Plaquenil (Page 2 of 3)
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 PLAQUENIL.
PLAQUENIL should be administered with caution in patients having glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.
Dermatologic Effects: Dermatologic reactions to PLAQUENIL 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.
Digoxin: Concomitant PLAQUENIL 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 PLAQUENIL 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: PLAQUENIL prolongs 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 PLAQUENIL is used concomitantly with other arrhythmogenic drugs.
Mefloquine and other drugs known to lower the convulsive threshold: PLAQUENIL can lower the convulsive threshold. Co-administration of PLAQUENIL 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 PLAQUENIL.
Methotrexate: Combined use of methotrexate with PLAQUENIL has not been studied and may increase the incidence of adverse effects.
Cyclosporin: An increased plasma cyclosporin level was reported when cyclosporin and PLAQUENIL 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 PLAQUENIL, 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 PLAQUENIL.
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.
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 PLAQUENIL 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 PLAQUENIL 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 PLAQUENIL 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.
The following adverse reactions have been identified during post-approval use of PLAQUENIL 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). PLAQUENIL prolongs the QT interval. Ventricular arrhythmias and torsade de pointes have been reported in patients taking PLAQUENIL (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 PLAQUENIL may precipitate attacks of psoriasis. It may be associated with pyrexia and hyperleukocytosis.
To report SUSPECTED ADVERSE REACTIONS, contact Concordia Pharmaceuticals at 1-877-370-1142 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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