dye-DAN-oh-seen

• HIV infection (with other antiretrovirals).

• Inhibits viral replication by interfering with viral RNA-directed DNA polymerase (reverse transcriptase). Converted intracellularly by the phosphorylation process to its active form.

• Increase in CD4 cell counts and decreased viral load, with decreased incidence of opportunistic infections and slowed progression in HIV-infected patients.

Absorption: Rapidly degrades at gastric pH.

Distribution: CSF levels are 21% of plasma levels in adults.

Metabolism/Excretion: Metabolized as a purine; 55% eliminated by the kidneys (18% as unchanged drug; urinary excretion is less in children).

Half-life: 1.6 hr (0.8 hr in children).

Contraindicated in:

• Hypersensitivity
• Concurrent use of ribavirin, allopurinol, or stavudine
• OB: Not recommended for use during pregnancy (↑ risk of lactic acidosis)
• Lactation: Breastfeeding not recommended for mothers with HIV.

Use Cautiously in:

• History of gout
• Renal impairment (dose modification required if CCr <60 mL/min; ↑ risk of pancreatitis)
• Advanced HIV disease, history of peripheral neuropathy, or concurrent use of neurotoxic medications (↑ risk of peripheral neuropathy)
• History of seizures
• Diabetes mellitus
• Pedi: ↑risk of pancreatitis in children.

CV: arrhythmias, edema, hypertension, vasodilation.

Derm: alopecia, ecchymoses, rash.

EENT: rhinitis, ear pain, epistaxis, optic neuritis, parotid gland enlargement, photophobia, retinal depigmentation, sialoadenitis.

Endo: hyperglycemia.

GI: HEPATOMEGALY (WITH STEATOSIS), LIVER FAILURE, NON-CIRRHOTIC PORTAL HYPERTENSION, PANCREATITIS, anorexia, diarrhea, ↑liver function tests, nausea, vomiting, abdominal pain, constipation, dry mouth, dyspepsia, flatulence, stomatitis.

GU: urinary frequency.

Hemat: granulocytopenia, anemia, bleeding, leukopenia.

Metab: LACTIC ACIDOSIS, ↓ weight, hyperlipidemia, hyperuricemia, lipoatrophy.

MS: RHABDOMYOLYSIS, arthritis, myalgia.

Neuro: peripheral neuropathy, poor coordination , SEIZURES, headache, dizziness, insomnia, lethargy, pain, weakness.

Resp: cough, asthma.

Misc: chills, fever, anaphylactoid reactions, immune reconstitution syndrome.

Drug-Drug:

• Concurrent use with stavudine may ↑ risk of lactic acidosis, pancreatitis, hepatotoxicity, and peripheral neuropathy; concurrent use contraindicated.
• Allopurinol may ↑ levels and risk of toxicity; concurrent use contraindicated.
• Ribavirin may ↑ levels and risk of peripheral neuropathy, pancreatitis, and lactic acidosis; concurrent use contraindicated.
• Tenofovir may ↑ levels; ↓ dose.
• Ganciclovir may ↑ levels; dose adjustments may be necessary.
• Methadone may ↓ levels; dose adjustments may be necessary.
• Buffers in didanosine ↑ absorption of ketoconazole, itraconazole, dapsone, tetracyclines, and fluoroquinolones; do not administer within 2 hr of didanosine.
• ↑risk of peripheral neuropathy with isoniazid, phenytoin, ethambutol, and chloramphenicol; use cautiously.
• ↑risk of pancreatitis with alcohol, thiazide diuretics, IV pentamidine, and tetracyclines; use with extreme caution.
• ↑risk of bone marrow depression with other drugs causing bone marrow depression.

Drug-Food:

• Administration with food↓ absorption by 50%.

• PO (Adults 60 kg): 400 mg once daily; Concurrent use with tenofovir — 250 mg once daily.
• PO (Adults <60 kg): 250 mg once daily; Concurrent use with tenofovir — 200 mg once daily.
• PO (Children 6 yr and 60 kg): 400 mg once daily.
• PO (Children 6 yr and 25–59.9 kg): 250 mg once daily.
• PO (Children 6 yr and 20–24.9 kg): 200 mg once daily.

• PO: Administer every 12 hr on an empty stomach, 30 min before or 2 hr after meals. Do not administer ketoconazole, dapsone, tetracyclines, or fluoroquinolones within 2 hr (6 hr for ciprofloxacin) of didanosine.
  • DNC: Swallow capsules whole; do not open, crush, or chew.

Videx, Videx EC

Therapeutic Classification: antiretrovirals

Pharmacologic Classification: nucleoside reverse transcriptase inhibitors

(Generic available)

• Delayed-release capsules (with enteric-coated beadlets): 125 mg; 200 mg; 250 mg; 400 mg;

(antiretroviral plasma levels)

• Monitor for change in severity of HIV symptoms and for symptoms of opportunistic infection before and during therapy.
• Monitor patient for peripheral neuropathy (distal numbness, tingling, or pain in feet or hands) during therapy. Dose may need to be decreased.
• Monitor for symptoms of pancreatitis (abdominal pain, nausea, vomiting, increased amylase, lipase, or triglyceride concentrations). If amylase is elevated 1.5–2 times the normal limit and/or the patient has symptoms of pancreatitis, didanosine should be discontinued. Pancreatitis may be fatal.
• May cause lactic acidosis and severe hepatomegaly with steatosis; increased risk in patients who are female, obese, or receiving nucleoside analog medications for extended periods of time. Monitor patient for signs (increased serum lactate levels, elevated liver enzymes, liver enlargement on palpation). Therapy should be suspended if clinical or laboratory signs occur.
• Assess for signs of non-cirrhotic portal hypertension (elevated liver enzymes, esophageal varices, hematemesis, ascites, and splenomegaly); may occur mo or years after starting therapy. Monitor for early signs (thrombocytopenia and splenomegaly) during therapy. Discontinue didanosine if signs occur; may lead to liver transplantation or death.

• Monitor viral load and CD4 count before and routinely during therapy to determine response.
  • Monitor CBC, hepatic function, and uric acid concentrations during therapy. May cause leukopenia, granulocytopenia, thrombocytopenia, and anemia. May cause ↑ AST, ALT, alkaline phosphatase, bilirubin, uric acid, amylase, lipase, and triglyceride concentrations.Lactic acidosis may occur with hepatic toxicity causing hepatic steatosis; may be fatal, especially in women. Monitor liver enzymes, serum bilirubin, albumin, complete blood count, and international normalized ratio (INR) and ultrasonography routinely; may be ↑ in patients with non-cirrhotic portal hypertension.
  • May cause hyperglycemia.
  • Monitor serum potassium concentrations routinely liver enzymes, serum bilirubin, albumin, complete blood count, and international normalized ratio (INR) and ultrasonography should be considered. Didanosine should be discontinued in patients with evidence of non-cirrhotic portal hypertension.

• Risk for infection (Indications, Side Effects).
• Risk for injury (Side Effects).

• Instruct patient on the importance of taking didanosine exactly as directed, even if feeling better. Take missed doses as soon as remembered; emphasize the importance of maintaining regimen to decrease risk of developing resistance. Caution patient not to share or trade this medication with others. Advise patient to read Medication Guide before starting therapy and with each Rx refill in case of changes.
• May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Inform patient that didanosine may cause hyperglycemia. Advise patient to notify health care professional if increased thirst or hunger; unexplained weight loss; increased urination; fatigue; or dry, itchy skin occurs.
• Instruct patient to notify health care professional immediately if symptoms of lactic acidosis (tiredness or weakness, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, cold especially in arms or legs, dizziness, fast or irregular heartbeat) or if signs of hepatotoxicity (yellow skin or whites of eyes, dark urine, light-colored stools, lack of appetite for several days or longer, nausea, abdominal pain) occur. These symptoms may occur more frequently in patients that are female, obese, or have been taking medications like didanosine for a long time.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, or herbal products.
• Caution patient to avoid crowds and persons with known infections.
• Advise patient to notify health care professional immediately if numbness or tingling of the hands or feet, occurs.
• Inform patient that didanosine does not cure HIV or prevent associated or opportunistic infections. Didanosine may reduce the risk of transmission of HIV to others through sexual contact or blood contamination. Caution patient to use a condom and to avoid sharing needles or donating blood to prevent spreading the HIV virus to others. If new symptoms of infection develop after starting didanosine, notify health care professional.
• Inform patient that redistribution and accumulation of body fat may occur, causing central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, breast enlargement, and cushingoid appearance. The cause and long-term effects are not known.
• Children should have dilated retinal exams every 3–6 mo or if there is a change in vision throughout therapy.
• Rep: Instruct females using hormonal contraceptives to use an alternative nonhormonal method of contraception. Advise patient to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding. If pregnant patient is exposed to didanosine, register patient in Antiretroviral Pregnancy Registry by calling 1-800-258-4263.
• Emphasize the importance of regular exams to monitor for side effects.

• Decreased incidence of opportunistic infection and slowed progression of HIV infection.

NDC Code^*

• 0087- Bristol-Myers Squibb Company
  • 0087-6632- VIDEX
    • 0087-6632-41- 1 BOTTLE in 1 CARTON (0087-6632-41) > 200 mL in 1 BOTTLE

• 0087- Bristol-Myers Squibb Company
  • 0087-6633- VIDEX
    • 0087-6633-41- 1 BOTTLE in 1 CARTON (0087-6633-41) > 400 mL in 1 BOTTLE

• 0087- Bristol-Myers Squibb Company
  • 0087-6671- VIDEX EC
    • 0087-6671-17- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0087-6671-17)

• 0087- Bristol-Myers Squibb Company
  • 0087-6672- VIDEX EC
    • 0087-6672-17- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0087-6672-17)

• 0087- Bristol-Myers Squibb Company
  • 0087-6673- VIDEX EC
    • 0087-6673-17- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0087-6673-17)

• 0087- Bristol-Myers Squibb Company
  • 0087-6674- VIDEX EC
    • 0087-6674-17- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0087-6674-17)

• 65862- Aurobindo Pharma Limited
  • 65862-310- Didanosine
    • 65862-310-05- 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-310-05)

• 65862- Aurobindo Pharma Limited
  • 65862-310- Didanosine
    • 65862-310-14- 10 BLISTER PACK in 1 CARTON (65862-310-14) > 14 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

• 65862- Aurobindo Pharma Limited
  • 65862-310- Didanosine
    • 65862-310-30- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-310-30)

• 65862- Aurobindo Pharma Limited
  • 65862-311- Didanosine
    • 65862-311-05- 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-311-05)

• 65862- Aurobindo Pharma Limited
  • 65862-311- Didanosine
    • 65862-311-10- 10 BLISTER PACK in 1 CARTON (65862-311-10) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

• 65862- Aurobindo Pharma Limited
  • 65862-311- Didanosine
    • 65862-311-30- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-311-30)

• 65862- Aurobindo Pharma Limited
  • 65862-312- Didanosine
    • 65862-312-05- 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-312-05)

• 65862- Aurobindo Pharma Limited
  • 65862-312- Didanosine
    • 65862-312-10- 10 BLISTER PACK in 1 CARTON (65862-312-10) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK

• 65862- Aurobindo Pharma Limited
  • 65862-312- Didanosine
    • 65862-312-30- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-312-30)

• 65862- Aurobindo Pharma Limited
  • 65862-313- Didanosine
    • 65862-313-05- 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-313-05)

• 65862- Aurobindo Pharma Limited
  • 65862-313- Didanosine
    • 65862-313-30- 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-313-30)

• 65862- Aurobindo Pharma Limited
  • 65862-313- Didanosine
    • 65862-313-50- 10 BLISTER PACK in 1 CARTON (65862-313-50) > 5 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK