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

lupin pharmaceuticals,inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (sodium cation - unii:lyr4m0nh37) - monobasic sodium phosphate and dibasic sodium phosphate tablets are indicated for cleansing of the colon as a preparation for colonoscopy in adults. monobasic sodium phosphate and dibasic sodium phosphate tablets are contraindicated in the following conditions: -   history of acute phosphate nephropathy [see warnings and precautions (5.1)] -   gastrointestinal (gi) obstruction [see warnings and precautions (5.7)] -   gastric bypass or stapling surgery -   bowel perforation -   toxic colitis -   toxic megacolon -   hypersensitivity to sodium phosphate salts or any component of monobasic sodium phosphate and dibasic sodium phosphate tablets[see warnings and precautions (5.7)]. risk summary there are no available data on sodium phosphate use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. animal reproduction studies have not been conducted with sodium phosphate. 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% to 4% and 15% to 20%, respectively. risk summary there are no data available to assess the presence of sodium phosphate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of monobasic sodium phosphate and dibasic sodium phosphate tablets to a child during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for monobasic sodium phosphate and dibasic sodium phosphate tablets and any potential adverse effects on the breastfed child from monobasic sodium phosphate and dibasic sodium phosphate tablets or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. of the 599 patients in clinical trials receiving at least 48 grams of monobasic sodium phosphate and dibasic sodium phosphate tablets, 134 (22%) were 65 years of age or older, while 27 (5%) were 75 years of age or older. no overall differences in safety or effectiveness were observed between geriatric patients and younger patients. however, the mean phosphate levels in geriatric patients were greater than the phosphate levels in younger patients after monobasic sodium phosphate and dibasic sodium phosphate tablets administration. the mean colonoscopy-day phosphate levels in patients 18-64, 65-74, and ≥ 75 years old who received the recommended monobasic sodium phosphate and dibasic sodium phosphate tablets dosage regimen in study 1were 7.0, 7.3, and 8.0 mg/dl, respectively. after monobasic sodium phosphate and dibasic sodium phosphate tablets administration, the mean phosphate levels in patients 18-64, 65-74, and ≥ 75 years old were 7.4, 7.9, and 8.0 mg/dl, respectively. greater sensitivity of some older individuals cannot be ruled out; therefore, use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in geriatric patients. advise geriatric patients to adequately hydrate before, during, and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets. sodium phosphate is known to be substantially excreted by the kidney, and the risk of adverse reactions with sodium phosphate may be greater in patients with impaired renal function. since geriatric patients are more likely to have impaired renal function, consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and bun) in these patients [see warnings and precautions (5.1)]. sodium phosphate is substantially excreted by the kidney. use monobasic sodium phosphate and dibasic sodium phosphate tablets with caution in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or patients taking concomitant medications that may affect renal function. these patients may be at risk for renal injury. advise these patients of the importance of adequate hydration before, during and after the use of monobasic sodium phosphate and dibasic sodium phosphate tablets, and consider performing baseline and post-colonoscopy labs (phosphate, calcium, potassium, sodium, creatinine, and bun) in these patients [see warnings and precautions (5.1), drug interactions (7.1)] .

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

lupin pharmaceuticals, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. it is also not known whether sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfate, potassium sulfate and magnesium sulfate oral solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium sulfate, potassium sulfate and magnesium sulfate oral solution is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. of the 375 patients who received sodium sulfate, potassium sulfate and magnesium sulfate oral solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. no overall differences in safety or effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. geriatric patients reported more vomiting when sodium sulfate, potassium sulfate and magnesium sulfate oral solution was given as a one-day preparation.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ceva animal health pty ltd - vitamin c sodium salt = sodium ascorbate - unknown - vitamin c sodium salt = sodium ascorbate vitamin-c active 0.0 - active constituent

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - sodium chloride; sodium chloride; glucose monohydrate; glucose monohydrate - solution for infusion - 0.9/5 %w/v percent weight/volume - salt solutions; sodium chloride

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

fresenius kabi usa, llc - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (phosphate ion - unii:nk08v8k8hr) - sodium phosphate, monobasic, monohydrate 276 mg in 1 ml - sodium phosphates injection, usp is indicated as a source of phosphate, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake.  it is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. the concomitant amount of sodium (4 meq/ml) must be calculated into total electrolyte dose of such prepared solutions. sodium phosphate is contraindicated in diseases where high phosphate or low calcium levels may be encountered, and in patients with hypernatremia.

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

novel laboratories, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. it is also not known whether sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfate, potassium sulfate and magnesium sulfate oral solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium sulfate, potassium sulfate and magnesium

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

affordable pharmaceuticals, llc - sodium sulfate (unii: 0ypr65r21j) (sodium cation - unii:lyr4m0nh37), potassium sulfate (unii: 1k573lc5tv) (potassium cation - unii:295o53k152), magnesium sulfate, unspecified form (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. sodium sulfate, potassium sulfate and magnesium sulfate oral solution is contraindicated in the following conditions: - gastrointestinal obstruction or ileus  [see warnings and precautions ( 5.6)] - bowel perforation [see warnings and precaution ( 5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution risk summary there are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproductive studies have not been conducted with sodium sulfate,

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

paddock laboratories, llc - sodium polystyrene sulfonate (unii: 1699g8679z) (polystyrene sulfonic acid - unii:70ko0r01ry) - sodium polystyrene sulfonate 15 g in 60 ml - sodium polystyrene sulfonate suspension, usp is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates (particularly in premature infants), and in any post-operative patient until normal bowel function resumes (see precautions ).

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

west-ward pharmaceuticals corp. - sodium polystyrene sulfonate (unii: 1699g8679z) (polystyrene sulfonic acid - unii:70ko0r01ry) - sodium polystyrene sulfonate 15 g in 60 ml - sodium polystyrene sulfonate is indicated for the treatment of hyperkalemia. sodium polystyrene sulfonate is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, oral or rectal administration in neonates (see precautions ).

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

rochester pharmaceuticals - sulfacetamide sodium (unii: 4nrt660kjq) (sulfacetamide - unii:4965g3j0f5), sulfur (unii: 70fd1kfu70) (sulfur - unii:70fd1kfu70) - sulfacetamide sodium 90 mg in 1 g - sodium sulfacetamide 9% and sulfur 4.5% wash is indicated for the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis. sodium sulfacetamide 9% and sulfur 4.5% wash is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation. sodium sulfacetamide 9% and sulfur 4.5% wash is not to be used by patients with kidney disease. safety and effectiveness in children under the age of 12 has not been established.