Visipaque

Visipaque Manufacturers

• Ge Healthcare Inc.
  

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  Visipaque | Ge Healthcare Inc.

  

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  For Pediatric dosing see the end of this Dosage and Administration section.

  GENERAL

  The combination of volume and concentration of VISIPAQUE Injection to be used should be individualized, accounting for factors such as age, body weight, size of the vessel, and rate of blood flow within the vessel. Specific dose adjustment studies for age, gender, weight and renal function have not been conducted with VISIPAQUE. As with other iodinated contrast agents, lower doses may have less risk. The efficacy of VISIPAQUE Injection below doses recommended has not been established. Other factors, such as pathology anticipated, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed, should be considered.

  The maximum recommended total dose of iodine is 80 grams.

  If an adverse reaction occurs during injection, consider stopping the injection immediately if warranted by the nature and severity of the event.

  Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents (see WARNINGS and PRECAUTIONS).

  INTRA-ARTERIAL ADMINISTRATION

  VISIPAQUE 320mgI/mL is recommended for intra-arterial injection in the radiographic contrast evaluation of arterial lesions of the brain, the coronary arteries and left ventricle, and for intra-arterial injection in the radiographic contrast evaluation of peripheral arteries. VISIPAQUE is also recommended for intra-arterial digital subtraction angiography, as specified in the dosing chart below.

  Injection rates should be approximately equal to the flow rate in the vessel being injected. The volume required will depend on the size, flow rate, and disease state of the injected vessel, on the size and condition of the patient, and on the imaging technique used. The usual single injection volumes or total dose per patient (mL/kg) for adults and adolescents over 12 years of age are listed in the tables below.

  ADULTS and ADOLESCENTS OVER 12 YEARS OF AGE USUAL SINGLE DOSES FOR INJECTION INTO SELECTED ARTERIES ARTERIOGRAPHY IA-DSA* Maximum Total Dose Intra-Arterial Injection Sites 320 mgI/mL 270 mgI/mL 320 mgI/mL * IA-DSA= Intra-Arterial Digital Subtraction Angiography Carotid Arteries 10 - 14 mL 5 - 8 mL Usually Not to Exceed 175 mL Vertebral Arteries 10 - 12 mL 5 - 8 mL Right Coronary Artery 3 - 8 mL Usually Not to Exceed 200 mL Left Coronary Artery 3 - 10 mL Left Ventricle 20 - 45 mL Renal Arteries 8 - 18 mL 10 - 25 mL — Usually Not to Exceed 250 mL Aortography 30 - 70 mL 20 - 50 mL 10 - 50 mL Major Branches of Aorta 10 - 70 mL 5 - 30 mL 2 - 10 mL Aortofemoral Runoffs 20 - 90 mL — 6 - 15 mL Peripheral Arteries 15 - 30 mL — 3 - 15 mL INTRAVENOUS ADMINISTRATION Contrast Enhanced Computed Tomography (CECT)

  Intravenous administration of VISIPAQUE Injection (270mgI/mL and 320mgI/mL) is recommended for contrast enhancement in the evaluation of neoplastic and nonneoplastic lesions of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions), evaluations of renal function, and evaluations of the peripheral venous system. Selected dosing for different indications in adults and pediatric patients are shown in the following tables.

  ADULTS and ADOLESCENTS OVER 12 YEARS OF AGE USUAL VISIPAQUE DOSING FOR INTRAVENOUS CONTRAST ADMINISTRATION Study Type Comment 270 mgI/mL 320 mgI/mL Maximum Total Volume CECT of Head or Body Bolus 75 - 150 mL 75 - 150 mL 150 mL Infusion 100 - 150 mL 100 - 150 mL Excretory Urography Normal Renal Function 1 mL/kg 1 mL/kg 100 mL Venography Per lower extremity 50 - 150 mL 250 mL PEDIATRIC DOSING

  The recommended dose in children over 1 year of age for the evaluation of:

  Intra-arterial Administration for Cerebral, Cardiac chambers and related major arteries, and Visceral Studies

  VISIPAQUE 320 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 4 mL/kg.

  Intravenous Administration for Contrast Enhanced Computerized Tomography or Excretory Urography

  VISIPAQUE 270 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 2 mL/kg.

  The safety and efficacy relationships of other doses, concentrations or procedures have not been established. (See Clinical Pharmacology–Special Populations, and Precautions–Pediatric Use sections.)

  The maximum total dose of iodine in the pediatric population has not been established.

  DRUG HANDLING

  As with all contrast agents because of the potential for chemical incompatibility, VISIPAQUE Injection should not be mixed with, or injected in, intravenous administration lines containing other drugs, solutions or total nutritional admixtures.

  Sterile technique must be used in all procedures involving vascular injections of contrast agents.

  VISIPAQUE Injection may be administered at body temperature as well as at room temperature.

  If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

  Withdrawal of contrast agents from their containers should be accomplished under strict aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately.

  Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, and should not be used if particulates are observed or marked discoloration has occurred.

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• Ge Healthcare Inc.
  

  ×

  Visipaque | Ge Healthcare Inc.

  

  ---

  For Pediatric dosing see the end of this DOSAGE AND ADMINISTRATION section.

  GENERAL

  The combination of volume and concentration of VISIPAQUE Injection to be used should be individualized, accounting for factors such as age, body weight, size of the vessel, and rate of blood flow within the vessel. Specific dose adjustment studies for age, gender, weight and renal function have not been conducted with VISIPAQUE. As with other iodinated contrast agents, lower doses may have less risk. The efficacy of VISIPAQUE Injection below doses recommended has not been established. Other factors, such as pathology anticipated, degree and extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed, should be considered.

  The maximum recommended total dose of iodine is 80 grams.

  If an adverse reaction occurs during injection, consider stopping the injection immediately if warranted by the nature and severity of the event.

  Patients should be adequately hydrated prior to and following the intravascular administration of iodinated contrast agents (see WARNINGS and PRECAUTIONS).

  INTRA-ARTERIAL ADMINISTRATION

  VISIPAQUE 320mgI/mL is recommended for intra-arterial injection in the radiographic contrast evaluation of arterial lesions of the brain, the coronary arteries and left ventricle, and for intra-arterial injection in the radiographic contrast evaluation of peripheral arteries. VISIPAQUE is also recommended for intra-arterial digital subtraction angiography, as specified in the dosing chart below.

  Injection rates should be approximately equal to the flow rate in the vessel being injected. The volume required will depend on the size, flow rate, and disease state of the injected vessel, on the size and condition of the patient, and on the imaging technique used. The usual single injection volumes or total dose per patient (mL/kg) for adults and adolescents over 12 years of age are listed in the tables below.

  ADULTS and ADOLESCENTS OVER 12 YEARS OF AGE USUAL SINGLE DOSES FOR INJECTION INTO SELECTED ARTERIES ARTERIOGRAPHY IA-DSA* Maximum Total Dose Intra-Arterial Injection Sites 320 mgI/mL 270 mgI/mL 320 mgI/mL * IA-DSA= Intra-Arterial Digital Subtraction Angiography Carotid Arteries 10 - 14 mL 5 - 8 mL Usually Not to Exceed 175 mL Vertebral Arteries 10 - 12 mL 5 - 8 mL Right Coronary Artery 3 - 8 mL Usually Not to Exceed 200 mL Left Coronary Artery 3 - 10 mL Left Ventricle 20 - 45 mL Renal Arteries 8 - 18 mL 10 - 25 mL — Usually Not to Exceed 250 mL Aortography 30 - 70 mL 20 - 50 mL 10 - 50 mL Major Branches of Aorta 10 - 70 mL 5 - 30 mL 2 - 10 mL Aortofemoral Runoffs 20 - 90 mL — 6 - 15 mL Peripheral Arteries 15 - 30 mL — 3 - 15 mL INTRAVENOUS ADMINISTRATION Contrast Enhanced Computed Tomography (CECT)

  Intravenous administration of VISIPAQUE Injection (270mgI/mL and 320mgI/mL) is recommended for contrast enhancement in the evaluation of neoplastic and nonneoplastic lesions of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions), evaluations of renal function, and evaluations of the peripheral venous system. Selected dosing for different indications in adults and pediatric patients are shown in the following table.

  ADULTS and ADOLESCENTS OVER 12 YEARS OF AGE USUAL VISIPAQUE DOSING FOR INTRAVENOUS CONTRAST ADMINISTRATION Study Type Comment 270 mgI/mL 320 mgI/mL Maximum Total Volume CECT of Head or Body Bolus 75 - 150 mL 75 - 150 mL 150 mL Infusion 100 - 150 mL 100 - 150 mL Excretory Urography Normal Renal Function 1 mL/kg 1 mL/kg 100 mL Venography Per lower extremity 50 - 150 mL 250 mL PEDIATRIC DOSING

  The recommended dose in children over 1 year of age for the evaluation of:

  Intra-arterial Administration for Cerebral, Cardiac chambers and related major arteries, and Visceral Studies

  VISIPAQUE 320 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 4 mL/kg.

  Intravenous Administration for Contrast Enhanced Computerized Tomography or Excretory Urography

  VISIPAQUE 270 mgI/mL as 1 to 2 mL/kg. The recommended total dose of VISIPAQUE should not exceed 2 mL/kg.

  The safety and efficacy relationships of other doses, concentrations or procedures have not been established. (See Clinical Pharmacology–Special Populations, and Precautions–Pediatric Use sections.)

  The maximum total dose of iodine in the pediatric population has not been established.

  DRUG HANDLING

  As with all contrast agents because of the potential for chemical incompatibility, VISIPAQUE Injection should not be mixed with, or injected in, intravenous administration lines containing other drugs, solutions or total nutritional admixtures.

  Sterile technique must be used in all procedures involving vascular injections of contrast agents.

  VISIPAQUE Injection may be administered at body temperature as well as at room temperature.

  If nondisposable equipment is used, scrupulous care should be taken to prevent residual contamination with traces of cleansing agents.

  Withdrawal of contrast agents from their containers should be accomplished under strict aseptic conditions using only sterile syringes and transfer devices. Contrast agents which have been transferred into other delivery systems should be used immediately.

  Parenteral products should be inspected visually for particulate matter and discoloration prior to administration, and should not be used if particulates are observed or marked discoloration has occurred.

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• Ge Healthcare Inc.
  

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  Visipaque | Preferred Pharmaceuticals, Inc.

  

  ---

  Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who require doses greater than 4 mg/day. In such cases, dosage should be increased cautiously to avoid adverse effects.

  Anxiety Disorders and Transient Symptoms of Anxiety

  Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.

  In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.

  Panic Disorder

  The successful treatment of many panic disorder patients has required the use of alprazolam tablets at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam tablets in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam tablets in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.

  Dose Titration

  Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam tablets. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.

  Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.

  Dose Maintenance

  For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam tablets greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).

  The necessary duration of treatment for panic disorder patients responding to alprazolam tablets is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.

  Dose Reduction

  Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).

  In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.

  In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

  Dosing in Special Populations

  In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.

  Anxiety Disorders and Transient Symptoms of Anxiety

  Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg given three times daily. The dose may be increased to achieve a maximum therapeutic effect, at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. The lowest possible effective dose should be employed and the need for continued treatment reassessed frequently. The risk of dependence may increase with dose and duration of treatment.

  In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every 3 days. Some patients may require an even slower dosage reduction.

  Panic Disorder

  The successful treatment of many panic disorder patients has required the use of alprazolam tablets at doses greater than 4 mg daily. In controlled trials conducted to establish the efficacy of alprazolam tablets in panic disorder, doses in the range of 1 to 10 mg daily were used. The mean dosage employed was approximately 5 to 6 mg daily. Among the approximately 1700 patients participating in the panic disorder development program, about 300 received alprazolam tablets in dosages of greater than 7 mg/day, including approximately 100 patients who received maximum dosages of greater than 9 mg/day. Occasional patients required as much as 10 mg a day to achieve a successful response.

  Dose Titration

  Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam tablets. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.

  Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.

  Dose Maintenance

  For patients receiving doses greater than 4 mg/day, periodic reassessment and consideration of dosage reduction is advised. In a controlled postmarketing dose-response study, patients treated with doses of alprazolam tablets greater than 4 mg/day for 3 months were able to taper to 50% of their total maintenance dose without apparent loss of clinical benefit. Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).

  The necessary duration of treatment for panic disorder patients responding to alprazolam tablets is unknown. After a period of extended freedom from attacks, a carefully supervised tapered discontinuation may be attempted, but there is evidence that this may often be difficult to accomplish without recurrence of symptoms and/or the manifestation of withdrawal phenomena.

  Dose Reduction

  Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).

  In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.

  In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

  Dosing in Special Populations

  In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.

  Dose Titration

  Treatment may be initiated with a dose of 0.5 mg three times daily. Depending on the response, the dose may be increased at intervals of 3 to 4 days in increments of no more than 1 mg per day. Slower titration to the dose levels greater than 4 mg/day may be advisable to allow full expression of the pharmacodynamic effect of alprazolam tablets. To lessen the possibility of interdose symptoms, the times of administration should be distributed as evenly as possible throughout the waking hours, that is, on a three or four times per day schedule.

  Generally, therapy should be initiated at a low dose to minimize the risk of adverse responses in patients especially sensitive to the drug. Dose should be advanced until an acceptable therapeutic response (i.e., a substantial reduction in or total elimination of panic attacks) is achieved, intolerance occurs, or the maximum recommended dose is attained.

  Dose Reduction

  Because of the danger of withdrawal, abrupt discontinuation of treatment should be avoided (see WARNINGS, PRECAUTIONS, DRUG ABUSE AND DEPENDENCE).

  In all patients, dosage should be reduced gradually when discontinuing therapy or when decreasing the daily dosage. Although there are no systematically collected data to support a specific discontinuation schedule, it is suggested that the daily dosage be decreased by no more than 0.5 mg every three days. Some patients may require an even slower dosage reduction.

  In any case, reduction of dose must be undertaken under close supervision and must be gradual. If significant withdrawal symptoms develop, the previous dosing schedule should be reinstituted and, only after stabilization, should a less rapid schedule of discontinuation be attempted. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome. It is suggested that the dose be reduced by no more than 0.5 mg every 3 days, with the understanding that some patients may benefit from an even more gradual discontinuation. Some patients may prove resistant to all discontinuation regimens.

  Dosing in Special Populations

  In elderly patients, in patients with advanced liver disease or in patients with debilitating disease, the usual starting dose is 0.25 mg, given two or three times daily. This may be gradually increased if needed and tolerated. The elderly may be especially sensitive to the effects of benzodiazepines. If side effects occur at the recommended starting dose, the dose may be lowered.

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