Theolin/Theolin SR Uses

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What is Theolin/Theolin SR?

Theolin/Theolin SR injection is used together with other medicines to treat the acute symptoms of asthma, bronchitis, emphysema, and other lung diseases in a hospital setting.

Theolin/Theolin SR 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.

Theolin/Theolin SR is available only with your doctor's prescription.

Theolin/Theolin SR 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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Intravenous Theolin/Theolin SR is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis.

How should I use Theolin/Theolin SR?

Use Theolin/Theolin SR 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 Theolin/Theolin SR.

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

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

Theolin/Theolin SR description

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

Theolin/Theolin SR dosage

General Considerations

The steady-state peak serum Theolin/Theolin SR concentration is a function of the infusion rate and the rate of Theolin/Theolin SR clearance in the individual patient. Because of marked individual differences in the rate of Theolin/Theolin SR clearance, the dose required to achieve a serum Theolin/Theolin SR concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter Theolin/Theolin SR clearance. For a given population there is no single Theolin/Theolin SR dose that will provide both safe and effective serum concentrations for all patients. Administration of the median Theolin/Theolin SR dose required to achieve a therapeutic serum Theolin/Theolin SR concentration in a given population may result in either sub-therapeutic or potentially toxic serum Theolin/Theolin SR concentrations in individual patients. The dose of Theolin/Theolin SR must be individualized on the basis of peak serum Theolin/Theolin SR concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects.

When Theolin/Theolin SR is used as an acute bronchodilator, the goal of obtaining a therapeutic serum concentration is best accomplished with an intravenous loading dose. Because of rapid distribution into body fluids, the serum concentration (C) obtained from an initial loading dose (LD) is related primarily to the volume of distribution (V), the apparent space into which the drug diffuses:

C = LD/V

If a mean volume of distribution of about 0.5 L/kg is assumed (actual range is 0.3 to 0.7 L/kg), each mg/kg (ideal body weight) of Theolin/Theolin SR administered as a loading dose over 30 minutes results in an average 2 mcg/mL increase in serum Theolin/Theolin SR concentration. Therefore, in a patient who has received no Theolin/Theolin SR in the previous 24 hours, a loading dose of intravenous Theolin/Theolin SR of 4.6 mg/kg, calculated on the basis of ideal body weight and administered over 30 minutes, on average, will produce a maximum post-distribution serum concentration of 10 mcg/mL with a range of 6-16 mcg/mL. When a loading dose becomes necessary in the patient who has already received Theolin/Theolin SR, estimation of the serum concentration based upon the history is unreliable, and an immediate serum level determination is indicated. The loading dose can then be determined as follows:

D = (Desired C - Measured C)(V)

where D is the loading dose, C is the serum Theolin/Theolin SR concentration, and V is the volume of distribution. The mean volume of distribution can be assumed to be 0.5 L/kg and the desired serum concentration should be conservative (e.g., 10 mcg/mL) to allow for the variability in the volume of distribution. A loading dose should not be given before obtaining a serum Theolin/Theolin SR concentration if the patient has received any Theolin/Theolin SR in the previous 24 hours.

A serum concentration obtained 30 minutes after an intravenous loading dose, when distribution is complete, can be used to assess the need for and size of subsequent loading doses, if clinically indicated, and for guidance of continuing therapy. Once a serum concentration of 10 to 15 mcg/mL has been achieved with the use of a loading dose(s), a constant intravenous infusion is started. The rate of administration is based upon mean pharmacokinetic parameters for the population and calculated to achieve a target serum concentration of 10 mcg/mL. For example, in nonsmoking adults, initiation of a constant intravenous Theolin/Theolin SR infusion of 0.4 mg/kg/hr at the completion of the loading dose, on average, will result in a steady-state concentration of 10 mcg/ mL with a range of 7-26 mcg/mL. The mean and range of steady-state serum concentrations are similar when the average child (age 1 to 9 years) is given a loading dose of 4.6 mg/kg Theolin/Theolin SR followed by a constant intravenous infusion of 0.8 mg/kg/ hr. Since there is large interpatient variability in Theolin/Theolin SR clearance, serum concentration will rise or fall when the patient's clearance is significantly different from the mean population value used to calculate the initial infusion rate. Therefore, a second serum concentration should be obtained one expected half-life after starting the constant infusion (e.g., approximately 4 hours for children age 1 to 9 and 8 hours for nonsmoking adults; See Table II for the expected half-life in additional patient populations) to determine if the concentration is accumulating or declining from the post loading dose level. If the level is declining as a result of a higher than average clearance, an additional loading dose can be administered and/or the infusion rate increased. In contrast, if the second sample demonstrates a higher level, accumulation of the drug can be assumed, and the infusion rate should be decreased before the concentration exceeds 20 mcg/mL. An additional sample is obtained 12 to 24 hours later to determine if further adjustments are required and then at 24-hour intervals to adjust for changes, if they occur. This empiric method, based upon mean pharmacokinetic parameters, will prevent large fluctuations in serum concentration during the most critical period of the patient's course.

In patients with cor pulmonale, cardiac decompensation, or liver dysfunction, or in those taking drugs that markedly reduce Theolin/Theolin SR clearance (e.g., cimetidine), the initial Theolin/Theolin SR infusion rate should not exceed 17 mg/hr unless serum concentrations can be monitored at 24-hour intervals. In these patients, 5 days may be required before steady-state is reached.

Theolin/Theolin SR distributes poorly into body fat, therefore, mg/kg dose should be calculated on the basis of ideal body weight. Table VI contains initial Theolin/Theolin SR infusion rates following an appropriate loading dose recommended for patients in various age groups and clinical circumstances. Table VII contains recommendations for final Theolin/Theolin SR dosage adjustment based upon serum Theolin/Theolin SR 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 Theolin/Theolin SR concentration.

Table VI : Initial Theolin/Theolin SR infusion rates following an appropriate loading dose.

Patient population Age Theolin/Theolin SR infusion rate (mg/kg/hr)*†
Neonates Postnatal age up to 24 days 1 mg/kg q12h/‡
Postnatal age beyond 24 days 1.5 mg/kg q 12h/‡
Infants 6-52 weeks old mg/kg/hr = (0.008) (age in weeks) + 0.21
Young children 1-9 years 0.8
Older children 9-12 years 0.7
Adolescents (cigarette or marijuana smokers) 12-16 years 0.7
Adolescents (nonsmokers) 12-16 years 0.5§
Adults (otherwise healthy nonsmokers) 16-60 years 0.4§
Elderly >60 years 0.3¶
Cardiac decompensation, cor pulmonale, liver dysfunction, sepsis with multi-organ failure, or shock 0.2¶
* To achieve a target concentration of 10 mcg/mL. Use ideal body weight for obese patients.

† Lower initial dosage may be required for patients receiving other drugs that decrease Theolin/Theolin SR clearance (e.g., cimetidine).

Theolin/Theolin SR interactions

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What other drugs will affect Theolin/Theolin SR?

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

The drugs listed in Table IV have either been documented not to interact with Theolin/Theolin SR or do not produce a clinically significant interaction (i.e., < 15% change in Theolin/Theolin SR clearance).

The listings of drugs in Tables III and IV are current as of September 1, 1995. New interactions are continuously being reported for Theolin/Theolin SR, especially with new chemical entities. The clinician should not assume that a drug does not interact with Theolin/Theolin SR if it is not listed in Table III. Before addition of a newly available drug in a patient receiving Theolin/Theolin SR, 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 Theolin/Theolin SR has been reported.

Table III : Clinically significant drug interactions with Theolin/Theolin SR.

albuterol, systemic and inhaled lomefloxacin mebendazole
amoxicillin medroxyprogesterone
ampicillin, with or without sulbactam methylprednisolone metronidazole
atenolol metoprolol
azithromycin nadolol
caffeine, dietary ingestion nifedipine

nizatidine

cefaclor norfloxacin
co-trimoxazole

(trimethoprim and sulfamethoxazole)

ofloxacin
omeprazole

prednisone, prednisolone

diltiazem ranitidine
dirithromycin rifabutin
enflurane roxithromycin
famotidine sorbitol (purgative doses do not inhibit Theolin/Theolin SR absorption)
felodipine
finasteride
hydrocortisone
insoflurane sucralfate
isoniazid terbutaline, systemic
isradipine terfenadine
influenza vaccine tetracycline
ketoconazole tocainide
* Refer to PRECAUTIONS, Drug Interactions for information regarding table.

The Effect of Other Drugs on Theolin/Theolin SR Serum Concentration Measurements

Most serum Theolin/Theolin SR assays in clinical use are immunoassays which are specific for Theolin/Theolin SR. 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 Theolin/Theolin SR concentration.

Theolin/Theolin SR side effects

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What are the possible side effects of Theolin/Theolin SR?

Adverse reactions associated with Theolin/Theolin SR are generally mild when peak serum Theolin/Theolin SR concentrations are < 20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When serum Theolin/Theolin SR concentrations exceed 20 mcg/mL, however, Theolin/Theolin SR produces a wide range of adverse reactions including persistent vomiting, cardiac arrhythmias, and intractable seizures which can be lethal.

Other adverse reactions that have been reported at serum Theolin/Theolin SR 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 Theolin/Theolin SR concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum Theolin/Theolin SR concentrations < 20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum Theolin/Theolin SR concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum Theolin/Theolin SR concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum Theolin/Theolin SR concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum Theolin/Theolin SR concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua).

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Theolin/Theolin SR contraindications

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What is the most important information I should know about Theolin/Theolin SR?

Theolin/Theolin SR

Oral Solution, USP is contraindicated in patients with a history of hypersensitivity to Theolin/Theolin SR or other components in the product.

Active ingredient matches for Theolin/Theolin SR:

Theophylline anhydrous in Singapore.


List of Theolin/Theolin SR substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Eiso 5.34 mg/1 mL x 1 mL
Eiso 5.34 mg/1 mL x 60 mL
Eiso 5.34 mg/1 mL x 120 mL
Theolin S.R. 250 mg x 500's
Theolin S.R. 250 mg x 50 x 10's
Theophylline Anhydrous tablet, extended release 400 mg/1 (Rhodes Pharmaceuticals L.P. (US))
Theophylline Anhydrous tablet, extended release 600 mg/1 (Rhodes Pharmaceuticals L.P. (US))
Theophylline Beacons 100 mg x 1000's
TR-PHYLLIN cap 125 mg x 10's (Sun (Symbiosis))
TR-PHYLLIN cap 250 mg x 10's (Sun (Symbiosis))
Xanlin 5.34 mg/1 mL x 60 mL
Xanlin 5.34 mg/1 mL x 120 mL

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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