Kayexalate — FDA prescribing information, side effects and uses

Kayexalate

Generic Name: sodium polystyrene sulfonate
Dosage Form: powder, for suspension

Medically reviewed by Drugs.com. Last updated on Jun 21, 2019.

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Indications and Usage for Kayexalate

Kayexalate is indicated for the treatment of hyperkalemia.

Limitation of Use:

Kayexalate should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action [see Clinical Pharmacology (12.2)] .

2 DOSAGE AND ADMINISTRATION

2.1 General Information

Administer Kayexalate 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 (5.5) and Drug Interaction (7)]

2.2 Recommended Dosage

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

The average total daily adult dose of Kayexalate is 15 g to 60 g, administered as a 15-g dose (four level teaspoons), one to four times daily.

The average adult dose is 30 g to 50 g every six hours.

2.3 Preparation and Administration

Prepare suspension fresh and use within 24 hours.

Do not heat Kayexalate as it could alter the exchange properties of the resin.

One level teaspoon contains approximately 3.5 g of Kayexalate and 15 mEq of sodium.

Suspend each dose in a small quantity of water or syrup, approximately 3 to 4 mL of liquid per gram of resin. Administer with patient in an upright position [see Warnings and Precautions (5.4)] .

After an initial cleansing enema, insert a soft, large size (French 28) rubber tube into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and tape in place.

Administer as a warm (body temperature) emulsion in 100 mL of aqueous vehicle and flush with 50 to 100 ml of fluid. A somewhat thicker suspension may be used, but do not form a paste.

Agitate the emulsion gently during administration. The resin should be retained for as long as possible and follow by a cleansing enema with a nonsodium containing solution. Ensure an adequate volume of cleansing solution (up to 2 liters) is utilized.

3 DOSAGE FORMS AND STRENGTHS

Kayexalate is a cream to light brown, finely ground powder and is available in 453.6 g jars.

4 CONTRAINDICATIONS

Kayexalate is contraindicated in patients with the following conditions:

  • Hypersensitivity to polystyrene sulfonate resins
  • Obstructive bowel disease
  • Neonates with reduced gut motility

5 WARNINGS AND PRECAUTIONS

5.1 Intestinal Necrosis

Cases of intestinal necrosis, some fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Kayexalate 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 sorbitol is not recommended.

  • 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.

5.2 Electrolyte Disturbances

Monitor serum potassium during therapy because severe hypokalemia may occur.

Kayexalate is not totally selective for potassium, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Monitor calcium and magnesium in patients receiving Kayexalate.

5.3 Fluid Overload in Patients Sensitive to High Sodium Intake

Each 15 g dose of Kayexalate contains 1500 mg (60 mEq) of sodium. Monitor patients who are sensitive to sodium intake (heart failure, hypertension, edema) for signs of fluid overload. Adjustment of other sources of sodium may be required.

5.4 Risk of Aspiration

Cases of acute bronchitis or bronchopneumonia caused by inhalation of sodium polystyrene sulfonate particles have been reported. Patients with impaired gag reflex, altered level of consciousness, or patients prone to regurgitation may be at increased risk. Administer Kayexalate with the patient in an upright position.

5.5 Binding to Other Orally Administered Medications

Kayexalate may bind orally administered medications, which could decrease their gastrointestinal absorption and lead to reduced efficacy. Administer other oral medications at least 3 hours before or 3 hours after Kayexalate. Patients with gastroparesis may require a 6 hour separation. [see Dosage and Administration (2.1) and Drug Interactions (7)] .

6 ADVERSE REACTIONS

The following adverse reactions are discussed elsewhere in the labeling:

The following adverse reactions have been identified during post-approval use of Kayexalate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.

Gastrointestinal: anorexia, constipation, diarrhea, fecal impaction, gastrointestinal concretions (bezoars), ischemic colitis, nausea, ulcerations, vomiting, gastric irritation, intestinal obstruction (due to concentration of aluminium hydroxide)

Metabolic: systemic alkalosis

7 DRUG INTERACTIONS

7.1 General Interactions

No formal drug interaction studies have been conducted in humans.

Kayexalate has the potential to bind other drugs. In in vitro binding studies, Kayexalate was shown to significantly bind the oral medications (n=6) that were tested. Decreased absorption of lithium and thyroxine have also been reported with co-administration of Kayexalate. Binding of Kayexalate to other oral medications could cause decreased gastrointestinal absorption and loss of efficacy when taken close to the time Kayexalate is administered. Administer Kayexalate at least 3 hours before or 3 hours after other oral medications. Patients with gastroparesis may require a 6 hour separation. Monitor for clinical response and/or blood levels where possible.

See also:  Millipedes, Millipede Pest Control

7.2 Cation-Donating Antacids

The simultaneous oral administration of Kayexalate with nonabsorbable cation-donating antacids and laxatives may reduce the resin’s potassium exchange capability and increase the risk of systemic alkalosis.

7.3 Sorbitol

Sorbitol may contribute to the risk of intestinal necrosis [see Warnings and Precautions (5.1)] and concomitant use is not recommended.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Kayexalate is not absorbed systemically following oral or rectal administration and maternal use is not expected to result in fetal risk.

8.2 Lactation

Kayexalate is not absorbed systemically by the mother, so breastfeeding is not expected to result in risk to the infant.

8.4 Pediatric Use

Studies of safety and efficacy have not been conducted in pediatric patients.

In pediatric patients, as in adults, Kayexalate is expected to bind potassium at the practical exchange ratio of 1mEq potassium per 1 gram of resin.

In neonates, Kayexalate should not be given by the oral route. In both children and neonates, excessive dosage or inadequate dilution could result in impaction of the resin. Premature infants or low birth weight infants may have an increased risk for gastrointestinal adverse effects with Kayexalate use [see Warnings and Precautions (5.4)] .

Overdosage

Overdosage may result in electrolyte disturbances including hypokalemia, hypocalcemia, and hypomagnesemia. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium, magnesium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

11 DESCRIPTION

Kayexalate is a benzene, diethenyl-polymer, with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:

The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq ( in vivo approximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or rectally as an enema.

One gram of Kayexalate contains 4.1 mEq of sodium.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Kayexalate is a non-absorbed, cation exchange polymer that contains a sodium counterion.

Kayexalate 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.

12.2 Pharmacodynamics

The effective lowering of serum potassium with Kayexalate may take hours to days.

12.3 Pharmacokinetics

The in vivo efficiency of sodium-potassium exchange resins is approximately 33 percent; hence, about one third of the resin’s actual sodium content is delivered to the body.

Kayexalate is not absorbed systemically.

In vitro binding studies showed that Kayexalate bound significantly to the following tested drugs – warfarin, metoprolol, phenytoin, furosemide, amlodipine and amoxicillin.

13 NONCLINCAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed.

16 HOW SUPPLIED/STORAGE AND HANDLING

Kayexalate is available as a cream to light brown, finely ground powder in jars of 1 pound (453.6 g), NDC 59212-075-01.

Store at 25° C (77° F); excursions permitted to 15° – 30° C (59° – 86° F) [see USP Controlled Room Temperature]

Patient Counseling Information

Advise patients who are taking other oral medication to separate the dosing of Kayexalate by at least 3 hours (before or after) [see Dosage and Administration (2.1), Warnings and Precautions (5.5), and Drug Interactions (7.1)]

Concordia Pharmaceutical Inc.
St. Michael, Barbados BB11005

©2015, 2017. Concordia Pharmaceuticals Inc. All rights reserved.

PRINCIPAL DISPLAY PANEL — 453.6 g Jar

NDC 59212-075-01 K-450 Rx only

sodium polystyrene
sulfonate, USP

Read package insert.

Average adult dose: 15 g (approximately 4 level
teaspoons) one to four time daily in water. See
complete prescribing information.

The effect must be carefully controlled by frequent
serum potassium determinations within each 24 hour
period. Sodium content approximately 60 mEq per 15 g.

Suspension should be freshly prepared and not
stored beyond 24 hours. dispense in tight, light-
resistant containers as defined in the official
compendia.

Store at 25°C (77°F); excursions permitted to
15°–30°C (59°–86°F) [see USP Controlled Room
Temperature].

Mfd. for: Concordia Pharmaceuticals Inc.
St. Michael, Barbados

www.drugs.com

7 Best Roach Bait (Reviewed by TH)

Cockroaches are one of the world’s most commonly found house insects. There are plenty of places where these tiny pests can be found but most abundantly are found in warm, moist or dark places. These creepy crawlies when at first invade your home are not much of a nuisance but the real problem starts, when they start growing in number and creep out of every other nook and corner of your house.

Here are some Best Roach baits you must Consider:

1. Advion Cockroach Gel Bait

Advion Cockroach Gel Bait is one of the most widely used and one of the high performing products designed for targeting all species of including German (also gel bait-averse), American, Australian, Brown, Smokybrown, Oriental, Brownbanded and Asian cockroaches.

Before going in more depth details, lets have a look at comparison table:

It is produced by Syngenta–a Chinese owned global company.

It combines a highly attractive gel based formulation with a potent non-repellent active ingredient which makes it impossible for cockroaches to resist this superior combination and even the toughest populations are quickly controlled.

The active ingredient present in Advion Cockroach Gel Bait includes indoxacarb that is known to be an effective roach killer.Upon entering an insect, indoxacarb is converted into a new molecule which has insect killing properties. This process is activated specifically by the insect’s own enzymes.

Since it is a gel product, it can be easily used both indoors and outdoors.

This product is handy too as it can be used in kitchens and in commercial, industrial, and residential areas. It can be used easily in the smallest places of roach activity such as along crevices, walls under the sink, in cabinets over the windows etc.

It is advised to keep out of reach of children and pets.

2. Combat Max Roach Bait Station

    Kills roaches fast Kills large roaches and entire nest too Effectively kills and non-stop for three months Can easily be used near food handling areas. The bait comes enclosed in a station out of the box, which makes it comparatively safer to use
    As other roach bait stations, this need to be kept out of the reach of pets and children. The bait doesn’t stop reproduction of roaches
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Combat roach bait stations are manufactured by a German Global company known as Henkel Ltd. and operates worldwide with leading brands & technologies in three business areas: Laundry & Home Care, Beauty Care and Adhesive Technologies. One of their renowned insect control brand is Combat.

This is one of the best cockroach bait station products for battling many troublesome and bigger roaches.

Mechanism of Action: Combat roach bait station is easy to use and quick to set up and leaves no vapours or smell.

The active ingredients present in this product are Fopronil and hydramethylnon–both of these are fast acting chemicals.

Fipronil works by disrupting the normal function of the central nervous system in insects.It is more toxic to insects than people and pets because it is more likely to bind to insect nerve endings.

Hydramethylnon is a slow-acting stomach poison which gives time to survive long enough to take the bait back to the colony and share it with others, killing off the entire population. Because it infects roaches that have not had direct exposure to the hydramethylnon, it is said the ingredient has a high secondary kill rate

It one of the best products in terms of immediate effectiveness and long-lasting results. In addition is perfect to be used in areas like under sinks, behind toilets and appliances.

Combat roach bait satiation is effective for treating even largest infestation, provided it is placed correctly around the habitat of roaches. It provides effective control against roaches by destroying the entire nest for up to 3 months .

3. Maxforce FC Roach Bait Station

    Leaves no odor or residue Can easily be used near food handling areas. Effective for household use and also for commercial areas Has long lasting effect
    Should be kept out of the reach of children and pets

Maxforce roach bait stations are produced by a multinational company called Bayer which deals with a variety of insecticides and pest control products.

Fipronil is the active ingredient in this product. It is highly effective and quick killer and has a long lasting effect. It works by disrupting the normal function of the central nervous system in insects and gives fast control

The Maxforce roach bait stations are very easy to use. Kill wide range of cockroaches including German cockroaches too and do not leave any odor or residue.

Although these bait stations are safe for kids or pets but care should be taken whilst using the product as short term contact with skin can result in slight skin irritation

These roach bait stations can be used in a number of places – in homes near food processing and handling areas in warehouses, in commercial areas, in hospitals, schools etc.

Another positive point about this product is that it has adhesive on back which allows convenient placement on walls or other vertical surfaces

3. Hot Shot Ultra Liquid Bait

    Easy to use for small spaces Kills roaches fast and their eggs Provides food and water source Kills both large and small roaches Affordable and can work up to two months Easy cleanup Kills ants too
    Suitable to be used indoors The plastic station must be used in a place where the cockroaches will enter it. Otherwise, the product will not work

‘Raid Double Control Small Roach Baits’ are designed for providing relief from severe roach problems whereas ‘Raid Plus Egg Stoppers’ prevent roach reproduction.

These products are produced by an American privately held company known as SC Johnson. They specialize in producing house cleaning products and insecticides.

This product comes with 12 small roach bait stations and 3 sterilizers or egg stoppers.Raid baits are unique because these can control reproduction and kill roaches at all stages of their life cycle. But are not effective in bigger infestations and may not kill the larger roaches.

The active ingredient in (Small Roach Baits) is Avermectin B1 (0.05 %) along with other ingredients where in (Egg Stopper) is S-Hydroprene and other ingredients. These baits are child resistant products, however, should be used with caution.

Since there are two separate products, so let’s look at how these can be used individually.

Instruction to Use:

Separate baits before placement

Place the baits next to the wall along baseboards, in corners, under sinks, in cabinets and near plumbing fixtures

For best results, use all 12 baits at once.

To keep roaches from returning, replace all baits every three months

Instruction to use Egg Stoppers™

To activate, press down firmly on the pouch on the side of the disc until a snapping sound is heard, indicating that the small capsule inside has been opened.

Place two per average size kitchen (one every 75 sq. ft.) or in areas of heavy roach activity.

Replace every three months for continued effectiveness.

4. Invict Gold Cockroach Gel bait

    Fast acting formula Can be used indoors and outdoors
    Targets German Roaches only Gel comes with a fragile plunger

Invict is a gel bait product manufactured by Rockwell Labs Ltd.—US based company that specializes in pest management products. It is an EPA approved product.

The active ingredient present in the product is 2.15% Imidacloprid –a slow acting poison that mimics the role of nicotine. It works by disrupting the nerves of the insects and freezes their nerve activities. Imidacloprid is more toxic to insects as compared to mammals and birds.

The active ingredient is present in minute quantities that is why it won’t be causing any inconvenience but ensure keeping an eye on your children and pets after applying it in your home.

Before buying this product, you should check which type of roaches is present in your house as using it on any other type won’t be effective.

How to Use: Application of the product is very easy. It is a ready to use bait and comes with a plunger. It can be easily used to the cracks along the walls and near the places with most roach activity.

5. Vendetta Roach Gel Bait

Another Gel Bait

    Highly palatable bait formulation Not runny in high temperature Attracts and kills bait averse and non averse roaches Can be placed anywhere and sticks to most surfaces in the house Dispenses smoothly and easily
    Harmful to fish and wildlife

Vendetta roach gel bait is light brown color product specially formulated to be highly attractive to cockroaches that are hard-to-kill.

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It is produced by an American company known as MGK–which provides numerous pest control products.

The active ingredient present in the Vendetta roach gel bait is 0.05% Abamectin . It acts on insects by interfering with brain signaling mechanism.

It is highly effective against all known types of cockroaches, including German, American, Brown, Oriental, Asian and many more.

It Leaves no odor or residue, making it very convenient for both indoor and outdoor use
Since it is used in very low quantities in insecticides it is not harmful for humans or pets but prolonged interaction might cause irritation in eyes and skin.

This gel bait product should be applied as follows:

For light infestation : 4-6 bait points or spots containing 0.25 to 0.50 grams of the product should be used per 100 sq feet of the area to be treated.

For heavy infestation of cockroaches : 12 to 24 baits points per 100 sq feet are recommended by the manufacturers.

6. Alpine Cockroach Gel Bait Insecticide

    Starts killing roaches within hours Labeled for use indoors and outdoors Attractive to bait-averse cockroaches
    Environmental stresses such as direct sunlight and water can reduce its effectiveness, so apply bait in protected areas whenever possible.

It is a Japanese gel based roach killer manufactured in USA by BASF Corporation. Alpine Cockroach Gel Bait can be used for virtually any roach infestation when a gel bait is desired.

Mechanism of Action: The active ingredient present in this product is Dinotefuran. Dinotefuran is a non-repellent active ingredient. Dinotefuran belongs to neuro-active insecticides that are modeled after nicotine. Dinotefuran is a central nervous system inhibitor that takes effect after insects ingest it.

The effects of the active ingredient are slow enough that roaches who have consumed this product come in contact with other roaches and transfer the active ingredient, either directly or indirectly through feeding on feces or poisoned dead ones. Thus eliminating the entire colonies.

10 spots per 100 sq. ft. – Low to moderate infestations

20 spots per 100 sq. ft. – Severe infestations

Use 3-6mm (1/8 – ¼”) diameter spots (0.25 – 0.50 g)

Ensure removing food sources for cockroaches for better results so that they eat only the gel bait. It is EPA approved and safe to use with care for humans.

For indoor use: This product can be applied to cracks and crevices in areas where roach activity has been observed or is likely to be seen such as near water sources, around pipe collars, around or under appliances, underneath counters, where cupboard frames meet the wall, along drawer slides, along baseboards, on door frames and window-sills.

Food handling areas – Limit application of the product to the cracks and crevices the insects are hiding in. Do not apply in open areas or surfaces where contamination of food and food handling equipment may occur.

For outside use: Inject into cracks and crevices around windows and doors, porches, screens, eaves, patios, garages, under stairways and other areas adjacent to structures where cockroaches may be find.

7. HaRuion Cockroach Gel Bait

No products found.

    Easy to apply Kills a variety of roaches effectively Good for residential and commercial use
    Cleaning of the product can be messy

HaRuion Cockroach Gel Bait is an EPA approved product manufactured in USA.

It works well to control numerous roach species including German, American, Australian,Smoky-Brown,Brown, Asian,Oriental and Brown-Banded etc.

Mechanism of Action:

It combines a highly attractive, proprietary gel formulation with a potent non-repellent active ingredient, cockroaches cannot resist this superior combination and come crawling towards this gel bait.

The Active ingredient present in this gel product is Indoxacarb 0.6% that is an excellent roach killer.

This product is also very easy to use and works well both indoors or outdoors. It can be applied to all places imagined to be infested by roaches.

It can be used in homes, offices, industrial areas,, warehouses, commercial kitchens, hospitals, schools, nursing homes, hotels, buses, trains, aircraft and other areas infested with cockroaches.

Instruction to Use:

In case of heavy infestations: apply 3-5 spots of gel per 10 linear feet.

For light to moderate infestations: apply 1-3 spots of gel bait per 10 linear feet.

Each spot of gel should be equal to about 0.5 grams

The product should be keep away from the reach of children

These can make your life living hell if aren’t controlled on time and can be found roaming around freely on kitchen shelves, counter top, in cooking utensils, in the pantry, on the ground and washrooms.

Similarly you might have observed roaches hiding in crack and crevices in your house, which if not controlled, might be found crawling on your skin one day or even worse can land on you–as some of them can fly. Also they can cause some serious health conditions that is why, it is very important to get rid of them as soon as possible in order to avoid getting caught up in a bigger infestation problem.

Like most insects, roaches like to nurture in some of the most filthy places such as dust bins, sewage pipes and drains.

What’s more disturbing and gross is the fact that– in search of food when they roam around in kitchens and food storage places, they happily leave secretions and feces thus transferring germs which can lead to allergy in humans and many other problems such as dermatitis, itching, swelling of the eyelids and some respiratory conditions.

Not just that, but they can also cause certain intestinal diseases, including diarrhoea, dysentery, typhoid fever and cholera in extreme cases, according to Word Health Organization, WHO.

Why Baits Are Most Efficient To Control Roaches?

Cockroaches are known as social insects and they prefer to live in colonies or nests. Baits are usually known as one of the effective means to kill roaches than any other way out there as they work by eliminating the entire colony or nest of roaches effectively.

Cockroaches upon consuming the bait carry the toxic material into their bodies and also bring it back to their colony, where other cockroaches either via eating their feces or by eating dead cockroaches consume the insecticide and get killed.

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