Level-K 15 gm/sachet Oral Powder

    Level-K 15 gm/sachet

    Sodium polystyrene sulfonate

    Category: Oral Powder

    Manufacturer: Incepta Pharmaceuticals Ltd.

    Price: 980.0

    15 gm sachet

    Hyperkalemia Hypersensitivity to polystyrene sulfonate resins. Oral admin to neonates; neonates with reduced gut motility; obstructive bowel disease. Hypokalaemia.
    Calcium Regulator
    Sodium Polystyrene Sulfonate is a non-absorbed, cation exchange polymer that contains a sodium counterion. Sodium Polystyrene Sulfonate increases fecal potassium excretion through binding of potassium in the lumen of the gastrointestinal tract. Binding of potassium reduces the concentration of free potassium in the gastrointestinal lumen, resulting in a reduction of serum potassium levels. The practical exchange ratio is 1 mEq K per 1 gram of resin.As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. This action occurs primarily in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable.
    Administration: Oral Preparation For each gram of powdered resin add 3-4 mL of water or syrup Do not heat solution to improve dissolution; heat impairs resin exchange Rectal Preparation Suspend dose in 100 mL of aqueous liquid (eg, water, sorbitol 25%, methylcellulose 1%, dextrose 10%) Oral Administration Shake suspension well before administering Administer PO or via NG tube with patient in upright position Do not take other oral medications within 3 hr of dosing (6 hr for patients with gastroparesis or other conditions) because of potential GI binding Do not mix with potassium containing liquids or food (eg, orange juice, bananas) Suspension may be chilled to improve palatability Rectal Administration Administer cleansing enema beforehand Administer sodium polystyrene sulfonate as warm emulsion (body temperature) Gently agitate suspension during administration Retain in colon for at least 30-60 min (several hours if possible) After completing retention, use nonsodium colonic irrigant to remove remaining resin Adult Dose: Oral Hyperkalaemia Adult: As suspension in water or syrup or as sweetened paste: 15 g up to 4 times daily. Not to be taken with fruit juices that have high potassium content. Rectal Hyperkalaemia Adult: As enema (suspension): 30 g in 100 ml of 2% methylcellulose '450' and 100 ml of water, retained for at least 9 hr, if possible. Higher doses may be retained for a shorter period of time. Irrigate colon after retention to remove the resin. Child Dose: Oral Hyperkalaemia Child: Acute hyperkalaemia: 1 g/kg daily in divided doses. Maintenance: 500 mg/kg daily. Rectal Hyperkalaemia Child: and neonates: Acute hyperkalaemia: 1 g/kg daily in divided doses. Maintenance: 500 mg/kg daily.
    Reduces absorption of thyroxine and lithium salts. Enhances adverse effects of cardiac glycosides. Potassium-lowering effect may be reduced when used with other cation-containing antacids.
    Hypersensitivity to polystyrene sulfonate resins. Oral admin to neonates; neonates with reduced gut motility; obstructive bowel disease. Hypokalaemia.
    1-10% GI disturbance Constipation Hypokalemia Hypocalcemia Hypomagnesemia Sodium retention Nausea Vomiting Frequency Not Defined GI concretions (bezoars) after oral use GI tract ulceration or necrosis, which could lead to perforation Fecal impaction after rectal administration (especially in children) Acute bronchitis or bronchopneumonia associated with inhalation of polystyrene particles (rare)
    Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Polystyrene Sulfonate. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.Nursing Mothers: 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 this product is administered to a nursing woman.
    Precaution: Renal failure and conditions requiring a restricted sodium intake e.g. heart failure and severe hypertension. Rectal admin to neonates and children. Monitor for electrolyte disturbances and symptoms of hypokalaemia. Discontinue treatment if clinically significant constipation develops. Irrigate colon after admin of enema to ensure removal of resin. Pregnancy; lactation. Lactation Not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant
    Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea.
    Store below 30°C. Keep out of the reach of children. Suspension of this drug should be freshly prepared and not to be stored beyond 24 hours.
    Calcium Regulator
    Sodium polysytrene sulfonate exchanges sodium ions for potassium ions and other cations in the GI tract before the resin is excreted in the faeces.
    Pregnancy Category C. Animal reproduction studies have not been conducted with Sodium Polystyrene Sulfonate. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.Nursing Mothers: 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 this product is administered to a nursing woman.
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