Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay.Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of albuterol sulfate up to 50 mg/kg (approximately 340 times the maximum recommended daily inhalation dose for adults on a mg/mStudies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histologic evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently.
VENTOLIN HFA is a pressurized metered-dose aerosol unit fitted with a counter. However, under certain circumstances, e.g., as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma.
If you are a consumer or patient please visit The decrease is usually transient, not requiring supplementation.Use of VENTOLIN HFA may be associated with the following:The safety data described below reflects exposure to VENTOLIN HFA in 248 patients treated with VENTOLIN HFA in 3 placebo-controlled clinical trials of 2 to 12 weeks’ duration. VENTOLIN HFA should be discarded 12 months after removal from the pouch.Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. VENTOLIN HFA may affect the way other medicines work, and other medicines may affect the way VENTOLIN HFA works.Especially tell your healthcare provider if you take:Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.Know the medicines you take. 0000002658 00000 n
The safety and effectiveness of VENTOLIN HFA administered with or without a spacer device in children under 4 years of age has not been demonstrated.Mean Medication Delivery Through AeroChamber Plus (mcg/actuation)Clinical studies of VENTOLIN HFA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. The label will usually tell you what dose to take and how often. albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin SY 6 801095 Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations PSN 7 801095 NDA020983 60 ACTUAT albuterol 0.09 MG SBD 8 Each dose of VENTOLIN HFA should last up to 4 to 6 hours. Treatment consists of discontinuation of VENTOLIN HFA together with appropriate symptomatic therapy. Prime the inhaler before you use it for the first time, if you have not used it for more than 14 days, or if it has been dropped. Patients should be informed to discard VENTOLIN HFA when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-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. 5. Shake the inhaler well and spray it once into the air away from your face. Do not use or store near heat or open flame. Overall Adverse Reactions With ≥3% Incidence in 2 Large 12-Week Clinical Trials in Adolescents and Adults[see Clinical Studies (14.1), Adverse Reactions (6.1)]Table 2.
Nilutamide should be given to a pregnant woman only if clearly needed.Safety and effectiveness in pediatric patients have not been determined.Administration of Nilutamide to beagle dogs resulted in drug-related deaths at dose levels that produce AUC exposures in dogs much lower than the AUC exposures of men receiving the therapeutic doses of 150 and 300 mg/day. For more information, ask your healthcare provider or pharmacist.Call your doctor for medical advice about side effects. Supplied in 18-g canister containing 200 actuations and 8-g canister containing 60 actuations. VENTOLIN HFA is intended for oral inhalation only.