Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride ophthalmic solution, usp 10%, is indicated to dilate the pupil. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [see dosage and administration (2.2)]. animal reproduction studies have not been conducted with topical phenylephrine. it is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human breast milk. because many drugs are excreted in human milk, caution shoul

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - nystatin (unii: bdf1o1c72e) (nystatin - unii:bdf1o1c72e), triamcinolone acetonide (unii: f446c597ka) (triamcinolone acetonide - unii:f446c597ka) - nystatin 100000 [usp'u] in 1 g - nystatin and triamcinolone acetonide ointment, usp is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment. these preparations are contraindicated in those patients with a history of hypersensitivity to any of their components.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - acetazolamide (unii: o3fx965v0i) (acetazolamide - unii:o3fx965v0i) - for adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. acetazolamide tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent. hypersensitivity to acetazolamide or any excipients in the formulation. since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible. acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and i

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - ofloxacin (unii: a4p49jaz9h) (ofloxacin - unii:a4p49jaz9h) - ofloxacin otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below: otitis externa in adults and pediatric patients, 6 months and older, due to escherichia coli , pseudomonas aeruginosa and staphylococcus aureus. chronic suppurative otitis media in patients 12 years and older with perforated tympanic membranes due to proteus mirabilis , pseudomonas aeruginosa and staphylococcus aureus. acute otitis media in pediatric patients one year and older with tympanostomy tubes due to haemophilus influenzae , moraxella catarrhalis , pseudomonas aeruginosa , staphylococcus aureus and streptococcus pneumoniae . ofloxacin otic solution 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - chlorthalidone (unii: q0mqd1073q) (chlorthalidone - unii:q0mqd1073q) - diuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. the routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developed toxemia. edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy. chlorthalidone is indicated in pregnancy when edema is due to

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - phenylephrine hydrochloride (unii: 04ja59tnsj) (phenylephrine - unii:1ws297w6mv) - phenylephrine hydrochloride ophthalmic solution 2.5%, is indicated to dilate the pupil. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in patients with hypertension or thyrotoxicosis. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients. phenylephrine hydrochloride ophthalmic solution 10% is contraindicated in pediatric patients less than 1 year of age due to the increased risk of systemic toxicity. phenylephrine hydrochloride ophthalmic solution 2.5% should be used in these patients [see dosage and administration (2.2)] . animal reproduction studies have not been conducted with topical phenylephrine. it is also not known whether phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. phenylephrine hydrochloride should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human breast milk. because many drugs are excreted in human milk, caution should b

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - prazosin hydrochloride (unii: x0z7454b90) (prazosin - unii:xm03yj541d) - prazosin hydrochloride capsules are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - famotidine (unii: 5qzo15j2z8) (famotidine - unii:5qzo15j2z8) - famotidinetablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: - active duodenal ulcer (du). - active gastric ulcer (gu). - symptomatic nonerosive gastroesophageal reflux disease (gerd). - erosive esophagitis due to gerd, diagnosed by biopsy. famotidinetablets are indicated in adults for the: -   treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine neoplasias). -   reduction of the risk of duodenal ulcer recurrence. famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (h2 ) receptor antagonists. risk summary available data with h2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (see data). the estimated background risk for 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine tablets. while no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher. there are, however, no adequate or well-controlled studies in pregnant women. because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. risk summary there are limited data available on the presence of famotidine in human breast milk. there were no effects on the breastfed infant. there are no data on famotidine effects on milk production. famotidine is present in the milk of lactating rats (see data) . the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for famotidine and any potential adverse effects on the breastfed child from famotidine tablets or from the underlying maternal condition. data animal data transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose. the safety and effectiveness of famotidine tablets have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and gerd (i.e., symptomatic nonerosive gerd, erosive esophagitis as diagnosed by endoscopy). the use of famotidine tablets and the recommended dosage of famotidine tablets in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine tablets in adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [see dosage and administration (2.1), clinical pharmacology (12.2, 12.3)] . in pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established. famotidine tablets 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients [see dosage and administration (2.1)] . for pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet). of the 1442 famotidine tablets-treated patients in clinical studies, approximately 10% were 65 and older. in these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. in postmarketing experience, cns adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine tablets [see warnings and precautions (5.1)] . famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine tablets may be greater in elderly patients, particularly those with impaired renal function [see use in specific populations (8.6)]. in general, use the lowest effective dose of famotidine tablets for an elderly patient and monitor renal function [see dosage and administration (2.2)]. cns adverse reactions and prolonged qt intervals have been reported in patients with moderate and severe renal impairment [see warnings and precautions (5.1)]. the clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function [see clinical pharmacology (12.3)]. no dosage adjustment is needed in patients with mild renal impairment (creatinine clearance greater than or equal to 60 ml/minute). dosage reduction is recommended in adult and pediatric patients greater than or equal to 40 kg with moderate or severe renal impairment (creatinine clearance less than 60 ml/minute) [see dosage and administration (2.2)].

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - ranolazine (unii: a6iez5m406) (ranolazine - unii:a6iez5m406) - ranolazine extended-release tablets are indicated for the treatment of chronic angina. ranolazine extended-release tablets may be used with beta-blockers, nitrates, calcium channel blockers, anti- platelet therapy, lipid-lowering therapy, ace inhibitors, and angiotensin receptor blockers.   ranolazine extended-release tablets are contraindicated in patients:   - taking strong inhibitors of cyp3a [see drug interactions (7.1)] - taking inducers of cyp3a [see drug interactions (7.1)] - with liver cirrhosis [see use in specific population (8.6)] there are no available data on ranolazine extended-release tablets use in pregnant women to inform any drug- associated risks. studies in rats and rabbits showed no evidence of fetal harm at exposures 4 times the maximum recommended human dose (mrhd) (see data) . in the u.s. general population, the estimated background risk of major birth defects and of miscarriage of clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data embryofetal toxicity

Amerika Syarikat - Inggeris - NLM (National Library of Medicine)

lifestar pharma llc - olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10) - olmesartan medoxomil is indicated for the treatment of hypertension in adults and children six years of age and older, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with olmesartan medoxomil tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. it may be used alone or in combination with other antihypertensive agents. do not co-administer aliskiren with olmesartan medoxomil tablets in patients with diabetes [see drug interactions (7.3)]. risk summary olmesartan medoxomil tablets can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. in animal reproduction studies, olmesartan medoxomil tablets treatment during organogenesis resulted in increased embryofetal toxicity in rats at doses lower than maternally toxic doses. when pregnancy is detected, discontinue olmesartan medoxomil tablets as soon as possible. consider alternative antihypertensive therapy during pregnancy. 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 considerations disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. in patients taking olmesartan medoxomil during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of gestation. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. closely observe infants with histories of in utero exposure to olmesartan medoxomil for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to olmesartan medoxomil, if oliguria or hypotension occurs, utilize measures to maintain adequate blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and supporting renal function. data animal data no teratogenic effects were observed when olmesartan medoxomil was administered to pregnant rats at oral doses up to 1000 mg/kg/day (240 times the maximum recommended human dose (mrhd) on a mg/m 2 basis) or pregnant rabbits at oral doses up to 1 mg/kg/day (half the mrhd on a mg/m 2 basis; higher doses could not be evaluated for effects on fetal development as they were lethal to the does). in rats, significant decreases in pup birth weight and weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones (delayed separation of ear auricula, eruption of lower incisors, appearance of abdominal hair, descent of testes, and separation of eyelids) and dose-dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥ 8 mg/kg/day. the no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the mrhd of 40 mg/day. risk summary there is no information regarding the presence of olmesartan in human milk, the effects on the breastfed infant, or the effects on milk production. olmesartan is secreted at low concentration in the milk of lactating rats (see data) . because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. data presence of olmesartan in milk was observed after a single oral administration of 5 mg/kg [ 14 c] olmesartan medoxomil to lactating rats. the antihypertensive effects of olmesartan medoxomil tablets were evaluated in one randomized, double-blind clinical study in pediatric patients 1 to 16 years of age [see clinical studies (14.2)] . the pharmacokinetics of olmesartan medoxomil tablets were evaluated in pediatric patients 1 to 16 years of age [see clinical pharmacology (12.3)] . olmesartan medoxomil tablets was generally well tolerated in pediatric patients, and the adverse experience profile was similar to that described for adults. olmesartan medoxomil tablets have not been shown to be effective for hypertension in children <6 years of age. use of olmesartan medoxomil in children <1 year of age is not recommended [see warnings and precautions (5.2)]. the renin-angiotensin aldosterone system (raas) plays a critical role in kidney development. raas blockade has been shown to lead to abnormal kidney development in very young mice. administering drugs that act directly on the renin­ angiotensin aldosterone system (raas) can alter normal renal development. of the total number of hypertensive patients receiving olmesartan medoxomil tablets in clinical studies, more than 20% were 65 years of age and over, while more than 5% were 75 years of age and older. no overall differences in effectiveness or safety were observed between elderly patients and younger patients. 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 [see clinical pharmacology (12.3)]. increases in auc 0-∞ and c max were observed in patients with moderate hepatic impairment compared to those in matched controls, with an increase in auc of about 60%. no initial dosage adjustment is recommended for patients with moderate to marked hepatic dysfunction [see clinical pharmacology (12.3)]. patients with renal insufficiency have elevated serum concentrations of olmesartan compared to subjects with normal renal function. after repeated dosing, the auc was approximately tripled in patients with severe renal impairment (creatinine clearance <20 ml/min). no initial dosage adjustment is recommended for patients with moderate to marked renal impairment (creatinine clearance <40 ml/min) [see dosage and administration (2.1) ,  warnings and precautions (5.4) and clinical pharmacology (12.3)]. the antihypertensive effect of olmesartan medoxomil tablets was smaller in black patients (usually a low-renin population), as has been seen with ace inhibitors, beta-blockers and other angiotensin receptor blockers.