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Videx
inhibits the replication of the human immunodeficiency virus.
Side Effects:
may cause: headache, cough, rash, weakness, loss of appetite, chills,
fever, sore tongue or mouth, change of taste, muscle or joint pain
or insomnia as your body adjusts to the medication.
Inform your doctor if these symptoms persist or become worse.
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
Related:
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.
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.
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.
The marketing authorisation holder responsible for this medicinal
product is Gilead Sciences International Ltd. Viread is approved
for once-daily administration. didanosine, European.
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