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bionpharma inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 5 mg

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bionpharma inc. - montelukast sodium (unii: u1o3j18sfl) (montelukast - unii:mhm278sd3e) - montelukast 10 mg - montelukast sodium is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients 2 years of age and older. montelukast sodium is indicated for prevention of exercise-induced bronchoconstriction (eib) in patients 6 years of age and older. montelukast sodium is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 2 years of age and older and perennial allergic rhinitis in patients 2 years of age and older. hypersensitivity to any component of this product. pregnancy   category   b: there are no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, montelukast sodium should be used during pregnancy only if clearly needed. teratogenic   effect: no teratogenicity was observed in rats and rabbits at doses approximately 100 and 110 times, respectively, the maximum recommended daily oral dose in adults based on aucs

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bionpharma inc., - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus anhydrous 0.5 mg - tacrolimus capsules is indicated for the prophylaxis of organ rejection, in patients receiving allogeneic kidney transplant  [see clinical studies ( 14.1)] , liver transplants  [see clinical studies ( 14.2)]  and heart transplant  [see clinical studies ( 14.3)] , in combination with other immunosuppressants. tacrolimus capsules are contraindicated in patients with a hypersensitivity to tacrolimus. tacrolimus injection is contraindicated in patients with a hypersensitivity to hco-60 (polyoxyl 60 hydrogenated castor oil). hypersensitivity symptoms reported include dyspnea, rash, pruritus, and acute respiratory distress syndrome [see adverse reactions ( 6)] . pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to tacrolimus during pregnancy. the transplantation pregnancy registry

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bionpharma inc. - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam 0.25 mg

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bionpharma inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg

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bionpharma inc. - glimepiride (unii: 6ky687524k) (glimepiride - unii:6ky687524k) - glimepiride 1 mg - glimepiride tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies (14.1) ]. glimepiride tablets usp should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings. glimepiride tablets are contraindicated in patients with a history of a hypersensitivity reaction to: -  glimepiride or any of the product’s ingredients [see warnings and precautions (5.2)]. sulfonamide derivatives: patients who have developed an allergic reaction to sulfonamide derivatives may develop an allergic reaction to glimepiride. do not use glimepiride in patients who have a history of an allergic reaction to sulfonamide derivatives. reported hypersensitivity reactions include cutaneous eruptions with or without pruritus as well as more serious reactions (e.g., anaphylaxis, angioedema, stevens-johnson syndrome, dyspnea) [see warnings and precautions (5.2) and adverse rea

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bionpharma inc. - paricalcitol (unii: 6702d36og5) (paricalcitol - unii:6702d36og5) - paricalcitol 1 ug - paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (ckd) stages 3 and 4. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with ckd stage 5 in patients on hemodialysis (hd) or peritoneal dialysis (pd). pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. paricalcitol capsules should not be given to patients with evidence of - hypercalcemia or hypercalcemia or - vitamin d toxicity [see warnings and precautions ( 5.1) ]. vitamin d toxicity [see warnings and precautions ( 5.1) ]. risk summary limited data with paricalcitol capsules in pregnant women are insufficient to inform a drug‑associated risk for major birth defects and miscarriage. there are risks to the mother and fetus associated with chronic kidney disease in pregnancy [see clinical considerations] . in animal reproduction studies, slightly increased embryofetal loss was observed in pregnant rats and rabbits administered paricalcitol intravenously during the period of organogenesis at doses 2 and 0.5 times, respectively, the maximum recommended human dose (mrhd). adverse reproductive outcomes were observed at doses that caused maternal toxicity [see data] . the estimated background risk of major birth defects and miscarriage for 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 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk chronic kidney disease in pregnancy increases the maternal risk for hypertension, spontaneous abortion, preterm labor, and preeclampsia. chronic kidney disease increases the fetal risk for intrauterine growth restriction (iugr), prematurity, polyhydramnios, still birth, and low birth weight. data animal data pregnant rats and rabbits were treated with paricalcitol by once-daily intravenous (iv) injection during the period of organogenesis (in rats, from gestation day (gd) 6 to 17; in rabbits, from gd 6 to 18). rats were dosed at 0, 0.3, 1.0 or 3.0 mcg/kg/day and rabbits at 0, 0.03, 0.1 or 0.3 mcg/kg/day, representing up to 2 or 0.5 times, respectively, the maximum recommended human dose (mrhd) of 0.24 mcg/kg, based on body surface area (mg/m 2 ). slightly decreased fetal viability was observed in both studies at the highest doses representing 2 and 0.5 times, respectively, the mrhd in the presence of maternal toxicity (decreased body weight and food consumption). pregnant rats were administered paricalcitol by iv injection three times per week at doses of 0, 0.3, 3.0 or 20.0 mcg/kg/day throughout gestation, parturition and lactation (gd 6 to lactation day (ld) 20) representing exposures up to 13 times the mhrd. a small increase in stillbirths and pup deaths from parturition to ld 4 were observed at the high dose when compared to the control group (9.2% versus 3.3% in controls) at 13 times the mrhd, which occurred at a maternally toxic dose known to cause hypercalcemia in rats. surviving pups were not adversely affected; body weight gains, developmental landmarks, reflex ontogeny, learning indices, and locomotor activity were all within normal parameters. f1 reproductive capacity was unaffected. risk summary there is no information available on the presence of paricalcitol in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production. studies in rats have shown that paricalcitol and/or its metabolites are present in the milk of lactating rats; however, due to specifies-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk [see data] . because of the potential for serious adverse reactions, including hypercalcemia in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with paricalcitol. data following a single oral administration of 20 mcg/kg of radioactive [ 3 h] paricalcitol to lactating rats, the concentrations of total radioactivity was determined. lower levels of total radioactivity were present in the milk compared to that in the plasma of the dams indicating that low levels of [ 3 h] paricalcitol and/or its metabolites are secreted into milk. exposure of the pups to [ 3 h] paricalcitol through milk was confirmed by the presence of radioactive material in the pups’ stomachs. safety and effectiveness of paricalcitol capsules in pediatric patients under the age of 10 years have not been established. pediatric use information for patients 10 to 16 years of age is approved for abbvie inc.’s zemplar (paricalcitol) capsules. however, due to abbvie inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. of the total number (n = 220) of ckd stages 3 and 4 patients in clinical studies of paricalcitol capsules, 49% were age 65 and over, while 17% were age 75 and over. of the total number (n = 88) of ckd stage 5 patients in the pivotal study of paricalcitol capsules, 28% were age 65 and over, while 6% were age 75 and over. no overall differences in safety and effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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bionpharma inc., - rizatriptan benzoate (unii: wr978s7qhh) (rizatriptan - unii:51086hbw8g) - rizatriptan 5 mg - rizatriptan benzoate orally disintegrating tablets are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. limitations of use - rizatriptan benzoate orally disintegrating tablets should only be used where a clear diagnosis of migraine has been established. if a patient has no response for the first migraine attack treated with rizatriptan benzoate orally disintegrating tablets, usp, the diagnosis of migraine should be reconsidered before rizatriptan benzoate orally disintegrating tablets, usp are administered to treat any subsequent attacks. - rizatriptan benzoate orally disintegrating tablets are not indicated for use in the management of hemiplegic or basilar migraine [see  contraindications (4)] . - rizatriptan benzoate orally disintegrating tablets are not indicated for the prevention of migraine attacks. - safety and effectiv

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bionpharma inc. - carisoprodol (unii: 21925k482h) (carisoprodol - unii:21925k482h) - carisoprodol 350 mg

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

bionpharma inc. - amantadine hydrochloride (unii: m6q1eo9td0) (amantadine - unii:bf4c9z1j53) - amantadine hydrochloride 100 mg - amantadine hydrochloride capsules, usp are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza a virus. amantadine hydrochloride capsules, usp are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. influenza a prophylaxis:  amantadine hydrochloride capsules, usp are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. because amantadine hydrochloride does not completely prevent the host immune response to influenza a infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and may be protected when later exposed to antigenically related viruses.  following vaccination during an influenza a outbreak, amantadine hydrochloride capsules, usp prophylaxis should be considered for the 2- to 4-week time period required to develop an antibody response. influenza a treatment:  amantadine hydrochloride capsules, usp are also indicated in the treatment of uncomplicated respiratory tract illness caused by influenza a virus strains especially when administered early in the course of illness. there are no well-controlled clinical studies demonstrating that treatment with amantadine hydrochloride capsules, usp will avoid the development of influenza a virus pneumonitis or other complications in high risk patients. there is no clinical evidence indicating that amantadine hydrochloride capsules, usp are effective in the prophylaxis or treatment of viral respiratory tract illnesses other than those caused by influenza a virus strains. the following points should be considered before initiating treatment or prophylaxis with amantadine hydrochloride capsules, usp: - amantadine hydrochloride capsules, usp is not a substitute for early vaccination on an annual basis as recommended by the centers for disease control and prevention advisory committee on immunization practices. - influenza viruses change over time. emergence of resistance mutations could decrease drug effectiveness.  other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs.  prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use amantadine hydrochloride capsules, usp. parkinson's disease/syndrome:  amantadine hydrochloride capsules, usp are indicated in the treatment of idiopathic parkinson's disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism which may follow injury to the nervous system by carbon monoxide intoxication. it is indicated in those elderly patients believed to develop parkinsonism in association with cerebral arteriosclerosis. in the treatment of parkinson's disease, amantadine hydrochloride capsules, usp are less effective than levodopa, (-),-3-(3,4-dihydroxyphenyl)-l-alanine, and its efficacy in comparison with the anticholinergic antiparkinson drugs has not yet been established. drug-induced extrapyramidal reactions:  amantadine hydrochloride capsules, usp are indicated in the treatment of drug-induced extrapyramidal reactions. although anticholinergic-type side effects have been noted with amantadine hydrochloride capsules, usp when used in patients with drug-induced extrapyramidal reactions, there is a lower incidence of these side effects than that observed with the anticholinergic antiparkinson drugs. amantadine hydrochloride capsules are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride capsules.