DRUGS & SUPPLEMENTS
Airomol usesAiromol consists of Albuterol, Oxtriphylline.
INDICATIONS AND USAGE
Airomol (Albuterol) tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.
Airomol (Albuterol) tablets are contraindicated in patients with a history of hypersensitivity to Airomol (Albuterol), or any of its components.
Airomol tablets can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, Airomol (Albuterol) tablets should be discontinued immediately and alternative therapy instituted.
Airomol (Albuterol) tablets, 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 Airomol (Albuterol) tablets 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, Airomol (Albuterol) tablets, 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 Airomol tablets 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.
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.
Immediate Hypersensitivity Reactions
Immediate hypersensitivity reactions may occur after administration of Airomol (Albuterol), as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema. Airomol (Albuterol), like other beta-adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.
Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral Airomol (Albuterol) sulfate in children.
Airomol, 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. 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.
Large doses of intravenous Airomol (Albuterol) have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, Airomol (Albuterol) 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.
Information for Patients
The action of Airomol (Albuterol) tablets may last up to 8 hours or longer. Airomol (Albuterol) tablets should not be taken more frequently than recommended. Do not increase the dose or frequency of Airomol (Albuterol) tablets without consulting your physician. If you find that treatment with Airomol (Albuterol) tablets becomes less effective for symptomatic relief, your symptoms get worse, and/or you need to take the product more frequently than usual, you should seek medical attention immediately. While you are taking Airomol (Albuterol) tablets, other asthma medications and inhaled drugs 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 Airomol (Albuterol) tablets. Effective and safe use of Airomol (Albuterol) tablets includes an understanding of the way that it should be administered.
The concomitant use of Airomol tablets and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving Airomol (Albuterol) tablets. Such concomitant use, however, should be individualized and not given on a routine basis. If regular coadministration is required, then alternative therapy should be considered.
Monoamine Oxidase Inhibitors or Tricyclic Antidepressants
Airomol (Albuterol) 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 Airomol (Albuterol) on the vascular system may be potentiated.
Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Airomol (Albuterol) tablets, 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.
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.
Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of Airomol (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 Airomol (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 Airomol (Albuterol).
Carcinogenesis, Mutagenesis, Impairment Of Fertility
In a 2-year study in Sprague-Dawley rats, Airomol (Albuterol) sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at dietary doses of 2, 10, and 50 mg/kg (approximately 1/2, 3 and 15 times, respectively, the maximum recommended daily oral dose for adults on a mg/m2 basis, or, 2⁄5, 2 and 10 times, respectively, the maximum recommended daily oral dose for children on a mg/m2 basis). In another study this effect was blocked by the coadministration of propranolol, a non-selective beta-adrenergic antagonist.
In an 18-month study in CD-1 mice Airomol (Albuterol) sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg, (approximately 65 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 50 times the maximum recommended daily oral dose for children on a mg/m2 basis). In a 22-month study in the Golden hamster Airomol (Albuterol) sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg, (approximately 8 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 7 times the maximum recommended daily oral dose for children on a mg/m2 basis).
Airomol (Albuterol) sulfate was not mutagenic in the Ames test with or without metabolic activation using tester strains S. typhimurium TA1537, TA1538, and TA98 or E. Coli WP2, WP2uvrA, and WP67. No forward mutation was seen in yeast strain S. cerevisiae S9 nor any mitotic gene conversion in yeast strain S. cerevisiae JD1 with or without metabolic activation. Fluctuation assays in S. typhimurium TA98 and E. Coli WP2, both with metabolic activation, were negative. Airomol (Albuterol) sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay at intraperitoneal doses of up to 200 mg/kg.
Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximately 15 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
Teratogenic Effects. Pregnancy Category C
Airomol has been shown to be teratogenic in mice. A study in CD-1 mice at subcutaneous (sc) doses of 0.025, 0.25, and 2.5 mg/kg, (approximately 3/1000, 3/100, and 3/10 times, respectively, the maximum recommended daily oral dose for adults on a mg/m2 basis), showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg. The drug did not induce cleft palate formation at the lowest dose, 0.025 mg/kg. Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated with 2.5 mg/kg of isoproterenol (positive control) subcutaneously (approximately 3/10 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when Airomol (Albuterol) was administered orally at a 50 mg/kg dose (approximately 25 times the maximum recommended daily oral dose for adults on a mg/m2 basis).
There are no adequate and well-controlled studies in pregnant women. Airomol (Albuterol) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been rarely reported in the offspring of patients being treated with Airomol (Albuterol). Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relationship between Airomol (Albuterol) use and congenital anomalies has not been established.
Use In Labor And Delivery
Because of the potential for beta-agonist interference with uterine contractility, use of Airomol (Albuterol) tablets for relief of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Airomol has not been approved for the management of preterm labor. The benefit/risk ratio when Airomol (Albuterol) is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta2-agonists, including Airomol (Albuterol).
It is not known whether this drug is excreted in human milk. Because of the potential for tumorigenicity shown for Airomol (Albuterol) in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in children below 6 years of age have not been established.
In clinical trials, the most frequent adverse reactions to Airomol (Albuterol) tablets were:
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of Airomol (Albuterol).
In addition, Airomol (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 Airomol (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.
The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under ADVERSE REACTIONS, 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. As with all sympathomimetic medications, cardiac arrest and even death may be associated with abuse of Airomol (Albuterol) tablets. Treatment consists of discontinuation of Airomol (Albuterol) tablets together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor 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 Airomol (Albuterol) tablets. The oral median lethal dose of Airomol (Albuterol) sulfate in mice is greater than 2000 mg/kg (approximately 250 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 200 times the maximum recommended daily oral dose for children on a mg/m2 basis). In mature rats, the subcutaneous (sc) median lethal dose of Airomol (Albuterol) sulfate is approximately 450 mg/kg (approximately 110 times the maximum recommended daily oral dose for adults on a mg/m2 basis or, approximately 90 times the maximum recommended daily oral dose for children on a mg/m2 basis). In small young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg (approximately 500 times the maximum recommended daily oral dose for adults on a mg/m2 basis, or, approximately 400 times the maximum recommended daily oral dose for children on a mg/m2 basis).
DOSAGE AND ADMINISTRATION
The following dosages of Airomol tablets are expressed in terms of Airomol (Albuterol) base.
Adults and Children Over 12 Years of Age
The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day.
Children 6 to 12 Years of Age
The usual starting dosage for children 6 to 12 years of age is 2 mg three or four times a day.
Adults and Children Over 12 Years of Age
For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated.
Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day
For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day.
Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators
An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day.
The total daily dose should not exceed 32 mg in adults and children 12 years and older.
Airomol (Albuterol) tablets, USP; 2 mg of Airomol (Albuterol) as the sulfate, are white, round, scored, debossed MP 47
Airomol (Albuterol) tablets, USP; 4 mg of Airomol (Albuterol) as the sulfate, are white, round, scored, debossed MP 88
Store at 20° to 25°C (68° to 77°F).
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
MUTUAL PHARMACEUTICAL CO., INC.
Philadelphia, PA 19124 USA
Rev 01, July 2009
Airomol (Albuterol) 4mg Tablet
Airomol (Oxtriphylline) is a cough medicine derived from xanthine and similar to theophylline, that acts as a bronchodilator to open up airways in the lung. It antagonizes adenosine receptors and promotes relaxation of airway smooth muscles. It is also thought to inhibit phosphodiesterases leading to higher levels of cAMP and increased bronchodilation.
Indication: Used to treat the symptoms of asthma, bronchitis, and emphysema.
Airomol (Oxtriphylline) is a bronchodilator. Airomol (Oxtriphylline) works in several ways: it relaxes muscles in your lungs and chest to allow more air in, decreases the sensitivity of your lungs to allergens and other substances that cause inflammation, and increases the contractions of your diaphragm to draw more air into the lungs.
Airomol pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Airomol available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Airomol destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Airomol Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Airomol pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Airomol?
Depending on the reaction of the Airomol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Airomol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Airomol addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
ReviewsDrugs.com conducted a study on Airomol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Airomol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
One visitor reported usefulHow is the drug Airomol useful in reducing or relieving the symptoms? How useful is it?
According to the survey conducted by the website sDrugs.com, there are variable results and below are the percentages of the users that say the medicine is useful to them and that say it is not helping them much. It is not ideal to continue taking the medication if you feel it is not helping you much. Contact your healthcare provider to check if there is a need to change the medicine or if there is a need to re-evaluate your condition. The usefulness of the medicine may vary from patient to patient, depending on the other diseases he is suffering from and slightly depends on the brand name.
One visitor reported side effectsDid you get side effects while taking the Airomol drug, or were there no side effects?
According to the survey conducted by website sDrugs.com users, the below-mentioned percentages indicate the number of people experiencing the side effects and the number of people not experiencing the side effects when taking Airomol medicine. Every drug produces minimal side effects, and they are negligible most times, when compared to the desired effect [use] of the medicine. Side effects depend on the dose you are taking, any drug interactions that happen when you are on other medications, if the patient is sensitive, and other associated conditions. If you cannot tolerate the side effects, consult your doctor immediately, so he can either adjust the dose or change the medication.
The information was verified by Dr. Arunabha Ray, MD Pharmacology