Resinsodio

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Resinsodio uses



CMP Pharma, Inc.

Cation-Exchange Resin

Rx Only

DESCRIPTION

Resinsodio Suspension USP (SPS® Suspension) can be administered orally or in an enema. It is a cherry-flavored suspension containing 15 grams of cation-exchange resin (Sodium Polystyrene Sulfonate USP); 21.5 mL of Sorbitol Solution USP (equivalent to approximately 20 grams of Sorbitol); 0.18 mL (0.3%) of Alcohol per 60 mL of suspension. Also contains Purified Water USP; Propylene Glycol USP; Magnesium Aluminum Silicate NF; Sodium Saccharin USP; Methylparaben NF; Propylparaben NF; and flavor.

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

The sodium content of the suspension is 1500 mg (65 mEq) per 60 mL. It is a brown, slightly viscous suspension with an in‑vitro exchange capacity of approximately 3.1 mEq (in-vivo approximately 1 mEq) of potassium per 4 mL (1 gram) of suspension. It can be administered orally or in an enema.

Chemical Structure

CLINICAL PHARMACOLOGY

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. For the most part, this action occurs 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. It commonly approximates the order of 33%, but the range is so large that definitive indices of electrolyte balance must be clearly monitored.

Metabolic data are unavailable.

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INDICATION AND USAGE

SPS® Suspension is indicated for the treatment of hyperkalemia.

CONTRAINDICATIONS

SPS® 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 ).

WARNINGS

Intestinal Necrosis

Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events have been reported in association with Resinsodio 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 ).

Alternative Therapy in Severe Hyperkalemia

Since the effective lowering of serum potassium with Resinsodio may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Hypokalemia

Serious potassium deficiency can occur from Resinsodio therapy. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with Resinsodio should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.

Electrolyte Disturbances

Like all cation-exchange resins, Resinsodio is not totally selective in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving Resinsodio should be monitored for all applicable electrolyte disturbances.

Systemic Alkalosis

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Resinsodio. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Resinsodio with magnesium hydroxide as a laxative (See PRECAUTIONS, Drug Interactions ).

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PRECAUTIONS

Caution is advised when Resinsodio is administered to patients who cannot tolerate even a small increase in sodium loads. In such instances compensatory restriction of sodium intake from other sources may be indicated.

Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

In the event of clinically significant constipation, treatment with SPS® Suspension should be discontinued until normal bowel motion is resumed (See WARNINGS, Intestinal Necrosis ).

Drug Interactions

Antacids

The simultaneous oral administration of Resinsodio with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability.

Nonabsorbable cation-donating antacids and laxatives

Systemic alkalosis has been reported after cation exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Resinsodio. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Resinsodio with magnesium hydroxide as a laxative.

Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with Resinsodio has been reported.

Digitalis

The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range".

Sorbitol

Concomitant use of sorbitol with Resinsodio has been implicated in cases of intestinal necrosis, which may be fatal (See WARNINGS ).

Lithium

SPS® Suspension may decrease absorption of lithium.

Thyroxine

SPS® Suspension may decrease absorption of thyroxine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with Resinsodio. It is also not known whether Resinsodio can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Resinsodio 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 Resinsodio is administered to a nursing woman.

Pediatric Use

The effectiveness of SPS® Suspension in pediatric patients has not been established. The use of SPS® Suspension is contraindicated in neonates and especially in premature infants. In children and neonates, particular care should be observed with rectal administration, as excessive dosage could result in impaction of the resin. Precautions should be taken to ensure the use of adequate volumes of sodium-free cleansing enemas after rectal administration.

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ADVERSE REACTIONS

SPS® 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 Resinsodio, has been reported.

The following events have been reported from worldwide post marketing experience:

OVERDOSAGE

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. Tetany may occur. Electrocardiographic changes may be consistent with hypokalemia or hypocalcemia; cardiac arrhythmias may occur. 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.

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DOSAGE AND ADMINISTRATION

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 SPS® Suspension one to four times daily. Each 60 mL of SPS® 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.

SPS® 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.

SPS® 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 should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped into place. The suspension is introduced at body temperature by gravity. The suspension is flushed with 50 or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. The suspension is kept in the sigmoid colon for several hours, if possible. Then the colon is irrigated with a sodium-free cleansing enema at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. Particular attention should be paid to this cleansing enema, because sorbitol is present in the vehicle.

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

SPS® Suspension should not be heated for to do so may alter the exchange properties of the resin.

HOW SUPPLIED

SPS® Suspension is a light brown, cherry-flavored suspension supplied in pint (473 mL) bottles (NDC 46287-006-01), 120 mL bottles (NDC 46287-006-04), and 60 mL unit dose bottles, 10 bottles per carton (NDC 46287-006-60).

Dispense in a tight container, as defined in the USP. If repackaging into other containers, store in refrigerator and use within 14 days of packaging.

SHAKE WELL BEFORE USING.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F)..

CMP Pharma, Inc.

P.O. Box 147

Farmville, North Carolina 27828

Revised January 2015

Copyright © CMP Pharma, Inc. 2015

NDC 46287–006–01

473 mL

SPS® Suspension

Resinsodio SUSPENSION, USP

For Oral or Rectal Use

Resinsodio USP 15 g/60 mL

Also contains: Sorbitol Solution USP (equivalent to

approximately 20 g of Sorbitol), Alcohol 0.3%, Purified

Water USP, Propylene Glycol USP, Magnesium Aluminum

Silicate NF, Sodium Saccharin USP, Methylparaben NF,

Propylparaben NF, & Flavor

Sodium content 1.5 g (65 mEq) in 60 mL

USUAL DOSE: See accompanying package insert for full

information.

Store at 20°-25°C (68°-77°F); excursions permitted

to 15°-30°C (59°-86°F). [See USP Controlled Room

Temperature].

Dispense in a tight container, as defined in the USP.

LOT:

EXP:

SHAKE WELL

Rx Only

cmp

PHARMA

Farmville, NC 27828

Resinsodio pharmaceutical active ingredients containing related brand and generic drugs:

Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Resinsodio available forms, composition, doses:

Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Resinsodio destination | category:

Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Resinsodio Anatomical Therapeutic Chemical codes:

A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Resinsodio pharmaceutical companies:

Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."SODIUM POLYSTYRENE SULFONATE SUSPENSION [CMP PHARMA, INC.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Resinsodio?

Depending on the reaction of the Resinsodio after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Resinsodio not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Resinsodio addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Resinsodio, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Resinsodio consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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