Theolair NF injection is used together with other medicines to treat the acute symptoms of asthma, bronchitis, emphysema, and other lung diseases in a hospital setting.
Theolair NF 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.
Theolair NF is available only with your doctor's prescription.
Theolair NF 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 Theolair NF 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 Theolair NF 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 Theolair NF 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 Theolair NF?
Use Theolair NF sustained-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Some foods may change the effectiveness or increase the side effects of Theolair NF sustained-release capsules. Talk to your doctor about how you should take Theolair NF sustained-release capsules with regard to food. Do not suddenly change your diet or eating habits without first checking with your doctor.
Swallow Theolair NF sustained-release capsules whole. Do not break, crush, or chew before swallowing.
Take Theolair NF sustained-release capsules at about the same time(s) each day. If you are using more than 1 dose per day, try to take the second dose 10 to 12 hours after your first dose and before the evening meal. Check with your doctor or pharmacist if you have questions about how to take Theolair NF sustained-release capsules.
If you are using 1 dose per day, take Theolair NF sustained-release capsules in the morning unless your doctor tells you otherwise.
Continue to take Theolair NF sustained-release capsules even if you feel well. Do not miss any doses.
If you miss a dose of Theolair NF sustained-release capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Theolair NF sustained-release capsules.
Uses of Theolair NF 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 Theolair NF as a long-term control medication for asthma in children ≤5 years of age. Additionally, GINA guidelines do not recommend Theolair NF for asthma in children 6 to 11 years of age.
Oral Theolair NF 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 Theolair NF due to efficacy concerns and potential for adverse events (GINA 2019). Both guidelines recommend against Theolair NF 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 Theolair NF in patients with COPD is controversial and lacks data. Theolair NF may favorably impact functional impairment in COPD patients, but exact effects are unclear. Studies that demonstrated improvement were done with slow-release preparations. Theolair NF 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 Theolair NF may be beneficial for the treatment of bradycardia following heart transplantation.
Theolair NF description
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Theolair NF is a chiral compound. The racemic mixture can be divided into its optical antipodes: levo- and dextro-amphetamine. Theolair NF 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. Theolair NF is a homologue of phenethylamine.
Theolair NF dosage
General Considerations
Theolair NF (Theolair NF anhydrous capsule) ®, like other extended-release Theolair NF products, is intended for patients with relatively continuous or recurring symptoms who have a need to maintain therapeutic serum levels of Theolair NF. 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 Theolair NF preparation (or other bronchodilators) and not with extended-release products.
Patients who metabolize Theolair NF at a normal or slow rate are reasonable candidates for once-daily dosing with Theolair NF (Theolair NF anhydrous capsule) ®. Patients who metabolize Theolair NF 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 Theolair NF (Theolair NF 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 Theolair NF products at night (after the evening meal) results in serum concentrations of Theolair NF 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 Theolair NF 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
Theolair NF (Theolair NF anhydrous capsule) ® (when used as a once-a-day product) be administered at night.
Patients who require a relatively high dose of Theolair NF (i.e., a dose equal to or greater than 900 mg or 13 mg/kg, whichever is less) should not take Theolair NF (Theolair NF 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 Theolair NF as compared to administration in the fasted state.
The steady-state peak serum Theolair NF concentration is a function of the dose, the dosing interval, and the rate of Theolair NF absorption and clearance in the individual patient. Because of marked individual differences in the rate of Theolair NF clearance, the dose required to achieve a peak serum Theolair NF concentration in the 10-20 mcg/mL range varies fourfold among otherwise similar patients in the absence of factors known to alter Theolair NF 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 Theolair NF dose that will provide both safe and effective serum concentrations for all patients. Administration of the median Theolair NF dose required to achieve a therapeutic serum Theolair NF concentration in a given population may result in either sub-therapeutic or potentially toxic serum Theolair NF 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 Theolair NF 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 Theolair NF must be individualized on the basis of peak serum Theolair NF 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 Theolair NF concentrations to reach the new steady state. Dosage adjustment should be guided by serum Theolair NF 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 Theolair NF concentrations should be monitored at 6 month intervals for rapidly growing children and at yearly intervals for all others. In acutely ill patients, serum Theolair NF concentrations should be monitored at frequent intervals, e.g., every 24 hours.
Theolair NF 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 Theolair NF dosage adjustment based upon serum Theolair NF 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 Theolair NF concentration.
Table V. Dosing initiation and titration (as anhydrous Theolair NF).*
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 Theolair NF concentration measurement is indicated whenever adverse effects are present, physiologic abnormalities that can reduce Theolair NF clearance occur (e.g., sustained fever), or a drug that interacts with Theolair NF is added or discontinued.
How supplied
Theolair NF (Theolair NF anhydrous capsule) ® (Theolair NF anhydrous) is supplied in extended-release capsules containing 100, 200, 300 or 400 mg of anhydrous Theolair NF.
Theolair NF (Theolair NF anhydrous capsule) ® 100 mg capsules are yellow-orange and clear, with markings Theolair NF (Theolair NF anhydrous capsule), 100 mg, ucb, and 2832, supplied as:
NDC Number
Size
50474-100-01
bottle of 100
Theolair NF® 200 mg capsules are red-orange and clear, with markings Theolair NF, 200 mg, ucb, and 2842, supplied as:
NDC Number
Size
50474-200-01
bottle of 100
50474-200-50
bottle of 500
Theolair NF® 300 mg capsules are red and clear, with markings Theolair NF, 300 mg, ucb, and 2852, supplied as:
NDC Number
Size
50474-300-01 50474-300-50
bottle of 100 bottle of 500
Theolair NF® 400 mg capsules are pink and clear, with markings Theolair NF, 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.
Theolair NF interacts with a wide variety of drugs. The interaction may be pharmacodynamic, i.e., alterations in the therapeutic response to Theolair NF or another drug or occurrence of adverse effects without a change in serum Theolair NF concentration. More frequently, however, the interaction is pharmacokinetic, i.e., the rate of Theolair NF clearance is altered by another drug resulting in increased or decreased serum Theolair NF concentrations. Theolair NF 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 Theolair NF. The information in the “Effect ” column of Table II assumes that the interacting drug is being added to a steady-state Theolair NF regimen. If Theolair NF is being initiated in a patient who is already taking a drug that inhibits Theolair NF clearance (e.g., cimetidine, erythromycin), the dose of Theolair NF required to achieve a therapeutic serum Theolair NF concentration will be smaller. Conversely, if Theolair NF is being initiated in a patient who is already taking a drug that enhances Theolair NF clearance (e.g., rifampin), the dose of Theolair NF required to achieve a therapeutic serum Theolair NF concentration will be larger. Discontinuation of a concomitant drug that increases Theolair NF clearance will result in accumulation of Theolair NF to potentially toxic levels, unless the Theolair NF dose is appropriately reduced. Discontinuation of a concomitant drug that inhibits Theolair NF clearance will result in decreased serum Theolair NF concentrations, unless the Theolair NF dose is appropriately increased.
The drugs listed in Table III have either been documented not to interact with Theolair NF or do not produce a clinically significant interaction (i.e., < 15% change in Theolair NF 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 Theolair NF, especially with new chemical entities. The healthcare professional should not assume that a drug does not interact with Theolair NF if it is not listed in Table II. Before addition of a newly available drug in a patient receiving Theolair NF, 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 Theolair NF has been reported.
Table II. Clinically significant drug interactions with Theolair NF*.
Drug
Type of Interaction
Effect**
Adenosine
Theolair NF 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 Theolair NF clearance for up to 24 hours.
30% increase
Allopurinol
Decreases Theolair NF clearance at allopurinol doses ≥ 600 mg/day.
25% increase
Aminoglutethimide
Increases Theolair NF clearance by induction of microsomal enzyme activity.
25% decrease
Carbamazepine
Similar to aminoglutethimide.
30% decrease
Cimetidine
Decreases Theolair NF 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 Theolair NF blocks adenosine receptors.
Larger diazepam doses may be required to produce desired level of sedation. Discontinuation of Theolair NF without reduction of diazepam dose may result in respiratory depression.
Disulfiram
Decreases Theolair NF 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.
35% increase. Erythromycin steady-state serum concentrations decrease by a similar amount.
Estrogen
Estrogen containing oral contraceptives decrease Theolair NF clearance in a dose-dependent fashion. The effect of progesterone on Theolair NF 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, Theolair NF increases release of endogenous catecholamines.
Increased risk of ventricular arrhythmias.
Interferon, human recombinant alpha-A
Decreases Theolair NF clearance.
100% increase
Isoproterenol (IV)
Increases Theolair NF clearance.
20% decrease
Ketamine
Pharmacologic.
May lower Theolair NF seizure threshold.
Lithium
Theolair NF 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 Theolair NF 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 Theolair NF clearance.
25% decrease
Pancuronium
Theolair NF may antagonize non-depolarizing neuromuscular blocking effects, possibly due to phosphodiesterase inhibition.
Larger dose of pancuronium may be required to achieve neuromuscular blockade
Serum Theolair NF and phenytoin concentrations decrease about 40%.
Propafenone
Decreases Theolair NF clearance and pharmacologic interaction.
40% increase. Beta blockingeffect may decrease efficacy oftheophylline
Rifampin
Increases Theolair NF clearance by increasing cytochrome P450 1A2 and 3A3 activity.
20-40% decrease
St. John's Wort (Hypericum Perforatum)
Decrease in Theolair NF plasma concentrations.
Higher doses of Theolair NF may be required to achieve desired effect. Stopping St. John's Wort may result in Theolair NF toxicity.
Sulfinpyrazone
Increases Theolair NF clearance by increasing demethylation and hydroxylation. Decreases renal clearance of Theolair NF.
20% decrease
Tacrine
Similar to cimetidine, also increases renal clearance of Theolair NF.
90% increase
Thiabendazole
Decreases Theolair NF clearance.
190% increase
Ticlopidine
Decreases Theolair NF 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 Theolair NF concentration or other clinical effect for pharmacologic interactions. Individual patients may experience larger changes in serum Theolair NF concentration than the value listed.
Table III. Drugs that have been documented not to interact with Theolair NF or drugs that produce no clinically significant interaction with Theolair NF.*
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 Theolair NF 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 Theolair NF (Theolair NF 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 Theolair NF 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 Theolair NF levels may exceed the 20 mcg/mL level, above which Theolair NF toxicity is more likely to occur.
The Effect of Other Drugs on Theolair NF Serum Concentration Measurements
Most serum Theolair NF assays in clinical use are immunoassays which are specific for Theolair NF. 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 Theolair NF concentration.
Adverse reactions associated with Theolair NF are generally mild when peak serum Theolair NF concentrations are < 20 mcg/ mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak serum Theolair NF concentrations exceed 20 mcg/mL, however, Theolair NF 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 Theolair NF 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 Theolair NF therapy, caffeine-like adverse effects may transiently alter patient behavior, especially in school age children, but this response rarely persists. Initiation of Theolair NF 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 Theolair NF 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 Theolair NF therapy and the potential therapeutic benefit of alternative treatment.
Other adverse reactions that have been reported at serum Theolair NF 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 Theolair NF concentrations ≥ 15 mcg/mL. There have been a few isolated reports of seizures at serum Theolair NF concentrations < 20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum Theolair NF concentrations < 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum Theolair NF concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum Theolair NF concentrations < 20 mcg/mL have generally been milder than seizures associated with excessive serum Theolair NF 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 Theolair NF 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 Theolair NF 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 Theolair NF 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 Theolair NF concentrations > 30 mcg/mL among 6000 blood samples obtained for measurement of serum Theolair NF concentrations in three emergency departments. Differences in the incidence of manifestations of Theolair NF 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.
Do not take Theolair NF in larger or smaller amounts or for longer than recommended. Theolair NF 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 Theolair NF, 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 Theolair NF. 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 Theolair NF and call your doctor at once if you have severe or continued vomiting, rapid heartbeats, confusion, tremors, or seizure.
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).
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