Hydroxychloroquine
Dosing in kidney impairment
Renal Toxicity: Consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders. Discontinue PLAQUENIL if renal toxicity is suspected or demonstrated by tissue biopsy in any organ system. ( 5.1 , 5.8 , 5.11 ) 5.1 Cardiomyopathy and Ventricular Arrhythmias Fatal and life-threatening cases of cardiotoxicity, including cardiomyopathy, have been reported in patients treated with PLAQUENIL.
In patients of Asian descent, retinal toxicity may first be noticed outside the macula. Risk factors for retinal damage include daily hydroxychloroquine sulfate dosages ≥5 mg/kg of actual body weight, durations of use greater than five years, renal impairment, use of concomitant drug products such as tamoxifen citrate, and concurrent macular disease.
Advise patients to seek medical attention if they develop any signs and symptoms of hypoglycemia. 5.11 Renal Toxicity Proteinuria with or without moderate reduction in glomerular filtration rate have been reported with the use of PLAQUENIL. Renal biopsy showed phospholipidosis without immune deposits, inflammation, and/or increased cellularity.
Physicians should consider phospholipidosis as a possible cause of renal injury in patients with underlying connective tissue disorders who are receiving PLAQUENIL. Drug-induced phospholipidosis may occur in other organ systems [see Warnings and Precautions ( 5.1 , 5.8 ) ]. Discontinue PLAQUENIL if renal toxicity is suspected or demonstrated by tissue biopsy.
Preparation and administration
Important Administration Instructions Administer PLAQUENIL orally with food or milk. Do not crush or divide the tablets.