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preferred pharmaceuticals inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 600 mg - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reac

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rebel distributors corp - zaleplon (unii: s62u433rmh) (zaleplon - unii:s62u433rmh) - zaleplon 5 mg - zaleplon is indicated for the short-term treatment of insomnia. zaleplon has been shown to decrease the time to sleep onset for up to 30 days in controlled clinical studies (see clinical trials   under clinical pharmacology ). it has not been shown to increase total sleep time or decrease the number of awakenings. the clinical trials performed in support of efficacy ranged from a single night to 5 weeks in duration. the final formal assessments of sleep latency were performed at the end of treatment. hypersensitivity to zaleplon or any excipients in the formulation (see also precautions). zaleplon is classified as a schedule iv controlled substance by federal regulation. abuse and addiction are separate and distinct from physical dependence and tolerance. abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. physical dependence is a state of adaption that is manifested by a specific withdrawal syndrome that can be produced by abrupt ces

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lake erie medical dba quality care products llc - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram tablets usp are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see clinical studies (14.1) ]. information related to usage of e scitalopram in adolescents is approved for forest laboratories, inc.'s escitalopram oxalate tablets and oral solution. however, due to forest laboratories, inc.'s marketing exclusivity rights, this drug product is not labeled with that adolescent usage information. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attem

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

preferred pharmaceuticals inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reac

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

preferred pharmaceuticals inc. - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibuprofen tablets are indicated for relief of mild to moderate pain. ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted. ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reac

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epic pharma, llc - trimipramine maleate (unii: 269k6498ld) (trimipramine - unii:6s082c9ndt) - trimipramine maleate capsules are indicated for the relief of symptoms of depression. endogenous depression is more likely to be alleviated than other depressive states. in studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. in hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression. the use of maois intended to treat psychiatric disorders with trimipramine maleate or within 14 days of stopping treatment with trimipramine maleate is contraindicated because of an increased risk of serotonin syndrome. the use of trimipramine maleate within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting trimipramine maleate in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also co

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drug ocean llc - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin is indicated in adult patients for treatment of skin and skin structure infections caused by escherichia coli , klebsiella pneumoniae , enterobacter cloacae , proteus mirabilis , proteus vulgaris , providencia stuartii , morganella morganii , citrobacter freundii , pseudomonas aeruginosa , methicillin-susceptible staphylococcus aureus , methicillin-susceptible staphylococcus epidermidis , or streptococcus pyogenes . ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. ciprofloxacin is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by escherichia coli, pseudomonas aeruginosa, proteus mirabilis, klebsiella pneumoniae, or bacteroides fragilis. ciprofloxacin is indicated in adult patients for treatment of infectious diarrhea caused by escherichia coli (enterotoxigenic isolates), campylobacter jejuni , shigella boydii† , shigella dysenteriae , shigella flexneri or shigella sonnei† when antibacterial therapy is indicated. †although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients. ciprofloxacin is indicated in adult patients for treatment of typhoid fever (enteric fever) caused by salmonella typhi . the efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated. ciprofloxacin is indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to neisseria gonorrhoeae [see warnings and precautions (5.17)]. ciprofloxacin is indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication. 1 supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of october 2001 [see clinical studies (14.2)]. ciprofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to yersinia pestis (y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to 17 years of age. efficacy studies of ciprofloxacin could not be conducted in humans with plague for feasibility reasons. therefore this indication is based on an efficacy study conducted in animals only [ see clinical studies (14.3)] . ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by escherichia coli or proteus mirabilis . ciprofloxacin is indicated in adult patients for treatment of lower respiratory tract infections caused by escherichia coli , klebsiella pneumoniae , enterobacter cloacae , proteus mirabilis , pseudomonas aeruginosa , haemophilus influenzae , haemophilus parainfluenzae , or streptococcus pneumoniae . ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to streptococcus pneumoniae . ciprofloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis (aecb) caused by moraxella catarrhalis . because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see warnings and precautions (5.1–5.16)] and for some patients aecb is self-limiting, reserve ciprofloxacin for treatment of aecb in patients who have no alternative treatment options. urinary tract infections in adults ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by escherichia coli , klebsiella pneumoniae , enterobacter cloacae , serratia marcescens , proteus mirabilis , providencia rettgeri , morganella morganii , citrobacter koseri , citrobacter freundii , pseudomonas aeruginosa , methicillin-susceptible staphylococcus epidermidis , staphylococcus saprophyticus , or enterococcus faecalis . acute uncomplicated cystitis ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by escherichia coli or staphylococcus saprophyticus . because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see warnings and precautions (5.1-5.16)] and for some patients acute uncomplicated cystitis is self-limiting, reserve ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative treatment options. complicated urinary tract infection and pyelonephritis in pediatric patients ciprofloxacin is indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections (cuti) and pyelonephritis due to escherichia coli [see use in specific populations (8.4)]. although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls, including reactions related to joints and/or surrounding tissues. ciprofloxacin, like other fluoroquinolones, is associated with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see warnings and precautions (5.13), adverse reactions (6.1), use in specific populations (8.4) and nonclinical toxicology (13.2)]. ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by haemophilus influenzae , streptococcus pneumoniae , or moraxella catarrhalis . because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see warnings and precautions (5.1-5.16)] and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin for treatment of acute sinusitis in patients who have no alternative treatment options. to reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin 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. if anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be administered. appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin. therapy with ciprofloxacin may be initiated before results of these tests are known; once results become available appropriate therapy should be continued. as with other drugs, some isolates of pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ciprofloxacin. culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance. ciprofloxacin tablet is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see warnings and precautions (5.7)]. concomitant administration with tizanidine is contraindicated [see drug interactions (7)]. risk summary prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ciprofloxacin administered during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes (see data). oral administration of ciprofloxacin during organogenesis at doses up to 100 mg/kg to pregnant mice and rats, and up to 30 mg/kg to pregnant rabbits did not cause fetal malformations (see data). these doses were up to 0.3, 0.6, and 0.4 times the maximum recommended clinical oral dose in mice, rats, and rabbits, respectively, based on body surface area. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancieshave a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risks 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 prospective observational studies over several decades have not established an association with ciprofloxacin use during pregnancy and major birth defects, miscarriage, or adverse maternalor fetal outcomes. available studies have methodological limitations including small sample size and some of them are not specific for ciprofloxacin. a controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and68% first trimester exposures) during gestation. in utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations. the reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% forthe control group (background incidence of major malformations is 1–5%). rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacinexposed children. another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures). there were 70 ciprofloxacin exposures, all within the first trimester. the malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. no specific patterns of congenital abnormalities were found. the study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin. no differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. however, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses.  animal data developmental toxicology studies have been performed with ciprofloxacin in rats, mice, and rabbits. in rats and mice, oral doses up to 100 mg/kg administered during organogenesis (gestation days, gd, 6-17) were not associated with adverse developmental outcomes, including embryofetal toxicity or malformations. in rats and mice, a 100 mg/kg dose is approximately 0.6 and 0.3 times the maximum daily human oral dose (1500 mg/day) based upon body surface area, respectively. in a series of rabbit developmental toxicology studies, does received oral or intravenous ciprofloxacin for one of the following 5 day periods: gd 6 to 10, gd 10 to 14, or gd 14 to 18, intended to cover the period of organogenesis. this was an attempt to mitigate the gastrointestinal intolerance observed in rabbits that receive antibacterials manifested by reduced maternal food consumption and weight loss, that can lead to embryofetal resorption or spontaneous abortion. an oral ciprofloxacin dose of 100 mg/kg (approximately 1.3 times the highest recommended clinical oral dose based on body surface area) caused excessive maternal toxicity confounding evaluation of the fetuses. a 30 mg/kg oral dose (approximately 0.4 times the highest recommended clinical oral dose) was associated with suppression of maternal and fetal body weight gain, but fetal malformations were not observed. intravenous administration of doses up to 20 mg/kg (approximately 0.3 times the highest recommended clinical oral dose based upon body surface area) to pregnant rabbits was not maternally toxic and neither embryofetal toxicity nor fetal malformations were observed. in peri-and post-natal studies, rats received ciprofloxacin doses up to 200 mg/kg/day (oral) or up to 30 mg/kg/day (subcutaneous) from gd 16 to 22 days postpartum. the 200 mg/kg dose is approximately 1.3-times the maximum recommended clinical oral dose based on body surfacearea. neither maternal toxicity nor adverse effects on growth and development of the pups were observed, including no sign of arthropathy on the rear leg joints of the pups. ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most speciestested when administered directly [see warnings and precautions (5.13) and nonclinical toxicology 13.2]. risk summary published literature reports that ciprofloxacin is present in human milk following intravenous and oral administration. there is no information regarding effects of ciprofloxacin on milk production or the breastfed infant. because of the potential risk of serious adverse reactions in breastfed infants, including arthropathy shown in juvenile animal studies [see use in specific populations (8.4), (clinical considerations)], for most indications a lactating woman may consider pumping and discarding breast milk during treatment with ciprofloxacin and an additional two days (five half-lives) after the last dose. alternatively, advise a woman that breastfeeding is not recommended during treatment with ciprofloxacin and for an additional two days (five half-lives) after the last dose. however, for inhalation anthrax (post exposure), during an incident resulting in exposure to anthrax, the risk-benefit assessment of continuing breastfeeding while the mother (and potentially the infant) is (are) on ciprofloxacin may be acceptable [see dosage and administration (2.2), pediatric use (8.4), and clinical studies (14.2)]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ciprofloxacin and any potential adverse effects on the breastfed child from ciprofloxacin or from the underlying maternal condition.  clinical considerations ciprofloxacin may cause intestinal flora alteration of the breastfeeding infant. advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis (thrush, diaper rash). although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. quinolones, including ciprofloxacin, cause arthropathy (arthralgia, arthritis), in juvenile animals [see warnings and precautions (5.13) and nonclinical toxicology (13.2)] . complicated urinary tract infection and pyelonephritis ciprofloxacin is indicated for the treatment of cuti and pyelonephritis due to escherichia coli in pediatric patients 1 to 17 years of age . although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to the controls, including events related to joints and/or surrounding tissues [see adverse reactions (6.1) and clinical studies (14.1)]. inhalational anthrax (post-exposure) ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for inhalational anthrax (post-exposure). the risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see dosage and administration (2.2) and clinical studies (14.2)]. plague ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to yersinia pestis (y. pestis) and prophylaxis for plague. efficacy studies of ciprofloxacin could not be conducted in humans with pneumonic plague for feasibility reasons. therefore, approval of this indication was based on an efficacy study conducted in animals. the risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see indications and usage (1.8), dosage and administration (2.2) and clinical studies (14.3)]. geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ciprofloxacin. this risk is further increased in patients receiving concomitant corticosteroid therapy. tendinitis or tendon rupture can involve the achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. caution should be used when prescribing ciprofloxacin to elderly patients especially those on corticosteroids. patients should be informed of this potential adverse reaction and advised to discontinue ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see boxed warning, warnings and precautions (5.2), and adverse reactions (6.2)]. epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [see warnings and precautions (5.9)]. in a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin encompassing over 3500 ciprofloxacin-treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age. 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, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. no alteration of dosage is necessary for patients greater than 65 years of age with normal renal function. however, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients [see dosage and administration (2.3) and clinical pharmacology (12.3)]. in general, elderly patients may be more susceptible to drug-associated effects on the qt interval. therefore, precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the qt interval (for example, class ia or class iii antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known qt prolongation, uncorrected hypokalemia) [see warnings and precautions (5.12)]. ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. these alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction [see  dosage and administration (2.3) and clinical pharmacology (12.3)]. in preliminary studies in patients with stable chronic liver cirrhosis, no significant changes in ciprofloxacin pharmacokinetics have been observed. the pharmacokinetics of ciprofloxacin in patients with acute hepatic insufficiency, have not been studied. read this medication guide before you start taking ciprofloxacin tablets and each time you get a refill. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. what is the most important information i should know about ciprofloxacin tablets? ciprofloxacin tablets, a fluoroquinolone antibacterial medicine, can cause serious side effects. some of these serious side effects can happen at the same time and could result in death. if you get any of the following serious side effects while you take ciprofloxacin tablets, you should stop taking ciprofloxacin tablets immediately and get medical help right away. 1. tendon rupture or swelling of the tendon (tendinitis). - tendon problems can happen in people of all ages who take ciprofloxacin tablets. tendons are tough cords of tissue that connect muscles to bones. symptoms of tendon problems may include: pain swelling tears and swelling of the tendons including the back of the ankle (achilles), shoulder, hand, or other tendon sites. - pain - swelling - tears and swelling of the tendons including the back of the ankle (achilles), shoulder, hand, or other tendon sites. - the risk of getting tendon problems while you take ciprofloxacin tablets is higher if you: are over 60 years of age are taking steroids (corticosteroids) have had a kidney, heart or lung transplant - are over 60 years of age - are taking steroids (corticosteroids) - have had a kidney, heart or lung transplant - tendon problems can happen in people who do not have the above risk factors when they take ciprofloxacin tablets. - other reasons that can increase your risk of tendon problems can include: physical activity or exercise kidney failure tendon problems in the past, such as in people with rheumatoid arthritis (ra) - physical activity or exercise - kidney failure - tendon problems in the past, such as in people with rheumatoid arthritis (ra) - stop taking ciprofloxacin tablets immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. the most common area of pain and swelling is the achilles tendon at the back of your ankle. this can also happen with other tendons. - tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin tablets. tendon ruptures can happen within hours or days of taking ciprofloxacin tablets and have happened up to several months after people have finished taking their fluoroquinolone. - stop taking ciprofloxacin tablets immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture: - hear or feel a snap or pop in a tendon area bruising right after an injury in a tendon area unable to move the affected area or bear weight - hear or feel a snap or pop in a tendon area - bruising right after an injury in a tendon area - unable to move the affected area or bear weight the tendon problems may be permanent. 2. changes in sensation and possible nerve damage (peripheral neuropathy). damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including ciprofloxacin tablets. stop taking ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet: - pain - burning - tingling - numbness - weakness ciprofloxacin tablets may need to be stopped to prevent permanent nerve damage. 3. central nervous system (cns) effects. seizures have been reported in people who take fluoroquinolone antibacterial medicines, including ciprofloxacin tablets. tell your healthcare provider if you have a history of seizures before you start taking ciprofloxacin tablets. cns side effects may happen as soon as after taking the first dose of ciprofloxacin. stop taking ciprofloxacin tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior: - seizures - hear voices, see things, or sense things that are not there (hallucinations) - feel restless - tremors - feel anxious or nervous - confusion - depression - reduced awareness of surroundings - trouble sleeping - nightmares - feel lightheaded or dizzy - feel more suspicious (paranoia) - suicidal thoughts or acts - headaches that will not go away, with or without blurred vision - memory problems - false or strange thoughts or beliefs (delusions) the cns changes may be permanent 4. worsening of myasthenia gravis (a problem that causes muscle weakness). fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. tell your healthcare provider if you have a history of myasthenia gravis before you start taking ciprofloxacin tablets. call your healthcare provider right away if you have any worsening muscle weakness or breathing problems. what are ciprofloxacin tablets? ciprofloxacin tablets are a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. these bacterial infections include: - urinary tract infection - chronic prostate infection - lower respiratory tract infection - sinus infection - skin infection - bone and joint infection - nosocomial pneumonia - intra-abdominal infection, complicated - infectious diarrhea - typhoid (enteric) fever - cervical and urethral gonorrhea, uncomplicated - people with a low white blood cell count and a fever - inhalational anthrax - plague - studies of ciprofloxacin tablets for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people. - ciprofloxacin should not be used in patients with acute exacerbation of chronic bronchitis, acute uncomplicated cystitis, and sinus infections, if there are other treatment options available. - ciprofloxacin should not be used as the first choice of antibacterial medicine to treat lower respiratory tract infections cause by a certain type of bacterial called streptococcus pneumoniae . - ciprofloxacin is also used in children younger than 18 years of age to treat complicated urinary tract and kidney infections or who may have breathed in anthrax germs, have plague or have been exposed to plague germs. - children younger than 18 years of age have a higher chance of getting bone, joint, or tendon (musculoskeletal) problems such as pain or swelling while taking ciprofloxacin. ciprofloxacin should not be used as the first choice of antibacterial medicine in children under 18 years of age. who should not take ciprofloxacin tablets? do not take ciprofloxacin tablets if you: - have ever had a severe allergic reaction to an antibacterial medicine known as a fluoroquinolone, or are allergic to ciprofloxacin hydrochloride or any of the ingredients in ciprofloxacin tablets. see the end of this medication guide for a complete list of ingredients in ciprofloxacin tablets. - also take a medicine called tizanidine (zanaflex ® ). ask your healthcare provider if you are not sure. what should i tell my healthcare provider before taking ciprofloxacin tablets? before you take ciprofloxacin tablets, tell your healthcare provider if you: - have tendon problems; ciprofloxacin tablets should not be used in patients who have a history of tendon problems - have a disease that causes muscle weakness (myasthenia gravis); ciprofloxacin tablets should not be used in patients who have a known history of myasthenia gravis - have liver problems - have central nervous system problems (such as epilepsy) - have nerve problems; ciprofloxacin tablets should not be used in patients who have a history of a nerve problem called peripheral neuropathy - have or anyone in your family has an irregular heartbeat, especially a condition called "qt prolongation" - have low blood potassium (hypokalemia) or low magnesium (hypomagnesemia). - have or have had seizures - have kidney problems. you may need a lower dose of ciprofloxacin tablets if your kidneys do not work well. - have diabetes or problems with low blood sugar (hypoglycemia). - have joint problems including rheumatoid arthritis (ra) - have trouble swallowing pills - are pregnant or plan to become pregnant. it is not known if ciprofloxacin will harm your unborn baby. - are breastfeeding or plan to breastfeed. ciprofloxacin passes into your breast milk. - you should not breastfeed during treatment with ciprofloxacin tablets and for 2 days after taking your last dose of ciprofloxacin tablets and for 2 days after taking your last dose of ciprofloxacin tablets. - if you are taking ciprofloxacin tablets for inhalation anthrax, you and your healthcare provider should decide whether you can continue breastfeeding while taking ciprofloxacin tablets. tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. - ciprofloxacin tablets and other medicines can affect each other causing side effects. - especially tell your healthcare provider if you take: a steroid medicine an anti-psychotic medicine a tricyclic antidepressant a water pill (diuretic) theophylline (such as theo-24 ® , elixophyllin ® , theochron ® , uniphyl ® , theolair ® ) a medicine to control your heart rate or rhythm (antiarrhythmics) an oral anti-diabetes medicine phenytoin (fosphenytoin sodium ® , cerebyx ® , dilantin-125 ® , dilantin ® , extended phenytoin sodium ® , prompt phenytoin sodium ® , phenytek ® ) cyclosporine (gengraf ® , neoral ® , sandimmune ® , sangcya ® ). a blood thinner (such as warfarin, coumadin ® , jantoven ® ) methotrexate (trexall ® ) ropinirole (requip ® ) clozapine (clozaril ® , fazaclo ® odt ® ) a non-steroidal anti-inflammatory drug (nsaid). many common medicines for pain relief are nsaids. taking an nsaid while you take ciprofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures. sildenafil (viagra ® , revatio ® ) duloxetine products that contain caffeine probenecid (probalan ® , col-probenecid ® ) - a steroid medicine - an anti-psychotic medicine - a tricyclic antidepressant - a water pill (diuretic) - theophylline (such as theo-24 ® , elixophyllin ® , theochron ® , uniphyl ® , theolair ® ) - a medicine to control your heart rate or rhythm (antiarrhythmics) - an oral anti-diabetes medicine - phenytoin (fosphenytoin sodium ® , cerebyx ® , dilantin-125 ® , dilantin ® , extended phenytoin sodium ® , prompt phenytoin sodium ® , phenytek ® ) - cyclosporine (gengraf ® , neoral ® , sandimmune ® , sangcya ® ). - a blood thinner (such as warfarin, coumadin ® , jantoven ® ) - methotrexate (trexall ® ) - ropinirole (requip ® ) - clozapine (clozaril ® , fazaclo ® odt ® ) - a non-steroidal anti-inflammatory drug (nsaid). many common medicines for pain relief are nsaids. taking an nsaid while you take ciprofloxacin or other fluoroquinolones may increase your risk of central nervous system effects and seizures. - sildenafil (viagra ® , revatio ® ) - duloxetine - products that contain caffeine - probenecid (probalan ® , col-probenecid ® ) - certain medicines may keep ciprofloxacin tablets from working correctly. take ciprofloxacin tablets either 2 hours before or 6 hours after taking these medicines, vitamins, or supplements: an antacid, multivitamin, or other medicine or supplements that has magnesium, calcium, aluminum, iron, or zinc sucralfate (carafate ® ) didanosine (videx ® , videx ec ® ) - an antacid, multivitamin, or other medicine or supplements that has magnesium, calcium, aluminum, iron, or zinc - sucralfate (carafate ® ) - didanosine (videx ® , videx ec ® ) ask your healthcare provider for a list of these medicines if you are not sure. know the medicines you take. keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. how should i take ciprofloxacin tablets? - take ciprofloxacin tablets exactly as your healthcare provider tells you to take it. - your healthcare provider will tell you how much ciprofloxacin tablets to take and when to take it. - take ciprofloxacin tablets in the morning and evening at about the same time each day. swallow the tablet whole. do not split, crush or chew the tablet. tell your healthcare provider if you cannot swallow the tablet whole. - ciprofloxacin tablets can be taken with or without food. - if you miss a dose of ciprofloxacin tablets and it is:o 6 hours or more until your next scheduled dose, take your missed dose right away. then take the next dose at your regular time.o less than 6 hours until your next scheduled dose, do not take the missed dose. take the next dose at your regular time. - do not take 2 doses of ciprofloxacin tablets at one time to make up for a missed dose. if you are not sure about when to take ciprofloxacin tablets after a missed dose, ask your doctor or pharmacist. - ciprofloxacin tablets should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone, but may be taken with a meal that contains these products. - drink plenty of fluids while taking ciprofloxacin tablets. - do not skip any doses of ciprofloxacin tablets, or stop taking it, even if you begin to feel better, until you finish your prescribed treatment unless: you have tendon problems. see " what is the most important information i should know about ciprofloxacin tablets?” you have nerve problems. see "what is the most important information i should know about ciprofloxacin tablets?" you have central nervous system problems. see "what is the most important information i should know about ciprofloxacin tablets?" you have a serious allergic reaction. see "what are the possible side effects of ciprofloxacin tablets?" your healthcare provider tells you to stop taking ciprofloxacin tablets. - you have tendon problems. see " what is the most important information i should know about ciprofloxacin tablets?” - you have nerve problems. see "what is the most important information i should know about ciprofloxacin tablets?" - you have central nervous system problems. see "what is the most important information i should know about ciprofloxacin tablets?" - you have a serious allergic reaction. see "what are the possible side effects of ciprofloxacin tablets?" - your healthcare provider tells you to stop taking ciprofloxacin tablets. taking all of your ciprofloxacin doses will help make sure that all of the bacteria are killed. taking all of your ciprofloxacin doses will help lower the chance that the bacteria will become resistant to ciprofloxacin. if you become resistant to ciprofloxacin, ciprofloxacin tablets and other antibacterial medicines may not work for you in the future. - if you take too much ciprofloxacin tablets, call your healthcare provider or get medical help right away. what should i avoid while taking ciprofloxacin tablets? - ciprofloxacin tablets can make you feel dizzy and lightheaded. do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how ciprofloxacin tablets affects you. - avoid sunlamps, tanning beds, and try to limit your time in the sun. ciprofloxacin tablets can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. you could get a severe sunburn, blisters or swelling of your skin. if you get any of these symptoms while you take ciprofloxacin tablets, call your healthcare provider right away. you should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight. what are the possible side effects of ciprofloxacin tablets? ciprofloxacin tablets may cause serious side effects, including: - see, "what is the most important information i should know about ciprofloxacin tablets?" - serious allergic reactions. serious allergic reactions, including death, can happen in people taking fluoroquinolones, including ciprofloxacin tablets, even after only 1 dose. stop taking ciprofloxacin tablets and get emergency medical help right away if you get any of the following symptoms of a severe allergic reaction: hives trouble breathing or swallowing swelling of the lips, tongue, face throat tightness, hoarseness rapid heartbeat faint skin rash - hives - trouble breathing or swallowing - swelling of the lips, tongue, face - throat tightness, hoarseness - rapid heartbeat - faint - skin rash skin rash may happen in people taking ciprofloxacin tablets even after only 1 dose. stop taking ciprofloxacin tablets at the first sign of a skin rash and call your healthcare provider, skin rash may be a sign of a more serious reaction to ciprofloxacin. - liver damage (hepatotoxicity). hepatotoxicity can happen in people who take ciprofloxacin tablets. call your healthcare provider right away if you have unexplained symptoms such as: nausea or vomiting stomach pain fever weakness abdominal pain or tenderness itching unusual tiredness loss of appetite light colored bowel movements dark colored urine yellowing of your skin or the whites of your eyes - nausea or vomiting - stomach pain - fever - weakness - abdominal pain or tenderness - itching - unusual tiredness - loss of appetite - light colored bowel movements - dark colored urine - yellowing of your skin or the whites of your eyes stop taking ciprofloxacin tablets and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. these can be signs of a serious reaction to ciprofloxacin tablets (a liver problem). - aortic aneurysm and dissection. tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. get emergency medical help right away if you have sudden chest, stomach, or back pain. - intestine infection (pseudomembranous colitis). pseudomembranous colitis can happen with many antibacterial medicines, including ciprofloxacin tablets. call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. you may have stomach cramps and a fever. pseudomembranous colitis can happen 2 or more months after you have finished your antibacterial medicine. - serious heart rhythm changes (qt prolongation and torsade de pointes). tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. ciprofloxacin tablets may cause a rare heart problem known as prolongation of the qt interval. this condition can cause an abnormal heartbeat and can be very dangerous. the chances of this event are higher in people: who are elderly with a family history of prolonged qt interval with low blood potassium (hypokalemia) who take certain medicines to control heart rhythm (antiarrhythmics) - who are elderly - with a family history of prolonged qt interval - with low blood potassium (hypokalemia) - who take certain medicines to control heart rhythm (antiarrhythmics) - joint problems. increased chance of problems with joints and tissues around joints in children under 18 years old can happen. tell your child's healthcare provider if your child has any joint problems during or after treatment with ciprofloxacin tablets. - sensitivity to sunlight (photosensitivity). see " what should i avoid while taking ciprofloxacin tablets?" - changes in blood sugar. people who take ciprofloxacin and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). follow your healthcare provider's instructions for how often to check your blood sugar. if you have diabetes and you get low blood sugar while taking ciprofloxacin tablets, stop taking ciprofloxacin tablets and call your healthcare provider right away. your antibiotic medicine may need to be changed. the most common side effects of ciprofloxacin tablets include: - nausea - diarrhea - changes in liver function tests - vomiting - rash tell your healthcare provider about any side effect that bothers you, or that does not go away. these are not all the possible side effects of ciprofloxacin tablets. for more information, ask your healthcare provider or pharmacist. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088 or drug ocean llc at 1-844-200-6566. how should i store ciprofloxacin tablets? - store at 20° to 25°c (68° to 77° f); excursions permitted to 15° to 30°c (59° to 86° f). keep ciprofloxacin tablets and all medicines out of the reach of children. general information about the safe & effective use of ciprofloxacin tablets. medicines are sometimes prescribed for purposes other than those listed in a medication guide. do not use ciprofloxacin tablets for a condition for which it is not prescribed. do not give ciprofloxacin tablets to other people, even if they have the same symptoms that you have. it may harm them. this medication guide summarizes the most important information about ciprofloxacin tablets. if you would like more information about ciprofloxacin tablets, talk with your healthcare provider. you can ask your healthcare provider or pharmacist for information about ciprofloxacin tablets that is written for healthcare professionals. what are the ingredients in ciprofloxacin tablets? - active ingredient: ciprofloxacin hydrochloride - inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch and titanium dioxide. this medication guide has been approved by the u.s. food and drug administration. trademarks are the property of their respective owner. rx only manufactured for: drug ocean llc, 1 bridge plaza, north central road, 6th floor, suite 675, fort lee, nj 07024 manufactured by: unique pharmaceutical laboratories (a div. of j. b. chemicals & pharmaceuticals ltd.), mumbai 400 030, india. revised: 10/2023

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

hf acquisition co llc, dba healthfirst - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . initial and repeat courses of moderately emetogenic cancer chemotherapy. radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron is contraindicated in patients: 1. known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see adverse reactions ( 6.2)] 2. receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness 8.1 pregnancy risk summary available data do not reliably inform the association of ondansetron and adverse fetal outcomes. published epidemiological studies on the association between ondansetron and fetal outcomes have reported inconsistent findings and have important methodological limitations hindering interpretation (see data). reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered during organogenesis at approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, based on body surface area, respectively [see data]. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data methodological limitations of the epidemiology studies preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of ondansetron in pregnancy. two large retrospective cohort studies of ondansetron use in pregnancy have been published. in one study with 1,349 infants born to women who reported the use of ondansetron or received an ondansetron prescription in the first trimester, no increased risk for major congenital malformations was seen in aggregate analysis. in this same study, however, a sub-analysis for specific malformations reported an association between ondansetron exposure and cardiovascular defect (odds ratio (or) 1.62 [95% ci (1.04, 2.14)]) and cardiac septal defect (or 2.05 [95% ci (1.19, 3.28)]). the second study examined 1970 women who received ondansetron prescription during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage or stillbirth, and infants of low-birth weight or small for gestational age. important methodological limitations with these studies include the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, and other unadjusted confounders that may account for the study findings. a case-control study evaluating associations between several common non-cardiac malformations and multiple antiemetic drugs reported an association between maternal use of ondansetron and isolated cleft palate (reported adjusted or = 2.37 [95% ci (1.18, 4.76)]). however, this association could be a chance finding, given the large number of drugs-birth defect comparisons in this study. it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy) or whether mothers of infants with cleft palate used other medications or had other risk factors for cleft palate in the offspring. in addition, no cases of isolated cleft palate were identified in the aforementioned 2 large retrospective cohort studies. at this time, there is no clear evidence that ondansetron exposure in early pregnancy can cause cleft palate. animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received oral doses of ondansetron up to 15 mg/kg/day and 30 mg/kg/day, respectively, during the period of organogenesis. with the exception of a slight decrease in maternal body weight gain in the rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. at doses of 15 mg/kg/day in rats and 30 mg/kg/day in rabbits, the maternal exposure margin was approximately 6 and 24 times the maximum recommended human oral dose of 24 mg/day, respectively, based on body surface area. in a pre-and postnatal developmental toxicity study, pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21. with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre-and postnatal development of their offspring, including reproductive performance of the mated f1 generation. at a dose of 15 mg/kg/day in rats, the maternal exposure margin was approximately 6 times the maximum recommended human oral dose of 24 mg/day, based on body surface area. 8.2 lactation risk summary it is not known whether ondansetron is present in human milk. there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. however, it has been demonstrated that ondansetron is present in the milk of rats. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breast fed infant from ondansetron or from the underlying maternal condition. 8.4 pediatric use the safety and effectiveness of orally administered ondansetron have been established in pediatric patients 4 years and older for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. use of ondansetron in these age-groups is supported by evidence from adequate and well-controlled studies of ondansetron in adults with additional data from 3 open-label, uncontrolled, non-us trials in 182 pediatric patients aged 4 to 18 years with cancer who were given a variety of cisplatin or noncisplatin regimens [see dosage and administration ( 2.2), clinical studies ( 14.1)]. additional information on the use of ondansetron in pediatric patients may be found in ondansetron injection prescribing information. the safety and effectiveness of orally administered ondansetron have not been established in pediatric patients for: • prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy • prevention of nausea and vomiting associated with radiotherapy • prevention of postoperative nausea and/or vomiting 8.5 geriatric use of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting in us-and foreign-controlled clinical trials, for which there were subgroup analyses, 938 (19%) were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years of age and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology ( 12.3)]. there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. no dosage adjustment is needed in elderly patients. 8.6 hepatic impairment no dosage adjustment is needed in patients with mild or moderate hepatic impairment. in patients with severe hepatic impairment, clearance is reduced and the apparent volume of distribution is increased, resulting in a significant increase in the half-life of ondansetron. therefore, do not exceed a total daily dose of 8 mg in patients with severe hepatic impairment (child-pugh score of 10 or greater) [see dosage and administration ( 2.2), clinical pharmacology ( 12.3)]. 8.7 renal impairment no dosage adjustment is recommended for patients with any degree of renal impairment (mild, moderate, or severe). there is no experience beyond first-day administration of ondansetron [see clinical pharmacology ( 12.3)]. animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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

fresenius kabi usa, llc - gadoterate meglumine (unii: l0nd3981ag) (gadolinium cation (3+) - unii:azv954tz9n) - gadoterate meglumine injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (mri) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (bbb) and/or abnormal vascularity. history of clinically important hypersensitivity reactions to gadoterate meglumine injection [see warnings and precautions (5.2)] . risk summary gbcas cross the human placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data) . in animal reproduction studies, there were no adverse developmental effects observed in rats or rabbits with intravenous administration of gadoterate meglumine during organogenesis at doses up to 16 and 10 times, respectively, the recommended human dose (see data) . because of the potential risks of gadolinium to the fetus, use gadoterate meglumine injection only if imaging is essential during pregnancy and cannot be delayed. the estimated background risk of major birth defects and miscarriage for the indicated population(s) are 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 contrast enhancement is visualized in the placenta and fetal tissues after maternal gbca administration. cohort studies and case reports on exposure to gbcas during pregnancy have not reported a clear association between gbcas and adverse effects in the exposed neonates. however, a retrospective cohort study, comparing pregnant women who had a gbca mri to pregnant women who did not have an mri, reported a higher occurrence of stillbirths and neonatal deaths in the group receiving gbca mri. limitations of this study include a lack of comparison with non-contrast mri and lack of information about the material indication for mri. overall, these data preclude a reliable evaluation of the potential risk of adverse fetal outcomes with the use of gbcas in pregnancy. animal data gadolinium retention gbcas administered to pregnant non-human primates (0.1 mmol/kg on gestational days 85 and 135) result in measurable gadolinium concentration in the offspring in bone, brain, skin, liver, kidney, and spleen for at least 7 months. gbcas administered to pregnant mice (2 mmol/kg daily on gestational days 16 through 19) result in measurable gadolinium concentrations in the pups in bone, brain, kidney, liver, blood, muscle, and spleen at one month postnatal age. reproductive toxicology gadoterate meglumine was administered in intravenous doses of 0, 2, 4 and 10 mmol/kg/day [3, 7 and 16 times the recommended human dose (rhd) based on body surface area (bsa)] to female rats for 14 days before mating, throughout the mating period and until gestation day (gd) 17. pregnant rabbits were administered gadoterate meglumine in intravenous doses of 0, 1, 3 and 7 mmol/kg/day ( 3, 10 and 23 times the rhd based on bsa) from gd6 to gd19. no effects on embryo-fetal development were observed at doses up to 10 mmol/kg/day in rats and 3 mmol/kg/day in rabbits. maternal toxicity was observed in rats at 10 mmol/kg/day and in rabbits at 7 mmol/kg/day. this maternal toxicity was characterized in rats by a slightly lower litter size and gravid uterus weight compared to the control group, and in rabbits by a reduction in body weight and food consumption. risk summary there are no data on the presence of gadoterate in human milk, the effects on the breastfed infant, or the effects on milk production. however, published lactation data on other gbcas indicate that 0.01 to 0.04% of the maternal gadolinium dose is present in breast milk. additionally, there is limited gbca gastrointestinal absorption in the breast-fed infant. gadoterate is present in goat milk (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for gadoterate meglumine injection and any potential adverse effects on the breastfed infant from gadoterate meglumine injection or from the underlying maternal condition. data nonclinical data demonstrate that gadoterate is detected in goat milk in amounts less than 0.1% of the dose intravenously administered. furthermore, in rats, absorption of gadoterate via the gastrointestinal tract is poor (1.2% of the administered dose was absorbed and eliminated in urine). the safety and efficacy of gadoterate meglumine at a single dose of 0.1 mmol/kg have been established in pediatric patients from birth (term neonates ≥ 37 weeks gestational age) to 17 years of age based on clinical data in 133 pediatric patients 2 years of age and older, and clinical data in 52 pediatric patients birth to less than 2 years of age that supported extrapolation from adult data [see clinical studies (14)] . adverse reactions in pediatric patients were similar to those reported in adults [see adverse reactions (6.1)] . no dosage adjustment according to age is necessary in pediatric patients [see dosage and administration (2.1), pharmacokinetics (12.3)] . the safety of gadoterate meglumine has not been established in preterm neonates. no cases of nsf associated with gadoterate meglumine or any other gbca have been identified in pediatric patients age 6 years and younger [see warnings and precautions (5.1)] . normal estimated gfr (egfr) is approximately 30 ml/minute/1.73m2 at birth and increases to adult values by 2 years of age. juvenile animal data single and repeat-dose toxicity studies in neonatal and juvenile rats did not reveal findings suggestive of a specific risk for use in pediatric patients including term neonates and infants. in clinical studies of gadoterate meglumine, 900 patients were 65 years of age and over, and 304 patients were 75 years of age and over. no overall differences in safety or efficacy were observed between these subjects and younger subjects. in general, use of gadoterate meglumine injection in elderly patients should be cautious, reflecting the greater frequency of impaired renal function and concomitant disease or other drug therapy. no age-related dosage adjustment is necessary. no gadoterate meglumine injection dosage adjustment is recommended for patients with renal impairment. gadoterate can be removed from the body by hemodialysis [see warnings and precautions (5.1) and clinical pharmacology (12.3) ].

Canada - English - Health Canada

veritiv canada inc - octyl decyl dimethyl ammonium chloride; dioctyl dimethyl ammonium chloride; didecyl dimethyl ammonium chloride; benzalkonium chloride - solution - 3.255%; 1.628%; 1.628%; 4.339% - octyl decyl dimethyl ammonium chloride 3.255%; dioctyl dimethyl ammonium chloride 1.628%; didecyl dimethyl ammonium chloride 1.628%; benzalkonium chloride 4.339% - disinfectants (for agents used on object)