Videx EC

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Didanosine 200mg;  

Available from:

Bristol-Myers Squibb (NZ) Limited

INN (International Name):

Didanosine 200 mg

Dosage:

200 mg

Pharmaceutical form:

Capsule

Composition:

Active: Didanosine 200mg   Excipient: Carmellose sodium Diethyl phthalate Gelatin Methacrylic acid copolymer Purified talc Sodium starch glycolate TekPrint green SB-4020 Titanium dioxide

Units in package:

Blister pack, 30 capsules

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Bristol-Myers Squibb Barceloneta Inc

Therapeutic indications:

Videx EC in combination with other antiretroviral drugs, is indicated for the treatment of HIV infected adults.

Product summary:

Package - Contents - Shelf Life: Blister pack, - 30 capsules - 18 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 30 capsules - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 60 capsules - 36 months from date of manufacture stored at or below 25°C

Authorization date:

2000-08-10

Summary of Product characteristics

Videx EC vs 4
page 1 of 15
DATA SHEET
1.
PRODUCT NAME
VIDEX EC

400 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Videx 400 mg hard capsules
Each hard capsule contains 400 mg of didanosine.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hard capsule
400 mg: capsules are opaque white and embossed in red with "6674" on
one half, and "BMS 400
mg" on the other half.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Videx EC in combination with other antiretroviral medicines, is
indicated for the treatment of HIV
infected adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE: ADULTS
Videx EC capsules should be administered on an empty stomach. Videx EC
capsules should be
swallowed intact. The recommended daily dose is dependent on body
weight and is administered as one
capsule given on a once daily schedule as outlined in Table 1.
Videx EC vs 4
page 2 of 15
TABLE 1:
PATIENT BASELINE WEIGHT
VIDEX EC CAPSULES
< 60kg
250mg OD

60kg
400mg OD
ADULT PATIENTS WITH RENAL IMPAIRMENT:
In adult patients with impaired renal function, the dose of Videx EC
should be adjusted to compensate
for the slower rate of elimination. The recommended doses and dosing
intervals of Videx E
C
in adult
patients with renal insufficiency are presented in Table 2.
TABLE 2. RECOMMENDED DOSAGE IN PATIENTS WITH RENAL IMPAIRMENT BY BODY
WEIGHT
A
CREATININE CLEARANCE
(ML/MIN)
DOSAGE (MG)
AT LEAST 60KG
LESS THAN 60KG
at least 60
400 once daily
250 once daily
30-59
200 once daily
125 once daily
10-29
125 once daily
125 once daily
Videx EC vs 4
page 3 of 15
Less than 10
125 once daily
b
a
Based on studies using buffered formulation of didanosine
b
Not suitable for use in patients less than 60kg with CL
cr
less then 10mL/min.
For patients requiring CAPD or haemodialysis, follow dosing
recommendations for patients with
creatinine clearance less than 10mL/min, shown in Table 2. It is not
necessary to administer a
supplemental dose of didanosine following haemodialysis.
4.3
CONTRAINDICATIONS
Videx
EC
is
contraindic