Estados Unidos - inglês - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate 200 mg - 1.1 malaria hydroxychloroquine sulfate tablet in 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: hydroxychloroquine sulfate tablet 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 prevention 1. 1.2 rheumatoid arthritis hydroxychloroquine sulfate tablet is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. 1.3 systemic lupus erythematosus hydroxychloroquine sulfate tablet is indicated for the treatment of systemic lupus erythematosus in adults. 1.4 chronic discoid lupus erythematosus hydroxychloroquine sulfate tablet is indicated for the treatment of chronic discoid lupus erythematosus in adults. hydroxychloroquine sulfate is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. 8.1 pregnancy pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate 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 hydroxychloroquine sulfate 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% to 4% and 15% to 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 2,500 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 hydroxychloroquine sulfate 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. 8.2 lactation 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 hydroxychloroquine sulfate and any potential adverse effects on the breastfed child from hydroxychloroquine sulfate or from the underlying maternal condition. 8.4 pediatric use the safety and effectiveness of hydroxychloroquine sulfate 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 hydroxychloroquine sulfate have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. 8.5 geriatric use clinical trials of hydroxychloroquine sulfate 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. 8.6 patients with renal or hepatic disease a reduction in the dosage of hydroxychloroquine sulfate may be necessary in patients with hepatic or renal disease.

Estados Unidos - inglês - NLM (National Library of Medicine)

carilion materials management - chloroquine phosphate (unii: 6e17k3343p) (chloroquine - unii:886u3h6uff) - chloroquine phosphate 500 mg - chloroquine phosphate tablets are indicated for suppressive treatment and for acute attacks of malaria due to and susceptible strains of the drug is also indicated for the treatment of extraintestinal amebiasis. p. vivax, p. malariae, p. ovale, p. falciparum. chloroquine phosphate tablets do not prevent relapses in patients with vivax or malariae malaria because it is not effective against exoerythrocytic forms of the parasite, nor will it prevent vivax or malariae infection when administered as a prophylactic. 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. use of this drug is contraindicated in the presence of retinal or visual field changes either attributable to 4-aminoquinoline compounds or to any other

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

amneal pharma australia pty ltd - hydroxychloroquine sulfate -

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - hydroxychloroquine sulfate - film-coated tablet - 200 milligram(s) - hydroxychloroquine

Estados Unidos - inglês - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate tablets, usp are indicated for the treatment of uncomplicated malaria due to p. falciparum , p. malariae , p. ovale , and p. vivax .   hydroxychloroquine sulfate tablets, usp are indicated for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. limitations of use in malaria   - hydroxychloroquine sulfate tablets, usp are not recommended for the treatment of complicated malaria. - hydroxychloroquine sulfate tablets, usp are not effective against chloroquine or hydroxychloroquine-resistant strains of plasmodium species (seeclinical pharmacology – microbiology) . hydroxychloroquine sulfate tablets, usp are not recommended for the treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the plasmodium species has not been identified. - hydroxychloroquine sulfate tablets, usp are not recommended for malaria prophylaxis in geographic areas where chloroquine

Estados Unidos - inglês - NLM (National Library of Medicine)

laurus labs limited - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate tablets are 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: hydroxychloroquine sulfate tablets are not recommended for:  • treatmentof 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 . hydroxychloroquine sulfate tablets are indicated for the treatment of acute and chronic rheumatoid arthritis in adults. hydroxychloroquine sulfate tablets are indicated for the treatment of systemic lupus erythematosus in adults.  hydroxychloroquine sulfate tablets are indicated for the treatment of chronic discoid lupus erythematosus in adults. hydroxychloroquine sulfate tablets are 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 hydroxychloroquine 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 hydroxychloroquine 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 to 4% and 15 to 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 2,500 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 hydroxychloroquine 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 hydroxychloroquine and any potential adverse effects on the breastfed child from hydroxychloroquine or from the underlying maternal condition. the safety and effectiveness of hydroxychloroquine 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 hydroxychloroquine have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. clinical trials of hydroxychloroquine 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 hydroxychloroquine may be necessary in patients with hepatic or renal disease.

Estados Unidos - inglês - NLM (National Library of Medicine)

rising pharma holdings, inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate tablets are 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: hydroxychloroquine sulfate tablets are 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-

Estados Unidos - inglês - NLM (National Library of Medicine)

rising pharma holdings, inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate tablets are 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: hydroxychloroquine sulfate tablets are 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-

Austrália - inglês - Department of Health (Therapeutic Goods Administration)

generic health pty ltd - hydroxychloroquine sulfate, quantity: 200 mg - tablet - excipient ingredients: hypromellose; magnesium stearate; calcium hydrogen phosphate; polysorbate 80; colloidal anhydrous silica; pregelatinised maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350 - rheumatoid arthritis; mild systemic and discoid lupus erythematosus; the suppression and treatment of malaria.

Estados Unidos - inglês - NLM (National Library of Medicine)

cardinal health - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate 200 mg