Hydroxychloroquine Sulfate (3 brand names, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- HYDROXYCHLOROQUINE SULFATE
- PLAQUENIL
- SOVUNA
Contraindications
Hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.
Adverse Reactions
The following adverse reactions are described in greater detail in other sections: Cardiomyopathy and Ventricular Arrhythmias [see Warnings and Precautions (5.1)] Retinal Toxicity [see Warnings and Precautions (5.2)] Serious Skin Reactions [see Warnings and Precautions (5.3)] Worsening of Psoriasis [see Warnings and Precautions (5.4)] Risks Associated with Use in Porphyria [see Warnings and Precautions (5.5)] Hematologic Toxicity [see Warnings and Precautions (5.6)] Hemolytic Anemia Associated with G6PD [see Warnings and Precautions (5.7)] Skeletal Muscle Myopathy or Neuropathy [see Warnings and Precautions (5.8)] Neuropsychiatric Reactions Including Suicidality [see Warnings and Precautions (5.9)] Hypoglycemia [see Warnings and Precautions (5.10)] The following adverse reactions have been identified during post-approval use of 4-aminoquinoline drugs, including hydroxychloroquine sulfate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Blood and lymphatic system disorders: Bone marrow depression, anemia, aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia Cardiac disorders: Cardiomyopathy, cardiac failure, QT-interval prolongation, ventricular tachycardia, torsades de pointes, atrioventricular block, bundle branch block, sick sinus syndrome, pulmonary hypertension Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, sensorineural hearing loss Eye disorders: Retinopathy, retinal pigmentation changes (typically bull’s eye appearance), visual field defects (paracentral scotomas), macular degeneration, corneal edema, corneal opacities, decreased dark adaptation Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain General disorders: Fatigue Hepatobiliary disorders: Abnormal liver function tests, fulminant hepatic failure Immune system disorders: Urticaria, angioedema, bronchospasm Meta
Mechanism of Action
Malaria Hydroxychloroquine is a 4-aminoquinoline antimalarial [see Microbiology (12.4)] and antirheumatic agent. Rheumatoid Arthritis, Systemic Lupus Erythematosus and Chronic Discoid Lupus Erythematosus The mechanisms underlying the anti-inflammatory and immunomodulatory effects of hydroxychloroquine sulfate in the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus and systemic lupus erythematosus are not fully known.
Overdosage
Hydroxychloroquine sulfate overdosage symptoms have an onset within 1 hour to 3 hours of ingestion. The following have been reported with hydroxychloroquine sulfate overdosage: Cardiovascular toxicity, including QRS or QTc prolongation, ventricular tachycardia, ventricular fibrillation, torsade de pointes, atrioventricular block, cardiac arrest and death. Life-threatening hypotension is common. Severe hypokalemia secondary to an intracellular shift is common in severe toxicity. Central nervous system (CNS) depression, seizures, visual disturbances, transient blindness, and coma may occur. Gastrointestinal decontamination procedures warrant consideration in patients that present within the first hour post-ingestion. If the level of consciousness rapidly deteriorates in severe poisoning, consider intubation before gastrointestinal decontamination procedures. Monitor plasma potassium levels and manage accordingly. Hemofiltration, hemodialysis, and hemoperfusion are not of benefit. Consider contacting a poison center (1-800-221-2222) or a medical toxicologist for overdosage management recommendations.