Dosing & Uses
Dosage Forms & Strengths
capsule, extended release
- 125mg
- 200mg
- 250mg
- 400mg
powder for oral solution
- 2 g
- 4 g
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
Renal Impairment
>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
Dosing Consideration
Monitoring
- Amylase q4-8Weeks; CBC with different, aminotransferases, K+, triglycerides q6-12Weeks
- Neurologic evaluation q4Weeks
- Periodic retinal exams
Dosage Forms & Strengths
capsule, extended release
- 125mg
- 200mg
- 250mg
- 400mg
powder for oral solution
- 10mg/mL (reconstituted)
tablet for oral suspension
- 100mg
- 150mg
- 200mg
HIV Infection
Indicated for treatment of HIV infection in combination with other antiretroviral agents
Oral solution
NIH HIV guidelines (March 2016)
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 (Videx EC or generic 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)
Dosing Consideration
Monitoring
- Amylase q4-8Weeks; CBC with different, aminotransferases, K+, triglycerides q6-12Weeks
- Neurologic evaluation q4Weeks
- Periodic retinal exams
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (3)
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
didanosine, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.
- febuxostat
febuxostat will increase the level or effect of didanosine by decreasing metabolism. Contraindicated.
- ribavirin
ribavirin increases toxicity of didanosine by unspecified interaction mechanism. Contraindicated. Risk of hepatic failure, peripheral neuropathy, pancreatitis, lactic acidosis.
Serious - Use Alternative (13)
- allopurinol
allopurinol increases levels of didanosine by unknown mechanism. Contraindicated.
- betibeglogene autotemcel
didanosine, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take antiretroviral medications for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. Antiretroviral medications may interfere with manufacturing of apheresed cells.
- busulfan
busulfan, didanosine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Pretomanid regimen associated with hepatotoxicity. Avoid alcohol and hepatotoxic agents, including herbal supplements and drugs other than bedaquiline and linezolid.
- cabotegravir
didanosine, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.
- ciprofloxacin
didanosine decreases levels of ciprofloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Oral ciprofloxacin should not be administered simultaneously with didanosine (chewable tablets or powder for oral solution). Administer oral doses of ciprofloxacin 2 hours before or 6 hours after didanosine, chewable tablets or powder for oral solution.
- elivaldogene autotemcel
elivaldogene autotemcel, didanosine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- gemifloxacin
didanosine decreases levels of gemifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Separate by 4-8 hours.
- hydroxyurea
hydroxyurea, didanosine. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Pancreatitis, hepatotoxicity, and peripheral neuropathy have occurred in HIV patients treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, avoid this combination. .
- levofloxacin
didanosine decreases levels of levofloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration.
- moxifloxacin
didanosine decreases levels of moxifloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration.
- ofloxacin
didanosine decreases levels of ofloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Avoid or Use Alternate Drug. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration; separate by 4-8 hours.
- pexidartinib
didanosine and pexidartinib both increase Other (see comment). Avoid or Use Alternate Drug. Pexidartinib can cause hepatotoxicity. Avoid coadministration of pexidartinib with other products know to cause hepatoxicity.
- selinexor
didanosine, selinexor. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
Monitor Closely (44)
- abacavir
abacavir and didanosine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- atazanavir
didanosine will decrease the level or effect of atazanavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
atazanavir and didanosine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - carbonyl iron
didanosine will decrease the level or effect of carbonyl iron by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- cefpodoxime
didanosine will decrease the level or effect of cefpodoxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- cefuroxime
didanosine will decrease the level or effect of cefuroxime by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- cisplatin
didanosine, cisplatin. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of peripheral neuropathy.
- dapsone
didanosine increases toxicity of dapsone by unknown mechanism. Use Caution/Monitor. May increase risk of nerve damage.
- darunavir
darunavir will decrease the level or effect of didanosine by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer didanosine 1 hr before or 2 hr after darunavir/ritonavir.
- dasatinib
didanosine will decrease the level or effect of dasatinib by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor.
- demeclocycline
didanosine will decrease the level or effect of demeclocycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- doxycycline
didanosine will decrease the level or effect of doxycycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- efavirenz
didanosine, efavirenz. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Concomitant administration increases risk of liver toxicity.
- elvitegravir
didanosine, elvitegravir. Other (see comment). Use Caution/Monitor. Comment: Didanosine must be administered on an empty stomach; administer didanosine at least 1 hr before or 2 hr after elvitegravir (which is administered with food).
- fosamprenavir
didanosine will decrease the level or effect of fosamprenavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution;dminister 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- ganciclovir
ganciclovir increases levels of didanosine by decreasing renal clearance. Use Caution/Monitor.
ganciclovir, didanosine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity. - indinavir
didanosine will decrease the level or effect of indinavir by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets or powder for oral solution; administer indinavir 1 hr prior to didanosine chewable tablets or powder; no significant interactions reported with didanosine capsules
- iron dextran complex
didanosine will decrease the level or effect of iron dextran complex by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- iron sucrose
didanosine will decrease the level or effect of iron sucrose by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- itraconazole
didanosine will decrease the level or effect of itraconazole by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- ketoconazole
didanosine will decrease the level or effect of ketoconazole by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- levoketoconazole
didanosine will decrease the level or effect of levoketoconazole by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- levothyroxine
didanosine will decrease the level or effect of levothyroxine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- liothyronine
didanosine will decrease the level or effect of liothyronine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- liotrix
didanosine will decrease the level or effect of liotrix by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- lopinavir
lopinavir will decrease the level or effect of didanosine by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Didanosine should be taken 1 hour prior or 2 hours after administration of lopinavir/ritonavir oral solution.
- mesalamine
didanosine decreases effects of mesalamine by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Extended release mesalamine capsules should be given 1 hour before or 4 hours after administration of didanosine.
- methadone
methadone decreases levels of didanosine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor.
- methylphenidate
didanosine will decrease the level or effect of methylphenidate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Interaction specifically associated with Ritalin LA.
- minocycline
didanosine will decrease the level or effect of minocycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- mycophenolate
didanosine will decrease the level or effect of mycophenolate by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- nitrofurantoin
didanosine will increase the level or effect of nitrofurantoin by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- orlistat
orlistat will decrease the level or effect of didanosine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.
- rilpivirine
didanosine, rilpivirine. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration; no dose adjustment is required when rilpivirine is coadministered with didanosine. Didanosine is to be administered on an empty stomach and at least two hours before or at least four hours after rilpivirine (which should be administered with a meal).
- ritonavir
ritonavir and didanosine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
ritonavir will decrease the level or effect of didanosine by increasing gastric pH. Applies only to oral form of both agents. Use Caution/Monitor. Didanosine should be taken 1 hour prior or 2 hours after administration of lopinavir/ritonavir oral solution. - stavudine
didanosine, stavudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. May cause pancreatitis; risk of peripheral neuropathy. Possibility of fatal lactic acidosis (esp. in pregnant pts.).
- tenofovir DF
tenofovir DF increases toxicity of didanosine by decreasing elimination. Use Caution/Monitor. May increase risk of pancreatitis; decrease didanosine dose to 250 mg/day if weight >60 kg and decrease to 200 mg/day if weight <60 kg .
- tetracycline
didanosine will decrease the level or effect of tetracycline by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Oral tetracycline should not be administered simultaneously with didanosine (chewable tablets or powder for oral solution); use alternatives if available. Tetracycline antibiotics should be taken 1 hour before or 4 hours after administration of didanosine.
- tinidazole
didanosine, tinidazole. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of peripheral neuropathy.
- tipranavir
tipranavir and didanosine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
tipranavir decreases levels of didanosine by unspecified interaction mechanism. Use Caution/Monitor. Separate by at least 2 hrs. - ublituximab
ublituximab decreases effects of didanosine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely.
- valganciclovir
valganciclovir, didanosine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.
- valoctocogene roxaparvovec
didanosine and valoctocogene roxaparvovec both increase Other (see comment). Use Caution/Monitor. Medications that may cause hepatotoxicity when combined with valoctogene roxaparvovec may potentiate the risk of elevated liver enzymes. Closely monitor these medications and consider alternative medications in case of potential drug interactions.
- vincristine
didanosine, vincristine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of peripheral neuropathy.
- vincristine liposomal
didanosine, vincristine liposomal. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Enhanced risk of peripheral neuropathy.
Minor (19)
- ampicillin
didanosine will decrease the level or effect of ampicillin by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.
- ethanol
didanosine, ethanol. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Enhanced risk of pancreatitis.
- ferric carboxymaltose
didanosine will decrease the level or effect of ferric carboxymaltose by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- ferric gluconate
didanosine will decrease the level or effect of ferric gluconate by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- ferric maltol
didanosine will decrease the level or effect of ferric maltol by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- ferrous fumarate
didanosine will decrease the level or effect of ferrous fumarate by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- ferrous gluconate
didanosine will decrease the level or effect of ferrous gluconate by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- ferrous sulfate
didanosine will decrease the level or effect of ferrous sulfate by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- food
food decreases levels of didanosine by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- isoniazid
didanosine, isoniazid. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Enhanced risk of peripheral neuropathy.
- metronidazole
didanosine, metronidazole. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Enhanced risk of peripheral neuropathy.
- nelfinavir
didanosine increases levels of nelfinavir by enhancing GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown.
- nitrofurantoin
didanosine, nitrofurantoin. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Enhanced risk of peripheral neuropathy.
- pentamidine
didanosine, pentamidine. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Enhanced risk of pancreatitis.
- polysaccharide iron
didanosine will decrease the level or effect of polysaccharide iron by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- posaconazole
didanosine will decrease the level or effect of posaconazole by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown. Applies to didanosine chewable tablets and powder for oral solution; administer 2 hr before or several hours after didanosine oral solution or chewable tablet administration
- rose hips
didanosine will decrease the level or effect of rose hips by increasing gastric pH. Applies only to oral form of both agents. Minor/Significance Unknown.
- valganciclovir
valganciclovir increases levels of didanosine by decreasing renal clearance. Minor/Significance Unknown.
- zidovudine
zidovudine increases levels of didanosine by decreasing renal clearance. Minor/Significance Unknown.
Adverse Effects
>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
Postmarking Reports
Noncirrhotic portal hypertension
Warnings
Black Box Warnings
Fatal and nonfatal pancreatitis reported; suspend if pancreatitis suspected and discontinue if confirmed
Lactic acidosis and severe hepatomegaly with steatosis (including fatal cases) reported with use of nucleoside analogues alone or in combination
Coadministration with stavudine is contraindicated because of increased risk of serious and/or life-threatening events; suspend treatment if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity occurs
Fatal lactic acidosis reported in pregnant women who have received didanosine and stavudine with other antiretroviral agents. Use the combination with caution in pregnant women
Contraindications
Hypersensitivity
Coadministration with allopurinol (may increase didanosine toxicity)
Coadministration with ribavirin (increases actrive metabolite dideoxyadenosine 5’-triphosphate levels, causing fatal hepatic failure, peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis)
Coadministration with stavudine
Cautions
(All NRTIs): Risk of potentially fatal lactic acidosis & severe hepatomegaly with steatosis when used alone or in combination with other antiretrovirals
Risk of potentially fatal pancreatitis, increases if used in combo with stavudine
Risk of potentially fatal bleeding from esophageal varices in patients with non-cirrhotic portal hypertension
Discontinue if pancreatitis occurs; reduce dose for other ADR's
Risk of immune reconstitution syndrome if used in combination w/ other antiretroviral drugs
Risk of retinal changes and optic neuritis
Rapidly degrades in acidic pH, however, EC is protected from stomach acids
Noncirrhotic portal hypertension reported; discontinue if signs/symptoms occur (eg, elevated liver enzymes, esophageal varices, hematemesis, ascites, splenomegaly)
Coadministration of methadone with Videx pediatric powder may significant decrease didanosine concentrations
Patients treated in combination with stavudine may be at increased risk for pancreatitis, lactic acidosis, and hepatic toxicity; coadministration is contraindicated
Treatment has been associated with loss of subcutaneous fat, which is most evident in the face, limbs, and buttocks; incidence and severity of lipoatrophy are related to cumulative exposure, and is often not reversible when treatment is stopped; patients receiving therapy should be frequently examined and questioned for signs of lipoatrophy, and if feasible, therapy should be switched to an alternative regimen if there is suspicion of lipoatrophy
Pregnancy & Lactation
Pregnancy
To monitor maternal-fetal outcomes of pregnant women exposed to didanosine and other antiretroviral agents, an Antiretroviral Pregnancy Registry has been established; physicians are encouraged to register patients by calling 1-800-258-4263
There are no adequate and well-controlled studies of didanosine in pregnant women; drug should be used during pregnancy only if potential benefit justifies potential risk
Lactation
The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed infants to avoid risking postnatal transmission of HIV; a study in rats showed that following oral administration, didanosine and/or its metabolites were excreted into the milk of lactating rats; it is not known if didanosine is excreted in human milk; because of both potential for HIV transmission and potential for serious adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving didanosine
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Inhibits in vitro replication of HIV via chain termination & interference with HIV-RNA dependent DNA polymerase
Pharmacokinetics
Bioavailability: 42% (adults); 25% (children)
Protein Bound: <5%
Metabolism: Liver
Excretion: Urine
Vd: 28 L/m² (children); 1.08 L/kg
Half-life elimination: 0.8 hr (children and adolescents); 1.5 hr (adults)
Administration
Powder for Oral Solution Preparation
Prior to dispensing, the pharmacist must reconstitute dry powder to an initial concentration of 20 mg/mL and immediately mix the resulting solution with antacid to a final concentration of 10 mg/mL
Initial solution (20 mg/mL): Reconstitute the product to 20 mg per mL by adding 100 mL or 200 mL of purified water USP, to the 2 g or 4 g of powder, respectively
Final solution (10 mg/mL): Immediately mix one part of the 20 mg/mL initial solution with one part of any commercially available antacid that contains as active ingredients aluminum hydroxide (400 mg/5 mL), magnesium hydroxide (400 mg/5 mL), and simethicone (40 mg/5 mL) for a final dispensing concentration of 10 mg/mL
Oral Administration
Oral solution dispensed as 10 mg/mL with antacid as diluent
Take on empty stomach, at least 30 minutes before food or 2 hr after food; Cmax and AUC reduced by ~46% and 19% respectively in the presence of food
EC not approved for aged <6 yr and for children who weigh <20 kg and unable to swallow capsule whole
Storage
Reconstituted oral solution (10 mg/mL): Refrigerate for up to 30 days at 36-46°F (2-8°C); discard any unused portion after 30 days
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| didanosine oral - | 400 mg capsule |  | |
| didanosine oral - | 250 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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