Theophylline Elixir Uses

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What is Theophylline Elixir?

Theophylline Elixir 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 Elixir 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 Elixir is available only with your doctor's prescription.

Theophylline Elixir 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.
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Oral

Acute bronchospasm

Adult: Patients not taking Theophylline Elixir 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 Elixir 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 Elixir 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 Elixir?

Use Theophylline Elixir sustained-release capsules 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 Elixir sustained-release capsules.

Uses of Theophylline Elixir 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 Elixir as a long-term control medication for asthma in children ≤5 years of age. Additionally, GINA guidelines do not recommend Theophylline Elixir for asthma in children 6 to 11 years of age.

Oral Theophylline Elixir 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 Elixir due to efficacy concerns and potential for adverse events (GINA 2019). Both guidelines recommend against Theophylline Elixir 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 Elixir in patients with COPD is controversial and lacks data. Theophylline Elixir may favorably impact functional impairment in COPD patients, but exact effects are unclear. Studies that demonstrated improvement were done with slow-release preparations. Theophylline Elixir 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 Elixir may be beneficial for the treatment of bradycardia following heart transplantation.

Theophylline Elixir description

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Theophylline Elixir is a chiral compound. The racemic mixture can be divided into its optical antipodes: levo- and dextro-amphetamine. Theophylline Elixir 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 Elixir is a homologue of phenethylamine.

Theophylline Elixir dosage

General Considerations

Theophylline Elixir (Theophylline Elixir anhydrous capsule) ®, like other extended-release Theophylline Elixir products, is intended for patients with relatively continuous or recurring symptoms who have a need to maintain therapeutic serum levels of Theophylline Elixir. 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 Elixir preparation (or other bronchodilators) and not with extended-release products.

Patients who metabolize Theophylline Elixir at a normal or slow rate are reasonable candidates for once-daily dosing with Theophylline Elixir (Theophylline Elixir anhydrous capsule) ®. Patients who metabolize Theophylline Elixir 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 Elixir (Theophylline Elixir 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 Elixir products at night (after the evening meal) results in serum concentrations of Theophylline Elixir 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 Elixir 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 Elixir (Theophylline Elixir anhydrous capsule) ® (when used as a once-a-day product) be administered at night.

Patients who require a relatively high dose of Theophylline Elixir (i.e., a dose equal to or greater than 900 mg or 13 mg/kg, whichever is less) should not take Theophylline Elixir (Theophylline Elixir 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 Elixir as compared to administration in the fasted state.

The steady-state peak serum Theophylline Elixir concentration is a function of the dose, the dosing interval, and the rate of Theophylline Elixir absorption and clearance in the individual patient. Because of marked individual differences in the rate of Theophylline Elixir clearance, the dose required to achieve a peak serum Theophylline Elixir concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter Theophylline Elixir 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 Elixir dose that will provide both safe and effective serum concentrations for all patients. Administration of the median Theophylline Elixir dose required to achieve a therapeutic serum Theophylline Elixir concentration in a given population may result in either sub-therapeutic or potentially toxic serum Theophylline Elixir 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 Elixir 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 Elixir must be individualized on the basis of peak serum Theophylline Elixir 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 Elixir concentrations to reach the new steady state. Dosage adjustment should be guided by serum Theophylline Elixir 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 Elixir 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 Elixir concentrations should be monitored at frequent intervals, e.g., every 24 hours.

Theophylline Elixir distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight. Table V contains Theophylline dosing titration schema recommended for patients in various age groups and clinical circumstances. Table VI contains recommendations for Theophylline Elixir dosage adjustment based upon serum Theophylline Elixir 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 Elixir concentration.

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

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 Elixir concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce Theophylline Elixir clearance occur (e.g., sustained fever), or a drug that interacts with Theophylline Elixir is added or discontinued.

How supplied

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

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

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

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What other drugs will affect Theophylline Elixir?

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Drug/Drug Interactions

Theophylline Elixir interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to Theophylline Elixir or another drug or occurrence of adverse effects without a change in serum Theophylline Elixir concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of Theophylline Elixir clearance is altered by another drug resulting in increased or decreased serum Theophylline Elixir concentrations. Theophylline Elixir 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 Elixir. The information in the “Effect ” column of Table II assumes that the interacting drug is being added to a steady-state Theophylline Elixir regimen. If Theophylline Elixir is being initiated in a patient who is already taking a drug that inhibits Theophylline Elixir clearance (e.g., cimetidine, erythromycin), the dose of Theophylline Elixir required to achieve a therapeutic serum Theophylline Elixir concentration will be smaller. Conversely, if Theophylline Elixir is being initiated in a patient who is already taking a drug that enhances Theophylline Elixir clearance (e.g., rifampin), the dose of Theophylline Elixir required to achieve a therapeutic serum Theophylline Elixir concentration will be larger. Discontinuation of a concomitant drug that increases Theophylline Elixir clearance will result in accumulation of Theophylline Elixir to potentially toxic levels, unless the Theophylline Elixir dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits Theophylline Elixir clearance will result in decreased serum Theophylline Elixir concentrations, unless the Theophylline Elixir dose is appropriately increased.

The drugs listed in Table III have either been documented not to interact with Theophylline Elixir or do not produce a clinically significant interaction (i.e., < 15% change in Theophylline Elixir 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 Elixir, especially with new chemical entities. The healthcare professional should not assume that a drug does not interact with Theophylline Elixir if it is not listed in Table II. Before addition of a newly available drug in a patient receiving Theophylline Elixir, 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 Elixir has been reported.

Table II. Clinically significant drug interactions with Theophylline Elixir*.

Drug Type of Interaction Effect**
Adenosine Theophylline Elixir 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 Elixir clearance for up to 24 hours. 30% increase
Allopurinol Decreases Theophylline Elixir clearance at allopurinol doses ≥ 600 mg/day. 25% increase
Aminoglutethimide Increases Theophylline Elixir clearance by induction of microsomal enzyme activity. 25% decrease
Carbamazepine Similar to aminoglutethimide. 30% decrease
Cimetidine Decreases Theophylline Elixir 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 Elixir blocks adenosine receptors. Larger diazepam doses may be required to produce desired level of sedation. Discontinuation of Theophylline Elixir without reduction of diazepam dose may result in respiratory depression.
Disulfiram Decreases Theophylline Elixir 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 Elixir 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 Elixir clearance in a dose-dependent fashion. The effect of progesterone on Theophylline Elixir 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 Elixir increases release of endogenous catecholamines. Increased risk of ventricular arrhythmias.
Interferon, human recombinant alpha-A Decreases Theophylline Elixir clearance. 100% increase
Isoproterenol (IV) Increases Theophylline Elixir clearance. 20% decrease
Ketamine Pharmacologic. May lower Theophylline Elixir seizure threshold.
Lithium Theophylline Elixir 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 Elixir 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 Elixir clearance. 25% decrease
Pancuronium Theophylline Elixir 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 Elixir clearance. 30% increase
Phenobarbital (PB) Similar to aminoglutethimide. 25% decrease after two weeks of concurrent PB.
Phenytoin Phenytoin increases Theophylline Elixir clearance by increasing microsomal enzyme activity. Theophylline Elixir decreases phenytoin absorption. Serum Theophylline Elixir and phenytoin concentrations decrease about 40%.
Propafenone Decreases Theophylline Elixir clearance and pharmacologic interaction. 40% increase. Beta blockingeffect may decrease efficacy oftheophylline
Rifampin Increases Theophylline Elixir clearance by increasing cytochrome P450 1A2 and 3A3 activity. 20-40% decrease
St. John's Wort (Hypericum Perforatum) Decrease in Theophylline Elixir plasma concentrations. Higher doses of Theophylline Elixir may be required to achieve desired effect. Stopping St. John's Wort may result in Theophylline Elixir toxicity.
Sulfinpyrazone Increases Theophylline Elixir clearance by increasing demethylation and hydroxylation. Decreases renal clearance of Theophylline Elixir. 20% decrease
Tacrine Similar to cimetidine, also increases renal clearance of Theophylline Elixir. 90% increase
Thiabendazole Decreases Theophylline Elixir clearance. 190% increase
Ticlopidine Decreases Theophylline Elixir 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 Elixir concentration or other clinical effect for pharmacologic interactions. Individual patients may experience larger changes in serum Theophylline Elixir concentration than the value listed.

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

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 Elixir 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 Elixir (Theophylline Elixir 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 Elixir 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 Elixir levels may exceed the 20 mcg/mL level, above which Theophylline Elixir toxicity is more likely to occur.

The Effect of Other Drugs on Theophylline Elixir Serum Concentration Measurements

Most serum Theophylline Elixir assays in clinical use are immunoassays which are specific for Theophylline Elixir. 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 Elixir concentration.

Theophylline Elixir side effects

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What are the possible side effects of Theophylline Elixir?

Adverse reactions associated with Theophylline Elixir are generally mild when peak serum Theophylline Elixir 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 Elixir concentrations exceed 20 mcg/mL, however, Theophylline Elixir 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 Elixir 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 Elixir therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of Theophylline Elixir 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 Elixir 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 Elixir therapy and the potential therapeutic benefit of alternative treatment.

Other adverse reactions that have been reported at serum Theophylline Elixir 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 Elixir concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum Theophylline Elixir 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 Elixir concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum Theophylline Elixir concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum Theophylline Elixir concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum Theophylline Elixir 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 Elixir 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 Elixir 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 Elixir 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 Elixir concentrations > 30 mcg/mL among 6000 blood samples obtained for measurement of serum Theophylline Elixir concentrations in three emergency departments. Differences in the incidence of manifestations of Theophylline Elixir 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 Elixir contraindications

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What is the most important information I should know about Theophylline Elixir?

Do not take Theophylline Elixir in larger or smaller amounts or for longer than recommended. Theophylline Elixir 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 Elixir, 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 Elixir. 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 Elixir and call your doctor at once if you have severe or continued vomiting, rapid heartbeats, confusion, tremors, or seizure.

Active ingredient matches for Theophylline Elixir:

Theophylline


Unit description / dosage (Manufacturer)Price, USD
Theophylline Elixir elixir 80 mg (Therapex Division De E Z Em Canada Inc (Canada))

List of Theophylline Elixir substitutes (brand and generic names):

Theopin CR 400 mg Tablet (Mefro Pharmaceuticals Pvt Ltd)$ 0.06
THEORESP Modified Release Capsule/ Tablet / 400mg / 10 units (Life Medicare & Biotech Pvt. Ltd.)$ 0.70
THEORESP Modified Release Capsule/ Tablet / 600mg / 10 units (Life Medicare & Biotech Pvt. Ltd.)$ 0.89
400 mg x 10's (Life Medicare & Biotech Pvt. Ltd.)$ 0.70
600 mg x 10's (Life Medicare & Biotech Pvt. Ltd.)$ 0.89
Theoresp 400 mg Tablet (Life Medicare & Biotech Pvt. Ltd.)$ 0.07
Theoresp 600 mg Tablet (Life Medicare & Biotech Pvt. Ltd.)$ 0.09
Theoresp 400mg TAB / 10 (Life Medicare & Biotech Pvt. Ltd.)$ 0.70
Theoresp 600mg TAB / 10 (Life Medicare & Biotech Pvt. Ltd.)$ 0.89
THEORESP 400 MG TABLET 1 strip / 10 tablets each (Life Medicare & Biotech Pvt. Ltd.)$ 0.70
THEORESP 600 MG TABLET 1 strip / 10 tablets each (Life Medicare & Biotech Pvt. Ltd.)$ 0.94
THEORESP modified-release tab 400 mg x 10's (Life Medicare & Biotech Pvt. Ltd.)$ 0.70
THEORESP modified-release tab 600 mg x 10's (Life Medicare & Biotech Pvt. Ltd.)$ 0.89
Theoresp 400mg TAB / 10 (Life Medicare & Biotech Pvt. Ltd.)$ 0.70
Theoresp 600mg TAB / 10 (Life Medicare & Biotech Pvt. Ltd.)$ 0.89
Theoresp 400mg Tablet (Life Medicare & Biotech Pvt. Ltd.)$ 0.07
Theoresp 600mg Tablet (Life Medicare & Biotech Pvt. Ltd.)$ 0.09
THEORESP PLUS 400 MG TABLET 1 strip / 10 tablets each (Life Medicare & Biotech Pvt Ltd)$ 0.87
THEORESP PLUS 600 MG TABLET 1 strip / 10 tablets each (Life Medicare & Biotech Pvt Ltd)$ 1.01
Theoresp Plus 400mg Tablet (Life Medicare & Biotech Pvt Ltd)$ 0.09
Theoresp Plus 600mg Tablet (Life Medicare & Biotech Pvt Ltd)$ 0.10
Theori-200 200 mg x 10 x 10's (Meditab)
Theori-200 SR tab 200 mg 10 x 10's (Meditab)
Theosal Forte 300+4 Tablet (Talent Laboratories)$ 0.02
Theostan 200mg Capsule CR (Sun Pharmaceutical Industries Ltd)$ 0.02
THEOSTAN - CR Modified Release Capsule/ Tablet / 200mg / 10 units (Ranbaxy (Stancare Division))$ 0.21
Theostan CR 200 mg Capsule (Stancare (Ranbaxy Laboratories Ltd))$ 0.02
THEOSTAN CR 200MG CAPSULE 1 strip / 10 capsule crs each (Stancare (Ranbaxy Laboratories Ltd))$ 0.21
200 mg x 10's (Ranbaxy (Stancare))$ 0.20
Theostan-CR 200mg TAB / 10 (Ranbaxy (Stancare))$ 0.20

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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