Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. 1. Contents: A microcrystalline suspension of albuterol sulfate in propellant HFA-134a (1,1,1,2-tetrafluoroethane). For more information, contact the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. Ventolin HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions (5.6), Description (11)]. If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately as this is often a sign of seriously worsening asthma that would require reassessment of therapy. 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. Ventolin HFA is used to treat or prevent bronchospasm, or narrowing of the airways in the lungs, in people with asthma or certain types of chronic obstructive pulmonary disease (COPD). Most Ventolin side effects start within minutes of inhaler use and last for between a few minutes and a few hours. Never throw canister into fire or incinerator. Signs of an allergic reaction include: swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing, itchy rash, feeling faint and light headed, and collapse. Drug class: Adrenergic bronchodilators. Following a 3-mg dose of nebulized albuterol in adults, the maximum albuterol plasma levels at 0.5 hours were 2.1 ng/mL (range, 1.4 to 3.2 ng/mL). It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial. In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg (approximately 1,900 and 740 times the MRHDID for adults and children, respectively, on a mg/m2 basis). Serial FEV1 measurements [shown below as percent change from test-day baseline at Day 1 (n = 297) and at Week 12 (n = 249)] demonstrated that 2 inhalations of Ventolin HFA produced significantly greater improvement in FEV1 over the pretreatment value than placebo. What are the ingredients in Ventolin HFA? Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including albuterol. See Figure H. If you need to use your inhaler before the plastic actuator is completely dry: For correct use of your Ventolin HFA inhaler, remember: For more information about Ventolin HFA or how to use your inhaler, call 1-888-825-5249. Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. Reviewed 2021-10-22 by Dr Claire Pugh. The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 810 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 300 times the maximum recommended daily dose for children on a mg/m2 basis). Diuretics: 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. Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. Clean your inhaler at least 1 time each week. The data from pediatric subjects are based upon 1 clinical trial in which 46 subjects with asthma aged 4 to 11 years were treated with Ventolin HFA 2 inhalations 4 times daily for 2 weeks duration. What are the possible side effects of Ventolin HFA? Adult and pediatric patients aged 4 years and older: 2 inhalations by oral inhalation repeated every 4 to 6 hours; in some patients, 1 inhalation every 4 hours may be sufficient. You may not see any medicine build-up on the inhaler, but it is important to keep it clean so medicine build-up will not block the spray. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution. In a 12-week, randomized, double-blind trial, Ventolin HFA (101 subjects) was compared with CFC 11/12-propelled albuterol (99 subjects) and an HFA-134a placebo inhaler (97 subjects) in adolescent and adult subjects aged 12 to 76 years with mild to moderate asthma. Before you take aspirin, talk to your doctor about the pros and cons. Immediate hypersensitivity reactions may occur after administration of albuterol, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. Gently swirl the nebulizer to mix the contents and connect it with the mouthpiece or face mask (Figure 3). Remember that this . There are no randomized clinical studies of use of albuterol sulfate during pregnancy. The population was 21 female, 25 male and 25 white, 17 black, 3 Hispanic, 1 other. Common side effects may include: flushing (sudden warmth, redness, or tingly feeling); stuffy nose, sinus pain; headache, dizziness; upset stomach; or. Albuterol has been shown in most controlled clinical trials to have more effect on the respiratory tract, in the form of bronchial smooth muscle relaxation, than isoproterenol at comparable doses while producing fewer cardiovascular effects. Frequency of side effects - listed below Common side effects (affects less than 1 in 10 people) Feeling shaky, your heart beating faster, headache Uncommon side effects (affects less than 1 in 100 people) Mouth and throat irritation, muscle cramps Rare side effects (affects less than 1 in 1,000 people) Physicians should recognize that individual responses to beta-adrenergic agonists administered via different propellants may vary and that equivalent responses in individual patients should not be assumed. The drug did not induce cleft palate formation at the lowest dose, 0.025 mg/kg. As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. Ventolin HFA has a counter attached to the canister. In addition, Ventolin HFA was shown to be clinically comparable to a CFC 11/12-propelled albuterol inhaler for this indication. The clinical significance of these findings is unknown. Side effects of Salbutamol and Beclometasone, The difference between blue and brown inhalers, Feeling shaky, your heart beating faster, headache, Mouth and throat irritation, muscle cramps, Low level of potassium in your blood, increased blood flow to your extremities (peripheral dilatation), Changes in sleep patterns and changes in behaviour, such as restlessness and excitability. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. In vitro dose characterization studies were performed to evaluate the delivery of Ventolin HFA via holding chambers with attached masks. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. See prescribing information for dosage information. Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN Inhalation Solution for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. Store at room temperature between 68oF and 77oF (20oC and 25oC). The studies were conducted with 2 different holding chambers with masks (small and medium size). Common side effects of Ventolin include coughing, sore throat, and nervousness. Avoid spraying in eyes. Mean Medication Delivery through AeroChamber Plus (mcg/actuation), Medication Delivered per Actuation (mcg/kg)b. Ventolin HFA is a blue plastic inhaler with a blue cap containing a pressurized metered-dose aerosol canister fitted with a counter. Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. Symptoms of ED include. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. H2SO4. Side Effects Nervousness, shaking (tremor), headache, mouth /throat dryness or irritation, changes in taste, cough, nausea or dizziness may occur. VENTOLIN Inhalation Solution is a clear, colorless to light yellow solution. The second 12-week randomized, double-blind trial was conducted to evaluate the efficacy and safety of switching subjects from CFC 11/12-propelled albuterol to Ventolin HFA. WARNING: Do not exceed the dose prescribed by your doctor. Glaxo Wellcome Inc, Research Triangle Park, NC 27709, September 1998 RL-634. Drug information provided by: Merative, Micromedex US Brand Name. In the second trial, Ventolin HFA 90 mcg (n = 29), Ventolin HFA 180 mcg (n = 29), and placebo HFA (n = 28) were administered to children aged between birth and 24 months. Common side effects of Ventolin include migraine headaches, non- migraine headaches, nausea, stomach upset, flu-like symptoms, cold symptoms, ear infections ( otitis media ), bronchitis, cough, allergic reactions ( rash, hives, itching ), nervousness, tremor, wheezing, increased sputum, and shortness of breath. Serial FEV1 measurements demonstrated that 2 inhalations of Ventolin HFA produced significantly greater improvement in pulmonary function than placebo. Ranges correspond to the average of the 50th percentile weight for boys and girls at the ages indicated. Each actuation delivers 108 mcg of albuterol sulfate equivalent to 90 mcg albuterol base from the mouthpiece. The action of VENTOLIN Inhalation Solution may last up to 6 hours or longer. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. Shake the inhaler well before each spray. In each of these trials, 2 inhalations of Ventolin HFA produced significantly greater improvement in FEV1 over the pretreatment value than placebo. If such effects occur, Ventolin HFA may need to be discontinued. At this point, the treatment is finished. Avoid spraying in eyes. Inform patients that the action of Ventolin HFA should last up to 4 to 6 hours. Common side effects of vardenafil include headache, flushing, and stuffy nose. How to take Levitra? The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Adult and Adolescent Subjects Aged 12 Years and Older. Animal Data: In a study in pregnant mice, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure less than the MRHDID for adults (on a mg/m2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the MRHDID (on a mg/m2 basis at a maternal dose of 2.5 mg/kg). It may harm them. Side effects Interactions Dosage FAQ What is Ventolin? The use of VENTOLIN Inhalation Solution can be continued as medically indicated to control recurring bouts of bronchospasm. The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. heart problems, including faster heart rate and higher blood pressure. Repeated dosing with 0.15 mg/kg of albuterol inhalation solution in children aged 5 to 17 years who were initially normokalemic has been associated with an asymptomatic decline of 20% to 25% in serum potassium levels. What is albuterol sulfate and can I take it if I'm allergic to sulfa? Disease-Associated Maternal and/or Embryofetal Risk: Medication Delivered per Actuation (mcg/kg). GlaxoSmithKline, Research Triangle Park, NC 27709. It is therefore essential that the physician instruct the patient in the need for further evaluation if his/her asthma becomes worse. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. worsening trouble breathing, coughing, and wheezing (paradoxical bronchospasm). Instruct patients to 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. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay. The counter starts at 204 or 064 and counts down each time a spray is released. To avoid microbial contamination, proper aseptic techniques should be used each time the bottle is opened. VENTOLIN Inhalation Solution can produce paradoxical bronchospasm, which may be life threatening. Sit in a comfortable, upright position; place the mouthpiece in your mouth (Figure 4) (or put on the face mask); and turn on the compressor. The data from adults and adolescents is based upon 2 clinical trials in which 202 subjects with asthma aged 12 years and older were treated with Ventolin HFA 2 inhalations 4 times daily for 12 weeks duration. Ventolin side effects are the same or similar to those of other salbutamol inhalers. The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. There are no available data on the presence of albuterol or the components of Ventolin HFA in human milk, the effects on the breastfed child, or the effects on milk production. Squeeze the solution into the nebulizer reservoir through the appropriate opening, taking care not to touch the tip of the dropper (Figure 2). 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