OVERDOSE
: CYTOVENE-IV: Overdosage with CYTOVENE-IV has
been reported in 17 patients (13 adults and 4 children under
2 years of age). Five patients experienced no adverse events
following overdosage at the following doses: 7 doses of
11 mg/kg over a 3-day period (adult), single dose of 3500
mg (adult), single dose of 500 mg (72.5 mg/kg) followed
by 48 hours of peritoneal dialysis (4-month-old), single
dose of approximately 60 mg/kg followed by exchange transfusion
(18-month-old), 2 doses of 500 mg instead of 31 mg (21-month-old).
Irreversible pancytopenia developed in 1 adult with AIDS
and CMV colitis after receiving 3000 mg of CYTOVENE-IV
solution on each of 2 consecutive days. He experienced
worsening GI symptoms and acute renal failure that required
short-term dialysis. Pancytopenia developed and persisted
until his death from a malignancy several months later.
Other adverse events reported following overdosage included:
persistent bone marrow suppression (1 adult with neutropenia
and thrombocytopenia after a single dose of 6000 mg),
reversible neutropenia or granulocytopenia (4 adults,
overdoses ranging from 8 mg/kg daily for 4 days to a single
dose of 25 mg/kg), hepatitis (1 adult receiving 10 mg/kg
daily, and one 2 kg infant after a single 40 mg dose),
renal toxicity (1 adult with transient worsening of hematuria
after a single 500 mg dose, and 1 adult with elevated
creatinine (5.2 mg/dL) after a single 5000 to 7000 mg
dose), and seizure (1 adult with known seizure disorder
after 3 days of 9 mg/kg). In addition, 1 adult received
0.4 mL (instead of 0.1 mL) CYTOVENE-IV solution by intravitreal
injection, and experienced temporary loss of vision and
central retinal artery occlusion secondary to increased
intraocular pressure related to the injected fluid volume.
CYTOVENE Capsules: There have been no reports of overdosage
with CYTOVENE capsules. Doses as high as 6000 mg/day,
given either as 1000 mg 6 times daily or as 2000 mg tid,
did not result in overt toxicity other than transient
neutropenia. Daily doses of more than 6000 mg have not
been studied.
Since ganciclovir is dialyzable, dialysis may be useful
in reducing serum concentrations. Adequate hydration should
be maintained. The use of hematopoietic growth factors
should be considered.
CONTRAINDICATIONS
: CYTOVENE-IV and CYTOVENE are contraindicated in patients
with hypersensitivity to ganciclovir or acyclovir.
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