oved patient labeling
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
RECENT MAJOR CHANGES
1 INDICATIONS AND USAGE
1.1 Bronchospasm
1.2 Exercise-Induced Bronchospasm
2 DOSAGE AND ADMINISTRATION
2.1 Bronchospasm
2.2 Exercise-Induced Bronchospasm
2.3 Administration Information
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Paradoxical Bronchospasm
5.2 Deterioration of Asthma
5.3 Use of Anti-Inflammatory Agents
5.4 Cardiovascular Effects
5.5 Do Not Exceed Recommended Dose
5.6 Immediate Hypersensitivity Reactions
5.7 Coexisting Conditions
5.8 Hypokalemia
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Beta-Blockers
7.2 Diuretics
7.3 Digoxin
7.4 Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Bronchospasm Associated With Asthma
14.2 Exercise-Induced Bronchospasm
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Frequency of Use
17.2 Priming and Cleaning
17.3 Dose Counter
17.4 Paradoxical Bronchospasm
17.5 Concomitant Drug Use
17.6 Common Adverse Effects
17.7 Pregnancy
17.8 FDA-Approved Patient Labeling
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
1.1 Bronchospasm
VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease.
1.2 Exercise-Induced Bronchospasm
VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older.
2 DOSAGE AND ADMINISTRATION
Administer VENTOLIN HFA by oral inhalation only. Shake VENTOLIN HFA well before each spray.
2.1 Bronchospasm
For treatment of acute episodes of bronchospasm or prevention of symptoms associated with bronchospasm, the usual dosage for adults and children is 2 inhalations repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations is not recommended.
2.2 Exercise-Induced Bronchospasm
The usual dosage for adults and children 4 years of age and older is 2 inhalations 15 to 30 minutes before exercise.
2.3 Administration Information
Priming
Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. Prime VENTOLIN HFA before using for the first time, when the inhaler has not been used for more than 2 weeks, or when the inhaler has been dropped. To prime VENTOLIN HFA, release 4 sprays into the air away from the face, shaking well before each spray.
Cleaning
To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week.
Dose Counter
VENTOLIN HFA has a dose counter attached to the canister that starts at 204 and co |
