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Indications:

Treatment of CMV retinitis in patients with AIDS.

Contraindications:

History of clinically severe hypersensitivity to probenecid or other sulfa-containing medications; direct intraocular injection. Patients receiving agents with a nephrotoxic potential must discontinue use of such agents at least 1 wk prior to beginning therapy. Initiation of therapy in patients with a serum creatinine greater than 1.5 mg/dL, a calculated Ccr of less than or equal to 55 mL/min, or a urine protein at least 100 mg/dL.

Adverse reactions:

Cardiovascular Hypotension; postural hypotension; pallor; syncope; tachycardia. CNS Headache; amnesia; anxiety; confusion; convulsion; depression; dizziness; abnormal gait; hallucinations; insomnia; neuropathy; paresthesia; somnolence; vasodilation. Dermatologic Alopecia; rash; acne; skin discoloration; dry skin; herpes simplex; pruritus; sweating; urticaria. EENT Amblyopia; conjunctivitis; eye disorder; iritis; retinal detachment; uveitis; abnormal vision; hypotonia. GI Nausea; vomiting; diarrhea; anorexia; abdominal pain; colitis; constipation; tongue discoloration; dyspepsia; dysphagia; flatulence; gastritis; melena; oral candidiasis; rectal disorder; stomatitis; aphthous stomatitis; mouth ulceration; dry mouth; taste perversion. Genitourinary Renal toxicity; proteinuria; elevated creatinine and decreased Ccr; glycosuria; hematuria; urinary incontinence; UTI. Hematologic Thrombocytopenia; neutropenia; anemia. Hepatic Hepatomegaly; abnormal LFTs; increased AST; increased ALT. Metabolic Dehydration; hyperglycemia; hyperlipidemia; hypocalcemia; hypokalemia; metabolic acidosis; increased alkaline phosphatase; weight loss. Respiratory Asthma; bronchitis; coughing; dyspnea; hiccough; increased sputum; lung disorder; pharyngitis; pneumonia; rhinitis; sinusitis. Miscellaneous Allergy; edema; malaise; back pain; chest pain; neck pain; sarcoma; sepsis; arthralgia; asthenia; myasthenia; myalgia; fever; chills; infection.

Interactions:

Nephrotoxic agents (eg, aminoglycosides, amphotericin B, foscarnet, IV pentamidine) Risk of nephrotoxicity is increased.

Warnings:

Warnings Animal data Carcinogenic and teratogenic effects and impaired fertility reported. Nephrotoxicity Major toxicity occurs. Cases of acute renal failure resulting in dialysis and/or contributing to death occurred with as few as 1 or 2 doses. Reduce possible nephrotoxicity with IV prehydration (normal saline) and administration of probenecid. Monitor serum creatinine and urine protein within 48 h prior to each dose. Dose adjustment required for changes in renal function. Neutropenia May occur; monitor neutrophil count. Monitor Creatine/Urine protein/WBC Monitor serum creatinine, urine protein, and WBC with differential prior to each dose. If proteinuria is noted, administer IV hydration and repeat the test. Ocular symptoms Ensure that IOP, visual acuity, and ocular symptoms are periodically monitored. Pregnancy Category C . Lactation Undetermined. Children Safety and efficacy not established. Elderly Because elderly individuals frequently have reduced glomerular filtration, assess renal function before and during cidofovir therapy. Renal Function Cidofovir administration is not recommended if serum creatinine greater than 1.5 mg/dL or Ccr less than or equal to 55 mL/min. Contraception Women of childbearing potential should use effective contraception during and for 1 mo following treatment. Men should use a barrier contraceptive during and for 3 mo following treatment. Intraocular pressure May be associated with decreases in intraocular pressure and impairment of vision. Direct intraocular injection May be associated with iritis, ocular hypotony, and permanent impairment of vision. Metabolic acidosis Decreased serum bicarbonate associated with proximal tubule injury and renal wasting syndrome may occur. Uveitis/Iritis Uveitis/Iritis has been reported. Zidovudine If patient is taking zidovudine, ensure that zidovudine is discontinued or reduce dose by 50% on days of cidofovir infusion.

Form:

SOLUTION FOR INJECTION

Dosage and Administration

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