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You may report side effects to FDA at 1-800-FDA-1088. View All, fOR oral inhalation only, prescribing Information. The exact cause of death is proventil unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected. 10 Worst Cities for Asthma Slideshow Pictures Proventil Professional Information side effects Adverse reaction information concerning proventil proventil HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study proventil which compared proventil HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler. Proventil HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant. Proventil HFA albuterol sulfate aerosol, metered Product Information Product Type human prescription drug label Item Code (Source) NDC: Route of Administration respiratory (inhalation) DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Albuterol Sulfate (Albuterol) Albuterol 108 ug Inactive Ingredients Ingredient Name Strength alcohol. In an inhalation reproduction study in sprague-dawley rats, the albuterol sulfate/HFA-134a formulation did not exhibit any teratogenic effects.5 mg/kg (approximately 70 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). Figure A Before you use proventil HFA for the first time make sure that the pointer on the dose indicator is pointing to the right of the 200 inhalation mark in the dose indicator display window (See Figure A). Store proventil HFA at room temperature between 59F and 77F (15C and 25C). Clinical pharmacology, mechanism of ActionIn vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on beta2-adrenergic receptors compared with proventil isoproterenol. Read the entire FDA prescribing information for Proventil (Albuterol Inhalation) Read More » Asthma Slideshow Pictures Take the Asthma Quiz! A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. Figure G Step 6: When the mouthpiece is dry, put the canister back in the actuator and put the cap on the mouthpiece. It contains a microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane ethanol, and oleic acid. Step 3: While breathing in deeply and slowly, press down on the center of the dose indicator with your index finger until the canister stops moving in the actuator and a puff of medicine has been released (See Figure D ). In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. There are no adequate and well-controlled studies of proventil HFA Inhalation Aerosol or albuterol sulfate in pregnant women. Palpitation and dizziness have also been observed with proventil HFA Inhalation Aerosol. In a 22-month study in Golden Hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 110 times the maximum recommended daily. Read all patient information, medication guides, and instruction sheets provided to you. When nearing the end of the usable inhalations, the background behind the number in the dose indicator display window changes to red at 20 actuations or lower. Manufactured for: Merck Sharp Dohme Corpa subsidiary of merck., INC., Whitehouse Station, NJ 08889, USA. A solution for use in a nebulizer is also available. The dose for preventing asthma attacks is two sprays of Proventil four times daily. If you do not use your proventil HFA for more than 2 weeks, you should re-prime it before use. A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37) fetuses when albuterol sulfate was administered orally at 50 mg/kg dose (approximately 680 times the maximum recommended daily inhalation dose for adults on a mg/m basis). Use Proventil HFA Inhalation Aerosol only with the actuator supplied with the product.
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