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

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

Statele Unite ale Americii - engleză - 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: • 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 . 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.

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

asclemed usa, 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 parasit

Statele Unite ale Americii - engleză - 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

Canada - engleză - Health Canada

jamp pharma corporation - hydroxychloroquine sulfate - tablet - 200mg - hydroxychloroquine sulfate 200mg - antimalarials

Canada - engleză - Health Canada

accord healthcare inc - hydroxychloroquine sulfate - tablet - 200mg - hydroxychloroquine sulfate 200mg - antimalarials

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

sun pharma anz pty ltd - hydroxychloroquine sulfate -

Malta - engleză - Medicines Authority

ipca produtos farmaceuticos unipessoal lda rua jose nogueira vaz no 8b 2625-099 povoa de santa iria , portugal - film-coated tablet - hydroxychloroquine sulfate 200 mg - antiprotozoals

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

covis pharmaceuticals inc - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate 200 mg

Statele Unite ale Americii - engleză - NLM (National Library of Medicine)

avkare, inc. - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate 200 mg