HYDROXYCHLOROQUINE SULFATE
Generic: HYDROXYCHLOROQUINE SULFATE
Basic Information
Manufacturer
AvPAK
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
a5b3455a-e842-7d4b-e053-2995a90adee3
Indications & Usage
INDICATIONS AND USAGE Malaria Hydroxychloroquine Sulfate Tablets are indicated for the treatment of uncomplicated malaria due to P.
falciparum, P.
malariae, P.
ovale , and P.
vivax.
Hydroxychloroquine Sulfate Tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use in Malaria Hydroxychloroquine Sulfate Tablets are not recommended for the treatment of complicated malaria.
Hydroxychloroquine Sulfate Tablets are not effective against chloroquine or hydroxychloroquine- resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY – Microbiology ).
Hydroxychloroquine Sulfate Tablets are not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Hydroxychloroquine Sulfate Tablets are not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs.
Hydroxychloroquine Sulfate Tablets does not prevent relapses of P.
vivax or P.
ovale because it is not active against the hypnozoite forms of these parasites.
For radical cure of P.
vivax and P.
ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY – Microbiology ).
Prior to prescribing hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website ( http://www.cdc.gov/malaria ).
Lupus Erythematosus Hydroxychloroquine Sulfate Tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.
Rheumatoid Arthritis Hydroxychloroquine Sulfate Tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
falciparum, P.
malariae, P.
ovale , and P.
vivax.
Hydroxychloroquine Sulfate Tablets are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.
Limitations of Use in Malaria Hydroxychloroquine Sulfate Tablets are not recommended for the treatment of complicated malaria.
Hydroxychloroquine Sulfate Tablets are not effective against chloroquine or hydroxychloroquine- resistant strains of Plasmodium species (see CLINICAL PHARMACOLOGY – Microbiology ).
Hydroxychloroquine Sulfate Tablets are not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified.
Hydroxychloroquine Sulfate Tablets are not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs.
Hydroxychloroquine Sulfate Tablets does not prevent relapses of P.
vivax or P.
ovale because it is not active against the hypnozoite forms of these parasites.
For radical cure of P.
vivax and P.
ovale infections, concomitant therapy with an 8-aminoquinoline compound is necessary (see CLINICAL PHARMACOLOGY – Microbiology ).
Prior to prescribing hydroxychloroquine sulfate tablets for the treatment or prophylaxis of malaria, consult the Centers for Disease Control and Prevention (CDC) Malaria website ( http://www.cdc.gov/malaria ).
Lupus Erythematosus Hydroxychloroquine Sulfate Tablets are indicated for the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus in adults.
Rheumatoid Arthritis Hydroxychloroquine Sulfate Tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults.
Warnings
WARNINGS: Resistant strains of malaria: Hydroxychloroquine Sulfate Tablets are not effective against chloroquine-resistant strains of P.
falciparum (see CLINICAL PHARMACOLOGY – Microbiology ).
Ocular: Irreversible retinal damage has been observed in some patients who had received hydroxychloroquine sulfate.
Significant risk factors for retinal damage include daily doses of hydroxychloroquine sulfate greater than 6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use greater than five years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate and concurrent macular disease.
A baseline ocular examination is recommended within the first year of starting hydroxychloroquine sulfate tablets.
The baseline exam should include: best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT).
For individuals with significant risk factors (daily dose of hydroxychloroquine sulfate greater than 5.0 mg/kg base of actual body weight, subnormal glomerular filtration, use of tamoxifen citrate or concurrent macular disease) monitoring should include annual examinations which include BCVA, VF and SD-OCT.
For individuals without significant risk factors, annual exams can usually be deferred until five years of treatment.
In individuals of Asian descent, retinal toxicity may first be noticed outside the macula.
In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees.
It is recommended that hydroxychloroquine be discontinued if ocular toxicity is suspected and the patient should be closely observed given that retinal changes (and visual disturbances) may progress even after cessation of therapy.
Cardiac Effects, including Cardiomyopathy and QT prolongation: Postmarketing cases of life-threatening and fatal cardiomyopathy have been reported with use of hydroxychloroquine sulfate tablets as well as with use of chloroquine.
Patients may present with atrioventricular block, pulmonary hypertension, sick sinus syndrome or with cardiac complications.
ECG findings may include atrioventricular, right or left bundle branch block.
Signs or symptoms of cardiac compromise have appeared during acute and chronic treatment.
Clinical monitoring for signs and symptoms of cardiomyopathy is advised, including use of appropriate diagnostic tools such as ECG to monitor patients for cardiomyopathy during hydroxychloroquine sulfate tablet therapy.
Chronic toxicity should be considered when conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy are diagnosed.
If cardiotoxicity is suspected, prompt discontinuation of hydroxychloroquine sulfate tablets may prevent life-threatening complications.
Hydroxychloroquine Sulfate Tablets prolongs the QT interval.
Ventricular arrhythmias and torsades de pointes have been reported in patients taking hydroxychloroquine sulfate tablets (see OVERDOSAGE ).
Therefore, hydroxychloroquine sulfate tablets should not be administered with other drugs that have the potential to prolong the QT interval (see DRUG INTERACTIONS ).
Worsening of psoriasis and porphyria: Use of hydroxychloroquine sulfate tablets in patients with psoriasis may precipitate a severe attack of psoriasis.
When used in patients with porphyria the condition may be exacerbated.
The preparation should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard.
Proximal Myopathy and Neuropathy: Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported.
Muscle and nerve biopsies have been associated with curvilinear bodies and muscle fiber atrophy with vacuolar changes.
Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with hydroxychloroquine sulfate tablets.
Neuropsychiatric events, including suicidality: Suicidal behavior has been rarely reported in patients treated with hydroxychloroquine sulfate tablets.
Hypoglycemia: Hydroxychloroquine Sulfate Tablets has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with or without antidiabetic medications (see DRUG INTERACTIONS and ADVERSE REACTIONS ).
Patients treated with hydroxychloroquine sulfate tablets should be warned about the risk of hypoglycemia and the associated clinical signs and symptoms.
Patients presenting with clinical symptoms suggestive of hypoglycemia during treatment with hydroxychloroquine sulfate tablets should have their blood glucose checked and treatment reviewed as necessary.
falciparum (see CLINICAL PHARMACOLOGY – Microbiology ).
Ocular: Irreversible retinal damage has been observed in some patients who had received hydroxychloroquine sulfate.
Significant risk factors for retinal damage include daily doses of hydroxychloroquine sulfate greater than 6.5 mg/kg (5 mg/kg base) of actual body weight, durations of use greater than five years, subnormal glomerular filtration, use of some concomitant drug products such as tamoxifen citrate and concurrent macular disease.
A baseline ocular examination is recommended within the first year of starting hydroxychloroquine sulfate tablets.
The baseline exam should include: best corrected distance visual acuity (BCVA), an automated threshold visual field (VF) of the central 10 degrees (with retesting if an abnormality is noted), and spectral domain ocular coherence tomography (SD-OCT).
For individuals with significant risk factors (daily dose of hydroxychloroquine sulfate greater than 5.0 mg/kg base of actual body weight, subnormal glomerular filtration, use of tamoxifen citrate or concurrent macular disease) monitoring should include annual examinations which include BCVA, VF and SD-OCT.
For individuals without significant risk factors, annual exams can usually be deferred until five years of treatment.
In individuals of Asian descent, retinal toxicity may first be noticed outside the macula.
In patients of Asian descent, it is recommended that visual field testing be performed in the central 24 degrees instead of the central 10 degrees.
It is recommended that hydroxychloroquine be discontinued if ocular toxicity is suspected and the patient should be closely observed given that retinal changes (and visual disturbances) may progress even after cessation of therapy.
Cardiac Effects, including Cardiomyopathy and QT prolongation: Postmarketing cases of life-threatening and fatal cardiomyopathy have been reported with use of hydroxychloroquine sulfate tablets as well as with use of chloroquine.
Patients may present with atrioventricular block, pulmonary hypertension, sick sinus syndrome or with cardiac complications.
ECG findings may include atrioventricular, right or left bundle branch block.
Signs or symptoms of cardiac compromise have appeared during acute and chronic treatment.
Clinical monitoring for signs and symptoms of cardiomyopathy is advised, including use of appropriate diagnostic tools such as ECG to monitor patients for cardiomyopathy during hydroxychloroquine sulfate tablet therapy.
Chronic toxicity should be considered when conduction disorders (bundle branch block/atrio-ventricular heart block) or biventricular hypertrophy are diagnosed.
If cardiotoxicity is suspected, prompt discontinuation of hydroxychloroquine sulfate tablets may prevent life-threatening complications.
Hydroxychloroquine Sulfate Tablets prolongs the QT interval.
Ventricular arrhythmias and torsades de pointes have been reported in patients taking hydroxychloroquine sulfate tablets (see OVERDOSAGE ).
Therefore, hydroxychloroquine sulfate tablets should not be administered with other drugs that have the potential to prolong the QT interval (see DRUG INTERACTIONS ).
Worsening of psoriasis and porphyria: Use of hydroxychloroquine sulfate tablets in patients with psoriasis may precipitate a severe attack of psoriasis.
When used in patients with porphyria the condition may be exacerbated.
The preparation should not be used in these conditions unless in the judgment of the physician the benefit to the patient outweighs the possible hazard.
Proximal Myopathy and Neuropathy: Skeletal muscle myopathy or neuropathy leading to progressive weakness and atrophy of proximal muscle groups, depressed tendon reflexes, and abnormal nerve conduction, have been reported.
Muscle and nerve biopsies have been associated with curvilinear bodies and muscle fiber atrophy with vacuolar changes.
Assess muscle strength and deep tendon reflexes periodically in patients on long-term therapy with hydroxychloroquine sulfate tablets.
Neuropsychiatric events, including suicidality: Suicidal behavior has been rarely reported in patients treated with hydroxychloroquine sulfate tablets.
Hypoglycemia: Hydroxychloroquine Sulfate Tablets has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with or without antidiabetic medications (see DRUG INTERACTIONS and ADVERSE REACTIONS ).
Patients treated with hydroxychloroquine sulfate tablets should be warned about the risk of hypoglycemia and the associated clinical signs and symptoms.
Patients presenting with clinical symptoms suggestive of hypoglycemia during treatment with hydroxychloroquine sulfate tablets should have their blood glucose checked and treatment reviewed as necessary.
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of hydroxychloroquine sulfate tablets or other 4-aminoquinoline compounds.
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 failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia.
Hemolysis reported in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Cardiac disorders: Cardiomyopathy which may result in cardiac failure and in some cases a fatal outcome (see WARNINGS and OVERDOSAGE ).
Hydroxychloroquine Sulfate Tablets prolong the QT interval.
Ventricular arrhythmias and torsade de pointes have been reported in patients taking hydroxychloroquine sulfate tablets (see OVERDOSAGE and DRUG INTERACTIONS ).
Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness.
Eye disorders: Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision).
Gastrointestinal disorders: Nausea, vomiting, diarrhea, and abdominal pain.
General disorders and administration site conditions: Fatigue.
Hepatobiliary disorders: Liver function tests abnormal, hepatic failure acute.
Immune system disorders: Urticaria, angioedema, bronchospasm.
Metabolism and nutrition disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased.
Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.
Nervous system disorders: Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs.
Psychiatric disorders: Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior.
Skin and subcutaneous tissue disorders: Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia.
Dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP).
AGEP has to be distinguished from psoriasis, although hydroxychloroquine sulfate tablets may precipitate attacks of psoriasis.
It may be associated with pyrexia and hyperleukocytosis.
To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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 failure, anemia, aplastic anemia, agranulocytosis, leukopenia, and thrombocytopenia.
Hemolysis reported in individuals with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Cardiac disorders: Cardiomyopathy which may result in cardiac failure and in some cases a fatal outcome (see WARNINGS and OVERDOSAGE ).
Hydroxychloroquine Sulfate Tablets prolong the QT interval.
Ventricular arrhythmias and torsade de pointes have been reported in patients taking hydroxychloroquine sulfate tablets (see OVERDOSAGE and DRUG INTERACTIONS ).
Ear and labyrinth disorders: Vertigo, tinnitus, nystagmus, nerve deafness, deafness.
Eye disorders: Irreversible retinopathy with retinal pigmentation changes (bull’s eye appearance), visual field defects (paracentral scotomas) and visual disturbances (visual acuity), maculopathies (macular degeneration), decreased dark adaptation, color vision abnormalities, corneal changes (edema and opacities) including corneal deposition of drug with or without accompanying symptoms (halo around lights, photophobia, blurred vision).
Gastrointestinal disorders: Nausea, vomiting, diarrhea, and abdominal pain.
General disorders and administration site conditions: Fatigue.
Hepatobiliary disorders: Liver function tests abnormal, hepatic failure acute.
Immune system disorders: Urticaria, angioedema, bronchospasm.
Metabolism and nutrition disorders: Decreased appetite, hypoglycemia, porphyria, weight decreased.
Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.
Nervous system disorders: Headache, dizziness, seizure, ataxia and extrapyramidal disorders such as dystonia, dyskinesia, and tremor have been reported with this class of drugs.
Psychiatric disorders: Affect/emotional lability, nervousness, irritability, nightmares, psychosis, suicidal behavior.
Skin and subcutaneous tissue disorders: Rash, pruritus, pigmentation disorders in skin and mucous membranes, hair color changes, alopecia.
Dermatitis bullous eruptions including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), photosensitivity, dermatitis exfoliative, acute generalized exanthematous pustulosis (AGEP).
AGEP has to be distinguished from psoriasis, although hydroxychloroquine sulfate tablets may precipitate attacks of psoriasis.
It may be associated with pyrexia and hyperleukocytosis.
To report SUSPECTED ADVERSE REACTIONS, contact AvKARE at 1-855-361-3993 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .