Adults
DINEX EC Capsules should be swallowed intact.
DINEX EC (didanosine) should be administered on an empty stomach, at least 30minutes before or 2 hours after a meal. The recommended daily dose is dependent on body weight and is administered as one capsule given on a once-daily schedule:
Patient Weight |
Dosage |
≥ 60 kg |
400 mg once daily |
< 60 kg |
250 mg once daily |
Dose adjustment: Clinical and laboratory signs suggestive of pancreatitis showed prompt dose suspension and careful evaluation of the possibility of pancreatitis. DINEX EC use should be discontinued in patients with confirmed pancreatitis. (See Warnings and Precautions: Drug Interactions)
Based on data with buffered didanosine formulations, patients with symptoms of peripheral neuropathy may tolerate a reduced dose of didanosine-delayed release, after resolution of the symptoms of peripheral neuropathy upon drug interruption. If neuropathy recurs after resumption of the drug, permanent discontinuation should be considered.
Concomitant therapy: Tenofovir disoproxil fumarate. A dose reduction of DINEX EC to 250 mg (adults weighing ³ 60 kg with creatinine clearance ³ 60 mL/min) or 200 mg (adults weighing <60 kg with creatinine clearance ³ 60 mL/min) once daily taken together with tenofovir and a light meal ( £ 400 kcalories, £ 20% fat) or in the fasted state is recommended. The appropriate dose of DINEX EC co-administered with tenofovir in patients with creatinine clearance <60 mL/min has not been established.
Renal impairment
Dosing recommendations for the enteric-coated and buffered formulations are different for patients with renal impairment.
In adult patients with impaired renal function, the dose of the enteric-coated formulation should be adjusted to compensate for the slower rate of elimination. The recommended doses and dosing intervals of this formulation in adult patients with renal insufficiency are given in table 2.
Table 2: Recommended dosage of didanosine in Renal Impairment by body weight a
Creatinine clearance (mL/min) |
Dosage |
|
≥ 60 kg |
< 60 kg |
≥ 60 |
400 once daily |
250 once daily |
30-59 |
200 once daily |
125 once daily |
10-29 |
125 once daily |
125 once daily |
< 10 |
125 once daily |
b |
- Based on studies using a buffered formulation of didanosine.
- Not suitable for use in patients < 60 kg with CL CR < 10 ml/min. An alternate formulation of didanosine should be used.
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Patients requiring continuous ambulatory peritoneal dialysis (CAPD) or Hemodialysis:
For patients requiring CAPD or haemodialysis, follow dosing recommendations for patients with creatinine clearance less than 10 ml/min, shown in the table 2.
It is not necessary to administer a supplemental dose of didanosine following hemodialysis.
Hepatic Impairment and Toxicity: See WARNINGS AND PRECAUTIONS .
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