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Theophylline Injection (Theophylline Injection) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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

Other adverse reactions that have been reported at serum theophylline concentrations less than 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 concentrations greater than or equal to 15 mcg/mL. There have been a few isolated reports of seizures at serum theophylline concentrations less than 20 mcg/mL in patients with an underlying neurological disease or in elderly patients. The occurrence of seizures in elderly patients with serum theophylline concentrations less than 20 mcg/mL may be secondary to decreased protein binding resulting in a larger proportion of the total serum theophylline concentration in the pharmacologically active unbound form. The clinical characteristics of the seizures reported in patients with serum theophylline concentrations less than 20 mcg/mL have generally been milder than seizures associated with excessive serum theophylline concentrations resulting from an overdose (i.e., they have generally been transient, often stopped without anticonvulsant therapy, and did not result in neurological residua). There have been reports of non-convulsive status epilepticus in patients receiving theophylline, and this possibility should be considered in patients with abnormal central nervous system function and a history of theophylline administration. Hypercalcemia has been reported in a patient with hyperthyroid disease at therapeutic theophylline concentrations (see OVERDOSAGE).

 Table IV. Manifestations of theophylline toxicity. 1
   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 2  0  NR 6
Gastrointestinal       
 Vomiting 73  93  30 61
 Abdominal Pain NR   21 NR  12
 Diarrhea  NR 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

1 These data are derived from two studies in patients with serum theophylline concentrations greater than 30 mcg/mL. In the first study (Study #1 - Shanon, Ann lntern Med 1993;119:1161–67), data were prospectively collected from 249 consecutive cases of theophylline 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 concentrations greater than 30 mcg/mL among 6000 blood samples obtained for measurement of serum theophylline concentrations in three emergency departments. Differences in the incidence of manifestations of theophylline 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.
2 NR = Not reported in a comparable manner.

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.

Drug label data at the top of this Page last updated: 2012-05-02

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