Plaquenil Recall

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Questions & Answers

Side Effects & Adverse Reactions

PLAQUENIL is not effective against chloroquine-resistant strains of . P. falciparum

. Before starting a long-term treatment, both eyes should be carefully examined for visual acuity, central visual field and color vision. Examination should also include fundoscopy. These examinations should be repeated at least annually. Retinal toxicity is largely dose-related

The risk of retinal damage is small with daily doses of up to 6.5 mg/kg body weight. Exceeding the recommended daily dose sharply increases the risk of retinal toxicity. This examination should be more frequent and adapted to the patient in the following situations:

  • daily dosage exceeding 6.5 mg/kg ideal 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 any visual disturbance occurs (visual acuity, color vision), the drug should be immediately discontinued and the patient closely observed for possible progression of the abnormality. Retinal changes (and visual disturbances) may progress even after cessation of the therapy. (See section) ADVERSE REACTIONS

Suicidal behavior has been reported in very rare cases in patients treated with hydroxychloroquine.

Children are especially sensitive to the 4-aminoquinoline compounds. A number of fatalities have been reported following the accidental ingestion of chloroquine, sometimes in relatively 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.

Use of PLAQUENIL 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.

Usage in Pregnancy

Usage of this drug during pregnancy should be avoided except in the suppression or treatment of malaria when in the judgment of the physician the benefit outweighs the possible hazard. It should be noted that radioactively-tagged chloroquine administered intravenously to pregnant, pigmented CBA mice passed rapidly across the placenta. It accumulated selectively in the melanin structures of the fetal eyes and was retained in the ocular tissues for five months after the drug had been eliminated from the rest of the body.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


PLAQUENIL is indicated for the suppressive treatment and treatment of acute attacks of malaria due to , , , and susceptible strains of . It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. Plasmodium vivaxP. malariaeP. ovaleP. falciparum


There is currently no drug history available for this drug.

Other Information

Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1).

PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration.

Dibasic Calcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polyethylene glycol 400, Polysorbate 80, Corn Starch, Titanium Dioxide. Inactive Ingredients:

Plaquenil Manufacturers

  • Carilion Materials Management
    Plaquenil (Hydroxychloroquine Sulfate) Tablet [Carilion Materials Management]
  • Sanofi-aventis U.s. Llc
    Plaquenil (Hydroxychloroquine Sulfate) Tablet, Film Coated [Sanofi-aventis U.s. Llc]
  • Covis Pharmaceuticals Inc
    Plaquenil (Hydroxychloroquine Sulfate) Tablet [Covis Pharmaceuticals Inc]

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