Medication Guide App

Generic Name: Ranitidine Hydrochloride
Class: Histamine H2-Antagonists
VA Class: GA301
Chemical Name: N - [2 - [[[ - 5 - [(Dimethylamino)methyl] - 2 - furanyl]methyl]thio]ethyl] - N′ - methyl - 2 - nitro - 1,1 - ethenediamine hydrochloride
CAS Number: 66357-59-3

Introduction

Histamine H2 receptor antagonist.1

Uses for Zantac

Duodenal Ulcer

Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).1 2

Maintenance of healing and reduction in recurrence of duodenal ulcer.1 4 120 121 136 178

Pathologic GI Hypersecretory Conditions

Long-term treatment of Zollinger-Ellison syndrome, systemic mastocytosis, postoperative hypersecretion, “short-gut” syndrome.1 48 49 100 117

Slideshow: OTC Medication Use In Pregnancy: Wise or Worrisome?

Gastric Ulcer

Short-term treatment of active benign gastric ulcer.1 4 44 45 80 84 119 140

Maintenance of healing and reduction in recurrence of gastric ulcer.1

Gastroesophageal Reflux (GERD)

Treatment of GERD to achieve acid suppression, control symptoms, and prevent complications.1 4 6 86 124 126 128 132 134 135 136 137 138 179 280

Treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.1

Maintain healing and decrease recurrence of erosive esophagitis.1

Self-medication as initial therapy for less severe symptomatic GERD.280

Short-term self-medication for treatment of heartburn (pyrosis) symptoms associated with acid indigestion and sour stomach in adults and adolescents ≥12 years of age.287

Short-term self-medication for prevention of heartburn symptoms associated with acid indigestion and sour stomach brought on by ingestion of certain foods and beverages in adults and children ≥12 years of age.287

Increasing Gastric pH in Neonates Undergoing Extracorporeal Membrane Oxygenation (ECMO)

May be useful for increasing gastric pH in neonates (<1 month of age) at risk for GI hemorrhage during ECMO.b c

Zantac Dosage and Administration

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.)

Cautions for Zantac

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

Interactions for Zantac

Binds weakly to hepatic CYP isoenzyme system in vitro.1 117 172

Affinity for CYP isoenzyme system is about 10% that of cimetidine; inhibition of CYP isoenzyme system is 2.4 times less than cimetidine.54 101

Does not inhibit CYP isoenzymes at recommended dosages.1 117 172

May minimally inhibit hepatic metabolism of some drugs,1 2 4 5 74 101 105 112 or affect bioavailability by another mechanism (e.g., pH-dependent absorption, altered volume of distribution).1 117 172

Specific Drugs, Foods, and Laboratory Tests

Drug, Food, or Test

Interaction

Comments

Acetaminophen

Dose-dependent inhibition of acetaminophen metabolism in vitro96 108

Alcohol

Moderate alcohol consumption by individuals receiving concurrent ranitidine unlikely to result in clinically important alterations of blood alcohol concentration and/or alcohol metabolism77 238 239 240 241 244 247

Controversy about psychomotor impairment potential;238 239 240 241 242 243 248 observe usual precautions about alcohol intake and hazardous tasks requiring mental alertness or physical coordination239 240 243

Antacids

Low doses (10–15 mEq HCl neutralizing capacity/10 mL) do not appear to decrease absorption or plasma concentrations of ranitidine1 2 4 5 6 38 76 Higher doses (e.g., 150 mEq HCl neutralizing capacity/30 mL) decrease absorption by 33%, decrease plasma concentrations, and AUC76

Atenolol

Atenolol pharmacokinetics apparently not affected72

Benzodiazepines (e.g., diazepam, lorazepam, midazolam, triazolam)

Diazepam AUC, mean half-life not substantially affected2

Lorazepam elimination half-life, volume of distribution, clearance unaffected106

Midazolam oral bioavailability may be increased by ranitidinef

Triazolam oral bioavailability may be increased by elevated gastric pH 1 117 124 172 clinical importance unknown1 b c

Observe carefully for signs of midazolam-induced respiratory and CNS depression; decrease midazolam dosage if requiredf

Food

Does not appear to decrease absorption or plasma concentrations of ranitidine1 2 4 5 6 38 76

Metoprolol

Increased metoprolol AUC, peak serum concentration, elimination half-life72 73

Multistix, test for urine protein

False positive1

Use sulfosalicylic acid reagent for urinary protein determinations while using ranitidine1

Nifedipine

Nifedipine AUC increased by 30%72

Phenytoin

Phenytoin serum concentrations unaffected107

Propantheline

Appears to delay absorption and increases peak serum concentrations of ranitidine; biovailability increased about 23% with concomitant administration2

Propranolol

Propranolol mean serum concentrations not substantially affected2 101

Smoking

Adversely affects duodenal ulcer healing and decreases ranitidine efficacy;67 87 number of cigarettes/day apparently does not influence healing rate67

Theophylline

Ranitidine apparently does not alter theophylline clearance71 105

Vitamin B12

Vitamin B12 malabsorption and deficiency may occur with long-term ranitidine therapy16

Warfarin

Increased or decreased PT reported1 91 117 122 172

Pharmacokinetic studies: up to 400 mg daily had no effect on warfarin clearance or PT1 91 117 122 172

Zantac Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed after oral2 5 6 37 40 or IM117 administration.

Oral bioavailability: About 50%;1 2 4 5 6 39 42 88 139 similar in children 3.5–16 years of age.160

Oral: Peak plasma concentration attained within 2–3 hours in adults and geriatric patients and within 1.6–2 hours in children 1 month to 16 years of age.1

IM: about 90–100% absorption.117

Commercially available oral solution, effervescent tablets, and conventional tablets are bioequivalent.1

Duration

Following oral administration of a single 150-mg dose, substantial inhibition of gastric acid secretion reportedly continues for about 9.5 hours.5

In pediatric patients, oral administration of 6–10 mg/kg daily (in 2 or 3 divided doses), maintained gastric pH throughout the dosing interval.1

Following a single 150-mg oral dose, serum concentrations required to inhibit 50% of stimulated gastric acid secretion are maintained for up to 12 hours.1 4

IM or IV: Following a 50-mg dose, serum concentrations required to inhibit 50% of stimulated gastric acid secretion are maintained for 6–8 hours.117

Food

Food does not appear to substantially affect absorption or peak plasma concentrations.1 2 4 5 6 38

Special Populations

Oral: In geriatric individuals, AUC may be substantially increased.159

In individuals with cirrhosis, oral bioavailability appears to increase to about 70% and peak serum ranitidine concentrations appear to be higher because of reduced first-pass metabolism;2 6 42 considered minor, clinically unimportant.1

Distribution

Extent

Widely distributed throughout body.1 2 4 39 88 103 249

Distributed into CSF following oral administration;4 5 33 158 CSF concentrations in individuals with uninflamed meninges are about 3–5% of concurrent peak serum concentrations.4 5 33 158

Distributed into human milk;1 milk concentrations appear to be 25–100% of concurrent serum concentrations.4

Plasma Protein Binding

10–19%.1 2 4 39 88 103 249

Special Populations

In individuals with cirrhosis, minor but clinically unimportant alterations in distribution occur following oral administration.1

Elimination

Metabolism

Extensive first-pass metabolism after oral administration.1 2 4 5 6 39 42 88 103

Metabolized in the liver to ranitidine N-oxide, desmethyl ranitidine, and ranitidine S-oxide.1 2 3

Elimination Route

Excreted principally in urine.1 3 37 88

Following oral administration, excretion of unchanged ranitidine in urine is dose-dependent; about 16–36% (unchanged) is excreted in urine within 24 hours.1 3 37 43

Following oral administration, about 4% as ranitidine N-oxide, 1–2% as desmethyl ranitidine, and 1% as ranitidine S-oxide is excreted in urine within 24 hours.1 3 4 5 249

Most of the urinary excretion occurs within the first 6 hours after administration.4

The remainder of an orally administered dose is eliminated in feces.1 3

Following IV administration, approximately 70% is excreted in urine as unchanged drug.117

Half-life

Adults: Averages 1.7–3.2 hours1 2 4 5 6 37 39 40 41 88 103 104 159 and may be positively correlated with age.159

Children 3.5–16 years of age: Averages 1.8–2 hours (range: 1.4–2.9 hours).117 160 172

Neonates (<1 month of age): Averages 6.6 hours.117 172

Special Populations

In patients with renal impairment, plasma clearance appears to be decreased94 and elimination half-life prolonged.2 94

In patients with cirrhosis, minor but clinically unimportant alterations in half-life and reduced clearance occur following oral administration.1 42

In geriatric individuals, clearance appears to be reduced and half-life prolonged because of decreased renal function; although half-life reported to be 3–4 hours following oral or parenteral administration in geriatric patients, 1 117 172 in one clinical study it was about 6 hours following an oral 100-mg dose.42

Stability

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%

Actions

  • Inhibits daytime and nocturnal basal gastric acid secretion, stimulated gastric acid secretion.1 5 5 12

  • Competitively inhibits histamine at parietal cell H2 receptors.1

Advice to Patients

  • Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients with phenylketonuria that oral effervescent tablets for solution contain aspartame.1

  • When used for self-medication, importance of reading the product labeling and carefully reviewing the warning information provided by the manufacturer.287 288

  • Importance of following dosage instructions, unless otherwise directed by a clinician, when ranitidine is administered for self-medication.287 288

  • Importance of promptly informing clinician of persistent abdominal pain or difficulty swallowing.287 288

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

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

* 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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Ranitidine 75 75MG Tablets (MAJOR PHARMACEUTICALS): 30/$13.99 or 60/$16.97

Ranitidine HCl 15MG/ML Syrup (ACTAVIS MID ATLANTIC): 30/$29.99 or 90/$62.97

Ranitidine HCl 150MG Capsules (PAR): 60/$50.99 or 90/$70.97

Ranitidine HCl 150MG Tablets (AMNEAL PHARMACEUTICALS): 90/$17.99 or 180/$25.97

Ranitidine HCl 300MG Capsules (SANDOZ): 30/$62.99 or 90/$171.97

Ranitidine HCl 300MG Tablets (AMNEAL PHARMACEUTICALS): 30/$15.99 or 90/$24.97

Zantac 15MG/ML Syrup (GLAXO SMITH KLINE): 300/$224.99 or 900/$656.97

Zantac 150MG Tablets (GLAXO SMITH KLINE): 60/$259.00 or 180/$743.95

Zantac 300MG Tablets (GLAXO SMITH KLINE): 30/$240.99 or 90/$684.94

Zantac EFFERdose 25MG Effervescent Tablets (GLAXO SMITH KLINE): 60/$241.00 or 180/$705.95

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 4, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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59. Shah RR. Histamine H2 antagonists and the heart. Lancet. 1982; 2:1281-2. [IDIS 161370] [PubMed 6128580]

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62. Camarri E, Chirone E, Fanteria G et al. Ranitidine induced bradycardia. Lancet. 1982; 2:160. [IDIS 153835] [PubMed 6123873]

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121. Gough KR. Interim analysis of a comparative trial of ranitidine and cimetidine in the prevention of duodenal ulcer. Am J Med. 1984; 77(Suppl 5B):39-42. [IDIS 194494] [PubMed 6095660]

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125. Ireland A, Colin-Jones DG, Gear P et al. Ranitidine 150 mg twice daily vs 300 mg nightly in the treatment of duodenal ulcers. Lancet. 1984; 2:274-5. [IDIS 188794] [PubMed 6146821]

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132. Castell DO. Medical therapy for reflux esophagitis: 1986 and beyond. Ann Intern Med. 1986; 104:112-4. [PubMed 2866742]

133. Temple JG, Bradby GV, O’Connor FO et al. Cimetidine and metoclopramide in oesophageal reflux disease. BMJ. 1983; 286:1863-4. [IDIS 172185] [PubMed 6407606]

134. Johansson KE, Tibbling L. Maintenance treatment with ranitidine compared with fundoplication in gastro-oesophageal reflux disease. Scand J Gastroenterol. 1986; 21:779-88. [IDIS 222500] [PubMed 3535005]

135. Johansson KE, Boeryd B, Johansson K et al. Double-blind crossover study of ranitidine and placebo in gastro-oesphageal reflux disease. Scand J Gastroenterol. 1986; 21:769-78. [IDIS 222499] [PubMed 3535004]

136. Lewis JH. Summary of the Gastrointestinal Drugs Advisory Committee Meeting—March 21 and 22, 1985. Am J Gastroenterol. 1985; 80:581-3. [PubMed 3893097]

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164. Karachalios GN. Ranitidine and hepatitis. Ann Intern Med. 1985; 103:634-5. [IDIS 205110] [PubMed 4037565]

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166. Souza Lima MA. Ranitidine and the liver. Ann Intern Med. 1985; 102:273-4. [IDIS 195785] [PubMed 3966769]

167. Souza Lima MA. Ranitidine and hepatic injury. Ann Intern Med. 1986; 105:140. [PubMed 3717793]

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