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bayshore pharmaceuticals, llc - ketotifen fumarate (unii: hbd503woro) (ketotifen - unii:x49220t18g) - antihistamine temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

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bayshore pharmaceuticals llc [fl] - sennosides a and b (unii: 1b5fpi42en) (sennosides a and b - unii:1b5fpi42en) - sennosides a and b 8.8 mg in 5 ml - laxative - relieves occasional constipation - generally produces bowel movement in 6-12 hours

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bayshore pharmaceuticals llc - nadolol (unii: fen504330v) (nadolol - unii:fen504330v) - nadolol tablets, usp is indicated for the long-term management of patients with angina pectoris. nadolol tablets, usp is 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 the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with nadolol tablets, usp. 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. nadolol tablets, usp may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. nadolol is contraindicated in bronchial asthma, sinus bradycardia and greater than first degree conduction block, cardiogenic shock, and overt cardiac failure (see warnings).

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bayshore pharmaceuticals llc - carvedilol (unii: 0k47ul67f2) (carvedilol - unii:0k47ul67f2) - carvedilol 3.125 mg - carvedilol tablets is indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ace inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see clinical studies (14.1)]. carvedilol tablet is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of less than or equal to 40% (with or without symptomatic heart failure) [see clinical studies (14.2) ]. carvedilol tablet is indicated for the management of essential hypertension [see clinical studies (14.3, 14.4) ]. it can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics [see drug interactions (7.2) ]. carvedilol tablet is contraindicated in the following conditions: - bronchial asthma or related bronchospastic conditions. deaths from status asthmaticus have been reported following single doses of carvedilol tablet. - second- or third-degree av block - sick sinus syndrome - severe bradycardia (unless a permanent pacemaker is in place) - patients with cardiogenic shock or who have decompensated heart failure requiring the use of intravenous inotropic therapy. such patients should first be weaned from intravenous therapy before initiating carvedilol tablet. - patients with severe hepatic impairment - patients with a history of a serious hypersensitivity reaction (e.g., stevens-johnson syndrome, anaphylactic reaction, angioedema) to any component of this medication or other medications containing carvedilol. risk summary available data regarding use of carvedilol in pregnant women are insufficient to determine whether there are drug-associated risks of adverse developmental outcomes. there are risks to the mother and fetus associated with poorly controlled hypertension in pregnancy. the use of beta blockers during the third trimester of pregnancy may increase the risk of hypotension, bradycardia, hypoglycemia, and respiratory depression in the neonate [see clinical considerations]. in animal reproduction studies, there was no evidence of adverse developmental outcomes at clinically relevant doses [see data]. oral administration of carvedilol to pregnant rats during organogenesis resulted in post-implantation loss, decreased fetal body weight, and an increased frequency of delayed fetal skeletal development at maternally toxic doses that were 50 times the maximum recommended human dose (mrhd). in addition, oral administration of carvedilol to pregnant rabbits during organogenesis resulted in increased post-implantation loss at doses 25 times the mrhd [see data]. the estimated background risk of major birth defects and miscarriage for the indicated populations are 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: 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: neonates of women with hypertension who are treated with beta-blockers during the third trimester of pregnancy may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. observe newborns for symptoms of hypotension, bradycardia, hypoglycemia, and respiratory depression and manage accordingly. data animal data: studies performed in rats and rabbits given carvedilol during fetal organogenesis revealed increased post-implantation loss in rats at a maternally toxic dose of 300 mg per kg per day (50 times the mrhd as mg per m2) and in rabbits (in the absence of maternal toxicity) at doses of 75 mg per kg per day (25 times the mrhd as mg per m2). in the rats, there was also a decrease in fetal body weight at 300 mg per kg per day (50 times the mrhd as mg per m’) accompanied by an increased incidence of fetuses with delayed skeletal development. in rats, the no-effect level for embryo-fetal toxicity was 60 mg per kg per day (10 times the mrhd as mg per m2; in rabbits, it was 15 mg per kg per day (5 times the mrhd as mg per m2). in a pre-and post-natal development study in rats administered carvedilol from late gestation through lactation, increased embryo-lethality was observed at a maternally toxic dose of 200 mg per kg per day (approximately 32 times the mrhd as mg per m2), and pup mortality and delays in physical growth/development were observed at 60 mg per kg per day (10 times the mrhd as mg per m2) in the absence of maternal toxicity. the no-effect level was 12 mg per kg per day (2 times the mrhd as mg per m2). carvedilol was present in fetal rat tissue. risk summary there are no data on the presence of carvedilol in human milk, the effects on the breastfed infant, or the effects on milk production. carvedilol is present in the milk of lactating rats. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for carvedilol and any potential adverse effects on the breastfed infant from carvedilol or from the underlying maternal condition. effectiveness of carvedilol tablets in patients younger than 18 years of age has not been established. in a double-blind trial, 161 children (mean age 6 years, range 2 months to 17 years; 45% less than 2 years old) with chronic heart failure [nyha class ii to iv, left ventricular ejection fraction less than 40% for children with a systemic left ventricle (lv), and moderate-severe ventricular dysfunction qualitatively by echo for those with a systemic ventricle that was not an lv] who were receiving standard background treatment were randomized to placebo or to two dose levels of carvedilol tablet. these dose levels produced placebo-corrected heart rate reduction of 4 to 6 heartbeats per minute, indicative of β- blockade activity. exposure appeared to be lower in pediatric subjects than adults. after 8 months of follow-up, there was no significant effect of treatment on clinical outcomes. adverse reactions in this trial that occurred in greater than 10% of patients treated with carvedilol tablet and at twice the rate of placebo-treated patients included chest pain (17% versus 6%), dizziness (13% versus 2%), and dyspnea (11% versus 0%). of the 765 subjects with heart failure randomized to carvedilol tablets in us clinical trials, 31% (235) were 65 years of age or older, and 7.3% (56) were 75 years of age or older. of the 1,156 subjects randomized to carvedilol tablets in a long-term, placebo-controlled trial in severe heart failure, 47% (547) were 65 years of age or older, and 15% (174) were 75 years of age or older. of 3,025 subjects receiving carvedilol tablets in heart failure trials worldwide, 42% were 65 years of age or older. of the 975 myocardial infarction patients randomized to carvedilol tablet in the capricorn trial, 48% (468) were 65 years of age or older, and 11% (111) were 75 years of age or older. of the 2,065 hypertensive patients in u.s. clinical trials of efficacy or safety who were treated with carvedilol tablet, 21% (436) were 65 years of age or older. of 3,722 patients receiving carvedilol tablet in hypertension clinical trials conducted worldwide, 24% were 65 years of age or older. with the exception of dizziness in hypertensive patients (incidence 8.8% in the elderly versus 6% in younger patients), no overall differences in the safety or effectiveness (see figure 2 and 4) were observed between the older subjects and younger subjects in each of these populations. similarly, other reported clinical experience has not identified differences in responses between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

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bayshore pharmaceuticals llc - sotalol hydrochloride (unii: hec37c70xx) (sotalol - unii:a6d97u294i) - sotalol hydrochloride 80 mg - sotalol hydrochloride tablets are indicated for the treatment of life-threatening, documented ventricular arrhythmias, such as sustained ventricular tachycardia (vt). limitation of use: sotalol hydrochloride tablets may not enhance survival in patients with ventricular arrhythmias. because of the proarrhythmic effects of sotalol hydrochloride tablets, including a 1.5 to 2% rate of torsade de pointes (tdp) or new ventricular tachycardia/fibrillation (vt/vf) in patients with either non-sustained ventricular tachycardia (nsvt) or supraventricular arrhythmias (svt), its use in patients with less severe arrhythmias, even if the patients are symptomatic, is generally not recommended. avoid treatment of patients with asymptomatic ventricular premature contractions [ see warnings and precautions (5.2) .] sotalol hydrochloride tablets are contraindicated in patients with: - sinus bradycardia, sick sinus syndrome, second and third degree av block, unless a functioning pacemaker is present - congenital or acquired long qt syndromes - cardiogenic shock or decompensated heart failure - serum potassium <4 meq/l - bronchial asthma or related bronchospastic conditions - hypersensitivity to sotalol pregnancy category b there are no adequate and well-controlled studies in pregnant women. sotalol has been shown to cross the placenta, and is found in amniotic fluid. in animal studies there was no increase in congenital anomalies, but an increase in early resorptions occurred at sotalol doses 18 times the maximum recommended human dose (mrhd, based on surface area). animal reproductive studies are not always predictive of human response. reproduction studies in rats and rabbits during organogenesis at 9 and 7 times the mrhd (based on surface area), respectively, did not reveal any teratogenic potential associated with sotalol. in rabbits, a dose of sotalol 6 times the mrhd produced a slight increase in fetal death as well as maternal toxicity. this effect did not occur at sotalol dose 3 times the mrhd. in rats a sotalol dose 18 times the mrhd increased the number of early resorptions, while a dose 2.5 times the mrhd, produced no increase in early resorptions. sotalol is excreted in the milk of laboratory animals and has been reported to be present in human milk. discontinue nursing on sotalol hydrochloride tablets. the safety and effectiveness of sotalol in children have not been established. however, the class iii electrophysiologic and beta-blocking effects, the pharmacokinetics, and the relationship between the effects (qtc interval and resting heart rate) and drug concentrations have been evaluated in children aged between 3 days and 12 years old [see dosage and administration (2.4) and clinical pharmacology (12.2) ]. sotalol is mainly eliminated via the kidneys. dosing intervals should be adjusted based on creatinine clearance [ see dosage and administration (2.5) ].

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bayshore pharmaceuticals llc - metformin hydrochloride (unii: 786z46389e) (metformin - unii:9100l32l2n) - metformin hydrochloride extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. metformin hydrochloride extended-release tablets, usp are contraindicated in patients with: - severe renal impairment (egfr below 30ml/min/1.73m 2 ) [see warnings and precautions (5.1) ]. - hypersensitivity to metformin. - acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. risk summary limited data with metformin hydrochloride extended-release tablets in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. published studies with metformin use during pregnancy have not reported a clear association with metformin and major birth defect or miscarriage risk [see data ]. there are risks to the mother and fetus associated with poorly controlled diabetes mellitus in pregnancy [see clinical considerations ]. no adverse developmental effects were observed when metformin was administered to pregnant sprague dawley rats and rabbits during the period of organogenesis at doses up to 2-and 5-times, respectively, a 2550 mg clinical dose, based on body surface area [see data ]. the estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes mellitus with an hba1c >7 and has been reported to be as high as 20 to 25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. 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 poorly-controlled diabetes mellitus in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications. poorly controlled diabetes mellitus increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data human data published data from post-marketing studies have not reported a clear association with metformin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when metformin was used during pregnancy. however, these studies cannot definitely establish the absence of any metformin-associated risk because of methodological limitations, including small sample size and inconsistent comparator groups. animal data metformin hydrochloride did not adversely affect development outcomes when administered to pregnant rats and rabbits at doses up to 600 mg/kg/day. this represents an exposure of about 2 and 5 times a 2550 mg clinical dose based on body surface area comparisons for rats and rabbits, respectively. determination of fetal concentrations demonstrated a partial placental barrier to metformin. risk summary limited published studies report that metformin is present in human milk [see data ]. however, there is insufficient information to determine the effects of metformin on the breastfed infant and no available information on the effects of metformin on milk production. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for metformin hydrochloride extended-release tablets and any potential adverse effects on the breastfed child from metformin hydrochloride extended-release tablets or from the underlying maternal condition. data published clinical lactation studies report that metformin is present in human milk which resulted in infant doses approximately 0.11% to 1% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 0.13 and 1. however, the studies were not designed to definitely establish the risk of use of metformin during lactation because of small sample size and limited adverse event data collected in infants. discuss the potential for unintended pregnancy with premenopausal women as therapy with metformin hydrochloride extended-release tablets may result in ovulation in some anovulatory women. metformin hydrochloride extended-release tablets safety and effectiveness of metformin hydrochloride extended-release tabletsin pediatric patients have not been established. controlled clinical studies of metformin hydrochloride extended-release tablets did not include sufficient numbers of elderly patients to determine whether they respond differently from younger patients, although 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 and the higher risk of lactic acidosis. assess renal function more frequently in elderly patients [see warnings and precautions (5.1) ]. metformin is substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increases with the degree of renal impairment. metformin hydrochloride extended-release tablets are contraindicated in severe renal impairment, patients with an estimated glomerular filtration rate (egfr) below 30 ml/min/1.73 m 2 [see  dosage and administration (2.3), contraindications (4), warnings and precautions (5.1), and clinical pharmacology (12.3) ]. use of metformin in patients with hepatic impairment has been associated with some cases of lactic acidosis. metformin hydrochloride extended-release tablets are not recommended in patients with hepatic impairment. [see warnings and precautions (5.1) ].

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bayshore pharmaceuticals llc - flecainide acetate (unii: m8u465q1wq) (flecainide - unii:k94fts1806) - in patients without structural heart disease, flecainide acetate tablets, usp are indicated for the prevention of: •paroxysmal supraventricular tachycardias (psvt), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms •paroxysmal atrial fibrillation/flutter (paf) associated with disabling symptoms flecainide acetate tablets, usp are also indicated for the prevention of: •documented ventricular arrhythmias, such as sustained ventricular tachycardia (sustained vt), that in the judgment of the physician are life-threatening. use of flecainide acetate tablets, usp for the treatment of sustained vt, like other antiarrhythmics, should be initiated in the hospital. the use of flecainide acetate is not recommended in patients with less severe ventricular arrhythmias even if the patients are symptomatic. because of the proarrhythmic effects of flecainide acetate tablets, usp, their use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment outweigh the risks. flecainide acetate tablets, usp should not be used in patients with recent myocardial infarction. (see boxed warnings. ) use of flecainide acetate tablets, usp in chronic atrial fibrillation has not been adequately studied and is not recommended. (see boxed warnings. ) as is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of flecainide acetate tablets, usp favorably affect survival or the incidence of sudden death. flecainide acetate tablets, usp are contraindicated in patients with pre-existing second- or third-degree av block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur. flecainide acetate tablets, usp are also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.

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bayshore pharmaceuticals llc - chloroquine phosphate (unii: 6e17k3343p) (chloroquine - unii:886u3h6uff) - chloroquine phosphate tablets are indicated for the: - treatment of uncomplicated malaria due to susceptible strains of p. falciparum, p.malariae, p. ovale , and p.vivax. - prophylaxis of malaria in geographic areas where resistance to chloroquine is not present. - treatment of extraintestinal amebiasis. chloroquine phosphate tablets do not prevent relapses in patients with vivax or ovale malaria because it is not effective against exoerythrocytic forms of the parasites. limitations of use in malaria: - do not use chloroquine phosphate tablets for the treatment of complicated malaria (high-grade parasitemia and/or complications e.g., cerebral malaria or acute renal failure). - do not use chloroquine phosphate tablets for malaria prophylaxis in areas where chloroquine resistance occurs, resistance to chloroquine phosphate tablets is widespread in p. falciparum, and is reported in p.vivax (see warnings). - concomitant therapy with an 8-aminoquinoline drug is necessary for treatment of the hypnozoite liver stage forms of p.vivax and p.ovale (see dosage and administration). use of chloroquine phosphate tablets for indications other than acute malaria is contraindicated in the presence of retinal or visual field changes of any etiology. use of chloroquine phosphate tablets is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds.

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bayshore pharmaceuticals llc - hydroxychloroquine sulfate (unii: 8q2869cnvh) (hydroxychloroquine - unii:4qwg6n8qkh) - hydroxychloroquine sulfate is indicated in adult and pediatric patients for the: - treatment of uncomplicated malaria due to plasmodium falciparum, plasmodium malariae, plasmodium vivax, and plasmodium ovale. - prophylaxis of malaria in geographic areas where chloroquine resistance is not reported. limitations of use: hydroxychloroquine sulfate is not recommended for: - treatment of complicated malaria. - treatment of malaria by chloroquine or hydroxychloroquine-resistant strains of plasmodium species [see microbiology (12.4)]. - treatment of malaria acquired in geographic areas where chloroquine resistance occurs or when the plasmodium species has not been identified. - prophylaxis of malaria in geographic areas where chloroquine resistance occurs. - prevention of relapses of p. vivax or p. ovale because it is not active against the hypnozoite liver stage forms of these parasites. for radical cure of p. vivax and p. ovale infections, concomitant therapy with an 8-aminoquinoline drug is necessary [see microbiology (12.4)]. for the most current information about drug resistance, refer to the latest recommendations from the center for disease control and prevention 1. hydroxychloroquine sulfate is indicated for the treatment of acute and chronic rheumatoid arthritis in adults. hydroxychloroquine sulfate is indicated for the treatment of systemic lupus erythematosus in adults. hydroxychloroquine sulfate is indicated for the treatment of chronic discoid lupus erythematosus in adults. hydroxychloroquine sulfate is contraindicated in patients with known hypersensitivity to 4-aminoquinoline compounds. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to hydroxychloroquine sulfate during pregnancy. encourage patients to register by contacting 1-877-311-8972. risk summary prolonged clinical experience over decades of use and available data from published epidemiologic and clinical studies with hydroxychloroquine sulfate use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal, or fetal outcomes (see data) . there are risks to the mother and fetus associated with untreated or increased disease activity from malaria, rheumatoid arthritis, and systemic lupus erythematosus in pregnancy (see clinical considerations). animal reproduction studies were not conducted with hydroxychloroquine. 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 us 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 malaria : malaria during pregnancy increases the risk for adverse pregnancy outcomes, including maternal anemia, prematurity, spontaneous abortion, and stillbirth. rheumatoid arthritis : published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with rheumatoid arthritis adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. systemic lupus erythematosus : pregnant women with systemic lupus erythematosus, especially those with increased disease activity, are at increased risk of adverse pregnancy outcomes, including spontaneous abortion, fetal death, preeclampsia, preterm birth, and intrauterine growth restriction. passage of maternal auto-antibodies across the placenta may result in neonatal illness, including neonatal lupus and congenital heart block. data human data data from published epidemiologic and clinical studies have not established an association with hydroxychloroquine sulfate use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes.  hydroxychloroquine readily crosses the placenta with cord blood levels corresponding to maternal plasma levels. no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine in utero .  available epidemiologic and clinical studies have methodological limitations including small sample size and study design. risk summary published lactation data report that hydroxychloroquine is present in human milk at low levels. no adverse reactions have been reported in breastfed infants.  no retinal toxicity, ototoxicity, cardiotoxicity, or growth and developmental abnormalities have been observed in children who were exposed to hydroxychloroquine through breastmilk. there is no information on the effect of hydroxychloroquine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for hydroxychloroquine sulfate and any potential adverse effects on the breastfed child from hydroxychloroquine sulfate or from the underlying maternal condition. the safety and effectiveness of hydroxychloroquine sulfate have been established in pediatric patients for the treatment of uncomplicated malaria due to p. falciparum, p. malariae, p. vivax , and p. ovale, as well as for the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported.  however, this product cannot be directly administered to pediatric patients weighing less than 31 kg because the film-coated tablets cannot be crushed or divided [see dosage and administration (2.1, 2.2)] . the safety and effectiveness of hydroxychloroquine sulfate have not been established in pediatric patients for the treatment of rheumatoid arthritis, chronic discoid lupus erythematosus, or systemic lupus erythematosus. clinical trials of hydroxychloroquine sulfate did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. nevertheless, 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. in general, dose selection in geriatric patients should start with the lowest recommended dose, taking into consideration the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. a reduction in the dosage of hydroxychloroquine sulfate may be necessary in patients with hepatic or renal disease.

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advanced rx pharmacy of tennessee, llc - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol tablets usp, 500 mg and 750 mg are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. the mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. methocarbamol does not directly relax tense skeletal muscles in man. methocarbamol tablets usp, 500 mg and 750 mg are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.