SOVUNA 200 mg/1

Hydroxychloroquine Sulfate · TABLET, FILM COATED · ANI Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Hydroxychloroquine sulfate is an oral prescription medication used to treat malaria, lupus, and rheumatoid arthritis. This 200 mg tablet is taken by mouth as directed by your doctor.

Key Facts

Brand Name: SOVUNA
Generic Name: Hydroxychloroquine Sulfate
NDC Code (Product): 70954-804
Manufacturer: ANI Pharmaceuticals, Inc.
Strength: 200 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA214581
Marketing Start: 09/15/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective18,095 reports

rheumatoid arthritis13,674 reports

pain10,809 reports

fatigue9,379 reports

drug intolerance9,240 reports

off label use8,457 reports

joint swelling8,397 reports

arthralgia8,376 reports

contraindicated product administered8,075 reports

alopecia7,711 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS & USAGE SOVUNA is an antimalarial and antirheumatic indicated for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium ovale, and Plasmodium vivax in adult and pediatric patients. (1.1) Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported in adult and pediatric patients. (1.1) Treatment of rheumatoid arthritis in adults. (1.2) Treatment of systemic lupus erythematosus in adults. (1.3) Treatment of chronic discoid lupus erythematosus in adults. (1.4) Limitations of Use (1.1): SOVUNA is not recommended for the: Treatment of complicated malaria. Treatment of chloroquine or hydroxychloroquine-resistant strains of Plasmodium species. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is nec…

Dosage & Administration

2 DOSAGE & ADMINISTRATION 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…

Contraindications

4 CONTRAINDICATIONS SOVUNA is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. Patients with hypersensitivity to 4-aminoquinoline compounds (4)

Drug Interactions

7 DRUG INTERACTIONS 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 S…

Adverse Reactions

6 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)] 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 : Bon…

Frequently Asked Questions

What is SOVUNA used for?

Hydroxychloroquine sulfate is an oral prescription medication used to treat malaria, lupus, and rheumatoid arthritis. This 200 mg tablet is taken by mouth as directed by your doctor.

Is SOVUNA a controlled substance?

SOVUNA is not classified as a controlled substance by the DEA.

What is the generic name for SOVUNA?

The generic name for SOVUNA is Hydroxychloroquine Sulfate. There are 11 other brand versions of Hydroxychloroquine Sulfate.

What is the NDC code for SOVUNA 200 mg/1?

The NDC (National Drug Code) for SOVUNA 200 mg/1 is 70954-804, listed by ANI Pharmaceuticals, Inc..

Product NDC

70954-804

Package NDC

70954-804-10

Other Hydroxychloroquine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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