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Cautions

Contraindications

• 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 agefor 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.