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

par pharmaceutical companies, inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of paget's disease of bone in men and women. treatment is indicated in patients with paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see clinical studies (14.5) ]. zoledronic acid injection is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.2) ] - creatinine clearance less than 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see warnings and precautions (5.3) ]. - known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see post-marketing experience (6.2) ]. pregnancy category d [see warnings and precautions

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

teva pharmaceuticals usa, inc. - zinc acetate (unii: fm5526k07a) (zinc cation - unii:13s1s8sf37) - zinc cation 25 mg - zinc acetate therapy is indicated for maintenance treatment of patients with wilson’s disease who have been initially treated with a chelating agent (see precautions: monitoring patients). zinc acetate capsules are contraindicated in patients with known hypersensitivity to any of the components of the formulation.

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

zydus pharmaceuticals usa inc. - zinc sulfate (unii: 89ds0h96tb) (zinc cation - unii:13s1s8sf37) - zinc sulfate injection is indicated in adult and pediatric patients as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. zinc sulfate injection is contraindicated in patients with known hypersensitivity to zinc [see warnings and precautions (5.6)] . risk summary administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with intravenous zinc sulfate. the estimated background risk of major birth defects and miscarriage for the indicated populations 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 deficiency of trace elements, including zinc, is associated with adverse pregnancy and fetal outcomes. pregnant women have an increased metabolic demand for trace elements, including zinc. parenteral nutrition with zinc should be considered if a pregnant woman's nutritional requirements cannot be fulfilled by oral or enteral intake. risk summary zinc is present in human milk. administration of the approved recommended dose of zinc sulfate injection in parenteral nutrition is not expected to cause harm to a breastfed infant. there is no information on the effects of zinc sulfate on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zinc sulfate injection and any potential adverse effects on the breastfed infant from zinc sulfate injection or from the underlying maternal condition. zinc sulfate injection is approved for use in the pediatric population, including neonates, as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. safety and dosing recommendations in pediatric patients are based on published literature describing controlled studies of zinc-containing products in pediatric patients [see dosage and administration (2.2)] . because of immature renal function, preterm infants receiving prolonged parenteral nutrition treatment with zinc sulfate injection may be at higher risk of aluminum toxicity [see warnings and precautions (5.3)] . reported clinical experience with intravenous zinc sulfate has not identified a difference in zinc requirements between elderly and younger patients. in general, dose selection should be individualized based on the patient's clinical condition, nutritional requirements, and additional nutritional intake provided orally or enterally to the patient.

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

ncs healthcare of ky, inc dba vangard labs - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 10 mg - the use of metoclopramide tablets is recommended for adults only. therapy should not exceed 12 weeks in duration. symptomatic gastroesophageal reflux: metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy. the principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. if symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12-week trial using doses of 15 mg q.i.d. as there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically. diabetic gastroparesis

Canada - English - Health Canada

avir pharma inc. - sincalide - powder for solution - 5mcg - sincalide 5mcg - gallbladder function

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

par pharmaceutical companies, inc. - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 4 mg in 5 ml - zoledronic acid injection is indicated for the treatment of hypercalcemia of malignancy defined as an albumin-corrected calcium (cca) of greater than or equal to 12 mg/dl [3.0 mmol/l] using the formula: cca in mg/dl=ca in mg/dl + 0.8 (4.0 g/dl - patient albumin [g/dl]). zoledronic acid injection is indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. prostate cancer should have progressed after treatment with at least one hormonal therapy. the safety and efficacy of zoledronic acid injection in the treatment of hypercalcemia associated with hyperparathyroidism or with other nontumor-related conditions have not been established. hypersensitivity to zoledronic acid or any components of zoledronic acid injection hypersensitivity reactions including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock have been reported [see adverse reactions (6.2) ].

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

par pharmaceutical inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg - levetiracetam extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients ≥16 years of age with epilepsy. ( 1) none pregnancy category c there are no adequate and well-controlled studies in pregnant women. in animal studies, levetiracetam produced evidence of developmental toxicity, including teratogenic effects, at doses similar to or greater than human therapeutic doses. levetiracetam extended-release tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. oral administration of levetiracetam to female rats throughout pregnancy and lactation led to increased incidences of minor fetal skeletal abnormalities and retarded offspring growth pre- and/or postnatally at doses ≥350 mg/kg/day (approximately equivalent to the maximum recommended human dose of 3000 mg [mrhd] on a mg/m 2 basis) and with increased pup mortality and offspring behavioral alterations at a dose of 1800 mg/kg/day (6 times the mrhd

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

par pharmaceutical, inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride 8 meq - because of reports of intestinal and gastric ulceration and bleeding with controlled-release potassium chloride preparations, these drugs should be reserved for those patients who cannot tolerate or refuse to take liquid or effervescent potassium preparations or for patients in whom there is a problem of compliance with these preparations. - 1.for the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxications, and in patients with hypokalemic familial periodic paralysis. if hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia. - 2.for the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop e.g., digitalized patients or patients with significant cardiac arrhythmias, hepatic cirrhosis with ascites, states of aldosterone excess with normal renal function, potassium-losing nephropathy, and certain diarrhe

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

par pharmaceutical, inc. - nifedipine (unii: i9zf7l6g2l) (nifedipine - unii:i9zf7l6g2l) - nifedipine 90 mg - nifedipine extended-release tablets, usp are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive agents. concomitant administration with strong p450 inducers, such as rifampin, are contraindicated since the efficacy of nifedipine tablets could be significantly reduced. (see precautions , drug interactions ) nifedipine must not be used in cases of cardiogenic shock. nifedipine is contraindicated in patients with a known hypersensitivity to any component of the tablet.

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

par pharmaceutical companies, inc. - levothyroxine sodium anhydrous (unii: 054i36cpmn) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium anhydrous 200 ug in 5 ml - levothyroxine sodium for injection is indicated for the treatment of myxedema coma. important limitations of use: the relative bioavailability between levothyroxine sodium for injection and oral levothyroxine products has not been established. caution should be used when switching patients from oral levothyroxine products to levothyroxine sodium for injection as accurate dosing conversion has not been studied. none. pregnancy category a – there are no reported cases of levothyroxine sodium for injection used to treat myxedema coma in patients who were pregnant or lactating. studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities. therefore, pregnant patients who develop myxedema should be treated with levothyroxine sodium for injection as the risk of non-treatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. patients in labor who develop myxedema have n