July 27, 2016
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Plaquenil

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Plaquenil




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

General

Observe caution in patients with gastrointestinal or neurological disorders, in those with sensitivity to quinine, and in porphyria.

Effects On Ability To Drive And Use Machinery

Patients should be warned about driving and operating machinery since PLAQUENIL (hydroxychloroquine sulfate) can impair accommodation and cause blurring of vision. If the condition is not self-limiting, dosage may need to be temporarily reduced.

Malaria: PLAQUENIL is not effective against chloroquine-resistant strains of P. falciparum and is not active against the exo-erythrocytic forms of P. vivax, P. ovale and P. malarias and therefore will neither prevent infection due to these organisms when given prophylactically, nor prevent relapse of infection due to these organisms.

Cardiovascular

Cases of cardiomyopathy resulting in cardiac failure, in some cases with a fatal outcome, have been reported in patients treated with PLAQUENIL. PLAQUENIL should be discontinued if signs and symptoms of cardiomyopathy develop. Chronic toxicity should be considered when conduction disorders (bundle branch block / atrio-ventricular heart block) as well as biventricular hypertrophy are diagnosed (see ADVERSE REACTIONS and Symptoms And Treatment Of Overdosage).

PLAQUENIL may induce cardiac arrhythmia (see DRUG INTERACTIONS and Symptoms And Treatment Of Overdosage).

Endocrine And Metabolism

PLAQUENIL has been shown to cause severe hypoglycemia including loss of consciousness that could be life threatening in patients treated with and without antidiabetic medications. Patients treated with PLAQUENIL 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 PLAQUENIL should have their blood glucose level checked and the need for PLAQUENIL treatment reviewed as necessary. In cases of severe hypoglycemia, PLAQUENIL should be discontinued and alternative therapy considered. If patients use PLAQUENIL concomitantly with antidiabetic drugs, a decrease in doses of insulin or antidiabetic drugs may be required as PLAQUENIL may enhance the effects of hypoglycemic treatment (see DRUG INTERACTIONS and ADVERSE REACTIONS).

Hematologic

Periodic blood counts should be obtained in patients requiring prolonged therapy due to the risk of bone marrow depression (see ADVERSE REACTIONS). If any severe blood disorder appears that is not attributable to the disease under treatment, the drug should be discontinued.

Observe caution in patients with blood disorders or glucose-6-phosphate dehydrogenase deficiency.

Musculoskeletal

All patients on long term therapy with this preparation should be questioned and examined periodically, including the examination of skeletal muscle function and tendon reflexes, testing of knee and ankle reflexes, to detect any evidence of muscular weakness. If weakness occurs, discontinue the drug.

Neurologic

Extrapyramidal reactions have been reported in patients taking PLAQUENIL (see ADVERSE REACTIONS). Symptoms may persist in some patients after discontinuation of therapy.

Ophthalmologic

Irreversible retinal damage has been observed in some patients who had received long-term or high-dosage 4-aminoquinoline therapy for discoid and systemic lupus erythematosus, or rheumatoid arthritis. Before starting a long term treatment, both eyes should be examined by careful ophthalmoscopy for visual acuity, central visual field and color vision, and fundoscopy. Then, the examination should be repeated at least annually.

Retinal toxicity is largely dose-related. The risk of retinal damages is small with daily doses of up to 6.5 mg/kg ideal (lean) body weight. Exceeding the recommended daily dose sharply increase the risk of retinal toxicity.

This examination should be more frequent and adapted to the patient, in the following situations:

  • daily doses exceeding 6.5 mg/kg ideal (lean) body weight. Absolute body weight used as a guide to dosage, could result in an overdosage in the obese;
  • renal insufficiency;
  • cumulative dose more than 200 g;
  • elderly;
  • impaired visual acuity.

If there is any indication of abnormality in the visual acuity, visual field, or retinal macular areas (such as pigmentary changes, loss of foveal reflex), or any visual symptoms (such as light flashes and streaks, abnormal colour vision) that are not fully explainable by difficulties of accommodation or corneal opacities, the drug should be stopped immediately. The patient should be closely observed for possible progression of the abnormality. Retinal changes (and visual disturbances) may progress even after cessation of the therapy (see ADVERSE REACTIONS).

Methods recommended for early diagnosis of retinopathy consist of (1) funduscopic examination of the macula for fine pigmentary disturbances or loss of the foveal reflex and (2) examination of the central visual field with a small red test object for pericentral or paracentral scotoma or determination of retinal thresholds to red. Any unexplained visual symptoms, such as light flashes or streaks also should be regarded with suspicion as possible manifestations of retinopathy.

Psychiatric

Suicidal behaviour has been reported in patients treated with PLAQUENIL.

Skin

Dermatological reactions to PLAQUENIL may occur. It is not recommended for the treatment of psoriasis or porphyria as these conditions may be exacerbated by its use. Observe caution in patients with psoriasis.

Special Populations

Pregnancy

Hydroxychloroquine crosses the placenta. Data are limited regarding the use of PLAQUENIL during pregnancy. PLAQUENIL should be avoided in pregnancy. It should be noted that the 4-aminoquinolines in therapeutic doses have been associated with central nervous system damage, including ototoxicity (auditory and vestibular toxicity, congenital deafness), retinal hemorrhages and abnormal retinal pigmentation to the foetus.

Nursing Mothers

Careful consideration should be given to using PLAQUENIL during lactation, since it has been known to be excreted in small amounts in human breast milk and it is known that infants are extremely sensitive to the toxic effects of 4-aminoquinolines.

Pediatric Use

Safety and efficacy has not been established in rheumatoid arthritis or systemic lupus erythematosus in children. Children are especially sensitive to the 4-aminoquinoline compounds.

The most reported fatalities follow the accidental ingestion of chloroquine, sometimes in small doses. Patients should be strongly warned to keep these drugs out of the reach of children (see CONTRAINDICATIONS).

Hepatic Impairment

PLAQUENIL should be used with caution in patients with hepatic disease or alcoholism, in whom a reduction in dosage may be necessary, or in conjunction with known hepatotoxic drugs. Isolated cases of abnormal liver function tests have been reported; fulminant hepatic failure has also been reported.

Renal Impairment

Observe caution in patients with renal disease, in whom a reduction in dosage may be necessary, as well as in those taking medicines known to affect this organ.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 3/16/2016

Warnings
Precautions

Plaquenil - User Reviews

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