Hydroxychloroquine is an antimalarial sold in the U.S. under 3 brand and generic names, for rheumatoid arthritis, systemic lupus erythematosus and malaria. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Sovuna (application NDA214581). Other hydroxychloroquine products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Malaria in Adult and Pediatric Patients (2.2): Prophylaxis: Begin weekly doses 2 weeks prior to travel to the endemic area, continue weekly doses while in the endemic area, and continue the weekly doses for 4 weeks after leaving the endemic area: Adults: 400 mg once a week Pediatric patients weighing greater than or equal to 23 kg: 6.5 mg/kg actual body weight up to 400 mg, once a week Treatment of Uncomplicated Malaria: See Full Prescribing Information (FPI) for complete dosing information. Rheumatoid Arthritis in Adults (2.3): Initial dosage: 400 mg to 600 mg daily Chronic dosage: 200 mg, 300 mg or 400 mg once daily (or in two divided doses) Systemic Lupus Erythematosus in Adults (2.4): 200 mg, 300 mg or 400 mg once daily (or in two divided doses) Chronic Discoid Lupus Erythematosus in Adults (2.5): 200 mg or 400 mg once daily (or in two divided doses) 2.1 Important Administration Instructions Administer SOVUNA orally with food or milk. Do not crush the tablets. 2.2 Dosage for Malaria in Adult and Pediatric Patients SOVUNA is not recommended in pediatric patients less than 23 kg because the lowest possible dose of 150 mg (half of the scored 300 mg tablet) exceeds the recommended dose for these patients. Prophylaxis Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to…
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)] Renal Toxicity [see Warnings and Precautions (5.11)] The following adverse reactions have been identified during post-approval use of 4 aminoquinoline drugs, including SOVUNA. 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,…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Tablet | Generic | $5 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $5 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| AC;384 | 200 mg | white | oval | — |
| lll | 200 mg | white | capsule | — |
| ZC38 | 200 mg | white | oval | — |
| PLAQUENIL | 200 mg | white | double circle | — |
| ZC38 | 200 mg | white | oval | — |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
SOVUNA is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds (4)
Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs. (7.1) See FPI for more important drug interactions. (7) 7.1 Drugs Prolonging QT Interval and Other Arrhythmogenic Drugs SOVUNA prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if SOVUNA is used concomitantly with other arrhythmogenic drugs. Therefore, SOVUNA is not recommended in patients taking other drugs that have the potential to prolong the QT interval or are arrhythmogenic [see Warnings and Precautions (5.1)]. 7.2 Insulin or Other Antidiabetic Drugs SOVUNA may enhance the effects of insulin and antidiabetic drugs, and consequently increase the hypoglycemic risk. Therefore, a decrease in dosage of insulin and other antidiabetic drugs may be necessary [see Warnings and Precautions (5.10 ) ] . 7.3 Drugs that Lower the Seizure Threshold SOVUNA can lower the seizure threshold. Co-administration of SOVUNA with other antimalarials known to lower the seizure threshold (e.g., mefloquine) may increase the risk of seizures. 7.4 Antiepileptics The activity of antiepileptic drugs might be impaired if co-administered with SOVUNA. 7.5 Methotrexate Concomitant use of SOVUNA and methotrexate may increase the incidence of adverse reactions. 7.6 Cyclosporine An increased plasma cyclosporin level was reported when cyclosporin and SOVUNA were co-administered. Monitor serum cyclosporine…
| View → |
| 3 | Not yet rated | Prescription | Tablet | Generic | $5 | View → |