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

evofem, inc. - lactic acid, l- (unii: f9s9ffu82n) (lactic acid, l- - unii:f9s9ffu82n), citric acid monohydrate (unii: 2968phw8qp) (anhydrous citric acid - unii:xf417d3psl), potassium bitartrate (unii: npt6p8p3uu) (tartaric acid - unii:w4888i119h) - phexxi is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. limitations of use phexxi is not effective for the prevention of pregnancy when administered after intercourse [see dosage and administration (2.1)]. risk summary there is no use for phexxi in pregnancy; therefore, discontinue phexxi during pregnancy. there are no data with the use of phexxi in pregnant women or animals. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. risk summary there are no data on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. the safety and effectiveness of phexxi have been established in females of reproductive potential. efficacy is expected to be the same for post-menarchal females

Philippines - English - FDA (Food And Drug Administration)

happy pet products incorporated; distributor: happy pet products incorporated - oral rehydration salts , ascorbic acid (vitamin c) (vet.) - powder for oral solution - formulation: each 1 gram contains: ascorbic acid......5 mg sodium chloride..................160 mg potassium citrate.........20 mg citric acid................. 90 mg magnesium chloride........ .. 10 mg calcium chloride.............. .. 10 mg d-glucose monohydrate........ ....... 100 g

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

remedyrepack inc. - potassium citrate (unii: ee90oni6ff) (anhydrous citric acid - unii:xf417d3psl) - potassium citrate 10 meq - potassium citrate is indicated for the management of renal tubular acidosis [see clinical studies (14.1)] . potassium citrate is indicated for the management of hypocitraturic calcium oxalate nephrolithiasis [see clinical studies (14.2)] . potassium citrate is indicated for the management of uric acid lithiasis with or without calcium stones [see clinical studies (14.3)] . urocit ® -k is contraindicated: - in patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride). - in patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those sufferi

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

arteriocyte medical systems, inc. - citric acid monohydrate (unii: 2968phw8qp) (anhydrous citric acid - unii:xf417d3psl), sodium citrate, unspecified form (unii: 1q73q2julr) (sodium cation - unii:lyr4m0nh37), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - anhydrous citric acid 0.08 g in 10 ml

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

mission pharmacal company - potassium citrate (unii: ee90oni6ff) (anhydrous citric acid - unii:xf417d3psl) - potassium citrate 5 meq - 1.1 renal tubular acidosis (rta) with calcium stones potassium citrate is indicated for the management of renal tubular acidosis [see clinical studies (14.1)]. 1.2 hypocitraturic calcium oxalate nephrolithiasis of any etiology potassium citrate is indicated for the management of hypocitraturic calcium oxalate nephrolithiasis [see clinical studies (14.2)]. 1.3 uric acid lithiasis with or without calcium stones potassium citrate is indicated for the management of uric acid lithiasis with or without calcium stones [see clinical studies (14.3)]. urocit ® -k is contraindicated: - in patients with hyperkalemia (or who have conditions pre-disposing them to hyperkalemia), as a further rise in serum potassium concentration may produce cardiac arrest. such conditions include: chronic renal failure, uncontrolled diabetes mellitus, acute dehydration, strenuous physical exercise in unconditioned individuals, adrenal insufficiency, extensive tissue breakdown or the administration of a potassium-sparing agent (such as triamterene, spironolactone or amiloride). - in patients in whom there is cause for arrest or delay in tablet passage through the gastrointestinal tract, such as those suffering from delayed gastric emptying, esophageal compression, intestinal obstruction or stricture, or those taking anticholinergic medication. - in patients with peptic ulcer disease because of its ulcerogenic potential. - in patients with active urinary tract infection (with either urea-splitting or other organisms, in association with either calcium or struvite stones). the ability of urocit ® -k to increase urinary citrate may be attenuated by bacterial enzymatic degradation of citrate. moreover, the rise in urinary ph resulting from urocit ® -k therapy might promote further bacterial growth. - in patients with renal insufficiency (glomerular filtration rate of less than 0.7 ml/kg/min), because of the danger of soft tissue calcification and increased risk for the development of hyperkalemia. 8.1 pregnancy animal reproduction studies have not been conducted. it is also not known whether urocit-k can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. urocit-k should be given to a pregnant woman only if clearly needed. 8.3 nursing mothers the normal potassium ion content of human milk is about 13 meq/l. it is not known if urocit-k has an effect on this content. urocit-k should be given to a woman who is breastfeeding only if clearly needed. 8.4 pediatric use safety and effectiveness in children have not been established.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - potassium clavulanate, quantity: 7.45 mg/ml (equivalent: clavulanic acid, qty 6.25 mg/ml); amoxicillin trihydrate, quantity: 28.7 mg/ml (equivalent: amoxicillin, qty 25 mg/ml) - suspension, powder for - excipient ingredients: sodium citrate; purified talc; guar gum; silicon dioxide; aspartame; citric acid; flavour - treatment of the following infections when caused by curam 125/31.25 sensitive, beta-lactamase producing organisms: skin and skin structure infections, including cases caused by beta-lactamase producing staph. aureus, e. coli and klebsiella sp. (only some strains may be sensitive). urinary tract infections, including cases caused by beta-lactamase producing e. coli, p. mirabilis and klebsiella sp. upper respiratory tract infections, such as sinusitis, including cases caused by beta-lactamase producing h. influenzae and m. catarrhalis, and otitis media, especially cases caused by beta-lactamase producing h. influenzae, m. catarrhalis and staph. aureus. lower respiratory tract infections, especially cases caused by beta-lactamase producing h. influenzae and m. catarrhalis. appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to curam 125/31.25. however, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in microbiology, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. once these results are known, therapy should be adjusted if appropriate. the treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to curam 125/31.25 should not require the addition of another antibiotic due to the amoxycillin content of curam 125/31.25.

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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate 10 mg in 160 ml - clenpiq is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. clenpiq is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute), which may result in accumulation of magnesium [see warnings and precautions (5.3)]. - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)]. - bowel perforation [see warnings and precautions (5.6)]. - toxic colitis or toxic megacolon. - gastric retention. - hypersensitivity to any of the ingredients in clenpiq [see adverse reactions (6.2)]. risk summary there are no data with clenpiq use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based

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

terumo bct, ltd. - citric acid monohydrate (unii: 2968phw8qp) (anhydrous citric acid - unii:xf417d3psl), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), trisodium citrate dihydrate (unii: b22547b95k) (anhydrous citric acid - unii:xf417d3psl) - anticoagulant citrate dextrose solution usp (acd) solution a is an anticoagulant for blood collection for use only with apheresis devices. [see dosage and administration (2).] do not infuse anticoagulant citrate dextrose solution usp (acd) solution a directly to the patients. anticoagulant citrate dextrose solution usp (acd) solution a has not been adequately studied in controlled clinical trials with specific populations.

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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - clenpiq is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. clenpiq is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute), which may result in accumulation of magnesium [see warnings and precautions (5.3)]. - gastrointestinal obstruction or ileus [see warnings and precautions (5.6)]. - bowel perforation [see warnings and precautions (5.6)]. - toxic colitis or toxic megacolon. - gastric retention. - hypersensitivity to any of the ingredients in clenpiq [see adverse reactions (6.2)]. risk summary there are no data with clenpiq use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based

Australia - English - Department of Health (Therapeutic Goods Administration)

care pharmaceuticals pty ltd - citric acid monohydrate, quantity: 4.8 mg/ml; glucose monohydrate, quantity: 16 mg/ml; sodium chloride, quantity: 2.5 mg/ml; potassium citrate, quantity: 2.2 mg/ml (equivalent: potassium, qty 800 microgram/ml) - oral liquid - excipient ingredients: carmellose sodium; potassium sorbate; sodium benzoate; sucralose; purified water; flavour - decrease/reduce/relieve symptoms of dehydration ; maintain/support body electrolyte balance ; helps restore body electrolyte balance ; helps decrease/reduce/relieve symptoms of traveller's diarrhoea ; helps decrease/reduce/relieve symptoms of occasional hangovers