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PLAQUENIL
Arthritis/rheumatic disorders
Malaria
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Drug Name:

PLAQUENIL Rx

Generic Name and Formulations:
Hydroxychloroquine sulfate 200mg; tabs.

Company:
Concordia Pharmaceuticals Inc.

Therapeutic Use:

Indications for PLAQUENIL:

Acute and chronic rheumatoid arthritis. Chronic discoid or systemic lupus erythematosus.

Adult:

Give with food or milk. Give in 1–2 divided doses. RA: initially 400–600mg daily. May reduce by 50% to maintenance dose of 200–400mg daily. Max 600mg daily or 6.5mg/kg/day, whichever is less. Lupus: 200–400mg daily; max 400mg daily.

Children:

Not established.

Warnings/Precautions:

Monitor for ocular toxicity, cardiomyopathy; discontinue if suspected. GI, neurologic, blood disorders. Psoriasis. Porphyria. G6PD deficiency. Monitor ocular function, muscle strength, deep tendon reflexes, and blood counts in long-term use. Alcoholism. Hepatic or renal impairment; may need dose reduction. Quinine sensitivity. Children. Pregnancy. Nursing mothers.

Interactions:

Avoid other hepatotoxic, dermatotoxic, QT-prolonging drugs. Increased ocular toxicity with concomitant tamoxifen. May potentiate digoxin, cyclosporine; monitor. May need to reduce dose of concomitant insulin or antidiabetic drugs. Increased seizure risk with other antimalarials (eg, mefloquine). Increased toxicity with methotrexate. May affect antiepileptics.

Pharmacological Class:

DMARD (aminoquinoline).

Adverse Reactions:

Headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, visual disturbances, rash; irreversible retinopathy, QT prolongation, myopathy, neuropathy, hypoglycemia (may be severe), blood dyscrasias (discontinue if occur); rare: suicidal behavior.

How Supplied:

Tabs—100

Indications for PLAQUENIL:

Treatment of uncomplicated P. falciparum, P. malariae, P. orale, and P. vivax malaria. Prophylaxis of malaria in areas with no chloroquine resistance.

Limitations Of use:

Not for treating complicated malaria. Not effective against chloroquine- or hydroxychloroquine-resistant strains. Not for preventing relapses of P. vivax or P. ovale. Not for treatment and prophylaxis in chloroquine-resistant areas.

Adult:

Take with food or milk. Prophylaxis (start 2wks before and continue for 4wks after trip): 400mg once weekly. Treatment: initially 800mg; then 400mg at 6, 24, and 48hrs after 1st dose (total 2g).

Children:

Take with food or milk. Prophylaxis (start 2wks before and continue for 4wks after trip): 6.5mg/kg (max 400mg) once weekly. Treatment: initially 13mg/kg (max 800mg); then 6.5mg/kg (max 400mg) at 6, 24 and 48hrs after 1st dose. <31kg: not recommended.

Warnings/Precautions:

Monitor for ocular toxicity, cardiomyopathy; discontinue if suspected. GI, neurologic, blood disorders. Psoriasis. Porphyria. G6PD deficiency. Monitor ocular function, muscle strength, deep tendon reflexes, and blood counts in long-term use. Alcoholism. Hepatic or renal impairment; may need dose reduction. Quinine sensitivity. Children. Pregnancy. Nursing mothers.

Interactions:

Avoid other hepatotoxic, dermatotoxic, QT-prolonging drugs. Increased ocular toxicity with concomitant tamoxifen. May potentiate digoxin, cyclosporine; monitor. May need to reduce dose of concomitant insulin or antidiabetic drugs. Increased seizure risk with other antimalarials (eg, mefloquine). Increased toxicity with methotrexate. May affect antiepileptics.

Pharmacological Class:

Aminoquinoline.

Adverse Reactions:

Headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, visual disturbances, rash; irreversible retinopathy, QT prolongation, myopathy, neuropathy, hypoglycemia (may be severe), blood dyscrasias (discontinue if occur); rare: suicidal behavior.

How Supplied:

Tabs—100

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