hydroxychloroquine sulfate (Rx)

Brand and Other Names:Plaquenil
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg

Malaria

Plasmodium malariae, P ovale, P vivax, or susceptible strains of P falciparum

Acute treatment

  • 800 mg (620 mg base) PO, then 400 mg (310 mg base) PO 6-8 hours later, then 400 mg (310 mg base) PO at 24 and 48 hours

Prophylaxis

  • 400 mg (310 mg base) PO weekly, starting 2 weeks before exposure and continued for 4 weeks after departure from area
  • With prolonged therapy, obtain CBCs periodically

Rheumatoid Arthritis

400-600 mg (310-465 mg base) PO daily for 4-12 weeks; maintenance: 200-400 mg (155-310 mg base) PO daily

With prolonged therapy, obtain CBCs periodically

Systemic Lupus Erythematosus

400 mg (310 mg base) PO once or twice daily; maintenance: 200-400 mg (155-310 mg base) PO daily

With prolonged therapy, obtain CBCs periodically

Porphyria Cutanea Tarda (Off-label)

100-200 mg (77.5-155 mg base) PO 2-3 times/wk

Administration

Take with food or milk

Dosage Forms & Strengths

tablet

  • 200mg

Malaria

Plasmodium malariae, P ovale, P vivax, or susceptible strains of P falciparum

Acute treatment

  • 13 mg/kg base PO, then 6.5 mg/kg base PO 6 hr later, then 6.5 mg/kg base PO at 24 and 48 hours; not to exceed 400 mg/day base

Prophylaxis

  • 6.5 mg/kg base (not to exceed 400 mg [310 mg base]) PO weekly, starting 2 weeks before exposure and continued for 4 weeks after departure from area
  • With prolonged therapy, obtain CBCs periodically

Porphyria Cutanea Tarda (Off-label)

Dosing schedules not well established in children

A case report describes 3 mg/kg PO twice weekly over 14 months reported as safe and effective in a child aged 4 yr

Administration

Take with food or milk

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Interactions

Interaction Checker

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            Adverse Effects

            Frequency Not Defined

            Nausea, vomiting

            Headache

            Dizziness

            Irritability

            Muscle weakness

            Aplastic anemia

            Leukopenia

            Thrombocytopenia

            Corneal changes or deposits (visual disturbances, blurred vision, photophobia; reversible on discontinuance)

            Retinal damage with long-term use

            Bleaching of hair

            Alopecia

            Pruritus

            Skin and musculoskeletal pigmentation changes

            Weight loss, anorexia

            Cardiomyopathy (rare)

            Hemolysis (individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency)

            Prolongs QT interval

            Ventricular arrhythmias and torsade de pointes

            Vertigo

            Tinnitus

            Nystagmus

            Nerve deafness

            Deafness

            Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance)

            Visual field defects (paracentral scotomas)

            Visual disturbances (visual acuity)

            Maculopathies (macular degeneration)

            Decreased dark adaptation

            Color vision abnormalities

            Corneal changes (edema and opacities)

            Abdominal pain

            Fatigue

            Liver function tests abnormal

            Hepatic failure acute

            Urticaria

            Angioedema

            Bronchospasm

            Decreased appetite

            Hypoglycemia

            Porphyria

            Weight decreased

            Sensorimotor disorder

            Skeletal muscle myopathy or neuromyopathy

            Headache

            Dizziness

            Seizure

            Ataxia

            Extrapyramidal disorders such as dystonia

            Dyskinesia

            Tremor

            Rash

            Pruritus

            Pigmentation disorders in skin and mucous membranes

            Hair color changes

            Alopecia

            Dermatitis bullous eruptions including erythema multiforme

            Stevens-Johnson syndrome

            Toxic epidermal necrolysis

            Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

            Photosensitivity

            Dermatitis exfoliative

            Acute generalized exanthematous pustulosis (AGEP); AGEP has to be distinguished from psoriasis; hydroxychloroquine may precipitate attacks of psoriasis

            Pyrexia

            Hyperleukocytosis

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            Warnings

            Black Box Warnings

            Should be prescribed by experienced physician familiar with complete contents of package insert

            Contraindications

            Hypersensitivity to 4-aminoquinoline derivatives

            Retinal or visual field changes due to 4-aminoquinoline compounds

            Long-term therapy in children

            Cautions

            Not effective against chloroquine-resistant strains of P. 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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug is concentrated in breast milk (American Academy of Pediatrics committee states that it is compatible with nursing)

            Pregnancy 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.

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            Pharmacology

            Mechanism of Action

            Unknown; may impair complement-dependent antigen-antibody reactions; inhibits locomotion of neutrophils and chemotaxis of eosinophils

            Increases pH and interferes with lysosomal degradation of hemoglobin, which in turn interferes with digestive vacuole function

            Absorption

            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

            Distribution

            Protein bound: 55%

            Metabolism

            Metabolites: Desethylhydroxychloroquine, desethylchloroquine

            Elimination

            Half-life: 32-50 days

            Excretion: Urine (60%)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.