الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

bausch health us llc - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride 120 mg - cardizem la is indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechani

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

actavis pharma, inc. - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride 120 mg - matzim la (diltiazem hydrochloride) extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety o

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

avera mckennan hospital - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate 2 mg - detrol la capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14) ]. detrol la is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. detrol la is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like detrol la, are metabolized to 5-hydroxymethyl tolterodine [see warnings and precautions (5.2) (5.3), (5.4) ]. pregnancy category c. at approximately 9–12 times the clinical exposure to the pharmacologically active components of detrol® la, no anomalies or malformations were observed in mice (based on the auc of tolterodine and its 5-hmt metabolite at a dose of 20 mg/kg/day). at 14–18 times the exposure (doses of 30 to 40 mg/kg/day) in mice, tolterodine has been shown to be embryolethal and reduce fetal weight, and increase the incidence of fetal abnorma

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

cardinal health - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate 2 mg - detrol la capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14) ]. detrol la is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. detrol la is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like detrol la, are metabolized to 5-hydroxymethyl tolterodine [see warnings and precautions (5.2) (5.3), (5.4) ]. pregnancy category c. at approximately 9–12 times the clinical exposure to the pharmacologically active components of detrol® la, no anomalies or malformations were observed in mice (based on the auc of tolterodine and its 5-hmt metabolite at a dose of 20 mg/kg/day). at 14–18 times the exposure (doses of 30 to 40 mg/kg/day) in mice, tolterodine has been shown to be embryolethal and reduce fetal weight, and increase the incidence of fetal abno

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

pharmacia and upjohn company llc - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate 2 mg - detrol la capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14) ] . detrol la is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. detrol la is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like detrol la, are metabolized to 5-hydroxymethyl tolterodine [see warnings and precautions (5.2) (5.3) , (5.4) ]. risk summary there are no available data with detrol la use in pregnant women to inform drug-associated risks. in animal reproduction studies, oral administration of tolterodine and its 5-hmt metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20 mg/kg/day; however, higher doses produced adverse developmental outcomes (see error! hyperlink reference not valid. ) . in the u.s. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data no anomalies or malformations were observed after oral administration of tolterodine to pregnant mice during organogenesis at approximately 9–12 times the clinical exposure to the pharmacologically active components of detrol la (based on the auc of tolterodine and its 5-hmt metabolite at a dose of 20 mg/kg/day). at 14–18 times the clinical exposure (doses of 30 to 40 mg/kg/day) in mice, tolterodine was embryo-lethal, caused reduced fetal weight, and increased the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra-abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification). pregnant rabbits administered tolterodine subcutaneously at about 0.3–2.5 times the clinical exposure (dose of 0.8 mg/kg/day) did not show any embryotoxicity or teratogenicity. risk summary there is no information on the presence of tolterodine or its 5-hmt metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. based on limited data, tolterodine is excreted into the milk in mice in low amounts (see data) . the development and health benefits of breastfeeding should be considered along with the mother's clinical need for detrol la and any potential adverse effects on the breastfed infant from detrol la or from the underlying maternal condition. animal data the use of radiolabeled tolterodine in pregnant mice produced milk: plasma ratios that ranged between 0.0 and 0.7. the effectiveness of detrol la has not been established in pediatric patients. efficacy was not established in two randomized, placebo-controlled, double-blind, 12-week studies that enrolled 710 pediatric patients (486 on detrol la, 224 on placebo) aged 5–10 years with urinary frequency and urge incontinence. the percentage of patients with urinary tract infections was higher in patients treated with detrol la (6.6%) compared to patients who received placebo (4.5%). aggressive, abnormal, and hyperactive behavior and attention disorders occurred in 2.9% of children treated with detrol la compared to 0.9% of children treated with placebo. no overall differences in safety were observed between the older and younger patients treated with tolterodine. in multiple-dose studies in which tolterodine immediate release 4 mg (2 mg bid) was administered, serum concentrations of tolterodine and of 5-hmt were similar in healthy elderly volunteers (aged 64 through 80 years) and healthy young volunteers (aged less than 40 years). in another clinical study, elderly volunteers (aged 71 through 81 years) were given tolterodine immediate release 2 or 4 mg (1 or 2 mg bid). mean serum concentrations of tolterodine and 5-hmt in these elderly volunteers were approximately 20% and 50% higher, respectively, than concentrations reported in young healthy volunteers. however, no overall differences were observed in safety between older and younger patients on tolterodine in the phase 3, 12-week, controlled clinical studies; therefore, no tolterodine dosage adjustment for elderly patients is recommended. renal impairment can significantly alter the disposition of tolterodine immediate release and its metabolites. in a study conducted in patients with creatinine clearance between 10 and 30 ml/min, tolterodine and 5-hmt levels were approximately 2–3 fold higher in patients with renal impairment than in healthy volunteers. exposure levels of other metabolites of tolterodine (e.g., tolterodine acid, n -dealkylated tolterodine acid, n -dealkylated tolterodine, and n -dealkylated hydroxy tolterodine) were significantly higher (10–30 fold) in renally impaired patients as compared to the healthy volunteers. the recommended dose for patients with severe renal impairment (ccr: 10–30 ml/min) is detrol la 2 mg daily. patients with ccr<10 ml/min have not been studied and use of detrol la in this population is not recommended [see dosage and administration (2.2) and warnings and precautions (5.6) ]. detrol la has not been studied in patients with mild to moderate renal impairment [ccr 30–80 ml/min]. liver impairment can significantly alter the disposition of tolterodine immediate release. in a study of tolterodine immediate release conducted in cirrhotic patients (child-pugh class a and b), the elimination half-life of tolterodine immediate release was longer in cirrhotic patients (mean, 7.8 hours) than in healthy, young, and elderly volunteers (mean, 2 to 4 hours). the clearance of orally administered tolterodine immediate release was substantially lower in cirrhotic patients (1.0 ± 1.7 l/h/kg) than in the healthy volunteers (5.7 ± 3.8 l/h/kg). the recommended dose for patients with mild to moderate hepatic impairment (child-pugh class a or b) is detrol la 2 mg once daily. detrol la is not recommended for use in patients with severe hepatic impairment (child-pugh class c) [see dosage and administration (2.2) and warnings and precautions (5.4) ].

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

physicians total care, inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate 2 mg - detrol la capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14) ]. - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma [see warnings and precautions (5.1), (5.3) ] . pregnancy category c. at approximately 9–12 times the clinical exposure to the pharmacologically active components of detrol® la, no anomalies or malformations were observed in mice (based on the auc of tolterodine and its 5-hmt metabolite at a dose of 20 mg/kg/day). at 14–18 times the exposure (doses of 30 to 40 mg/kg/day) in mice, tolterodine has been shown to be embryolethal and reduce fetal weight, and increase the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra-abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification). pregnant rabbits treated subcutaneously at about 0.3 – 2.5 times the clinical exposure (dose of 0.8 mg/kg/day) did not show any

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate 4 mg - detrol la capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14) ] . detrol la is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. detrol la is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like detrol la, are metabolized to 5-hydroxymethyl tolterodine [see warnings and precautions (5.2) (5.3) , (5.4) ]. risk summary there are no available data with detrol la use in pregnant women to inform drug-associated risks. in animal reproduction studies, oral administration of tolterodine and its 5-hmt metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

l'oreal usa products inc - titanium dioxide (unii: 15fix9v2jp) (titanium dioxide - unii:15fix9v2jp) - titanium dioxide 106.6 mg in 1 ml - sunscreen - helps prevent sunburn - if  used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun on damaged or broken skin rash occurs

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

l'oreal usa products inc - octinoxate 3%, octisalate 3.5%, octocrylene 4.5%, titanium dioxide 6.2% - sunscreen - helps prevent sunburn - if used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun on damaged or broken skin rash occurs

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

henan lingrui pharmaceutical co ltd - menthol   3% - menthol     external analgesic for the temporary relief of minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains on wounds on irritated or damaged skin if the appearance of this product has changed in excess of 12 hours if you have known hypersensitives to this product otherwise than as directed pregnant taking other medications condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritaion of the skin develops when using for pain of athritis pain persists for more than 10 days redness is present in conditions affecting children under 12 years of age