Ditanex-100
Tablets
Warning
PANCREATITIS, WHICH HAS BEEN
FATAL IN SOME CASES, HAS OCCURRED DURING
THERAPY WITH DIDANOSINE. DIDANOSINE USE SHOULD BE
SUSPENDED IN PATIENTS
WITH SIGNS OR SYMPTOMS OF PANCREATITIS AND
DISCONTINUED IN PATIENTS
WITH CONFIRMED PANCREATITIS (SEE WARNINGS AND
PRECAUTIONS). LACTIC
ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS
INCLUDING FATAL CASES
HAVE BEEN REPORTED WITH THE USE OF ANTIRETROVIRAL
NUCLEOSIDE
ANALOGUES ALONE OR IN COMBINATION, INCLUDING
DIDANOSINE
Composition
Each chewable tablet
contains: Didanosine 100 mg
Description
Didanosine (formerly called
dideoxyinosine-ddI) is a synthetic purine nucleoside
analogue of the naturally occurring nucleoside
deoxyadenosine, in which the 3'' hydroxyl group is
replaced by hydrogen. Intracellularly, didanosine is
converted by cellular enzymes to the active
metabolite, dideoxyadenosine 5''-triphosphate. This
metabolite inhibits the activity of HIV-1 reverse
transcriptase both by competing with the natural
substrate, and by its incorporation into viral DNA.
The lack of a 3''-hydroxyl group in the incorporated
nucleoside analogue prevents DNA chain elongation
and therefore, the viral DNA growth is terminated.
Indications
Ditanex-100
is indicated for the treatment of HIV infection when
antiretroviral
therapy is warranted.
Dosage and
Administration
Adults: Dosage:
The dosing interval should be 12 hours. Didanosine
should be administered on an empty stomach, at least
30 minutes before or 2 hours after eating. Adult
patients should take 2 tablets at each dose so that
adequate buffering is provided to prevent gastric
acid degradation of didanosine. No more than 4
tablets should be taken at each dose to reduce the
risk of gastrointestinal side effects. The
recommended starting dose in adults is dependent on
weight, as outlined in the table below:
|
Table 1: Adult Dosing
|
|
Patient Weight
|
Didanosine Tablets
|
|
> 60 kg
|
200 mg b.d.
|
|
< 60 kg
|
125 mg b.d.
|
Administration:
For full therapeutic effect, 2 tablets must be
thoroughly chewed, crushed or dispersed in water
before swallowing. The tablets should not be
swallowed whole. To disperse the tablets, 2 tablets
should be added to 2 tablespoons (30 ml) of water.
The water should then be
stirred until a uniform dispersion forms. The entire
dispersion should be swallowed immediately.
Dose Adjustment: Clinical signs suggestive
of pancreatitis should prompt dose suspension and
careful evaluation of the possibility of
pancreatitis. Didanosine use should be discontinued
in patients with confirmed pancreatitis.
Patients who have presented with symptoms of
neuropathy may tolerate a reduced dose of didanosine
after resolution of these symptoms upon drug
discontinuation.
In adult patients with impaired renal function, the
dose of didanosine should be adjusted to compensate
for the slower rate of elimination. The recommended
doses and dosing intervals of didanosine in adult
patients with renal insufficiency are given in the
table below:
|
Table 2: Recommended dose (mg) of didanosine
by body weight
|
|
Creatinine Clearance (mL/min)
|
> 60 kg
|
< 60 kg
|
Interval (hr)
|
|
> 60 kg
|
200
|
125
|
12
|
|
30-59
|
100
|
75
|
12
|
|
10-29
|
150
|
100
|
24
|
|
< 10
|
100
|
75
|
24
|
Patients requiring
continuous ambulatory peritoneal dialysis (CAPD) or
hemodialysis: It is recommended that one-fourth
of the total daily dose of didanosine be
administered once a day (See Table 2, recommended
dosage for patients with CLCR < 10 mL/min). It is
not necessary to administer a supplemental dose of
didanosine following hemodialysis.
PAEDIATRICS
Dosage: The recommended dose is 120 mg/m2
twice daily. Didanosine should be administered on an
empty stomach, 30 minutes before or 2 hours after
food. Tablets should be crushed, chewed or dispersed
in water, as described for adults. Use at least 2
tablets per dose to provide adequate
buffering. Maximum 4 tablets per dose.
Contraindications
Ditanex-100
is contraindicated in patients with previously
demonstrated clinically significant hypersensitivity
to any of the components of the formulation.
Presentation:
Ditanex-100
Container pack of 60 tablets
|
