by administering 50 mg more frequently.117 172

Maximum 400 mg daily.117 172

Intermittent IV Infusion

50 mg every 6–8 hours.117 172

Increase dosage when necessary by administering 50 mg more frequently.117 172

Maximum 400 mg daily.117 172

Continuous IV Infusion

150 mg/24 hours (6.25 mg/hour).117 172 See Pathologic GI Hypersecretory Conditions under Dosage.

Duodenal Ulcer Treatment of Active Duodenal Ulcer Oral

Usual dosage: 150 mg twice daily.1 118

Alternative: 300 mg daily after evening meal or at bedtime for optimum convenience and compliance.1 123 125 139 140

100 mg twice daily reported to be as effective in healing ulcers as 150 mg twice daily.1

Healing usually within 4 weeks; may occur in 2 weeks.124

Additional 4 weeks of therapy may be beneficial.1 91 124

Maintenance of Healing of Duodenal Ulcer Oral

150 mg daily at bedtime.1 136 178

Gastric Ulcer Oral

150 mg twice daily.1 118

Healing usually within 6 weeks.1

Maintenance of Gastric Ulcer Healing Oral

150 mg daily at bedtime.1

Gastroesophageal Reflux Treatment of GERD Oral

150 mg twice daily.1 136 179

Treatment of Erosive Esophagitis Oral

150 mg 4 times daily.1

Maintenance of Healing of Erosive Esophagitis Oral

150 mg twice daily.1

Self-medication for Heartburn Oral

75 mg or 150 mg once or twice daily.287 288

Maximum 150 mg (as 75-mg tablets) or 300 mg (as 150-mg tablets) in 24 hours; maximum 2 weeks of continuous use as self-medication.287 288

Self-medication for Prevention of Heartburn Oral

75 or 150 mg once or twice daily; administer 30–60 minutes before ingestion of causative food or beverage.287 288

Maximum 150 mg (as 75-mg tablets) or 300 mg (as 150-mg tablets) in 24 hours; maximum 2 weeks of continuous use as self-medication.287 288

Pathologic GI Hypersecretory Conditions Oral

150 mg twice daily; may administer more frequently, if needed.1 100

Adjust dosage according to patient response.1 100

Dosages up to 6 g daily have been used for severe disease.1 100

Continue as long as necessary.1 98 100

Continuous IV Infusion

Initiate at 1 mg/kg per hour.91 117 172

Titrate upward in 0.5 mg/kg per hour increments and redetermine gastric acid secretion if symptoms occur or gastric acid output is >10 mEq per hour after 4 hours.117 172

Dosages up to 2.5 mg/kg per hour and infusion rates up to 220 mg/hour have been used.117 172

Prescribing Limits

Pediatric Patients

Gastroesophageal Reflux Self-medication for Heartburn Oral

Adolescents ≥12 years of age: Maximum 150 mg (as 75-mg tablets) or 300 mg (as 150-mg tablets) in 24 hours; maximum 2 weeks of continuous use as self-medication.287 288

Self-medication for Prevention of Heartburn Oral

Adolescents ≥12 years of age: Maximum 150 mg (as 75-mg tablets) or 300 mg (as 150-mg tablets) in 24 hours; maximum 2 weeks of continuous use as self-medication.287 288

Duodenal Ulcer Treatment of Active Duodenal Ulcer Oral

Children 1 month to 16 years of age: Maximum 300 mg daily.1

IV

Children 1 month to 16 years of age: Maximum 50 mg every 6–8 hours.117 172

Maintenance of Healing of Duodenal Ulcer: Oral

Children 1 month to 16 years of age: Maximum 150 mg daily.1

Gastric Ulcer Treatment of Gastric Ulcer Oral

Children 1 month to 16 years of age: Maximum 300 mg daily.1

Maintenance of Healing of Gastric Ulcer Oral

Children 1 month to 16 years of age: Maximum 150 mg daily.1

Adults

General Parenteral Dosage Hospitalized Patients with Pathologic Hypersecretory Conditions or Intractable Duodenal Ulcer, or Short-term Use When Oral Therapy is not Feasible IM

Maximum 400 mg daily.117 172

Maximum 50 mg per dose.117 172

Intermittent Direct IV

Maximum 400 mg daily.117 172

Maximum 50 mg per dose.117 172

Maximum concentration 2.5 mg/mL (50 mg/20 mL).117 172

Maximum injection rate: 4 mL/minute (i.e., over 5 minutes).117 172

Intermittent IV Infusion

Maximum 400 mg daily.117 172

Maximum 50 mg per dose.117 172

Maximum concentration 0.5 mg/mL (50 mg/100 mL).117 172

Maximum infusion rate: 5–7 mL/minute (100 mL over 15–20 minutes).117 172

Commercially available infusion solution (50 mg in 50 mL of 0.45% sodium chloride): over 15–20 minutes.117

Gastroesophageal Reflux Self-Medication for Heartburn Oral

Maximum 150 mg (as 75-mg tablets) or 300 mg (as 150-mg tablets) in 24 hours; maximum 2 weeks of continuous use as self-medication.287 288

Self-medication for Prevention of Heartburn Oral

Maximum 150 mg (as 75-mg tablets) or 300 mg (as 150-mg tablets) in 24 hours; maximum 2 weeks of continuous use as self-medication.287 288

Duodenal Ulcer Treatment of Active Duodenal Ulcer Oral

Safety and efficacy for >8 weeks have not been established.1

Gastric Ulcer Treatment of Active Benign Gastric Ulcer Oral

Safety and efficacy for >6 weeks have not been established.1

Pathologic GI Hypersecretory Conditions Continuous IV Infusion

Zollinger-Ellison Syndrome: Maximum concentration 2.5 mg/mL.91 117 172

Up to 2.5 mg/kg per hour or 220 mg/hour has been used.117 172

Special Populations

Renal Impairment

Clcr <50 mL/minute Oral

150 mg once every 24 hours.1 If necessary, may cautiously increase dosage frequency to every 12 hours or more frequently.1

IM

50 mg every 18–24 hours.117 172 If necessary, may cautiously increase dosage frequency to every 12 hours or more frequently.117 172

Intermittent Direct IV

50 mg every 18–24 hours.117 172 If necessary, may cautiously increase dosage frequency to every 12 hours or more frequently.117 172

Intermittent IV Infusion

50 mg every 18–24 hours.117 172 If necessary, may cautiously increase dosage frequency to every 12 hours or more frequently.117 172

Continuous IV Infusion

Not evaluated.117 172

Hemodialysis

Decreases blood levels; administer at the end of hemodialysis.1 4 117 124 172

Geriatric Patients

Careful dosage selection recommended because of possible age-related decrease in renal function.a b c (See Geriatric Use under Cautions.)

Contraindications

• Known hypersensitivity to ranitidine or any ingredient in the formulation.1 91 124

• Do not use for self-medication if swallowing is difficult.287

• Do not use for self-medication with other drugs that decrease gastric acid secretion.287 288

• Do not use for self-medication if difficulty or pain occurs when swallowing food, if experiencing vomiting with blood, or if passing bloody or blackened stools.288 Instead, consult a clinician since such manifestations may indicate presence of a serious condition requiring alternative treatment.288

Warnings/Precautions

General Precautions

Gastric Malignancy

Response to ranitidine does not preclude presence of gastric malignancy.1

Hepatic Effects

Discontinue immediately in patients with hepatitis.1 117 124 172 Occasional hepatotoxicity, rarely, hepatic failure and death have been reported.1 161 162 163 164 165 166 167 168 169 170 171 b c

Increased serum ALT concentrations have occurred with ≥5 days of histamine H2-receptor antagonist therapy at higher than recommended IV dosages.117 Monitor serum ALT from day 5 to end of therapy when ranitidine is administered IV at dosages ≥400 mg daily for ≥5 days.117

Cardiovascular Effects

Rapid IV administration: associated rarely with bradycardia.117 172 Avoid rapid administration.117 172

Acute Intermittent Porphyria

Ranitidine may precipitate acute porphyric attacks.1 117 172 Avoid use in such patients.1 117 172

Respiratory Effects

Administration of H2-receptor antagonists has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).283 284

Phenylketonuria

Zantac EFFERdose tablets for solution contain aspartame (NutraSweet), which is metabolized in the GI tract to provide 2.81 or 16.84 mg of phenylalanine per 25- or 150-mg tablet, respectively.1

Specific Populations

Pregnancy

Category B.1 117 172

Self-medication in pregnant women: Consult clinician before using.287 288

Lactation

Distributed into milk; use with caution.1 124

Self-medication in nursing women: Consult clinician before using.287 288

Pediatric Use

Oral: Safety and efficacy for erosive esophagitis healing maintenance or pathologic hypersecretory condition treatment not established in pediatric patients.1

Oral: Safety and efficacy not established in neonates (< 1 month of age).1

Oral: Safety and efficacy established in infants, children, and adolescents 1 month to 16 years of age for duodenal and gastric ulcer treatment and healing maintenance, GERD treatment, and erosive esophagitis treatment.1

Parenteral: Safety and efficacy not established in pediatric patients for treatment of pathologic hypersecretory conditions.117 172

Parenteral: Safety and efficacy established in infants, children, and adolescents 1 month to 16 years of age for duodenal ulcer treatment.117 172

Parenteral (IV) use in neonates (< 1 month of age) receiving extracorporeal membrane oxygenation (ECMO): Limited data in neonates suggest that ranitidine may be safe and useful to increase gastric pH in infants at risk of GI hemorrhage.117 172

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1 117 172

Use with caution due to greater frequency of decreased renal function observed in the elderly.1 117 172

Select dosage with caution; monitoring renal function may be useful.1 117 172

Hepatic Impairment

Use with caution.1 (See Hepatic Effects under Cautions.)

Renal Impairment

Use with caution; dosage adjustment necessary based on degree of renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Oral or parenteral therapy: Headache, sometimes severe.1 2 4 5 81 88 97 117 124 147 172

IM therapy: Transient pain at injection site.117 172

IV therapy: Transient local burning or itching.117 172

Storage

Oral

Tablets and Tablets for Self-medication

Tablets: 15–30°C in tight, light resistant container.1 Replace cap securely after opening.1

Tablets for self-administration: 20–25°C.287 288

Tablets, Effervescent for Solution (foil-packaged)

2–30°C.1 157

Solution

4–30°C in tight, light resistant container.1 124 157

Parenteral

Injection

4–25°C; may be exposed to temperatures up to 30°C.172

Protect from light.117 157 172

Protect from freezing.117 157

Darkening of undiluted injection does not affect potency.117 172

Dilutions in most IV solutions: stable for up to 48 hours at room temperature.117 157 172

Injection for IV infusion only

2–25°C.117 157 Brief exposure to temperatures up to 40°C does not affect stability.117

Protect from light.117 157

Protect from freezing.117 157

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution CompatibilityHID

Compatible
Dextrose 5% in sodium chloride 0.45%
Dextrose 5 or 10% in water
Fat emulsion 10%, IV
Ringer's injection, lactated
Sodium chloride 0.9%
Variable
Dextrose 5% in Ringer’s injection, lactated. (stable for 48 hours)117

Drug Compatibility Admixture CompatibilityHID

Compatible
Acetazolamide sodium
Amikacin sulfate
Aminophylline
Chloramphenicol sodium succinate
Chlorothiazide sodium
Ciprofloxacin
Colistimethate sodium
Dexamethasone sodium phosphate
Digoxin
Dobutamine HCl
Dopamine HCl
Doxycycline hyclate
Epinephrine HCl
Erythromycin lactobionate
Fluconazole with ondansetron HCl
Flumazenil
Furosemide
Gentamicin sulfate
Heparin sodium
Isoproterenol HCl
Lidocaine HCl
Lincomycin HCl
Meropenem
Methylprednisolone sodium succinate
Midazolam HCl
Penicillin G potassium
Penicillin G sodium
Polymyxin B sulfate
Potassium chloride
Protamine sulfate
Quinidine gluconate
Sodium nitroprusside
Tobramycin sulfate
Vancomycin HCl
Zidovudine
Incompatible
Amphotericin B
Atracurium besylate
Cefoxitin sodium
Ceftazidime
Ethacrynate sodium
Insulin, regular
Phytonadione
Variable
Ampicillin sodium
Cefazolin sodium
Cefuroxime sodium
Clindamycin phosphate
Norepinephrine bitartrate

Y-Site CompatibilityHID

Compatible
Acyclovir sodium
Aldesleukin
Allopurinol sodium
Amifostine
Aminophylline
Anidulafungin
Atracurium besylate
Aztreonam
Bivalirudin
Cefazolin sodium
Cefoxitin sodium
Ceftaroline fosamil
Ceftazidime
Ciprofloxacin
Cisatracurium besylate
Cladribine
Clarithromycin
Dexmedetomidine HCl
Diltiazem HCl
Dobutamine HCl
Docetaxel
Dopamine HCl
Doripenem
Doxapram HCl
Doxorubicin HCl liposome injection
Enalaprilat
Epinephrine HCl
Esmolol HCl
Etoposide phosphate
Fenoldopam mesylate
Fentanyl citrate
Filgrastim
Fluconazole
Fludarabine phosphate
Foscarnet sodium
Furosemide
Gallium nitrate
Gemcitabine HCl
Granisetron HCl
Heparin sodium
Hetastarch in lactated electrolyte injection (Hextend)
Hydromorphone HCl
Idarubicin HCl
Labetalol HCl
Linezolid
Lorazepam
Melphalan HCl
Meperidine HCl
Midazolam HCl
Milrinone lactate
Morphine sulfate
Nicardipine HCl
Nitroglycerin
Norepinephrine bitartrate
Ondansetron HCl
Ondansetron HCl with paclitaxel
Oxaliplatin
Paclitaxel
Pancuronium bromide
Pemetrexed disodium
Piperacillin sodium–tazobactam sodium
Procainamide HCl
Propofol
Remifentanil HCl
Sargramostim
Tacrolimus
Telavancin HCl
Teniposide
Theophylline
Thiotepa
Tigecycline
Vecuronium bromide
Vinorelbine tartrate
Warfarin sodium
Zidovudine
Incompatible
Amphotericin B cholesteryl sulfate complex
Insulin, regular
Variable
Hetastarch in sodium chloride 0.9%

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

raNITIdine Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules, liquid-filled	150 mg (of ranitidine)*	raNITIdine Hydrochloride Capsules
		300 mg (of ranitidine)*	raNITIdine Hydrochloride Capsules
	Solution	75 mg (of ranitidine) per 5 mL	Zantac Syrup	GlaxoSmithKline
	Tablets, film-coated	75 mg (of ranitidine)*	raNITIdine Hydrochloride Tablets
			Zantac 75	Pfizer
		150 mg (of ranitidine)*	Zantac	GlaxoSmithKline
			Zantac Maximum Strength 150	GlaxoSmithKline
		300 mg (of ranitidine)*	Zantac	GlaxoSmithKline
	Tablets, for solution	25 mg (of ranitidine)	Zantac EFFERdose	GlaxoSmithKline
		150 mg (of ranitidine)	Zantac EFFERdose	GlaxoSmithKline
Parenteral	Injection	25 mg (of ranitidine) per mL*	raNITIdine Injection
			Zantac	GlaxoSmithKline
	Injection, for preparation of IV admixtures	25 mg (of ranitidine) per mL (1 g) pharmacy bulk package	Zantac	GlaxoSmithKline

raNITIdine Hydrochloride in Sodium Chloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection	1 mg (of ranitidine) per mL (50 mg) in 0.45% Sodium Chloride	Zantac Premixed (in flexible plastic container)	GlaxoSmithKline