Should theophyllines be sold over the counter?

1992 ◽  
Vol 30 (25) ◽  
pp. 99-100
Keyword(s):  
Therapeutic Range ◽  
Plasma Levels ◽  
Theophylline Concentration ◽  
Over The Counter ◽  
Plasma Theophylline

Theophylline preparations are difficult to use. Ideally doses should be adjusted to give a plasma theophylline concentration in the therapeutic range.1 This goal can be achieved when the drug is prescribed by a doctor and plasma levels are regularly measured.2 Problems could arise when these drugs are bought over the counter. This article discusses how difficulties can be avoided.

scholarly journals Studies on the Latex Agglutination Inhibition Method for Assay of Plasma Theophylline Concentration.

1996 ◽  
Vol 22 (4) ◽  
pp. 330-341
Author(s):  
JUNKO KIZU ◽  
SHIGEKAZU WATANABE ◽  
HIDEKI ONO ◽  
JUN INATOMI ◽  
KYOKO SASAKI ◽  
...  
Keyword(s):  
Latex Agglutination ◽  
Theophylline Concentration ◽  
Plasma Theophylline

Long-term weekly treatment of colorectal metastatic cancer with fluorouracil and leucovorin: results of a multicentric prospective trial of fluorouracil dosage optimization by pharmacokinetic monitoring in 152 patients.

1998 ◽  
Vol 16 (4) ◽  
pp. 1470-1478 ◽  
Author(s):  
E Gamelin ◽  
M Boisdron-Celle ◽  
R Delva ◽  
C Regimbeau ◽  
P E Cailleux ◽  
...  
Keyword(s):  
Therapeutic Range ◽  
Plasma Levels ◽  
Dose Adjustment ◽  
Metastatic Cancer ◽  
Prospective Trial ◽  
High Dose ◽  
High Survival ◽  
Time Curve ◽  
Minor Response ◽  
Grade 3

PURPOSE A relationship between fluorouracil (5-FU) dose and response has been previously shown in advanced colorectal cancer. In a previous study with 5-FU stepwise dose escalation in a weekly regimen, and pharmacokinetic monitoring, we defined a therapeutic range for 5-FU plasma levels: 2,000 to 3,000 microg/L (area under the concentration-time curve at 0 to 8 hours [AUC0-8], 16 to 24 mg x h/L). The current study investigated 5-FU therapeutic intensification with individual dose adjustment in a multicentric phase II prospective trial. PATIENTS AND METHODS Weekly high-dose 5-FU was administered by 8-hour infusion with 400 mg/m2 leucovorin. The initial dose of 5-FU (1,300 mg/m2) was adapted weekly according to 5-FU plasma levels, to reach the therapeutic range previously determined. RESULTS A total of 152 patients entered the study from December 1991 to December 1994: 117 patients with measurable metastatic disease and 35 with assessable disease. Toxicity was mainly diarrhea (39%, with 5% grade 3) and hand-foot syndrome (30%, with 2% grade 3). Among 117 patients with measurable disease, 18 had a complete response (CR), 48 a partial response (PR), 35 a minor response (MR) and stable disease (SD), and 16 progressive disease (PD). Median overall survival time was 19 months. The 5-FU therapeutic plasma range was rapidly reached with a variable 5-FU dose in the patient population: mean, 1,803 +/- 386 mg/m2/wk (range, 950 to 3,396). Thirteen patients were immediately in the toxic zone, whereas 51 required a > or = 50% dose increase. CONCLUSION Individual 5-FU dose adjustment with pharmacokinetic monitoring provided a high survival rate and percentage of responses, with good tolerance.

Bioavailability of a New Sustained-Release Anhydrous Theophylline Product

1996 ◽  
Vol 24 (4) ◽  
pp. 331-339 ◽  
Author(s):  
G Tatsis ◽  
G Tsoukalas ◽  
A Haviaras ◽  
A Peristerakis ◽  
V Filaditaki ◽  
...  
Keyword(s):  
Sustained Release ◽  
Adverse Reactions ◽  
Chronic Obstructive Lung Disease ◽  
New Product ◽  
Chronic Obstructive ◽  
Maximum Plasma ◽  
Theophylline Concentration ◽  
Time Curve ◽  
Plasma Theophylline ◽  
Anhydrous Theophylline

The bioavailability of a new sustained-release anhydrous theophylline product (Theophylline Lavipharm®) was evaluated and compared with the bioavailability of a well-established product, Theodur®. Two groups of 12 healthy non-smokers were given single doses of 200 or 300 mg of each product and two groups of 12 patients with asthma or chronic obstructive lung disease were given doses of 200 or 300 mg of each product every 12 h for 5-day periods. The values of the area under the plasma theophylline concentration against time curve (AUC), the maximum plasma theophylline concentration ( Cmax) and the time taken to reach Cmax (Tmax) for the two products did not differ significantly in the healthy groups or in the patients. The minimum and the average plasma theophylline concentrations and the fluctuation index were also calculated for the patients and there were no significant differences between the values for the two products. The new anhydrous theophylline product, Theophylline Lavipharm®, appears to show very similar bioavailability to Theodur®. No adverse reactions to the new product were reported.

Indirect Plasma-Theophylline Monitoring in Asthmatic Children by Determination of Theophylline Concentration in Saliva

PEDIATRICS ◽  
1974 ◽  
Vol 53 (6) ◽  
pp. 873-876
Author(s):  
Gerhard Levy ◽  
Elliot F. Ellis ◽  
Renu Koysooko
Keyword(s):  
Flow Rate ◽  
Maintenance Dose ◽  
Theophylline Concentration ◽  
Asthmatic Children ◽  
Plasma Theophylline ◽  
Mixed Saliva

The concentration of theophylline in mixed saliva and in plasma of 16 asthmatic children on regular theophylline therapy was obtained two and four hours after a maintenance dose. There is a strong and highly statistically significant correlation between the theophylline concentration in saliva and plasma. This correlation is not affected by the pH or flow rate of saliva. The concentration of theophylline in plasma could be predicted from the concentration in saliva within ± 10% in 20, and within ± 20% in all of the 32 samples. Determination of theophylline concentrations in saliva is an effective, convenient, noninvasive, and painless method for routine indirect monitoring of plasma-theophylline concentrations in asthmatic children on regular theophylline therapy.

Treatment of Chronic Obstructive Pulmonary Disease with Two Sustained-Release Theophylline Preparations

1987 ◽  
Vol 15 (6) ◽  
pp. 352-360
Author(s):  
S. Giosue' ◽  
D Bernocchi ◽  
D. Parola ◽  
R. Munno ◽  
P. Mancini
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Sustained Release ◽  
Slow Release ◽  
Chronic Obstructive ◽  
Theophylline Concentration ◽  
Obstructive Pulmonary Disease ◽  
Blood Samples ◽  
Theophylline Preparation ◽  
Plasma Theophylline ◽  
Sustained Release Theophylline

A sustained-release theophylline preparation in capsule form was compared with standard slow-release theophylline tablets for variation in plasma theophylline concentration, effectiveness and tolerability in 30 adults with chronic broncho-obstructive pathology. They were administered every 12 h and blood samples were collected after 8 days of treatment during the steady-state period. In this double-dummy crossover study, the sequence of the two regimens (sustained-release capsules versus tablets) was selected at random. The results of this study demonstrate that plasma theophylline levels remain within the therapeutic range for both preparations. Effectiveness and tolerability of the two drugs were satisfactory.

A Single-Blind Crossover Study of Two Different Slow Release Theophylline Preparations

1988 ◽  
Vol 16 (6) ◽  
pp. 452-458 ◽  
Author(s):  
G. Tatsis ◽  
J. Danos ◽  
M. Gaga ◽  
D. Pantelakis ◽  
M. Veslemes ◽  
...  
Keyword(s):  
Crossover Study ◽  
Adverse Reactions ◽  
Slow Release ◽  
Theophylline Concentration ◽  
Plasma Theophylline ◽  
Days Of Therapy ◽  
The Mean ◽  
Anhydrous Theophylline ◽  
Single Blind ◽  
Blind Crossover Study

In a single-blind crossover study, two slow release theophylline preparations were evaluated in 18 patients with chronic bronchitis or asthma without cardiac, renal or liver disease. After randomization into two groups, patients were treated, in a crossover study design, with 600 mg choline theophyllinate or 300 mg anhydrous theophylline administered orally every 12 h for 7 days. A 2-day washout period separated the two periods of treatment evaluation. Blood samples in which plasma theophylline concentration was to be measured were taken at 7.30 a.m., 2.00 p.m. and 7.30 p.m. during the last 5 days of therapy with each drug. The mean fluctuation in plasma theophylline concentration was ≤40% in all 18 patients taking choline theophyllinate yet in only 15 (83%) patients administered anhydrous theophylline. Salbutamol inhaler was more frequently required for the relief of bronchospasm when taking anhydrous theophylline than when taking choline theophyllinate (total of 41 vs 25 puffs, respectively, over 7 days). Drug-related adverse reactions occurred in four patients while taking anhydrous theophylline and in one patient while taking choline theophyllinate.

Frequent Toxicity from IV Aminophylline Infusions in Critically Ill Patients

1977 ◽  
Vol 11 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Leslie Hendeles ◽  
Lyle Bighley ◽  
Robert H. Richardson ◽  
Charles D. Hepler ◽  
Jan Carmichael
Keyword(s):  
Plasma Concentration ◽  
Strong Relationship ◽  
Constant Infusion ◽  
Poor Correlation ◽  
Chronic Obstructive ◽  
Strongly Correlated ◽  
Theophylline Concentration ◽  
Drug Induced ◽  
Obstructive Pulmonary Disease ◽  
Plasma Theophylline

Use of recommended IV aminophylline dosage regimens in 48 older, acutely ill, hospitalized patients with chronic obstructive pulmonary disease (COPD) resulted in excessive plasma theophylline concentrations in 29 percent of these patients. A mean dose of 0.89 mg/kg/hr produced a plasma concentration which ranged from 7 to 52 mcg/ml with a mean of 21.9 mcg/ml. Plasma theophylline concentration was determined spectrophotometrically from plasma samples drawn at least 12 hours after a loading dose and initiation of a constant infusion. Severity of toxicity strongly correlated with the plasma theophylline concentration in 18 patients. Nausea and/or vomiting preceded life-threatening drug-induced arrhythmias and seizures less than half the time. Tachycardia was found to be the most consistent symptom associated with toxicity. These patients had lower plasma clearances than otherwise healthy younger adult asthmatics and healthy volunteers. Toxicity and identifiable risk factors for excessive plasma levels strongly correlated with reduced plasma clearance. Dosage modifications based upon plasma clearances from COPD patients without concurrent functional abnormalities and those with liver dysfunction and cardiac decompensation ranged from 0.7 to 0.12 mg/kg/hr. This study clearly demonstrates the poor correlation between dose and plasma concentration and the strong relationship between toxicity and plasma concentration. These results as well as those previously reported mandate that the relatively simple, rapid and inexpensive theophylline plasma measurement be used in all patients receiving IV aminophylline for longer than 24 hours in order to prevent toxicity.

Cardiotoxic Effects in Rats and Rabbits Treated with Terbutaline Alone and in Combination with Aminophylline

1983 ◽  
Vol 2 (2) ◽  
pp. 147-153 ◽  
Author(s):  
Virgil E. Whitehurst ◽  
Xavier Joseph ◽  
John R. Hohmann ◽  
Gordon Pledger ◽  
Tibor Balazs
Keyword(s):  
Plasma Levels ◽  
Beta Adrenoceptor ◽  
Adrenoceptor Agonist ◽  
Plasma Theophylline ◽  
Cardiac Lesions ◽  
Dose Dependent ◽  
Myocardial Lesions

Studies were conducted to determine the myocardial effects of a selective beta-adrenoceptor agonist, terbutaline, administered alone and in combination with aminophylline in the 4-to 5-month-old, 500-600 g (heavy) rat and the rabbit, using electrocardiographic and histopathological methods. Terbutaline given at high (5.0 mg/kg) and low (0.1 mg/kg) doses was not arrhythmogenic in the heavy rat; however, dose-dependent myocardial lesions were observed. Terbutaline given at the same doses to heavy rats pretreated with aminophylline was arrhythmogenic and produced severe cardiac lesions. Rats administered aminophylline at a dose of 18.75 mg/kg had plasma theophylline levels of 15-22 μg/ml; these concentrations are similar to the recommended human therapeutic levels, i.e., 10-20 μg/ml. The administration of terbutaline in conjunction with aminophylline did not seem to affect the plasma levels of theophylline. No arrythmias were detected in rabbits given terbutaline alone or in combination with aminophylline and no deaths occurred.

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