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Ranitidine

    Discontinued

    DEA Class; Rx

    Common Brand Names; Zantac, Zantac 150 Maximum Strength, Zantac 75

    • Histamine H2 Antagonists

    On April 1, 2020, FDA requests removal of all ranitidine products (Zantac) from the market

    Oral and parenteral histamine type 2-receptor antagonist; ranitidine products withdrawn from U.S. market due to NDMA impurity
    Used for gastrointestinal disorders such as peptic ulcer and gastroesophageal reflux disease
    More potent histamine antagonist than cimetidine; less affinity for CYP450 enzymes

    Indicated for 

    • Gastroesophageal Reflux Disease
    • Gastric Ulcer, Benign
    • Erosive Esophagitis
    • Hypersecretory Conditions

    Hypersensitivity to ranitidine or components of the formulation

    • Headache (3%)
    • Abdominal pain
    • Agitation
    • Alopecia
    • Confusion
    • Constipation
    • Diarrhea
    • Dizziness
    • Hypersensitivity reaction
    • Nausea
    • Vomiting

    If gastroesophageal reflux disease does not respond adequately in 6-8 weeks, do not increase dosage; prescribe proton pump inhibitor instead

    Prolonged treatment may lead to B12 malabsorption and subsequent vitamin B12 deficiency; degree of deficiency is dose-related and association stronger in females and younger in age (<30 years)

    Use caution in renal impairment; adjust dosage

    Use caution in hepatic impairment

    Elevation of ALT levels reported with higher doses (≥100 mg) or prolonged IV therapy (≥5 days); monitor for ALT levels for the remainder of treatment

    Avoid in patients with acute porphyria; may precipitate attack

    Symptom relieve does not rule out presence of gastric malignancy

    Reversible confusional state reported with use (linked to age >50 years and renal or hepatic impairment); clears within 3-4 days after discontinuation

    If patient taking a prescription drug, the patient should ask a doctor or a pharmacist whether acid reducers can be taken concomitantly with it

    Patients with kidney disease should ask doctor before use

    Pregnancy category: B

    Lactation: Drug crosses into breast milk; discontinue drug, use caution

    Adults

    300 mg/day PO or 200 mg/day IV for most indications; up to 6 g/day PO or 220 mg/hour continuous IV for pathologic hypersecretory conditions.

    Geriatric

    300 mg/day PO or 200 mg/day IV for most indications; up to 6 g/day PO or 220 mg/hour continuous IV for pathologic hypersecretory conditions.

    Adolescents

    17 years: 300 mg/day PO or 200 mg/day IV for most indications; up to 6 g/day PO or 220 mg/hour continuous IV for pathologic hypersecretory conditions.
    13 to 16 years: 10 mg/kg/day PO (Usual Max: 300 mg/day); 4 mg/kg/day IV (Max: 200 mg/day) is FDA-approved maximum dosage; however, doses up to 6 mg/kg/day IV (Max: 200 mg/day) have been used off-label.

    Children

    10 mg/kg/day PO (Usual Max: 300 mg/day); 4 mg/kg/day IV (Max: 200 mg/day) is FDA-approved maximum dosage; however, doses up to 6 mg/kg/day IV (Max: 200 mg/day) have been used off-label.

    Infants

    10 mg/kg/day PO; 4 mg/kg/day IV is FDA-approved maximum dosage; however, doses up to 6 mg/kg/day IV have been used off-label.

    Neonates

    Safety and efficacy have not been established; however, doses up to 8 mg/kg/day PO or 5 mg/kg/day have been used off-label.

    Ranitidine hydrochloride

    injection solution

    • 25mg/mL

    syrup

    • 15mg/mL

    tablet

    • 75mg
    • 150mg
    • 300mg

    capsule

    • 150mg
    • 300mg