Albuterol Sulfate (Albuterol Sulfate Inhalation Solution)
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Albuterol Sulfate (Albuterol Sulfate Inhalation Solution)

Albuterol Sulfate
Inhalation Solution 0.042% (1.25 mg*/3 mL) and 0.021% (0.63 mg*/3 mL)
(*Potency expressed as albuterol, equivalent to 1.5 mg and 0.75 mg albuterol sulfate)

DRUG DESCRIPTION

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is a sterile, clear, colorless solution of the sulfate salt of racemic albuterol, albuterol sulfate (albuterol sulfate inhalation solution) . Albuterol sulfate (albuterol sulfate inhalation solution) is a relatively selective beta2-adrenergic bronchodilator (see CLINICAL PHARMACOLOGY). The chemical name for albuterol sulfate (albuterol sulfate inhalation solution) is α1 [(tert-butylamino) methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt), and its established chemical structure is as follows:

Albuterol Sulfate Structural Formula Illustration

The molecular weight of albuterol sulfate (albuterol sulfate inhalation solution) is 576.7 and the empirical formula is (C13 H21 NO3)2 •H2 SO4. Albuterol sulfate (albuterol sulfate inhalation solution) is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol is salbutamol.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied in two strengths in unit dose vials. Each unit dose vial contains either 0.75 mg of albuterol sulfate (albuterol sulfate inhalation solution) (equivalent to 0.63 mg of albuterol) or 1.50 mg of albuterol sulfate (albuterol sulfate inhalation solution) (equivalent to 1.25 mg of albuterol) with sodium chloride and sulfuric acid in a 3-mL isotonic, sterile, aqueous solution. Sodium chloride is added to adjust isotonicity of the solution and sulfuric acid is added to adjust pH of the solution to 4.0 (see HOW SUPPLIED).

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution does not require dilution prior to administration by nebulization. For albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari LC Plus™ nebulizer (with face mask or mouthpiece) connected to a Pari PRONEB™ compressor, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 43% of albuterol (1.25 mg strength) and 39% of albuterol (0.63 mg strength) at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered from a jet nebulizer at an adequate flow rate, via a mouthpiece or face mask (see DOSAGE AND ADMINISTRATION).

What are the possible side effects of albuterol inhalation (Accuneb, ProAir HFA, Proventil, Proventil HFA, Ventolin HFA)?

Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;
  • chest pain and fast, pounding, or uneven heart beats;
  • tremor, nervousness;
  • low potassium (confusion, uneven...

Read All Potential Side Effects and See Pictures of Albuterol Sulfate »

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

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INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is indicated for the relief of bronchospasm in patients 2 to 12 years of age with asthma (reversible obstructive airway disease).

DOSAGE AND ADMINISTRATION

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial [3 mL of 0.042% (1.25 mg) or 0.021% (0.63 mg) inhalation solution] by nebulization. Adjust nebulizer flow rate to deliver albuterol sulfate over 5 to 15 minutes.

The use of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV1 less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of albuterol sulfate inhalation solution when administered with other nebulizer systems have not been established.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

HOW SUPPLIED

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.021% (0.63 mg) and 0.042% (1.25 mg) of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil-pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution is available in a shelf carton containing multiple foil pouches.

Albuterol sulfate (albuterol sulfate inhalation solution) inhalation solution 0.021% (0.63 mg/3 mL) (potency expressed as albuterol) contains 0.75 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3467-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Albuterol Sulfate (albuterol sulfate inhalation solution) Inhalation Solution, 0.042% (1.25 mg/3 mL) (potency expressed as albuterol) contains 1.50 mg albuterol sulfate (albuterol sulfate inhalation solution) per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 0591-3468-53: 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature]. Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial (s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

Manufactured for: Watson Laboratories Inc. Corona, C.A. 92880, USA. Manufactured by: Cipla Ltd., Verna Goa, INDIA. Issued: June 2006. FDA rev date: 9/25/2007

Last reviewed on RxList: 6/12/2008
This monograph has been modified to include the generic and brand name in many instances.

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