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Indications And Clinical Use
PLAQUENIL (hydroxychloroquine sulfate) is indicated for the treatment of rheumatoid arthritis, and discoid and systemic lupus erythematosus, in patients who have not responded satisfactorily to drugs with less potential for serious side effects.
It is also indicated for the suppressive treatment and treatment of acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is not active against the exo-erythrocytic forms of P. vivax, P. malariae and P. ovale and therefore will neither prevent infection due to these organisms when given prophylactically, nor prevent relapse of infection due to these organisms. It is highly effective as a suppressive agent in patients with vivax or malariae malaria in terminating acute attacks and significantly lengthening the interval between treatment and relapse. In patients with falciparum malaria, it abolishes the acute attack and effects complete cure of the infection, unless due to a resistant strain of P. falciparum.
DOSAGE AND ADMINISTRATION
Absolute body weight used as a guide to dosage could result in an overdosage; daily doses should not exceed 6.5 mg/kg ideal (lean) body weight. Exceeding the recommended daily dose sharply increase the risk of retinal toxicity.
The dosages cited below are stated in terms of hydroxychloroquine sulfate. One 200 mg tablet is equivalent to 155 mg base. Each dose should be taken with a meal or a glass of milk.
The compound is cumulative in action and will require several weeks to exert its beneficial therapeutic effects, whereas minor side effects may occur somewhat early. Several months of therapy may be required before maximum effects can be obtained. If objective improvement (such as reduced joint swelling, increased mobility) does not occur within six months, the drug should be stopped. Safe use of the drug in the treatment of juvenile rheumatoid arthritis has not been established.
Initial dosage – In adults, from 400 to 600 mg daily. In a few patients, the side effects may require temporary reduction of the initial dosage. Generally, after five to ten days the dose may be gradually increased to the optimum response level, frequently, without return of side effects.
Maintenance dosage – When a good response is obtained (usually in four to twelve weeks), the dosage is reduced by 50 percent and continued at an acceptable maintenance level of 200 to 400 mg daily. The incidence of retinopathy has been reported to be higher when the maintenance dose is exceeded.
If a relapse occurs after medication is withdrawn, therapy may be resumed or continued on an intermittent schedule if there are no ocular contraindications.
Use in Combination Therapy: PLAQUENIL may be used safely and effectively in combination with corticosteroids, salicylates, NSAIDS, and methotrexate and other second line therapeutic agents. Corticosteroids and salicylates can generally be decreased gradually in dosage or eliminated after the drug has been used for several weeks. When gradual reduction of steroid dosage is suggested, it may be done by reducing every four to five days, the dose of cortisone by no more than 5 to 15 mg; of hydrocortisone from 5 to 10 mg; of prednisolone and prednisone from 1 to 2.5 mg; of methylprednisolone and triamcinolone from 1 to 2 mg and dexamethasone from 0.25 to 0.5 mg. Regimens of treatment using other agents than steroids and NSAIDS are under development. No definitive dose combinations have been established.
Initially, the average adult dose is 400 mg once or twice daily. This may be continued for several weeks or months, depending upon the response of the patient. For prolonged maintenance therapy, a smaller dose, from 200 to 400 mg daily will suffice. The incidence of retinopathy has been reported to be higher when this maintenance dose is exceeded.
Suppression – In adults, 400 mg on exactly the same day of each week. In children (6 years of age and older), the weekly suppressive dose is 5 mg base/kg, but should not exceed the adult dose regardless of body weight.
Suppressive therapy should begin two weeks before exposure. When not administered before exposure, give an initial loading dose of 800 mg to adults, or 10 mg base/kg to children in two divided doses, six hours apart. The suppressive therapy should be continued for eight weeks after leaving the endemic area.
Treatment of the acute attack – In adults, an initial loading dose of 800 mg followed by 400 mg in six to eight hours. This is followed by 400 mg on each of the next two days for a total of 2 g of hydroxychloroquine sulfate or 1.55 g base. Alternatively, the administration of a single dose of 800 mg has also proved effective. The dosage for adults may also be calculated by body weight.
For children (6 years of age and older) – dosage calculated by body weight is preferred. A total dose representing 25 mg of base/kg is administered over three days as follows:
First dose: 10 mg base/kg (not to exceed 620 mg base)
Second dose: 5 mg base/kg 6 hours after the first dose (not to exceed 310 mg base)
Third dose: 5 mg base/kg 18 hours after the second dose
Fourth dose: 5 mg base/kg 24 hours after the third dose
For radical cure of vivax and malariae malaria - concomitant therapy with an 8-aminoquinoline compound is necessary.
Availability Of Dosage Forms
PLAQUENIL (hydroxychloroquine sulfate) is available as: white to off-white, film coated, peanut-shaped tablets, containing 200 mg hydroxychloroquine sulfate (equivalent to 155 mg base), with PLAQUENIL printed in black on one side, bottles of 100.
The non-medicinal ingredients are blank ink, calcium hydrogenophosphate, carnauba wax, corn starch, magnesium stearate, Opadry White YS-I-7443 and polyethylene glycol 400.
Storage And Stability
Store at room temperature (15°C -30°C).
Keep in a safe place out of reach of children.
By sanofi-aventis Canada Inc. Revised: Nov 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/16/2016
Additional Plaquenil Information
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