Hydroxychloroquine 200mg Tablets

Description

Plaquenil (hydroxychloroquine 200 Mg) is an antimalarial medication used to treat or prevent malaria, a disease caused by parasites, which enter the body through the bite of a mosquito. Plaquenil is also used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus. Plaquenil is available in generic form. DESCRIPTION Hydroxychloroquine sulfate is a colorless crystalline solid, soluble in water to at least 20 percent; chemically the drug is 2-[[4-[(7-Chloro-4-quinolyl)amino]pentyl]ethylamino] ethanol sulfate (1:1). PLAQUENIL (hydroxychloroquine sulfate) tablets contain 200 mg hydroxychloroquine sulfate, equivalent to 155 mg base, and are for oral administration. Inactive Ingredients: Dibasic Calcium Phosphate, Hydroxypropyl Methylcellulose, Magnesium Stearate, Polyethylene glycol 400, Polysorbate 80, Corn Starch, Titanium Dioxide. INDICATIONS Malaria PLAQUENIL is indicated in adult and pediatric patients for the: Treatment of uncomplicated malaria due to Plasmodium falciparum, Plasmodium malariae, Plasmodium vivax, and Plasmodium ovale. Prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. Limitations Of Use PLAQUENIL is not recommended for: Treatment of complicated malaria. Treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of Plasmodium species [see Microbiology]. Treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the Plasmodium species has not been identified. Prophylaxis of malaria in geographic areas where chloroquine resistance occurs. Prevention of relapses of P. vivax or P. ovale because it is not active against the hypnozoite liver stage forms of these parasites. For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see Microbiology]. For the most current information about drug resistance, refer to the latest recommendations from the Center for Disease Control and Prevention1. Rheumatoid Arthritis PLAQUENIL is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. Systemic Lupus Erythematosus PLAQUENIL is indicated for the treatment of systemic lupus erythematosus in adults. Chronic Discoid Lupus Erythematosus PLAQUENIL is indicated for the treatment of chronic discoid lupus erythematosus in adults. DOSAGE AND ADMINISTRATION Important Administration Instructions Administer PLAQUENIL orally with food or milk. Do not crush or divide the tablets. Dosage For Malaria In Adult And Pediatric Patients PLAQUENIL is not recommended in pediatric patients less than 31 kg because the lowest available strength (200 mg) exceeds the recommended dose for these patients and it cannot be divided. Prophylaxis Treatment must start 2 weeks before travel to an endemic area. Advise the patient to take the prophylaxis dosage once a week, staring 2 weeks prior to travel to the endemic area, on the same day every week, continuing the same weekly dose while in the endemic area, and for 4 weeks after leaving the endemic area. The recommended prophylaxis dosage is: Adult patients: 400 mg once a week Pediatric patients ≥ 31kg: 6.5 mg/kg actual body weight (up to 400 mg) once a week Treatment Of Uncomplicated Malaria The dosages for the treatment of uncomplicated malaria are: Adult patients: Administer 800 mg initially; subsequently administer 400 mg at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 2000 mg). Pediatric patients ≥ 31 kg: Administer 13 mg/kg (up to 800 mg) initially; subsequently administer 6.5 mg/kg (up to 400 mg) at 6 hours, 24 hours, and 48 hours after the initial dose (total dosage = 31 mg/kg -up to 2000 mg). For radical cure of P. vivax and P. ovale infections, concomitant therapy with an 8aminoquinoline drug is necessary [see Microbiology]. Dosage For Rheumatoid Arthritis In Adults The recommended dosage is