GERD, treatment: Oral:
Infants and Children ≤11 years: Limited data available: 5 mg/kg/dose twice daily; maximum daily dose: 300 mg/day (AAP [Lightdale] 2013; Vandenplas 2009)
Children ≥12 years and Adolescents: 150 mg twice daily; maximum daily dose: 300 mg/day
Esophagitis, treatment: Oral:
Infants ≥6 months and Children ≤11 years: Limited data available: 5 mg/kg/dose twice daily. Dosing based on a double blind, placebo controlled trial in 26 pediatric patients (treatment group: n=13; age range: 0.5 to 12 years) with mild to moderate esophagitis (Simeone 1997).
Children ≥12 years and Adolescents: 150 mg twice daily; maximum daily dose: 300 mg/day
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Active treatment: Children ≥12 years and Adolescents:
CrCl 20 to 50 mL/minute: 150 mg once daily
CrCl <20 mL/minute: 150 mg every other day
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Nizatidine: Drug information")
Gastroesophageal reflux disease: Oral: 150 mg twice daily; duration of therapy depends on symptoms.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Manufacturer's labeling:
Active treatment:
CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl 20 to 50 mL/minute: 150 mg once daily
CrCl <20 mL/minute: 150 mg every other day
Maintenance treatment:
CrCl >50 mL/minute: No dosage adjustment necessary
CrCl 20 to 50 mL/minute: 150 mg every other day
CrCl <20 mL/minute: 150 mg every 3 days
Alternate recommendations (Aronoff 2007):
GFR >50 mL/minute: Administer 75% to 100% of normal dose
GFR 10 to 50 mL/minute: 150 mg every 24 to 48 hours
GFR <10 mL/minute: 150 mg every 48 to 72 hours
Hemodialysis: 150 mg every 48 to 72 hours
Peritoneal dialysis: 150 mg every 48 to 72 hours
There are no dosage adjustments provided in the manufacturer's labeling.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Generic: 150 mg, 300 mg
Solution, Oral:
Generic: 15 mg/mL (480 mL)
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Axid: 150 mg, 300 mg
Generic: 150 mg, 300 mg
Oral: May administer with or without food; do not administer or mix capsule contents with apple juice
Administer with or without food.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Nizatidine is stable for 48 hours at room temperature when the contents of a capsule are mixed in Gatorade® lemon-lime, Cran-Grape® grape-cranberry drink, V8®, or aluminum- and magnesium hydroxide suspension (approximate concentration 2.5 mg/mL) (Lantz 1990)
Oral solution: Treatment of endoscopically diagnosed esophagitis (erosive and ulcerative) and associated heartburn due to gastroesophageal reflux disease (GERD) (FDA approved in ages ≥12 years and adults); treatment and maintenance therapy of duodenal ulcer (FDA approved in adults); treatment of active benign gastric ulcer (FDA approved in adults)
Capsule: Treatment and maintenance therapy of duodenal ulcer; treatment of active benign gastric ulcer; treatment of endoscopically diagnosed esophagitis (erosive and ulcerative) and associated heartburn due to gastroesophageal reflux disease (GERD) (All indications: FDA approved in adults)
Axid may be confused with Ansaid
Nizatidine may be confused with tiZANidine
Tazac [Australia] may be confused with Tazact brand name for piperacillin/tazobactam [India]; Tiazac brand name for dilTIAZem [US, Canada]
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Central nervous system: Headache (16%)
1% to 10%:
Central nervous system: Anxiety, dizziness, drowsiness, insomnia, irritability (children), nervousness
Dermatologic: Pruritus, skin rash
Gastrointestinal: Abdominal pain, anorexia, constipation, diarrhea, flatulence, heartburn, nausea, vomiting, xerostomia
Respiratory: Cough (children), nasal congestion (children), nasopharyngitis (children)
Miscellaneous: Fever (children)
<1%, postmarketing, and/or case reports: Anaphylaxis, anemia, bronchospasm, confusion, eosinophilia, exfoliative dermatitis, gynecomastia, hepatitis, immune thrombocytopenia, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, jaundice, laryngeal edema, serum sickness-like reaction, thrombocytopenia, vasculitis, ventricular tachycardia
Hypersensitivity to nizatidine, other H2 antagonists, or any component of the formulation.
Concerns related to adverse effects:
• Vitamin B12 deficiency: Prolonged treatment (≥2 years) may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years); prevalence is decreased after discontinuation of therapy (Lam 2013).
Disease-related concerns:
• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.
• Renal impairment: Use with caution in patients with moderate to severe renal impairment; dosage adjustment recommended.
Special populations:
• Pediatric: Use of gastric acid inhibitors, including proton pump inhibitors and H2 blockers, has been associated with an increased risk for development of acute gastroenteritis and community-acquired pneumonia in pediatric patients (Canani 2006).
None known.
Acalabrutinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Acalabrutinib. Management: To minimize the potential for a significant interaction, separate administration of these agents by giving acalabrutinib 2 hours before ingestion of a histamine-2 receptor antagonist. Risk D: Consider therapy modification
Atazanavir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Atazanavir. Management: Specific dose limitations and administration guidelines exist; consult full interaction monograph or atazanavir prescribing information. Risk D: Consider therapy modification
Belumosudil: Histamine H2 Receptor Antagonists may decrease the serum concentration of Belumosudil. Risk C: Monitor therapy
Bosutinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Bosutinib. Management: Administer histamine H2 receptor antagonists more than 2 hours before or after bosutinib. Risk D: Consider therapy modification
Cefditoren: Histamine H2 Receptor Antagonists may decrease the serum concentration of Cefditoren. Management: Concomitant use of cefditoren with H2-antagonists and antacids is not recommended. Consider alternative methods to control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of H2-antagonists can not be avoided. Risk D: Consider therapy modification
Cefpodoxime: Histamine H2 Receptor Antagonists may decrease the serum concentration of Cefpodoxime. Risk C: Monitor therapy
Cefuroxime: Histamine H2 Receptor Antagonists may decrease the absorption of Cefuroxime. Separate oral doses by at least 2 hours. Risk X: Avoid combination
Cysteamine (Systemic): Histamine H2 Receptor Antagonists may diminish the therapeutic effect of Cysteamine (Systemic). Risk C: Monitor therapy
Dacomitinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Dacomitinib. Management: Administer dacomitinib at least 6 hours before or 10 hours after an histamine H2-receptor antagonist (H2RA). Risk D: Consider therapy modification
Dasatinib: Histamine H2 Receptor Antagonists may decrease the absorption of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of H2-antagonists if some acid-reducing therapy is needed. Risk X: Avoid combination
Delavirdine: Histamine H2 Receptor Antagonists may decrease the serum concentration of Delavirdine. Risk X: Avoid combination
Enoxacin: Histamine H2 Receptor Antagonists may decrease the absorption of Enoxacin. Risk C: Monitor therapy
Erlotinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Erlotinib. Management: Avoid H2-antagonists in patients receiving erlotinib when possible. If concomitant treatment cannot be avoided, erlotinib should be dosed once daily, 10 hours after and at least 2 hours before H2-antagonist dosing. Risk D: Consider therapy modification
Fosamprenavir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Fosamprenavir. Cimetidine may also inhibit the metabolism of the active metabolite amprenavir, making its effects on fosamprenavir/amprenavir concentrations difficult to predict. Risk C: Monitor therapy
Gefitinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Gefitinib. Management: Administer gefitinib at least 6 hours before or 6 hours after administration of a histamine H2 receptor antagonist (H2RA), and closely monitor clinical response to gefitinib. Risk D: Consider therapy modification
Indinavir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Indinavir. Risk C: Monitor therapy
Infigratinib: Histamine H2 Receptor Antagonists may decrease serum concentrations of the active metabolite(s) of Infigratinib. Histamine H2 Receptor Antagonists may decrease the serum concentration of Infigratinib. Management: Avoid coadministration of infigratinib with histamine receptor antagonists (H2RAs) or other gastric acid-lowering agents. If H2RAs cannot be avoided, administer infigratinib 2 hours before or 10 hours after administration of H2RAs. Risk D: Consider therapy modification
Itraconazole: Histamine H2 Receptor Antagonists may increase the serum concentration of Itraconazole. Histamine H2 Receptor Antagonists may decrease the serum concentration of Itraconazole. Management: Administer Sporanox brand itraconazole at least 2 hours before or 2 hours after administration of any histamine H2 receptor antagonists (H2RAs). Exposure to Tolsura brand itraconazole may be increased by H2RAs; consider itraconazole dose reduction. Risk D: Consider therapy modification
Ketoconazole (Systemic): Histamine H2 Receptor Antagonists may decrease the serum concentration of Ketoconazole (Systemic). Management: Administer oral ketoconazole at least 2 hours prior to use of any H2-receptor antagonist. Monitor patients closely for signs of inadequate clinical response to ketoconazole. Risk D: Consider therapy modification
Ledipasvir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Ledipasvir. Management: Administer H2 receptor antagonist doses less than or comparable to famotidine 40 mg twice daily simultaneously or 12 hours prior to ledipasvir. The effect of administering H2 receptor antagonists at other time intervals is unknown and not recommended. Risk D: Consider therapy modification
Levoketoconazole: Histamine H2 Receptor Antagonists may decrease the absorption of Levoketoconazole. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): Histamine H2 Receptor Antagonists may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be impaired by H2-antagonists. Risk C: Monitor therapy
Nelfinavir: Histamine H2 Receptor Antagonists may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Histamine H2 Receptor Antagonists may decrease the serum concentration of Nelfinavir. Concentrations of the active M8 metabolite may also be reduced. Risk C: Monitor therapy
Neratinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Neratinib. Specifically, histamine H2 receptor antagonists may reduce neratinib absorption. Management: Administer neratinib at least 2 hours before or 10 hours after administration of a histamine H2 receptor antagonist to minimize the impact of this interaction. Risk D: Consider therapy modification
Nilotinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Nilotinib. Management: The nilotinib dose should be given 10 hours after or 2 hours before the H2 receptor antagonist in order to minimize the risk of a significant interaction. Risk D: Consider therapy modification
Octreotide: Histamine H2 Receptor Antagonists may decrease the serum concentration of Octreotide. Risk C: Monitor therapy
PAZOPanib: Histamine H2 Receptor Antagonists may decrease the serum concentration of PAZOPanib. Risk X: Avoid combination
Pexidartinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Pexidartinib. Management: Administer pexidartinib 2 hours before or 10 hours after histamine H2 receptor antagonists. Risk D: Consider therapy modification
Posaconazole: Histamine H2 Receptor Antagonists may decrease the serum concentration of Posaconazole. Management: Avoid concurrent use of oral suspension with H2-antagonists whenever possible. Monitor patients closely for decreased antifungal effects if this combination is used. Delayed-release posaconazole tablets may be less likely to interact. Risk D: Consider therapy modification
Rilpivirine: Histamine H2 Receptor Antagonists may decrease the serum concentration of Rilpivirine. Management: Administer histamine H2 receptor antagonists at least 12 hours before or 4 hours after rilpivirine. Risk D: Consider therapy modification
Risedronate: Histamine H2 Receptor Antagonists may increase the serum concentration of Risedronate. This applies specifically to delayed-release risedronate. Risk X: Avoid combination
Saquinavir: Histamine H2 Receptor Antagonists may increase the serum concentration of Saquinavir. Risk C: Monitor therapy
Secretin: Histamine H2 Receptor Antagonists may diminish the diagnostic effect of Secretin. Specifically, use of H2-Antagonists may cause a hyperresponse in gastrin secretion in response to secretin stimulation testing, falsely suggesting gastrinoma. Management: Avoid concomitant use of histamine H2-antagonists (H2RAs) and secretin. Discontinue H2RAs at least 2 days prior to secretin administration. Risk D: Consider therapy modification
Selpercatinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Selpercatinib. Management: Coadministration of selpercatinib and H2 receptor antagonists should be avoided. If coadministration cannot be avoided, selpercatinib should be administered 2 hours before or 10 hours after H2 receptor antagonists. Risk D: Consider therapy modification
Sotorasib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Sotorasib. Risk X: Avoid combination
Velpatasvir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Velpatasvir. Risk C: Monitor therapy
Prolonged treatment (≥2 years) may lead to malabsorption of dietary vitamin B12 and subsequent vitamin B12 deficiency (Lam 2013).
Adverse events have not been observed in animal reproduction studies. Nizatidine crosses the placenta (Dicke 1988). Information related to the use of nizatidine in pregnancy is limited; other agents may be preferred (Richter 2005).
Competitive inhibition of histamine at H2-receptors of the gastric parietal cells, which inhibits gastric acid secretion, gastric volume, and hydrogen ion concentration are reduced. Does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion, or serum gastrin.
Distribution: Vd: 0.8 to 1.5 L/kg
Protein binding: 35% to alpha-1 acid glycoprotein
Metabolism: Partially hepatic; forms metabolites
Bioavailability: >70%
Half-life elimination: 1 to 2 hours; prolonged with moderate to severe renal impairment
Time to peak, plasma: 0.5 to 3 hours
Excretion: Urine (>90%; ~60% as unchanged drug); feces (<6%)
Renal function impairment: Moderate to severe renal impairment decreases clearance and prolongs half-life.
A 2.5 mg/mL oral solution may be made with capsules and one of three different vehicles (lemon-lime Gatorade®, Ocean Spray® Cran-Grape® juice or V8® 100% vegetable juice). Empty the contents of one 300 mg capsule in a mortar. Add small portions of the chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 120 mL. Label "shake well". Stable for 2 days refrigerated.
Capsules (Nizatidine Oral)
150 mg (per each): $2.38
300 mg (per each): $4.77
Solution (Nizatidine Oral)
15 mg/mL (per mL): $1.53
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