Plaquenil

— THERAPEUTIC DISORDERS TREATED —
  • Arthritis/rheumatic disorders
  • Malaria
  • Miscellaneous immune disorders

Plaquenil Generic Name & Formulations

General Description

Hydroxychloroquine sulfate 200mg; tabs.

Pharmacological Class

DMARD (aminoquinoline).

How Supplied

Tabs—60, 100

Generic Availability

YES

Plaquenil Indications

Indications

Acute and chronic rheumatoid arthritis.

Plaquenil Dosage and Administration

Adult

Give with food or milk. Give in 1–2 divided doses. Initially 400–600mg daily. Chronic dose: 200–400mg daily.

Children

Not established.

Plaquenil Contraindications

Not Applicable

Plaquenil Boxed Warnings

Not Applicable

Plaquenil Warnings/Precautions

Warnings/Precautions

Cardiomyopathy. Ventricular arrhythmias. Avoid in patients with congenital or documented acquired QT prolongation and/or known risk factors for QT prolongation (eg, heart failure, MI, bradycardia, ventricular dysrhythmias, uncorrected hypokalemia and/or hypomagnesemia). Risk for retinal damage if daily dosage is ≥5mg/kg, duration of use >5yrs, renal impairment, concurrent macular disease. Monitor for ocular toxicity, cardiotoxicity, and renal toxicity; discontinue if suspected or demonstrated by tissue biopsy. Correct electrolyte imbalances prior to initiation. Monitor for severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis); discontinue if reactions occur. Avoid in those with psoriasis or porphyria. Monitor ocular function, muscle strength, deep tendon reflexes, and blood counts in long-term use; discontinue if myelosuppression, muscle or nerve toxicity is suspected or demonstrated by tissue biopsy. Hypoglycemia; monitor diabetics. G6PD deficiency. Hepatic or renal impairment; may need dose reduction. Elderly. Pregnancy. Nursing mothers.

Plaquenil Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal. Half-life (plasma): 123.5 days.

Plaquenil Interactions

Interactions

Avoid concomitant QT-prolonging drugs, cimetidine, rifampicin. 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). May increase toxicity with methotrexate. May affect antiepileptics. May antagonize praziquantel, ampicillin. May be antagonized by antacids or kaolin; separate dosing by at least 4 hours.

Plaquenil Adverse Reactions

Adverse Reactions

Headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, visual disturbances, rash; cardiomyopathy, irreversible retinopathy, QT prolongation, myopathy, neuropathy, hypoglycemia (may be severe), severe skin reactions, hematologic toxicity, hemolytic anemia; rare: suicidal behavior.

Plaquenil Clinical Trials

See Literature

Plaquenil Note

Not Applicable

Plaquenil Patient Counseling

See Literature

Plaquenil Generic Name & Formulations

General Description

Hydroxychloroquine sulfate 200mg; tabs.

Pharmacological Class

Aminoquinoline.

How Supplied

Tabs—60, 100

Generic Availability

YES

Plaquenil Indications

Indications

Treatment of uncomplicated P. falciparum, P. malariae, P. ovale, 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.

Plaquenil Dosage and Administration

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

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

Plaquenil Contraindications

Not Applicable

Plaquenil Boxed Warnings

Not Applicable

Plaquenil Warnings/Precautions

Warnings/Precautions

Cardiomyopathy. Ventricular arrhythmias. Avoid in patients with congenital or documented acquired QT prolongation and/or known risk factors for QT prolongation (eg, heart failure, MI, bradycardia, ventricular dysrhythmias, uncorrected hypokalemia and/or hypomagnesemia). Risk for retinal damage if daily dosage is ≥5mg/kg, duration of use >5yrs, renal impairment, concurrent macular disease. Monitor for ocular toxicity, cardiotoxicity, and renal toxicity; discontinue if suspected or demonstrated by tissue biopsy. Correct electrolyte imbalances prior to initiation. Monitor for severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis); discontinue if reactions occur. Avoid in those with psoriasis or porphyria. Monitor ocular function, muscle strength, deep tendon reflexes, and blood counts in long-term use; discontinue if myelosuppression, muscle or nerve toxicity is suspected or demonstrated by tissue biopsy. Hypoglycemia; monitor diabetics. G6PD deficiency. Hepatic or renal impairment; may need dose reduction. Elderly. Pregnancy. Nursing mothers.

Plaquenil Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal. Half-life (plasma): 123.5 days.

Plaquenil Interactions

Interactions

Avoid concomitant QT-prolonging drugs, cimetidine, rifampicin. 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). May increase toxicity with methotrexate. May affect antiepileptics. May antagonize praziquantel, ampicillin. May be antagonized by antacids or kaolin; separate dosing by at least 4 hours.

Plaquenil Adverse Reactions

Adverse Reactions

Headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, visual disturbances, rash; cardiomyopathy, irreversible retinopathy, QT prolongation, myopathy, neuropathy, hypoglycemia (may be severe), severe skin reactions, hematologic toxicity, hemolytic anemia; rare: suicidal behavior.

Plaquenil Clinical Trials

See Literature

Plaquenil Note

Not Applicable

Plaquenil Patient Counseling

See Literature

Plaquenil Generic Name & Formulations

General Description

Hydroxychloroquine sulfate 200mg; tabs.

Pharmacological Class

DMARD (aminoquinoline).

How Supplied

Tabs—60, 100

Generic Availability

YES

Plaquenil Indications

Indications

Chronic discoid or systemic lupus erythematosus.

Plaquenil Dosage and Administration

Adult

Give with food or milk. 200–400mg daily in 1–2 divided doses; max 400mg daily.

Children

Not established.

Plaquenil Contraindications

Not Applicable

Plaquenil Boxed Warnings

Not Applicable

Plaquenil Warnings/Precautions

Warnings/Precautions

Cardiomyopathy. Ventricular arrhythmias. Avoid in patients with congenital or documented acquired QT prolongation and/or known risk factors for QT prolongation (eg, heart failure, MI, bradycardia, ventricular dysrhythmias, uncorrected hypokalemia and/or hypomagnesemia). Risk for retinal damage if daily dosage is ≥5mg/kg, duration of use >5yrs, renal impairment, concurrent macular disease. Monitor for ocular toxicity, cardiotoxicity, and renal toxicity; discontinue if suspected or demonstrated by tissue biopsy. Correct electrolyte imbalances prior to initiation. Monitor for severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis); discontinue if reactions occur. Avoid in those with psoriasis or porphyria. Monitor ocular function, muscle strength, deep tendon reflexes, and blood counts in long-term use; discontinue if myelosuppression, muscle or nerve toxicity is suspected or demonstrated by tissue biopsy. Hypoglycemia; monitor diabetics. G6PD deficiency. Hepatic or renal impairment; may need dose reduction. Elderly. Pregnancy. Nursing mothers.

Plaquenil Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal. Half-life (plasma): 123.5 days.

Plaquenil Interactions

Interactions

Avoid concomitant QT-prolonging drugs, cimetidine, rifampicin. 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). May increase toxicity with methotrexate. May affect antiepileptics. May antagonize praziquantel, ampicillin. May be antagonized by antacids or kaolin; separate dosing by at least 4 hours.

Plaquenil Adverse Reactions

Adverse Reactions

Headache, dizziness, nausea, vomiting, diarrhea, abdominal pain, visual disturbances, rash; cardiomyopathy, irreversible retinopathy, QT prolongation, myopathy, neuropathy, hypoglycemia (may be severe), severe skin reactions, hematologic toxicity, hemolytic anemia; rare: suicidal behavior.

Plaquenil Clinical Trials

See Literature

Plaquenil Note

Not Applicable

Plaquenil Patient Counseling

See Literature

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