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pfizer laboratories div pfizer inc - taliglucerase alfa (unii: 0r4nlx88o4) (taliglucerase alfa - unii:0r4nlx88o4) - taliglucerase alfa 200 u in 5 ml - elelyso is indicated for the treatment of patients 4 years of age and older with a confirmed diagnosis of type 1 gaucher disease. none. risk summary the limited available data on elelyso use in pregnant women are not sufficient to inform a drug-associated risk. however, there are clinical considerations [see clinical considerations] . in animal reproduction studies when pregnant rats and rabbits were administered taliglucerase alfa at intravenous doses up to 5 times the recommended human dose (rhd), there was no evidence of embryo-fetal toxicity [see data] . the estimated background risk of major birth defects and miscarriage for the indicated population(s) are 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. clinical considerations disease-associated maternal and/or embryo/fetal risk women with type 1 gaucher disease have an increased risk of spontaneous abortion if diseas

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pfizer inc. - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - kit - 1 mg - exubera is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. exubera has an onset of action similar to rapid-acting insulin analogs and has a duration of glucose-lowering activity comparable to subcutaneously administered regular human insulin. in patients with type 1 diabetes, exubera should be used in regimens that include a longer-acting insulin. in patients with type 2 diabetes, exubera can be used as monotherapy or in combination with oral agents or longer-acting insulins. exubera is contraindicated in patients hypersensitive to exubera or one of its excipients. exubera is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting exubera therapy. if a patient starts or resumes smoking, exubera must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see clinical pharmacology, special populations, smoking). the safety and efficacy of exube

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pfizer laboratories div pfizer inc - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate 4 mg - toviaz is indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. toviaz is indicated for the treatment of neurogenic detrusor overactivity (ndo) in pediatric patients 6 years of age and older with a body weight greater than 25 kg. toviaz is contraindicated in patients with any of the following: risk summary there are no available data with the use of toviaz in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times respectively the maximum recommended human dose (mrhd) of 8 mg/day, based on auc (see data) . the background risk of major birth defects and miscarriage for the indicated population are unknown. however, 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. data animal data no dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. in mice at 6 to 27 times the expected exposure at the maximum recommended human dose (mrhd) of 8 mg based on auc (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. one fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. in rabbits treated at 3 to 11 times the mrhd (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. in rabbits at 9 to 11 times the mrhd (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). in rabbits at 3 times the mrhd (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. no effects were noted on mating and reproduction of the f1 dams or on the f2 offspring. risk summary there is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for toviaz and any potential adverse effects on the breastfed child from toviaz or from the underlying maternal condition. the safety and effectiveness of toviaz have been established for the treatment of neurogenic detrusor overactivity (ndo) in pediatric patients aged 6 years and older and weighing greater than 25 kg. the information on this use is discussed throughout labeling. use of toviaz for treatment of ndo is supported by evidence from a randomized, open-label trial with an initial 12-week efficacy phase followed by a 12-week safety extension phase in pediatric patients from 6 years to 17 years of age (study 3) [see adverse reactions (6.1) and clinical studies (14.2)]. study results demonstrated that treatment with toviaz 4 mg and 8 mg daily resulted in improvements from baseline to week 12 in maximum cystometric bladder capacity (mcbc) for patients weighing greater than 25 kg [see clinical studies (14.2) and clinical pharmacology (12.3)] . the most commonly reported adverse reactions in patients who received toviaz 4 mg or 8 mg in study 3 (≥2%) were diarrhea, uti, dry mouth, constipation, abdominal pain, nausea, weight increase and headache [see adverse reactions (6.1)]. mean increases from baseline in heart rate were reported with both the 4 mg and 8 mg daily doses of toviaz, with larger mean increases reported in pediatric patients who received the 8 mg daily dose [see adverse reactions (6.1)]. the safety and effectiveness of toviaz have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less. no dose adjustment is recommended for the elderly. the pharmacokinetics of fesoterodine are not significantly influenced by age. of the 1,567 patients who received toviaz 4 mg or 8 mg orally once daily in phase 2 and 3, placebo-controlled, efficacy and safety studies for oab, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. no overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies. however, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see clinical studies (14.1) and adverse reactions (6)]. in adult patients with severe renal impairment (clcr <30 ml/min), cmax and auc are increased 2.0- and 2.3-fold, respectively. doses of toviaz greater than 4 mg are not recommended in adult patients with severe renal impairment. in patients with mild or moderate renal impairment (clcr ranging from 30–80 ml/min), cmax and auc of the active metabolite are increased up to 1.5- and 1.8-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3) and dosage and administration (2.2, 2.3 )] . the recommended dosage of toviaz in pediatric patients weighing greater than 25 kg and up to 35 kg with mild-to-moderate renal impairment (egfr 30 to 89 ml/min/1.73m2 ) is 4 mg once daily and toviaz is not recommend in those with severe renal impairment (egfr 15 to 29 ml/min/1.73m2 ). in pediatric patients weighing greater than 35 kg with mild-to-moderate renal impairment (egfr 30 to 89 ml/min/1.73m2 ), the recommended starting dosage of toviaz is 4 mg orally once daily, with increase to the recommended dosage of toviaz 8 mg orally once daily, and in those with severe renal impairment (egfr 15 to 29 ml/min/1.73m2 ) the recommended dose is 4 mg once daily [see dosage and administration (2.2, 2.4)] . patients with severe hepatic impairment (child-pugh c) have not been studied; therefore toviaz is not recommended for use in these patients. in patients with moderate (child-pugh b) hepatic impairment, cmax and auc of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3)] .

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pfizer laboratories div pfizer inc - penicillin g benzathine (unii: rit82f58gk) (penicillin g - unii:q42t66vg0c), penicillin g procaine (unii: 17r794esyn) (penicillin g - unii:q42t66vg0c) - penicillin g 600000 [iu] in 2 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of bicillin c-r and other antibacterial drugs, bicillin c-r should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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. this drug is indicated in the treatment of moderately severe infections due to penicillin-g-susceptible microorganisms that are susceptible to serum levels common to this particular dosage form. therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response. bicillin c-r is indicated in the treatment of the following in adults and pediatric patients: moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci. note: streptococci in groups a, c, g, h, l, and m are very sensitive to penicillin g. other groups, including group d (enterococci), are resistant. penicillin g sodium or potassium is recommended for streptococcal infections with bacteremia. moderately severe pneumonia and otitis media due to susceptible streptococcus pneumoniae . note: severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with penicillin g sodium or potassium during the acute stage. when high, sustained serum levels are required, penicillin g sodium or potassium, either im or iv, should be used. this drug should not be used in the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, and pinta. a previous hypersensitivity reaction to any penicillin or to procaine is a contraindication.

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pfizer laboratories div pfizer inc - ramipril (unii: l35jn3i7sj) (ramiprilat - unii:6n5u4qfc3g) - ramipril 1.25 mg - altace 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 mechanisms o

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pfizer laboratories div pfizer inc - diphenoxylate hydrochloride (unii: w24od7yw48) (diphenoxylate - unii:73312p173g), atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - diphenoxylate hydrochloride 2.5 mg - lomotil is indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older. lomotil is contraindicated in: lomotil is classified as a schedule v controlled substance by federal regulation. diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine. in doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction. diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. at high doses it exhibits codeine-like subjective effects. the dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. the insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. a dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tablets, administered to humans for 40 to 70 days, produced opiate withdrawal symptoms. since addiction to diphenoxylate hydrochlo

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pfizer laboratories div pfizer inc - idarubicin hydrochloride (unii: 5vv3mdu5ie) (idarubicin - unii:zrp63d75jw) - idarubicin hydrochloride 1 mg in 1 ml - idamycin pfs injection in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (aml) in adults. this includes french-american-british (fab) classifications m1 through m7.

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pfizer laboratories div pfizer inc - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium anhydrous 25 ug - hypothyroidism levoxyl is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. pituitary thyrotropin (thyroid-stimulating hormone, tsh) suppression levoxyl is indicated in pediatric and adult patients as an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. limitations of use : - levoxyl is not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients as there are no clinical benefits and overtreatment with levoxyl may induce hyperthyroidism [see warnings and precautions (5.4)] . - levoxyl is not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency [see warnings and precautions (5.3)] . risk summary experience with levothyroxine use in pregnant women, including d

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pfizer laboratories div pfizer inc - axitinib (unii: c9lvq0yuxg) (axitinib - unii:c9lvq0yuxg) - axitinib 1 mg - inlyta in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (rcc). inlyta in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced rcc. inlyta as a single agent is indicated for the treatment of advanced rcc after failure of one prior systemic therapy. none. risk summary based on findings in animal studies and its mechanism of action, inlyta can cause fetal harm when administered to a pregnant woman. there are no available human data to inform the drug-associated risk. in developmental toxicity studies, axitinib was teratogenic, embryotoxic and fetotoxic in mice at exposures lower than human exposures at the recommended starting dose (see data) . advise females of reproductive potential of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the united states (u.s.) general population of major birth defects is 2%–4% and of miscarriage is 15%–20% of clinically recognized pregnancies. when inlyta is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for pregnancy information. data animal data oral axitinib administered twice daily to female mice prior to mating and through the first week of pregnancy caused an increase in post-implantation loss at all doses tested (≥15 mg/kg/dose, approximately 10 times the systemic exposure (auc) in patients at the recommended starting dose). in an embryo-fetal developmental toxicity study, pregnant mice received oral doses of 0.15, 0.5 and 1.5 mg/kg/dose axitinib twice daily during the period of organogenesis. embryo-fetal toxicities observed in the absence of maternal toxicity included malformation (cleft palate) at 1.5 mg/kg/dose (approximately 0.5 times the auc in patients at the recommended starting dose) and variation in skeletal ossification at ≥0.5 mg/kg/dose (approximately 0.15 times the auc in patients at the recommended starting dose). risk summary there are no data on the presence of axitinib in human milk, or its effects on the breastfed child or on milk production. because of the potential for serious adverse reactions in a breastfed child from inlyta, advise lactating women not to breastfeed during treatment and for 2 weeks after the last dose. when inlyta is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for lactation information. based on findings in animal studies, inlyta can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. when inlyta is used in combination with avelumab or pembrolizumab, refer to the full prescribing information of avelumab or pembrolizumab for contraception information. pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating treatment with inlyta. contraception females advise females of reproductive potential to use effective contraception during treatment with inlyta and for 1 week after the last dose. males based on findings in animal studies, advise males with female partners of reproductive potential to use effective contraception during treatment and for 1 week after the last dose. infertility females and males based on findings in animals, inlyta may impair fertility in females and males of reproductive potential [see nonclinical toxicology (13.1)] . the safety and efficacy of inlyta in pediatric patients have not been studied. juvenile animal toxicity data toxicities in bone and teeth were observed in immature mice and dogs administered oral axitinib twice daily for 1 month or longer. effects in bone consisted of thickened growth plates in mice and dogs at ≥15 mg/kg/dose (approximately 6 and 15 times, respectively, the systemic exposure (auc) in patients at the recommended starting dose). abnormalities in growing incisor teeth (including dental caries, malocclusions and broken and/or missing teeth) were observed in mice administered oral axitinib twice daily at ≥5 mg/kg/dose (approximately 1.5 times the auc in patients at the recommended starting dose). other toxicities of potential concern to pediatric patients have not been evaluated in juvenile animals. in a controlled clinical study with inlyta for the treatment of patients with rcc, 123/359 patients (34%) treated with inlyta were ≥65 years of age. although greater sensitivity in some older individuals cannot be ruled out, no overall differences were observed in the safety and effectiveness of inlyta between patients who were ≥65 years of age and younger. of the 434 patients randomized to inlyta 5 mg twice daily administered in combination with avelumab 10 mg/kg in the javelin renal 101 trial, 38% were 65 years or older and 8% were 75 years or older. no overall difference in safety or efficacy was reported between patients who were ≥65 years of age and younger. of the 432 patients randomized to inlyta 5 mg twice daily administered in combination with pembrolizumab 200 mg in the keynote-426 trial, 40% were 65 years or older. no overall difference in safety or efficacy was reported between patients who were ≥65 years of age and younger. no dosage adjustment is required in elderly patients [see dosage and administration (2.2), clinical pharmacology (12.3)] . in a dedicated hepatic impairment trial, compared to subjects with normal hepatic function, systemic exposure following a single dose of inlyta was similar in subjects with baseline mild hepatic impairment (child-pugh class a) and higher in subjects with baseline moderate hepatic impairment (child-pugh class b). no starting dose adjustment is required when administering inlyta to patients with mild hepatic impairment (child-pugh class a). a starting dose decrease is recommended when administering inlyta to patients with moderate hepatic impairment (child-pugh class b) [see dosage and administration (2.2), warnings and precautions (5.12), clinical pharmacology (12.3)] . inlyta has not been studied in subjects with severe hepatic impairment (child-pugh class c). no dedicated renal impairment trial for axitinib has been conducted. based on the population pharmacokinetic analyses, no significant difference in axitinib clearance was observed in patients with pre-existing mild to severe renal impairment (15 ml/min ≤creatinine clearance [clcr] <89 ml/min) [see clinical pharmacology (12.3)] . no starting dose adjustment is needed for patients with pre-existing mild to severe renal impairment. caution should be used in patients with end-stage renal disease (clcr <15 ml/min).

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pfizer laboratories div pfizer inc - penicillin g benzathine (unii: rit82f58gk) (penicillin g - unii:q42t66vg0c) - penicillin g 600000 [iu] in 1 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of bicillin l-a and other antibacterial drugs, bicillin l-a should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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. intramuscular penicillin g benzathine is indicated in the treatment of infections due to penicillin-g-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. the following infections will usually respond to adequate dosage of intramuscular penicillin g benzathine: mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci. venereal infections —syphilis, yaws, bejel, and pinta. medical conditions in which penicillin g benzathine therapy is indicated as prophylaxis: rheumatic fever and/or chorea —prophylaxis with penicillin g benzathine has proven effective in preventing recurrence of these conditions. it has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis. a history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.