Classes
DEA Class; Rx
Common Brand Names; Zantac, Zantac 150 Maximum Strength, Zantac 75
- Histamine H2 Antagonists
Description
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Oral and parenteral histamine type 2-receptor antagonist; ranitidine products withdrawn from U.S. market due to NDMA impurity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
Indications
Indicated for
- Gastroesophageal Reflux Disease
- Gastric Ulcer, Benign
- Erosive Esophagitis
- Hypersecretory Conditions
Contraindications
Hypersensitivity to ranitidine or components of the formulation
Adverse Effects
- Headache (3%)
- Abdominal pain
- Agitation
- Alopecia
- Confusion
- Constipation
- Diarrhea
- Dizziness
- Hypersensitivity reaction
- Nausea
- Vomiting
Warnings
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 and Lactation
Pregnancy category: B
Lactation: Drug crosses into breast milk; discontinue drug, use caution
Maximum Dosage
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.
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.
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.
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.
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.
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.
How supplied
Ranitidine hydrochloride
injection solution
- 25mg/mL
syrup
- 15mg/mL
tablet
- 75mg
- 150mg
- 300mg
capsule
- 150mg
- 300mg
