Etosal Tablet Uses

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Consists of Etophylline, Theophylline

Etophylline (Etosal Tablet) side effects

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Vomiting, Nausea, Restlessness, Nervousness, Frequent urge to urinate, Allergic reaction, Flushing, Diarrhoea, Abdominal pain, Headache, Insomnia, Irritation, Loss of appetite, Tremor

What is Theophylline (Etosal Tablet)?

Theophylline (Etosal Tablet) injection is used together with other medicines to treat the acute symptoms of asthma, bronchitis, emphysema, and other lung diseases in a hospital setting.

Theophylline (Etosal Tablet) belongs to a group of medicines known as bronchodilators. Bronchodilators are medicines that relax the muscles in the bronchial tubes (air passages) of the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

Theophylline (Etosal Tablet) is available only with your doctor's prescription.

Theophylline (Etosal Tablet) indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Oral

Acute bronchospasm

Adult: Patients not taking Theophylline (Etosal Tablet) or other xanthine medication: Loading dose: 5 mg/kg.

Child: ≥1 yr Same as adult dose.

Elderly: Lower doses should be used.

Hepatic impairment: Reduce dose.

Oral

Chronic bronchospasm

Adult: 300-1,000 mg in divided doses 6-8 hrly. As modified-release preparation: 175-500 mg 12 hrly.

Child: <6 yr Not recommended; 6-12 yr 20-35 kg: 120-250 mg bid; >12 yr 250-500 mg bid.

Elderly: Lower doses should be used.

Hepatic impairment: Reduce dose.

Intravenous

Acute severe bronchospasm

Adult: Patients not taking Theophylline (Etosal Tablet) or other xanthine medication: Loading dose: 4-5 mg/kg by infusion over 20-30 min. Maintenance dose: 0.4-0.6 mg/kg/hr.

Child: Patients not taking Theophylline (Etosal Tablet) or other xanthine medication: Loading dose: 4-5 mg/kg by infusion over 20-30 min. Maintenance dose: 1-9 yr Initially, 0.8-1 mg/kg/hr; >9-12 yr Initially, 0.7-0.77 mg/kg/hr.

Elderly: Lower doses should be used.

Hepatic impairment: Reduce dose.

Incompatibility: Y-site: Cefepime, hetastarch in normal saline, phenytoin, ceftazidime. Syringe: Ceftriaxone.

Special Populations: Reduce dose in patients w/ cor pulmonale, heart failure, liver disease and fever. Smokers and those who consume alcohol may require higher maintenance dose.

How should I use Theophylline (Etosal Tablet)?

Use Theophylline (Etosal Tablet) as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Theophylline (Etosal Tablet).

Uses of Theophylline (Etosal Tablet) in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Reversible airflow obstruction:

Oral: Treatment of symptoms and reversible airflow obstruction associated with chronic asthma, or other chronic lung diseases (eg, emphysema, chronic bronchitis).

Injection: Treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases (eg, chronic bronchitis, emphysema) as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids. Guideline recommendations:

Guideline recommendations:

Asthma: The 2019 Global Initiative for Asthma Guidelines (GINA) and the 2007 National Heart, Lung and Blood Institute Asthma Guidelines recommends against Theophylline (Etosal Tablet) as a long-term control medication for asthma in children ≤5 years of age. Additionally, GINA guidelines do not recommend Theophylline (Etosal Tablet) for asthma in children 6 to 11 years of age.

Oral Theophylline (Etosal Tablet) is a potential alternative option (not preferred) in adolescents and adults as a long-term control medication in mild asthma or as an add-on long-term control medication in moderate to severe asthma; however, a stepwise approach using inhaled corticosteroids (+/- inhaled long-acting beta agonists depending on asthma severity) is preferred to Theophylline (Etosal Tablet) due to efficacy concerns and potential for adverse events (GINA 2019). Both guidelines recommend against Theophylline (Etosal Tablet) for the treatment of asthma exacerbations due to poor efficacy and safety concerns (GINA 2019; NAEPP 2007).

COPD: Based on the Global Initiative for Chronic Obstructive Lung Disease Guidelines (2019), use of Theophylline (Etosal Tablet) in patients with COPD is controversial and lacks data. Theophylline (Etosal Tablet) may favorably impact functional impairment in COPD patients, but exact effects are unclear. Studies that demonstrated improvement were done with slow-release preparations. Theophylline (Etosal Tablet) is not a preferred agent for COPD exacerbations due to its potential for toxicity.

Off Label Uses

Bradycardia, heart transplantation

Data from small observational studies suggest that Theophylline (Etosal Tablet) may be beneficial for the treatment of bradycardia following heart transplantation.

Theophylline (Etosal Tablet) description

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Theophylline (Etosal Tablet) is a chiral compound. The racemic mixture can be divided into its optical antipodes: levo- and dextro-amphetamine. Theophylline (Etosal Tablet) is the parent compound of its own structural class, comprising a broad range of psychoactive derivatives, e.g., MDMA (Ecstasy) and the N-methylated form, methamphetamine. Theophylline (Etosal Tablet) is a homologue of phenethylamine.

Theophylline (Etosal Tablet) dosage

General Considerations

Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule) ®, like other extended-release Theophylline (Etosal Tablet) products, is intended for patients with relatively continuous or recurring symptoms who have a need to maintain therapeutic serum levels of Theophylline (Etosal Tablet). It is not intended for patients experiencing an acute episode of bronchospasm (associated with asthma, chronic bronchitis, or emphysema). Such patients require rapid relief of symptoms and should be treated with an immediate-release or intravenous Theophylline (Etosal Tablet) preparation (or other bronchodilators) and not with extended-release products.

Patients who metabolize Theophylline (Etosal Tablet) at a normal or slow rate are reasonable candidates for once-daily dosing with Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule) ®. Patients who metabolize Theophylline (Etosal Tablet) rapidly (e.g., the young, smokers, and some nonsmoking adults) and who have symptoms repeatedly at the end of a dosing interval, will require either increased doses given once a day or preferably, are likely to be better controlled by a schedule of twice-daily dosing. Those patients who require increased daily doses are more likely to experience relatively wide peak-trough differences and may be candidates for twice-a-day dosing with Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule) ®.

Patients should be instructed to take this medication each morning at approximately the same time and not to exceed the prescribed dose.

Recent studies suggest that dosing of extended-release Theophylline (Etosal Tablet) products at night (after the evening meal) results in serum concentrations of Theophylline (Etosal Tablet) which are not identical to those recorded during waking hours and may be characterized by early trough and delayed peak levels. This appears to occur whether the drug is given as an immediate-release, extended-release, or intravenous product. To avoid this phenomenon when two doses per day are prescribed, it is recommended that the second dose be given 10 to 12 hours after the morning dose and before the evening meal.

Food and posture, along with changes associated with circadian rhythm, may influence the rate of absorption and/or clearance rates of Theophylline (Etosal Tablet) from extended-release dosage forms administered at night. The exact relationship of these and other factors to nighttime serum concentrations and the clinical significance of such findings require additional study. Therefore, it is not recommended that

Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule) ® (when used as a once-a-day product) be administered at night.

Patients who require a relatively high dose of Theophylline (Etosal Tablet) (i.e., a dose equal to or greater than 900 mg or 13 mg/kg, whichever is less) should not take Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule) ® less than 1 hour before a high-fat-content meal since this may result in a significant increase in peak serum level and in the extent of absorption of Theophylline (Etosal Tablet) as compared to administration in the fasted state.

The steady-state peak serum Theophylline (Etosal Tablet) concentration is a function of the dose, the dosing interval, and the rate of Theophylline (Etosal Tablet) absorption and clearance in the individual patient. Because of marked individual differences in the rate of Theophylline (Etosal Tablet) clearance, the dose required to achieve a peak serum Theophylline (Etosal Tablet) concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter Theophylline (Etosal Tablet) clearance (e.g., 400-1600 mg/day in adults < 60 years old and 10-36 mg/kg/day in children 1-9 years old). For a given population there is no single Theophylline (Etosal Tablet) dose that will provide both safe and effective serum concentrations for all patients. Administration of the median Theophylline (Etosal Tablet) dose required to achieve a therapeutic serum Theophylline (Etosal Tablet) concentration in a given population may result in either sub-therapeutic or potentially toxic serum Theophylline (Etosal Tablet) concentrations in individual patients. For example, at a dose of 900 mg/day in adults < 60 years or 22 mg/kg/day in children 1-9 years, the steady-state peak serum Theophylline (Etosal Tablet) concentration will be < 10 mcg/mL in about 30% of patients, 10-20 mcg/mL in about 50% and 20-30 mcg/mL in about 20% of patients. The dose of Theophylline (Etosal Tablet) must be individualized on the basis of peak serum Theophylline (Etosal Tablet) concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.

Transient caffeine-like adverse effects and excessive serum concentrations in slow metabolizers can be avoided in most patients by starting with a sufficiently low dose and slowly increasing the dose, if judged to be clinically indicated, in small increments. Dose increases should only be made if the previous dosage is well tolerated and at intervals of no less than 3 days to allow serum Theophylline (Etosal Tablet) concentrations to reach the new steady state. Dosage adjustment should be guided by serum Theophylline (Etosal Tablet) concentration measurement. Health care providers should instruct patients and care givers to discontinue any dosage that causes adverse effects, to withhold the medication until these symptoms are gone and to then resume therapy at a lower, previously tolerated dosage.

If the patient's symptoms are well controlled, there are no apparent adverse effects, and no intervening factors that might alter dosage requirements, serum Theophylline (Etosal Tablet) concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum Theophylline (Etosal Tablet) concentrations should be monitored at frequent intervals, e.g., every 24 hours.

Theophylline (Etosal Tablet) distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight. Table V contains Theophylline (Etosal Tablet) dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for Theophylline (Etosal Tablet) dosage adjustment based upon serum Theophylline (Etosal Tablet) concentrations. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, these recommendations should serve as the upper limit for dosage adjustments in order to decrease the risk of potentially serious adverse events associated with unexpected large increases in serum Theophylline (Etosal Tablet) concentration.

Table V. Dosing initiation and titration (as anhydrous Theophylline (Etosal Tablet)).*

A. Children (12-15 years) and adults (16-60 years) without risk factors for impaired clearance.
Titration Step Children < 45 kg Children > 45 kg and adults
1. Starting Dosage 12-14 mg/kg/day up to a maximum of 300 mg/day divided Q 24 hrs* 300-400 mg/day Dose reduction and/or serum Theophylline (Etosal Tablet) concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce Theophylline (Etosal Tablet) clearance occur (e.g., sustained fever), or a drug that interacts with Theophylline (Etosal Tablet) is added or discontinued.

How supplied

Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule) ® (Theophylline (Etosal Tablet) anhydrous) is supplied in extended-release capsules containing 100, 200, 300 or 400 mg of anhydrous Theophylline (Etosal Tablet).

Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule) ® 100 mg capsules are yellow-orange and clear, with markings Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule), 100 mg, ucb, and 2832, supplied as:

NDC Number Size
50474-100-01 bottle of 100
Theophylline (Etosal Tablet)® 200 mg capsules are red-orange and clear, with markings Theophylline (Etosal Tablet), 200 mg, ucb, and 2842, supplied as:
NDC Number Size
50474-200-01 bottle of 100
50474-200-50 bottle of 500
Theophylline (Etosal Tablet)® 300 mg capsules are red and clear, with markings Theophylline (Etosal Tablet), 300 mg, ucb, and 2852, supplied as:
NDC Number Size
50474-300-01 50474-300-50 bottle of 100 bottle of 500
Theophylline (Etosal Tablet)® 400 mg capsules are pink and clear, with markings Theophylline (Etosal Tablet), 400 mg, ucb, and 2902, supplied as:
NDC Number Size
50474-400-01 bottle of 100

Storage

Store below 77 °F (25 °C).

FOR MEDICAL INFORMATION Contact: Medical Affairs Department Phone: (800) 477-7877, Fax: (770) 970-8859. Manufactured for: UCB Pharma, Inc. Smyrna, GA 30080. by Pfizer Pharmaceuticals LLC Caguas, PR 00725. 04/2005.

Theophylline (Etosal Tablet) interactions

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What other drugs will affect Theophylline (Etosal Tablet)?

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Drug/Drug Interactions

Theophylline (Etosal Tablet) interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to Theophylline (Etosal Tablet) or another drug or occurrence of adverse effects without a change in serum Theophylline (Etosal Tablet) concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of Theophylline (Etosal Tablet) clearance is altered by another drug resulting in increased or decreased serum Theophylline (Etosal Tablet) concentrations. Theophylline (Etosal Tablet) only rarely alters the pharmacokinetics of other drugs.

The drugs listed in Table II have the potential to produce clinically significant pharmacodynamic or pharmacokinetic interactions with Theophylline (Etosal Tablet). The information in the “Effect ” column of Table II assumes that the interacting drug is being added to a steady-state Theophylline (Etosal Tablet) regimen. If Theophylline (Etosal Tablet) is being initiated in a patient who is already taking a drug that inhibits Theophylline (Etosal Tablet) clearance (e.g., cimetidine, erythromycin), the dose of Theophylline (Etosal Tablet) required to achieve a therapeutic serum Theophylline (Etosal Tablet) concentration will be smaller. Conversely, if Theophylline (Etosal Tablet) is being initiated in a patient who is already taking a drug that enhances Theophylline (Etosal Tablet) clearance (e.g., rifampin), the dose of Theophylline (Etosal Tablet) required to achieve a therapeutic serum Theophylline (Etosal Tablet) concentration will be larger. Discontinuation of a concomitant drug that increases Theophylline (Etosal Tablet) clearance will result in accumulation of Theophylline (Etosal Tablet) to potentially toxic levels, unless the Theophylline (Etosal Tablet) dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits Theophylline (Etosal Tablet) clearance will result in decreased serum Theophylline (Etosal Tablet) concentrations, unless the Theophylline (Etosal Tablet) dose is appropriately increased.

The drugs listed in Table III have either been documented not to interact with Theophylline (Etosal Tablet) or do not produce a clinically significant interaction (i.e., < 15% change in Theophylline (Etosal Tablet) clearance).

The listing of drugs in Table II is current as of June 2004. The listing of drugs in Table III is current as of January 2, 1996. New interactions are continuously being reported for Theophylline (Etosal Tablet), especially with new chemical entities. The healthcare professional should not assume that a drug does not interact with Theophylline (Etosal Tablet) if it is not listed in Table II. Before addition of a newly available drug in a patient receiving Theophylline (Etosal Tablet), the package insert of the new drug and/or the medical literature should be consulted to determine if an interaction between the new drug and Theophylline (Etosal Tablet) has been reported.

Table II. Clinically significant drug interactions with Theophylline (Etosal Tablet)*.

Drug Type of Interaction Effect**
Adenosine Theophylline (Etosal Tablet) blocks adenosine receptors. Higher doses of adenosine may be required to achieve desired effect.
Alcohol A single large dose of alcohol (3 mL/kg of whiskey) decreases Theophylline (Etosal Tablet) clearance for up to 24 hours. 30% increase
Allopurinol Decreases Theophylline (Etosal Tablet) clearance at allopurinol doses ≥ 600 mg/day. 25% increase
Aminoglutethimide Increases Theophylline (Etosal Tablet) clearance by induction of microsomal enzyme activity. 25% decrease
Carbamazepine Similar to aminoglutethimide. 30% decrease
Cimetidine Decreases Theophylline (Etosal Tablet) clearance by inhibiting cytochrome P450 1A2. 70% increase
Ciprofloxacin Similar to cimetidine. 40% increase
Clarithromycin Similar to erythromycin. 25% increase
Diazepam Benzodiazepines increase CNS concentrations of adenosine, a potent CNS depressant, while Theophylline (Etosal Tablet) blocks adenosine receptors. Larger diazepam doses may be required to produce desired level of sedation. Discontinuation of Theophylline (Etosal Tablet) without reduction of diazepam dose may result in respiratory depression.
Disulfiram Decreases Theophylline (Etosal Tablet) clearance by inhibiting hydroxylation and demethylation. 50% increase
Enoxacin Similar to cimetidine. 300% increase
Ephedrine Synergistic CNS effects. Increased frequency of nausea, nervousness, and insomnia.
Erythromycin Erythromycin metabolite decreases Theophylline (Etosal Tablet) clearance by inhibiting cytochrome P450 3A3. 35% increase. Erythromycin steady-state serum concentrations decrease by a similar amount.
Estrogen Estrogen containing oral contraceptives decrease Theophylline (Etosal Tablet) clearance in a dose-dependent fashion. The effect of progesterone on Theophylline (Etosal Tablet) clearance is unknown. 30% increase
Flurazepam Similar to diazepam. Similar to diazepam.
Fluvoxamine Similar to cimetidine. Similar to cimetidine
Halothane Halothane sensitizes the myocardium to catecholamines, Theophylline (Etosal Tablet) increases release of endogenous catecholamines. Increased risk of ventricular arrhythmias.
Interferon, human recombinant alpha-A Decreases Theophylline (Etosal Tablet) clearance. 100% increase
Isoproterenol (IV) Increases Theophylline (Etosal Tablet) clearance. 20% decrease
Ketamine Pharmacologic. May lower Theophylline (Etosal Tablet) seizure threshold.
Lithium Theophylline (Etosal Tablet) increases renal lithium clearance. Lithium dose required to achieve a therapeutic serum concentration increased an average of 60%.
Lorazepam Similar to diazepam. Similar to diazepam.
Methotrexate (MTX) Decreases Theophylline (Etosal Tablet) clearance. 20% increase after low dose MTX, higher dose MTX may have a greater effect.
Mexiletine Similar to disulfiram. 80% increase
Midazolam Similar to diazepam. Similar to diazepam.
Moricizine Increases Theophylline (Etosal Tablet) clearance. 25% decrease
Pancuronium Theophylline (Etosal Tablet) may antagonize non-depolarizing neuromuscular blocking effects, possibly due to phosphodiesterase inhibition. Larger dose of pancuronium may be required to achieve neuromuscular blockade
Pentoxifylline Decreases Theophylline (Etosal Tablet) clearance. 30% increase
Phenobarbital (PB) Similar to aminoglutethimide. 25% decrease after two weeks of concurrent PB.
Phenytoin Phenytoin increases Theophylline (Etosal Tablet) clearance by increasing microsomal enzyme activity. Theophylline (Etosal Tablet) decreases phenytoin absorption. Serum Theophylline (Etosal Tablet) and phenytoin concentrations decrease about 40%.
Propafenone Decreases Theophylline (Etosal Tablet) clearance and pharmacologic interaction. 40% increase. Beta blockingeffect may decrease efficacy oftheophylline
Rifampin Increases Theophylline (Etosal Tablet) clearance by increasing cytochrome P450 1A2 and 3A3 activity. 20-40% decrease
St. John's Wort (Hypericum Perforatum) Decrease in Theophylline (Etosal Tablet) plasma concentrations. Higher doses of Theophylline (Etosal Tablet) may be required to achieve desired effect. Stopping St. John's Wort may result in Theophylline (Etosal Tablet) toxicity.
Sulfinpyrazone Increases Theophylline (Etosal Tablet) clearance by increasing demethylation and hydroxylation. Decreases renal clearance of Theophylline (Etosal Tablet). 20% decrease
Tacrine Similar to cimetidine, also increases renal clearance of Theophylline (Etosal Tablet). 90% increase
Thiabendazole Decreases Theophylline (Etosal Tablet) clearance. 190% increase
Ticlopidine Decreases Theophylline (Etosal Tablet) clearance. 60% increase
Troleandomycin Similar to erythromycin. 33-100% increase depending on troleandomycin dose.
Verapamil Similar to disulfiram. 20% increase
* Refer to PRECAUTIONS, Drug Interactions for further information regarding table.

** Average effect on steady state Theophylline (Etosal Tablet) concentration or other clinical effect for pharmacologic interactions. Individual patients may experience larger changes in serum Theophylline (Etosal Tablet) concentration than the value listed.

Table III. Drugs that have been documented not to interact with Theophylline (Etosal Tablet) or drugs that produce no clinically significant interaction with Theophylline (Etosal Tablet).*

albuterol, systemic and inhaled finasteride norfloxacin
hydrocortisone ofloxacin
amoxicillin isoflurane omeprazole
ampicillin, with or without sulbactam isoniazid prednisone, prednisolone
isradipine ranitidine
atenolol influenza vaccine rifabutin
azithromycin ketoconazole roxithromycin
caffeine, dietary ingestion lomefloxacin sorbitol
cefaclor mebendazole (purgative doses do not inhibit Theophylline (Etosal Tablet) absorption)
co-trimoxazole (trimethoprim and sulfamethoxazole) medroxyprogesterone
methylprednisolone
metronidazole sucralfate
diltiazem metoprolol terbutaline,systemic
dirithromycin nadolol terfenadine
enflurane nifedipine tetracycline
famotidine nizatidine tocainide
felodipine
* Refer to PRECAUTIONS: DRUG INTERACTIONS for information regarding table.

Drug/Food Interactions

Taking Theophylline (Etosal Tablet) (Theophylline (Etosal Tablet) anhydrous capsule) ® less than one hour before a high-fat-content meal, such as 8 oz whole milk, 2 fried eggs, 2 bacon strips, 2 oz hashed brown potatoes, and 2 slices of buttered toast (about 985 calories, including approximately 71 g of fat) may result in a significant increase in peak serum level and in the extent of absorption of Theophylline (Etosal Tablet) as compared to administration in the fasted state. In some cases (especially with doses of 900 mg or more taken less than one hour before a high-fat-content meal) serum Theophylline (Etosal Tablet) levels may exceed the 20 mcg/mL level, above which Theophylline (Etosal Tablet) toxicity is more likely to occur.

The Effect of Other Drugs on Theophylline (Etosal Tablet) Serum Concentration Measurements

Most serum Theophylline (Etosal Tablet) assays in clinical use are immunoassays which are specific for Theophylline (Etosal Tablet). Other xanthines such as caffeine, dyphylline, and pentoxifylline are not detected by these assays. Some drugs (e.g., cefazolin, cephalothin), however, may interfere with certain HPLC techniques. Caffeine and xanthine metabolites in neonates or patients with renal dysfunction may cause the reading from some dry reagent office methods to be higher than the actual serum Theophylline (Etosal Tablet) concentration.

Theophylline (Etosal Tablet) side effects

See also:
What are the possible side effects of Theophylline (Etosal Tablet)?

Adverse reactions associated with Theophylline (Etosal Tablet) are generally mild when peak serum Theophylline (Etosal Tablet) concentrations are < 20 mcg/ mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum Theophylline (Etosal Tablet) concentrations exceed 20 mcg/mL, however, Theophylline (Etosal Tablet) produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal. The transient caffeine-like adverse reactions occur in about 50%of patients when Theophylline (Etosal Tablet) therapy is initiated at doses higher than recommended initial doses (e.g., > 300 mg/day in adults and > 12 mg/kg/day in children beyond 1 year of age). During the initiation of Theophylline (Etosal Tablet) therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of Theophylline (Etosal Tablet) therapy at a low dose with subsequent slow titration to a predetermined age-related maximum dose will significantly reduce the frequency of these transient adverse effects. In a small percentage of patients ( < 3%of children and < 10%of adults)the caffeine-like adverse effects persist during maintenance therapy, even at peak serum Theophylline (Etosal Tablet) concentrations within the therapeutic range (i.e., 10-20 mcg/mL). Dosage reduction may alleviate the caffeine-like adverse effects in these patients, however, persistent adverse effects should result in a reevaluation of the need for continued Theophylline (Etosal Tablet) therapy and the potential therapeutic benefit of alternative treatment.

Other adverse reactions that have been reported at serum Theophylline (Etosal Tablet) concentrations < 20 mcg/mL include diarrhea, irritability, restlessness, fine skeletal muscle tremors, and transient diuresis. In patients with hypoxia secondary to COPD, multifocal atrial tachycardia and flutter have been reported at serum Theophylline (Etosal Tablet) concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum Theophylline (Etosal Tablet) concentrations < 20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum Theophylline (Etosal Tablet) concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum Theophylline (Etosal Tablet) concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum Theophylline (Etosal Tablet) concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum Theophylline (Etosal Tablet) concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).

Table IV. Manifestations of Theophylline (Etosal Tablet) toxicity.*

Percentage of Patients Reported With Sign or Symptom
Acute Overdose

(Large Single Ingestion)

Chronic Overdosage

(Multiple Excessive Doses)

Sign/Symptom Study 1

(n=157)

Study 2

(n=14)

Study 1

(n=92)

Study 2

(n=102)

Asymptomatic NR** 0 NR** 6
Gastrointestinal
Vomiting 73 93 30 61
Abdominal Pain NR** 21 NR** 12
Diarrhea NR** 0 NR** 14
Hematemesis NR** 0 NR** 2
Metabolic/Other
Hypokalemia 85 79 44 43
Hyperglycemia 98 NR** 18 NR**
Acid/base disturbance 34 21 9 5
Rhabdomyolysis NR** 7 NR** 0
Cardiovascular
Sinus tachycardia 100 86 100 62
Other supraventricular tachycardias 2 21 12 14
Ventricular premature beats 3 21 10 19
Atrial fibrillation or flutter 1 NR** 12 NR**
Multifocal atrial tachycardia 0 NR** 2 NR**
Ventricular arrhythmias with hemodynamic instability 7 14 40 0
Hypotension/shock NR** 21 NR** 8
Neurologic
Nervousness NR** 64 NR** 21
Tremors 38 29 16 14
Disorientation NR** 7 NR** 11
Seizures 5 14 14 5
Death 3 21 10 4
* These data are derived from two studies in patients with serum Theophylline (Etosal Tablet) concentrations > 30 mcg/mL. In the first study (Study #1 –Shanon, Ann Intern Med 1993; 119: 1161-67), data were prospectively collected from 249 consecutive cases of Theophylline (Etosal Tablet) toxicity referred to a regional poison center for consultation. In the second study (Study #2 –Sessler, Am J Med 1990; 88: 567-76), data were retrospectively collected from 116 cases with serum Theophylline (Etosal Tablet) concentrations > 30 mcg/mL among 6000 blood samples obtained for measurement of serum Theophylline (Etosal Tablet) concentrations in three emergency departments. Differences in the incidence of manifestations of Theophylline (Etosal Tablet) toxicity between the two studies may reflect sample selection as a result of study design (e.g., in Study #1, 48%of the patients had acute intoxications versus only 10% in Study #2) and different methods of reporting results.

** NR =Not reported in a comparable manner.

Theophylline (Etosal Tablet) contraindications

See also:
What is the most important information I should know about Theophylline (Etosal Tablet)?

Do not take Theophylline (Etosal Tablet) in larger or smaller amounts or for longer than recommended. Theophylline (Etosal Tablet) overdose can occur if you accidentally take too much at one time, or if your daily doses are too high. To be sure you are using the correct dose, your blood will need to be tested often.

Do not start or stop smoking without first talking to your doctor. Smoking changes the way your body uses Theophylline (Etosal Tablet), and you may need to use a different dose.

Sometimes it is not safe to use certain drugs at the same time. Many drugs can interact with Theophylline (Etosal Tablet). Tell your doctor about all other medicines you use. Also tell your doctor if you start or stop using any of your other medications.

Stop using Theophylline (Etosal Tablet) and call your doctor at once if you have severe or continued vomiting, rapid heartbeats, confusion, tremors, or seizure.

Active ingredient matches for Etosal Tablet:

Etophylline/Theophylline


Unit description / dosage (Manufacturer)Price, USD
Etosal Tablet (Indica Laboratories Pvt Ltd)$ 0.01

List of Etosal Tablet substitutes (brand and generic names):

10's (Agron Rem. (Agrogem))$ 0.04
Tablets; Oral; Etofylline 23 mg; Theophylline 77 mg (Agron Rem. (Agrogem))
Agrophyllin Theophylline 77 mg, etofylline23 mg. TAB / 10 (Agron Rem. (Agrogem))$ 0.04
AGROPHYLLIN 23MG/77MG TABLET 1 strip / 10 tablets each (Agron Rem. (Agrogem))$ 0.04
AGROPHYLLIN inj 2ml (Agron Rem. (Agrogem))$ 0.05
AGROPHYLLIN tab 10's (Agron Rem. (Agrogem))$ 0.04
Agrophyllin Theophylline 77 mg, etofylline23 mg. TAB / 10 (Agron Rem. (Agrogem))$ 0.04
Agrophyllin 23 mg/77 mg Tablet (Agron Rem. (Agrogem))$ 0.00
DERICIP RETARD 150 TABLET 1 strip / 10 tablets each (Cipla)$ 0.09
DERICIP RETARD 69 MG/231 MG TABLET 1 strip / 10 tablets each (Cipla)$ 0.12
DERICIP RETARD modified-release tab 10's (Cipla)$ 0.12
Dericip Retard 150 Tablet SR (Cipla)$ 0.01
DERITARD INJECTION 1 vial / 2 ML injection each (Lupin Ltd)$ 0.06
ETOBROSMIN 25.3MG/84.7MG INJECTION 1 vial / 2 ml injection each (Synthiko Formulations & Pharma Pvt Ltd)$ 0.06
Etobrosmin 25.3 mg/84.7 mg Injection (Synthiko Formulations & Pharma Pvt Ltd)$ 0.03
ETOPHYLLINE 84.7MG + THEOPHYLLINE 25.3MG INJECTION 1 vial / 2 ML injection each (Jan Aushadhi)$ 0.11
ETOSAL 231MG/69MG TABLET 1 strip / 10 tablets each (Indica Laboratories Pvt Ltd)$ 0.08
MERIPHYLLIN INJECTION 1 vial / 2 ML injection each (Wockhardt Ltd)$ 0.05
THEOPHYLLINE 23MG+ ETOPHYLLIN 77MG TABLET 1 strip / 10 tablets each (Jan Aushadhi)$ 0.06

References

  1. DailyMed. "THEOPHYLLINE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. PubChem. "theophylline". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  3. DrugBank. "theophylline". http://www.drugbank.ca/drugs/DB00277 (accessed September 17, 2018).

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