USA - engelsk - NLM (National Library of Medicine)

qpharma inc - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 20 mg - citalopram tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)] . citalopram tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois (including maois such as linezolid or intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.3), drug interactions (7)] . - taking pimozide because of risk of qt prolongation [see drug interactions (7)] . - with known hypersensitivity to citalopram or any of the inactive ingredients in citalopram tablets. reactions have included angioedema and anaphylaxis [see adverse reactions (6.2)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. h

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qpharma inc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 500 mg - carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation) . naproxen as naproxen tablets are indicated: naproxen tablets are contraindicated in the following patients:

USA - engelsk - NLM (National Library of Medicine)

qpharma inc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 75 mg - venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: -   major depressive disorder (mdd)  [see clinical studies ( 14.1)] - generalized anxiety disorder (gad) [see clinical studies ( 14.2)] -   social anxiety disorder (sad) [see clinical studies ( 14.3)] -   panic disorder (pd) [see clinical studies ( 14.4)] venlafaxine hydrochloride extended-release capsules are contraindicated in patients: - with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see adverse reactions ( 6.2)]. - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see dosage and administration ( 2.11), warnings and precautions ( 5.2), and drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including venlafaxine hydrochloride extended-release capsules, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ . risk summary available data from published epidemiologic studies on venlafaxine use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse fetal outcomes (see data). available data from observational studies with venlafaxine have identified a potential increased risk for preeclampsia when used during mid to late pregnancy; exposure to snris near delivery may increase the risk for postpartum hemorrhage (see clinical considerations). there are risks associated with untreated depression in pregnancy and poor neonatal adaptation in newborns with exposure to snris, including venlafaxine hydrochloride extended-release capsules, during pregnancy (see clinical considerations). in animal studies, there was no evidence of malformations or fetotoxicity following administration of venlafaxine during organogenesis at doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m 2 basis. postnatal mortality and decreased pup weights were observed following venlafaxine administration to pregnant rats during gestation and lactation at 2.5 times (mg/m 2 ) the maximum human daily dose. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the 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 women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depression who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. maternal adverse reactions exposure to venlafaxine in mid to late pregnancy may increase the risk for preeclampsia, and exposure to snris near delivery may increase the risk for postpartum hemorrhage. fetal/neonatal adverse reactions neonates exposed to snris late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremors, jitteriness, irritability, and constant crying. these findings are consistent with either a direct toxic effect of snris or possibly a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome  [see warnings and precautions ( 5.2)] . monitor neonates who were exposed to venlafaxine hydrochloride extended-release capsules in the third trimester of pregnancy for drug discontinuation syndrome (see data). data human data published epidemiological studies of pregnant women exposed to venlafaxine have not established an increased risk of major birth defects, miscarriage or other adverse developmental outcomes. methodological limitations may both fail to identify true findings and also identify findings that are not true. retrospective cohort studies based on claims data have shown an association between venlafaxine use and preeclampsia, compared to depressed women who did not take an antidepressant during pregnancy. one study that assessed venlafaxine exposure in the second trimester or first half of the third trimester and preeclampsia showed an increased risk compared to unexposed depressed women (adjusted [adj] rr 1.57, 95% confidence interval [ci] 1.29 to 1.91). preeclampsia was observed at venlafaxine doses equal to or greater than 75 mg per day and a duration of treatment >30 days. another study that assessed venlafaxine exposure in gestational weeks 10 to 20 and preeclampsia showed an increased risk at doses equal to or greater than 150 mg per day. available data are limited by possible outcome misclassification and possible confounding due to depression severity and other confounders. retrospective cohort studies based on claims data have suggested an association between venlafaxine use near the time of delivery or through delivery and postpartum hemorrhage. one study showed an increased risk for postpartum hemorrhage when venlafaxine exposure occurred through delivery, compared to unexposed depressed women (adj rr 2.24 [95% ci 1.69 to 2.97]). there was no increased risk in women who were exposed to venlafaxine earlier in pregnancy. limitations of this study include possible confounding due to depression severity and other confounders. another study showed an increased risk for postpartum hemorrhage when snri exposure occurred for at least 15 days in the last month of pregnancy or through delivery, compared to unexposed women (adj rr 1.64 to 1.76). the results of this study may be confounded by the effects of depression. animal data venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m 2 basis. however, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. the cause of these deaths is not known. these effects occurred at 2.5 times (mg/m 2 ) the maximum human daily dose. the no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m 2 basis. when desvenlafaxine succinate, the major metabolite of venlafaxine, was administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 300 mg/kg/day and 75 mg/kg/day, respectively, no fetal malformations were observed. these doses were associated with a plasma exposure (auc) 19 times (rats) and 0.5 times (rabbits) the auc exposure at an adult human dose of 100 mg per day. however, fetal weights were decreased and skeletal ossification was delayed in rats in association with maternal toxicity at the highest dose, with an auc exposure at the no-effect dose that is 4.5-times the auc exposure at an adult human dose of 100 mg per day. risk summary data from published literature report the presence of venlafaxine and its active metabolite in human milk and have not shown adverse reactions in breastfed infants (see data) . there are no data on the effects of venlafaxine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for venlafaxine hydrochloride extended-release capsules and any potential adverse effects on the breastfed child from venlafaxine hydrochloride extended-release capsules or from the underlying maternal condition. data in a lactation study conducted in 11 breastfeeding women (at a mean of 20.1 months post-partum) who were taking a mean daily dose of 194.3 mg of venlafaxine and in a lactation study conducted in 6 breastfeeding women who were taking a daily dose of 225 mg to 300 mg of venlafaxine (at a mean of 7 months post-partum), the estimated mean relative infant dose was 8.1 % and 6.4% based on the sum of venlafaxine and its major metabolite, desvenlafaxine. no adverse reactions were seen in the infants. safety and effectiveness of venlafaxine hydrochloride extended-release capsules in pediatric patients have not been established. two placebo-controlled trials in 766 pediatric patients with mdd and two placebo-controlled trials in 793 pediatric patients with gad have been conducted with venlafaxine hydrochloride extended-release capsules, and the data were not sufficient to support use in pediatric patients. in the studies conducted in pediatric patients ages 6 to17 years, the occurrence of blood pressure and cholesterol increases was considered to be clinically relevant in pediatric patients and was similar to that observed in adult patients   [see  warnings and precautions ( 5.3), adverse reactions ( 6.1)] . the following adverse reactions were also observed in pediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis, and myalgia. although no studies have been designed to primarily assess venlafaxine hydrochloride extended-release capsules impact on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine hydrochloride extended-release capsules may adversely affect weight and height  [see warnings and precautions ( 5.10,  5.11)].  decreased appetite and weight loss were observed in placebo-controlled studies of pediatric patients 6 to 17 years.  in pediatric clinical studies, the adverse reaction, suicidal ideation, was observed. antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients  [ see boxed warning,  warnings and precautions ( 5.1)].   the percentage of patients in clinical studies for venlafaxine hydrochloride extended-release capsules for mdd, gad, sad, and pd who were 65 years of age or older are shown in table 16. indication venlafaxine hydrochloride extended-release capsules mdd 4 (14/357) gad 6 (77/1,381) sad 1 (10/819) pd 2 (16/1,001) a in addition, in the premarketing assessment of venlafaxine tablets (immediate release), 12% (357/2,897) of patients were ≥ 65 years of age. no overall differences in effectiveness or safety were observed between geriatric patients and younger patients, and other reported clinical experience generally has not identified differences in response between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out. ssris and snris, including venlafaxine hydrochloride extended-release capsules, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions ( 5.9)] . the pharmacokinetics of venlafaxine and odv are not substantially altered in the elderly [see clinical pharmacology ( 12.3)] (see figure 1). no dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction [see dosage and administration ( 2.8,  2.9)]. dosage adjustment is recommended in patients with mild (child-pugh class a), moderate (child-pugh class b), or severe (child-pugh class c) hepatic impairment or hepatic cirrhosis [see dosage and administration ( 2.8) and clinical pharmacology ( 12.3)] .  dosage adjustment is recommended in patients with mild (clcr= 60 to 89 ml/min), moderate (clcr= 30 to 59 ml/min), or severe (clcr < 30 ml/min) renal impairment, and in patients undergoing hemodialysis  [see dosage and administration ( 2.9) and clinical pharmacology ( 12.3)]. venlafaxine hydrochloride extended-release capsules contain venlafaxine which is not a controlled substance. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. while venlafaxine has not been systematically studied in clinical studies for its potential for abuse, there was no indication of drug-seeking behavior in the clinical studies. however, it is not possible to predict on the basis of premarketing experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, providers should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. in vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (pcp), or n-methyl-d-aspartic acid (nmda) receptors. venlafaxine was not found to have any significant cns stimulant activity in rodents. in primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. discontinuation effects have been reported in patients receiving venlafaxine [see dosage and administration (2.10)  and warnings and precautions (5.7)] .

USA - engelsk - NLM (National Library of Medicine)

qpharma, inc. - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis - tendonitis - bursitis - acute gout the management of: - pain - primary dysmenorrhea naproxen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see warnings and precautions (5.7, 5.9)] - 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 and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1)] r isk summary use of nsaids, including naproxen, can cause premature closure of the fetal ductus arteriosus and f

USA - engelsk - NLM (National Library of Medicine)

qpharma inc - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib capsules are indicated for the management of the signs and symptoms of oa [ see clinical studies ( 14.1) ] for the management of the signs and symptoms of ra [ see clinical studies ( 14.2) ] for the management of the signs and symptoms of jra in patients 2 years and older [ see clinical studies ( 14.3) ] for the management of the signs and symptoms of as [ see clinical studies ( 14.4) ] for the management of acute pain in adults [ see clinical studies ( 14.5) ] for the management of primary dysmenorrhea [ see clinical studies ( 14.5) ] celecoxib is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [

USA - engelsk - NLM (National Library of Medicine)

qpharma inc - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [ see dosage and administration ( 2.4) and clinical studies ( 14.2) ]. meloxicam tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reac

USA - engelsk - NLM (National Library of Medicine)

qpharma inc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation) . naproxen as naproxen tablets are indicated: naproxen tablets are contraindicated in the following patients:

USA - engelsk - NLM (National Library of Medicine)

qpharma inc - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin tablets are 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, methicillin­susceptible staphylococcus aureus, methicillin-susceptible staphylococcus epidermidis, or streptococcus pyogenes. ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by enterobacter cloacae, serratia marcescens, or pseudomonas aeruginosa. ciprofloxacin tablets are 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 tablets are 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 tablets are 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 tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to neisseria gonorrhoeae [see warnings and precautions (5.17) ]. ciprofloxacin tablets are 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 [ s ee clinical studies (14.2) ] . ciprofloxacin tablets are 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 tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused by  esc h er i ch i a co l i   or  p ro t eus   m i ra b i l i s. ciprofloxacin tablets are indicated in adult patients for treatment of lower respiratory tract infections caused by esche r i c h i a   co l i , kl eb s i e l l a   pneu m o n i ae, e n t e roba c t er   c l oa c ae, p r o t e us   mi ra b i l i s,   pseudo m on a s aeru g i nos a , h ae m op h il u s   i n fl u enz a e, h ae m op h i l us   p a ra i n fl u enz a e, or  s t re p t oc oc cus   p n eu m on i a e. ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed pneumonia secondary to s t re p t o c occ u s   pn e u m on i a e. ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis (aecb) caused by m or a xe l l a   ca t a rrh a l i s. because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions  [see w arn i ngs   and p r eca u t i ons ( 5.1 to 5.16 ) ]   and for some patients aecb is self-limiting, reserve ciprofloxacin tablets for treatment of aecb in patients who have no alternative treatment options . u r i na r y   tr a ct   i n f ec t i o n s i n   adu l t s ciprofloxacin tablets are indicated in adult patients for treatment of urinary tract infections caused by  esche r i c h i a c o l i , k l eb s i e ll a p neu m o n i ae , e n t eroba c t e r   c l oac a e , s e rr a ti a   m arce s cen s , pr o t eus   m i r a b i l i s , p ro v i de n c i a re t t ge r i ,  m or g an e ll a m o rg a n ii , c i t roba c t e r   ko s e r i , ci t r obac t er   f re u nd i i , p s eudo m o nas   a e rug i nosa , methicillin-susceptible  s t a p hy l o c occ u s   e p i d e r m i d i s , s t aphy l o co c cus   s apro p hy t i c u s , or  e n t e roco c cus f aec a l i s . acu t e   u n co m p l i c a t ed c ys ti ti s ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis caused by esche r i c h i a   co l i   or  s t a ph y l ococc u s   sa p rop h y t i cu s . because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions  [ see wa r n i n g s   and p r e ca u ti o n s  ( 5.1 to 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. c o m p li c a t e d u r i n ary   t ra c t   i n f ec t i on a nd p y e l o n eph r i t i s   i n pe d i a t r i c   pa t i e n t s ciprofloxacin tablets are indicated in pediatric patients aged one to 17 years of age for treatment of complicated urinary tract infections (cuti) and pyelonephritis due to  e s ch e r i c h i a c o l i [ s ee   u s e i n   spe c i f i c  pop u l a ti o ns   (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 w arn i ngs and p rec a u t i ons (5.13) , adverse rea c t i ons   (6.1) , u se i n s pe c i f i c   p o pu l a ti o ns   (8.4)  and n on c l i n i c a l to x i c o l ogy   (13.2) ] . ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by  h a e m oph i l us   i n f l ue n zae, s t re p t o c occ u s   pn e u m on i a e,   or  m ora x e l l a c a t a rrh a l i s. because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions ( 5.1 to 5.16)] and for some patients acute sinusitis is self-limiting, reserve ciprofloxacin tablets 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 tablets and other antibacterial drugs, ciprofloxacin tablets 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 tablets 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 tablets are 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 pregnancies have 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 maternal or 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 and 68% 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% for the control group (background incidence of major malformations is 1% to 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 ciprofloxacin exposed 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 to 17) were not associated with adverse developmental outcomes, including embryo-fetal 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 embryo-fetal 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 embryo-fetal 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 surface area. 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 species tested 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 [ s ee 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 (post­exposure). 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 [ s ee 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 [ s ee 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 3,500 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 [ s ee 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) [ s ee 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 [ s ee 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.

USA - engelsk - NLM (National Library of Medicine)

qpharma inc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation) . naproxen as naproxen tablets are indicated: naproxen tablets are contraindicated in the following patients:

USA - engelsk - NLM (National Library of Medicine)

qpharma inc - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam tablets are indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. meloxicam tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients who weigh ≥60 kg [ see dosage and administration ( 2.4) and clinical studies ( 14.2) ]. meloxicam tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reac