Serial FEVIn the 2 adult trials, the efficacy results from Ventolin HFA were significantly greater than placebo and were clinically comparable to those achieved with CFC 11/12-propelled albuterol, although small numerical differences in mean FEVThe efficacy of Ventolin HFA was evaluated in one 2-week, randomized, double-blind, placebo-controlled trial in 135 pediatric subjects aged 4 to 11 years with mild to moderate asthma. The mean time to peak concentrations (TIn a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2 mg/kg (approximately 15 and 6 times the MRHDID for adults and children, respectively, on a mg/mAlbuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. IMPORTANT SAFETY INFORMATION. Instruct them to discontinue Ventolin HFA if paradoxical bronchospasm occurs.Advise patients that while they are using Ventolin HFA, other inhaled drugs and asthma medications should be taken only as directed by the physician.Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, and nervousness.Inform women there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications, including Ventolin HFA, during pregnancy and that they can enroll in the Pregnancy Exposure Registry by calling 1-877-311-8972 or by visiting https://mothertobaby.org/ongoing-study/asthma Ventolin is owned by or licensed to the GSK group of companies.The other brands listed are trademarks owned by or licensed to their respective owners and are not owned by or licensed to the GSK group of companies. A trial conducted in 12 healthy male and female subjects using a higher dose (1,080 mcg of albuterol base) showed that mean peak plasma concentrations of approximately 3 ng/mL occurred after dosing when albuterol was delivered using propellant HFA-134a. VENTOLIN HFA is a prescription inhaled medicine used to treat or prevent bronchospasm in people aged 4 years and older with reversible obstructive airway disease. people Administration of Ventolin HFA to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose (MRHDID). Do not use Ventolin HFA for a condition for which it was not prescribed. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. The mean duration of effect as measured by a 15% increase in PEFR over the pretreatment value was greater than 3 hours. found this review helpful.2 Inform patients that detailed cleaning instructions are included in the Patient Information leaflet.Inform patients that Ventolin HFA can produce paradoxical bronchospasm. Adult and Adolescent Subjects Aged 12 Years and OlderDisease-Associated Maternal and/or Embryofetal Risk:Mean Medication Delivery through AeroChamber Plus (mcg/actuation)Adult and Adolescent Subjects Aged 12 Years and OlderBefore using Ventolin HFA, tell your healthcare provider about all of your medical conditions, including if you:Tell your healthcare provider about all the medicines you take,Read the step-by-step instructions for using Ventolin HFA at the end of this Patient Information.What are the possible side effects of Ventolin HFA?Ventolin HFA can cause serious side effects, including:worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm).heart problems, including faster heart rate and higher blood pressure.possible death in people with asthma who use too much Ventolin HFA.changes in laboratory blood levels (sugar, potassium).The contents of your Ventolin HFA are under pressure: Do notKeep Ventolin HFA and all medicines out of the reach of children.General information about the safe and effective use of Ventolin HFA.Do not try to change the numbers or take the counter off the metal canister.Before you use Ventolin HFA for the first time, you must prime the inhaler so that you will get the right amount of medicine when you use it.Follow these steps every time you use Ventolin HFA.If your healthcare provider has told you to use more spraysIf you need to use your inhaler before the actuator is completely dry:For correct use of your Ventolin HFA inhaler, remember:WARNING: Do not exceed the dose prescribed by your doctor.If difficulty in breathing persists, get immediate medical help.We comply with the HONcode standard for trustworthy health information - 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. Get expert answers by video or live chat about allergies, pregnancy, sleep, and more. found this review helpful.Reviewer: 25-34 Female on Treatment for less than 1 month (Patient) 0 Some of these opinions may contain information about treatment or uses of drug products that have not been approved by the U.S. Food and Drug Administration.

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