Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

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 do 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.

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Advisory information

contraindications
CONTRAINDICATIONS Use of hydroxychloroquine sulfate tablets are contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.
Special warnings and precautions
PRECAUTIONS General Use with caution in patients with gastrointestinal, neurological, or blood disorders, and in those with a sensitivity to quinine. Hepatic/Renal Disease Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs. A reduction in dosage may be necessary in patients with hepatic or renal disease, as well as in those taking medicines known to affect these organs. Hematologic Effects/Laboratory Tests Antimalarial compounds should be used with caution in patients with hepatic disease or alcoholism or in conjunction with known hepatotoxic drugs. Periodic blood cell counts should be performed if patients are given prolonged therapy. If any severe blood disorder such as aplastic anemia, agranulocytosis, leukopenia, or thrombocytopenia, appears which is not attributable to the disease under treatment, consider discontinuation of hydroxychloroquine sulfate tablets. Hydroxychloroquine sulfate tablets should be administered with caution in patients having glucose-6-phosphate dehydrogenase (G-6-PD) deficiency. Dermatologic Effects Dermatologic reactions to hydroxychloroquine sulfate tablets may occur and, therefore, proper care should be exercised when it is administered to any patient receiving a drug with a significant tendency to produce dermatitis. Drug Interactions Digoxin Concomitant hydroxychloroquine sulfate tablets and digoxin therapy may result in increased serum digoxin levels: serum digoxin levels should be closely monitored in patients receiving combined therapy. Insulin or Antidiabetic Drugs As hydroxychloroquine sulfate tablets may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required. Drugs that Prolong QT Interval and Other Arrhythmogenic Drugs Hydroxychloroquine sulfate tablets prolong the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias. Also, there may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate tablets are used concomitantly with other arrhythmogenic drugs. Mefloquine and Other Drugs Known to Lower the Convulsive Threshold Hydroxychloroquine sulfate tablets can lower the convulsive threshold. Co-administration of hydroxychloroquine sulfate tablets with other antimalarials known to lower the convulsion threshold (e.g., mefloquine) may increase the risk of convulsions. Antiepileptics The activity of antiepileptic drugs might be impaired if co-administered with hydroxychloroquine sulfate tablets. Methotrexate Combined use of methotrexate with hydroxychloroquine sulfate tablets have not been studied and may increase the incidence of adverse effects. Cyclosporin An increased plasma cyclosporin level was reported when cyclosporin and hydroxychloroquine sulfate tablets were co-administered. The following interactions have been observed on treatment with the structurally related substance chloroquine phosphate, and therefore cannot be ruled out for hydroxychloroquine. Praziquantel Chloroquine has been reported to reduce the bioavailability of praziquantel. Antacids and Kaolin Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed. Cimetidine Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level. Concomitant use of cimetidine should be avoided. Ampicillin In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin. Information for Patients Patients should be informed of the early signs and symptoms of toxicity such as rash or visual changes. Patients must see their physicians promptly in case of the appearance of these or of any unusual effects. Periodic laboratory tests may be recommended in some patients. Patients should be fully informed of the potential risks of the use of hydroxychloroquine sulfate tablets, especially in pregnancy and in children. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals have not been conducted to evaluate the carcinogenic potential of hydroxychloroquine sulfate tablets. The mutagenic potential of hydroxychloroquine was not evaluated. However, chloroquine has been shown to be a catalytic inhibitor of DNA repair enzymes (topoisomerase II) and to produce weak genotoxic effects through this mode of action. Pregnancy Teratogenic Effects Human pregnancies resulting in live births have been reported in the literature and no increase in the rate of birth defects has been demonstrated. Embryonic deaths and malformations of anophthalmia and microphthalmia in the offspring have been reported when pregnant rats received large doses of chloroquine. Nursing Mothers Caution should be exercised when administering hydroxychloroquine sulfate tablets to nursing women. It has been demonstrated that hydroxychloroquine administered to nursing women is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines. Pediatric Use Safety and efficacy have not been established in the chronic use of hydroxychloroquine sulfate tablets for systemic lupus erythematosus and juvenile idiopathic arthritis in children. Children are especially sensitive to the 4-aminoquinoline compounds. Most reported fatalities followed the accidental ingestion of chloroquine, sometimes in small doses (0.75 g or 1 g in one 3-year-old child). Patients should be strongly warned to keep these drugs out of the reach of children (see OVERDOSAGE). Geriatric Use Clinical studies of hydroxychloroquine sulfate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function.
Adverse reactions
ADVERSE REACTIONS The following adverse reactions have been identified during post-approval use of hydroxychloroquine sulfate tablets or other 4-aminoqunoline 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION One hydroxychloroquine sulfate tablet contains 200 mg of hydroxychloroquine sulfate, which is equivalent to 155 mg base. Take hydroxychloroquine sulfate tablets with a meal or a glass of milk. Malaria Prophylaxis Adults 400 mg (310 mg base) once weekly on the same day of each week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area. Weight-Based Dosing in Adults and Pediatric Patients 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), once weekly on the same day of the week starting 2 weeks prior to exposure, and continued for 4 weeks after leaving the endemic area. Treatment of Uncomplicated Malaria Adults 800 mg (620 mg base) followed by 400 mg (310 mg base) at 6 hours, 24 hours and 48 hours after the initial dose (total 2000 mg hydroxychloroquine sulfate or 1550 mg base). Weight Based Dosage in Adults and Pediatric Patients 13 mg/kg (10 mg/kg base), not to exceed 800 mg (620 mg base) followed by 6.5 mg/kg (5 mg/kg base), not to exceed 400 mg (310 mg base), at 6 hours, 24 hours and 48 hours after the initial dose. Hydroxychloroquine sulfate film-coated tablets cannot be divided, therefore they should not be used to treat patients who weigh less than 31 kg. For radical cure of P. vivax and P. malariae infections, concomitant therapy with an 8-aminoquinoline compound is necessary. Lupus Erythematosus The recommended adult dosage is 200 to 400 mg (155 to 310 mg base) daily, administered as a single daily dose or in two divided doses. Doses above 400 mg a day are not recommended. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded. Rheumatoid Arthritis The action of hydroxychloroquine is cumulative and may require weeks to months to achieve the maximum therapeutic effect (see CLINICAL PHARMACOLOGY). Initial Adult Dosage 400 mg to 600 mg (310 to 465 mg base) daily, administered as a single daily dose or in two divided doses. In a small percentage of patients, side effects may require temporary reduction of the initial dosage. Maintenance Adult Dosage When a good response is obtained, the dosage may be reduced by 50 percent and continued at a maintenance level of 200 mg to 400 mg (155 mg to 310 mg base) daily, administered as a single daily dose or in two divided doses. Do not exceed 600 mg or 6.5 mg/kg (5 mg/kg base) per day, whichever is lower, as the incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded. Corticosteroids and salicylates may be used in conjunction with hydroxychloroquine sulfate tablets, and they can generally be decreased gradually in dosage or eliminated after a maintenance dose of hydroxychloroquine sulfate tablets has been achieved.
Pregnancy and lactation
Nursing Mothers Caution should be exercised when administering hydroxychloroquine sulfate tablets to nursing women. It has been demonstrated that hydroxychloroquine administered to nursing women is excreted in human milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines.

Interactions

Drug Interactions Digoxin Concomitant hydroxychloroquine sulfate tablets and digoxin therapy may result in increased serum digoxin levels: serum digoxin levels should be closely monitored in patients receiving combined therapy. Insulin or Antidiabetic Drugs As hydroxychloroquine sulfate tablets may enhance the effects of a hypoglycemic treatment, a decrease in doses of insulin or antidiabetic drugs may be required. Drugs that Prolong QT Interval and Other Arrhythmogenic Drugs Hydroxychloroquine sulfate tablets prolong the QT interval and should not be administered with other drugs that have the potential to induce cardiac arrhythmias. Also, there may be an increased risk of inducing ventricular arrhythmias if hydroxychloroquine sulfate tablets are used concomitantly with other arrhythmogenic drugs. Mefloquine and Other Drugs Known to Lower the Convulsive Threshold Hydroxychloroquine sulfate tablets can lower the convulsive threshold. Co-administration of hydroxychloroquine sulfate tablets with other antimalarials known to lower the convulsion threshold (e.g., mefloquine) may increase the risk of convulsions. Antiepileptics The activity of antiepileptic drugs might be impaired if co-administered with hydroxychloroquine sulfate tablets. Methotrexate Combined use of methotrexate with hydroxychloroquine sulfate tablets have not been studied and may increase the incidence of adverse effects. Cyclosporin An increased plasma cyclosporin level was reported when cyclosporin and hydroxychloroquine sulfate tablets were co-administered. The following interactions have been observed on treatment with the structurally related substance chloroquine phosphate, and therefore cannot be ruled out for hydroxychloroquine. Praziquantel Chloroquine has been reported to reduce the bioavailability of praziquantel. Antacids and Kaolin Antacids and kaolin can reduce absorption of chloroquine; an interval of at least 4 hours between intake of these agents and chloroquine should be observed. Cimetidine Cimetidine can inhibit the metabolism of chloroquine, increasing its plasma level. Concomitant use of cimetidine should be avoided. Ampicillin In a study of healthy volunteers, chloroquine significantly reduced the bioavailability of ampicillin.

More information

Category Value
Authorisation number ANDA040274
Agency product number 8Q2869CNVH
Orphan designation No
Product NDC 0378-0373
Date Last Revised 08-06-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 979092
Marketing authorisation holder Mylan Pharmaceuticals Inc.