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aminophylline injection, USP Adverse Reactions

ADVERSE REACTIONS

Adverse reactions associated with theophylline are generally mild when peak serum theophylline concentrations are <20 mcg/mL and mainly consist of transient caffeine-like adverse effects such as nausea, vomiting, headache, and insomnia. When peak 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 <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 ≥15 mcg/mL. There have been a few isolated reports of seizures at serum theophylline concentrations <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 <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 <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).

Products containing aminophylline may rarely produce severe allergic reactions of the skin, including exfoliative dermatitis, after systemic administration in a patient who has been previously sensitized by topical application of a substance containing ethylenediamine. In such patients skin patch tests are positive for ethylenediamine, a component of aminophylline, and negative for theophylline. Pharmacists and other individuals who experience repeated skin exposure while physically handling aminophylline may develop a contact dermatitis due to the ethylenediamine component.

Table IV. Manifestations of Theophylline Toxicity* Percentage of Patients Reported With Sign or Symptom
*  These data are derived from two studies in patients with serum theophylline 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 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 >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.
** NR = Not reported in a comparable manner.

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

2

  21

12

 14

        tachycardias

   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

7

 14

 40

0

        hemodynamic instability

   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

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