Metoclopramide Hydrochloride

Metoclopramide Hydrochloride Manufacturers

• Gavis Pharmaceuticals, Llc
  

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  Metoclopramide Hydrochloride | Gavis Pharmaceuticals, Llc

  

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  2.1 Important Instructions for Use

  Take on an empty stomach at least 30 minutes before eating since food can decrease the peak concentrations of drug in the bloodstream and/or the time it takes to achieve the maximum drug level in the bloodstream [see Clinical Pharmacology (12.3)]. Do not repeat dose if inadvertently taken with food.

  Since the tablet absorbs moisture rapidly, only remove each dose from the packaging just prior to taking. Handle the tablet with dry hands and place on the tongue. If the tablet should break or crumble while handling, discard and remove a new tablet.

  Metoclopramide Hydrochloride Orally Disintegrating Tablet disintegrates on the tongue in approximately one minute (with a range of 10 seconds to 14 minutes). Metoclopramide Hydrochloride Orally Disintegrating Tablet is designed to be taken without liquid; however, the effect on the pharmacokinetics of Metoclopramide Hydrochloride Orally Disintegrating Tablets taken with liquid is unknown.

  2.2 Symptomatic Gastroesophageal Reflux Disease

  For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks in duration.

  Take 10 mg to 15 mg dose of Metoclopramide Hydrochloride Orally Disintegrating Tablets up to four times daily (e.g., at least 30 minutes before each meal and at bedtime). Doses may vary depending upon the symptoms being treated and the clinical response. If symptoms only occur intermittently or at specific times of the day, metoclopramide may be used in single doses up to 20 mg prior to the symptoms rather than continuous treatment.

  Since there is a poor correlation between symptomatic relief and healing of esophageal lesions, any therapy directed at esophageal lesions is best confirmed by endoscopic evaluation. Although experience with the effects of metoclopramide on esophageal erosions and ulcerations is limited, healing was documented in a controlled trial using four times daily therapy at 15 mg/dose. Prolonged treatment (>12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia. [see Warnings and Precautions (5.1)]

  2.3 Diabetic Gastroparesis (Diabetic Gastric Stasis)

  For the relief of symptoms associated with diabetic gastroparesis (diabetic gastric stasis), therapy of two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.

  Take a 10 mg dose of Metoclopramide Hydrochloride Orally Disintegrating Tablets up to four times a day (e.g., at least 30 minutes before each meal and at bedtime).

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of Metoclopramide Hydrochloride Orally Disintegrating Tablets may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection.

  Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, Metoclopramide Hydrochloride Orally Disintegrating Tablets therapy should be reinstituted at the earliest manifestation.

  2.4 Renal Impairment

  Some patients, such as the elderly or those with impaired kidney function (creatinine clearance below 40 mL/min) may be more sensitive to the therapeutic dose or the adverse effects of metoclopramide. Therefore, these patients should start therapy at a lower dose (approximately half the recommended dosage) and the dose should be titrated according to their overall clinical response and/or adverse event profile. Dialysis is not likely to be an effective method of drug removal in overdose situations.

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• Direct Rx
  

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  Metoclopramide Hydrochloride | Direct Rx

  

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  Therapy with metoclopramide tablets, USP should not exceed 12 weeks in duration.

  For the Relief of Symptomatic Gastroesophageal Reflux

  Administer from 10 mg to 15 mg of metoclopramide tablet, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated With Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide tablets, USP may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide tablet, USP therapy should be reinstituted at the earliest manifestation.

  Use in Patients With Renal or Hepatic Impairment

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Remedyrepack Inc.
  

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  Metoclopramide Hydrochloride | Remedyrepack Inc.

  

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  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.
  
  For the Relief of Symptomatic Gastroesophageal Reflux
  Administer from 10 mg to 15 mg metoclopramide tablets, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGYand INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.
  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.
  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.
  
  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)
  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.
  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide tablets may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).
  Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide tablets therapy should be reinstituted at the earliest manifestation.
  
  Use in Patients with Renal or Hepatic Impairment
  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
  See OVERDOSAGEsection for information regarding dialysis.
  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
  
  

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• Bryant Ranch Prepack
  

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  Metoclopramide Hydrochloride | Bryant Ranch Prepack

  

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  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

  
  For the Relief of Symptomatic Gastroesophageal Reflux:  

  Administer from 10 mg to 15 mg metoclopramide hydrochloride, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg per dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of the metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment:

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

        See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
  

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• Cardinal Health
  

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  Metoclopramide Hydrochloride | Cardinal Health

  

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  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

  For the Relief of Symptomatic Gastroesophageal Reflux: Administer from 10 mg to 15 mg of metoclopramide tablets, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see

  CLlNlCAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (DiabeticGastric Stasis):

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment: Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min., therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Remedyrepack Inc.
  

  ×

  Metoclopramide Hydrochloride | Remedyrepack Inc.

  

  ---

  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.
  
  For the Relief of Symptomatic Gastroesophageal Reflux
  Administer from 10 mg to 15 mg metoclopramide hydrochloride orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGYand INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.
  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.
  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.
  
  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)
  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.
  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).
  Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.
  
  USE IN PATIENTS WITH RENAL OR HEPATIC IMPAIRMENT
  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
  See OVERDOSAGEsection for information regarding dialysis.
  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
  
  

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• Watson Laboratories, Inc.
  

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  Metoclopramide Hydrochloride | Watson Laboratories, Inc.

  

  ---

  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

  
  For the Relief of Symptomatic Gastroesophageal Reflux:  

  Administer from 10 mg to 15 mg metoclopramide hydrochloride, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg per dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of the metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment:

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Rebel Distributors Corp
  

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  Metoclopramide Hydrochloride | Rebel Distributors Corp

  

  ---

  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

  
  For the Relief of Symptomatic Gastroesophageal Reflux:  

  Administer from 10 mg to 15 mg metoclopramide hydrochloride, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg per dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of the metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment:

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Preferred Pharmaceuticals, Inc.
  

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  Metoclopramide Hydrochloride | Preferred Pharmaceuticals, Inc.

  

  ---

  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

  
  For the Relief of Symptomatic Gastroesophageal Reflux:  

  Administer from 10 mg to 15 mg metoclopramide hydrochloride, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (seeCLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg per dose, and this regimen should be used when lesions are present, so long as it is tolerated (seeADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of the metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment:

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  SeeOVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Rebel Distributors Corp
  

  ×

  Metoclopramide Hydrochloride | Rebel Distributors Corp

  

  ---

  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

  
  For the Relief of Symptomatic Gastroesophageal Reflux:  

  Administer from 10 mg to 15 mg metoclopramide hydrochloride, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg per dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of the metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment:

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Northstar Rxllc
  

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  Metoclopramide Hydrochloride | Northstar Rxllc

  

  ---

  Therapy with metoclopramide tablets, USP should not exceed 12 weeks in duration.

  For the Relief of Symptomatic Gastroesophageal Reflux

  Administer from 10 mg to 15 mg metoclopramide tablets, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment.Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  
  

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide tablets, USP may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide tablets therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Mckesson Packaging Services A Business Unit Of Mckesson Corporation
  

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  Metoclopramide Hydrochloride | Mckesson Packaging Services A Business Unit Of Mckesson Corporation

  

  ---

  Therapy with metoclopramide tablets, USP should not exceed 12 weeks in duration.

  For the Relief of Symptomatic Gastroesophageal Reflux

  Administer from 10 mg to 15 mg metoclopramide tablets, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment.Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide tablets, USP may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide tablets therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• State Of Florida Doh Central Pharmacy
  

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  Metoclopramide Hydrochloride | State Of Florida Doh Central Pharmacy

  

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  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

  
  For the Relief of Symptomatic Gastroesophageal Reflux:  

  Administer from 10 mg to 15 mg metoclopramide hydrochloride, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg per dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of the metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment:

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Aphena Pharma Solutions – Tennessee, Llc
  

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  Metoclopramide Hydrochloride | Aphena Pharma Solutions - Tennessee, Llc

  

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  Therapy with metoclopramide tablets should not exceed 12 weeks in duration.

  
  For the Relief of Symptomatic Gastroesophageal Reflux:  

  Administer from 10 mg to 15 mg metoclopramide hydrochloride, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.

  Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg per dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.

  Therapy longer than 12 weeks has not been evaluated and cannot be recommended.

  For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis)

  Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).

  Administration of the metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide therapy should be reinstituted at the earliest manifestation.

  Use in Patients with Renal or Hepatic Impairment:

  Since metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.

  See OVERDOSAGE section for information regarding dialysis.

  Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.

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• Novel Laboratories, Inc.
  

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  Metoclopramide Hydrochloride | Novel Laboratories, Inc.

  

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  2.1 Important Instructions for Use

  Take on an empty stomach at least 30 minutes before eating since food can decrease the peak concentrations of drug in the bloodstream and/or the time it takes to achieve the maximum drug level in the bloodstream [see Clinical Pharmacology (12.3)]. Do not repeat dose if inadvertently taken with food.

  Since the tablet absorbs moisture rapidly, only remove each dose from the packaging just prior to taking. Handle the tablet with dry hands and place on the tongue. If the tablet should break or crumble while handling, discard and remove a new tablet.

  Metoclopramide Hydrochloride Orally Disintegrating Tablet disintegrates on the tongue in approximately one minute (with a range of 10 seconds to 14 minutes). Metoclopramide Hydrochloride Orally Disintegrating Tablet is designed to be taken without liquid; however, the effect on the pharmacokinetics of Metoclopramide Hydrochloride Orally Disintegrating Tablets taken with liquid is unknown.

  2.2 Symptomatic Gastroesophageal Reflux Disease

  For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks in duration.

  Take 10 mg to 15 mg dose of Metoclopramide Hydrochloride Orally Disintegrating Tablets up to four times daily (e.g., at least 30 minutes before each meal and at bedtime). Doses may vary depending upon the symptoms being treated and the clinical response. If symptoms only occur intermittently or at specific times of the day, metoclopramide may be used in single doses up to 20 mg prior to the symptoms rather than continuous treatment.

  Since there is a poor correlation between symptomatic relief and healing of esophageal lesions, any therapy directed at esophageal lesions is best confirmed by endoscopic evaluation. Although experience with the effects of metoclopramide on esophageal erosions and ulcerations is limited, healing was documented in a controlled trial using four times daily therapy at 15 mg/dose. Prolonged treatment (>12 weeks) with metoclopramide should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia. [see Warnings and Precautions (5.1)]

  2.3 Diabetic Gastroparesis (Diabetic Gastric Stasis)

  For the relief of symptoms associated with diabetic gastroparesis (diabetic gastric stasis), therapy of two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.

  Take a 10 mg dose of Metoclopramide Hydrochloride Orally Disintegrating Tablets up to four times a day (e.g., at least 30 minutes before each meal and at bedtime).

  The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of Metoclopramide Hydrochloride Orally Disintegrating Tablets may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection.

  Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, Metoclopramide Hydrochloride Orally Disintegrating Tablets therapy should be reinstituted at the earliest manifestation.

  2.4 Renal Impairment

  Some patients, such as the elderly or those with impaired kidney function (creatinine clearance below 40 mL/min) may be more sensitive to the therapeutic dose or the adverse effects of metoclopramide. Therefore, these patients should start therapy at a lower dose (approximately half the recommended dosage) and the dose should be titrated according to their overall clinical response and/or adverse event profile. Dialysis is not likely to be an effective method of drug removal in overdose situations.

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• Cardinal Health
  

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  Metoclopramide Hydrochloride | Merck Sharp & Dohme Corp.

  

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  General

  IMPORTANT: INTRON® A is supplied as 1) Powder for Injection/Reconstitution; 2) Solution for Injection in Vials. Not all dosage forms and strengths are appropriate for some indications. It is important that you carefully read the instructions below for the indication you are treating to ensure you are using an appropriate dosage form and strength.

  To enhance the tolerability of INTRON A, injections should be administered in the evening when possible.

  To reduce the incidence of certain adverse reactions, acetaminophen may be administered at the time of injection.

  The solution should be allowed to come to room temperature before using.

  Hairy Cell Leukemia

  (see DOSAGE AND ADMINISTRATION, General)

  Dose

  The recommended dose for the treatment of hairy cell leukemia is 2 million IU/m2 administered intramuscularly or subcutaneously 3 times a week for up to 6 months. Patients with platelet counts of less than 50,000/mm3 should not be administered INTRON A intramuscularly, but instead by subcutaneous administration. Patients who are responding to therapy may benefit from continued treatment.

  Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL IM, SC N/A Solution 18 MIU multidose 6 MIU/mL IM, SC N/A Solution 25 MIU multidose 10 MIU/mL IM, SC N/A

  NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

  Dose Adjustment If severe adverse reactions develop, the dosage should be modified (50% reduction) or therapy should be temporarily withheld until the adverse reactions abate and then resume at 50% (1 MIU/m2 TIW). If severe adverse reactions persist or recur following dosage adjustment, INTRON A should be permanently discontinued. INTRON A should be discontinued for progressive disease or failure to respond after six months of treatment. Malignant Melanoma

  (see DOSAGE AND ADMINISTRATION, General)

  INTRON A adjuvant treatment of malignant melanoma is given in two phases, induction and maintenance.

  Induction Recommended Dose

  The recommended daily dose of INTRON A in induction is 20 million IU/m2 as an intravenous infusion, over 20 minutes, 5 consecutive days per week, for 4 weeks (see Dose Adjustment below).

  Dosage Forms for This Indication Dosage Form Concentration Route Powder 10 MIU 10 MIU/mL IV Powder 18 MIU 18 MIU/mL IV Powder 50 MIU 50 MIU/mL IV

  NOTE: INTRON A Solution for Injection in vials is NOT recommended for intravenous administration and should not be used for the induction phase of malignant melanoma.

  NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

  Dose Adjustment

  NOTE: Regular laboratory testing should be performed to monitor laboratory abnormalities for the purpose of dose modifications (see PRECAUTIONS, Laboratory Tests).

  INTRON A should be withheld for severe adverse reactions, including granulocyte counts greater than 250/mm3 but less than 500/mm3 or SGPT/SGOT greater than 5-10× upper limit of normal, until adverse reactions abate. INTRON A treatment should be restarted at 50% of the previous dose. INTRON A should be permanently discontinued for: Toxicity that does not abate after withholding INTRON A Severe adverse reactions which recur in patients receiving reduced doses of INTRON A Granulocyte count less than 250/mm3 or SGPT/SGOT of greater than 10× upper limit of normal Maintenance Recommended Dose

  The recommended dose of INTRON A for maintenance is 10 million IU/m2 as a subcutaneous injection three times per week for 48 weeks (see Dose Adjustment below).

  Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses * Patients receiving 50% dose reduction only † Patients receiving full dose only Powder 10 MIU (single dose)* 10 MIU/mL SC N/A Powder 18 MIU (single dose)† 18 MIU/mL SC N/A Solution 18 MIU multidose 6 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A

  NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

  Dose Adjustment

  NOTE: Regular laboratory testing should be performed to monitor laboratory abnormalities for the purpose of dose modifications (see PRECAUTIONS, Laboratory Tests).

  INTRON A should be withheld for severe adverse reactions, including granulocyte counts greater than 250/mm3 but less than 500/mm3 or SGPT/SGOT greater than 5-10× upper limit of normal, until adverse reactions abate. INTRON A treatment should be restarted at 50% of the previous dose. INTRON A should be permanently discontinued for: Toxicity that does not abate after withholding INTRON A Severe adverse reactions which recur in patients receiving reduced doses of INTRON A Granulocyte count less than 250/mm3 or SGPT/SGOT of greater than 10× upper limit of normal Follicular Lymphoma

  (see DOSAGE AND ADMINISTRATION, General)

  Dose

  The recommended dose of INTRON A for the treatment of follicular lymphoma is 5 million IU subcutaneously three times per week for up to 18 months in conjunction with anthracycline-containing chemotherapy regimen and following completion of the chemotherapy regimen.

  Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL SC N/A Solution 18 MIU multidose 6 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A

  NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

  Dose Adjustment Doses of myelosuppressive drugs were reduced by 25% from a full-dose CHOP regimen, and cycle length increased by 33% (e.g., from 21 to 28 days) when alpha interferon was added to the regimen. Delay chemotherapy cycle if neutrophil count was less than 1500/mm3 or platelet count was less than 75,000/mm3. INTRON A should be permanently discontinued if SGOT exceeds greater than 5× the upper limit of normal or serum creatinine greater than 2.0 mg/dL (see WARNINGS). Administration of INTRON A therapy should be withheld for a neutrophil count less than 1000/mm3, or a platelet count less than 50,000/mm3. INTRON A dose should be reduced by 50% (2.5 MIU TIW) for a neutrophil count greater than 1000/mm3, but less than 1500/mm3. The INTRON A dose may be re-escalated to the starting dose (5 million IU TIW) after resolution of hematologic toxicity (ANC greater than 1500/mm3). Condylomata Acuminata

  (see DOSAGE AND ADMINISTRATION, General)

  Dose

  The recommended dose is 1.0 million IU per lesion in a maximum of 5 lesions in a single course. The lesions should be injected three times weekly on alternate days for 3 weeks. An additional course may be administered at 12 to 16 weeks.

  Dosage Forms for This Indication Dosage Form Concentration Route Powder 10 MIU (single dose) 10 MIU/mL IL Solution 25 MIU multidose 10 MIU/mL IL

  NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

  NOTE: Do not use the following formulations for this indication:

  the 18 million or 50 million IU Powder for Injection the 18 million IU multidose INTRON A Solution for Injection Dose Adjustment

  None

  Technique for Injection

  The injection should be administered intralesionally using a Tuberculin or similar syringe and a 25- to 30-gauge needle. The needle should be directed at the center of the base of the wart and at an angle almost parallel to the plane of the skin (approximately that in the commonly used PPD test). This will deliver the interferon to the dermal core of the lesion, infiltrating the lesion and causing a small wheal. Care should be taken not to go beneath the lesion too deeply; subcutaneous injection should be avoided, since this area is below the base of the lesion. Do not inject too superficially since this will result in possible leakage, infiltrating only the keratinized layer and not the dermal core.

  AIDS-Related Kaposi's Sarcoma

  (see DOSAGE AND ADMINISTRATION, General)

  Dose

  The recommended dose of INTRON A for Kaposi's Sarcoma is 30 million IU/m2/dose administered subcutaneously or intramuscularly three times a week until disease progression or maximal response has been achieved after 16 weeks of treatment. Dose reduction is frequently required (see Dose Adjustment below).

  Dosage Forms for This Indication Dosage Form Concentration Route Powder 50 MIU 50 MIU/mL IM, SC

  NOTE: INTRON A Solution for Injection in vials should NOT be used for AIDS-Related Kaposi's Sarcoma.

  NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

  Dose Adjustment INTRON A dose should be reduced by 50% or withheld for severe adverse reactions. INTRON A may be resumed at a reduced dose if severe adverse reactions abate with interruption of dosing. INTRON A should be permanently discontinued if severe adverse reactions persist or if they recur in patients receiving a reduced dose. Chronic Hepatitis C

  (see DOSAGE AND ADMINISTRATION, General)

  Dose

  The recommended dose of INTRON A for the treatment of chronic hepatitis C is 3 million IU three times a week (TIW) administered subcutaneously or intramuscularly. In patients tolerating therapy with normalization of ALT at 16 weeks of treatment, INTRON A therapy should be extended to 18 to 24 months (72 to 96 weeks) at 3 million IU TIW to improve the sustained response rate (see CLINICAL PHARMACOLOGY, Chronic Hepatitis C). Patients who do not normalize their ALTs or have persistently high levels of HCV RNA after 16 weeks of therapy rarely achieve a sustained response with extension of treatment. Consideration should be given to discontinuing these patients from therapy.

  When INTRON A is administered in combination with REBETOL®, patients with impaired renal function and/or those over the age of 50 should be carefully monitored with respect to the development of anemia. See REBETOL prescribing information for dosing when used in combination with REBETOL for adults and pediatric patients.

  Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Solution 18 MIU multidose 6 MIU/mL IM, SC N/A Dose Adjustment

  If severe adverse reactions develop during INTRON A treatment, the dose should be modified (50% reduction) or therapy should be temporarily discontinued until the adverse reactions abate. If intolerance persists after dose adjustment, INTRON A therapy should be discontinued.

  Chronic Hepatitis B Adults

  (see DOSAGE AND ADMINISTRATION, General)

  Dose

  The recommended dose of INTRON A for the treatment of chronic hepatitis B is 30 to 35 million IU per week, administered subcutaneously or intramuscularly, either as 5 million IU daily (QD) or as 10 million IU three times a week (TIW) for 16 weeks.

  Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL IM, SC N/A Solution 25 MIU multidose 10 MIU/mL IM, SC N/A

  NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

  Chronic Hepatitis B Pediatrics

  (see DOSAGE AND ADMINISTRATION, General)

  Dose

  The recommended dose of INTRON A for the treatment of chronic hepatitis B is 3 million IU/m2 three times a week (TIW) for the first week of therapy followed by dose escalation to 6 million IU/m2 TIW (maximum of 10 million IU TIW) administered subcutaneously for a total duration of 16 to 24 weeks.

  Dosage Forms for This Indication Dosage Form Concentration Route Fixed Doses Powder 10 MIU (single dose) 10 MIU/mL SC N/A Solution 25 MIU multidose 10 MIU/mL SC N/A

  NOTE: INTRON A Powder for Injection does not contain a preservative. The vial must be discarded after reconstitution and withdrawal of a single dose.

  Dose Adjustment

  If severe adverse reactions or laboratory abnormalities develop during INTRON A therapy, the dose should be modified (50% reduction) or discontinued if appropriate, until the adverse reactions abate. If intolerance persists after dose adjustment, INTRON A therapy should be discontinued.

  For patients with decreases in white blood cell, granulocyte or platelet counts, the following guidelines for dose modification should be followed:

  INTRON A Dose White Blood Cell Count Granulocyte Count Platelet Count Reduce 50% <1.5 × 109/L <0.75 × 109/L <50 × 109/L Permanently Discontinue <1.0 × 109/L <0.5 × 109/L <25 × 109/L

  INTRON A therapy was resumed at up to 100% of the initial dose when white blood cell, granulocyte, and/or platelet counts returned to normal or baseline values.

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