Albuterol Sulfate Extended-Release Tablets (VoSpire ER)
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Albuterol Sulfate Extended-Release Tablets (VoSpire ER)

VoSpire ER®
(Albuterol Sulfate) Extended-Release Tablets

DRUG DESCRIPTION

Albuterol extended-release tablets contain albuterol sulfate, the racemic form of albuterol and a relatively selective beta2-adrenergic bronchodilator, in an extended-release formulation. Albuterol sulfate has the chemical name (±) α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α-diol sulfate (2:1) (salt), and the following structural formula:

VoSpire ER® (Albuterol Sulfate) Structural Formula Illustration

Albuterol sulfate has a molecular weight of 576.7, and the molecular formula is (C13H21NO3)2•H2SO4. Albuterol sulfate is a white crystalline powder, soluble in water and slightly soluble in ethanol.

The World Health Organization recommended name for albuterol base is salbutamol.

Each tablet for oral administration contains 4 mg or 8 mg of albuterol as 4.8 mg or 9.6 mg, respectively, of albuterol sulfate in a cellulosic material that serves as a diffusion-release membrane. In addition each tablet contains the following inactive ingredients: Calcium sulfate, carnauba wax, ethylcellulose, ferric oxide black, hypromellose, ink-thinner XI, lactose monohydrate, magnesium stearate, polyethylene glycol, propylene glycol, shellac, stearic acid, titanium dioxide, triacetin, D&C Yellow #10, (4 mg only) and FD&C Blue #1 (4 mg only).

What are the precautions when taking albuterol sulfate extended-release tablets (VoSpire ER)?

Before taking albuterol, tell your doctor or pharmacist if you are allergic to it; or if you have had a serious reaction to similar drugs (e.g., metaproterenol, terbutaline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems (e.g., irregular heartbeat, angina, heart attack), high blood pressure, diabetes, low levels of potassium in the blood, seizure, overactive thyroid (hyperthyroidism).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such...

Read All Potential Precautions of VoSpire ER »

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Albuterol extended-release tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE AND ADMINISTRATION

The following dosages of albuterol extended-release tablets are expressed in terms of albuterol base:

Usual Dosage

Adults and Children over 12 years of age: The usual recommended dosage for adults and pediatric patients over 12 years of age is 8 mg every 12 hours. In some patients, 4 mg every 12 hours may be sufficient.

Children 6 to 12 years of age: The usual recommended dosage for children 6 through 12 years of age is 4 mg every 12 hours.

Dosage adjustment in Adults and Children over 12 years of age: In unusual circumstances, such as adults of low body weight, it may be desirable to use a starting dosage of 4 mg every 12 hours and progress to 8 mg every 12 hours according to response.

If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 32 mg per day in divided doses (i.e., every 12 hours).

Dosage adjustment in Children 6 to 12 years of age: If control of reversible airway obstruction is not achieved with the recommended doses in patients on otherwise optimized asthma therapy, the doses may be cautiously increased stepwise under the control of the supervising physician to a maximum dose of 24 mg per day in divided doses (i.e., every 12 hours).

Switching from oral albuterol, USP products: Patients currently maintained on albuterol tablets, USP or albuterol sulfate syrup can be switched to albuterol extended-release tablets. For example, the administration of one 4 mg albuterol extended-release tablet every 12 hours is comparable to one 2 mg albuterol tablet, USP every 6 hours. Multiples of this regimen up to the maximum recommended daily dose also apply.

Albuterol extended-release tablets must be swallowed whole with the aid of liquids. DO NOT CHEW OR CRUSH THESE TABLETS.

HOW SUPPLIED

Albuterol Extended-Release Tablets, equivalent to 4 mg and 8 mg of Albuterol:

4 mg - Green, round, coated tablets in bottles of 100. (NDC 68774-600-01)
Printed V on one side and 4 on the other side in black ink.

8 mg - White, round, coated tablets in bottles of 100. (NDC 68774-601-01)
Printed V on one side and 8 on the other side in black ink.

Dispense in a well-closed, light-resistant container as defined in the USP. Replace cap securely after each opening. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Manufactured by: PLIVA® Inc. East Hanover, NJ 07936. For: DAVA Pharmaceuticals, Inc. Fort Lee, New Jersey 07024, USA. Rev. 9/05. FDA Rev date: 09/30/02

Last reviewed on RxList: 8/8/2008
This monograph has been modified to include the generic and brand name in many instances.

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