raNITIdine

Brand name: Zantac
Drug class: Histamine H2-Antagonists
- Antiulcer Agents
- Gastric Antisecretory Agents
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

Warning

Special Alerts:

[Posted 04/01/2020]

ISSUE: The FDA announced it is requesting manufacturers to withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately.

This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). NDMA is a probable human carcinogen (a substance that could cause cancer). FDA has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.

BACKGROUND: Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach. Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease.

RECOMMENDATION:

Consumers: The FDA is also advising consumers taking OTC ranitidine to stop taking any tablets or liquid they currently have, dispose of them properly and not buy more; for those who wish to continue treating their condition, they should consider using other approved OTC products.
Patients: Patients taking prescription ranitidine should speak with their health care professional about other treatment options before stopping the medicine, as there are multiple drugs approved for the same or similar uses as ranitidine that do not carry the same risks from NDMA. To date, the FDA's testing has not found NDMA in famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid) or omeprazole (Prilosec).
Consumers and Patients: In light of the current COVID-19 pandemic, the FDA recommends patients and consumers not take their medicines to a drug take-back location but follow the FDA's recommended steps, available at: [Web], which include ways to safely dispose of these medications at home.

For more information visit the FDA website at: [Web] and [Web].

Introduction

Histamine H₂ receptor antagonist.

Uses for raNITIdine

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Duodenal Ulcer

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

Maintenance of healing and reduction in recurrence of duodenal ulcer.

Pathologic GI Hypersecretory Conditions

Long-term treatment of Zollinger-Ellison syndrome, systemic mastocytosis, postoperative hypersecretion, “short-gut” syndrome.

Gastric Ulcer

Short-term treatment of active benign gastric ulcer.

Maintenance of healing and reduction in recurrence of gastric ulcer.

Gastroesophageal Reflux (GERD)

Treatment of GERD to achieve acid suppression, control symptoms, and prevent complications.

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

Maintain healing and decrease recurrence of erosive esophagitis.

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

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.

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.

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†.

raNITIdine Dosage and Administration

Administration

Administered orally.

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.

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

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

Oral Administration

Administer antacids concomitantly as necessary for relief of pain.

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. Effervescent tablets should not be chewed, swallowed whole, or dissolved on the tongue.

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

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

IM Injection

May be administered undiluted.

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.

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).

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.

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

Rate of Administration

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

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

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.

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.

Rate of Administration

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

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.

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Available as ranitidine hydrochloride; dosage expressed in terms of ranitidine.

Pediatric Patients

Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

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

Maximum 300 mg daily.

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

Maximum 50 mg every 6–8 hours.

Maintenance of Healing of Duodenal Ulcer

Oral

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

Maximum 150 mg daily.

Gastric Ulcer

Treatment

Oral

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

Maximum 300 mg daily.

Maintenance of Healing of Gastric Ulcer

Oral

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

Maximum 150 mg daily.

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.

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.

Self-medication for Heartburn

Oral

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

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.

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.

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.

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).

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

Adults

General Parenteral Dosage

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

50 mg every 6–8 hours.

Increase dosage when necessary by administering 50 mg more frequently.

Maximum 400 mg daily.

Intermittent Direct IV Injection

50 mg every 6–8 hours.

Increase dosage when necessary by administering 50 mg more frequently.

Maximum 400 mg daily.

Intermittent IV Infusion

50 mg every 6–8 hours.

Increase dosage when necessary by administering 50 mg more frequently.

Maximum 400 mg daily.

Continuous IV Infusion

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

Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

Usual dosage: 150 mg twice daily.

Alternative: 300 mg daily after evening meal or at bedtime for optimum convenience and compliance.

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

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

Additional 4 weeks of therapy may be beneficial.

Maintenance of Healing of Duodenal Ulcer

Oral

150 mg daily at bedtime.

Gastric Ulcer

Oral

150 mg twice daily.

Healing usually within 6 weeks.

Maintenance of Gastric Ulcer Healing

Oral

150 mg daily at bedtime.

Gastroesophageal Reflux

Treatment of GERD

Oral

150 mg twice daily.

Treatment of Erosive Esophagitis

Oral

150 mg 4 times daily.

Maintenance of Healing of Erosive Esophagitis

Oral

150 mg twice daily.

Self-medication for Heartburn

Oral

75 mg or 150 mg once or twice daily.

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.

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.

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.

Pathologic GI Hypersecretory Conditions

Oral

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

Adjust dosage according to patient response.

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

Continue as long as necessary.

Continuous IV Infusion

Initiate at 1 mg/kg per hour.

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.

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

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.

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.

Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

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

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

Maintenance of Healing of Duodenal Ulcer:

Oral

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

Gastric Ulcer

Treatment of Gastric Ulcer

Oral

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

Maintenance of Healing of Gastric Ulcer

Oral

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

Adults

General Parenteral Dosage

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

Maximum 400 mg daily.

Maximum 50 mg per dose.

Intermittent Direct IV

Maximum 400 mg daily.

Maximum 50 mg per dose.

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

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

Intermittent IV Infusion

Maximum 400 mg daily.

Maximum 50 mg per dose.

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

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

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

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.

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.

Duodenal Ulcer

Treatment of Active Duodenal Ulcer

Oral

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

Gastric Ulcer

Treatment of Active Benign Gastric Ulcer

Oral

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

Pathologic GI Hypersecretory Conditions

Continuous IV Infusion

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

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

Special Populations

Renal Impairment

Clcr <50 mL/minute

Oral

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

IM

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

Intermittent Direct IV

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

Intermittent IV Infusion

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

Continuous IV Infusion

Not evaluated.

Hemodialysis

Decreases blood levels; administer at the end of hemodialysis.

Geriatric Patients

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

Cautions for raNITIdine

Contraindications

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Known hypersensitivity to ranitidine or any ingredient in the formulation.
Do not use for self-medication if swallowing is difficult.
Do not use for self-medication with other drugs that decrease gastric acid secretion.
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. Instead, consult a clinician since such manifestations may indicate presence of a serious condition requiring alternative treatment.

Warnings/Precautions

General Precautions

Gastric Malignancy

Response to ranitidine does not preclude presence of gastric malignancy.

Hepatic Effects

Discontinue immediately in patients with hepatitis. Occasional hepatotoxicity, rarely, hepatic failure and death have been reported.

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

Cardiovascular Effects

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

Acute Intermittent Porphyria

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

Respiratory Effects

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

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.

Specific Populations

Pregnancy

Category B.

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

Lactation

Distributed into milk; use with caution.

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

Pediatric Use

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

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

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.

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

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

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.

Geriatric Use

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

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

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

Hepatic Impairment

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

Renal Impairment

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

Common Adverse Effects

Oral or parenteral therapy: Headache, sometimes severe.

IM therapy: Transient pain at injection site.

IV therapy: Transient local burning or itching.

Interactions for raNITIdine

Binds weakly to hepatic CYP isoenzyme system in vitro.

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

Does not inhibit CYP isoenzymes at recommended dosages.

May minimally inhibit hepatic metabolism of some drugs, or affect bioavailability by another mechanism (e.g., pH-dependent absorption, altered volume of distribution).

Specific Drugs, Foods, and Laboratory Tests

Drug, Food, or Test	Interaction	Comments
Acetaminophen	Dose-dependent inhibition of acetaminophen metabolism in vitro
Alcohol	Moderate alcohol consumption by individuals receiving concurrent ranitidine unlikely to result in clinically important alterations of blood alcohol concentration and/or alcohol metabolism	Controversy about psychomotor impairment potential; observe usual precautions about alcohol intake and hazardous tasks requiring mental alertness or physical coordination
Antacids	Low doses (10–15 mEq HCl neutralizing capacity/10 mL) do not appear to decrease absorption or plasma concentrations of ranitidine Higher doses (e.g., 150 mEq HCl neutralizing capacity/30 mL) decrease absorption by 33%, decrease plasma concentrations, and AUC
Atenolol	Atenolol pharmacokinetics apparently not affected
Benzodiazepines (e.g., diazepam, lorazepam, midazolam, triazolam)	Diazepam AUC, mean half-life not substantially affected Lorazepam elimination half-life, volume of distribution, clearance unaffected Midazolam oral bioavailability may be increased by ranitidine Triazolam oral bioavailability may be increased by elevated gastric pH clinical importance unknown	Observe carefully for signs of midazolam-induced respiratory and CNS depression; decrease midazolam dosage if required
Food	Does not appear to decrease absorption or plasma concentrations of ranitidine
Metoprolol	Increased metoprolol AUC, peak serum concentration, elimination half-life
Multistix, test for urine protein	False positive	Use sulfosalicylic acid reagent for urinary protein determinations while using ranitidine
Nifedipine	Nifedipine AUC increased by 30%
Phenytoin	Phenytoin serum concentrations unaffected
Propantheline	Appears to delay absorption and increases peak serum concentrations of ranitidine; biovailability increased about 23% with concomitant administration
Propranolol	Propranolol mean serum concentrations not substantially affected
Smoking	Adversely affects duodenal ulcer healing and decreases ranitidine efficacy; number of cigarettes/day apparently does not influence healing rate
Theophylline	Ranitidine apparently does not alter theophylline clearance
Vitamin B₁₂	Vitamin B₁₂ malabsorption and deficiency may occur with long-term ranitidine therapy
Warfarin	Increased or decreased PT reported	Pharmacokinetic studies: up to 400 mg daily had no effect on warfarin clearance or PT

raNITIdine Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed after oral or IM administration.

Oral bioavailability: About 50%; similar in children 3.5–16 years of age.

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.

IM: about 90–100% absorption.

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

Duration

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

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

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.

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.

Food

Food does not appear to substantially affect absorption or peak plasma concentrations.

Special Populations

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

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; considered minor, clinically unimportant.

Distribution

Extent

Widely distributed throughout body.

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

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

Plasma Protein Binding

10–19%.

Special Populations

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

Elimination

Metabolism

Extensive first-pass metabolism after oral administration.

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

Elimination Route

Excreted principally in urine.

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

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.

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

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

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

Half-life

Adults: Averages 1.7–3.2 hours and may be positively correlated with age.

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

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

Special Populations

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

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

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, in one clinical study it was about 6 hours following an oral 100-mg dose.

Stability

Storage

Oral

Tablets and Tablets for Self-medication

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

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

Tablets, Effervescent for Solution (foil-packaged)

2–30°C.

Solution

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

Parenteral

Injection

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

Protect from light.

Protect from freezing.

Darkening of undiluted injection does not affect potency.

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

Injection for IV infusion only

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

Protect from light.

Protect from freezing.

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)

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.
Competitively inhibits histamine at parietal cell H₂ receptors.

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Importance of patients informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.
Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients with phenylketonuria that oral effervescent tablets for solution contain aspartame.
When used for self-medication, importance of reading the product labeling and carefully reviewing the warning information provided by the manufacturer.
Importance of following dosage instructions, unless otherwise directed by a clinician, when ranitidine is administered for self-medication.
Importance of promptly informing clinician of persistent abdominal pain or difficulty swallowing.
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.

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