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preferred pharmaceuticals inc. - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride 250 mg - mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax. there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae. note: patients with acute p. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum. use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or

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h.j. harkins company, inc. - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride 250 mg - mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax . there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae . -  note: patients with acute p. vivax malaria, treated with mefloquine hydrochloride tablets, are at high risk of relapse because mefloquine hydrochloride tablets do not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum . use of mefloquine hydrochloride tablets is contraindicated in patients

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rebel distributors corp - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax . there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae . -  note: patients with acute p. vivax malaria, treated with mefloquine hydrochloride tablets, are at high risk of relapse because mefloquine hydrochloride tablets do not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum . use of mefloquine hydrochloride tablets is contraindicated in patients

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nucare pharmaceuticals,inc. - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax. there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae. note: patients with acute p. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparu

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gensco laboratories, llc - lidocaine hydrochloride (unii: v13007z41a) (lidocaine - unii:98pi200987) - methemoglobinemia cases of methemoglobinemia have been reported in association with local anesthetic use. although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. if local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. disco

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almirall, llc - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - aczone® (dapsone) gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. none. risk summary there are no available data on aczone gel, 7.5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. the systemic absorption of aczone in humans following topical application is low relative to oral dapsone administration [see clinical pharmacology (12.3)] . in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 400 times the systemic exposure at the maximum recommended human dose (mrhd) of aczone gel, 7.5%, resulted in embryocidal effects. when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 500 times the exposure at the mrhd, dapsone resulted in increased stillbirths and decreased pup weight [see data] . the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally daily to females during organogenesis at dosages of 75 mg/kg/day and 150 mg/kg/day, respectively. these dosages resulted in systemic exposures that represented approximately 1407 times [rats] and 425 times [rabbits] the systemic exposure observed in human females as a result of use of the mrhd of aczone gel, 7.5%, based on auc comparisons. these effects were probably secondary to maternal toxicity. dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day of gestation and continuing until the twenty-seventh day postpartum. maternal toxicity (decreased body weight and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were seen at a dapsone dose of 30 mg/kg/day (approximately 563 times the systemic exposure that is associated with the mrhd of aczone gel, 7.5%, based on auc comparisons). no effects were observed on the viability, physical development, behavior, learning ability, or reproductive function of surviving pups. risk summary there is no information regarding the presence of topical dapsone in breastmilk, the effects on the breastfed infant or the effects on milk production. orally administered dapsone appears in human milk and could result in hemolytic anemia and hyperbilirubinemia especially in infants with g6pd deficiency. systemic absorption of dapsone following topical application is low relative to oral dapsone administration. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for aczone gel, 7.5% and any potential adverse effects on the breastfed child from aczone gel, 7.5% or from the underlying maternal condition. the safety and effectiveness of aczone gel, 7.5% for the topical treatment of acne vulgaris have been established in patients 9 years of age and older. use of aczone gel, 7.5% in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 subjects 12 years of age and older and with additional pharmacokinetic and safety data in pediatric subjects 9 to 11 years of age from an open label study of 100 subjects with acne [see adverse reactions (6.1), and clinical pharmacology (12.3)] . the safety profile for aczone gel, 7.5% in clinical trials was similar to the vehicle control group. safety and effectiveness of aczone gel, 7.5%, have not been established in pediatric patients below the age of 9 years. clinical trials of aczone gel, 7.5% did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. individuals with glucose-6-phosphate dehydrogenase (g6pd) deficiency may be more prone to methemoglobinemia and hemolysis [see warnings and precautions (5.1)] . aczone gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical study of 64 subjects with g6pd deficiency and acne vulgaris. subjects were black (88%), asian (6%), hispanic (2%) or of other racial origin (5%). blood samples were taken at baseline, week 2, and week 12 during both vehicle and aczone gel, 5% treatment periods. some of these subjects developed laboratory changes suggestive of hemolysis, but there was no evidence of clinically significant hemolytic anemia in this study [see warnings and precautions (5.1)] .

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a-s medication solutions - mefloquine hydrochloride (unii: 5y9l3636o3) (mefloquine - unii:tml814419r) - mefloquine hydrochloride tablets are indicated for the treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of p. falciparum (both chloroquine-susceptible and resistant strains) or by plasmodium vivax. there are insufficient clinical data to document the effect of mefloquine in malaria caused by p. ovale or p. malariae. note: patients with acute p. vivax malaria, treated with mefloquine, are at high risk of relapse because mefloquine does not eliminate exoerythrocytic (hepatic phase) parasites. to avoid relapse, after initial treatment of the acute infection with mefloquine, patients should subsequently be treated with an 8-aminoquinoline derivative (e.g., primaquine). mefloquine hydrochloride tablets are indicated for the prophylaxis of p. falciparum and p. vivax malaria infections, including prophylaxis of chloroquine-resistant strains of p. falciparum. use of mefloquine hydrochloride tablets is contraindicated in patients with a known hypersensitivity to mefloquine or

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

amneal pharmaceuticals llc - nitrofurantoin monohydrate (unii: e1qi2cqq1i) (nitrofurantoin - unii:927ah8112l), nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - nitrofurantoin 75 mg - nitrofurantoin capsules, usp (monohydrate/macrocrystals) are indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of escherichia coli or staphylococcus saprophyticus . nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin capsules, usp (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin capsules, usp (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. nitrofurantoins lack the broader tissue distribution of other the

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bryant ranch prepack - nitrofurantoin monohydrate (unii: e1qi2cqq1i) (nitrofurantoin - unii:927ah8112l), nitrofurantoin (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - nitrofurantoin monohydrate 75 mg - nitrofurantoin (monohydrate/macrocrystals) is indicated only for the treatment of acute uncomplicated urinary tract infections (acute cystitis) caused by susceptible strains of escherichia coli or staphylococcus saprophyticus. nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nitrofurantoin (monohydrate/macrocrystals) and other antibacterial drugs, nitrofurantoin (monohydrate/macrocrystals) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract i

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procter & gamble pharmaceuticals - nitrofurantoin, macrocrystalline (unii: 927ah8112l) (nitrofurantoin - unii:927ah8112l) - capsule - 25 mg - macrodantin is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of escherichia coli, enterococci, staphylococcus aureus , and certain susceptible strains of klebsiella and enterobacter species. nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. to reduce the development of drug-resistant bacteria and maintain the effectiveness of macrodantin and other antibacterial drugs, macrodantin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. consequently, many patient