Indications
Dinex EC Tablet is used for:
HIV infection
Adult Dose
HIV Infection
<60 kg: Extended-release 250 mg PO qDay; 125 mg PO q12hr
>60 kg: Extended-release 400 mg PO qDay; suspension 200 mg PO q12hr
Dosage Modifications
Coadministration with tenofovir
>60 kg: Decrease didanosine dose to 250 mg/day
<60 kg: Decrease didanosine dose to 200 mg/day
Child Dose
HIV Infection
Indicated for treatment of HIV infection in combination with other antiretroviral agents
Oral solution
NIH HIV guidelines (March 2016)
2 weeks to <3 months: 50 mg/m² PO q12hr
3-8 months: 100 mg/m² PO q12hr
>8 months: 120 mg/m² (range 90-150 mg/m²) PO q12hr
Manufacturer prescribing information
2 week to 8 months: 100 mg/m² PO q12hr
>8 months: 120 mg/m² PO q12hr
Capsule
Weight-based dosing (6-18 years)
Children who can safely swallow enteric-coated beadlets or delayed-release capsules
20 to <25 kg: 200 mg PO qDay
25 to <60 kg: 250 mg PO qDay
>60 kg: As adults; 400 mg PO qDay (oral suspension: 200 mg PO q12hr)
Renal Dose
>60 kg
CrCl >60 mL/min: Normal dose
CrCl 30-59 mL/min: 200 mg PO qDay (extended release/solution) or divided q12hr (solution only)
CrCl 10-29 mL/min: 125 mg (extended release) or 150 mg (solution) PO qDay
CrCl <10 mL/min; PD/HD: 125 mg (extended release) or 100 mg (solution) PO qDay
<60 kg
CrCl >60 mL/min: Normal dose
CrCl 30-59 mL/min: Extended release 125 mg PO qDay; solution 150 mg PO qDay or divided q12hr
CrCl 10-29 mL/min: 125 mg (extended release) or 100 mg (solution) PO qDay
CrCl <10 mL/min; PD/HD: Solution only: 75 mg PO qDay
Administration
Should be taken on an empty stomach. Take on an empty stomach ½ hr before or 2 hr after meals.
Contra Indications
Hypersensitivity; lactation.
Precautions
History of pancreatitis and liver disease; pregnancy; impaired hepatic and renal function; peripheral neuropathy; hyperuricaemia. Half-yrly dilated retinal examinations are recommended. May be associated with the development of non-cirrhotic portal hypertension; monitor patients for the development of portal hypertension and oesophageal varices. Suspend use in patients with suspected pancreatitis and discontinue use in patients with confirmed pancreatitis. Suspend use in patients who develop clinical symptoms or signs with or without laboratory findings of lactic acidosis and severe hepatomegaly with steatosis. Consider usage discontinuation or interruption in patients with worsening liver disease. Patients may develop peripheral neuropathy, retinal changes and optic neuritis, immune reconstitution syndrome and redistribution/accumulation of body fat.
Lactation: Not known whether distributed into milk. Because of both the potential for HIV transmission and the potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed.
Pregnancy-Lactation
Interactions
Increased effect with allopurinol and ganciclovir; hydroxyurea; increased toxicity with ribavirin or tenofovir. Decreased effects of quinolones, tetracyclines, indinavir. Increased risk of pancreatitis when used with pentamidine, stavudine or co-trimoxazole. Increased risk of liver toxicity when used with other antiretroviral agens, hydroxyurea or ribavirin.
Adverse Effects
Side effects of Didanosine :
>10%
Diarrhea (19-28%),Peripheral neuropathy (17-20%),Increased amylase (15-17%),Abdominal pain (7-13%)
1-10%
Increased LFT,Increased uric acid,Pancreatitis (patients >65 years had higher frequency of pancreatitis than younger patients),Pruritus,Rash
Mechanism of Action
Didanosine is a nucleoside reverse transcriptase inhibitor that inhibits DNA synthesis of retroviruses by competitive inhibition of reverse transcriptase and incorporation into viral DNA.
Note
Dinex EC 400mg Tablet manufactured by Cipla Ltd.. Its generic name is Didanosine. Dinex EC is availble in Nepal.
Farmaco Nepal drug index information on Dinex EC Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.