Nizatidine (Axid) is an H-2 receptor antagonist that inhibits acid production. It is used in the treatment of peptic ulcer disease and GERD (gastroesophageal reflux disease).
Nizatidine Uses:
-
Duodenal ulcer:
- For up to 8 weeks, treatment of active duodenal ulcer & maintenance therapy after healing of active ulcers in adults.
-
Benign Gastric ulcer:
- For up to 8 weeks, treatment of active benign gastric ulcer in adults.
-
Gastroesophageal reflux disease:
- For up to 12 weeks in adults (capsules and oral solution) and up to 8 weeks in children 12 years and older (oral solution only), treatment of endoscopically diagnosed esophagitis, including erosive & ulcerative esophagitis, and associated heartburn due to gastroesophageal reflux disease (GERD .
-
Off Label Use of Nizatidine in Adults:
- Helicobacter pylori eradication (a component of a multidrug regimen)
- Stress ulcer prophylaxis in critically ill patients.
Nizatidine Dose in Adults
Nizatidine Dose in the treatment of Duodenal ulcer:
P/O:
-
Treatment:
- For up to 8 weeks, 300 mg once a day at bedtime or 150 mg twice a day.
-
Maintenance of healing:
- At bedtime, 150 mg once a day.
Nizatidine Dose in the treatment of Benign Gastric ulcer:
- P/O:
- For up to 8 weeks, 150 mg twice a day, or 300 mg once a day at bedtime.
Nizatidine dose in the treatment of GERD:
- P/O:
- For up to 12 weeks, 150 mg twice a day.
Nizatidine Dose in the treatment of Helicobacter Pylori eradication (off-label):
- P/O:
- 150 milligram twice a day (in combination with amoxicillin and clarithromycin or bismuth, metronidazole, and tetracycline) for 10 to 14 days.
Nizatidine Dose in Childrens
Nizatidine Dose in the treatment of GERD:
P/O:
-
Infants and Children ≤11 years:
- 5 milligram/kilogram/dose twice a day.
- Max daily dose:
- 300 mg/day.
-
Children ≥12 years and Adolescents:
- 150 milligram twice everyday
- Max daily dose:
- 300 mg/day
Nizatidine Dose in the treatment of Esophagitis:
P/O:
-
Infants ≥6 months and Children ≤11 years:
- 5 mg/kg/dose twice a day.
-
Children ≥12 years and Adolescents:
-
-
- 150 milligram twice a day.
-
- Max daily dose:
- 300 milligram/day
-
Pregnancy Risk Factor B
- Negative events have not been reported in animal reproduction studies.
- Nizatidine crosses over the placenta.
- There is limited information available on the use of nizatidine during pregnancy.
- You may prefer other agents.
Use during breastfeeding:
- Breast milk contains 0.1% of the maternal dose after oral administration.
- According to the manufacturer, the decision about whether to breastfeed during therapy or not should consider the risks to the infant as well as the benefits to the mother.
Nizatidine Dose in Kidney Disease:
Manufacturer's labeling:
-
Active treatment:
-
CrCl >50 mL/minute:
- No dosage adjustment is necessary.
-
CrCl 20 to 50 mL/minute:
- 150 mg once a day
-
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 percent to 100 percent of normal dose
-
GFR 10 to 50 mL/minute:
- 150 mg every 24 - 48 hours
-
GFR <10 mL/minute:
- 150 mg every 48 - 72 hours
-
Hemodialysis:
- 150 mg every 48 - 72 hours
-
Peritoneal dialysis:
- 150 mg every 48 - 72 hours
Nizatidine Dose in Liver Disease:
- In the manufacturer's labeling, there are no dosage adjustments provided.
Common Side Effects of Nizatidine:
-
Central nervous system:
- Headache
Less Common Side Effects of Nizatidine:
-
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)
Contraindications to Nizatidine:
- Hypersensitivity to the drug, other H-2 antagonists, or any component of the formulation.
Warnings and precautions
-
Vitamin B deficiency:
- Vitamin B malabsorption may occur if prolonged treatment is continued for more than 2 years.
- The severity of the deficiency depends on the dose. It is more severe in women than in those who are younger (30 years).
- The prevalence of the disease is reduced after discontinuation.
-
Gastric cancer:
- Gastric malignancy can still be present despite symptoms being relieved.
-
Renal impairment
- Patients with severe or moderate renal impairment should be cautious.
- Recommendations for dosage adjustment
Nizatidine: Drug Interaction
Note: Drug Interaction Categories:
- Risk Factor C: Monitor When Using Combination
- Risk Factor D: Consider Treatment Modification
- Risk Factor X: Avoid Concomitant Use
Risk Factor C (Monitor therapy) |
|
| Cefpodoxime | Histamine H2 Receptor Antagonists may decrease the absorption of Cefpodoxime. Separate oral doses by at least 2 hours. |
| Cysteamine (Systemic) | Histamine H2 Receptor Antagonists may diminish the therapeutic effect of Cysteamine (Systemic). |
| Dexmethylphenidate | Histamine H2 Receptor Antagonists may increase the absorption of Dexmethylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. |
| 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. |
| Indinavir | Histamine H2 Receptor Antagonists may decrease the serum concentration of Indinavir. |
| Iron Salts | Histamine H2 Receptor Antagonists may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Isomaltoside; Iron Sucrose. |
| Methylphenidate | Histamine H2 Receptor Antagonists may increase the absorption of Methylphenidate. Specifically, H2-antagonists may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. |
| 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. |
| Nelfinavir | Histamine H2 Receptor Antagonists may decrease the serum concentration of Nelfinavir. Concentrations of the active M8 metabolite may also be reduced. |
| Saquinavir | Histamine H2 Receptor Antagonists may increase the serum concentration of Saquinavir. |
| Varenicline | Histamine H2 Receptor Antagonists may increase the serum concentration of Varenicline. Management: Monitor for increased varenicline adverse effects with concomitant use of cimetidine or other H2-antagonists, particularly in patients with severe renal impairment. International product labeling recommendations vary. Consult appropriate labeling. |
| Velpatasvir | Histamine H2 Receptor Antagonists may decrease the serum concentration of Velpatasvir. |
Risk Factor D (Consider therapy modification) |
|
| 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. |
| 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. |
| 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. |
| 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. |
| 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). |
| 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. |
| Gefitinib | Histamine H2 Receptor Antagonists may decrease the serum concentration of Gefitinib. Management: Administer gefitinib at least 6 hours before or after administration of a histamine H2-antagonist, and closely monitor clinical response to gefitinib. |
| 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. |
| 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. |
| Ledipasvir | Histamine H2 Receptor Antagonists may decrease the serum concentration of Ledipasvir. |
| Mesalamine | Histamine H2 Receptor Antagonists may diminish the therapeutic effect of Mesalamine. Histamine H2-Antagonist-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose histamine H2-receptor antagonists with sustained-release mesalamine products. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 Factor X (Avoid combination) |
|
| Cefuroxime | Histamine H2 Receptor Antagonists may decrease the absorption of Cefuroxime. Separate oral doses by at least 2 hours. |
| 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. |
| Delavirdine | Histamine H2 Receptor Antagonists may decrease the serum concentration of Delavirdine. Management: Chronic therapy with H2-antagonists should be avoided in patients who are being treated with delavirdine. The clinical significance of short-term H2-antagonist therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. |
| 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. |
| PAZOPanib | Histamine H2 Receptor Antagonists may decrease the serum concentration of PAZOPanib. Management: Avoid the use of histamine H2-antagonists in combination with pazopanib. Strategies to minimize the expected interaction between these agents (eg, dose separation) have not been investigated. |
| Risedronate | Histamine H2 Receptor Antagonists may increase the serum concentration of Risedronate. This applies specifically to delayed-release risedronate. |
Monitoring parameters:
None mentioned. Monitor the response to therapy.
How to administer Nizatidine?
- Administer with or without food.
Mechanism of Action of Nizatidine:
- Competitive inhibition of histamine at H-2 cells of the gastric parietal cell's gastric parietal cells inhibits gastric acid production, gastric volume and hydrogen ion concentration.
- It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion, or serum gastrin.
Protein binding:
- 35 percent to alpha-1 acid glycoprotein
Metabolism:
- Partially hepatic
- Forms metabolites
Bioavailability:
- >70 percent
Half-life elimination:
- 1 to 2 hours
- lengthened with moderate to severe renal impairment
Time to peak plasma concentration:
- 0.5-3 hours
Excretion:
- Urine (>90 percent; ~60 percent as unchanged drug).
- Feces (<6 percent)
- Competitive inhibition of histamine at H-2 receptors of the gastric parietal cells, which inhibits gastric acid secretion, gastric volume, & hydrogen ion concentration is reduced.
- It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion, or serum gastrin.
Protein binding:
- 35 percent to alpha-1 acid glycoprotein
Metabolism:
- Partially hepatic.
- Forms metabolites
Bioavailability:
- >70 percent
Half-life elimination:
- 1-2 hours
- lengthened with moderate to severe renal impairment
Time to peak plasma concentrations:
- 0.5-3 hours
Excretion:
- Urine (>90 percent; ~60 percent as unchanged drug)
- feces (<6 percent)
International Brands of Nizatidine:
- APO-Nizatidine
- Axid
- DOM-Nizatidine
- NOVO-Nizatidine
- NU-Nizatidine
- PHLNizatidine
- PMS-Nizatidine
- Acinon
- Acitidin
- Acitidine
- Axadine
- Axid
- Axid Pulvules
- Axin
- Calmaxid
- Cronizat
- Fixit
- Gastrax
- Jadin
- Nacid
- Naxidin
- Naxidine
- Nizac
- Nizaractine
- Nizatect
- Nizatid
- Nizax
- Nizaxid
- Nolcer
- Panaxid
- Receptoloc
- Tazac
- Tinza
- Ulxit
- Zastidin
Nizatidine Brand Names in Pakistan:
Nizatidine 300 mg Capsules |
|
| Simko | Xenon Pharmaceuticals (Pvt) Ltd. |
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