Plaquenil 200 mg/1

Hydroxychloroquine Sulfate · TABLET · Aphena Pharma Solutions - Tennessee, LLC

No Recall HistoryCurrently in Shortage

Plain English

Plaquenil is a tablet containing hydroxychloroquine sulfate at 200 mg/1, taken oral. Manufactured by Aphena Pharma Solutions - Tennessee, LLC.

Key Facts

Brand Name: Plaquenil
Generic Name: Hydroxychloroquine Sulfate
NDC Code (Product): 71610-473
Manufacturer: Aphena Pharma Solutions - Tennessee, LLC
Strength: 200 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: NDA009768
Marketing Start: 06/28/2013

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective29,072 reports

rheumatoid arthritis20,306 reports

pain16,567 reports

fatigue14,062 reports

arthralgia13,793 reports

drug intolerance12,315 reports

joint swelling12,248 reports

off label use11,210 reports

rash10,628 reports

abdominal discomfort9,652 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PLAQUENIL 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): PLAQUENIL 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…

Dosage & Administration

2 DOSAGE AND 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 ≥ 31 kg: 6.5 mg/kg 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 once daily or 400 mg once daily (or in two divided doses) Systemic Lupus Erythematosus in Adults ( 2.4 ): 200 mg once daily or 400 mg once daily (or in two divided doses) Chronic Discoid Lupus Erythematosus in Adults ( 2.5 ): 200 mg once daily or 400 mg once daily (or in two divided doses) 2.1 Important Administration Instructions Administer PLAQUENIL orally with food or milk. Do not crush or divide the tablets. 2.2 Dosage for Malaria in Adult and Pediatric Patients PLAQUENIL is not recommended in pediatric patients less than 31 kg because the lowest available strength (200 mg) exceeds the recommended dose fo…

Contraindications

4 CONTRAINDICATIONS PLAQUENIL 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 PLAQUENIL prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if PLAQUENIL is used concomitantly with other arrhythmogenic drugs. Therefore, PLAQUENIL 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 PLAQUENIL 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 PLAQUENIL can lower the seizure threshold. Co-administration of PLAQUENIL 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 PLAQUENIL. 7.5 Methotr…

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 PLAQUENIL. 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 a…

Frequently Asked Questions

What is Plaquenil used for?

Plaquenil contains Hydroxychloroquine Sulfate. It is a tablet taken oral. Consult your doctor for specific uses.

Is Plaquenil a controlled substance?

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

What is the generic name for Plaquenil?

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

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

The NDC (National Drug Code) for Plaquenil 200 mg/1 is 71610-473, listed by Aphena Pharma Solutions - Tennessee, LLC.

Product NDC

71610-473

Package NDC

71610-473-04

Other Hydroxychloroquine Brands

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

Data from openFDA · Public domain (CC0 1.0)