Phospho-soda (Solution) Instructions for Use

Marketing Authorization Holder

Casen Recordati, S.L. (Spain)

ATC Code

A06AD17 (Sodium phosphate)

Dosage Form

Phospho-soda

Oral solution: 45 ml bottle 2 pcs.

Dosage Form, Packaging, and Composition

Oral solution transparent, colorless, with a faint characteristic odor.

45 ml of the preparation (1 bottle) contains 5 g of sodium and 15 g of sodium benzoate.

Excipients: purified water, glycerol (E422), sodium saccharin, sodium benzoate (E211), ginger and lemon flavor*.

Composition of ginger and lemon flavor: ginger oil, alcohol, lemon oil, partially stabilized lemon oil, citric acid, water.

45 ml – polyethylene bottles (2) – cardboard packages.

Clinical-Pharmacological Group

Laxative drug with osmotic properties

Pharmacotherapeutic Group

Laxative

Pharmacological Action

Laxative drug with osmotic properties.

The mechanism of action of the drug is based on increasing the retention of water in the lumen of the small intestine through osmotic processes. The accumulation of fluid in the ileum leads to increased peristalsis and subsequent bowel cleansing.

Pharmacokinetics

The drug has only a local action, therefore pharmacokinetic studies are not considered necessary. Sodium phosphate is poorly absorbed from the gastrointestinal tract, however, slight absorption of sodium and phosphate ions occurs and is dose-dependent.

Indications

• Preparation for endoscopic or radiological examination of the colon;
• Preparation for surgical intervention on the colon.

ICD codes

Dosage Regimen

The drug is used in adults and adolescents over 15 years of age. No dose adjustment is required for elderly patients.

Administration of Phospho-soda should begin on the day preceding the scheduled endoscopic or radiological procedure. If the procedure is scheduled for a time before noon, it is recommended to follow the instructions for morning administration. If the procedure is scheduled for a time after noon, it is recommended to follow the instructions for afternoon administration.

Morning administration

Day before the procedure

At 7:00 AM, instead of breakfast, drink at least 1 glass of “clear liquids” (including soups cleared of solid particles, fruit juices without pulp, tea and coffee, clear carbonated and non-carbonated soft drinks) or water.

The first dose of the drug should be taken immediately after breakfast. Dissolve the contents of 1 bottle (45 ml) in half a glass (120 ml) of cold water. Drink the prepared solution and follow with one (or more) glass (240 ml) of cold water.

At 1:00 PM, instead of lunch, drink at least 3 glasses (720 ml) of “clear liquids” or water.

At 7:00 PM, instead of dinner, drink at least 1 glass of “clear liquids” or water.

The second dose of the drug should be taken immediately after dinner. Dissolve the contents of the second bottle (45 ml) in half a glass (120 ml) of cold water. Drink the prepared solution and follow with one (or more) glass (240 ml) of cold water.

If desired, a larger volume of fluid can be consumed. “Clear liquids” and water can be consumed until midnight.

Afternoon administration

Day before the procedure

At 1:00 PM, during lunch, a light snack is allowed. After lunch, no solid food should be consumed.

At 7:00 PM, instead of dinner, drink 1 glass of “clear liquids” or water. If desired, a larger volume of fluid can be consumed.

The first dose of the drug should be taken immediately after dinner. Dissolve the contents of the second bottle (45 ml) in half a glass (120 ml) of cold water. Drink the prepared solution and follow with one (or more) glass (240 ml) of cold water. If desired, a larger volume of fluid can be consumed.

During the evening, it is necessary to drink at least 3 glasses of “clear liquids” or water.

Day of the procedure

At 7:00 AM, instead of breakfast, drink 1 glass of “clear liquids” or water. If desired, a larger volume of fluid can be consumed.

The second dose of the drug should be taken immediately after breakfast. Dissolve the contents of the second bottle (45 ml) in half a glass (120 ml) of cold water. Drink the prepared solution and follow with one (or more) glass (240 ml) of cold water.

Water and “clear liquids” can be consumed until 8:00 AM.

This preparation usually induces a bowel movement within half an hour to 6 hours.

Adverse Reactions

From the digestive system nausea, vomiting, abdominal pain, abdominal bloating, diarrhea; very rarely – during endoscopy, single or multiple aphthous-like formations may be observed on the mucosa of the sigmoid and rectum (clinically insignificant, disappear spontaneously without treatment).

From the CNS asthenia, weakness, headache, dizziness.

From metabolism in individual patients from risk groups – dehydration and/or electrolyte imbalance (including hyperphosphatemia, hypocalcemia, hypokalemia, hypernatremia, acidosis).

Other allergic reactions.

Contraindications

The drug should not be used in patients with the following diseases, conditions, or suspicions thereof

• Partial or complete intestinal obstruction;
• Impaired integrity of the intestine;
• Megacolon (congenital or acquired);
• Acute inflammatory bowel diseases;
• Heart failure;
• Renal failure;
• Presence of nausea, vomiting, abdominal pain;
• Childhood and adolescence under 15 years;
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Phospho-soda should not be used during pregnancy, as there is insufficient reliable information on the ability of the drug to toxically affect the fetus and/or cause its malformation.

Since sodium phosphate is excreted in breast milk, breastfeeding should be discontinued immediately after taking the first dose of the drug and for the following 24 hours after taking the last dose.

Use in Renal Impairment

Use of the drug is contraindicated in renal failure.

Pediatric Use

The drug is contraindicated in children and adolescents under 15 years of age.

Geriatric Use

The drug should be used with caution in elderly patients.

Special Precautions

The drug should not be used as a means for treating constipation.

The drug should be used with caution in elderly patients, debilitated patients, those with reduced renal function, heart disease, colostomy, those on a low-salt diet, since there is a possibility of developing hyperphosphatemia, hypocalcemia, hypokalemia, dehydration against a background of hypernatremia, acidosis.

The patient should be warned about the possible frequent loose stools.

Very rarely, during endoscopy, single or multiple aphthous-like changes were observed on the mucosa of the sigmoid and rectum: lymphoid follicles, discrete inflammatory formations, or changes caused by the preparation performed. These abnormalities are not clinically significant and disappear spontaneously without treatment.

Rarely, QT interval prolongation on the ECG may be observed as a result of electrolyte imbalance such as hypocalcemia or hypokalemia.

Effect on ability to drive vehicles and operate machinery

The drug does not affect the ability to drive vehicles and operate machinery.

Overdose

Cases of fatal outcome due to hyperphosphatemia with concomitant hypocalcemia, hypernatremia and acidosis have been described after using the drug in high doses in children and patients with constipation.

At the same time, there are cases of complete recovery after accidental overdose of the drug in children or patients with constipation (one of them received a 6-fold dose of the agent).

Drug Interactions

The drug should be used with caution in patients taking calcium channel blockers, diuretics, lithium-based agents and other drugs that can affect electrolyte levels, since there is a possibility of developing hyperphosphatemia, hypocalcemia, hypokalemia, dehydration against a background of hypernatremia, acidosis.

During the administration of Phospho-soda, the absorption of drugs in the gastrointestinal tract may be delayed or stopped. The effect of regularly taken drugs (including antibiotics, oral contraceptives, antiepileptic and hypoglycemic agents) may be reduced or absent altogether.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

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.