Notify your doctor immediately if you experience: severe diarrhea, stomach pain, nausea, vomiting, tingling, numbness or pain in your hands or feet, yellowing of eyes or skin, unusual bleeding or bruising, dark urine or rapid breathing.

In the unlikely event you have an allergic reaction to this drug, seek immediate medical attention.

Symptoms of an allergic reaction include rash, itching, swelling, dizziness or breathing trouble.

Precautions:

tell your doctor if you have a history of pancreatic disease or tingling of the hands or feet (called peripheral neuropathy).

Also mention if you have: a history of kidney disease, liver disease, are on a sodium restricted diet, heart disease, any major surgery/infection/injury, alcohol usage and of any allergies.

Before using didanosine, tell your doctor if you are pregnant.

It is not known if didanosine is excreted into breast milk.

Because breast milk can transmit HIV, do not breast-feed.

Avoid alcohol because it may worsen pancreatitis.

Generic Name: Didanosine

Videx 100 mg Packet - Prescription

Videx 167 mg Packet - Prescription

Videx 250 mg Packet - Prescription

didanosine

Therapeutic Products Directorate (TPD) and Biologic and Genetic Therapies Directorate (BGTD) posts safety alerts, public health advisories, press releases and other notices from industry as a service to health professionals, consumers, and other interested parties.
Potentially fatal hepatotoxicity and pancreatitis in patients treated for HIV infection with HYDREA (hydroxyurea) in combination with didanosine and/or stavudine, with or without other antiretroviral agents.
Bristol-Myers Squibb would like to bring to your attention reports of hepatotoxicity and pancreatitis that occurred in HIV-infected patients treated with hydroxyurea in combination with antiretroviral agents, in particular, didanosine and/or stavudine.

The proportion of patients with previously documented viral hepatitis was similar among those with and without fatal hepatotoxicity (40% versus 37%, respectively). hydroxyurea, pancreatitis.

didanosi

FATAL AND NONFATAL PANCREATITIS HAVE OCCURRED DURING THERAPY WITH VIDEX USED ALONE OR IN COMBINATION REGIMENS IN BOTH TREATMENT-NAIVE AND TREATMENT-EXPERIENCED PATIENTS, REGARDLESS OF DEGREE OF IMMUNOSUPPRESSION.
Increases in plasma didanosine concentrations were dose proportional over the range of 50 to 400 mg. Steady-state pharmacokinetic parameters did not differ significantly from values obtained after a single dose.
Percent of patients at each time point who have HIV RNA <400 or <50 copies/mL, are on their original study medication (except stavudine-zidovudine switches), and have not experienced an AIDS-defining event.

http://www.fda.gov/cder/pediatric/labels/didanosi.pdf
The efficacy of VIDEX was demonstrated in two randomized, double-blind studies comparing VIDEX, given on a twice-daily schedule, to zidovudine, given three times daily, in 617 (ACTG 116A, conducted 1989-1992) and 913 (ACTG116B/117, conducted 1989-1991) patients with symptomatic HIV infection or AIDS who were treated for more than one year. didanosine, stavudine.

didanosine

An antiviral drug that slows the growth of HIV, the virus associated with AIDS.
It will help to decreases muscle aches and night sweats.
Stomach acid and food decrease the amount of ddI that is absorbed into the blood stream.
Each dose of tablets must consist of at least two tablets in order to effectively neutralize stomach acid.
This liquid contains ddI as well as some antacid (Maalox) which is necessary to neutralize the stomach acid so that the drug will be absorbed.
If it is more than 6 hours before the next dose, then take missed dose as soon as you remember and then take the next dose at the normal time.

http://www.oaktreeclinic.bc.ca/oaktree/pdf/didanosine.pdf
Do NOT take a double dose of this medication. dose, normal time.

virological failure

The European Medicines Agency (EMEA) and its Scientific Committee for human medicines (CHMP) have been made aware of new reports of virological failure and emergence of resistance following co-administration of tenofovir disoproxil fumarate and didanosine.
These have been observed in several clinical studies3-5 in which tenofovir disoproxil fumarate and didanosine were coadministered with a non-nucleoside reverse transcriptase inhibitor in HIV-infected treatment-naïve adult patients with high baseline viral load and low CD4 cell counts.
The Product Information for Viread has now been modified to reflect the above-mentioned information and is appended (Annex 2) to this Public Statement.

http://www.emea.eu.int/pdfs/human/press/pus/6233105en.pdf
The marketing authorisation holder responsible for this medicinal product is Gilead Sciences International Ltd. Viread is approved for once-daily administration. didanosine, European.