Amlodipine Besylate And Benazepril Hydrochloride

Amlodipine Besylate And Benazepril Hydrochloride Manufacturers

• Pd-rx Pharmaceuticals, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Pd-rx Pharmaceuticals, Inc.

  

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  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. All patient groups benefited from the reduction in amlodipine-induced edema (see below).

        The hazards (see WARNINGS) of benazepril are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter. When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced. Therapy with any combination of amlodipine and benazepril will thus be associated with both sets of dose-independent hazards, but the incidence of edema will generally be less than that seen with similar (or higher) doses of amlodipine monotherapy.

        Rarely, the dose-independent hazards of benazepril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride combination capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Dose Titration Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with amlodipine besylate and benazepril hydrochloride combination capsules. The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema. Dosage must be guided by clinical response; steady-state levels of benazepril and amlodipine will be reached after approximately 2 and 7 days of dosing, respectively.

        In patients whose blood pressures are adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control without edema. Especially in nonblacks, it may be prudent to minimize the risk of excessive response by reducing the dose of amlodipine as benazepril is added to the regimen.

  Replacement Therapy: For convenience, patients receiving amlodipine and benazepril from separate tablets may instead wish to receive capsules of amlodipine besylate and benazepril hydrochloride combination capsules containing the same component doses.

  Use in Patients With Metabolic Impairments: Regimens of therapy with amlodipine besylate and benazepril hydrochloride combination capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, the recommended initial dose of benazepril is 5 mg. Amlodipine besylate and benazepril hydrochloride combination capsules is not recommended in these patients.

        In small, elderly, frail, or hepatically impaired patients, the recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Pd-rx Pharmaceuticals, Inc.

  

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  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. All patient groups benefited from the reduction in amlodipine-induced edema (see below).

        The hazards (see WARNINGS) of benazepril are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter. When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced. Therapy with any combination of amlodipine and benazepril will thus be associated with both sets of dose-independent hazards, but the incidence of edema will generally be less than that seen with similar (or higher) doses of amlodipine monotherapy.

        Rarely, the dose-independent hazards of benazepril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride combination capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Dose Titration Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with amlodipine besylate and benazepril hydrochloride combination capsules. The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema. Dosage must be guided by clinical response; steady-state levels of benazepril and amlodipine will be reached after approximately 2 and 7 days of dosing, respectively.

        In patients whose blood pressures are adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control without edema. Especially in nonblacks, it may be prudent to minimize the risk of excessive response by reducing the dose of amlodipine as benazepril is added to the regimen.

  Replacement Therapy: For convenience, patients receiving amlodipine and benazepril from separate tablets may instead wish to receive capsules of amlodipine besylate and benazepril hydrochloride combination capsules containing the same component doses.

  Use in Patients With Metabolic Impairments: Regimens of therapy with amlodipine besylate and benazepril hydrochloride combination capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, the recommended initial dose of benazepril is 5 mg. Amlodipine besylate and benazepril hydrochloride combination capsules is not recommended in these patients.

        In small, elderly, frail, or hepatically impaired patients, the recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. All patient groups benefited from the reduction in amlodipine-induced edema (see below).

        The hazards (see WARNINGS) of benazepril are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter. When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced. Therapy with any combination of amlodipine and benazepril will thus be associated with both sets of dose-independent hazards, but the incidence of edema will generally be less than that seen with similar (or higher) doses of amlodipine monotherapy.

        Rarely, the dose-independent hazards of benazepril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride combination capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Dose Titration Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with amlodipine besylate and benazepril hydrochloride combination capsules. The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema. Dosage must be guided by clinical response; steady-state levels of benazepril and amlodipine will be reached after approximately 2 and 7 days of dosing, respectively.

        In patients whose blood pressures are adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control without edema. Especially in nonblacks, it may be prudent to minimize the risk of excessive response by reducing the dose of amlodipine as benazepril is added to the regimen.

  Replacement Therapy: For convenience, patients receiving amlodipine and benazepril from separate tablets may instead wish to receive capsules of amlodipine besylate and benazepril hydrochloride combination capsules containing the same component doses.

  Use in Patients With Metabolic Impairments: Regimens of therapy with amlodipine besylate and benazepril hydrochloride combination capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, the recommended initial dose of benazepril is 5 mg. Amlodipine besylate and benazepril hydrochloride combination capsules is not recommended in these patients.

        In small, elderly, frail, or hepatically impaired patients, the recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

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• Pd-rx Pharmaceuticals, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Pd-rx Pharmaceuticals, Inc.

  

  ---

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. All patient groups benefited from the reduction in amlodipine-induced edema (see below).

        The hazards (see WARNINGS) of benazepril are generally independent of dose; those of amlodipine are a mixture of dose-dependent phenomena (primarily peripheral edema) and dose-independent phenomena, the former much more common than the latter. When benazepril is added to a regimen of amlodipine, the incidence of edema is substantially reduced. Therapy with any combination of amlodipine and benazepril will thus be associated with both sets of dose-independent hazards, but the incidence of edema will generally be less than that seen with similar (or higher) doses of amlodipine monotherapy.

        Rarely, the dose-independent hazards of benazepril are serious. To minimize dose-independent hazards, it is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride combination capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Dose Titration Guided by Clinical Effect: A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with amlodipine besylate and benazepril hydrochloride combination capsules. The addition of benazepril to a regimen of amlodipine should not be expected to provide additional antihypertensive effect in African-Americans. However, all patient groups benefit from the reduction in amlodipine-induced edema. Dosage must be guided by clinical response; steady-state levels of benazepril and amlodipine will be reached after approximately 2 and 7 days of dosing, respectively.

        In patients whose blood pressures are adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control without edema. Especially in nonblacks, it may be prudent to minimize the risk of excessive response by reducing the dose of amlodipine as benazepril is added to the regimen.

  Replacement Therapy: For convenience, patients receiving amlodipine and benazepril from separate tablets may instead wish to receive capsules of amlodipine besylate and benazepril hydrochloride combination capsules containing the same component doses.

  Use in Patients With Metabolic Impairments: Regimens of therapy with amlodipine besylate and benazepril hydrochloride combination capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). In patients with more severe renal impairment, the recommended initial dose of benazepril is 5 mg. Amlodipine besylate and benazepril hydrochloride combination capsules is not recommended in these patients.

        In small, elderly, frail, or hepatically impaired patients, the recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

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• Physicians Total Care, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Physicians Total Care, Inc.

  

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  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. 

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. 

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema. 

  Renal Impairment: Regimens of therapy with amlodipine besylate and benazepril hydrochloride capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73 m2 (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with more severe renal impairment. 

  Hepatic Impairment and Elderly Patients: The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

  2.2 Add-on Therapy

  A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with amlodipine besylate and benazepril hydrochloride capsules .

  In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Physicians Total Care, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Physicians Total Care, Inc.

  

  ---

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride is largely attained within 2 weeks.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Renal Impairment

  Regimens of therapy with amlodipine besylate and benazepril hydrochloride need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). Amlodipine besylate and benazepril hydrochloride is not recommended in patients with more severe renal impairment.

  Hepatic Impairment and Elderly Patients

  The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

  2.1 Add-on Therapy

  A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with amlodipine besylate and benazepril hydrochloride.

  In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

  2.2 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride may be substituted for the titrated components.

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• Rebel Distributors Corp
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Rebel Distributors Corp

  

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  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups. 

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. 

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema. 

  Renal Impairment: Regimens of therapy with amlodipine besylate and benazepril hydrochloride capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73 m2 (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with more severe renal impairment. 

  Hepatic Impairment and Elderly Patients: The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg.

  2.2 Add-on Therapy

  A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with amlodipine besylate and benazepril hydrochloride capsules .

  In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Ncs Healthcare Of Ky, Inc Dba Vangard Labs
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

  

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  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  The antihypertensive effect of Amlodipine Besylate and Benazepril Hydrochloride Capsules is largely attained within 2 weeks.

  It is usually appropriate to begin therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Renal Impairment: Regimens of therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). Amlodipine Besylate and Benazepril Hydrochloride Capsules are not recommended in patients with more severe renal impairment.

  Hepatic Impairment and Elderly Patients: The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg. 

  2.2 Add-on Therapy

  A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules.

  In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

  2.3 Replacement Therapy 

  Amlodipine Besylate and Benazepril Hydrochloride Capsules may be substituted for the titrated components.

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• Dr.reddy’s Laboratories Limited
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Dr.reddy's Laboratories Limited

  

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  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is 1 capsule of amlodipine 2.5 mg/benazepril 10 mg orally once-daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once-daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance (CrCl) less than or equal to 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients with CrCl greater than 30 mL/min/1.73m2 (serum creatinine roughly less than or equal to 3 mg/dL or 265 micromol/L). [see Warnings and Precautions (5.7), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Dr.reddy’s Laboratories Limited
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Dr.reddy's Laboratories Limited

  

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  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is 1 capsule of amlodipine 2.5 mg/benazepril 10 mg orally once-daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once-daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance (CrCl) less than or equal to 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients with CrCl greater than 30 mL/min/1.73m2 (serum creatinine roughly less than or equal to 3 mg/dL or 265 micromol/L). [see Warnings and Precautions (5.7), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Par Pharmaceutical Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Par Pharmaceutical Inc.

  

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  2.1 General Considerations

  The recommended initial dose of Amlodipine Besylate and Benazepril Hydrochloride is one capsule of amlodipine 2.5mg/benazepril 10mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10mg/benazepril 40mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10mg while benazepril is effective in doses of 10-80mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10mg and benazepril doses of 10-40mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules is not recommended in patients with creatinine clearance ≤30 mL/min. No dose adjustment of Amlodipine besylate and benazepril hydrochloride capsules is required in patients creatinine clearance >30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). [See Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3).]

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Teva Pharmaceuticals Usa Inc
  

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  Amlodipine Besylate And Benazepril Hydrochloride | The Body Shop Wake Forest

  

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  Directions

  Apply liberally 15 minutes before sun exposure

  Sun Protection measures

  Spending time in the sun increases  your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including

  Limit time in sun especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats and sunglasses reapply this product at least every 2 hours use water resistant sunscreen if swimming or sweating children under 6 months of age: ask a doctor

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• Pd-rx Pharmaceuticals, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Pd-rx Pharmaceuticals, Inc.

  

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  2.1 General considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsule is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage adjustment in renal impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules are required in patients creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  The antihypertensive effect of Amlodipine Besylate and Benazepril Hydrochloride Capsules is largely attained within 2 weeks.

  It is usually appropriate to begin therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Renal Impairment: Regimens of therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). Amlodipine Besylate and Benazepril Hydrochloride Capsules are not recommended in patients with more severe renal impairment.

  Hepatic Impairment and Elderly Patients: The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg. 

  2.2 Add-on Therapy

  A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules.

  In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

  2.3 Replacement Therapy

  Amlodipine Besylate and Benazepril Hydrochloride Capsules may be substituted for the titrated components.

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  Amlodipine Besylate And Benazepril Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  The antihypertensive effect of Amlodipine Besylate and Benazepril Hydrochloride Capsules is largely attained within 2 weeks.

  It is usually appropriate to begin therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Renal Impairment: Regimens of therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). Amlodipine Besylate and Benazepril Hydrochloride Capsules are not recommended in patients with more severe renal impairment.

  Hepatic Impairment and Elderly Patients: The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg. 

  2.2 Add-on Therapy

  A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules.

  In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

  2.3 Replacement Therapy

  Amlodipine Besylate and Benazepril Hydrochloride Capsules may be substituted for the titrated components.

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• Sandoz Inc
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Sandoz Inc

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage adjustment in renal impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients with creatinine clearance > 30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 μmol/L) [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy 

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Clinical Solutions Wholesale
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Clinical Solutions Wholesale

  

  ---

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  The antihypertensive effect of Amlodipine Besylate and Benazepril Hydrochloride Capsules is largely attained within 2 weeks.

  It is usually appropriate to begin therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with one or the other monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  Renal Impairment: Regimens of therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules need not take account of renal function as long as the patient’s creatinine clearance is >30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). Amlodipine Besylate and Benazepril Hydrochloride Capsules are not recommended in patients with more severe renal impairment.

  Hepatic Impairment and Elderly Patients: The recommended initial dose of amlodipine, as monotherapy or as a component of combination therapy, is 2.5 mg. 

  2.2 Add-on Therapy

  A patient whose blood pressure is not adequately controlled with amlodipine (or another dihydropyridine) alone or with benazepril (or another ACE inhibitor) alone may be switched to combination therapy with Amlodipine Besylate and Benazepril Hydrochloride Capsules.

  In patients whose blood pressure is adequately controlled with amlodipine but who experience unacceptable edema, combination therapy may achieve similar (or better) blood pressure control with less edema.

  2.3 Replacement Therapy

  Amlodipine Besylate and Benazepril Hydrochloride Capsules may be substituted for the titrated components.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage adjustment in renal impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients with creatinine clearance > 30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 μmol/L) [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Lupin Pharmaceuticals, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Claris Lifesciences, Inc

  

  ---

  Adults: Parenteral therapy with Furosemide Injection should be used only in patients unable to take oral medication or in emergency situations and should be replaced with oral therapy as soon as practical.

  Edema

  The usual initial dose of furosemide is 20 to 40 mg given as a single dose, injected intramuscularly or intravenously. The intravenous dose should be given slowly (1 to 2 minutes). Ordinarily a prompt diuresis ensues. If needed, another dose may be administered in the same manner 2 hours later or the dose may be increased. The dose may be raised by 20 mg and given not sooner than 2 hours after the previous dose until the desired diuretic effect has been obtained. This individually determined single dose should then be given once or twice daily. Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response. Close medical supervision is necessary.

  When furosemide is given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable. (See PRECAUTIONS: Laboratory Tests.)

  If the physician elects to use high dose parenteral therapy, add the furosemide to either Sodium Chloride Injection USP, Lactated Ringer's Injection USP, or Dextrose (5%) Injection USP after pH has been adjusted to above 5.5, and administer as a controlled intravenous infusion at a rate not greater than 4 mg/min. Furosemide Injection is a buffered alkaline solution with a pH of about 9 and drug may precipitate at pH values below 7. Care must be taken to ensure that the pH of the prepared infusion solution is in the weakly alkaline to neutral range. Acid solutions, including other parenteral medications (e.g., labetalol, ciprofloxacin, amrinone, milrinone) must not be administered concurrently in the same infusion because they may cause precipitation of the furosemide. In addition, furosemide injection should not be added to a running intravenous line containing any of these acidic products.

  Acute Pulmonary Edema

  The usual initial dose of furosemide is 40 mg injected slowly intravenously (over 1 to 2 minutes). If a satisfactory response does not occur within 1 hour, the dose may be increased to 80 mg injected slowly intravenously (over 1 to 2 minutes).

  If necessary, additional therapy (e.g., digitalis, oxygen) may be administered concomitantly.

  Geriatric Patients

  In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range. (See PRECAUTIONS: Geriatric Use.)

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• Remedyrepack Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Remedyrepack Inc.

  

  ---

  Dose once-daily May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor (2.2) Patients who experience edema with amlodipine may be switched to amlodipine besylate and benazepril hydrochloride containing a lower dose of amlodipine (2.2) Start amlodipine besylate and benazepril hydrochloride at 2.5 mg/10 mg in patients ≥ 75 years old or in patients with hepatic impairment (2)

   

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient's clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

   

  Renal Impairment

  Amlodipine besylate and benazepril hydrochloride is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride is required in patients with creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see WARNINGS AND PRECAUTIONS (5.7), USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].

   

  Amlodipine besylate and benazepril hydrochloride may be substituted for the titrated components.

   

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• Remedyrepack Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Remedyrepack Inc.

  

  ---

  Dose once-daily May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor (2.2) Patients who experience edema with amlodipine may be switched to amlodipine besylate and benazepril hydrochloride containing a lower dose of amlodipine (2.2) Start amlodipine besylate and benazepril hydrochloride at 2.5 mg/10 mg in patients ≥ 75 years old or in patients with hepatic impairment (2)

   

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient's clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

   

  Renal Impairment

  Amlodipine besylate and benazepril hydrochloride is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride is required in patients with creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see WARNINGS AND PRECAUTIONS (5.7), USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].

   

  Amlodipine besylate and benazepril hydrochloride may be substituted for the titrated components.

   

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• Aidarex Pharmaceuticals Llc
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Aidarex Pharmaceuticals Llc

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsules of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Remedyrepack Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Remedyrepack Inc.

  

  ---

  Dose once-daily May be used as add-on therapy for patients not adequately controlled with either a dihydropyridine calcium channel blocker or an ACE inhibitor (2.2) Patients who experience edema with amlodipine may be switched to amlodipine besylate and benazepril hydrochloride containing a lower dose of amlodipine (2.2) Start amlodipine besylate and benazepril hydrochloride at 2.5 mg/10 mg in patients ≥ 75 years old or in patients with hepatic impairment (2)

   

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient's clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

   

  Renal Impairment

  Amlodipine besylate and benazepril hydrochloride is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride is required in patients with creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see WARNINGS AND PRECAUTIONS (5.7), USE IN SPECIFIC POPULATIONS (8.7) and CLINICAL PHARMACOLOGY (12.3)].

   

  Amlodipine besylate and benazepril hydrochloride may be substituted for the titrated components.

   

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• Aidarex Pharmaceuticals Llc
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Aidarex Pharmaceuticals Llc

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsules of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Aidarex Pharmaceuticals Llc
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Aidarex Pharmaceuticals Llc

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsule of amlodipine 2.5 mg and benazepril 10 mg orally once daily.
  
  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema. 
  
  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg and benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response .

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine and benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L) [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Watson Laboratories, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Actavis Pharma, Inc.

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks.  If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients creatinine clearance >30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L).  [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Bryant Ranch Prepack
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Bryant Ranch Prepack

  

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  2.1 General Considerations

  The recommended initial dose of Amlodipine Besylate and Benazepril Hydrochloride is one capsule of amlodipine 2.5mg/benazepril 10mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10mg/benazepril 40mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10mg while benazepril is effective in doses of 10-80mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10mg and benazepril doses of 10-40mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules is not recommended in patients with creatinine clearance ≤30 mL/min. No dose adjustment of Amlodipine besylate and benazepril hydrochloride capsules is required in patients creatinine clearance >30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 µmol/L). [See Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3).]

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Watson Laboratories, Inc.
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Watson Laboratories, Inc.

  

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  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks.  If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients creatinine clearance >30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L).  [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• American Health Packaging
  

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  Amlodipine Besylate And Benazepril Hydrochloride | American Health Packaging

  

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  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsules of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride  capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 mg to 10 mg while benazepril is effective in doses of 10 mg to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 mg to 10 mg and benazepril doses of 10 mg to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment in Renal Impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Carilion Materials Management
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Carilion Materials Management

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage adjustment in renal impairment

   Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients with creatinine clearance > 30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 μmol/L) [see ]. Renal Impairment:Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)

  2.3 Replacement Therapy 

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Carilion Materials Management
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Carilion Materials Management

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient's clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage Adjustment In Renal Impairment

  Renal Impairment

  Amlodipine besylate and benazepril hydrochloride is not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride is required in patients with creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see ( ), ( ) and ( )]. WARNINGS AND PRECAUTIONS5.7USE IN SPECIFIC POPULATIONS8.7CLINICAL PHARMACOLOGY12.3

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride may be substituted for the titrated components.

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• Carilion Materials Management
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Carilion Materials Management

  

  ---

  2.1 General Considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsules is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5-10 mg while benazepril is effective in doses of 10-80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5-10 mg and benazepril doses of 10-40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage adjustment in renal impairment

   Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules is required in patients with creatinine clearance > 30 mL/min/1.73m2 (serum creatinine roughly ≤3 mg/dL or 265 μmol/L) [see ]. Renal Impairment:Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)

  2.3 Replacement Therapy 

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Bryant Ranch Prepack
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Bryant Ranch Prepack

  

  ---

  2.1 General considerations

  The recommended initial dose of amlodipine besylate and benazepril hydrochloride capsule is one capsule of amlodipine 2.5 mg/benazepril 10 mg orally once daily.

  It is usually appropriate to begin therapy with amlodipine besylate and benazepril hydrochloride capsules only after a patient has either (a) failed to achieve the desired antihypertensive effect with amlodipine or benazepril monotherapy, or (b) demonstrated inability to achieve adequate antihypertensive effect with amlodipine therapy without developing edema.

  The antihypertensive effect of amlodipine besylate and benazepril hydrochloride capsules is largely attained within 2 weeks. If blood pressure remains uncontrolled, the dose may be titrated up to amlodipine 10 mg/benazepril 40 mg once daily. The dosing should be individualized and adjusted according to the patient’s clinical response.

  Amlodipine is an effective treatment of hypertension in once-daily doses of 2.5 to 10 mg while benazepril is effective in doses of 10 to 80 mg. In clinical trials of amlodipine/benazepril combination therapy using amlodipine doses of 2.5 to 10 mg and benazepril doses of 10 to 40 mg, the antihypertensive effects increased with increasing dose of amlodipine in all patient groups, and the effects increased with increasing dose of benazepril in nonblack groups.

  2.2 Dosage adjustment in renal impairment

  Renal Impairment: Amlodipine besylate and benazepril hydrochloride capsules are not recommended in patients with creatinine clearance ≤ 30 mL/min. No dose adjustment of amlodipine besylate and benazepril hydrochloride capsules are required in patients creatinine clearance > 30 mL/min (serum creatinine roughly ≤3 mg/dL or 265 μmol/L). [see Warnings and Precautions (5.7), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.3 Replacement Therapy

  Amlodipine besylate and benazepril hydrochloride capsules may be substituted for the titrated components.

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• Bluepoint Laboratories
  

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  Amlodipine Besylate And Benazepril Hydrochloride | Kadmon Pharmaceuticals, Llc

  

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  Ribasphere (ribavirin, USP) should be taken with food. Ribasphere should be given in combination with peginterferon alfa-2a; it is important to note that Ribasphere should never be given as monotherapy. See Peginterferon alfa-2a Package Insert for all instructions regarding peginterferon alfa-2a dosing and administration.

  2.1 Chronic Hepatitis C Monoinfection

  Adult Patients

  The recommended dose of Ribasphere tablets is provided in Table 1. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.

  The daily dose of Ribasphere is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 1).

  Table 1  Peginterferon alfa-2a and Ribasphere Dosing Recommendations Hepatitis C Virus (HCV)
  Genotype Peginterferon
  alfa-2a Dose*
  (once weekly) Ribasphere Dose
  (daily) Duration Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 10).
  Data on genotypes 5 and 6 are insufficient for dosing recommendations.
  *See Peginterferon alfa-2a Package Insert for further details on peginterferon alfa-2a dosing and administration, including dose modification in patients with renal impairment.

  Genotypes 1, 4

  180 mcg

  <75 kg = 1000 mg
  ≥75 kg = 1200 mg

  48 weeks
  48 weeks

  Genotypes 2, 3

  180 mcg

  800 mg

  24 weeks

  Pediatric Patients

  Peginterferon alfa-2a is administered as 180 mcg/1.73m2 x BSA once weekly subcutaneously, to a maximum dose of 180 mcg, and should be given in combination with ribavirin. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks.

  Ribasphere should be given in combination with peginterferon alfa-2a. Ribasphere is available as a 200 mg, 400 mg and 600 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. The recommended doses for Ribasphere are provided in Table 2. Patients who initiate treatment prior to their 18th birthday should maintain pediatric dosing through the completion of therapy.

  Table 2  Ribasphere Dosing Recommendations for Pediatric Patients *approximately 15 mg/kg/day
  **or 1 x 400 mg tablet
  ***or 1 x 600 mg tablet

  Body Weight in
  kilograms (kg)

  Ribasphere Daily Dose*

  Ribasphere
  Number of Tablets

  23 – 33

  400 mg/day

  1 x 200 mg tablet A.M.
  1 x 200 mg tablet P.M.

  34 – 46

  600 mg/day

  1 x 200 mg tablet A.M.
  2 x 200 mg tablets P.M.**

  47 – 59

  800 mg/day

  2 x 200 mg tablets A.M.**
  2 x 200 mg tablets P.M.**

  60 – 74

  1000 mg/day

  2 x 200 mg tablets A.M.**
  3 x 200 mg tablets P.M.***

  ≥75

  1200 mg/day

  3 x 200 mg tablets A.M.***
  3 x 200 mg tablets P.M.***

  2.2 Chronic Hepatitis C with HIV Coinfection

  Adult Patients

  The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is peginterferon alfa-2a 180 mcg subcutaneous once weekly and Ribasphere 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.

  2.3 Dose Modifications

  Adult and Pediatric Patients

  If severe adverse reactions or laboratory abnormalities develop during combination Ribasphere/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dose adjustment, Ribasphere/peginterferon alfa-2a therapy should be discontinued. Table 3 provides guidelines for dose modifications and discontinuation based on the patient’s hemoglobin concentration and cardiac status.

  Ribasphere should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see Warnings and Precautions (5.2)].

  Table 3  Ribasphere Dose Modification Guidelines in Adults and Pediatrics

  Body weight in kilograms (kg)

  Laboratory Values

  Hemoglobin <10 g/dL in patients with no cardiac disease, or

  Decrease in hemoglobin of ≥2 g/dL during any 4 week period in patients with history of stable cardiac disease

  Hemoglobin <8.5 g/dL in patients with no cardiac disease, or

  Hemoglobin <12 g/dL despite 4 weeks at reduced dose in patients with history of stable cardiac disease

  Adult Patients older than 18 years of age

  Any weight

  1 x 200 mg tablet A.M.
  2 x 200 mg tablets or 1 x 400 mg tablet P.M.

  Discontinue Ribasphere

  Pediatric Patients 5 to 18 years of age

  23 – 33 kg

  1 x 200 mg tablet A.M.

  Discontinue Ribasphere

  34 – 46 kg

  1 x 200 mg tablet A.M.
  1 x 200 mg tablet P.M.

  47 – 59 kg

  1 x 200 mg tablet A.M.
  1 x 200 mg tablet P.M.

  60 – 74 kg

  1 x 200 mg tablet A.M.
  2 x 200 mg tablets P.M. or 1 x 400 mg tablet P.M.

  ≥75 kg

  1 x 200 mg tablet A.M.
  2 x 200 mg tablets P.M. or 1 x 400 mg tablet P.M.

  The guidelines for Ribasphere dose modifications outlined in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.

  Adult Patients

  Once Ribasphere has been withheld due to either a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart Ribasphere at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that Ribasphere be increased to the original assigned dose (1000 mg to 1200 mg).

  Pediatric Patients

  Upon resolution of a laboratory abnormality or clinical adverse reaction, an increase in Ribasphere dose to the original dose may be attempted depending upon the physician’s judgment. If Ribasphere has been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart Ribasphere at one-half the full dose.

  2.4 Renal Impairment

  The total daily dose of Ribasphere should be reduced for patients with creatinine clearance less than or equal to 50 mL/min; and the weekly dose of peginterferon alfa-2a should be reduced for creatinine clearance less than 30 mL/min as follows in Table 4 [see Use in Specific Populations (8.7), Pharmacokinetics (12.3), and Peginterferon alfa-2a Package Insert].

  Table 4  Dosage Modification for Renal Impairment

  Creatinine
  Clearance

  Peginterferon alfa-2a Dose
  (once weekly)

  Ribasphere Dose (daily)

  30 to 50 mL/min

  180 mcg

  Alternating doses, 200 mg and 400 mg every other day

  Less than 30 mL/min

  135 mcg

  200 mg daily

  Hemodialysis

  135 mcg

  200 mg daily

  The dose of Ribasphere should not be further modified in patients with renal impairment. If severe adverse reactions or laboratory abnormalities develop, Ribasphere should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after restarting Ribasphere, Ribasphere/peginterferon alfa-2a therapy should be discontinued.

  No data are available for pediatric subjects with renal impairment.

  2.5 Discontinuation of Dosing

  Discontinuation of peginterferon alfa-2a/Ribasphere therapy should be considered if the patient has failed to demonstrate at least a 2 log10 reduction from baseline in HCV RNA by 12 weeks of therapy, or undetectable HCV RNA levels after 24 weeks of therapy.

  Peginterferon alfa-2a/Ribasphere therapy should be discontinued in patients who develop hepatic decompensation during treatment [see Warnings and Precautions (5.3)].

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