Falciparum Discontinue in 6 months if improvement is inadequate Use in patients with psoriasis may precipitate a severe attack of psoriasis; use with caution Postmarketing cases of life-threatening and fatal cardiomyopathy reported with use of hydroxychloroquine as well as of chloroquine Irreversible retinal damage observed in some patients who had received hydroxychloroquine sulfate; significant risk factors for retinal damage include daily doses of hydroxychloroquine sulfate greater than 6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use greater than five years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate and concurrent macular disease Ocular examination is recommended within first year of therapy; baseline exam should include: best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT) For individuals with significant risk factors (daily dose of hydroxychloroquine sulfate 5.0 mg/kg base of actual body weight, subnormal glomerular filtration, use of tamoxifen citrate or concurrent macular disease) monitoring should include annual examinations which include BCVA, VF and SD-OCT; for individuals without significant risk factors, annual exams can usually be deferred until five years of treatment In individuals of Asian descent, retinal toxicity may first be noticed outside macula; in patients of Asian descent, it is recommended that visual field testing be performed in central 24 degrees instead of central 10 degrees Hydroxychloroquine should be discontinued if ocular toxicity is suspected and patient should be closely observed given that retinal changes (and visual disturbances) may progress even after cessation of therapy Hepatic disease or alcoholism Glucose-6-phosphate dehydrogenase (G6PD) deficiency is associated with hemolysis and renal impairment; use with caution Dermatologic reactions to hydroxychloroquine may occur Patients are prone to dermatitis outbreaks Signs or symptoms of cardiac compromise have appeared during acute and chronic treatment; clinical monitoring for signs and symptoms of cardiomyopathy is advised, including use of appropriate diagnostic tools such as ECG to monitor patients for cardiomyopathy during therapy; if cardiotoxicity is suspected, prompt discontinuation may prevent life-threatening complications Not for administration with other drugs that have potential to prolong QT interval; hydroxychloroquine prolongs QT interval; ventricular arrhythmias and torsades de pointes reported in patients taking hydroxychloroquine Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, reported; muscle and nerve biopsies have been associated with curvilinear bodies and muscle fiber atrophy with vacuolar changes; assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy Suicidal behavior rarely reported in patients treated with hydroxychloroquine Hematologic reactions (including aplastic anemia) and agranulocytosis may occur May exacerbate heart failure Shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with or without antidiabetic medications; warn patients about risk of hypoglycemia and associated clinical signs and symptoms; patients presenting with clinical symptoms suggestive of hypoglycemia during treatment should have their blood glucose checked and treatment reviewed as necessary A reduction in dosage may be necessary in patients with hepatic or renal disease, as well as in those taking medicines known to affect these organs Use with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs Consider discontinuing therapy if any severe blood disorder such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia, which is not attributable to the disease under treatment appears; perform periodic blood cell counts if patients are given prolonged therapy Pregnancy category: C Lactation: Drug is concentrated in breast milk (American Academy of Pediatrics committee states that it is compatible with nursing) A: Generally acceptable. Contact the applicable plan provider for the most current information. Controlled studies in pregnant women show no evidence of fetal risk. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. Animal studies show risk and human studies not available or neither animal nor human studies done. Malaria prophylaxis with chloroquine Plaquenil indication Availability. 200 mg tablets. Actions. Derivative closely related to chloroquine. Antimalarial activity is believed to be based on ability to form complexes with DNA of parasite, thereby inhibiting replication and transcription to RNA and DNA synthesis of the parasite. Oct 14, 2004 To determine the effect of hydroxychloroquine treatment during pregnancy and lactation on babies of mothers affected by rheumatic diseases. A total of 40 infants born from mothers affected by. Anti-malarial drugs hydroxychloroquine, chloroquine are considered pregnancy category C drugs. While there is evidence of risk for damage to the eye and ear, if the benefits of these drugs in controlling RA symptoms are judged to outweigh the risks, they may continue to be used during pregnancy. 1,2 Unknown; may impair complement-dependent antigen-antibody reactions; inhibits locomotion of neutrophils and chemotaxis of eosinophils Increases p H and interferes with lysosomal degradation of hemoglobin, which in turn interferes with digestive vacuole function Bioavailability: Rapid and complete absorption Onset: May take 4-6 months to show response; peak response takes several months (rheumatic disease) Duration: Unknown Peak plasma time: 1-3 hr Protein bound: 55% Metabolites: Desethylhydroxychloroquine, desethylchloroquine Half-life: 32-50 days Excretion: Urine (60%) The above information is provided for general informational and educational purposes only. D: Use in LIFE-THREATENING emergencies when no safer drug available. Hydroxychloroquine lactation category Hydroxychloroquine Oral Uses, Side Effects, Interactions., Follow-Up of Infants Exposed to Hydroxychloroquine Given to. Hydroxychloroquine off label usesQue es plaquenil 200 mg May 13, 2009 Background. The anti-malarial drugs Hydroxychloroquine HCQ is widely used to treat various rheumatic diseases mechanism of action of this drug is to increase the pH in acidic vesicles, inhibiting receptor mediated endocytosis that affects many cellular functions including antigen presentation, toll receptor signaling and post-transcriptional modification of proteins 2-4. Systematic review of hydroxychloroquine use in pregnant.. Drug Safety in Pregnant & Nursing Women. Hydroxychloroquine and Breastfeeding - Help? breastfeeding. Hydroxychloroquine is considered safer than chloroquine during pregnancy and lactation. Hydroxychloroquine is rapidly absorbed from the gastrointestinal tract, and steady-state concentrations are reached after 4–6 weeks; 45% of hydroxychloroquine binds to plasma proteins that are deposited in tissues such as the liver, spleen, kidney, and lung. Lactation Risk Category L2 Safer; "Drug which has been studied in a limited number of breastfeeding women without adverse effects on the infant. And/or, the evidence of demonstrated risk which is likely to follow use of this mediction in a breastfeeding woman is remote." Pregnancy Category C Lactation Category S probably • Hydroxychloroquine should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk. • The additional risk imposed by hydroxychloroquine on pregnancy appears modest, and the drug should not be withheld when necessary.