Albuterol Side Effects - for the Professional
Albuterol
In clinical trials, the most frequent adverse reactions to Albuterol tablets were:
Percent Incidence of Adverse Reactions
Reaction Percent Incidence |
|
| Central nervous system | |
| Nervousness | 20% |
| Tremor | 20% |
| Headache | 7% |
| Sleeplessness | 2% |
| Weakness | 2% |
| Dizziness | 2% |
| Drowsiness | <1% |
| Restlessness | <1% |
| Irritability | <1% |
| Cardiovascular | |
| Tachycardia | 5% |
| Palpitations | 5% |
| Chest discomfort | <1% |
| Flushing | <1% |
| Musculoskeletal | |
| Muscle cramps | 3% |
| Gastrointestinal | |
| Nausea | 2% |
| Genitourinary | |
| Difficulty in micturition | <1% |
In addition, Albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.
The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with Albuterol tablets. In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage.
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Less frequent adverse reactions are muscle cramps, insomnia, nausea, weakness, dizziness, drowsiness, flushing, restlessness, irritability, chest discomfort, and difficulty in micturition.
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of Albuterol.
In addition, Albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.
In controlled clinical trials of adult patients conducted in the United States, the following incidence of adverse events was reported:
A trend was observed among patients treated with Albuterol sulfate
extended-release tablets toward increasing frequency of muscle cramps
with increasing patient age (12 to 20 years, 1.2%; 21 to 30 years, 2.6%;
31 to 40 years, 6.9%; 41 to 50 years, 6.9%), compared with no such
events in the placebo group. Also observed was an increasing frequency
of tremor with increasing patient age (12 to 20 years, 29.4%; 21 to 30
years, 29.9%; 31 to 40 years, 27.6%; 41 to 50 years, 37.9%), compared to
2.9% or less in the placebo group.
The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with Albuterol sulfate extended-release tablets.
TopAlbuterol Extended-release tablets
The adverse reactions to Albuterol are similar in nature to reactions to other sympathomimetic agents.
The most frequent adverse reactions to Albuterol are nervousness, tremor, headache, tachycardia, and palpitations.Less frequent adverse reactions are muscle cramps, insomnia, nausea, weakness, dizziness, drowsiness, flushing, restlessness, irritability, chest discomfort, and difficulty in micturition.
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of Albuterol.
In addition, Albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx.
In controlled clinical trials of adult patients conducted in the United States, the following incidence of adverse events was reported:
| Albuterol Sulfate Extended-Release Tablets | Theophylline | Other Beta-Agonists | Placebo | |
| Event | (n = 330) | (n = 197) | (n = 20) | (n = 178) |
| Tremor | 24.2% | 6.1% | 35% | 1.1% |
| Headache | 18.8% | 26.9% | 35% | 20.8% |
| Nervousness | 8.5% | 5.1% | 10% | 2.8% |
| Nausea/Vomiting | 4.2% | 19.8% | 5% | 3.9% |
| Tachycardia | 2.7% | 0.5% | 5% | 0% |
| Muscle Cramps | 2.7% | 0.5% | 5% | 0.6% |
| Palpitations | 2.4% | 0.5% | 0% | 1.1% |
| Insomnia | 2.4% | 6.1% | 0% | 1.7% |
| Dizziness | 1.5% | 2% | 0% | 5.1% |
| Somnolence | 0.3% | 1% | 0% | 0.6% |
The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with Albuterol sulfate extended-release tablets.
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Side Effects by Body System - for Healthcare Professionals
General
Albuterol is generally well-tolerated and adverse effects seen are consistent with its pharmacological activity. In general, the severity of these adverse effects is dependent on the dose and route of administration. Administration by metered-dose inhaler (MDI) is associated with less systemic effects than administration of higher dosages orally or by nebulizer. Tolerance may develop to the adverse effects of albuterol.Cardiovascular
Changes in heart rate of approximately 20% may be produced by 0.18 mg of albuterol by MDI. Aggravation of angina may be due to tachycardia produced by albuterol. Atrial fibrillation was reported in one patient when a spacer device was utilized with an albuterol inhaler, thus increasing the available dose for systemic absorption. Supraventricular ectopic beats and ventricular tachycardia have also been reported. Higher doses of albuterol should be used with caution in patients with cardiac disease, arrhythmias, or hypertension. All of these effects are dose-related and lower doses may be tolerated.The cardiovascular side effects have included palpitations, peripheral vasodilatation and reflex tachycardia with blood pressure increasing or decreasing. Albuterol in higher dosages has been reported to aggravate angina, myocardial ischemia, or cause atrial or ventricular arrhythmias. Pulmonary edema has been reported in pregnant patients receiving intravenous albuterol. Postmarketing reports have included hypotension.
Musculoskeletal
Musculoskeletal side effects have included tremors, particularly at higher dosages. Tolerance can develop to the tremorogenic effects. Severe muscle cramping may occur infrequently.Metabolic
Following doses of 15 mg albuterol via nebulizer, hyperkalemic patients on hemodialysis experienced a 0.9 mEq/L decrease in plasma potassium which was sustained for 6 hours. Albuterol may stimulate sodium-potassium ATPase, resulting in an intracellular shift of potassium.Transient lactic acidosis has been reported after administration of inhaled albuterol for an asthma attack.
Metabolic side effects have included hypokalemia, and less commonly, hyperglycemia and lactic acidosis. Postmarketing reports have included metabolic acidosis. Diabetic ketoacidosis has been reported due to overdose of albuterol.
Nervous system
Nervous system side effects have included restlessness, anxiety, nervousness, irritability, and insomnia. Postmarketing reports have included tremor.Psychiatric
Psychiatric side effects have included psychoses presenting as auditory hallucinations and persecutory delusions. These effects are generally associated with higher dosages.Other
Concern over the development of tachyphylaxis to the bronchodilating effects of albuterol has been expressed. Although conflicting data exist, complete tolerance has not been reported.Respiratory
Respiratory side effects have included paradoxical bronchospasm.Top
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