he amount of drug remaining in the canister.
Keep out of reach of children. Avoid spraying in eyes.
Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator.
Store between 15° and 25°C (59° and 77°F). Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. SHAKE WELL BEFORE EACH SPRAY.
VENTOLIN HFA does not contain chlorofluorocarbons (CFCs) as the propellant.
17 PATIENT COUNSELING INFORMATION
See FDA-Approved Patient Labeling (17.8)
17.1 Frequency of Use
The action of VENTOLIN HFA should last up to 4 to 6 hours. VENTOLIN HFA should not be used more frequently than recommended. Do not increase the dose or frequency of doses of VENTOLIN HFA without consulting the physician. If patients find that treatment with VENTOLIN HFA becomes less effective for symptomatic relief, symptoms become worse, and/or they need to use the product more frequently than usual, they should seek medical attention immediately.
17.2 Priming and Cleaning
Priming
Patients should be instructed that priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. Patients should 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, patients should 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, patients should be instructed to wash the actuator and dry thoroughly at least once a week. Patients should be informed that detailed cleaning instructions are included in the Information for the Patient leaflet.
17.3 Dose Counter
Patients should be informed that VENTOLIN HFA has a dose counter that starts at 204 and counts down each time a spray is released. Patients should be informed to discard VENTOLIN HFA when the counter reads 000 (after 200 sprays have been used) or 6 months after removal from the moisture-protective foil pouch, whichever comes first. When the counter reads 020, the patient should contact the pharmacist for a refill of medication or consult the physician to determine whether a prescription refill is needed. Patients should never try to alter the numbers or remove the counter from the metal canister. Patients should never immerse the canister in water to determine the amount of drug remaining in the canister.
17.4 Paradoxical Bronchospasm
Patients should be informed that VENTOLIN HFA can produce paradoxical bronchospasm. If paradoxical bronchospasm occurs, patients should discontinue VENTOLIN HFA.
17.5 Concomitant Drug Use
While patients are using VENTOLIN HFA, other inhaled drugs and asthma medications should be taken only as directed by the physician.
17.6 Common Adverse Effects
Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness.
17.7 Pregnancy
Patients who are pregnant or nursing should contact their physicians about the use of VENTOLIN HFA.
17.8 FDA-Approved Patient Labeling
See tear-off leaflet below.
VENTOLIN is a registered trademark of GlaxoSmithKline.
AeroChamber Plus is a registered trademark of Monaghan Medical Inc.
OptiChamber is a registered trademark |
