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Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

endstream endobj startxref For best results, the inhaler should be at room temperature before use. Ventolin hfa package insert. Look inside the mouthpiece for foreign objects and take out any you see.Breathe out through your mouth and push as much air from your lungs as you can. %%EOF These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to albuterol or a combination of these factors.Cases of paradoxical bronchospasm, hoarseness, arrhythmias (including atrial fibrillation, supraventricular tachycardia), and hypersensitivity reactions (including urticaria, angioedema, rash) have been reported after the use of Ventolin HFA.In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypokalemia, hypertension, peripheral vasodilatation, angina, tremor, central nervous system stimulation, hyperactivity, sleeplessness, headache, muscle cramps, drying or irritation of the oropharynx, and metabolic acidosis.Other short-acting sympathomimetic aerosol bronchodilators should not be used concomitantly with albuterol. This Instructions for Use has been approved by the U.S. Food and Drug Administration      Revised: December 2019Discard when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch.The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. During the 3-week run-in phase of the trial, all subjects received CFC 11/12-propelled albuterol. Put the cap back on the mouthpiece.For more information about Ventolin HFA or how to use your inhaler, call 1-888-825-5249 or visit our website at www.Ventolin.com.Trademarks are owned by or licensed to the GSK group of companies. Take the canister out of the actuator and take the cap off the mouthpiece.

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In each trial, subjects received 2 inhalations of Ventolin HFA, CFC 11/12-propelled albuterol, or HFA-134a placebo 4 times daily for 12 weeks’ duration. Put the mouthpiece in your mouth and close your lips around it. Inform patients that detailed cleaning instructions are included in the Patient Information leaflet.Inform patients that Ventolin HFA can produce paradoxical bronchospasm. The adult/adolescent population was 92 female, 110 male and 163 white, 19 black, 18 Hispanic, 2 other. Do not give Ventolin HFA to other people, even if they have the same symptoms that you have. It is not known if VENTOLIN HFA is safe and effective in children 4 years of age. In the responder population treated with Ventolin HFA, the mean time to onset of a 15% increase in peak expiratory flow rate (PEFR) over the pretreatment value was 7.8 minutes, and the mean time to peak effect was approximately 90 minutes. VENTOLIN HFA is intended for oral inhalation only. Each actuation delivers 108 mcg of albuterol sulfate (90 mcg of albuterol base) from the mouthpiece.Ventolin HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients Ventolin HFA can produce paradoxical bronchospasm, which may be life threatening. Look into the mouthpiece to make sure any medicine build-up has been completely washed away.

The studies were conducted with 2 different holding chambers with masks (small and medium size). Overall, the incidence and nature of the adverse reactions reported for Ventolin HFA and a CFC 11/12-propelled albuterol inhaler were comparable. If there is any build-up, repeat Steps 9 and 10.When the actuator is dry, put the protective cap on the mouthpiece and then put the canister in the actuator and make sure it fits firmly.

Each inhaler is packaged with a Patient Information leaflet.The blue actuator supplied with Ventolin HFA should not be used with any other product canisters, and actuators from other products should not be used with a Ventolin HFA canister.Ventolin HFA has a counter attached to the canister.

It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister.Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution.The ECG changes and/or hypokalemia that may result from the administration of non‑potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Never throw canister into fire or incinerator.Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. In this trial, subjects received Ventolin HFA, CFC 11/12-propelled albuterol, or HFA-134a placebo. SHAKE WELL BEFORE EACH SPRAY.Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).Inform patients that the action of Ventolin HFA should last up to 4 to 6 hours. VENTOLIN HFA should be administered by the orally inhaled route only. Ventolin HFA was delivered with an AeroChamber Plus Valved Holding Chamber in this trial. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.These are not all the possible side effects of Ventolin HFA.Call your doctor for medical advice about side effects. Exposure to temperatures above 120°F may cause bursting. Serial pulmonary function measurements demonstrated that 2 inhalations of Ventolin HFA produced significantly greater improvement in pulmonary function than placebo and that there were no significant differences between the groups treated with Ventolin HFA and CFC 11/12-propelled albuterol.