United States - English - NLM (National Library of Medicine)

concordia pharmaceuticals inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate 200 mg - 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 (12.4)].   • 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 (12.4)] . for the most current information about drug resistance, refer to the latest recommendations from the center for disease control and prevention1  .   plaquenil is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. plaquenil is indicated for the treatment of systemic lupus erythematosus in adults. plaquenil is indicated for the treatment of chronic discoid lupus erythematosus in adults. plaquenil is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to plaquenil during pregnancy. encourage patients to register by contacting 1-877-311-8972. risk summary  prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with plaquenil use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see data ).  there are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see clinical considerations ). animal reproduction studies were not conducted with hydroxychloroquine.   the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes.  in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations  disease-associated maternal and/or embryo-fetal risk         malaria:  malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth.       rheumatoid arthritis:  published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth.        systemic lupus erythematosus:  pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction. passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. data human data data from published epidemiologic and clinical studies have not established an association with plaquenil use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.  hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels.  no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero .  available epidemiologic and clinical studies have methodological limitations including small sample size and study design. risk summary  published lactation data report that hydroxychloroquine is present in human milk at low levels. no adverse reactions have been reported in breastfed infants.  no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breastmilk.  there is no information on the effect of hydroxychloroquine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for plaquenil and any potential adverse effects on the breastfed child from plaquenil or from the underlying maternal condition. the safety and effectiveness of plaquenil have been established in pediatric patients for the treatment of uncomplicated malaria due to p. falciparum, p. malariae, p. vivax , and p. ovale , as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.  however, this product cannot be directly administered to pediatric patients weighing less than 31 kg because the film-coated tablets cannot be crushed or divided [see dosage and administration (2.1, 2.2)] .   the safety and effectiveness of plaquenil have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. clinical trials of plaquenil did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.  nevertheless, this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. in general, dose selection in geriatric patients should start with the lowest recommended dose, taking into consideration the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. a reduction in the dosage of plaquenil may be necessary in patients with hepatic or renal disease.

United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - 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 (12.4)]   • 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 microbiolog

United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate 200 mg - plaquenil is indicated for the suppressive treatment and treatment of acute attacks of malaria due to plasmodium vivax , p. malariae , p. ovale , and susceptible strains of p. falciparum . it is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.

United States - English - NLM (National Library of Medicine)

proficient rx lp - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - plaquenil is indicated for the treatment of uncomplicated malaria due to p. falciparum, p. malariae, p. ovale, and p. vivax . plaquenil is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. limitations of use in malaria • plaquenil is not recommended for the treatment of complicated malaria. • plaquenil is not effective against chloroquine or hydroxychloroquine-resistant strains of plasmodium species (see clinical pharmacology – microbiology ). plaquenil is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the plasmodium species has not been identified. • plaquenil is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. • plaquenil does not prevent relapses of p. vivax or p. ovale because it is not active against the hypnozoite forms of these parasites. for radical cure of p. vivax and p. ovale infections, concomitant therapy with

United States - English - NLM (National Library of Medicine)

redpharm drug, inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - plaquenil is indicated for the treatment of uncomplicated malaria due to p. falciparum, p. malariae, p. ovale, and p. vivax . plaquenil is indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. limitations of use in malaria • plaquenil is not recommended for the treatment of complicated malaria. • plaquenil is not effective against chloroquine or hydroxychloroquine-resistant strains of plasmodium species (see clinical pharmacology – microbiology ). plaquenil is not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the plasmodium species has not been identified. • plaquenil is not recommended for malaria prophylaxis in geographic areas where chloroquine resistance occurs. • plaquenil does not prevent relapses of p. vivax or p. ovale becau

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - hydroxychloroquine sulfate, quantity: 200 mg - tablet, film coated - excipient ingredients: maize starch; calcium hydrogen phosphate dihydrate; macrogol 400; carnauba wax; magnesium stearate; titanium dioxide; hypromellose; polysorbate 80 - rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.

Israel - English - Ministry of Health

sanofi israel ltd - hydroxychloroquine sulfate - film coated tablets - hydroxychloroquine sulfate 200 mg - hydroxychloroquine - hydroxychloroquine - plaquenil is indicated for the suppressive treatment and treatment of acute attacks of malaria due to plasmodium vivax, p. malaria. p. ovale and susceptible strains of p. falciparum it is also indicated for the treatment of discoid and sustemic lupus erythematosus and rheumatoid arthritis.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - hydroxychloroquine sulfate 200mg - film coated tablet - 200 mg - active: hydroxychloroquine sulfate 200mg excipient: calcium hydrogen phosphate dihydrate carnauba wax ready to use white colorant (corresponding generic name to opadry® ys-1-7443) macrogol 400 magnesium stearate maize starch - acute and chronic rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.

United States - English - NLM (National Library of Medicine)

carilion materials management - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - plaquenil is indicated for the suppressive treatment and treatment of acute attacks of malaria due to , , , and susceptible strains of . it is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. plasmodium vivax p. malariae p. ovale p. falciparum use of this drug is contraindicated (1) in the presence of retinal or visual field changes attributable to any 4-aminoquinoline compound, (2) in patients with known hypersensitivity to 4-aminoquinoline compounds, and (3) for long-term therapy in children.

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - hydroxychloroquine sulfate -