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Didanosine.

Structure

Didanosine 250 capsules:
- 250 mg - Didanosine

Didanosine 400 capsules:
- 400 mg - Didanosine

Indications

Didanosine in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection.

Dosage

Adults Didanosine Capsules should be swallowed intact.

Didanosine (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:
- > 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. Didanosine use should be discontinued in patients with confirmed pancreatitis.

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.

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:
- > 60 250 once daily;
- 30-59 - 200 once daily;
- 10-29 - 125 once daily;
- < 10 - 125 once daily;

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.

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.

Contraindications

Didanosine is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to any component of the formulation.

Form

Container of 30 capsules.

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2004 - 2017