Hemodialysis is about as efficient as multiple-dose oral activated charcoal and has a lower risk of serious complications than charcoal hemoperfusion. Administration of the median Theophylline dose required to achieve a therapeutic serum Theophylline concentration in a given population may result in either sub-therapeutic or potentially toxic serum Theophylline concentrations in individual patients. Application of these general dosing recommendations to individual patients must take into account the unique clinical characteristics of each patient. In general, maintaining peak serum Theophylline concentrations between 10 and 15 mcg/mL will achieve most of the drug's potential therapeutic benefit while minimizing the risk of serious adverse events. Similarly, a patient with decreased Theophylline binding may have a sub-therapeutic total drug concentration while the pharmacologically active unbound concentration is in the therapeutic range. Geriatric The clearance of Theophylline is decreased by an average of 30% in healthy elderly adults (> 60 yrs) compared to healthy young adults. General: The chronicity and pattern of Theophylline overdosage significantly influences clinical manifestations of toxicity, management and outcome. Institute extracorporeal removal if emesis, seizures, or cardiac arrhythmias cannot be adequately controlled (see OVERDOSAGE, Extracorporeal Removal). Decrease dose by 25% even if no adverse effects are present. for these treatments were 73.3 mcg x hr/mL and 82.2 mcg x hr/mL, respectively. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Significant reduction in Theophylline clearance, however, has been reported in women on the 20th day of the menstrual cycle and during the third trimester of pregnancy. Theophylline has been studied in Ames salmonella, in vivo and in vitro cytogenetics, micronucleus and Chinese hamster ovary test systems and has not been shown to be genotoxic. Dispense in a tight, light-resistant container as defined in the USP. 1. The dose of Theophylline must be individualized on the basis of peak serum Theophylline concentration measurements in order to achieve a dose that will provide maximum potential benefit with minimal risk of adverse effects. The 10-mg tablets are round, white to off-white, scored on one side and the other side debossed with "J95". Other factors associated with decreased Theophylline clearance include the third trimester of pregnancy, sepsis with multiple organ failure, and hypothyroidism. Theophylline has two distinct actions in the airways of patients with reversible obstruction; smooth muscle relaxation (i.e., bronchodilation) and suppression of the response of the airways to stimuli (i.e., non-bronchodilator prophylactic effects). At serum Theophylline concentrations > 20 mcg/mL, both the frequency and severity of adverse reactions increase. Increases in the dose of Theophylline should not be made in response to an acute exacerbation of symptoms of chronic lung disease since Theophylline provides little added benefit to inhaled beta2-selective agonists and systemically administered corticosteroids in this circumstance and increases the risk of adverse effects. The Effect Of Other Drugs On Theophylline Serum Concentration Measurements: Most serum Theophylline assays in clinical use are immunoassays which are specific for Theophylline. (see PRECAUTIONS, Drug Interactions, Table II). If you miss a dose, skip the missed dose and take your next dose at the regular time. Taking Theophylline extended-release tablets immediately after a high-fat content meal may result in a somewhat higher Cmax and delayed Tmax and somewhat greater extent of absorption. Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 Benzodiazepines increase CNS concentrations of adenosine, a potent CNS depressant, while Theophylline blocks adenosine receptors. As the rate of Theophylline clearance may be dose-dependent (i.e., steady-state serum concentrations may increase disproportionately to the increase in dose), an increase in dose based upon a sub-therapeutic serum concentration measurement should be conservative. 5. In the second study (Study #2 - Sessler, Am J Med 1990;88:567-76), data were retrospectively collected from 116 cases with serum Theophylline concentrations >30 mcg/mL among 6000 blood samples obtained for measurement of serum Theophylline concentrations in three emergency departments. The maximum daily dose of Theophylline in patients greater than 60 years of age ordinarily should not exceed 400 mg/day unless the patient continues to be symptomatic and the peak steady-state serum Theophylline concentration is <10 mcg/mL (see DOSAGE AND ADMINISTRATION). General anesthesia should be used with caution in patients with Theophylline overdose because fluorinated volatile anesthetics may sensitize the myocardium to endogenous catecholamines released by Theophylline. 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 (see WARNINGS). Administer a single dose of oral activated charcoal. A high carbohydrate/low protein diet can decrease the clearance and prolong the half-life of Theophylline. D. Loading Dose for Acute Bronchodilatation: An inhaled beta-2 selective agonist, alone or in combination with a systemically administered corticosteroid, is the most effective treatment for acute exacerbations of reversible airways obstruction. In patients with reduced protein binding, measurement of unbound serum Theophylline concentration provides a more reliable means of dosage adjustment than measurement of total serum Theophylline concentration. In these patients a slow release formulation would allow a longer dosing interval (8-12 hours) with a smaller peak/trough difference. While simultaneously instituting treatment, contact a regional poison center to obtain updated information and advice on individualizing the recommendations that follow. Patients receiving Theophylline tablets may pass an intact matrix tablet in the stool or via colostomy. They are available as follows: Bottles of 100 NDC 60793-104-01. Some drugs (e.g., cefazolin, cephalothin), however, may interfere with certain HPLC techniques. Initiation of Theophylline 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 (see DOSAGE AND ADMINISTRATION, Table V). The Effect of Other Drugs on Theophylline Serum Concentration Measurements: Most serum Theophylline assays in clinical use are immunoassays which are specific for Theophylline. For example, at a dose of 900 mg/d in adults <60 years or 22 mg/kg/d in children 1-9 years, the steady-state peak serum Theophylline 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. Theophylline clearance has been shown to increase by approximately 50% in young adult tobacco smokers and by approximately 80% in elderly tobacco smokers compared to non-smoking subjects. 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