United States - English - NLM (National Library of Medicine)

bryant ranch prepack - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride tablets, usp are indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride tablets are 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 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 [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 3 times the maximum recommended human daily dose (mrhd) of memantine (20 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 30 times the mrhd of memantine 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 3 times the mrhd of memantine 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 3 times the mrhd of memantine 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 on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for memantine and any potential adverse effects on the breastfed infant from memantine 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 risk profile of memantine in pediatric patients was generally consistent with the known risk 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 at twice the frequency of the full-dose memantine treatment group (n=157) was irritability (5.0% vs 2.5%). juvenile animal study in a study in which memantine (0, 15, 30 or 45 mg/kg/day) was orally administered to rats during the juvenile period of development (postnatal days [pnd] 14 through 70), delays in sexual maturation were noted in males and females at all but the lowest dose tested, and body weight was reduced at the high dose. in rats orally administered memantine as a single dose (pnd 14) or three daily doses (pnd 14-16), neuronal lesions were observed in several areas of the brain at all but the lowest dose tested. adverse neurobehavioral effects (decreased auditory startle habituation) were observed at the high dose. the no effect dose for developmental toxicity was the lowest dose tested (15 mg/kg/day). in a second juvenile animal study, memantine (0, 1, 3, 8, 15, 30, and 45 mg/kg/day) was orally administered to male and female rats beginning on pnd 7 and continuing for various periods during postnatal development. because of early memantine-related mortality, the 30 and 45 mg/kg/day groups were terminated without further evaluation. apoptosis or neuronal degeneration in the brain was observed on pnds 8-17 at a dose of 15 mg/kg/day. the no-effect dose for apoptosis and neuronal degeneration was 8 mg/kg/day. in animals in which memantine (0, 1, 3, 8, or 15 mg/kg/day) was orally administered on pnds 7-70, adverse neurobehavioral effects (increased locomotor motor activity, increased auditory startle response and decreased habituation, and deficit in learning and memory) were observed at all but the lowest dose tested. effects on auditory startle persisted after drug discontinuation. the no-effect dose for developmental toxicity was the lowest dose tested (1 mg/kg/day). the majority of people with alzheimer's disease are 65 years and older. in the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% 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 events 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) and clinical pharmacology (12.3)] . no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride tablet should be administered with caution to patients with severe hepatic impairment [see dosage and administration (2) and clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - nystatin (unii: bdf1o1c72e) (nystatin - unii:bdf1o1c72e) - nystatin ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by candida albicans and other susceptible candida species. nystatin ointment is not indicated for systemic, oral, intravaginal or ophthalmic use. nystatin ointment is contraindicated in patients with a history of hypersensitivity to any of their components.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride tablets, usp are indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride tablets are 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 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 [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 3 times the maximum recommended human daily dose (mrhd) of memantine (20 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 30 times the mrhd of memantine 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 3 times the mrhd of memantine 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 3 times the mrhd of memantine 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 on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for memantine and any potential adverse effects on the breastfed infant from memantine 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 risk profile of memantine in pediatric patients was generally consistent with the known risk 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 at twice the frequency of the full-dose memantine treatment group (n=157) was irritability (5.0% vs 2.5%). juvenile animal study in a study in which memantine (0, 15, 30 or 45 mg/kg/day) was orally administered to rats during the juvenile period of development (postnatal days [pnd] 14 through 70), delays in sexual maturation were noted in males and females at all but the lowest dose tested, and body weight was reduced at the high dose. in rats orally administered memantine as a single dose (pnd 14) or three daily doses (pnd 14-16), neuronal lesions were observed in several areas of the brain at all but the lowest dose tested. adverse neurobehavioral effects (decreased auditory startle habituation) were observed at the high dose. the no effect dose for developmental toxicity was the lowest dose tested (15 mg/kg/day). in a second juvenile animal study, memantine (0, 1, 3, 8, 15, 30, and 45 mg/kg/day) was orally administered to male and female rats beginning on pnd 7 and continuing for various periods during postnatal development. because of early memantine-related mortality, the 30 and 45 mg/kg/day groups were terminated without further evaluation. apoptosis or neuronal degeneration in the brain was observed on pnds 8-17 at a dose of 15 mg/kg/day. the no-effect dose for apoptosis and neuronal degeneration was 8 mg/kg/day. in animals in which memantine (0, 1, 3, 8, or 15 mg/kg/day) was orally administered on pnds 7-70, adverse neurobehavioral effects (increased locomotor motor activity, increased auditory startle response and decreased habituation, and deficit in learning and memory) were observed at all but the lowest dose tested. effects on auditory startle persisted after drug discontinuation. the no-effect dose for developmental toxicity was the lowest dose tested (1 mg/kg/day). the majority of people with alzheimer's disease are 65 years and older. in the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% 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 events 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) and clinical pharmacology (12.3)] . no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride tablet should be administered with caution to patients with severe hepatic impairment [see dosage and administration (2) and clinical pharmacology (12.3)] .

United States - English - NLM (National Library of Medicine)

bryan corp - talc (unii: 7sev7j4r1u) (talc - unii:7sev7j4r1u) - talc 4 g in 25.0 g - sclerosol® intrapleural aerosol, administered by aerosol during thoracoscopy or open thoracotomy, is indicated to prevent recurrence of malignant pleural effusions in symptomatic patients. none known.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: 1.endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2.rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode orexacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis 3.collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus s

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 240 mg - verapamil hcl extended-release tablets are indicated for the management of essential hypertension. verapamil hydrochloride extended-release tablets are contraindicated in: - severe left ventricular dysfunction (see warnings ). - hypotension (systolic pressure less than 90 mmhg) or cardiogenic shock. - sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker). - second- or third-degree av block (except in patients with a functioning artificial ventricular pacemaker). - patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., wolff-parkinson-white, lown-ganong-levine syndromes) (see warnings ). - patients with known hypersensitivity to verapamil hydrochloride.

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate (unii: h527kap6l5) (amphetamine - unii:ck833kgx7e), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate 2.5 mg - adderall® is indicated for the treatment of attention deficit hyperactivity disorder (adhd) and narcolepsy. a diagnosis of attention deficit hyperactivity disorder (adhd; dsm-iv® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least six of the following symptoms must have persisted for a

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - acyclovir (unii: x4hes1o11f) (acyclovir - unii:x4hes1o11f) - acyclovir 200 mg - acyclovir is indicated for the acute treatment of herpes zoster (shingles). acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. acyclovir is indicated for the treatment of chickenpox (varicella). acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.