ddI


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didanosine (ddI, 2,3-dideoxyinosine)

Videx, Videx EC

Pharmacologic class: Nucleoside reverse transcriptase inhibitor

Therapeutic class: Antiretroviral, antiviral

Pregnancy risk category B

FDA Box Warning

• Pancreatitis has occurred when drug was used alone or in combination regimens in treatment-naive or treatment-experienced patients. Suspend therapy in patients with suspected pancreatitis; discontinue in patients with confirmed pancreatitis.

• Drug may cause lactic acidosis and severe hepatomegaly with steatosis when used alone or in combination with other antiretrovirals. Fatal lactic acidosis has occurred in pregnant women receiving didanosine-stavudine combination with other antiretrovirals. In pregnant patients, use this combination with caution and only if benefit clearly outweighs risk.

Action

Inhibits replication of human immunodeficiency virus (HIV) by disrupting synthesis of DNA polymerase, an enzyme crucial to DNA and RNA formation

Availability

Capsules (delayed-release): 125 mg, 200 mg, 250 mg, 400 mg

Powder for oral solution (pediatric): 2 g in 4-oz glass bottle, 4 g in 8-oz glass bottle

Indications and dosages

HIV infection

Adults weighing 60 kg (132 lb) or more: 400 mg (capsules) P.O. once daily

Adults weighing less than 60 kg (132 lb): 250 mg (capsules) P.O. once daily

Children: 120 mg/m2 (powder for oral solution, pediatric) P.O. q 12 hours

Dosage adjustment

• Renal impairment

Contraindications

• Hypersensitivity to drug

• Concurrent use of allopurinol or ribavirin

Precautions

Use cautiously in:

• renal or hepatic impairment, peripheral neuropathy, hyperuricemia

• elderly patients

• pregnant or breastfeeding patients

• children.

Administration

• Know that drug is usually given in conjunction with other antiretrovirals.

• Give on empty stomach 30 minutes before or 2 hours after a meal.

• Don't administer with fruit juice.

• Know that pharmacist must prepare pediatric powder for oral solution by diluting with water and antacid to a concentration of 10 mg/ml.

• Be aware that delayed-release capsules aren't intended for use in children.

Adverse reactions

CNS: dizziness, anxiety, abnormal thinking, hypoesthesia, agitation, confusion, hypertonia, asthenia, peripheral neuropathy, seizures, coma

CV: peripheral coldness, palpitations, hypotension, bradycardia, weak pulse, pseudoaneurysm, incomplete atrioventricular (AV) block, complete AV block, nodal arrhythmias, ventricular tachycardia, thrombophlebitis, embolism

EENT: diplopia, abnormal vision, ocular hypotony, iritis, retinal detachment

GI: nausea, vomiting, diarrhea, abdominal enlargement, dyspepsia, ileus, GI reflux, hematemesis, dysphagia, dry mouth, pancreatitis

GU: urinary retention, frequency, or incontinence; dysuria; cystalgia; prostatitis; renal dysfunction; nephrotoxicity

Hematologic: anemia, leukocytosis, thrombocytopenia, bleeding, neutropenia

Hepatic: hepatomegaly with steatosis, noncirrhotic portal hypertension

Metabolic: diabetes mellitus, hyperkalemia, lactic acidosis, noncirrhotic portal hypertension

Musculoskeletal: muscle contractions

Respiratory: pneumonia, crackles, rhonchi, bronchitis, pleurisy, dyspnea, wheezing, pleural effusion, pulmonary edema, pulmonary embolism, bronchospasm

Skin: diaphoresis, pallor, rash, urticaria, pruritus, bullous eruption, petechiae, cellulitis, abscess

Other: edema, development of human antichimeric antibodies

Interactions

Drug-drug. Allopurinol, ganciclovir (oral), ribavirin, tenofovir: increased didanosine blood level

Amprenavir, delavirdine, indinavir, ritonavir, saquinavir: altered didanosine pharmacokinetics

Antacids, other drugs that increase gastric pH: increased risk of didanosine toxicity

Co-trimoxazole, pentamidine: increased risk of pancreatic toxicity

Dapsone, fluoroquinolones, ketoconazole: decreased blood levels of these drugs

Itraconazole: decreased itraconazole blood level

Methadone: 50% decrease in didanosine blood level

Drug-diagnostic tests. Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, uric acid: increased levels

Granulocytes, hemoglobin, platelets, white blood cells: decreased values

Drug-food. Any food: decreased rate and extent of drug absorption

Patient monitoring

Monitor patient for signs and symptoms of pancreatitis. Withhold drug in patients with signs or symptoms of pancreatitis and discontinue drug in patients with confirmed pancreatitis.

Monitor patient for early signs and symptoms of portal hypertension (thrombocytopenia, splenomegaly). Discontinue drug in patients with evidence of noncirrhotic portal hypertension.

Assess carefully for signs and symptoms of lactic acidosis, such as dizziness, light-headedness, and bradycardia.

• Monitor for signs and symptoms of peripheral neuropathy.

• In patients with renal impairment, watch for drug toxicity and hypermagnesemia (suggested by muscle weakness and confusion).

Patient teaching

• Tell patient to take drug on empty stomach.

• Advise patient using buffered powder to mix it with water, not juice, and to let powder dissolve for several minutes before taking.

Instruct patient to immediately report abdominal pain, nausea, vomiting, tiredness, fast or irregular heartbeats, easy bruising, difficulty breathing, yellowing of skin or eyes, or dark urine.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.

DDI

or

ddI

(dē′dē-ī′)
n.
An antiviral drug, C10H12N4O3, that is a nucleoside reverse transcriptase inhibitor and is used in combination with other drugs for the treatment of HIV infection. Also called didanosine.

ddI

2',3'-dideoxyinosine, Videx AIDS An anti-HIV nucleoside analogue Adverse effects Neuropathy of hands and feet, pancreatic damage, pancreatitis, diarrhea. See AIDS, Didanosine.
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