Names and pronunciation
(dye-dan′oh-seen) Videx EC
PDF page 388
Loading InternPractice…
Drug reference
(dye-dan′oh-seen) Videx EC
PDF page 388
Func. class.: Antiretroviral
PDF page 388
Chem. class.: Nucleoside reverse transcriptase inhibitor (NRTI)
PDF page 388
ACTION: Nucleoside analog incorpo- rating into cellular DNA by viral reverse transcriptase, thereby terminating the cellular DNA chain
PDF page 388
USES: HIV-1 infection in combination with at least 2 other antiretrovirals
PDF page 389
CONTRAINDICATIONS: Hyper- sensitivity, lactic acidosis, pancreatitis, phenylketonuria Precautions: Pregnancy, breastfeeding, children, renal disease, sodium-restricted diets, elevated amylase, preexisting periph- eral neuropathy, hyperuricemia, gout, HF, noncirrhotic portal hypertension
PDF page 389
Black Box Warning: Hepatic disease, lactic acidosis, pancreatitis Black Box Warning: Increase: fatal ace- tic acidosis: Stavudine (pregnancy), do not use together Decrease: absorption—ketoconazole, dapsone Decrease: concentrations of fluoroquino- lones, other antiretrovirals, itraconazole, tetracyclines Black Box Warning: Increase: fatal lactic acidosis—stavudine, tenofovir, other antiretrovirals; do not use to- gether • Do not use with these products PO: gatifloxacin, gemifloxacin, levoFLOXacin, moxifloxacin, norfloxacin Drug/Food • Any food decreases rate of absorption 50%; do not use with food • Do not use with acidic juices Black Box Warning: Pancreatitis: do not use in those with symptoms of pancreatitis; may be dose related in advanced HIV, alcoholism, history of pancreatitis • Peripheral neuropathy: tingling or pain in hands and feet, distal numbness; onset usually occurs 2-6 mo after begin- ning treatment; may persist if product not discontinued Black Box Warning: Lactic acidosis, severe hepatomegaly, pancreatitis: abdominal pain, nausea, vomiting, el- evated hepatic enzymes; product should be discontinued because condition can be fatal • Children by dilated retinal exam q6mo may be considered to rule out retinal depigmentation • CBC, differential, platelet count monthly; notify prescriber of results; al- kaline phosphatase, monitor amylase; viral load, CD4 count • Renal studies: BUN, serum uric acid, urine CCr prior to, during therapy • Temperature may indicate beginning infection • Hepatic studies prior to, during therapy (bilirubin, AST, ALT) as needed, monthly • Cleanup of powdered products; use wet mop or damp sponge Black Box Warning: Pregnancy/breast- feeding: identify if pregnancy is planned or suspected; product is not recom- mended in initial treatment due to tox- icity; do not breastfeed; enroll in the Antiretroviral Pregnancy Registry (800- 258-4263); do not use with stavudine Black Box Warning: Pancreatitis: to report immediately abdominal pain, diar- rhea, nausea, vomiting • To report numbness, tingling in ex- tremities • To take on an empty stomach; not to take dapsone at same time as ddI; not to mix powder with fruit juice; to chew tablets or crush and dissolve in water; to drink pow- der immediately after mixing • To report signs of infection: in- creased temperature, sore throat, flulike symptoms; other infections and compli- cations may still occur • To report signs of anemia: fatigue, headache, faintness, SOB, irritability • To report bleeding; to avoid use of razors, commercial mouthwash • That product does not cure symptoms, only controls them; that infection of oth- ers may occur via sex or blood Black Box Warning: Pregnancy/breast- feeding: identify if pregnancy is planned or suspected, do not use with stavudine, fatal lactic acidosis may occur
PDF pages 389, 390, 391
SIDE EFFECTS CNS: Peripheral neuropathy, seizures, confusion, anxiety, hypertonia, abnor- mal thinking, asthenia, insomnia, CNS depression, pain, dizziness, chills, fever CV: Hypertension, vasodilation, dysrhyth- mia, syncope, HF, palpitation EENT: Ear pain, otitis, photophobia, visual impairment, retinal depigmenta- tion, optic neuritis GI: Pancreatitis, diarrhea, nausea, vom- iting, abdominal pain, constipation, stomatitis, dyspepsia, liver abnormalities, flatulence, taste perversion, dry mouth, oral thrush, melena, increased ALT/AST, alkaline phosphatase, amylase, hepatic failure, noncirrhotic portal hypertension GU: Increased bilirubin, uric acid HEMA: Leukopenia, granulocytopenia, thrombocytopenia, anemia INTEG: Rash, pruritus, alopecia, ecchy- mosis, hemorrhage, petechiae, sweating MS: Myalgia, arthritis, myopathy, muscu- lar atrophy RESP: Cough, pneumonia, dyspnea, asthma, epistaxis, hypoventilation, sinusitis SYST: Lactic acidosis, anaphylaxis
PDF page 389
INTERACTIONS Increase: didanosine level—allopurinol, tenofovir Increase: side effects from magnesium, aluminum antacids Increase: pancreatitis risk—stavudine
PDF page 390
DOSAGE AND ROUTES • Adult/adolescent/child ≥6 yr and ≥60 kg: PO DELAYED-RELEASE CAP- SULE 400 mg/day; if used with tenofo- vir, reduce to 250 mg/day • Adult/adolescent/child ≥6 yr and 25 kg to <60 kg: PO DELAYED-RELEASE CAPSULE 250 mg/day; if used with teno- fovir, reduce to 200 mg/day • Adolescent 20 kg to <25 kg: PO DE- LAYED-RELEASE CAPSULE 200 mg/day • Adult ≥60 kg: PO ORAL SOLUTION 200 mg bid or 400 mg/day; if used with tenofovir, reduce to 250 mg/day • Adult <60 kg: PO ORAL SOLUTION 125 mg bid or 250 mg/day; if used with tenofovir, reduce to 200 mg/day • Adolescent/child/infant >8 mo: PO ORAL SOLUTION 120 mg/m2 every 12 hr, max adult dosing • Infant <8 mo/neonate ≥2 wk: PO ORAL SOLUTION 100 mg/m2 every 12 hr for up to 3 mo Renal dose • Adult: PO CrCl ≥60 mL/min: No change • Adult/adolescent ≥60 kg: PO CCr 30-59 mL/min: reduce oral solution to 100 mg 12 hr or 200 mg every 24 hr; reduce extended-re- lease capsules to 200 mg/day; CCr 10-29 mL/min: reduce oral solution to 150 mg every 24 hr; reduce extended-release capsules to 125 mg/day; CCr <10 mL/min: reduce oral solution to 100 mg every 24 hr; reduce ex- tended-release capsules to 125 mg/day • Adult/adolescent <60 kg: PO CCr 30- 59 mL/min: reduce oral solution to 75 mg every 12 hr or to 150 mg every 24 hr; reduce extended-release capsules to 125 mg/day; CCr 10-29 mL/min: reduce oral solution to 100 mg every 24 hr; reduce extended-re- lease capsules to 125 mg/day; CCr <10 mL/ min: reduce oral solution to 75 mg every 24 hr; extended-release capsules are not rec- ommended D
PDF page 389
Available forms: Powder for oral solution 10 mg/mL; delayed-release capsules 125, 200, 250, 400 mg
PDF page 389
Administer: • Pediatric: powder for oral solution af- ter preparation by pharmacist; dilution required using purified USP water, then antacid (10 mg/mL), refrigerate, shake before use • On an empty stomach ≥30 min prior to or 2 hr after meals • Adjust dose with renal impairment • Store tablets, capsules in tightly closed bot- tle at room temperature; store oral solution after dissolving at room temperature ≤4 hr
PDF page 389
Assess:
PDF page 390
Evaluate: • Therapeutic response: absence of in- fection; symptoms of HIV
PDF page 390
CLINICAL CONSIDERATIONS
PDF page 390
Patient and caregiver information:
PDF page 390
PHARMACOKINETICS PO: Peak 0.67 hr, delayed release 2 hr; half-life 1½ hr, child 1 hr; extensive metabolism; administration within 5 min of food will decrease absorption (50%); excreted in urine, feces
PDF page 390
• Adult/adolescent/child ≥6 yr and ≥60 kg: PO DELAYED-RELEASE CAP- SULE 400 mg/day; if used with tenofo- vir, reduce to 250 mg/day
PDF page 389
• Adult/adolescent/child ≥6 yr and 25 kg to <60 kg: PO DELAYED-RELEASE CAPSULE 250 mg/day; if used with teno- fovir, reduce to 200 mg/day
PDF page 389
• Adolescent/child/infant >8 mo: PO ORAL SOLUTION 120 mg/m2 every 12 hr, max adult dosing
PDF page 389