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vitruvias therapeutics - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib is 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: pregnancy category c. pregnancy category d from 30 weeks of gestation onward . risk summary use of nsaids, including celecoxib, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. a

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vitruvias therapeutics - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [seeclinical studies(14.1) ]. bupropion hydrochloride extended-release tablets (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in ad

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vitruvias therapeutics - aminocaproic acid (unii: u6f3787206) (aminocaproic acid - unii:u6f3787206) - aminocaproic acid tablets is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. in life-threatening situations, transfusion of appropriate blood products and other emergency measures may be required. fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as amegakaryocytic thrombocytopenia (accompanying aplastic anemia); acute and life-threatening abruptio placentae; hepatic cirrhosis; and neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix. urinary fibrinolysis, usually a normal physiological phenomenon, may contribute to excessive urinary tract fibrinolytic bleeding associated with surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (see warnings .) aminocaproic acid tablets should not be used when there is

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vitruvias therapeutics - cyanocobalamin (unii: p6yc3eg204) (cyanocobalamin - unii:p6yc3eg204) - cyanocobalamin is indicated for vitamin b12 deficiencies due to malabsorption which may be associated with the following conditions: - addisonian (pernicious) anemia - gastrointestinal pathology, dysfunction, or surgery, including gluten enteropathy or sprue, small bowel bacteria overgrowth, total or partial gastrectomy - fish tapeworm infestation - malignancy of pancreas or bowel - folic acid deficiency it may be possible to treat the underlying disease by surgical correction of anatomic lesions leading to small bowel bacterial overgrowth, expulsion of fish tapeworm, discontinuation of drugs leading to vitamin malabsorption (see drug interactions), use of a gluten-free diet in nontropical sprue, or administration of antibiotics in tropical sprue. such measures remove the need for long-term administration of cyanocobalamin. requirements of vitamin b12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with oral supplementation. cyanocobalamin injection, usp is also suitable for the vitamin b12 absorption test (schilling test). sensitivity to cobalt and/or vitamin b12 is a contraindication.

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vitruvias therapeutics - lidocaine (unii: 98pi200987) (lidocaine - unii:98pi200987) - lidocaine ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. it is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of lidocaine ointment 5%.

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vitruvias therapeutics - hydrocortisone acetate (unii: 3x7931po74) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone acetate suppositories are indicated for use in inflamed hemorrhoids, post–irradiation (factitial) proctitis, as an adjunct in the treatment of chronic ulcerative colitis, cryptitis, other inflammatory conditions of the anorectum, and pruritus ani. drug abuse and dependence has not been reported in patients treated with hydrocortisone acetate suppositories.

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vitruvias therapeutics - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. potassium chloride is contraindicated in patients on triamterene or amiloride. risk summary there are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary the normal potassium ion content of human milk

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vitruvias therapeutics, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride extended-release capsules is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride extended-release capsules is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk  summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride extended-release capsules in pregnant women.  adverse developmental effects (decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride extended-release capsules [see  data]. 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal  data oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats during the period of organogenesis resulted in decreased skeletal ossification in fetuses at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg) is 2 times the maximum recommended human daily dose (mrhd) of memantine hydrochloride extended-release capsules (28 mg) on a body surface area (mg/m2 ) basis. oral administration of memantine to rabbits (0, 3, 10, or 30 mg/kg/day) during the period of organogenesis resulted in no adverse developmental effects. the highest dose tested is approximately 20 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m2  basis. in rats, memantine (0, 2, 6, or 18 mg/kg/day) was administered orally prior to and throughout mating and, in females, through the period of organogenesis or continuing throughout lactation to weaning. decreased skeletal ossification in fetuses and decreased body weight in pups were observed at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg/day) is 2 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m2  basis. oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats from late gestation throughout lactation to weaning, resulted in decreased pup weights at the highest dose tested. the higher no-effect dose (6 mg/kg/day) is approximately 2 times the mrhd of memantine hydrochloride extended-release capsules on a mg/m2  basis. risk  summary there are no data on the presence of memantine in human milk, the effects on the breastfed infant, or the effects of memantine hydrochloride extended-release capsules on milk production.   the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for memantine hydrochloride extended-release capsules and any potential adverse effects on the breastfed infant from memantine hydrochloride extended-release capsules or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6-12 years with autism spectrum disorders (asd), including autism, asperger's disorder and pervasive development disorder - not otherwise specified (pdd-nos).memantine has not been studied in pediatric patients under 6 years of age or over 12 years of age. memantine treatment was initiated at 3 mg/day and the dose was escalated to the target dose (weight-based) by week 6. oral doses of memantine 3, 6, 9, or 15 mg extended-release capsules were administered once daily to patients with weights < 20 kg, 20-39 kg, 40-59 kg and ≥ 60 kg, respectively. in a randomized, 12-week double-blind, placebo-controlled parallel study (study a) in patients with autism, there was no statistically significant difference in the social responsiveness scale (srs) total raw score between patients randomized to memantine (n=54) and those randomized to placebo (n=53). in a 12-week responder-enriched randomized withdrawal study (study b) in 471 patients with asd, there was no statistically significant difference in the loss of therapeutic response rates between patients randomized to remain on full-dose memantine (n=153) and those randomized to switch to placebo (n=158). the overall safety profile of memantine in pediatric patients was generally consistent with the known safety profile in adults [see adverse reactions ( 6.1 )] . in study a, the adverse reactions in the memantine group (n=56) that were reported in at least 5% of patients and at least twice the frequency of the placebo group (n=58) are listed in table 2. the adverse reactions that were reported in at least 5% of patients in the 12-48 week open-label study to identify responders to enroll in study b are listed in table 3. in the randomized withdrawal study (study b), the adverse reaction in patients randomized to placebo (n=160) and reported in at least 5% of patients and twice that of the full-dose memantine treatment group (n=157) was irritability (5.0% vs 2.5%). juvenile animal study in a juvenile animal study, male and female juvenile rats were administered memantine (15, 30, and 45 mg/kg/day) starting on postnatal day (pnd) 14 through pnd 70. body weights were reduced at 45 mg/kg/day. delays in sexual maturation were noted in male and female rats at doses ≥ 30 mg/kg/day. memantine induced neuronal lesions in several areas of the brain on pnd 15 and 17 at doses ≥ 30 mg/kg/day. behavioral toxicity (decrease percent of auditory startle habituation) was noted for animals in the 45 mg/kg/day dose group. the 15 mg/kg/day dose was considered the no-observed-adverse-effect-level (noael) for this study. in a second juvenile rat toxicity study, male and female juvenile rats were administered memantine (1, 3, 8, 15, 30, and 45 mg/kg/day) starting on postnatal day (pnd) 7 through pnd 70.  due to early memantine-related mortality, the 30 and 45 mg/kg/day dose groups were terminated without further evaluation. memantine induced apoptosis or neuronal degeneration in several areas of the brain on pnd 8, 10, and 17 at a dose of 15 mg/kg/day. the noael for apoptosis and neuronal degeneration was 8 mg/kg/day. behavioral toxicity (effects on motor activity, auditory startle habituation, and learning and memory) was noted at doses ≥ 3 mg/kg/day during treatment, but was not seen after drug discontinuation. therefore, the 1 mg/kg/day dose was considered the noael for the neurobehavioral effect in this study. the majority of people with alzheimer's disease are 65 years of age and older. in the clinical study of memantine hydrochloride extended-release, the mean age of patients was approximately 77 years; over 91% of patients were 65 years and older, 67% were 75 years and older, and 14% were at or above 85 years of age. the efficacy and safety data presented in the clinical trial sections were obtained from these patients. there were no clinically meaningful differences in most adverse reactions reported by patient groups ≥ 65 years old and < 65 years old. no dosage adjustment is needed in patients with mild or moderate renal impairment. a dosage reduction is recommended in patients with severe renal impairment [see dosage and administration ( 2.3 ) and clinical pharmacology ( 12.3 )] . no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride extended-release capsules was not studied in patients with severe hepatic impairment [see clinical pharmacology ( 12.3 )] .

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vitruvias therapeutics - propafenone hydrochloride (unii: 33xch0hocd) (propafenone - unii:68iqx3t69u) - propafenone hydrochloride extended-release capsules is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (af) in patients with episodic (most likely paroxysmal or persistent) af who do not have structural heart disease. usage considerations: - the use of propafenone hydrochloride extended-release capsules in patients with permanent af or in patients exclusively with atrial flutter or paroxysmal supraventricular tachycardia (psvt) has not been evaluated. do not use propafenone hydrochloride extended-release capsules to control ventricular rate during af. - some patients with atrial flutter treated with propafenone have developed 1:1 conduction, producing an increase in ventricular rate. concomitant treatment with drugs that increase the functional atrioventricular (av) nodal refractory period is recommended. - the effect of propafenone on mortality has not been determined [see boxed warning] . propafenone hydrochloride extended-release capsules is contraindicated in the following c

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vitruvias therapeutics - sevelamer carbonate (unii: 9ycx42i8iu) (sevelamer - unii:941n5duu5c) - sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (ckd) on dialysis. sevelamer carbonate tablets are contraindicated in patients with bowel obstruction. sevelamer carbonate tablets are contraindicated in patients with known hypersensitivity to sevelamer carbonate, sevelamer hydrochloride, or to any of the excipients. risk summary sevelamer carbonate is not absorbed systemically following oral administration and maternal use is not expected to result in fetal exposure to the drug. clinical considerations sevelamer carbonate may decrease serum levels of fat soluble vitamins and folic acid in pregnant women [see clinical pharmacology (12.2)] . consider supplementation. data animal data in pregnant rats given dietary doses of 0.5, 1.5 or 4.5 g/kg/day of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin d, o