Hydroxychloroquine sulfate
Generic: HYDROXYCHLOROQUINE SULFATE
Basic Information
Manufacturer
Zydus Pharmaceuticals USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
805a1acd-2e0d-48f1-af6b-0e5d8e06c228
Indications & Usage
1 INDICATIONS AND USAGE Hydroxychloroquine sulfate tablets 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): Hydroxychloroquine sulfate Tablets 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 necessary.
1.1 Malaria Hydroxychloroquine sulfate tablet is indicated in adult and pediatric patients for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use: Hydroxychloroquine sulfate tablet is not recommended for: Treatment of complicated malaria.
Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology ( 12.4 )].
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 necessary [see Microbiology ( 12.4 )].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention 1 .
1.2 Rheumatoid Arthritis Hydroxychloroquine sulfate tablet is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus Hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus Hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults.
( 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 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 necessary.
1.1 Malaria Hydroxychloroquine sulfate tablet is indicated in adult and pediatric patients for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale.
Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use: Hydroxychloroquine sulfate tablet is not recommended for: Treatment of complicated malaria.
Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology ( 12.4 )].
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 necessary [see Microbiology ( 12.4 )].
For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention 1 .
1.2 Rheumatoid Arthritis Hydroxychloroquine sulfate tablet is indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
1.3 Systemic Lupus Erythematosus Hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults.
1.4 Chronic Discoid Lupus Erythematosus Hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults.
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.
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 - Metabolism and nutrition disorders : Anorexia, hypoglycemia, weight loss - Musculoskeletal and connective tissue disorders : Proximal myopathy, depressed tendon reflexes, abnormal nerve conduction - Nervous system disorders : Ataxia, dizziness, headache, seizure, extrapyramidal disorders (dystonia, dyskinesia, tremor) - Neuro psychiatric disorders: Affect/emotional lability, irritability, nervousness, psychosis, suicidal ideation, suicidal behavior, depression, hallucinations, anxiety, agitation, confusion, delusions, paranoia, mania and sleep disorders (insomnia, night terrors, nightmares) - Skin and subcutaneous tissue disorders : Alopecia, hair color changes, rash, pruritus, photosensitivity, psoriasis exacerbation, hyperpigmentation, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
at 1-877-993-8779 or FDA at 1-800-FDA-1088 or w w w.fd a .g o v/ m e d w a t ch .
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 - Metabolism and nutrition disorders : Anorexia, hypoglycemia, weight loss - Musculoskeletal and connective tissue disorders : Proximal myopathy, depressed tendon reflexes, abnormal nerve conduction - Nervous system disorders : Ataxia, dizziness, headache, seizure, extrapyramidal disorders (dystonia, dyskinesia, tremor) - Neuro psychiatric disorders: Affect/emotional lability, irritability, nervousness, psychosis, suicidal ideation, suicidal behavior, depression, hallucinations, anxiety, agitation, confusion, delusions, paranoia, mania and sleep disorders (insomnia, night terrors, nightmares) - Skin and subcutaneous tissue disorders : Alopecia, hair color changes, rash, pruritus, photosensitivity, psoriasis exacerbation, hyperpigmentation, exfoliative dermatitis, erythema multiforme, acute generalized exanthematous pustulosis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS syndrome), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) The most common adverse reactions reported are: nausea, vomiting, diarrhea, and abdominal pain.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc.
at 1-877-993-8779 or FDA at 1-800-FDA-1088 or w w w.fd a .g o v/ m e d w a t ch .