Spojené štáty - angličtina - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - paroxetine hydrochloride anhydrous (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - major depressive disorder: paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine tablets in hospitalized depressed patients have not been adequately studied.

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen delayed-release tablets are indicated for: the relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - polyarticular juvenile idiopathic arthritis naproxen delayed-release tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [ see warnings and precautions (5.7, 5.9) ]. - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions (5.7, 5.8) ]. - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1) ]. use of nsaids, including naproxen delayed-release tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma llc - glipizide (unii: x7wdt95n5c) (glipizide - unii:x7wdt95n5c) - glipizide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glipizide tablets are contraindicated in patients with: - known hypersensitivity to the drug. - type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. this condition should be treated with insulin.

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - baclofen (unii: h789n3fke8) (baclofen - unii:h789n3fke8) - baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. limitations of use baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. baclofen oral solution is contraindicated in patients with hypersensitivity to baclofen. risk summary there are no adequate data on the developmental risk associated with the use of baclofen oral solution in pregnant women. oral administration of baclofen to pregnant rats resulted in an increased incidence of fetal structural abnormalities at a dose which was also associated with maternal toxicity. the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated backgroun

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - clonidine (unii: mn3l5rmn02) (clonidine - unii:mn3l5rmn02) - clonidine extended-release tablets are indicated in the treatment of hypertension. clonidine extended-release tablets may be employed alone or concomitantly with other antihypertensive agents. clonidine extended-release tablets should not be used in patients with known hypersensitivity to clonidine [ see warnings and precautions (5.2) ]. pregnancy category c. reproduction studies performed in rabbits at doses up to approximately 3 times the oral maximum recommended daily human dose (mrdhd) of clonidine hydrochloride produced no evidence of a teratogenic or embryotoxic potential in rabbits. in rats, however, doses as low as 1/3 the oral mrdhd (1/15 the mrdhd on a mg/m 2 basis) of clonidine were associated with increased resorptions in a study in which dams were treated continuously from 2 months prior to mating. increased resorptions were not associated with treatment at the same time or at higher dose levels (up to 3 times the oral mrdhd) when the dams were treated on gestation days 6 to 15. increases in resorption were observed at much higher dose levels (40 times the oral mrdhd on a mg/kg basis; 4 to 8 times the mrdhd on a mg/m 2 basis) in mice and rats treated on gestation days 1 to 14 (lowest dose employed in the study was 500 mcg/kg). no adequate, well-controlled studies have been conducted in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. clonidine is secreted in human milk. safety and effectiveness in pediatric patients have not been established. elderly patients may benefit from a lower initial dose [ see dosage and administration (2) ]. the initial dosage should be based on the degree of impairment. monitor patients carefully for hypotension and bradycardia, and titrate to higher doses cautiously. only a minimal amount of clonidine is removed during routine hemodialysis.

Spojené štáty - angličtina - NLM (National Library of Medicine)

trupharma, llc - dapsone (unii: 8w5c518302) (dapsone - unii:8w5c518302) - dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris. none. risk summary there are no available data on dapsone gel, 5%, use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. in animal reproduction studies, oral doses of dapsone administered to pregnant rats and rabbits during organogenesis that resulted in systemic exposures more than 250 times the systemic exposure at the maximum recommended human dose (mrhd) of dapsone gel, 5%, resulted in embryocidal effects. when orally administered to rats from the onset of organogenesis through the end of lactation at systemic exposures approximately 400 times the exposure at the mrhd, dapsone resulted in increased stillbirths and decreased pup weight [see data]. the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. 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. data animal data dapsone has been shown to have an embryocidal effect in rats and rabbits when administered orally daily to females during organogenesis at dosages of 75 mg/kg/day and 150 mg/kg/day, respectively. these dosages resulted in systemic exposures that represented approximately 956 times [rats] and 289 times [rabbits] the systemic exposure observed in human females as a result of use of the mrhd of dapsone gel, 5%, based on auc comparisons. these effects were probably secondary to maternal toxicity. dapsone was assessed for effects on perinatal/postnatal pup development and postnatal maternal behavior and function in a study in which dapsone was orally administered to female rats daily beginning on the seventh day of gestation and continuing until the twenty-seventh day postpartum. maternal toxicity (decreased body weight and food consumption) and developmental effects (increase in stillborn pups and decreased pup weight) were seen at a dapsone dose of 30 mg/kg/day (approximately 382 times the systemic exposure that is associated with the mrhd of dapsone gel, 5%, based on auc comparisons). no effects were observed on the viability, physical development, behavior, learning ability, or reproductive function of surviving pups. risk summary there is no information regarding the presence of topical dapsone in breastmilk, the effects on the breastfed infant, or the effects on milk production. orally administered dapsone appears in human milk and could result in hemolytic anemia and hyperbilirubinemia especially in infants with g6pd deficiency. systemic absorption of dapsone following topical application is minimal relative to oral dapsone administration; however, it is known that dapsone is present in human milk following administration of oral dapsone. safety and efficacy was evaluated in 1169 children aged 12-17 years old treated with dapsone gel, 5%, in the clinical trials. the adverse event rate for dapsone gel, 5%, was similar to the vehicle control group. safety and efficacy was not studied in pediatric patients less than 12 years of age, therefore dapsone gel, 5%, is not recommended for use in this age group. clinical trials of dapsone gel, 5%, did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. dapsone gel, 5% and vehicle were evaluated in a randomized, double-blind, cross-over design clinical trial of 64 subjects with g6pd deficiency and acne vulgaris. subjects were black (88%), asian (6%), hispanic (2%) or of other racial origin (5%). blood samples were taken at baseline. week 2, and week 12 during both vehicle and dapsone gel, 5% treatment periods. there were 56 out of 64 subjects who had a week 2 blood draw and applied at least 50% of treatment applications. table 3 contains results from testing of relevant hematology parameters for these two treatment periods. dapsone gel, 5%  was associated with a 0.32 g/dl drop in hemoglobin after two weeks of treatment, but hemoglobin levels generally returned to baseline levels at week 12. there were no changes from baseline in haptoglobin or lactate dehydrogenase during dapsone gel, 5% or vehicle treatment at either the 2-week or 12-week time point. the proportion of subjects who experienced decreases in hemoglobin ≥ 1 g/dl was similar between dapsone gel, 5% and vehicle treatment (8 of 58 subjects had such decreases during dapsone gel, 5% treatment compared to 7 of 56 subjects during vehicle treatment among subjects with at least one on-treatment hemoglobin assessment). subgroups based on gender, race, or g6pd enzyme activity did not display any differences in laboratory results from the overall study group. there was no evidence of clinically significant hemolytic anemia in this study. some of these subjects developed laboratory changes suggestive of hemolysis.

Spojené štáty - angličtina - NLM (National Library of Medicine)

remedyrepack inc. - cyproheptadine hydrochloride (unii: nj82j0f8qc) (cyproheptadine - unii:2yhb6175do) - cyproheptadine hydrochloride 4 mg - perennial and seasonal allergic rhinitis vasomotor rhinitis allergic conjunctivitis due to inhalant allergens and foods mild, uncomplicated allergic skin manifestations of urticarial and angioedema. amelioration of allergic reactions to blood or plasma cold urticaria dermatographism as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. newborn or premature infants this drug should not be used in newborn or premature infants. nursing mothers because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. other conditions hypersensitivity to cyproheptadine and other drugs of similar chemical structure. monoamine oxidase inhibitor therapy ( see drug interactions. ) angle-closure glaucoma stenosing peptic ulcer symptomatic prostatic hypertrophy bladder neck obstruction pyloroduodenal obstr

Spojené štáty - angličtina - NLM (National Library of Medicine)

remedyrepack inc. - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc) - glyburide 2.5 mg - glyburide tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide tablets are contraindicated in patients with: - known hypersensitivity or allergy to the drug. - diabetic ketoacidosis, with or without coma. this condition should be treated with insulin. - type i diabetes mellitus. - concomitant administration of bosentan.

Spojené štáty - angličtina - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - glyburide (unii: sx6k58tvwc) (glyburide - unii:sx6k58tvwc) - glyburide 5 mg - glyburide tablets usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. glyburide tablets are contraindicated in patients with: - known hypersensitivity or allergy to the drug. - diabetic ketoacidosis, with or without coma. this condition should be treated with insulin. - type i diabetes mellitus. - concomitant administration of bosentan.

Spojené štáty - angličtina - NLM (National Library of Medicine)

carilion materials management - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 50 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 immediate-release 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 adu