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SIDE EFFECTS

CAUTION: Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the I.M. and I.V. routes. The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated.

Of 424 patients treated with pentamidine isethionate, 244 (57.5%) developed some adverse reaction. Most of the patients had the acquired immunodeficiency syndrome (AIDS). In the following table, ''Severe'' refers to life- threatening reactions or reactions that required immediate corrective measures and led to discontinuation of pentamidine isethionate.

Adverse Reactions Number

%

Severe
Leukopenia (< 1000/ mm³)

12

2.8

Hypoglycemia (< 25 mg/dL)

10

2.4

Thrombocytopenia (< 20,000/mm³)

7

1.7

Hypotension (< 60 mm Hg systolic)

4

0.9

Acute renal failure
(serum creatinine >6 mg/ dL)

2

0.5

Hypocalcemia

1

0.2

Stevens- Johnson syndrome

1

0.2

Ventricular tachycardia

1

0.2

Total number of patients with
severe effects*

37

8.7

Moderate
Elevated serum
creatinine (2.4 to 6.0 mg/dL)

98

23.1

Sterile abscess, pain, or induration
at the site of I.M. injection

47

11.1

Elevated liver function tests

37

8.7

Leukopenia

32

7.5

Nausea, anorexia

25

5.9

Hypotension

17

4.0

Fever

15

3.5

Hypoglycemia

15

3.5

Rash

14

3.3

Bad taste in mouth

7

1.7

Confusion/ hallucinations

7

1.7

Anemia

5

1.2

Neuralgia

4

0.9

Thrombocytopenia

4

0.9

Hyperkalemia

3

0.7

Phlebitis

3

0.7

Dizziness (without hypotension)

2

0.5

Other moderate adverse reactions**

5

1.2

Total number of patients with
moderate adverse reactions*

207

48.8

      * Patient total may not equal sum of reactions, since some patients had more than one reaction.
      ** Each of the following moderate adverse reactions was reported in one patient : Hypocalcemia, abnormal ST segment of electrocardiogram, bronchospasm, diarrhea, and hyperglycemia.

DRUG INTERACTIONS

Brand Name: Nebupent
Generic Name: Pentamidine Isethionate

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