Malaisie - anglais - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

hovid berhad - potassium bicarbonate; sodium alginate -

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

forum health products ltd - sodium alginate; potassium bicarbonate - oral suspension - 100mg/1ml ; 20mg/1ml

États-Unis - anglais - 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,

Irlande - anglais - HPRA (Health Products Regulatory Authority)

reckitt benckiser ireland ltd - sodium alginate; potassium hydrogen carbonate - oral suspension - 1000/200 milligram(s) - other drugs for peptic ulcer and gastro-oesophageal reflux disease (gord); alginic acid

Irlande - anglais - HPRA (Health Products Regulatory Authority)

reckitt benckiser ireland ltd - sodium alginate; potassium hydrogen carbonate - oral suspension - 1000/200 milligram(s) - other drugs for peptic ulcer and gastro-oesophageal reflux disease (gord); alginic acid

États-Unis - anglais - NLM (National Library of Medicine)

hospira, inc. - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698), sodium lactate (unii: tu7hw0w0qt) (sodium cation - unii:lyr4m0nh37, lactic acid, unspecified form - unii:33x04xa5at), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0 - potassium chloride 1.79 g in 1000 ml - these solutions are indicated in patients requiring parenteral administration of potassium chloride and the replacement of extracellular losses of fluids and electrolytes with minimal carbohydrate calories. solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. solutions containing lactate are not for use in the treatment of lactic acidosis. to open tear outer wrap at notch and remove solution container. if supplemental medication is desired, follow directions below before preparing for administration. some opacity of the plastic due to moisture absorption during the sterilization process may be observed. this is normal and does not affect the solution quality or safety. the opacity will diminish gradually. to add medication - prepare additive port. prepare additive port. - using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. withdraw need

États-Unis - anglais - NLM (National Library of Medicine)

braintree laboratories, inc. - 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 17.5 g in 1 ml - suprep bowel prep kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. suprep bowel prep kit 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 suprep bowel prep kit risk summary there are no available data on suprep bowel prep kit 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, potassium sulfate, and magnesium sulfate (suprep bowel prep kit). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies

États-Unis - anglais - NLM (National Library of Medicine)

sandoz inc. - potassium bicarbonate (unii: hm5z15lebn) (potassium cation - unii:295o53k152) - potassium cation 978 mg - the use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. serum potassium should be checked periodically, however, and if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. in more severe cases, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with potassium salts may be indicated. potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency or the administration of a potassium-sparing diuretic (e.g., spironolactone, triamterene

États-Unis - anglais - NLM (National Library of Medicine)

nomax inc. - potassium bicarbonate (unii: hm5z15lebn) (potassium cation - unii:295o53k152) - potassium cation 391 mg - - for therapeutic use in patients with hypokalemia with or without metabolic alkalosis; in chronic digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. - for prevention of potassium depletion when the dietary intake of potassium ion is inadequate in the following conditions; patients receiving digitalis and diuretics for congestive heart failure; hepatic cirrhosis with ascites; states of aldosterone excess with normal renal function; potassium-losing nephropathy, and certain diarrheal states; long-term corticosteroid therapy. - the use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension or receiving certain antibiotics is often unnecessary when such patients have a normal dietary pattern. serum potassium should be checked periodically, however, and, if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. in more severe cases supplementation with potassium salts may be indica

États-Unis - anglais - NLM (National Library of Medicine)

padagis us llc - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride 600 mg - potassium chloride extended-release tablets is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. potassium chloride is contraindicated in patients on triamterene and amiloride. risk summary there are no human data related to use of potassium chloride extended-release tablets during pregnancy, and animal reproduction studies have not been conducted. potassium supplementation that does not lead to hyperkalemia is not expected to cause fetal harm. the background risk for major birth defects and miscarriage in 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 2-4% and 15-20%, respectively. risk summary the normal potassium ion content of human milk is about 13 meq per liter. since oral potassium becomes part of the body potassium pool, so long as body potassium is not excessive, the contribution of potassium chloride supplementation should have little or no effect on the level in human milk. safety and effectiveness in the pediatric population have not been established. clinical studies of potassium chloride extended-release tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 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. 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. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. based on publish literature, the baseline corrected serum concentrations of potassium measured over 3 hours after administration in cirrhotic subjects who received an oral potassium load rose to approximately twice that of normal subjects who received the same load. patients with cirrhosis should usually be started at the low end of the dosing range, and the serum potassium level should be monitored frequently [see clinical pharmacology (12.3)]. patients with renal impairment have reduced urinary excretion of potassium and are at substantially increased risk of hyperkalemia [see warnings and precautions (5.2)] . patients with impaired renal function, particularly if the patient is on raas inhibitors or nsaids, should usually be started at the low end of the dosing range because of the potential for development of hyperkalemia [see drug interactions (7.2, 7.3)] . the serum potassium level should be monitored frequently. renal function should be assessed periodically.