Philippines - English - FDA (Food And Drug Administration)

starpharm, inc. - multivitamins - capsule - (see reverse)

Philippines - English - FDA (Food And Drug Administration)

starpharm, inc. - ascorbic acid (as sodium ascorbate) - capsule - 500mg (equi. to 562.43mg sodium ascorbate)

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: n/a; distributor: starpharma, inc. - paracetamol - suspension - 250 mg/ml

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronate sodium tablets, usp are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets, usp increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies (14.1).] alendronate sodium tablets, usp are indicated for the prevention of postmenopausal osteoporosis [see clinical studies (14.2)] . alendronate sodium tablets, usp are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3)] . alendronate sodium tablets, usp are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see clinical studies (14.4)] . alendronate sodium tablets, usp are indicated for the treatment of paget's disease of bone in men and women. treatment is indicated in patients wit

United States - English - NLM (National Library of Medicine)

austarpharma llc - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients: - with urinary retention [see warnings and precautions (5.2)] , - with gastric retention [see warnings and precautions (5.3)] , - with uncontrolled narrow-angle glaucoma [see warnings and precautions (5.5)] , and - who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions (6.2)] . risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (mrhd) of 10 mg/day. however, administration of doses 3.6 times and greater than the mrhd during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see data] . in the u.s. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data oral administration of 14 c-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. in pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the mrhd of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality. administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the mrhd, resulted in reduced fetal body weights and reduced maternal body weight gain. no embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the mrhd). administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the mrhd, respectively), resulted in no findings of embryo-fetal toxicity. oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the mrhd) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). an increase in the percentage of male offspring was also observed in litters from offspring (f2 generation) exposed to maternal doses of 250 mg/kg/day. there were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the mrhd. risk summary there is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production. solifenacin is present in mouse milk [see data] . when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for solifenacin succinate and any potential adverse effects on the breastfed child from solifenacin succinate or from the underlying maternal condition. data animal data oral administration of 14 c-solifenacin succinate to lactating mice resulted in the recovery of radioactivity in maternal milk. lactating female mice orally administered solifenacin succinate at a maternally toxic dose of 100 mg/kg/day (3.6 times the systemic exposure at the mrhd) had increased postpartum pup mortality, pups with reduced body weights, or delays in the onset of reflex and physical development. pups from lactating dams orally administered solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the mrhd) had no discernible adverse findings. the concentrations of solifenacin in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of solifenacin succinate tablets have not been established in pediatric patients. in placebo-controlled clinical studies, similar safety and effectiveness were observed between geriatric patients (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger adult patients (1188 patients < 65 years) treated with solifenacin succinate tablets [see clinical pharmacology (12.3)] . solifenacin plasma concentrations are greater in patients with severe renal impairment compared to subjects with normal renal function [see clinical pharmacology (12.3)] . because increased solifenacin plasma concentrations increase the risk of antimuscarinic adverse reactions, the maximum recommended dose of solifenacin succinate tablets in patients with severe renal impairment (cl cr < 30 ml/min/1.73 m 2 ) is 5 mg once daily [see dosage and administration (2.2)] . the recommended dose in patients with mild or moderate renal impairment is the same as in patients with normal renal function. solifenacin plasma concentrations are greater in patients with moderate hepatic impairment compared to subjects with normal hepatic function [see clinical pharmacology (12.3)] . because increased solifenacin plasma concentrations increase the risk of antimuscarinic adverse reactions, the maximum recommended dose of solifenacin succinate tablets in patients with moderate hepatic impairment (child-pugh b) is 5 mg once daily [see dosage and administration (2.3)] and solifenacin succinate tablets are not recommended for use in patients with severe hepatic impairment (child-pugh c). the pharmacokinetics of solifenacin is not significantly influenced by gender.

United States - English - NLM (National Library of Medicine)

austarpharma llc - sildenafil citrate (unii: bw9b0ze037) (sildenafil - unii:3m7ob98y7h) - sildenafil tablets is indicated for the treatment of erectile dysfunction. consistent with its known effects on the nitric oxide/cgmp pathway [see  clinical pharmacology (12.1,  12.2) ], sildenafil tablets was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using nitric oxide donors such as organic nitrates or organic nitrites in any form either regularly and/or intermittently is therefore contraindicated. after patients have taken sildenafil tablets, it is unknown when nitrates, if necessary, can be safely administered. although plasma levels of sildenafil at 24 hours post dose are much lower than at peak concentration, it is unknown whether nitrates can be safely co-administered at this time point [see  dosage and administration (2.3),  drug interactions (7.1), and clinical pharmacology (12.2) ]. sildenafil tablets is contraindicated in patients with a known hyperse

United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol 500 mg - methocarbamol is 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 is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components. methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities. safety and effectiveness of methocarbamol in pediatric patients below the age of 16 have not been established.

United States - English - NLM (National Library of Medicine)

austarpharma, llc - fenofibrate (unii: u202363uos) (fenofibric acid - unii:bgf9mn2hu1) - treatment of hypercholesterolemia fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of ldl-c, total-c, triglycerides and apo b in adult patients with primary hypercholesterolemia or mixed dyslipidemia (fredrickson types iia and iib). lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see national cholesterol education program [ncep] treatment guidelines, below). treatment of hypertriglyceridemia fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (fredrickson types iv and v hyperlipidemia). improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl)

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - methocarbamol (unii: 125od7737x) (methocarbamol - unii:125od7737x) - methocarbamol is 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 is contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components. methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities. safety and effectiveness of methocarbamol in pediatric patients below the age of 16 have not been established.

United States - English - NLM (National Library of Medicine)

golden state medical supply, inc. - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronic acid 35 mg - alendronate sodium tablets, usp are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets, usp increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies (14.1).] alendronate sodium tablets, usp are indicated for the prevention of postmenopausal osteoporosis [see clinical studies (14.2)] . alendronate sodium tablets, usp are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3)] . alendronate sodium tablets, usp are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivale