Isuprel

ISUPREL injection 1:5000 should generally be started at the lowest recommended dose and the rate of administration gradually increased if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

Recommended dosage for adults with heart block, Adams-Stroke attacks, and cardiac arrest: Route of
Administration Preparation of Dilution Initial Dose Subsequent
Dose Range * Bolus
intravenous
injection
Dilute 1 mL (0.2 mg)to
10 mL with Sodium Chloride
Injection, USP, or 5%
Dextrose Injection, USP
0.02 mg to 0.06 mg
(1 mL to 3 mL of
diluted solution)
0.01 mg to 0.2 mg
(0.5 mL to 10 mL
of diluted solution)
Intravenous
infusion
Dilute 10 mL (2 mg) in 500 mL
of 5% Dextrose Injection, USP
5 mcg/min
(1.25 mL of diluted solution
per minute)

Intramuscular
Use Solution 1:5000 undiluted
0.2 mg (1 mL)
0.02 mg to 1 mg
(0.1 mL to 5 mL)
Subcutaneous
Use Solution 1:5000 undiluted 0.2 mg (1 mL) 0.15 mg to 0.2 mg (0.75 to 1mL)
Intracardiac
Use Solution 1:5000 undiluted 0.02 mg (0.1 mL

*Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Recommended dosage for adults with shock and hypoperfusion states: Route of Administration Preparation of Dilution† Infusion Rate †† Intravenous Infusion
Dilute 5 mL (1mg) in 500 mL of 5%
Dextrose Injection, USP

0.5 mcg to 5 mcg per minute (0.25 mL to 2.5 mL of
diluted solution)

†Concentrations up to 10 times greater have been used when limitation of volume is essential.
††Rates over 30 mcg per minute have been used in advanced states of shock.  The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow.  If the heard rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

Recommended dosage for adults with bronchospasm occurring during anesthesia: Route
of Administration Preparation of Dilution Initial Dose Subsequent
Dose Bolus
intravenous
injection
Dilute 1 mL (0.2 mg) to 10 mL with Sodium Chloride Injection,
USP, or 5% Dextrose Injection, USP
0.01 mg to 0.02 mg (0.5 mL to 1 mL
of diluted solution)
The initial dose may
be repeated when
necessary.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.

ISUPREL injection 1:5000 should generally be started at the lowest recommended dose and the rate of administration gradually increased if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest:

Route of
Administration

Preparation of Dilution

Initial Dose

Subsequent
Dose Range*

Bolus
    intravenous
    injection

Dilute 1 mL (0.2 mg) to
10 mL with Sodium Chloride
Injection, USP, or 5%
Dextrose Injection, USP

0.02 mg to 0.06 mg
(1 mL to 3 mL of
diluted solution)

0.01 mg to 0.2 mg
(0.5 mL to 10 mL
of diluted solution)

Intravenous
    infusion

Dilute 10 mL (2 mg) in 500 mL
of 5% Dextrose Injection, USP

5 mcg/min.
(1.25 mL of diluted
solution per minute)

Intramuscular

Use Solution 1:5000 undiluted

0.2 mg (1 mL)

0.02 mg to 1 mg
(0.1 mL to 5 mL)

Subcutaneous

Use Solution 1:5000 undiluted

0.2 mg (1 mL)

0.15 mg to 0.2 mg
(0.75 mL to 1 mL)

Intracardiac

Use Solution 1:5000 undiluted

0.02 mg (0.1 mL)

*Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Recommended dosage for adults with shock and hypoperfusion states:

Route of Administration

Preparation of Dilution†

Infusion Rate††

Intravenous infusion

Dilute 5 mL (1 mg) in 500 mL
of 5% Dextrose Injection, USP

0.5 mcg to 5 mcg per minute
(0.25 mL to 2.5 mL of diluted solution)

†Concentrations up to 10 times greater have been used when limitation of volume is essential.
††Rates over 30 mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

  Recommended dosage for adults with bronchospasm occurring during anesthesia:

Route of
Administration

Preparation of Dilution

Initial Dose

Subsequent
Dose

Bolus
    intravenous
    injection

Dilute 1 mL (0.2 mg) to 10 mL
with Sodium Chloride Injection,
USP, or 5% Dextrose Injection, USP

0.01 mg to 0.02 mg
(0.5 mL to 1 mL of
diluted solution)

The initial dose may be
repeated when necessary

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.

ISUPREL injection 1:5000 should generally be started at the lowest recommended dose and the rate of administration gradually increased if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest:

Route of
Administration

Preparation of Dilution

Initial Dose

Subsequent
Dose Range*

Bolus
    intravenous
    injection

Dilute 1 mL (0.2 mg) to
10 mL with Sodium Chloride
Injection, USP, or 5%
Dextrose Injection, USP

0.02 mg to 0.06 mg
(1 mL to 3 mL of
diluted solution)

0.01 mg to 0.2 mg
(0.5 mL to 10 mL
of diluted solution)

Intravenous
    infusion

Dilute 10 mL (2 mg) in 500 mL
of 5% Dextrose Injection, USP

5 mcg/min.
(1.25 mL of diluted
solution per minute)

Intramuscular

Use Solution 1:5000 undiluted

0.2 mg (1 mL)

0.02 mg to 1 mg
(0.1 mL to 5 mL)

Subcutaneous

Use Solution 1:5000 undiluted

0.2 mg (1 mL)

0.15 mg to 0.2 mg
(0.75 mL to 1 mL)

Intracardiac

Use Solution 1:5000 undiluted

0.02 mg (0.1 mL)

*Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Recommended dosage for adults with shock and hypoperfusion states:

Route of Administration

Preparation of Dilution†

Infusion Rate††

Intravenous infusion

Dilute 5 mL (1 mg) in 500 mL
of 5% Dextrose Injection, USP

0.5 mcg to 5 mcg per minute
(0.25 mL to 2.5 mL of diluted solution)

†Concentrations up to 10 times greater have been used when limitation of volume is essential.
††Rates over 30 mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

  Recommended dosage for adults with bronchospasm occurring during anesthesia:

Route of
Administration

Preparation of Dilution

Initial Dose

Subsequent
Dose

Bolus
    intravenous
    injection

Dilute 1 mL (0.2 mg) to 10 mL
with Sodium Chloride Injection,
USP, or 5% Dextrose Injection, USP

0.01 mg to 0.02 mg
(0.5 mL to 1 mL of
diluted solution)

The initial dose may be
repeated when necessary

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.

ISUPREL injection 1:5000 should generally be started at the lowest recommended dose and the rate of administration gradually increased if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest:

Route of
Administration

Preparation of Dilution

Initial Dose

Subsequent
Dose Range*

Bolus
    intravenous
    injection

Dilute 1 mL (0.2 mg) to
10 mL with Sodium Chloride
Injection, USP, or 5%
Dextrose Injection, USP

0.02 mg to 0.06 mg
(1 mL to 3 mL of
diluted solution)

0.01 mg to 0.2 mg
(0.5 mL to 10 mL
of diluted solution)

Intravenous
    infusion

Dilute 10 mL (2 mg) in 500 mL
of 5% Dextrose Injection, USP

5 mcg/min.
(1.25 mL of diluted
solution per minute)

Intramuscular

Use Solution 1:5000 undiluted

0.2 mg (1 mL)

0.02 mg to 1 mg
(0.1 mL to 5 mL)

Subcutaneous

Use Solution 1:5000 undiluted

0.2 mg (1 mL)

0.15 mg to 0.2 mg
(0.75 mL to 1 mL)

Intracardiac

Use Solution 1:5000 undiluted

0.02 mg (0.1 mL)

*Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Recommended dosage for adults with shock and hypoperfusion states:

Route of Administration

Preparation of Dilution†

Infusion Rate††

Intravenous infusion

Dilute 5 mL (1 mg) in 500 mL
of 5% Dextrose Injection, USP

0.5 mcg to 5 mcg per minute
(0.25 mL to 2.5 mL of diluted solution)

†Concentrations up to 10 times greater have been used when limitation of volume is essential.
††Rates over 30 mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

  Recommended dosage for adults with bronchospasm occurring during anesthesia:

Route of
Administration

Preparation of Dilution

Initial Dose

Subsequent
Dose

Bolus
    intravenous
    injection

Dilute 1 mL (0.2 mg) to 10 mL
with Sodium Chloride Injection,
USP, or 5% Dextrose Injection, USP

0.01 mg to 0.02 mg
(0.5 mL to 1 mL of
diluted solution)

The initial dose may be
repeated when necessary

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.

Start ISUPREL injection at the lowest recommended dose and increase the rate of administration gradually if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest:

Route of
Administration

Preparation of Dilution

Initial Dose

Subsequent
Dose Range*

Bolus intravenous injection

Dilute 1 mL (0.2 mg) in 9 mL
of Sodium Chloride Injection, USP,
or 5% Dextrose Injection, USP

0.02 mg to 0.06 mg
(1 mL to 3 mL of diluted solution)

0.01 mg to 0.2 mg
(0.5 mL to 10 mL
of diluted solution)

Intravenous infusion

Dilute 10 mL (2 mg) in 500 mL
of 5% Dextrose Injection, USP

5 mcg/min. (1.25 mL of diluted solution per minute)

 

Intramuscular

Use Solution undiluted

0.2 mg (1 mL)

0.02 mg to 1 mg
(0.1 mL to 5 mL)

Subcutaneous

Use Solution undiluted

0.2 mg (1 mL)

0.15 mg to 0.2 mg
(0.75 mL to 1 mL)

Intracardiac

Use Solution undiluted

0.02 mg (0.1 mL)

 

*      Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Recommended dosage for adults with shock and hypoperfusion states:

Route of Administration

Preparation of Dilution†

Infusion Rate††

Intravenous infusion

 

Dilute 5 mL (1 mg) in 500 mL
of 5% Dextrose Injection, USP

0.5 mcg to 5 mcg per minute
(0.25 mL to 2.5 mL
of diluted solution)

†          Concentrations up to 10 times greater have been used when limitation of volume is essential.

††        Rates over 30 mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

Recommended dosage for adults with bronchospasm occurring during anesthesia:

Route of
Administration

Preparation of Dilution

Initial Dose

Subsequent
Dose

Bolus intravenous injection

 

Dilute 1 mL (0.2 mg) in 9 mL
of Sodium Chloride Injection, USP,
or 5% Dextrose Injection, USP

0.01 mg to 0.02 mg
(0.5 mL to 1 mL of diluted solution)

The initial dose may be repeated when necessary

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.

2.1 Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia ( Fredrickson Types IIa and IIb)

The recommended starting dose of atorvastatin calcium tablets are 10 or 20 mg once daily. Patients who require a large reduction in LDL-C (more than 45%) may be started at 40 mg once daily. The dosage range of atorvastatin calcium tablets are 10 to 80 mg once daily. Atorvastatin calcium tablets can be administered as a single dose at any time of the day, with or without food. The starting dose and maintenance doses of atorvastatin calcium tablets should be individualized according to patient characteristics such as goal of therapy and response (see current NCEP Guidelines). After initiation and/or upon titration of atorvastatin calcium tablets, lipid levels should be analyzed within 2 to 4 weeks and dosage adjusted accordingly.   

2.2  Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10 to 17 years of age)

The recommended starting dose of atorvastatin calcium tablets is 10 mg/day; the maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been studied in this patient population). Doses should be individualized according to the recommended goal of therapy [see current NCEP Pediatric Panel Guidelines, Clinical Pharmacology (12), and Indications and Usage (1.2)] . Adjustments should be made at intervals of 4 weeks or more.

2.3 Homozygous Familial Hypercholesterolemia  

The dosage of atorvastatin calcium tablets in patients with homozygous FH is 10 to 80 mg daily. Atorvastatin calcium tablets should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

2.4 Concomitant Lipid-Lowering Therapy 

Atorvastatin calcium tablets may be used with bile acid resins. The combination of HMG-CoA reductase inhibitors (statins) and fibrates should generally be used with caution [see Warnings and Precautions, Skeletal Muscle (5.1), Drug Interactions (7)] .

2.5 Dosage in Patients With Renal Impairment

Renal disease does not affect the plasma concentrations nor LDL-C reduction of atorvastatin; thus, dosage adjustment in patients with renal dysfunction is not necessary [see Warnings and Precautions, Skeletal Muscle (5.1), Clinical Pharmacology, Pharmacokinetics (12.3)] .

2.6 Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or Certain Protease Inhibitors 

In patients taking cyclosporine or the HIV protease inhibitors (tipranavir plus ritonavir) or the hepatitis C protease inhibitor (telaprevir), therapy with atorvastatin should be avoided. In patients with HIV taking lopinavir plus ritonavir, caution should be used when prescribing atorvastatin and the lowest dose necessary employed.  In patients taking clarithromycin, itraconazole, or in patients with HIV taking a combination of saquinavir plus ritonavir, darunavir plus ritonavir, fosamprenavir, or fosamprenavir plus ritonavir, therapy with atorvastatin should be limited to  20 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed. In patients taking the HIV protease inhibitor nelfinavir or the hepatitis C protease inhibitor boceprevir, therapy with atorvastatin should be limited to 40 mg, and appropriate clinical assessment is recommended to ensure that the lowest dose necessary of atorvastatin is employed [see Warnings and Precautions, Skeletal Muscle (5.1), Drug Interactions (7)] .

Start ISUPREL injection at the lowest recommended dose and increase the rate of administration gradually if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

Table 1: Recommended dosage for adults with heart block, Adams-Stokes attacks, and cardiac arrest: * Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.

Route of

Administration

Preparation of Dilution

Initial
Dose

Subsequent

Dose Range *

Bolus intravenous injection

Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP

0.02 mg to 0.06 mg

(1 mL to 3 mL of diluted solution)

  1.%2 mg to 0.2 mg

(0.5 mL to 10 mL of diluted solution)

Intravenous infusion

Dilute 10 mL (2 mg) in 500 mL of 5% Dextrose Injection, USP

5 mcg/min. (1.25 mL of diluted solution per minute)

Intramuscular

Use Solution undiluted

0.2 mg (1 mL)

0.02 mg to 1 mg

(0.1 mL to 5 mL)

Subcutaneous

Use Solution undiluted

0.2 mg (1 mL)

0.15 mg to 0.2 mg

(0.75 mL to 1 mL)

Intracardiac

Use Solution undiluted

0.02 mg (0.1 mL)

There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Table 2: Recommended dosage for adults with shock and hypoperfusion states: * Concentrations up to 10 times greater have been used when limitation of volume is essential. † Rates over 30 mcg per minute have been used in advanced stages of shock. The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

Route of Administration

Preparation of Dilution*

Infusion Rate†

Intravenous infusion

Dilute 5 mL (1 mg) in 500 mL of 5% Dextrose Injection, USP

0.5 mcg to 5 mcg per minute (0.25 mL to 2.5 mL of diluted solution)

Route of Administration

Preparation of Dilution

Initial Dose

Subsequent Dose

Bolus intravenous injection

Dilute 1 mL (0.2 mg) in 9 mL of Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP

  1.%2 mg to 0.02 mg

(0.5 mL to 1 mL of diluted solution)

The initial dose may be repeated when necessary

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.