Yhdysvallat - englanti - 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.

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 200 mg - quetiapine fumarate extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine fumarate tablets [see clinical studies (14.1)]. quetiapine fumarate extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine fumarate extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive trial in adults with manic episodes

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical inc. - fentanyl (unii: uf599785jz) (fentanyl - unii:uf599785jz) - fentanyl 25 ug in 1 h - fentanyl transdermal system is contraindicated in the following patients and situations: clinical considerations fetal/neonatal adverse reactions prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. observe newborns for symptoms of neonatal opioid withdrawal syndrome, such as poor feeding, diarrhea, irritability, tremor, rigidity, and seizures, and manage accordingly [see warnings precautions (5.4)]. teratogenic effects pregnancy c: there are no adequate and well-controlled studies in pregnant women. fentanyl transdermal system should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the potential effects of fentanyl on embryo-fetal development were studied in the rat, mouse, and rabbit models. published literature reports that administration of fentanyl (0, 10, 100, or 500 mcg/kg/day) to pregnant female sprague-dawley

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical inc. - dexamethasone (unii: 7s5i7g3jql) (dexamethasone - unii:7s5i7g3jql) - dexamethasone 0.5 mg - control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, seasonal or perennial allergic rhinitis and serum sickness. bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, and severe erythema multiforme (stevens-johnson syndrome). primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; may be used in conjunction with synthetic mineralocorticoid analogs where applicable; in infancy mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, and nonsuppurative thyroiditis. to tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (diamond-blackfan anemia), idiopathic thrombocytopenic purpura in adul

Yhdysvallat - englanti - 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

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical inc. - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c) - morphine sulfate 20 mg - morphine sulfate extended-release capsules, usp are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time (seeclinical pharmacology ). morphine sulfate extended-release capsules, usp are not indicated for pain in the immediate postoperative period (the first 12 to 24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. morphine sulfate extended-release capsules, usp are only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (see american pain society guidelines.) morphine sulfate extended-release capsules are contraindicated in patients with a known hyper

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical inc - nabumetone (unii: lw0tiw155z) (nabumetone - unii:lw0tiw155z) - nabumetone 500 mg - carefully consider the potential benefits and risks of nabumetone and other treatment options before deciding to use nabumetone. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). nabumetone tablets are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis. nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. nabumetone should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings , anaphylactoid reactions , and precautions , preexisting asthma ). nabumetone tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery (see warnings ).

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - amiloride hydrochloride anhydrous (unii: 7m458q65s3) (amiloride - unii:7dzo8eb0z3) - amiloride hydrochloride anhydrous 5 mg - amiloride hcl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to: - help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic. - prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. the use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when such patients have a normal diet. amiloride hcl has little additive diuretic or antihypertensive effect when added to a thiazide diuretic. amiloride hcl should rarely be used alone. it has weak (compared with thiazides) diuretic and antihypertensive effects. used as single agents, potassium sparing diuretics, including amiloride hcl, result in an increased risk of hyperkalemia (approximately 10% with amiloride). amilo

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - labetalol hydrochloride (unii: 1gev3baw9j) (labetalol - unii:r5h8897n95) - labetalol hydrochloride 100 mg - labetalol hydrochloride tablets, usp are indicated in the management of hypertension. labetalol hydrochloride tablets, usp may be used alone or in combination with other antihypertensive agents, especially thiazide and loop diuretics. labetalol hydrochloride tablets are contraindicated in bronchial asthma, overt cardiac failure, greater-than-first-degree heart block, cardiogenic shock, severe bradycardia, other conditions associated with severe and prolonged hypotension, and in patients with a history of hypersensitivity to any component of the product (see warnings ). beta-blockers, even those with apparent cardioselectivity, should not be used in patients with a history of obstructive airway disease, including asthma.  

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - nifedipine (unii: i9zf7l6g2l) (nifedipine - unii:i9zf7l6g2l) - nifedipine 30 mg - 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.