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Plaquenil (hydroxychloroquine sulfate)

BOXED WARNING

Before prescribing, physicians should be completely familiar with the complete prescribing information.

THERAPEUTIC CLASS

Quinine derivative

DEA CLASS

RX

INDICATIONS

Suppression and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale and susceptible strains of P. falciparum. Treatment of lupus erythematosus (chronic discoid and systemic) and acute or chronic rheumatoid arthritis (RA).

ADULT DOSAGE

Rheumatoid Arthritis

Initial: 400-600mg/day
Some patients may require temporary reduction of initial dose due to troublesome side effects; later (usually from 5-10 days), dose may be gradually increased to optimum response level

Maint: When a good response is obtained (usually in 4-12 weeks), reduce dose by 50% and continue at 200-400mg/day

May resume therapy or continue on an intermittent schedule if relapse occurs after drug withdrawal

Malaria

Suppression:
400mg on exactly the same day of each week; begin 2 weeks prior to exposure

If Unable to Begin 2 Weeks Prior to Exposure:
800mg in 2 divided doses, 6 hrs apart

Continue suppressive therapy for 8 weeks after leaving endemic area

Treatment of Acute Attack:
800mg, followed by 400mg 6-8 hrs later, then 400mg on each of 2 consecutive days

Alternative Dosing:
800mg single dose, or calculate on the basis of body weight

Lupus Erythematosus

Chronic Discoid and Systemic:
Initial: 400mg qd-bid for several weeks or months
Prolonged Maint: 200-400mg/day

PEDIATRIC DOSAGE

Malaria

Suppression:
5mg base/kg weekly; begin 2 weeks prior to exposure
Max: 400mg/dose

If Unable to Begin 2 Weeks Prior to Exposure:
10mg base/kg in 2 divided doses, 6 hrs apart

Continue suppressive therapy for 8 weeks after leaving endemic area

Treatment of Acute Attack:
1st Dose: 10mg base/kg
Max: Single dose of 620mg
2nd Dose: 5mg base/kg 6 hrs after 1st dose
Max: Single dose of 310mg base
3rd Dose: 5mg base/kg 18 hrs after 2nd dose
Max: Single dose of 310mg base
4th Dose: 5mg base/kg 24 hrs after 3rd dose
Max: Single dose of 310mg base

ADMINISTRATION

Oral route

Rheumatoid Arthritis
Take w/ a meal or glass of milk

HOW SUPPLIED

Tab: 200mg (200mg tab=155mg base)

CONTRAINDICATIONS

Long-term therapy in children or in the presence of retinal/visual field changes attributable to any 4-aminoquinoline compound.

WARNINGS/PRECAUTIONS

Not effective against chloroquine-resistant strains of Plasmodium falciparum. Carefully examine for visual acuity, central visual field and color vision including fundoscopy prior to long-term therapy; repeat exam at least annually. Irreversible retinal damage reported with long-term or high dosage of 4-aminoquinoline therapy. Perform baseline and periodic (every 3 months) ophthalmologic exams with prolonged therapy. Increased risk of retinal toxicity if recommended daily dose is exceeded sharply. D/C therapy immediately if any visual disturbance occurs and closely observe for possible progression of the abnormality. Retinal and visual disturbances may progress even after discontinuation of therapy. Suicidal behavior reported. May precipitate a severe attack of psoriasis and may exacerbate porphyria; avoid use in these conditions unless benefits outweigh possible hazard. Avoid in pregnancy except in the suppression/treatment of malaria if benefit outweighs the risk. Caution with hepatic disease, alcoholism, and G6PD deficiency. Perform periodic blood cell counts with prolonged therapy; d/c therapy if any severe blood disorder appears that is not attributable to the disease under treatment. (Lupus erythematosus/RA) Examine all patients periodically including testing of knee and ankle reflexes; d/c treatment if muscular weakness occurs. Dermatologic reactions may occur with a significant tendency to produce dermatitis. Caution with impaired renal function and/or metabolic acidosis. In treatment of RA, d/c if no improvement occurs after 6 months.

ADVERSE REACTIONS

Dizziness, headache, convulsions, diarrhea, nervousness, emotional lability, psychosis, suicidal behavior, retinopathy with changes in pigmentation, visual field defects, erythema multiforme, Stevens-Jonhson syndrome, toxic epidermal necrolysis, photosensitivity, exfoliative dermatitis.

DRUG INTERACTIONS

Caution with hepatotoxic drugs.

PREGNANCY AND LACTATION

Safety in pregnancy and nursing not known.

MECHANISM OF ACTION

Quinine derivative; has not been established. Possesses antimalarial action.

ASSESSMENT

Assess for retinal or visual field defects, psoriasis, porphyria, hepatic/renal disease, alcoholism, G6PD deficiency, chloroquine-resistant strains of P. falciparum, or any other conditions where treatment is contraindicated or cautioned, pregnancy/nursing status, and possible drug interactions. Perform baseline ophthalmologic exams with prolonged therapy.

MONITORING

Monitor for retinal/visual disturbances, severe psoriasis attack, exacerbation of porphyria, dermatologic reactions, and other adverse reactions. Perform periodic (every 3 months) ophthalmologic exams with prolonged therapy and monitor CBC with differential and platelet count. Periodically test for knee and ankle reflexes in RA patients.

PATIENT COUNSELING

Counsel about adverse effects and instruct to d/c drug and seek medical attention if any signs/symptoms develop. Advise about need for periodic follow-up.

STORAGE

Room temperature up to 30°C (86°F).

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