Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

breckenridge pharmaceutical, inc. - mefenamic acid (unii: 367589pj2c) (mefenamic acid - unii:367589pj2c) - mefenamic acid 250 mg - carefully consider the potential benefits and risks of mefenamic acid and other treatment options before deciding to use mefenamic acid. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation ). mefenamic acid is indicated: - for relief of mild to moderate pain in patients ≥ 14 years of age, when therapy will not exceed one week (7 days). - for treatment of primary dysmenorrhea. mefenamic acid is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to mefenamic acid or any components of the drug product (see warnings; anaphylactic reactions, serious skin reactions) . - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients (see warnings; anaphylactic reaction, exacerbation of asth

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

mckesson corporation dba sky packaging - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 100 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. doxycycline is indicated for the treatment of the following infections: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae . - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. - inclusion conjunctivitis caused by chlamydia trachomatis . - uncomplicated urethral, endocervical, or rectal infections in adults caused by  chlamydia   trachomatis . - nongonococcal urethritis caused by ureaplasma urealyticum . - relapsing fever due to borrelia recurrentis . doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: - chancroid caused by haemophilus ducreyi. - plague due to yersinia pestis. - tularemia due to francisella tularensis. - cholera caused by vibrio cholerae. - campylobacter fetus infections caused by campylobacter fetus. - brucellosis due to brucella species (in conjunction with streptomycin). - bartonellosis due to bartonella bacilliformis . - granuloma inguinale caused by  klebsiella granulomatis . because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: - escherichia coli. - enterobacter aerogenes. - shigella species. - acinetobacter species. - respiratory tract infections caused by haemophilus influenzae . - respiratory tract and urinary tract infections caused by klebsiella species. doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: - upper respiratory infections caused by streptococcus pneumoniae. - anthrax due to bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease  following exposure to aerosolized bacillus anthracis . when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: - uncomplicated gonorrhea caused by neisseria gonorrhoeae. - syphilis caused by treponema pallidum . - yaws caused by treponema pallidum subspecies pertenue. - listeriosis due to listeria monocytogenes . - vincent’s infection caused by fusobacterium fusiforme . - actinomycosis caused by actinomyces isr aelii . - infections caused by clostridium species. in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. in severe acne, doxycycline may be useful adjunctive therapy. doxycycline is indicated for the prophylaxis of malaria due to plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (see dosage and administration section and information for patients subsection of the precautions section.) this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

cobalt laboratories, inc. - ipratropium bromide (unii: j697uz2a9j) (ipratropium cation - unii:gr88g0i6ul) - solution - 0.5 mg in 2.5 ml - ipratropium bromide inhalation solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. ipratropium bromide is contraindicated in known or suspected cases of hypersensitivity to ipratropium bromide, or to atropine and its derivatives.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil 20 mg - adults sildenafil tablets are indicated for the treatment of pulmonary arterial hypertension (pah) (world health organization [who] group i) in adults to improve exercise ability and delay clinical worsening [see clinical studies ( 14)] .  pediatric use information is approved for viatris specialty llc’s, revatio (sildenafil) tablets. however, due to viatris specialty llc’s marketing exclusivity rights, this drug product is not labeled with that information. sildenafil is contraindicated in patients with: - concomitant use of organic nitrates in any form, either regularly or intermittently, because of the greater risk of hypotension [see warnings and precautions ( 5.1)]. - concomitant use of riociguat, a guanylate cyclase stimulator. phosphodiesterase-5 (pde-5) inhibitors, including sildenafil, may potentiate the hypotensive effects of riociguat. - known hypersensitivity to sildenafil or any component of the tablet. hypersensitivity, including anaphylactic reaction, anaphylactic shock and anaphylactoid reaction, has been reported in association with the use of sildenafil. risk summary limited published data from randomized controlled trials, case-controlled trials, and case series do not report a clear association with sildenafil and major birth defects, miscarriage, or adverse maternal or fetal outcomes when sildenafil is used during pregnancy. there are risks to the mother and fetus from untreated pulmonary arterial hypertension (see clinical considerations). animal reproduction studies conducted with sildenafil showed no evidence of embryo-fetal toxicity or teratogenicity at doses up to 32- and 65-times the recommended human dose (rhd) of 20 mg three times a day in rats and rabbits, respectively (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. clinical considerations     disease-associated maternal and/or embryo/fetal risk   pregnant women with untreated pulmonary arterial hypertension are at risk for heart failure, stroke, preterm delivery, and maternal and fetal death. data     animal data     no evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or rabbits dosed with sildenafil 200 mg/kg/day during organogenesis, a level that is, on a mg/m 2 basis, 32- and 65-times, respectively, the recommended human dose (rhd) of 20 mg three times a day. in a rat pre- and postnatal development study, the no-observed-adverse-effect dose was 30 mg/kg/day (equivalent to 5-times the rhd on a mg/m 2 basis). risk summary limited published data from a case report describe the presence of sildenafil and its active metabolite in human milk. there is insufficient information about the effects of sildenafil on the breastfed infant and no information on the effects of sildenafil on milk production. limited clinical data during lactation preclude a clear determination of the risk of sildenafil to an infant during lactation. the safety and effectiveness of sildenafil have not been established in pediatric patients younger than 1 year of age. pediatric use information is approved for viatris specialty llc’s, revatio (sildenafil) tablets. however, due to viatris specialty llc’s marketing exclusivity rights, this drug product is not labeled with that information. clinical studies of sildenafil did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see clinical pharmacology ( 12.3)]. no dose adjustment for mild to moderate impairment is required. severe impairment has not been studied [see clinical pharmacology ( 12.3)]. no dose adjustment is required (including severe impairment clcr <30 ml/min) [see clinical pharmacology ( 12.3)].

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

us worldmeds, llc - dantrolene sodium (unii: 287m0347ev) (dantrolene - unii:f64qu97qcr) - dantrolene sodium 20 mg in 60 ml - revonto (dantrolene sodium for injection) is indicated, along with appropriate supportive measures, for the management of the fulminant hypermetabolism of skeletal muscle characteristic of malignant hyperthermia crises in patients of all ages. revonto should be administered by continuous rapid intravenous push as soon as the malignant hyperthermia reaction is recognized (i.e., tachycardia, tachypnea, central venous desaturation, hypercarbia, metabolic acidosis, skeletal muscle rigidity, increased utilization of anesthesia circuit carbon dioxide absorber, cyanosis and mottling of the skin, and, in many cases, fever). revonto is also indicated preoperatively, and sometimes postoperatively, to prevent or attenuate the development of clinical and laboratory signs of malignant hyperthermia in individuals judged to be malignant hyperthermia susceptible. none.

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

cebert pharmaceuticals, inc. - methadone hydrochloride (unii: 229809935b) (methadone - unii:uc6vbe7v1z) - concentrate - 10 mg in 1 ml - - detoxification treatment of opioid addiction (heroin or other morphine-like drugs). - maintenance treatment of opioid addiction (heroin or other morphine-like drugs), in conjunction with appropriate social and medical services. outpatient maintenance and outpatient detoxification treatment may be provided only by opioid treatment programs (otps) certified by the federal substance abuse and mental health services administration (samhsa) and registered by the drug enforcement administration (dea). this does not preclude the maintenance treatment of a patient with concurrent opioid addiction who is hospitalized for conditions other than opioid addiction and who requires temporary maintenance during the critical period of his/her stay, or of a patient whose enrollment has been verified in a program which has been certified for maintenance treatment with methadone. methadone hydrochloride oral concentrate is contraindicated in patients with a known hypersensitivity to methadone hydrochloride or any other ingred

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 2 g in 100 g - ketoconazole foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. limitations of use safety and efficacy of ketoconazole foam, 2% for treatment of fungal infections have not been established. none. risk summary there are no available data on ketoconazole foam, 2% use in pregnant women to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. no reproductive studies in animals have been performed with ketoconazole foam, 2%. in animal reproduction studies with pregnant mice, rats and rabbits both embryotoxic and developmental effects (structural abnormalities) were observed following oral dosing of ketoconazole during organogenesis. assuming equivalent systemic absorption of topical and oral ketoconazole doses and a ketoconazole foam, 2% maximum recommended human dose (mrhd) of 8 grams (equivalent to 160 mg ketoconazole), embryotoxic effects were observed at 0.8 to 2.4 times the mrhd an

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 100 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - temozolomide (unii: yf1k15m17y) (temozolomide - unii:yf1k15m17y) - temozolomide 5 mg - temozolomide capsules are indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. temozolomide capsules are indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. temozolomide is contraindicated in patients with a history of hypersensitivity reactions to: - temozolomide or any other ingredients in temozolomide capsules; and - dacarbazine, since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3methyltriazen-1-yl)-imidazole-4-carboxamide. reactions to temozolomide have included anaphylaxis [see adverse reactions (6.2)]. risk summary based on its mechanism of action [see clinical pharmacology (12.1)] and findings from animal studies, temozolomide can cause fetal harm when administered to a pregnant woman. available postmarketing reports describe

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

epic pharma, llc - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 100 mg in 5 ml - azithromycin for oral suspension usp is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] [see use in specific populations (8.4) and clinical studies (14.2)] azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat 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