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AA-THEO LA is a brand name for Theophylline, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AA-THEO LA (theophylline) Tablets are indicated for: Symptomatic treatment of reversible bronchospasm associated with asthma, chronic bronchitis, emphysema and related bronchospastic disorders in patients 12 years and older. 1.1 Pediatrics Pediatrics (<12 years of age): The use of AA-THEO LA in children under the age…
Verbatim from this product's HC label. Tap a section to expand.
and 7 WARNINGS AND PRECAUTIONS). 2 CONTRAINDICATIONS AA-THEO LA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see Dosage Forms, Strengths, Composition and Packaging. AA-THEO LA (theophylline sustained release tablets) should not be administered in patients with: - hypersensitivity to theophylline, xanthines derivative, or the excipients used in these drug products, or component of the container.
- coronary artery disease (where cardiac stimulation might prove harmful) - peptic ulcers - concomitant use with ephedrine in children 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Theophylline clearance can be changed by various disease states, as well as by the age of the patient, concomitant use of other medications and lifestyle habits.
Serum theophylline levels should be monitored in patients (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). Serious side effects associated with overdosage include tachycardia, arrhythmia, seizures, vascular collapse and even death may occur without warning and may not be preceded by less severe symptoms such as nausea and restlessness.
Use with caution in patients with severe cardiac disease, severe hypoxemia, hypertension, hyperthyroidism, acute myocardial injury, cor pulmonale, congestive heart failure, liver disease, in the elderly (especially males). 1 Dosing Considerations Therapeutic serum levels are generally considered to be between 10 and 20 mcg/mL (55 mcmol/L and 110 mcmol/L).
Due to variable rates of elimination, there is patient-to-patient variation in dosage needed to achieve a therapeutic serum level. Because of the variation from patient to patient, the variation within the same patient, and the relatively narrow therapeutic range, dosage should be individualized.
Monitoring of serum theophylline concentrations is also extremely important, especially in the initial stages of therapy (see 7 WARNINGS AND PRECAUTIONS). It is preferable to monitor peak concentrations rather than trough concentrations.
Therefore, blood samples should be drawn 4-8 hours after AA-THEO LA dosing. It should be ascertained that all doses have been taken for 60 hours prior to blood sampling (steady state is usually achieved within 3 days). Depending on the sensitivity of the assay method used, dietary xanthines may interfere with assay results.
1 Adverse Reaction Overview The most common adverse reactions are gastric irritation, nausea, vomiting, epigastric pain, headache and tremor. These are usually early signs of toxicity; however, with high doses cardiac arrhythmias or seizures may be the first signs to appear.
Adverse reactions reported with classified by body system include:
Gastrointestinal: Abdominal pain, nausea, vomiting, epigastric pain, hematemesis, diarrhea, anorexia, reactivation of peptic ulcer, intestinal bleeding. Central Nervous System: headaches, irritability, restlessness, insomnia, hyperactivity, reflex hyperexcitability, muscle twitching and tremors, clonic and tonic generalized convulsions.
Cardiovascular: palpitation, atrial tachycardia, extrasystoles, flushing, hypotension, circulatory failure, life-threatening ventricular arrhythmias.
Skin and Subcutaneous:
Prurtius and rash.
Immune:
Anaphlactic reaction, anaphylactoid reaction and hypersensitivity. Respiratory: tachypnea.
Psychiatric:
Agitation, anxiety, insomnia and sleep disorder. PrAA-THEO LA Page 11 of 24 Renal: albuminuria, diuresis, hematuria and urinary retention. Others: hyperuricemia, hyperglycemia and inappropriate ADH syndrome.
). 2 CONTRAINDICATIONS AA-THEO LA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
AA-THEO LA (theophylline sustained release tablets) should not be administered in patients with: - hypersensitivity to theophylline, xanthines derivative, or the excipients used in these drug products, or component of the container.
- coronary artery disease (where cardiac stimulation might prove harmful) - peptic ulcers - concomitant use with ephedrine in children 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Theophylline clearance can be changed by various disease states, as well as by the age of the patient, concomitant use of other medications and lifestyle habits.
Serum theophylline levels should be monitored in patients (see 7 WARNINGS AND PRECAUTIONS and 9 DRUG INTERACTIONS). Serious side effects associated with overdosage include tachycardia, arrhythmia, seizures, vascular collapse and even death may occur without warning and may not be preceded by less severe symptoms such as nausea and restlessness.
Use with caution in patients with severe cardiac disease, severe hypoxemia, hypertension, hyperthyroidism, acute myocardial injury, cor pulmonale, congestive heart failure, liver disease, in the elderly (especially males). 1 Dosing Considerations Therapeutic serum levels are generally considered to be between 10 and 20 mcg/mL (55 mcmol/L and 110 mcmol/L).
Due to variable rates of elimination, there is patient-to-patient variation in dosage needed to achieve a therapeutic serum level. Because of the variation from patient to patient, the variation within the same patient, and the relatively narrow therapeutic range, dosage should be individualized.
AA-THEO LA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
AA-THEO LA (theophylline sustained release tablets) should not be administered in patients with: - hypersensitivity to theophylline, xanthines derivative, or the excipients used in these drug products, or component of the container.
- coronary artery disease (where cardiac stimulation might prove harmful) - peptic ulcers - concomitant use with ephedrine in children
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Theophylline in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
If a dosage increase is not tolerated, dosage should be reduced to the previously tolerated level. Do not attempt to maintain dosage which is not tolerated or which produces serum concentrations above the therapeutic range. Elderly patients are at a greater risk of experiencing serious toxic effects from theophylline than younger patients.
Careful attention to dose reduction and monitoring of serum theophylline concentrations are required in elderly patients due to pharmacokinetic and pharmacodynamic changes associated with aging, including the potential for decreased theophylline clearance.
2 Recommended Dose and Dosage Adjustment Adults: The usual initial adult dose is 200-300 mg every 12 hours. This dose may be increased by 50-100 mg every 12 hours at 3 day intervals until a satisfactory response is obtained or toxic effects appear.
Dosage adjustments should be based upon serum theophylline concentration and/or upon the patient's clinical response. However, doses of 450 mg every 12 hours or higher (900mg/day) should not be given unless serum theophylline concentration can be monitored.
It should not be necessary to exceed a daily dose of 16 mg/kg in adult patients. Even with serum level monitoring, this dose may lead to side effects because of day-to-day variations in blood levels within individual patients.
Children:
The use of AA-THEO LA in children under the age of twelve years is not recommended. 4 Administration AA-THEO LA tablets should be swallowed whole. Do not break, chew or crush.
Monitoring of serum theophylline concentrations is also extremely important, especially in the initial stages of therapy (see 7 WARNINGS AND PRECAUTIONS). It is preferable to monitor peak concentrations rather than trough concentrations.
Therefore, blood samples should be drawn 4-8 hours after AA-THEO LA dosing. It should be ascertained that all doses have been taken for 60 hours prior to blood sampling (steady state is usually achieved within 3 days). Depending on the sensitivity of the assay method used, dietary xanthines may interfere with assay results.
If a dosage increase is not tolerated, dosage should be reduced to the previously tolerated level. Do not attempt to maintain dosage which is not tolerated or which produces serum concentrations above the therapeutic range. Elderly patients are at a greater risk of experiencing serious toxic effects from theophylline than younger patients.
Careful attention to dose reduction and monitoring of serum theophylline concentrations are required in elderly patients due to pharmacokinetic and pharmacodynamic changes associated with aging, including the potential for decreased theophylline clearance.
2 Recommended Dose and Dosage Adjustment Adults: The usual initial adult dose is 200-300 mg every 12 hours. This dose may be increased by 50-100 mg every 12 hours at 3 day intervals until a satisfactory response is obtained or toxic effects appear.
Dosage adjustments should be based upon serum theophylline concentration and/or upon the patient's clinical response. However, doses of 450 mg every 12 hours or higher (900mg/day) should not be given unless serum theophylline concentration can be monitored.
It should not be necessary to exceed a daily dose of 16 mg/kg in adult patients. Even with serum level monitoring, this dose may lead to side effects because of day-to-day variations in blood levels within individual patients.
Children:
The use of AA-THEO LA in children under the age of twelve years is not recommended. 4 Administration AA-THEO LA tablets should be swallowed whole. Do not break, chew or crush. 5 OVERDOSAGE Overdoses of theophylline may cause serious side effects such as tachycardia, arrhythmias, seizures, vascular collapse and even death.
These may occur without warning and may not be preceded by less severe side effects such as nausea or restlessness. PrAA-THEO LA Page 6 of 24 Symptoms Insomnia, restlessness, mild excitement or irritability, and rapid pulse, are early symptoms which may progress to mild delirium.
Sensory disturbances such as tinnitus or flashes of light are common. Anorexia, nausea and vomiting are frequently early observations of theophylline overdosage. Fever, diuresis, dehydration and extreme thirst may be seen. Severe poisoning results in bloody, syrup- like 'coffee-ground' vomitus, tremors, tonic extensor spasm interrupted by clonic convulsions, extrasystoles, quickened respiration, stupor and finally coma.
Cardiovascular disorders and respiratory collapse, leading to shock, cyanosis and death follow gross overdosages. Treatment A. Monitoring serum theophylline levels Following intake of theophylline sustained-release tablets, the blood theophylline peak levels may not show until 5-8 hours post-ingestion in adults.
Patients ingesting overdoses of sustained-release theophylline formulations may have, after the initial rise in blood theophylline, also a secondary increase in theophylline levels. One report on fatal self- poisoning has attributed this to compacted tablet masses in the gastrointestinal tract.
Careful clinical and laboratory monitoring of stabilized patients is advisable. B. If potential oral overdose is established and seizure has not occurred: 1) Administration of oral activated charcoal has been found to reduce high theophylline serum concentrations.
Multiple doses of activated charcoal should be also considered. Seizure prophylaxis may be indicated for certain patients. 2) Administer a cathartic (this is particularly important when a sustained-release preparation has been […]