Nizatidine label

Nizatidine

Nizatidine Recall

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Side Effects & Adverse Reactions

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Nizatidine is indicated for up to 8 weeks for the treatment of active duodenal ulcer. In most patients, the ulcer will heal within 4 weeks.

Nizatidine is indicated for maintenance therapy for duodenal ulcer patients, at a reduced dosage of 150 mg h.s. after healing of an active duodenal ulcer. The consequences of continuous therapy with nizatidine for longer than 1 year are not known.

Nizatidine is indicated for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis, including erosive and ulcerative esophagitis, and associated heartburn due to GERD.

Nizatidine is indicated for up to 8 weeks for the treatment of active benign gastric ulcer. Before initiating therapy, care should be taken to exclude the possibility of malignant gastric ulceration.

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History

There is currently no drug history available for this drug.

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Other Information

Nizatidine USP is a histamine H2-receptor antagonist. Chemically, it is N-[2-[[[2-[(Dimethylamino)methyl]-4-thiazolyl]methyl]thio]ethyl]-N’-methyl-2-nitro-1,1-ethenediamine. The structural formula is represented below:

Nizatidine Chemical Structure

It is an off-white to buff crystalline solid that is soluble in water. Nizatidine has a bitter taste and mild sulfur-like odor. Nizatidine Capsules USP, for oral administration, contain 150 mg or 300 mg nizatidine and the following inactive ingredients: colloidal silicon dioxide, corn starch, croscarmellose sodium, magnesium stearate and pregelatinized starch. The capsule shells contain: ammonium hydroxide, black iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac, silicon dioxide, sodium lauryl sulfate and titanium dioxide.

The 150 mg capsule shell also contains D&C Yellow No. 10 and FD&C Yellow No. 6.

The 300 mg capsule shell also contains black iron oxide, red iron oxide and yellow iron oxide.

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Nizatidine Manufacturers

  • Lake Erie Medical Dba Quality Care Products Llc
    Nizatidine | Lake Erie Medical Dba Quality Care Products Llc
    No Recall

    Nizatidine | Lake Erie Medical Dba Quality Care Products Llc

    Nizatidine | Lake Erie Medical Dba Quality Care Products Llc

    Active Duodenal Ulcer – The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer – The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease – The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer – The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency – The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer  Ccr  Dose  20-50 mL/min  150 mg daily  <20 mL/min  150 mg every other day Maintenance Therapy  Ccr  Dose  20-50 mL/min  150 mg every other day  <20 mL/min  150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Proficient Rx Lp
    Nizatidine | Proficient Rx Lp
    No Recall

    Nizatidine | Proficient Rx Lp

    Nizatidine | Proficient Rx Lp
    Active Duodenal Ulcer

    The recommended oral dosage of adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer

    Ccr

    Dose

    20-50 mL/min

    150 mg daily

    <20 mL/min

    150 mg every other day

    Maintenance Therapy

    Ccr

    Dose

    20-50 mL/min

    150 mg every other day

    <20 mL/min

    150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Genpharm Inc.
    Nizatidine | Genpharm Inc.
    No Recall

    Nizatidine | Genpharm Inc.

    Nizatidine | Genpharm Inc.

    Active Duodenal Ulcer

    The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer

    Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day

    Maintenance Therapy

    Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Dr Reddy’s Laboratories Limited
    Nizatidine | Dr Reddy's Laboratories Limited
    No Recall

    Nizatidine | Dr Reddy's Laboratories Limited

    Nizatidine | Dr Reddy's Laboratories Limited
    Active Duodenal Ulcer

    The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Nizatidine
    Nizatidine | Nizatidine
    No Recall

    Nizatidine | Nizatidine

    Nizatidine | Nizatidine
    DOSAGE AND ADMINISTRATION Active Duodenal Ulcer

    The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

     Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Dispensing Solutions Inc.
    Nizatidine | Dispensing Solutions Inc.
    No Recall

    Nizatidine | Dispensing Solutions Inc.

    Nizatidine | Dispensing Solutions Inc.
    Active Duodenal Ulcer

    The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Rebel Distributors Corp
    Nizatidine | Rebel Distributors Corp
    No Recall

    Nizatidine | Rebel Distributors Corp

    Nizatidine | Rebel Distributors Corp
    Active Duodenal Ulcer

    The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

     Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Watson Laboratories, Inc.
    Nizatidine | Watson Laboratories, Inc.
    No Recall

    Nizatidine | Watson Laboratories, Inc.

    Nizatidine | Watson Laboratories, Inc.

    Active Duodenal Ulcer – The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer – The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease – The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer – The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency – The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer    Ccr    Dose      20-50 mL/min    150 mg daily      <20 mL/min    150 mg every other day   Maintenance Therapy    Ccr    Dose      20-50 mL/min    150 mg every other day      <20 mL/min    150 mg every 3 days  

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Glenmark Generics Inc.,usa
    Nizatidine | Glenmark Generics Inc.,usa
    No Recall

    Nizatidine | Glenmark Generics Inc.,usa

    Nizatidine | Glenmark Generics Inc.,usa
    Active Duodenal Ulcer

    The recommended oral dosage of adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Eon Labs, Inc.
    Nizatidine | Eon Labs, Inc.
    No Recall

    Nizatidine | Eon Labs, Inc.

    Nizatidine | Eon Labs, Inc.
    Active Duodenal Ulcer

    The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

     Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • H.j. Harkins Company, Inc.
    Nizatidine | H.j. Harkins Company, Inc.
    No Recall

    Nizatidine | H.j. Harkins Company, Inc.

    Nizatidine | H.j. Harkins Company, Inc.

    Active Duodenal Ulcer – The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer – The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease – The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer – The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency – The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer    Ccr    Dose      20-50 mL/min    150 mg daily      <20 mL/min    150 mg every other day   Maintenance Therapy    Ccr    Dose      20-50 mL/min    150 mg every other day      <20 mL/min    150 mg every 3 days  

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Preferred Pharmaceuticals, Inc
    Nizatidine | Preferred Pharmaceuticals, Inc
    No Recall

    Nizatidine | Preferred Pharmaceuticals, Inc

    Nizatidine | Preferred Pharmaceuticals, Inc
    Active Duodenal Ulcer

    The recommended oral dosage of adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Rebel Distributors Corp
    Nizatidine | Rebel Distributors Corp
    No Recall

    Nizatidine | Rebel Distributors Corp

    Nizatidine | Rebel Distributors Corp

    Active Duodenal Ulcer – The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer – The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease – The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer – The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency – The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer    Ccr    Dose      20-50 mL/min    150 mg daily      <20 mL/min    150 mg every other day   Maintenance Therapy    Ccr    Dose      20-50 mL/min    150 mg every other day      <20 mL/min    150 mg every 3 days  

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Rebel Distributors Corp
    Nizatidine | Rebel Distributors Corp
    No Recall

    Nizatidine | Rebel Distributors Corp

    Nizatidine | Rebel Distributors Corp

    Active Duodenal Ulcer – The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer – The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease – The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer – The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency – The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer    Ccr    Dose      20-50 mL/min    150 mg daily      <20 mL/min    150 mg every other day   Maintenance Therapy    Ccr    Dose      20-50 mL/min    150 mg every other day      <20 mL/min    150 mg every 3 days  

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Bryant Ranch Prepack
    Nizatidine | Bryant Ranch Prepack
    No Recall

    Nizatidine | Bryant Ranch Prepack

    Nizatidine | Bryant Ranch Prepack
    Active Duodenal Ulcer

    The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Bryant Ranch Prepack
    Nizatidine | Bryant Ranch Prepack
    No Recall

    Nizatidine | Bryant Ranch Prepack

    Nizatidine | Bryant Ranch Prepack
  • Mylan Pharmaceuticals Inc.
    Nizatidine | Mylan Pharmaceuticals Inc.
    No Recall

    Nizatidine | Mylan Pharmaceuticals Inc.

    Nizatidine | Mylan Pharmaceuticals Inc.
    Active Duodenal Ulcer

    The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer Ccr Dose

    20–50 mL/min

    150 mg daily

    < 20 mL/min

    150 mg every other day

    Maintenance Therapy Ccr Dose

    20–50 mL/min

    150 mg every other day

    < 20 mL/min

    150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Carilion Materials Management
    Nizatidine | Carilion Materials Management
    No Recall

    Nizatidine | Carilion Materials Management

    Nizatidine | Carilion Materials Management

    – The recommended oral dosage for adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily. Active Duodenal Ulcer

    – The recommended oral dosage for adults is 150 mg once daily at bedtime. Maintenance of Healed Duodenal Ulcer

    – The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily. Gastroesophageal Reflux Disease

    – The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration. Active Benign Gastric Ulcer

    – The dose for patients with renal dysfunction should be reduced as follows: Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    Active Duodenal Ulcer, GERD and Benign Gastric Ulcer    C cr    Dose      20-50 mL/min    150 mg daily      <20 mL/min    150 mg every other day   Maintenance Therapy    C cr    Dose      20-50 mL/min    150 mg every other day      <20 mL/min    150 mg every 3 days  

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Medsource Pharmaceuticals
    Nizatidine | Medsource Pharmaceuticals
    No Recall

    Nizatidine | Medsource Pharmaceuticals

    Nizatidine | Medsource Pharmaceuticals
    Active Duodenal Ulcer

    The recommended oral dosage of adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer Ccr Dose 20-50 mL/min 150 mg daily <20 mL/min 150 mg every other day Maintenance Therapy Ccr Dose 20-50 mL/min 150 mg every other day <20 mL/min 150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

  • Preferred Pharmaceuticals Inc.
    Nizatidine | Preferred Pharmaceuticals Inc.
    No Recall

    Nizatidine | Preferred Pharmaceuticals Inc.

    Nizatidine | Preferred Pharmaceuticals Inc.
    Active Duodenal Ulcer

    The recommended oral dosage of adults is 300 mg once daily at bedtime. An alternative dosage regimen is 150 mg twice daily.

    Maintenance of Healed Duodenal Ulcer

    The recommended oral dosage for adults is 150 mg once daily at bedtime.

    Gastroesophageal Reflux Disease

    The recommended oral dosage in adults for the treatment of erosions, ulcerations, and associated heartburn is 150 mg twice daily.

    Active Benign Gastric Ulcer

    The recommended oral dosage is 300 mg given either as 150 mg twice daily or 300 mg once daily at bedtime. Prior to treatment, care should be taken to exclude the possibility of malignant gastric ulceration.

    Dosage Adjustment for Patients With Moderate to Severe Renal Insufficiency

    The dose for patients with renal dysfunction should be reduced as follows:

    Active Duodenal Ulcer, GERD, and Benign Gastric Ulcer

    Ccr

    Dose

    20-50 mL/min

    150 mg daily

    <20 mL/min

    150 mg every other day

    Maintenance Therapy

    Ccr

    Dose

    20-50 mL/min

    150 mg every other day

    <20 mL/min

    150 mg every 3 days

    Some elderly patients may have creatinine clearances of less than 50 mL/min, and, based on pharmacokinetic data in patients with renal impairment, the dose for such patients should be reduced accordingly. The clinical effects of this dosage reduction in patients with renal failure have not been evaluated.

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