didanosine (Rx)

Brand and Other Names:Videx, Videx EC
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Dosing & Uses

AdultPediatric

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)
    • 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 (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
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Interactions

Interaction Checker

and didanosine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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             activity indicator 

            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 (11)

            • allopurinol

              allopurinol increases levels of didanosine by unknown mechanism. Contraindicated.

            • 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.

            • 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 (41)

            • 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

            • 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.

            • 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.

            • 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.

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            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

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            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

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            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.

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            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)

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            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

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            didanosine oral
            -
            250 mg capsule
            didanosine oral
            -
            125 mg capsule
            didanosine oral
            -
            400 mg capsule
            didanosine oral
            -
            200 mg capsule

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.