Hydroxychloroquine sulfate 200 mg/1
Hydroxychloroquine sulfate · TABLET, FILM COATED · NCS HealthCare of KY, LLC dba Vangard Labs
Hydroxychloroquine sulfate is a tablet, film coated containing hydroxychloroquine sulfate at 200 mg/1, taken oral. Manufactured by NCS HealthCare of KY, LLC dba Vangard Labs.
Key Facts
- Brand Name
- Hydroxychloroquine sulfate
- Generic Name
- Hydroxychloroquine sulfate
- NDC Code (Product)
0615-8459- Manufacturer
- NCS HealthCare of KY, LLC dba Vangard Labs
- Strength
- 200 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040657
- Marketing Start
- 01/03/2008
Recall History
Aidapak Services, LLC
Labeling:Label Mixup; HYDROXYCHLOROQUINE SULFATE, Tablet, 200 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD70629_7, EXP: 5/29/2014.
Sandoz Incorporated
Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Hydroxychloroquine sulfate tablets are 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 ): Hydroxychloroquine sulfate tablets are 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. ov…
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 hydroxychloroquine sulfate tablets orally with food or milk. Do not crush or divide the tablets. 2.2 Dosage for Malaria in Adult and Pediatric Patients Hydroxychloroquine sulfate tablets are not recommended in pediatric patients less than 31 kg because the lowest availa…
Contraindications
4 CONTRAINDICATIONS Hydroxychloroquine sulfate tablets are 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 Hydroxychloroquine sulfate tablets prolongs the QT interval. There may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate tablets are used concomitantly with other arrhythmogenic drugs. Therefore, hydroxychloroquine sulfate tablets are 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 Hydroxychloroquine sulfate tablets 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 Hydroxychloroquine sulfate tablets can lower the seizure threshold. Co-administration of hydroxychloroquine sulfate tablets with other antimalarials known to lower the seizure threshold (e.g., mefloquine) may …
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 hydroxychloroquine sulfate tablets. 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: Bloo…
Frequently Asked Questions
What is Hydroxychloroquine sulfate used for?
Hydroxychloroquine sulfate contains Hydroxychloroquine sulfate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Hydroxychloroquine sulfate a controlled substance?
Hydroxychloroquine sulfate is not classified as a controlled substance by the DEA.
What is the generic name for Hydroxychloroquine sulfate?
The generic name for Hydroxychloroquine sulfate is Hydroxychloroquine sulfate. There are 7 other brand versions of Hydroxychloroquine sulfate.
What is the NDC code for Hydroxychloroquine sulfate 200 mg/1?
The NDC (National Drug Code) for Hydroxychloroquine sulfate 200 mg/1 is 0615-8459, listed by NCS HealthCare of KY, LLC dba Vangard Labs.