Nizatidine: Drug information

(For additional information see "Nizatidine: Patient drug information" and see "Nizatidine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: Canada

Axid;
DOM-Nizatidine;
PMS-Nizatidine [DSC]

Pharmacologic Category

Histamine H₂ Antagonist

Dosing: Adult

Note: Nizatidine oral solution has been discontinued in the United States for >1 year.

Erosive esophagitis due to gastroesophageal reflux disease

Erosive esophagitis due to gastroesophageal reflux disease (alternative agent): Note: Although a labeled indication, H₂-receptor antagonists (eg, nizatidine) are not preferred for the treatment of erosive esophagitis due to gastroesophageal reflux disease because of the availability of proton pump inhibitors (PPIs) (ACG [Katz 2022]).

Oral: 150 mg twice daily for up to 12 weeks.

Gastroesophageal reflux disease

Gastroesophageal reflux disease: Oral: 150 mg twice daily; duration of therapy depends on symptoms.

Peptic ulcer disease

Peptic ulcer disease (duodenal or benign gastric ulcers) (alternative agent): Note: Although a labeled indication, current guidelines recommend PPIs as standard of care for treatment of peptic ulcer disease rather than H₂-receptor antagonists (eg, nizatidine) (ACG [Laine 2021]).

Duodenal ulcer, active: Oral: 150 mg twice daily or 300 mg once daily at bedtime for up to 8 weeks.

Duodenal ulcer, prophylaxis: Oral: 150 mg once daily at bedtime for up to 1 year.

Gastric ulcer, active: Oral: 150 mg twice daily or 300 mg once daily at bedtime for up to 8 weeks.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Use with caution; refer to adult dosing.

Dosing: Pediatric

(For additional information see "Nizatidine: Pediatric drug information")

Gastroesophageal reflux disease, treatment

Gastroesophageal reflux disease, 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

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.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults unless otherwise indicated.

>10%: Nervous system: Headache (17%)

1% to 10%:

Dermatologic: Pruritus (2%)

Gastrointestinal: Diarrhea (children and adolescents), vomiting (children and adolescents)

Infection: Infection (2%)

Nervous system: Anxiety (2%), dizziness (5%), irritability (children and adolescents), nervousness (1%)

Ophthalmic: Amblyopia (1%)

Respiratory: Cough (children and adolescents), nasal congestion (children and adolescents), nasopharyngitis (children and adolescents)

<1%:

Cardiovascular: Ventricular tachycardia

Hematologic & oncologic: Anemia

Nervous system: Seizure (children and adolescents)

Frequency not defined (any population): Hepatic: Increased serum alanine aminotransferase, increased serum alkaline phosphatase, increased serum aspartate aminotransferase

Postmarketing (any population):

Cardiovascular: Vasculitis

Dermatologic: Diaphoresis, exfoliative dermatitis, skin rash, urticaria (Yap 1991)

Endocrine & metabolic: Gynecomastia, hyperuricemia

Gastrointestinal: Nausea

Genitourinary: Impotence (Kassianos 1989)

Hematologic & oncologic: Aplastic anemia (Nakano 2004), eosinophilia, immune thrombocytopenia

Hepatic: Cholestatic jaundice (including mixed hepatocellular), hepatitis, jaundice

Hypersensitivity: Anaphylaxis (Mira-Perceval 1996), hypersensitivity angiitis (Suh 1997), hypersensitivity reaction, serum sickness-like reaction

Nervous system: Confusion

Miscellaneous: Fever

Contraindications

Hypersensitivity to nizatidine, other H₂ antagonists, or any component of the formulation.

Warnings/Precautions

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).

Product Availability

Nizatidine oral solution has been discontinued in the United States for >1 year.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Generic: 150 mg, 300 mg

Solution, Oral:

Generic: 15 mg/mL (480 mL [DSC])

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Nizatidine Oral)

150 mg (per each): $2.38

300 mg (per each): $4.77

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Axid: 150 mg

Generic: 150 mg [DSC], 300 mg

Administration: Adult

Administer with or without food.

Administration: Pediatric

Oral: May administer with or without food; do not administer or mix capsule contents with apple juice

Use: Labeled Indications

Erosive esophagitis due to gastroesophageal reflux disease: Treatment of erosive gastroesophageal reflux disease (GERD).

Note: Although a labeled indication, H₂-receptor antagonists (eg, nizatidine) are not preferred for the treatment of erosive esophagitis due to GERD because of the availability of proton pump inhibitors (PPIs) (ACG [Katz 2022]).

Gastroesophageal reflux disease: Treatment of endoscopically diagnosed esophagitis and associated heartburn due to GERD in adults (capsules and oral solution) and children 12 years of age and older (oral solution only).

Peptic ulcer disease (duodenal or benign gastric ulcers): Short-term treatment of active duodenal or active benign gastric ulcers and maintenance therapy after the healing of active duodenal ulcer.

Note: Although a labeled indication, current guidelines recommend PPIs as standard of care for treatment of peptic ulcer disease rather than H₂-receptor antagonists (eg, nizatidine) (ACG [Laine 2021]).

Medication Safety Issues

Sound-alike/look-alike issues:

Axid may be confused with Ansaid

Nizatidine may be confused with tiZANidine

International issues:

Tazac [Australia] may be confused with Tazact brand name for piperacillin/tazobactam [India]; Tiazac brand name for dilTIAZem [US, Canada]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acalabrutinib: Histamine H2 Receptor Antagonists may decrease the serum concentration of Acalabrutinib. Management: Give acalabrutinib capsules 2 hours before a histamine H2 receptor antagonist (H2RA). No action is required if acalabrutinib tablets are coadministered with H2RAs. 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 (H2RAs) 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. Risk X: Avoid combination

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. 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 ketoconazole with an acidic beverage (eg, non-diet cola) and monitor for reduced efficacy if concomitant use with a H2RA is required. Increases in ketoconazole dose may be required. 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

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

Nirogacestat: Histamine H2 Receptor Antagonists may decrease the serum concentration of Nirogacestat. Risk X: Avoid combination

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. Risk C: Monitor therapy

Rilpivirine: Histamine H2 Receptor Antagonists may decrease the serum concentration of Rilpivirine. Management: Administer histamine H2 receptor antagonists (H2RAs) at least 12 hours before or 4 hours after oral 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. Management: Consider alternatives to this combination for patients taking the Invirase formulation of saquinavir. No action beyond standard clinical care measures is required for patients taking the Fortovase formulation of saquinavir. Risk D: Consider therapy modification

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

Sparsentan: Histamine H2 Receptor Antagonists may decrease the serum concentration of Sparsentan. Risk X: Avoid combination

Velpatasvir: Histamine H2 Receptor Antagonists may decrease the serum concentration of Velpatasvir. Risk C: Monitor therapy

Food Interactions

Prolonged treatment (≥2 years) may lead to malabsorption of dietary vitamin B₁₂ and subsequent vitamin B₁₂ deficiency (Lam 2013).

Pregnancy Considerations

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).

Breastfeeding Considerations

Following oral administration of nizatidine, 0.1% of the maternal dose is found in breast milk. According to the manufacturer, the decision to continue or discontinue breast-feeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother.

Mechanism of Action

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.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: V_d: 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%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Moderate to severe renal impairment decreases clearance and prolongs half-life.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Axid | Fixit;
(AT) Austria: Ulxit;
(AU) Australia: Nizac | Nizaction | Tacidine | Tazac;
(BE) Belgium: Panaxid;
(BG) Bulgaria: Axid;
(BR) Brazil: Axid;
(CH) Switzerland: Calmaxid;
(CL) Chile: Nizaxid;
(CN) China: Axid;
(CO) Colombia: Axid;
(DE) Germany: Gastrax | Nizax;
(DK) Denmark: Izatax;
(DO) Dominican Republic: Axid | Nizalap;
(EE) Estonia: Axid;
(EG) Egypt: Nizatect | Nizatine | Receptoloc | Ulcfree;
(ES) Spain: Distaxid;
(FI) Finland: Nizax;
(FR) France: Nizatidine Dci | Nizaxid;
(GB) United Kingdom: Axid | Nizatidine almus | Nizatidine arrow | Nizatidine cox | Nizatidine kent | Nizatidine sandoz;
(GR) Greece: Axid | Flexidon;
(HK) Hong Kong: Axid;
(HU) Hungary: Axid | Naxidin | Naxidin-s;
(ID) Indonesia: Axid;
(IE) Ireland: Axid;
(IT) Italy: Cronizat | Nizax | Zanizal;
(JO) Jordan: Axid;
(JP) Japan: Acinon eli lilly | Acinon zeria | Ateminon | Dorusen | Nisatenon | Nisatenon choseido | Nizamerck | Nizanon | Nizatidine alfresa | Nizatidine ohara | Nizatin | Nizatiron | Nizatoric | Tizanon;
(KR) Korea, Republic of: Acitidine | Actidin | Alzatine | Anitidine | Anytidine | Axadin | Axatid | Axid | Axidin | Bicsidin | Bigcidine | Cellnidine | Exad | Exadin | Exatid | Exitidine | Huniz nizatidine | Huons nizatidine | Kenatine | Megatidin | Nacid | Naicid | Nazitine | Neizatin | Newtidine | Newxanthine | Newzantine | Newzatin | Nex | Nitadin | Niza ex | Niza x | Nizad | Nizadine | Nizadinem | Nizant | Nizar | Nizaractine | Nizaridine | Nizatan | Nizaten | Nizatide | Nizatin | Nizatwo | Nizaxid | Nizixid | Samsung nizatidine | Tinza | Zadin | Zanide | Zanitan | Zanitidine | Zanitin | Zastidine | Zatidine | Zatinol | Zenitidine | Zinadine | Zinatine | Zynide;
(KW) Kuwait: Axid | Fixit;
(LB) Lebanon: Axid;
(LU) Luxembourg: Panaxid;
(MA) Morocco: Axid;
(MX) Mexico: Axid;
(MY) Malaysia: Axid;
(NL) Netherlands: Axid | Nizatidinum;
(NZ) New Zealand: Axid;
(PE) Peru: Axid;
(PH) Philippines: Axid;
(PK) Pakistan: Axid | Ulcid;
(PL) Poland: Nizax;
(PR) Puerto Rico: Axid;
(PT) Portugal: Nizaxid;
(QA) Qatar: Fixit;
(RO) Romania: Axid;
(SA) Saudi Arabia: Axid | Fixit;
(SG) Singapore: Axid;
(TH) Thailand: Axid;
(TR) Turkey: Axid | Nyzant;
(TW) Taiwan: Acid reducer | Tazac;
(VE) Venezuela, Bolivarian Republic of: Axid;
(VN) Viet Nam: Farnatyl | Kagawas | Mezagastro | Mizatin | Nizastric;
(ZA) South Africa: Antizid

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Nizatidine: Drug information