Kolokit (Tablets) Instructions for Use

Marketing Authorization Holder

Laboratoires Mayoly-Spindler (France)

Manufactured By

Wellspring Pharmaceutical, Corp. (Canada)

ATC Code

A06AD (Osmotic laxatives)

Active Substances

Sodium dihydrogen phosphate (BP British Pharmacopoeia)

Sodium hydrogen phosphate (Group Name)

Dosage Form

Kolokit

Tablets: 32 pcs.

Dosage Form, Packaging, and Composition

Excipients: macrogol 8000 – 167.6 mg, magnesium stearate – 8.4 mg.

32 pcs. – high-density polyethylene bottles (1) – cardboard packages.

Clinical-Pharmacological Group

Laxative drug with osmotic properties

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Saline laxative.

The action is based on increasing fluid retention in the intestine through osmotic processes.

When taken orally, the accumulation of fluid in the ileum leads to stretching of its walls, increased peristalsis, and subsequent bowel emptying.

Pharmacokinetics

Sodium phosphate is poorly absorbed in the intestine; however, absorption of sodium and phosphate ions does occur and is dose-dependent.

Indications

For oral administration bowel preparation for endoscopic examination of the colon or for radiological examination of the colon, for operations requiring the absence of contents in the colon, for radiological examination of the abdominal organs.

ICD codes

Dosage Regimen

For oral administration according to a special schedule for bowel preparation prior to a medical procedure.

Take the tablets with a full glass of clear liquid. Do not chew or crush the tablets.

Adults and elderly patients: The total dose is 20 tablets. Take 4 tablets with 240 mL (8 oz) of clear liquid every 15 minutes until all 20 tablets are consumed.

Complete the regimen the evening before the procedure. Do not take any other laxatives concurrently.

Maintain adequate fluid intake before, during, and after administration to prevent dehydration.

Discontinue use and consult a physician if no bowel movement occurs within 6 hours of taking the first dose.

Do not use for the treatment of constipation. This regimen is for bowel cleansing only.

Adverse Reactions

Immune system disorders very rarely – hypersensitivity reactions.

Metabolism and nutrition disorders infrequently – dehydration; very rarely – hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremia, metabolic acidosis, tetany.

Nervous system disorders: very frequently – dizziness; frequently – headache; very rarely – loss of consciousness, paresthesia, generalized tonic-clonic seizures.

Cardiac and vascular disorders very rarely – myocardial infarction, arrhythmia, arterial hypotension.

Gastrointestinal disorders very frequently – diarrhea, abdominal pain, abdominal distension, nausea; frequently – vomiting, deviations during visual examination at colonoscopy.

Skin and subcutaneous tissue disorders: very rarely – allergic dermatitis.

Musculoskeletal and connective tissue disorders very rarely – muscle spasm.

Renal and urinary disorders very rarely – increased urine nitrogen, increased creatinine, acute renal failure, nephrocalcinosis, acute phosphate nephropathy and acute tubular necrosis.

General disorders and administration site conditions very frequently – chills, asthenia; frequently chest pain.

Contraindications

In the presence of the following diseases/conditions/risk factors or suspicion of them: partial or complete gastrointestinal obstruction; primary hyperparathyroidism associated with hypercalcemia; ascites; gastrointestinal perforations; megacolon (congenital or acquired); acute inflammatory bowel diseases, ulcerative intestinal lesions; acute hemorrhoids, anal fissures; intestinal obstruction (ileus); heart failure; impaired renal function; hypokinesia syndrome (resulting from hypothyroidism, scleroderma); concomitant use with other laxatives containing sodium phosphate; nausea, vomiting, abdominal pain; hypersensitivity to the active substances; age under 18 years, pregnancy, breastfeeding period.

With caution

General debilitated condition or elderly age; acute myocardial infarction; unstable angina; arterial hypotension; changes in body salt concentrations (electrolyte imbalance) or risk of their development, for example, in case of dehydration; use of drugs that can lead to dehydration; impaired gastrointestinal motor-evacuation function of the hypokinetic type; colostomy or ileostomy; stomach or intestinal surgery or surgical intervention leading to subsequent partial obstruction (except for appendectomy); low sodium diet; patients on a low sodium diet; patients taking ACE inhibitors, angiotensin receptor blockers or diuretics, parathyroid hormone.

Use in Pregnancy and Lactation

Contraindicated for oral use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Use with caution in cases of impaired liver function.

Use in Renal Impairment

The drug is contraindicated for use in cases of impaired renal function.

Pediatric Use

The drug is contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

There are rare reports of serious and potentially fatal cases of electrolyte disturbances in elderly patients. The benefit/risk ratio should be considered before starting the use of this combination in at-risk patients.

Special Precautions

This oral combination is not intended for the treatment of constipation.

There are rare reports of serious and potentially fatal cases of electrolyte disturbances in elderly patients. The benefit/risk ratio should be considered before starting the use of this combination in at-risk patients.

When using this product, patients should maintain adequate fluid intake. Electrolyte levels should be monitored before and after use.

If no bowel movement occurs within 6 hours after oral administration, the patient should be asked to discontinue use of this product and consult a doctor, as dehydration may develop.

In rare cases, nephrocalcinosis with acute renal failure and deposition of calcium phosphate crystals in the renal tubules has been reported in patients taking sodium phosphate for bowel cleansing. Nephrocalcinosis is a serious adverse reaction that can lead to irreversible renal impairment requiring long-term dialysis. Most cases of nephrocalcinosis occurred in elderly women receiving antihypertensive drugs or other medications (e.g., diuretics or NSAIDs) that can cause dehydration.

Symptoms of overdose: dehydration, hypotension, tachycardia, bradycardia, tachypnea, cardiac arrest, shock, respiratory arrest, dyspnea, convulsions, paralytic ileus, anxiety, pain.
Overdose can lead to increased serum sodium and phosphate concentrations and decreased calcium and potassium concentrations. This may result in hypernatremia, hyperphosphatemia, hypocalcemia, hypokalemia, and acidosis. Overdose therapy: rehydration and intravenous administration of calcium gluconate.

Effect on ability to drive and operate machinery

Should not be used in patients driving vehicles and/or operating machinery on the day of preparation and the procedure due to the possibility of side effects, or patients should refrain from driving vehicles and/or operating machinery.

Drug Interactions

Concomitant use with calcium channel blockers, diuretics, lithium preparations, or other drugs that can affect serum electrolyte concentrations increases the likelihood of developing hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremic dehydration, or acidosis.

When used concomitantly with this combination, the effectiveness of oral contraceptives, antiepileptic drugs, and hypoglycemic agents may be partially reduced or completely absent.

Caution should also be exercised when used concomitantly with drugs that can prolong the QT interval.

Use with caution in patients receiving parathyroid hormone preparations.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.