sulfate, yellow fever vaccine. Other (see comment). Minor/Significance Unknown. Comment: The prescribing information states: "although chloroquine inhibits replication of yellow fever vaccine in vitro, it does not appear to adversely affect antibody responses to yellow fever vaccine among persons receiving chloroquine" .ziprasidoneSerious - Use Alternative (1)hydroxychloroquine sulfate and ziprasidone both increase QTc interval. Avoid or Use Alternate Drug.zoster vaccine liveSerious - Use Alternative (1)hydroxychloroquine sulfate decreases effects of zoster vaccine live by pharmacodynamic antagonism. Contraindicated. Immunosuppressants also increase risk of infection with concomitant live vaccines.zoster vaccine recombinantMonitor Closely (1)hydroxychloroquine sulfate decreases effects of zoster vaccine recombinant by pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce the effectiveness of zoster vaccine recombinant. Frequency Not Defined Blood and lymphatic system disorders: Bone marrow failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia; hemolysis reported in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency Cardiac disorders: Cardiomyopathy, QT interval prolongation, and ventricular arrhythmias and torsade de pointes Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness Eye disorders: Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision) Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain General disorders and administration site conditions: Fatigue Hepatobiliary disorders: Liver function tests abnormal, hepatic failure acute Immune system disorders: Urticaria, angioedema, bronchospasm Metabolism and nutrition disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction Nervous system disorders: Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, tremor Psychiatric disorders: Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior Skin and subcutaneous tissue disorders: Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia; dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP) Contraindications Hypersensitivity to 4-aminoquinoline derivatives Cautions Not effective against chloroquine-resistant strains of P falciparum Rare suicidal behavior has been reported May cause severe hypoglycemia including loss of consciousness that could be life-threatening in patients treated with or without antidiabetic medications; check blood glucose and adjust treatment if necessary Exercise caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs; a dosage reduction may be necessary in patients with hepatic or renal disease, as well as in those taking medicines known to affect these organs Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs; perform periodic blood cell counts if patients are given prolonged therapy; if any severe blood disorder (eg, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia) appears which is not attributable to the disease under treatment, consider discontinuing treatment Endomyocardial biopsy showed association of cardiomyopathy with phospholipidosis in absence of inflammation, infiltration, or necrosis; drug-induced phospholipidosis may occur in other organ systems Correct electrolyte imbalances prior to use; monitor cardiac function as clinically indicated during therapy; discontinue therapy if cardiotoxicity is suspected or demonstrated by tissue biopsy Use with caution in patients having glucose-6-phosphate dehydrogenase (G-6-PD) deficiency Dermatologic reactions may occur Skeletal muscle myopathy or neuropathy Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported; muscle and nerve biopsies have shown associated phospholipidosis; Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy; discontinue therapy if muscle or nerve toxicity suspected or demonstrated by tissue biopsy Renal toxicity Proteinuria with or without moderate reduction in glomerular filtration reported with therapy 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 therapy Discontinue therapy if renal toxicity suspected or demonstrated by tissue biopsy Cardiac effects Postmarketing cases of life-threatening and fatal cardiomyopathy have been reported May present with AV block, pulmonary hypertension, sick sinus syndrome or with cardiac complications ECG findings include atrioventricular, right or left bundle branch block Monitor for signs and symptoms of cardiomyopathy is advised If cardiotoxicity is suspected, promptly discontinue treatment Ocular toxicity Irreversible retinal damage observed; significant risk factors for retinal damage include daily doses of hydroxychloroquine sulfate >6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use >5 years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate and concurrent macular disease Recommend an ocular exam 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) In individuals of Asian descent, retinal toxicity may first be noticed outside macula; in patients of Asian descent, perform visual field testing in central 24 degrees instead of central 10 degrees Discontinue if ocular toxicity is suspected and closely observe any retinal changes (and visual disturbances) even after cessation of therapy Drug interaction overview Avoid use 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 Concomitant use with hydroxychloroquine and digoxin therapy may result in increased serum digoxin levels: closely monitor serum digoxin levels in patients receiving combined therapy May enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required Coadministration with other antimalarials known to lower the convulsion threshold (eg, mefloquine) may increase the risk of convulsions Activity of antiepileptic drugs might be impaired if coadministered with hydroxychloroquine An increased plasma cyclosporine level was reported when cyclosporine and hydroxychloroquine were coadministered Pregnancy There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy; encourage patients to register by contacting 1-877-311-8972 Prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes There are risks to mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy Animal reproduction studies were not conducted with hydroxychloroquine Clinical considerations Malaria during pregnancy increases risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth Published data on rheumatoid arthritis suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth Pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction; passage of maternal auto-antibodies across placenta may result in neonatal illness, including neonatal lupus and congenital heart block Embryonic deaths and malformations of anophthalmia and microphthalmia in the offspring have been reported when pregnant rats received large doses of chloroquine Lactation Exercise caution when administering hydroxychloroquine to nursing women Published lactation data report that hydroxychloroquine is present in human milk at low levels; no adverse reactions have been reported in breastfed infants; no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities observed in children exposed to hydroxychloroquine through breastmilk There is no information on effect of hydroxychloroquine on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition When administered to nursing women, hydroxychloroquine is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolinesPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. 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. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Malaria Precise mechanism of action against Plasmodium is unknown Hydroxychloroquine, like chloroquine, is a weak base and may exert its effect by concentrating in the acid vesicles of the parasite and by inhibiting polymerization of heme It can also inhibit certain enzymes by its interaction with DNA Rheumatoid arthritis and systemic lupus erythematosus Mechanisms underlying the anti-inflammatory and immunomodulatory effects of hydroxychloroquine are unknown Absorption Peak plasma concentration: 129.6 ng/mL (single 200-mg dose) Peak plasma time: 3.26 hr (single 200-mg dose); 3-4 hr (chronic PO administration) Metabolism Metabolites: Desethylhydroxychloroquine, desethylchloroquine Elimination Half-life: 40-50 days Oral Administration Take with a meal or a glass of milk Do not crush or split tablets Storage Dispense in a tight, light-resistant container Keep out of the reach of children Store at room temperature (20-25ºC [68-77ºF]), allows excursions at 15-30ºC (59-86ºF) BRAND FORM. UNIT PRICE PILL IMAGE hydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tablethydroxychloroquine oral- 200 mg tabletPlaquenil oral- 200 mg tabletCopyright © 2010 First DataBank, Inc.Print Patient Educationhydroxychloroquine oral HYDROXYCHLOROQUINE - ORAL (hi-DROX-ee-KLOR-oh-kwin) COMMON BRAND NAME(S): Plaquenil USES: Hydroxychloroquine is used to prevent or treat malaria caused by mosquito bites. The United States Center for Disease Control provides updated guidelines and travel recommendations for the prevention and treatment of malaria in different parts of the world. Discuss the most recent information with your doctor before traveling to areas where malaria occurs.This medication is also used to treat certain auto-immune diseases (lupus, rheumatoid arthritis). It belongs to a class of medications known as disease-modifying antirheumatic drugs (DMARDs). It can reduce skin problems in lupus and prevent swelling/pain in arthritis.Hydroxychloroquine is not recommended for coronavirus infection, also known as COVID-19, unless you are enrolled in a study. Talk to your doctor about the risks and benefits. HOW TO USE: Take this medication by mouth exactly as directed by your doctor. To help prevent stomach upset, take it with food or milk. Swallow the tablets whole since breaking or crushing them may leave a bitter taste. The dosage and length of treatment are based on your medical condition and response to treatment. Children's dose is also based on weight.To prevent malaria, take this medication by mouth as directed by your doctor, usually once a week on the same day each week. Mark a calendar to help you remember. This drug is usually started 1 to 2 weeks before entering the malarious area. Continue to take it weekly while in the area and for 4 to 8 weeks after leaving the area, or as directed by your doctor. To treat malaria, follow your doctor's instructions.For lupus or rheumatoid arthritis, take this medication by mouth as directed by your doctor, usually once or twice daily. Your doctor may gradually increase your dose. Once you have been taking the medication for a while and your condition has improved, your doctor may instruct you to lower your dose until you find the dose that works best with the fewest side effects.If you are also taking a certain drug for diarrhea (kaolin) or taking antacids (such as magnesium/aluminum hydroxide), take hydroxychloroquine at least 4 hours before or after these products. These products may bind with hydroxychloroquine, preventing your body from fully absorbing it.Use this medication regularly in order to get the most benefit from it. If you are taking it on a daily schedule, take it at