Didanosine


Concise Prescribing Info
Indications/Uses
HIV-1 infection.
Dosage/Direction for Use
Adult : PO Given w/ other antiretrovirals: As tab/soln: <60 kg: 125 mg 12 hrly or 250 mg once daily; ≥60 kg: 200 mg 12 hrly or 400 mg once daily. As cap: 20-<25 kg: 200 mg once daily; 25-<60 kg: 250 mg once daily; ≥60 kg: 400 mg once daily.
Dosage Details
Oral
HIV-1 infection
Adult: Given in combination w/ other antiretrovirals: As chewable or dispersible tab/soln: <60 kg: 125 mg 12 hrly or 250 mg once daily; ≥60 kg: 200 mg 12 hrly or 400 mg once daily. As delayed-release cap: 20-<25 kg: 200 mg once daily; 25-<60 kg: 250 mg once daily; ≥60 kg: 400 mg once daily.
Child: Given in combination w/ other antiretrovirals: As soln: ≥3-≤8 mth 100 mg/m2 12 hrly. >8 mth 120 mg/m2 12 hrly, not exceeding adult dose. As chewable or dispersable tab: >3 mth 240 mg/m2 daily. As delayed-release cap: >6 yr Same as adult dose.
Renal Impairment
As chewable or dispersible tab/soln:
<60 kg:
CrCl (mL/min) Dosage
<10 75 mg once daily.
10-29 100 mg once daily.
30-59 150 mg in 1-2 divided doses.
≥60 kg:
<10 100 mg once daily.
10-29 150 mg once daily.
30-59 200 mg in 1-2 divided doses.

As delayed-release cap:
<60 kg:
<10 Contraindicated.
10-59 125 mg once daily.
≥60 kg:
<30 125 mg once daily.
30-59 200 mg once daily.
Administration
Should be taken on an empty stomach. Take 30 min before or 2 hr after meals.
Contraindications
Hypersensitivity to didanosine. Renal (CrCl <10 mL/min) impairment (delayed-release cap). Lactation. Concomitant use w/ allopurinol, ribavirin, tenofovir, stavudine, and hydroxyurea.
Special Precautions
Patient w/ history and risk of pancreatitis, history of neuropathy, hepatomegaly. Hepatic (e.g. chronic active hepatitis) and renal impairment. Childn. Pregnancy.
Adverse Reactions
Significant: Peripheral neuropathy, immune reconstitution syndrome, fat redistribution (e.g. central obesity, peripheral and facial wasting, breast enlargement, buffalo hump, cushingoid appearance), osteonecrosis. Rarely, retinal changes (e.g. depigmentation), optic neuritis.
Nervous: Headache, anxiety, insomnia, irritability, restlessness, seizures, fatigue, asthenia.
CV: Increased risk of MI, cardiomyopathy.
GI: Diarrhoea, nausea, vomiting, abdominal pain, anorexia, constipation, dyspepsia, dry mouth, flatulence, parotid gland enlargement, sialedenitis.
Hepatic: Hepatitis, abnormal LFT.
Endocrine: DM, hypo- and hyperglycaemia, hypertriglyceridaemia, hypercholesterolaemia, insulin resistance, hyperlactataemia, hyperuricaemia.
Haematologic: Anaemia, leucopenia, thrombocytopenia.
Musculoskeletal: Increased creatine phosphokinase, myalgia, arthralgia, myopathy, myositis, rhabdomyolysis.
Ophthalmologic: Diplopia, dry eyes, optic atrophy, blindness.
Dermatologic: Rash, alopecia, pruritus, mild erythematous macular eruption.
Immunologic: Anaphylaxis.
Others: Chills, fever, hypokalaemia, pain.
Potentially Fatal: Pancreatitis, lactic acidosis associated w/ hepatomegaly and steatosis. Rarely, noncirrhotic portal HTN, hepatic failure.
MonitoringParameters
Monitor serum K, uric acid, creatinine, Hb, CBC w/ neutrophil and platelet count, CD4 cells, viral load, LFT, serum bilirubin, albumin, INR, amylase, wt gain. Monitor for signs and symptoms of peripheral neuropathy, hepatotoxicity, GI pain, and visual changes regularly during therapy. Perform dilated retinal exam every 6 mth.
Overdosage
Symptoms: Pancreatitis, peripheral neuropathy, diarrhoea, hyperuricaemia and hepatic dysfunction. Management: Supportive and symptomatic treatment. Induce emesis or perform gastric lavage.
Drug Interactions
Decreased plasma concentration w/ methadone. Increased plasma concentration w/ ganciclovir and valganciclovir. Decreased effects of quinolones, tetracyclines, ketoconazole w/ buffered didanosine preparations. Increased risk of pancreatitis when used w/ pentamidine. Increased bioavailability of didanosine when concomitantly used w/ antacid.
Potentially Fatal: Increased toxicity w/ allopurinol. Increased plasma concentration and risk of adverse effects (hepatic failure, peripheral neuropathy, pancreatitis, lactic acidosis) w/ ribavirin, tenofovir, stavudine, and hydroxyurea.
Food Interaction
Food decreases rate of absorption. Enhanced adverse effects w/ alcohol.
Action
Description: Didanosine is converted intracellularly to dideoxyadenosine triphosphate which inhibits HIV nucleoside reverse transcriptase, hence blocking viral DNA synthesis and suppressing HIV replication.
Pharmacokinetics:
Absorption: Rapidly hydrolysed in the gastric acid. Reduced bioavailability w/ food. Bioavailability: 20-40%. Time to peak plasma concentration: Approx 1 hr.
Distribution: Extensive intracellular distribution. Crosses placenta and distributed into cord blood and amniotic fluid. Plasma protein binding: <5%.
Metabolism: Undergoes intracellular phosphorylation to the active metabolite, dideoxyadenosine triphosphate.
Excretion: Via urine (20% as unchanged drug). Elimination half-life: Approx 1.5 hr.
Chemical Structure

Click on icon to see table/diagram/image
Storage
Tab/Oral Soln: Store between 15-30°C. Cap: Store at 25°C.
MIMS Class
ATC Classification
J05AF02 - didanosine ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.
Disclaimer: This information is independently developed by MIMS based on Didanosine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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