Stati Uniti - inglese - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20, sodium cation - unii:lyr4m0nh37) - sodium bicarbonate injection, usp is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments. sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis ― e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. but since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total co2 content is crucial ― e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis. sodium bicarbonate injection, usp is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis.

Stati Uniti - inglese - NLM (National Library of Medicine)

sandoz inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride 600 mg - klor-con is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. potassium chloride is contraindicated in patients on triamterene and amiloride. risk summary there are no human data related to use of klor-con during pregnancy, and animal reproduction studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in 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. risk summary the normal potassium ion content of human milk is about 13 meq per liter. since oral potassium becomes part

Stati Uniti - inglese - NLM (National Library of Medicine)

apotex corp - ciprofloxacin hydrochloride (unii: 4ba73m5e37) (ciprofloxacin - unii:5e8k9i0o4u) - ciprofloxacin 250 mg

Stati Uniti - inglese - NLM (National Library of Medicine)

allergan, inc. - milnacipran hydrochloride (unii: rnz43o5ww5) (milnacipran - unii:g56vk1hf36) - milnacipran hydrochloride 12.5 mg - savella is indicated for the management of fibromyalgia.  savella is not approved for use in pediatric patients [see use in specific populations ( 8.4 )] . the use of maois intended to treat psychiatric disorders with savella or within 5 days of stopping treatment with savella is contraindicated because of an increased risk of serotonin syndrome. the use of savella within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration ( 2.5 ), warnings and precautions ( 5.2 )] . starting savella in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration ( 2.6 ), warnings and precautions ( 5.2 )] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to savella during pregnancy.  physicians are advised to recommend that pregnant patients taking savella enroll in the savella pregnancy registry. enrollment is voluntary and may be initiated by pregnant patients or their healthcare providers by contacting the registry at 1-877-643-3010 or by email at pregnancyregistries@incresearch.com. data forms may also be downloaded from the registry website at www.savellapregnancyregistry.com. risk summary based on data from published observational studies, exposure to snris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions ( 5.2 )] . the available data on savella use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks associated with exposure to serotonin and norepinephrine reuptake inhibitors (snris) and selective-serotonin reuptake inhibitors (ssris), including savella, during pregnancy (see clinical considerations). animal reproduction studies have been performed in rats, rabbits and mice. milnacipran was shown to increase embryofetal and perinatal lethality in rats and the incidence of a minor skeletal variation in rabbits at doses below (rat) or approximately equal to (rabbit) the maximum recommended human dose (mrhd) of 200 mg/day on a mg/m2 basis. no effects were seen in mice when treated with milnacipran during the period of organogenesis at doses up to 3 times the mhrd on a mg/m2 basis (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%-4% and 15%-20%, respectively. clinical consideration maternal adverse reactions use of savella in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions ( 5.9 )]. fetal/neonatal   adverse reactions neonates exposed to snris or ssris, including savella, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these findings are consistent with either direct toxic effect of ssris and snris or possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see   warnings and precautions ( 5.2 , 5.7 )]. data animal data studies were conducted in rats, rabbits and mice with dosing of milnacipran during the period of organogenesis. in rats, milnacipran was shown to increase embryofetal lethality at doses of 5 mg/kg/day (0.25 times the mrhd on a mg/m2 basis). in rabbits, dose-dependent increases in the incidence of the skeletal variation of an extra single rib were observed in several pups from multiple litters in the absence of maternal toxicity at 15 mg/kg/day (1.5 times the mrhd on a mg/m2 basis). the clinical significance of this finding is unknown. in mice, no embryotoxic or teratogenic effects were seen at doses up to 125 mg/kg/day (3 times the mhrd on a mg/m2 basis). with peri- and postnatal exposure to oral milnacipran in rats, decreases in viability and body weight were observed on postpartum day 4 at a dose of 5 mg/kg/day (approximately 0.25 times the mrhd on a mg/m2 basis). the no-effect dose for maternal and offspring toxicity was 2.5 mg/kg/day (approximately 0.1 times the mrhd on a mg/m2 basis). risk summary milnacipran is present in human milk [see data] . there are no reports on the effects of milnacipran on the breastfed child and on milk production/excretion. however, there are reports of agitation, irritability, poor feeding, and poor weight gain in infants exposed to ssris or snris through breast milk (see clinical considerations). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for savella and any potential adverse effects on the breastfed child from savella or from the underlying maternal conditions. clinical considerations monitor infants exposed to milnacipran for agitation, irritability, poor feeding and poor weight gain. data human data milnacipran is present in the milk of lactating women treated with milnacipran. in a lactation pharmacokinetic study with milnacipran, a single, oral dose of 50 mg milnacipran hcl tablet was administered to 8 lactating women who were at least 12 weeks postpartum and weaning their infants. the milk/plasma auc ratio of milnacipran was 1.85 ± 0.38. the maximum estimated weight adjusted daily infant dose for milnacipran from breast milk (assuming mean milk consumption of 150 ml/kg/day) was 5% of the maternal dose based on peak plasma concentrations.   safety and effectiveness of savella in a fibromyalgia pediatric population below the age of 18 have not been established [see boxed warning , indications and usage ( 1 ),   and warnings and precautions ( 5.1 )] . the use of savella is not recommended in pediatric patients. in controlled clinical studies of savella, 402 patients were 60 years or older, and no overall differences in safety and efficacy were observed between these patients and younger patients. in view of the predominant excretion of unchanged milnacipran via kidneys and the expected decrease in renal function with age, renal function should be considered prior to use of savella in the elderly [see dosage and administration ( 2.2 )] . snris, ssris, and savella, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions ( 5.8 )] . milnacipran is not a controlled substance. milnacipran did not produce behavioral signs indicative of abuse potential in animal or human studies. milnacipran produces physical dependence, as evidenced by the emergence of withdrawal symptoms following drug discontinuation, similar to other snris and ssris. these withdrawal symptoms can be severe. thus, taper savella and do not abruptly discontinue after extended use [see warnings and precautions ( 5.7 )] .

Stati Uniti - inglese - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - ropinirole hydrochloride (unii: d7zd41rzi9) (ropinirole - unii:030pyr8953) - ropinirole extended-release tablets are indicated for the treatment of parkinson’s disease.  ropinirole extended-release tablets are contraindicated in patients known to have a hypersensitivity/allergic reaction including urticaria, angioedema, rash, pruritus) to ropinirole or any of the excipients. risk summary   there are no adequate data on the developmental risk associated with the use of ropinirole extended-release tablets in pregnant women. in animal studies, ropinirole had adverse effects on development when administered to pregnant rats at doses similar to (neurobehavioral impairment) or greater than (teratogenicity and embryolethality at >36 times) the mrhd for parkinson’s disease. ropinirole doses associated with teratogenicity and embryolethality in pregnant rats were associated with maternal toxicity. in pregnant rabbits, ropinirole potentiated the teratogenic effects of l-dopa when these drugs were administered in combination [see data] . in the u.s. general population, the estimated background r

Stati Uniti - inglese - NLM (National Library of Medicine)

bryant ranch prepack - enalapril maleate (unii: 9o25354epj) (enalaprilat anhydrous - unii:q508q118jm) - enalapril maleate is indicated for the treatment of hypertension. enalapril maleate is effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. the blood pressure lowering effects of enalapril maleate and thiazides are approximately additive. enalapril maleate is indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. in these patients enalapril maleate improves symptoms, increases survival, and decreases the frequency of hospitalization (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate decreases the rate of development of overt heart failure and decreases the incidence of hospitalization for heart failure (see clinical pharmacology, heart failure, mortality trials for details and limitations of survival trials). in using enalapril maleate consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate does not have a similar risk (see warnings, neutropenia/agranulocytosis ). in considering use of enalapril maleate, it should be noted that in controlled clinical trials ace inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. in addition, it should be noted that black patients receiving ace inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks (see warnings, head and neck angioedema ). enalapril maleate is contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. do not coadminister aliskiren with enalapril maleate in patients with diabetes (see precautions, drug interactions ). enalapril maleate is contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). do not administer enalapril maleate within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see warnings, head and neck angioedema ).

Stati Uniti - inglese - NLM (National Library of Medicine)

torrent pharmaceuticals limited - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 20 mg - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder in adults - generalized anxiety disorder in adults and pediatric patients 7 years of age and older - diabetic peripheral neuropathic pain in adults - fibromyalgia in adults and pediatric patients 13 years of age and older - chronic musculoskeletal pain in adults the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)]. starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of ser

Stati Uniti - inglese - NLM (National Library of Medicine)

bryant ranch prepack - labetalol hydrochloride (unii: 1gev3baw9j) (labetalol - unii:r5h8897n95) - 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.

Stati Uniti - inglese - NLM (National Library of Medicine)

a-s medication solutions - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9) - adults and pediatric patients - upper respiratory tract infections of the ear, nose, and throat:   amoxicillin capsules   are indicated in the treatment of infections due to susceptible (only β-lactamase–negative) isolates of streptococcus species. (α- and β-hemolytic isolates only), streptococcus pneumoniae , staphylococcus spp., or haemophilus influenzae . - infections of the genitourinary tract: amoxicillin capsules  are indicated in the treatment of infections due to susceptible (only β-lactamase–negative) isolates of escherichia coli, proteus mirabilis , or enterococcus faecalis . - infections of the skin and skin structure:  amoxicillin capsules are indicated in the treatment of infections due to susceptible (only β-lactamase–negative) isolates of streptococcus spp. (α- and β-hemolytic isolates only), staphylococcus spp., or e. coli . - infections of the lower respiratory tract:  amoxicillin capsules are indicated in the treatment of infections due to susceptible (only β-lactamase–negative) isolates of streptococcus spp. (α- and β-hemolytic isolates only), s. pneumoniae, staphylococcus spp., or h. influenzae . adult patients only - helicobacter pylori infection  and duodenal ulcer disease: triple therapy for helicobacter pylori (h. pylori) with clarithromycin and lansoprazole : amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate h. pylori . eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. dual therapy for h. pylori with lansoprazole : amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected . (see the clarithromycin package insert, microbiology.) eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. usage   to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. amoxicillin capsules are  contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or stevens-johnson syndrome) to amoxicillin capsules or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). teratogenic effects:   pregnancy category b. reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). there was no evidence of harm to the fetus due to amoxicillin. there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed. oral ampicillin is poorly absorbed during labor. it is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. penicillins have been shown to be excreted in human milk. amoxicillin use by nursing mothers may lead to sensitization of infants. caution should be exercised when amoxicillin is administered to a nursing woman. the safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. the safety and effectiveness of amoxicillin for the treatment of h.pylori infection have not been established in pediatric patients. because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. dosing of amoxicillin should be modified in pediatric patients   12 weeks or younger (3 months or younger) [see dosage and administration (2.3)]. an analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. these analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. 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 it may be useful to monitor renal function. amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (gfr less than 30 ml/min). see dosing in renal impairment (2.5) for specific recommendations in patients with renal impairment.

Stati Uniti - inglese - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam 0.5 mg - clonazepam tablets are useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic, and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets may be useful. some loss of effect may occur during the course of clonazepam treatment (see precautions: loss of effect). clonazepam tablets are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. the efficacy of clonazepam tablets was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir category of panic disorder (see clinical pharmacology: clinical trials). panic disorder (dsm-v) is character