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tagi pharma, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronic acid 70 mg in 75 ml - alendronate sodium is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate increases bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures) [see clinical studies ( 14.1) ] . alendronate sodium is indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies ( 14.3) ] . the optimal duration of use has not been determined. the safety and effectiveness of alendronate for the treatment of osteoporosis are based on clinical data of four years duration. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. alendronate sodium is contraindicated in patients with the following conditions: risk summary: availabl

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tagi pharma, inc. - tetrabenazine (unii: z9o08yrn8o) (tetrabenazine - unii:z9o08yrn8o) - tetrabenazine 12.5 mg - tetrabenazine tablet is indicated for the treatment of chorea associated with huntington's disease. tetrabenazine tablet is contraindicated in patients: risk summary there are no adequate data on the development risk associated with the use of tetrabenazine tablet in pregnant women. administration of tetrabenazine tablets to rats throughout pregnancy and lactation resulted in an increase in stillbirths and postnatal offsprings mortality. administration of major human metabolite of tetrabenazine to rats during pregnancy or during pregnancy and lactation produced adverse effects on developing fetus and offspring (increased mortality, decreased growth and neurobehavioral and reproductive impairment). the adverse development effects of tetrabenazine and a major human metabolite of tetrabenazine in rats occurred at clinically relevant doses [see data]. 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%,

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

tagi pharma, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin is indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal an

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

tagi pharma, inc. - hydromorphone hydrochloride (unii: l960up2krw) (hydromorphone - unii:q812464r06) - hydromorphone hydrochloride 8 mg - hydromorphone hydrochloride tablets, usp are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use   because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve hydromorphone hydrochloride tablets, usp for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: •  have not been tolerated, or are not expected to be tolerated, • have not provided adequate analgesia, or are not expected to provide adequate analgesia hydromorphone hydrochloride tablets, usp are contraindicated in patients with: •  significant respiratory depression [see warnings and precautions (5.6)] • acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings and precautions (5.6)] • known or suspected gastrointestinal obstruction, including paralyti

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

tagi pharma, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin is indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increased fetal skeletal and visceral abnormalities, and increased embryofetal mortality) when administered to pregnant animals at doses similar to or lower than those used clinically [see data] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data when pregnant mice received oral doses of gabapentin (500, 1,000, or 3,000 mg/kg/day) during the period of organogenesis, embryofetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effect dose for embryofetal developmental toxicity in mice (500 mg/kg/day) is less than the maximum recommended human dose (mrhd) of 3,600 mg on a body surface area (mg/m2 ) basis. in studies in which rats received oral doses of gabapentin (500 to 2,000 mg/kg/day) during pregnancy, adverse effect on offspring development (increased incidences of hydroureter and/or hydronephrosis) were observed at all doses. the lowest dose tested is similar to the mrhd on a mg/m2 basis. when pregnant rabbits were treated with gabapentin during the period of organogenesis, an increase in embryofetal mortality was observed at all doses tested (60, 300, or 1,500 mg/kg). the lowest dose tested is less than the mrhd on a mg/m2 basis. in a published study, gabapentin (400 mg/kg/day) was administered by intraperitoneal injection to neonatal mice during the first postnatal week, a period of synaptogenesis in rodents (corresponding to the last trimester of pregnancy in humans). gabapentin caused a marked decrease in neuronal synapse formation in brains of intact mice and abnormal neuronal synapse formation in a mouse model of synaptic repair. gabapentin has been shown in vitro to interfere with activity of the α2δ subunit of voltage-activated calcium channels, a receptor involved in neuronal synaptogenesis. the clinical significance of these findings is unknown. risk summary gabapentin is secreted in human milk following oral administration. the effects on the breastfed infant and on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for gabapentin and any potential adverse effects on the breastfed infant from gabapentin or from the underlying maternal condition. safety and effectiveness of gabapentin in the management of postherpetic neuralgia in pediatric patients have not been established. safety and effectiveness as adjunctive therapy in the treatment of partial seizures in pediatric patients below the age of 3 years has not been established [see clinical studies (14.2)] . the total number of patients treated with gabapentin in controlled clinical trials in patients with postherpetic neuralgia was 336, of which 102 (30%) were 65 to 74 years of age, and 168 (50%) were 75 years of age and older. there was a larger treatment effect in patients 75 years of age and older compared to younger patients who received the same dosage. since gabapentin is almost exclusively eliminated by renal excretion, the larger treatment effect observed in patients ≥ 75 years may be a consequence of increased gabapentin exposure for a given dose that results from an age-related decrease in renal function. however, other factors cannot be excluded. the types and incidence of adverse reactions were similar across age groups except for peripheral edema and ataxia, which tended to increase in incidence with age. clinical studies of gabapentin in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and dose should be adjusted based on creatinine clearance values in these patients [see dosage and administration (2.4), adverse reactions (6), and clinical pharmacology (12.3)] . dosage adjustment in adult patients with compromised renal function is necessary [see dosage and administration (2.3) and clinical pharmacology (12.3)] . pediatric patients with renal insufficiency have not been studied. dosage adjustment in patients undergoing hemodialysis is necessary [see dosage and administration (2.3) and clinical pharmacology (12.3)] . gabapentin is not a scheduled drug. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. gabapentin does not exhibit affinity for benzodiazepine, opioid (mu, delta or kappa), or cannabinoid 1 receptor sites. gabapentin misuse and abuse have been reported in the postmarketing setting and published literature. most of the individuals described in these reports had a history of polysubstance abuse. some of these individuals were taking higher than recommended doses of gabapentin for unapproved uses. when prescribing gabapentin, carefully evaluate patients for a history of drug abuse and observe them for signs and symptoms of gabapentin misuse or abuse (e.g., self-dose escalation and drug-seeking behavior). the abuse potential of gabapentin has not been evaluated in human studies. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. there are rare postmarketing reports of individuals experiencing withdrawal symptoms shortly after discontinuing higher than recommended doses of gabapentin used to treat illnesses for which the drug is not approved. such symptoms included agitation, disorientation and confusion after suddenly discontinuing gabapentin that resolved after restarting gabapentin. the dependence potential of gabapentin has not been evaluated in human studies.

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

tagi pharma, inc. - ibandronate sodium (unii: j12u072ql0) (ibandronic acid - unii:umd7g2653w) - ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women with osteoporosis, ibandronate sodium increases bone mineral density (bmd) and reduces the incidence of vertebral fractures [see clinical studies(14)] . the safety and effectiveness of ibandronate sodium for the treatment of osteoporosis are based on clinical data of one year duration. the optimal duration of use has not been determined. all patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. patients who discontinue therapy should have their risk for fracture re-evaluated periodically. ibandronate sodium is contraindicated in patients with the following conditions: hypocalcemia [see warnings and precautions (5.1) ] known hypersensitivity to ibandronate sodium injection or to any of

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

tagi pharma, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride tablets are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2 , or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. the limited usefulness of agents of this class, including phentermine, [see clinical pharmacology (12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. - history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled

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

tagi pharma, inc - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 15 mg - phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2 , or ≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. the limited usefulness of agents of this class, including phentermine, [see clinical pharmacology (12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. - history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled h

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

tagi pharma, inc. - cholestyramine (unii: 4b33bgi082) (cholestyramine - unii:4b33bgi082) - 1) cholestyramine for oral suspension usp, light is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [ldl] cholesterol) who do not respond adequately to diet. cholestyramine for oral suspension usp, light may be useful to lower ldl cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. prior

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

tagi pharma, inc. - cholestyramine (unii: 4b33bgi082) (cholestyramine - unii:4b33bgi082) - 1) cholestyramine for oral suspension, usp is indicated as adjunctive therapy to diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [ldl] cholesterol) who do not respond adequately to diet. cholestyramine for oral suspension, usp may be useful to lower ldl cholesterol in patients who also have hypertriglyceridemia, but it is not indicated where hypertriglyceridemia is the abnormality of most concern. therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. treatment should begin and continue with dietary therapy specific for the type of hyperlipoproteinemia determined prior to initiation of drug therapy. excess body weight may be an important factor and caloric restriction for weight normalization should be addressed prior to drug therapy in the overweight. prior to initiatin