Združene države Amerike - angleščina - NLM (National Library of Medicine)

rugby laboratories inc. - hypromellose 2910 (3 mpa.s) (unii: 0vut3pmy82) (hypromelloses - unii:3nxw29v3wo) - hypromellose 2910 (3 mpa.s) 4 mg in 1 ml - lubricant - relieves dryness of the eye - prevents further irritation

Združene države Amerike - angleščina - NLM (National Library of Medicine)

padagis israel pharmaceuticals ltd - alogliptin benzoate (unii: een99869sc) (alogliptin - unii:jhc049lo86) - alogliptin 6.25 mg - alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use alogliptin tablet is not recommended for use in patients with type 1 diabetes mellitus. alogliptin tablets is contraindicated in patients with a history of serious hypersensitivity to alogliptin or any of the excipients in alogliptin tablets. reactions such as anaphylaxis, angioedema and severe cutaneous adverse reactions have been reported [see warnings and precautions (5.3), adverse reactions (6.2)] . risk summary limited data with alogliptin in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations]. no adverse developmental effects were observed when alogliptin was administered to pregnant rats and rabbits during organogenesis at exposures 180- and 149-times the 25 mg clinical dose, respectively, based on plasma drug exposure (auc) [see data] . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes mellitus with a hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. poorly controlled diabetes mellitus increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data animal data alogliptin administered to pregnant rabbits and rats during the period of organogenesis did not cause adverse developmental effects at doses of up to 200 mg/kg and 500 mg/kg, or 149 times and 180 times, the 25 mg clinical dose, respectively, based on plasma drug exposure (auc). placental transfer of alogliptin into the fetus was observed following oral dosing to pregnant rats. no adverse developmental outcomes were observed in offspring when alogliptin was administered to pregnant rats during gestation and lactation at doses up to 250 mg/kg (~ 95 times the 25 mg clinical dose, based on auc). risk summary there is no information regarding the presence of alogliptin in human milk, the effects on the breastfed infant, or the effects on milk production. alogliptin is present in rat milk: however, due to species specific differences in lactation physiology, animal lactation data may not reliably predict levels in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for alogliptin tablets and any potential adverse effects on the breastfed infant from alogliptin tablets or from the underlying maternal condition. the safety and effectiveness of alogliptin tablets have not been established in pediatric patients. effectiveness of alogliptin tablets was not demonstrated in a 52 week, randomized, double-blind, placebo-controlled trial (nct02856113) in 151 pediatric patients aged 10 to 17 years with inadequately controlled type 2 diabetes mellitus. of the total number of patients (n=9052) in clinical safety and efficacy trials treated with alogliptin tablets, 2,257 (24.9%) patients were 65 years and older and 386 (4.3%) patients were 75 years and older. no overall differences in safety or effectiveness were observed between patients 65 years and over and younger patients. a total of 602 adult patients with moderate renal impairment (egfr ≥30 and <60 ml/min/1.73 m2 ) and 4 patients with severe renal impairment/end-stage renal disease (egfr <30 ml/min/1.73 m2 or <15 ml/min/1.73 m2 , respectively) at baseline were treated with alogliptin tablets in clinical trials in patients with type 2 diabetes mellitus. in the examine trial of high cv risk type 2 diabetes mellitus patients, 694 patients had moderate renal impairment and 78 patients had severe renal impairment or end-stage renal disease at baseline. the recommended dose is 12.5 mg once daily in patients with moderate renal impairment and 6.25 mg once daily in patients with severe renal impairment, as well as in patients with esrd requiring dialysis. alogliptin tablets may be administered without regard to the timing of the dialysis. no dose adjustments are required in patients with mild to moderate hepatic impairment (child-pugh grade a and b) [see clinical pharmacology (12.3)] . alogliptin tablets have not been studied in patients with severe hepatic impairment (child-pugh grade c). use caution when administering alogliptin tablets to patients with liver disease [see warnings and precautions (5.4)] .

Združene države Amerike - angleščina - NLM (National Library of Medicine)

alcon laboratories, inc. - hypromellose 2910 (4000 mpa.s) (unii: rn3152op35) (hypromellose 2910 (4000 mpa.s) - unii:rn3152op35), dextran 70 (unii: 7sa290yk68) (dextran 70 - unii:7sa290yk68) - hypromellose 2910 (4000 mpa.s) 3 mg in 1 ml - - for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun. - if this solution changes color or becomes cloudy. - if you are sensitive to any ingredient in this product. - you experience eye pain. - you experience changes in vision. - you experience continued redness or irritation of the eye. - the condition worsens or persists for more than 72 hours.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - desloratadine (unii: fvf865388r) (desloratadine - unii:fvf865388r) - desloratadine 5 mg - desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older. desloratadine tablets are contraindicated in patients who are hypersensitive to this medication or to any of its ingredients or to loratadine [see warnings and precautions (5.1) and adverse reactions (6.2)]. risk summary   the limited available data with desloratadine in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. there are no adequate and well-controlled studies in pregnant women. desloratadine given during organogenesis to pregnant rats was not teratogenic at the summed area under the concentration-time curve (auc)-based exposures of desloratadine and its metabolite approximately 320 times that at the recommended human daily oral dose (rhd) of 5 mg/day. desloratadine given during organogenesis to pregnant rabbits was not teratogenic at the auc-based exposures of desloratadine approximately 230 times that at the rhd. desloratadine given to pregnant rats during organogenesis through lactation resulted in reduced body weight and slow righting reflex of f1 pups at the summed auc-based exposures of desloratadine and its metabolite approximately 70 times or greater than that at the rhd [see data] . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. 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 animal data: desloratadine was given orally during organogenesis to pregnant rats at doses of 6, 24 and 48 mg/kg/day (approximately 50, 200 and 320 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). no fetal malformations were present. reduced fetal weights and skeletal variations noted at doses of 24 and 48 mg/kg/day were likely secondary to the maternal toxicities of reduced body weight gain and food consumption observed at the same doses. desloratadine was also given orally during organogenesis to pregnant rabbits at doses of 15, 30 and 60 mg/kg/day (approximately 30, 70 and 230 times the auc- based exposure of desloratadine at the rhd). no adverse effects to the fetus were noted. reduced maternal body weight gain was noted in rabbits at 60 mg/kg/day. in a peri- and post-natal development study, desloratadine was given to rats orally during the peri- natal (gestation day 6) through lactation periods (postpartum day 21) at doses of 3, 9 and 18 mg/kg/day. reduced body weight and slow righting reflex were reported in f1 pups at doses of 9 mg/kg/day or greater (approximately 70 times or greater than the summed auc-based exposure of desloratadine and its metabolite at the rhd). desloratadine had no effect on f1 pup development at 3 mg/kg/day (approximately 10 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). maternal toxicities including reduced body weight gain and food consumption were noted at 18 mg/kg/day for f0 dams. f1 offspring were subsequently mated and there was no developmental toxicity for f2 pups observed. risk summary desloratadine passes into breast milk. there are not sufficient data on the effects of desloratadine on the breastfed infant or the effects of desloratadine on milk production. the decision should be made whether to discontinue nursing or to discontinue desloratadine, taking into account the developmental and health benefits of breastfeeding, the nursing mother's clinical need, and any potential adverse effects on the breastfed infant from desloratadine or from the underlying maternal condition. infertility there are no data available on human infertility associated with desloratadine. there were no clinically relevant effects of desloratadine on female fertility in rats. a male specific decrease in fertility occurred at an oral desloratadine dose of 12 mg/kg or greater in rats (approximately 65 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). male fertility was unaffected at a desloratadine dose of 3 mg/kg (approximately 10 times the summed auc-based exposure of desloratadine and its metabolite at the rhd). [see nonclinical toxicology (13.1).] the recommended dose of desloratadine oral solution in the pediatric population is based on cross-study comparison of the plasma concentration of desloratadine in adults and pediatric subjects. the safety of desloratadine oral solution has been established in 246 pediatric subjects aged 6 months to 11 years in three placebo-controlled clinical studies. since the course of seasonal and perennial allergic rhinitis and the effects of desloratadine are sufficiently similar in the pediatric and adult populations, it allows extrapolation from the adult efficacy data to pediatric patients. the effectiveness of desloratadine oral solution in these age groups is supported by evidence from adequate and well-controlled studies of desloratadine tablets in adults. the safety and effectiveness of desloratadine tablets or desloratadine oral solution have not been demonstrated in pediatric patients less than 6 months of age. [see clinical pharmacology (12.3)]. clinical studies of desloratadine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. [see clinical pharmacology (12.3)]. dosage adjustment for patients with renal impairment is recommended [see dosage and administration (2.5) and clinical pharmacology (12.3)]. dosage adjustment for patients with hepatic impairment is recommended [see dosage and administration (2.5) and clinical pharmacology (12.3)]. there is no information to indicate that abuse or dependency occurs with desloratadine tablets.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

sandoz inc - pilocarpine hydrochloride (unii: 0ww6d218xj) (pilocarpine - unii:01mi4q9di3) - pilocarpine hydrochloride 10 mg in 1 ml - pilocarpine hydrochloride ophthalmic solution is indicated for the: . . . . none. pregnancy. category c. animal reproduction studies have not been conducted with pilocarpine hydrochloride. it is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. pilocarpine hydrochloride ophthalmic solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when pilocarpine hydrochloride ophthalmic solution is administered to a nursing woman. safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

american health packaging - phenytoin (unii: 6158tkw0c5) (phenytoin - unii:6158tkw0c5) - phenytoin 50 mg - phenytoin chewable tablets are indicated for the treatment of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin chewable tablets are contraindicated in patients with: - a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins [see warnings and precautions (5.5)] . reactions have included angioedema. - a history of prior acute hepatotoxicity attributable to phenytoin [see warnings and precautions (5.8)] . - coadministration with delavirdine because of the potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as phenytoin, during pregnancy. physicians are advised to recommend that pregnant patients taking phenytoin enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org/. risk summary in humans, prenatal exposure to phenytoin may increase the risks for congenital malformations and other adverse developmental outcomes. prenatal phenytoin exposure is associated with an increased incidence of major malformations, including orofacial clefts and cardiac defects. in addition, the fetal hydantoin syndrome, a pattern of abnormalities including dysmorphic skull and facial features, nail and digit hypoplasia, growth abnormalities (including microcephaly), and cognitive deficits has been reported among children born to epileptic women who took phenytoin alone or in combination with other antiepileptic drugs during pregnancy [see data] . there have been several reported cases of malignancies, including neuroblastoma, in children whose mothers received phenytoin during pregnancy. administration of phenytoin to pregnant animals resulted in an increased incidence of fetal malformations and other manifestations of developmental toxicity (including embryofetal death, growth impairment, and behavioral abnormalities) in multiple species at clinically relevant doses [see data] . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal risk an increase in seizure frequency may occur during pregnancy because of altered phenytoin pharmacokinetics. periodic measurement of serum phenytoin concentrations may be valuable in the management of pregnant women as a guide to appropriate adjustment of dosage [see dosage and administration (2.4, 2.8)] . however, postpartum restoration of the original dosage will probably be indicated [see clinical pharmacology (12.3)] . fetal/neonatal adverse reactions a potentially life-threatening bleeding disorder related to decreased levels of vitamin k-dependent clotting factors may occur in newborns exposed to phenytoin in utero . this drug-induced condition can be prevented with vitamin k administration to the mother before delivery and to the neonate after birth. data human data meta-analyses using data from published observational studies and registries have estimated an approximately 2.4-fold increased risk for any major malformation in children with prenatal phenytoin exposure compared to controls. an increased risk of heart defects, facial clefts, and digital hypoplasia has been reported. the fetal hydantoin syndrome is a pattern of congenital anomalies including craniofacial anomalies, nail and digital hypoplasia, prenatal-onset growth deficiency, and neurodevelopmental deficiencies. animal data administration of phenytoin to pregnant rats, rabbits, and mice during organogenesis resulted in embryofetal death, fetal malformations, and decreased fetal growth. malformations (including craniofacial, cardiovascular, neural, limb, and digit abnormalities) were observed in rats, rabbits, and mice at doses as low as 100 mg/kg, 75 mg/kg, and 12.5 mg/kg, respectively. risk summary phenytoin is secreted in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for phenytoin and any potential adverse effects on the breastfed infant from phenytoin or from the underlying maternal condition. initially, 5 mg/kg/day in two or three equally divided doses, with subsequent dosage individualized to a maximum of 300 mg daily. a recommended daily maintenance dosage is usually 4 mg/kg to 8 mg/kg. children over 6 years and adolescents may require the minimum adult dosage (300 mg/day) [see dosage and administration (2.3)] . phenytoin clearance tends to decrease with increasing age [see clinical pharmacology (12.3)] . lower or less frequent dosing may be required [see dosage and administration (2.7)] . the liver is the chief site of biotransformation of phenytoin; patients with impaired liver function, elderly patients, or those who are gravely ill may show early signs of toxicity. because the fraction of unbound phenytoin is increased in patients with renal or hepatic disease, or in those with hypoalbuminemia, the monitoring of phenytoin serum levels should be based on the unbound fraction in those patients. patients who are intermediate or poor metabolizers of cyp2c9 substrates (e.g., *1/*3, *2/*2, *3/*3) may exhibit increased phenytoin serum concentrations compared to patients who are normal metabolizers (e.g., *1/*1). thus, patients who are known to be intermediate or poor metabolizers may ultimately require lower doses of phenytoin to maintain similar steady-state concentrations compared to normal metabolizers. if early signs of dose-related central nervous system (cns) toxicity develop, serum concentrations should be checked immediately [see clinical pharmacology (12.5)].

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - moclobemide, quantity: 150 mg - tablet, film coated - excipient ingredients: magnesium stearate; povidone; purified talc; titanium dioxide; sodium starch glycollate; hypromellose; iron oxide yellow; lactose monohydrate; macrogol 6000; maize starch; purified water; ethylcellulose; cetyl alcohol; hydrogen peroxide; sodium lauryl sulfate; octamethylcyclotetrasiloxane; silica dimethicone silylate; dimeticone 5000; cyclomethicone - treatment of major depression.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

alcon laboratories, inc. - pilocarpine hydrochloride (unii: 0ww6d218xj) (pilocarpine - unii:01mi4q9di3) - pilocarpine hydrochloride 10 mg in 1 ml - isopto® carpine is indicated for the:         none. pregnancy. category c. animal reproduction studies have not been conducted with pilocarpine hydrochloride. it is also not known whether pilocarpine hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. isopto® carpine should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when isopto® carpine is administered to a nursing woman. safety and effectiveness of pilocarpine hydrochloride ophthalmic solution in pediatric patients have been established. no overall differences in safety or effectiveness have been observed between elderly and younger patients.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

navajo manufacturing company inc. - ranitidine hydrochloride (unii: bk76465ihm) (ranitidine - unii:884kt10yb7) - ranitidine 150 mg - • relieves heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain foods and beverages

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - carbidopa monohydrate, quantity: 40.5 mg (equivalent: carbidopa, qty 37.5 mg); entacapone, quantity: 200 mg; levodopa, quantity: 150 mg - tablet, film coated - excipient ingredients: iron oxide yellow; croscarmellose sodium; povidone; magnesium stearate; polysorbate 80; glycerol; sucrose; iron oxide red; hypromellose; mannitol; titanium dioxide; maize starch - l.c.e. sandoz 150/37.5/200 is indicated for the management of patients with parkinson's disease who are experiencing motor fluctuations.