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

dispensing solutions, inc. - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 500 mg

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

ascend laboratories, llc - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 500 mg - cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of streptococcus pneumoniae and streptococcus pyogenes. cephalexin is indicated for the treatment of otitis media caused by susceptible isolates of streptococcus pneumoniae, haemophilus influenzae, staphylococcus aureus, streptococcus pyogenes, and moraxella catarrhalis. cephalexin is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus and streptococcus pyogenes. cephalexin is indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus and proteus mirabilis. cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escherichia coli, proteus mirabilis, and klebsiella pneumoniae. to reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin

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

lupin pharmaceuticals, inc. - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 125 mg in 5 ml - cephalexin for oral suspension is indicated for the treatment of respiratory tract infections caused by susceptible isolates of streptococcus pneumoniae and streptococcus pyogenes . cephalexin for oral suspension is indicated for the treatment of otitis media caused by susceptible isolates of streptococcus pneumoniae, haemophilus influenzae, staphylococcus aureus, streptococcus pyogenes, and moraxella catarrhalis. cephalexin for oral suspension is indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus and streptococcus pyogenes. cephalexin for oral suspension is indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus and proteus mirabilis. cephalexin for oral suspension is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escherichia coli, proteus mirabilis, and klebsiella pneumon

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

central texas community health centers - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 500 mg - cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of streptococcus pneumoniae and streptococcus pyogenes. cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of streptococcus pneumoniae , haemophilus influenzae , staphylococcus aureus , streptococcus pyogenes , and moraxella catarrhalis. cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus and streptococcus pyogenes . cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus and proteus mirabilis. cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escherichia coli , proteus mirabilis , and klebsiella pneumoniae . to reduce the development of drug-resist

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

aurobindo pharma limited - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 250 mg - cephalexin capsules are indicated for the treatment of respiratory tract infections caused by susceptible isolates of streptococcus pneumoniae and streptococcus pyogenes. cephalexin capsules are indicated for the treatment of otitis media caused by susceptible isolates of streptococcus pneumoniae , haemophilus influenzae , staphylococcus aureus , streptococcus pyogenes , and moraxella catarrhalis. cephalexin capsules are indicated for the treatment of skin and skin structure infections caused by susceptible isolates of the following gram-positive bacteria: staphylococcus aureus and streptococcus pyogenes . cephalexin capsules are indicated for the treatment of bone infections caused by susceptible isolates of staphylococcus aureus and proteus mirabilis. cephalexin capsules are indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of escherichia coli , proteus mirabilis , and klebsiella pneumoniae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules and other antibacterial drugs, cephalexin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information is available, this information 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. cephalexin capsules are contraindicated in patients with known hypersensitivity to cephalexin or other members of the cephalosporin class of antibacterial drugs. risk summary available data from published epidemiologic studies and pharmacovigilance case reports over several decades with cephalosporin use, including cephalexin use in pregnant women have not established drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . animal reproduction studies with mice and rats using oral doses of cephalexin that are 0.6- and 1.2-times the maximum recommended human dose (mrhd) based on body surface area during organogenesis revealed no evidence of harm to the fetus (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. 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. data human data while available studies cannot definitively establish the absence of risk, published data from epidemiologic studies and postmarketing case reports over several decades have not identified a consistent association with cephalosporin use, including cephalexin, during pregnancy, and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups. animal data in animal reproduction studies, pregnant mice and rats administered oral cephalexin doses of 250 or 500 mg/kg/day (approximately 0.6 and 1.2 times the mrhd) based on body surface area, respectively during the period of organogenesis showed no adverse effects on embryofetal development. in a pre-and post-natal developmental toxicity study, pregnant rats that received oral doses of 250 or 500 mg/kg/day of cephalexin from day 15 of pregnancy to litter day 21 showed no adverse effects on parturition, litter size, or growth of offspring. risk summary data from a published clinical lactation study reports that cephalexin is present in human milk. the relative infant dose (rid) is considered to be <1% of the maternal weight adjusted dose. there are no data on the effects of cephalexin on the breastfed child or on milk production. the development of health benefits of breastfeeding should be considered along with the mother’s clinical need for cephalexin and any potential adverse effects on the breastfed child from cephalexin or from the underlying maternal condition. the safety and effectiveness of cephalexin in pediatric patients was established in clinical trials for the dosages described in the dosage and administration section [see dosage and administration (2.2)]. of the 701 subjects in 3 published clinical studies of cephalexin, 433 (62%) were 65 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. this drug is substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection [see warnings and precautions (5.4)]. cephalexin should be administered with careful monitoring in the presence of renal impairment (creatinine clearance < 30 ml/min, with or without dialysis). under such conditions, careful clinical observation and laboratory studies renal function monitoring should be conducted because safe dosage may be lower than that usually recommended [see dosage and administration (2.3)] . monitor patients longer for toxicity and drug interactions due to delayed clearance.

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

american antibiotics, inc - cephalexin (unii: obn7uds42y) (cephalexin - unii:obn7uds42y) - cephalexin 250 mg - cephalexin capsules are indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: respiratory tract infections caused by streptococcus pneumoniae and  (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cephalexin is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin in the subsequent prevention of rheumatic fever are not available at present.) otitis media due to streptococcus pneumoniae, haemophilus influenzae, staphylococcus aureus, streptococcus pyogenes, and moraxella catarrhalis skin and skin structure infections caused by staphylococcus aureus and/or streptococcus pyogenes bone infections caused by staphylococcus aureus and/or proteus mirabilis genitourinary tract infections, including acute prostatitis, caused by escherichia coli, proteus mirabilis

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

altura pharmaceuticals, inc. - cephalexin (unii: obn7uds42y) (cephalexin - unii:obn7uds42y) - cephalexin 250 mg - cephalexin capsules, usp is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: -  respiratory tract infections caused by streptococcus pneumoniae and streptococcus pyogenes (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cephalexin capsules, usp is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, usp in the subsequent prevention of rheumatic fever are not available at present.) -  otitis media due to streptococcus pneumoniae, haemophilus influenzae , staphyloccus aureus, streptococcus pyogenes, and moraxella catarrhalis -  skin and skin structure infections caused by staphylococcus aureus  and/or streptococcus pyogenes   -  bone infections caused by staphylococcus aureus  and/or proteus mirabilis -  genitourinary tract infections, inc

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

redpharm drug inc. - cephalexin (unii: obn7uds42y) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 500 mg - cephalexin capsules, usp is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms: -  respiratory tract infections caused by streptococcus pneumoniae and streptococcus pyogenes (penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. cephalexin capsules, usp is generally effective in the eradication of streptococci from the nasopharynx; however, substantial data establishing the efficacy of cephalexin capsules, usp in the subsequent prevention of rheumatic fever are not available at present.) -  otitis media due to streptococcus pneumoniae, haemophilus influenzae , staphyloccus aureus, streptococcus pyogenes, and moraxella catarrhalis -  skin and skin structure infections caused by staphylococcus aureus  and/or streptococcus pyogenes   -  bone infections caused by staphylococcus aureus  and/or proteus mirabilis -  genitourinary tract in

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

aidarex pharmaceuticals llc - cephalexin anhydrous (unii: 5sff1w6677) (cephalexin anhydrous - unii:5sff1w6677) - cephalexin anhydrous 250 mg

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

janssen-cilag pty ltd - daratumumab, quantity: 1800 mg - injection, solution - excipient ingredients: vorhyaluronidase alfa; histidine; histidine hydrochloride monohydrate; sorbitol; methionine; polysorbate 20; water for injections - darzalex sc is indicated for the treatment of patients:,? with newly diagnosed multiple myeloma:,- who are eligible for autologous stem cell transplant. for use in combination with:-bortezomib, thalidomide, and dexamethasone.,- who are ineligible for autologous stem cell transplant. for use in combination with: - bortezomib, melphalan and prednisone, or - lenalidomide and dexamethasone.,? with multiple myeloma who have received: - at least one prior therapy. for use in combination with: - bortezomib and dexamethasone, or - lenalidomide and dexamethasone.,- at least three prior lines of therapy including a proteasome inhibitor (pi) and an immunomodulatory agent or who are refractory to both a pi and an immunomodulatory agent. for use as: - monotherapy.,darzalex sc in combination with bortezomib, cyclophosphamide and dexamethasone, is indicated for the treatment of patients with light chain al amyloidosis.