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Generic Names: Albuterol Brand names: Salbutamol, Aerolin, Airomir, Asmasal, Asmaven, Maxivent, Salamol, Salbulin, Ventodisks, Ventolin, Volmax, Proventil| Product | Qty | Price | Medical Fees & Shipping | Price/ Qty | Click to Order |
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| Ventolin 4mg | 100 | $34.31 | $10.95 | $0.34 | Buy from PharmaWebCanada |
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Ventolin Information
Brand Names: Ventolin, Proventil
Generic Name: Albuterol
Other Names: Salbutamol
Ventolin (albuterol) is used for asthma relief.
Indications
Inhalation Aerosol and Capsules for Inhalation: Albuterol inhalation aerosol is indicated for the prevention and relief of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. The capsules for inhalation formulation is particularly useful in patients who are unable to properly use the pressurized aerosol form of albuterol or who prefer an alternative formulation.
Albuterol inhalation aerosol can be used with or without concomitant steroid therapy.
Inhalation Solution: Albuterol inhalation solution is indicated for the relief of bronchospasm in patients 2 years of age or older with reversible obstructive airway disease and acute attacks of bronchospasm.
Ventolin Ingredients and Composition
The active component of Ventolin is albuterol racemic (a1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-a,a-diol) and a relatively selective beta2-adrenergic bronchodilator. The molecular weight is 239.3 and the empirical formula is C13H21NO3. Albuterol is a white to off-white crystalline solid. It is soluble in ethanol, sparingly soluble in water, and very soluble in chloroform.
Ventolin inhalation aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It contains a microcrystalline (95% <10 mcm) suspension of albuterol in propellants (trichloromonofluoromethane and dichlorodifluoromethane) with oleic acid. Each Ventolin actuation delivers 100 mcg of albuterol from the valve and 90 mcg of albuterol from the mouthpiece. Each 6.8-g canister provides 80 inhalations and each 17-g canister provides 200 inhalations.
How Does Ventolin Work?
Clinical Pharmacology
In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol, the active ingredient of Ventolin, has a preferential effect on beta2-adrenergic receptors compared with isoproterenol. While it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart existing in a concentration between 10% and 50%. The precise function of these receptors has not been established.
The pharmacologic effects of beta-adrenergic agonist drugs, including albuterol, are at least in party attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyclic-3,5-adenosine monophosphate (cyclic AMP). Increased cyclic AMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.
Albuterol, the active ingredient in Ventolin, 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.
Controlled Ventolin clinical studies and other clinical experience have shown that inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.
Albuterol, the active ingredient in Ventolin, is longer acting than isoproterenol in most patients by any route of administration because it is not a substrate for the cellular uptake processes for catecholamines nor for catechol-O-methyl transferase.
How To Take Ventolin and Ventolin Dosage and Administration
Inhalation Aerosol
For treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms, the usual Ventolin dosage for adults and children 4 years of age and older is two inhalations repeated every 4 to 6 hours; in some patients, one Ventolin inhalation every 4 hours may be sufficient. More frequent administration or a larger number of inhalations are not recommended. It is recommended to test spray Ventolin inhalation aerosol. Do this by spraying four times into the air before using for the first time and when the inhaler has not been used for a prolonged period of time (i.e., more than 4 weeks).
The use of Ventolin (albuterol) inhalation aerosol can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhaler. Safe Ventolin usage for periods extending over several years has been documented.
If a previously effective Ventolin dosage regimen fails to provide the usual response, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment (e.g., corticosteroids).
Exercise-Induced Bronchospasm Prevention: The usual Ventolin dosage for adults and children 4 years and older is two inhalations 15 minutes before exercise.
For treatment, see above.
Ventolin Inhalation Solution, 0.5%
To avoid microbial contamination, proper aseptic techniques should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the Ventolin solution changes color or becomes cloudy, it should not be used.
Adults and Children Over 12 Years of Age: The usual Ventolin dosage for adults and children 12 years of age and older is 2.5 mg of albuterol administered three to four times daily by nebulization. More frequent administration or higher Ventolin doses are not recommended. To administer 2.5 mg of Ventolin (albuterol), dilute 0.5 ml of the 0.5% inhalation solution with 2.5 ml of sterile normal saline solution. The flow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution will be delivered over approximately 5 to 15 minutes.
The use of albuterol sulfate inhalation solution 0.5% can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the inhalation solution.
If a previously effective Ventolin 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.
Drug compatibility (physical and chemical), efficacy, and safety of albuterol inhalation solution 0.5% when mixed with other drugs in a nebulizer have not been established.
Inhalation Solution, 0.083%
Adults and Children 2 to 12 Years of Age: The usual Ventolin dosage for adults and children weighing at least 15 kg is 2.5 mg of albuterol (one Ventolin Nebule) administered three to four times daily by nebulization. Children weighing less than 15 kg who require less than 2.5 mg/dose (i.e., less than a full Ventolin Nebule) should use albuterol inhalation solution 0.5% instead of 0.083%. More frequent administration or higher Ventolin doses are not recommended. To administer 2.5 mg of albuterol, administer the contents of one sterile unit dose Nebule (3 ml of 0.083% inhalation solution) by nebulization. The wflow rate is regulated to suit the particular nebulizer so that albuterol inhalation solution 0.083% will be delivered over approximately 5 to 15 minutes.
The use of albuterol inhalation solution 0.083% can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimal benefit from regular use of the Ventolin.
If a previously effective Ventolin 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.
Drug compatibility (physical and chemical), efficacy, and safety of albuterol inhalation solution 0.083% when mixed with other drugs in a nebulizer have not been established.
If you suspect a Ventolin Overdose
The expected symptoms with Ventolin overdoe are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under side effects (e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness.) Hypokalemia may also occur. Ventolin Inhalation Solution Only: In isolated cases in children 2 to 12 years of age, tachycardia with rates >200 beats/min has been observed.
As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Ventolin (albuterol). Treatment consists of discontinuation of Ventolin (albuterol) together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-recptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Ventolin (albuterol).
The oral median lethal dose of Ventolin active ingredient, 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 inhalation dose for children on a mg/m2 basis for Ventolin inhalation solution, and approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation aerosol or approximately 3400 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 1600 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation capsules). In mature rats, the subcutaneous median lethal dose of Ventolin active ingredient, albuterol sulfate is approximately 450 mg/kg (approximately 365 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 135 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation solution and approximately 3000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 1400 times the maximum recommended daily Ventolin inhalation dose for children on a mg/m2 basis for inhalation aerosol or approximately 1500 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 1700 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation capsules). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 1600 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 600 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation solution and approximately 14,000 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 6400 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation aerosol or approximately 6800 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis or approximately 3200 times the maximum recommended daily inhalation dose for children on a mg/m2 basis for inhalation capsules). The inhalational median lethal dose has not been determined in animals.
Dialysis is not appropriate treatment for overdosage of albuterol capsules for inhalation.
Ventolin Side Effects
Ventolin side effects may include:
- urticaria
- angioedema
- rash
- bronchospasm
- hoarseness
- oropharyngeal edema
- arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)
There may be additional Ventolin side effects.
Ventolin Precautions and Contraindications
General
Provientil (albuterol), as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, albuterol in Ventolin may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation. Inhalation Aerosol and Inhalation Solutions: Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after use of any beta-adrenergic bronchodilator.
Ventolin Warnings
Paradoxical Bronchospasm: Albuterol in Ventolin can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new canister or vial. Solutions: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs and with the home use of nebulizers. It is therefore essential that the physician instruct the patient in the need for further evaluation if his/her asthma becomes worse.
Cardiovascular Effects: Albuterol in Ventolin, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of Ventolin (albuterol) at recommended doses, if they occur, the drug may need to be discontinued. 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. The clinical significance of these findings is unknown. Therefore, Ventolin (albuterol), like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Deterioration of Asthma: Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Ventolin (albuterol) than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, (e.g., corticosteroids).
Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of Ventolin (albuterol), as demonstrated by rare cases or urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema and, for inhalation aerosol and capsules for inhalation, anaphylaxis.
Use of Anti-Inflammatory Agents: The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents (e.g., corticosteroids).
Additional Information for Inhalation Aerosol
The contents of Ventolin (albuterol) inhalation aerosol are under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children.
Additional Information for Inhalation Solution 0.05%
Microbial Contamination: To avoid microbial contamination, proper aseptic technique should be used each time the bottle is opened. Precautions should be taken to prevent contact of the dropper tip of the bottle with any surface, including the nebulizer reservoir and associated ventilatory equipment. In addition, if the solution changes color or becomes cloudy, it should not be used.
Additional Information for Inhalation Capsules
Inhalation of capsule particles may result if damage to the capsule has occurred from handling by the patient.
Ventolin Drug Interactions
Other short-acting sympathomimetic aerosol bronchodilators (and for inhalation solutions, epinephrine) should not be used concomitantly with Ventolin. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Ventolin should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated.
Beta-Blockers
Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as albuterol, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. 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. In this setting), cardioselective beta-blockers could be considered, although they should be administered with caution.
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. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.
Digoxin
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. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.
Ventolin Clinical Trials and Studies
Ventolin Inhalation Aerosol
In controlled Ventolin clinical trials involving adults with asthma, the onset of improvement in pulmonary function was within 15 minutes, as determined by both MMEF (maximum midexpiratory wflow rate) and FEV1 (forced expiratory volume in 1 second). MMEF measurements also showed that near maximum improvement in pulmonary function generally occurs within 60 to 90 minutes following two inhalations of Ventolin and that clinically significant improvement generally continues for 3 to 4 hours in most patients. Some patients showed a therapeutic response (defined by maintaining FEV1 values 15% or more above baseline) that was still apparent at 6 hours. Continued effectiveness of Ventolin was demonstrated over a 13-week period in these same trials.
In controlled Ventolin clinical trials involving children 4 to 12 years of age, FEV1 measurements showed that maximum improvement in pulmonary function occurs within 30 to 60 minutes. The onset of clinically significant (>15%) improvement in FEV1 was observed as soon as 5 minutes following 180 mcg of albuterol in 18 of 30 (60%) children in a controlled dose-ranging study. Clinically significant improvement in FEV1 continued in the majority of patients for 2 hours and in 33% to 47% for 4 hours among 56 patients receiving inhalation aerosol in one pediatric study. In a second study among 48 patients receiving Ventolin inhalation aerosol, clinically significant improvement continued in the majority for up to 1 hour and in 23% to 40% for 4 hours. In addition, at least 50% of the patients in both studies achieved an improvement in FEF25%-75% (forced expiratory wflow rate between 25% and 75% of the forced vital capacity) of at least 20% for 2 to 5 hours. Continued effectiveness of albuterol was demonstrated over the 12-week study period.
In other Ventolin clinical studies in adults and children, two inhalations of albuterol inhalation aerosol taken approximately 15 minutes before exercise prevented exercise-induced bronchospasm, as demonstrated by the maintenance of FEV1 within 80% of baseline values in the majority of patients. One study in adults also evaluated the duration of the prophylactic effect to repeated exercise challenges, which was evident at 4 hours in the majority of patients and at 6 hours in approximately one third of the patients.
Inhalation Solution
In controlled Ventolin clinical trials in adults, most patients exhibited an onset of improvement in pulmonary function within 5 minutes as determined by FEV1. FEV1 measurements also showed that the maximum average improvement in pulmonary function usually occurred at approximately 1 hour following inhalation of 2.5 mg of albuterol by compressor-nebulizer and remained close to peak for 2 hours. Clinically significant improvement in pulmonary function (defined as maintenance of a 15% or more increase in FEV1 over baseline values) continued for 3 to 4 hours in most patients, with some patients continuing up to 6 hours.
Published reports of Ventolin trials in asthmatic children aged 3 years or older have demonstrated significant improvement in either FEV1 or PEFR within 2 to 20 minutes following single doses of albuterol inhalation solution. An increase of 15% or more in baseline FEV1 has been observed in children aged 5 to 11 years up to 6 hours after treatment with doses of 0.10 mg/kg or higher of albuterol inhalation solution. Single doses of 3, 4, or 10 mg resulted in improvement in baseline PEFR that was comparable in extent and duration to a 2-mg dose, but Ventolin doses above 3 mg were associated with heart rate increases of more than 10%.
Capsules for Inhalation
In single, dose-range, crossover trials with Ventolin capsules for inhalation in patients 12 years of age and older, the onset of improvement in pulmonary function was within 5 minutes as determined by a 15% increase in forced expiratory volume in 1 second (FEV1) following administration of either a 200- or 400-mcg dose. Maximum increases in FEV1 occurred within 60 minutes following inhalation of either dose. The duration of effect (defined as an increase in FEV1 of 15% or greater in a single-dose study) was 1 to 2 hours after the 200-mcg dose and 3 to 4 hours after the 400 mcg dose. In a single-dose study, an increase in forced expiratory flow rate between 25% and 75% of the forced vital capacity (FEF25%-75%) of 20% or greater continued for 3 to 4 hours after the 200-mcg dose and for 3 to 6 hours following the 400 mcg dose. A therapeutic response continued for 4 hours in the majority of patients and for 6 hours in 38% of the patients following the 400-mcg dose. Twenty-two percent of the patients receiving the 200-mcg dose had a duration of effect of 8 hours.
In 12-week, double-blind, comparative Ventolin evaluations in patients 12 years of age and older of one 200-mcg albuterol capsule for inhalation versus two inhalations of albuterol inhalation aerosol, the two dosage regimens were found to be clinically comparable. Based on a 15% or more increase in FEV1 determinations, both provided a therapeutic response that persisted for 2 or 3 hours in 50% of 231 patients aged 12 years and older. Similar results were found in two controlled, 12-week clinical trials involving 204 children aged 4 to 11 years. Both formulations produced a therapeutic response (defined as maintenance of mean increase over baseline of at least 15% in FEV1, or 20% in FEF25%- 75%). Therapeutic improvement of FEF25%-75% persisted for 3 to 5 hours in over 50% of the children throughout the study. Continued effectiveness and safety of albuterol capsules for inhalation were demonstrated over the 12-week study periods in both adults and children.
In other clinical Ventolin studies in adults and children, one 200-mcg albuterol capsule for inhalation taken approximately 15 minutes before exercise prevented exercise-induced bronchospasm, as demonstrated by the maintenance of FEV1 within 80% of baseline values in the majority of patients. One study in adults also evaluated the duration of the prophylactic effect to repeated exercise challenges, which was evident at 4 hours in the majority of patients and at 6 hours in approximately one third of the patients.
Storing Ventolin
Store Ventolin between 2-25°C (36-77°F).
Additional Patient Information for Ventolin
The action of Ventolin may last up to 6 hours or longer. Ventolin should not be used more frequently than recommended. Do not increase the dose or frequency of Ventolin without consulting your physician. If you find that treatment with Ventolin becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, you should seek medical attention immediately. While you are using Ventolin, other inhaled drugs and asthma medications should be taken only as directed by your physician. Common adverse effects include palpitations, chest pain, rapid heart rate, and tremor or nervousness. If you are pregnant or nursing, contact your physician about use of Ventolin. Effective and safe use of Ventolin includes an understanding of the way that it should be administered.
Additional Notes
The World Health Organization recommended name for albuterol base is salbutamol.
Credits for Ventolin Information
Ventolin information on this page is copyright by Drug Information at Pharma-Help.com, reprinted with Permission. All Rights Reserved. Other pages with reprint permission include Ventolin. Additional encyclopaedic information: Ventolin.