Hydroxychloroquine sulfate Warnings And Precautions

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Hydroxychloroquine sulfate
HYDROXYCHLOROQUINE SULFATE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications And Usage
Contraindications
Warnings And Precautions
Adverse Reactions
Overdosage
Dosage And Administration
How Supplied
Labels And Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

WARNINGS

General

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

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 hydroxychloroquine sulfate 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.

Precautions

General

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 made if patients are given prolonged therapy. If any severe blood disorder appears which is not attributable to the disease under treatment, discontinuation of the drug should be considered. The drug should be administered with caution in patients having G-6-PD (glucose-6-phosphate dehydrogenase) deficiency.[1]

References

  1. "HYDROXYCHLOROQUINE SULFATE (HYDROXYCHLOROQUINE SULFATE) TABLET, FILM COATED [IPCA LABORATORIES LIMITED]".

Adapted from the FDA Package Insert.