Kionex 15 g/60mL

Sodium Polystyrene Sulfonate · SUSPENSION · ANI Pharmaceuticals, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Kionex is a suspension containing sodium polystyrene sulfonate at 15 g/60mL, taken oral. Manufactured by ANI Pharmaceuticals, Inc..

Key Facts

Brand Name: Kionex
Generic Name: Sodium Polystyrene Sulfonate
NDC Code (Product): 62559-356
Manufacturer: ANI Pharmaceuticals, Inc.
Strength: 15 g/60mL
Dosage Form: SUSPENSION
Route: ORAL
Marketing Status
Application #: ANDA040028
Drug Class: Potassium Binder [EPC]
Marketing Start: 05/03/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

hyperkalaemia109 reports

diarrhoea108 reports

acute kidney injury99 reports

constipation97 reports

renal failure95 reports

chronic kidney disease91 reports

death82 reports

nausea76 reports

fatigue69 reports

vomiting69 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Kionex Suspension is indicated for the treatment of hyperkalemia.

Dosage & Administration

DOSAGE AND ADMINISTRATION Administer Kionex Suspension at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation (see WARNINGS and PRECAUTIONS, Drug Interactions ). The average daily adult dose is 15 g (60 mL) to 60 g (240 mL) of suspension. This is best provided by administering 15 g (60 mL) of Kionex Suspension one to four times daily. Each 60 mL of Kionex Suspension contains 1500 mg (65 mEq) of sodium. Since the in-vivo efficiency of sodium-potassium exchange resins is approximately 33%, about one-third of the resin’s actual sodium content is being delivered to the body. In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation. Administer with patient in an upright position (see WARNINGS ). Kionex Suspension may be introduced into the stomach through a plastic tube and, if desired, given with a diet appropriate for a patient in renal failure. Kionex Suspension may also be given, although with less effective results, as an enema consisting (for adults) of 30 g (120 mL) to 50 g (200 mL) every six hours. The enema …

Warnings

WARNINGS Intestinal Necrosis Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of additional sorbitol is not recommended (see PRECAUTIONS, Drug Interactions ). • Use only in patients who have normal bowel function. Avoid use in patients who have not had a bowel movement post-surgery. • Avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction). • Discontinue use in patients who develop constipation. Alternative Therapy in Severe Hyperkalemia Since the effective lowering of serum potassium with sodium polystyrene sulfo…

Contraindications

CONTRAINDICATIONS Kionex Suspension 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 ).

Adverse Reactions

ADVERSE REACTIONS Kionex Suspension may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, hypomagnesemia and significant sodium retention, and their related clinical manifestations, may occur (see WARNINGS ). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (see PRECAUTIONS ). Rare instances of intestinal necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported. The following events have been reported from worldwide post marketing experience: • Fecal impaction following rectal administration, particularly in children; • Gastrointestinal concretions (bezoars) following oral administration; • Ischemic colitis, gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and • Rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate (see WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1…

Frequently Asked Questions

What is Kionex used for?

Kionex contains Sodium Polystyrene Sulfonate. It is a suspension taken oral. Consult your doctor for specific uses.

Is Kionex a controlled substance?

Kionex is not classified as a controlled substance by the DEA.

What is the generic name for Kionex?

The generic name for Kionex is Sodium Polystyrene Sulfonate. There are 11 other brand versions of Sodium Polystyrene Sulfonate.

What is the NDC code for Kionex 15 g/60mL?

The NDC (National Drug Code) for Kionex 15 g/60mL is 62559-356, listed by ANI Pharmaceuticals, Inc..

Product NDC

62559-356

Package NDC

62559-356-01

Other Sodium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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