LacTEST^® (Powder) Instructions for Use

Marketing Authorization Holder

Novamedica, LLC (Russia)

Manufactured By

Farmasierra Manufacturing, S.L. (Spain)

Bom, S.A. (Spain)

Quality Control Release

Idifarma Desarrollo Farmaceutico, S.L. (Spain)

ATC Code

V04CX (Other diagnostic preparations)

Active Substance

Gaxilose (Prop.INN)

Dosage Form

LacTEST^®

Powder for preparation of oral solution: sachet 0.45 g

Dosage Form, Packaging, and Composition

Powder for preparation of oral solution crystalline, from white to white with a yellowish or grayish tint; reconstituted solution: a clear colorless solution.

	1 sachet
Gaxilose	0.45 g

0.45 g – sachets (1) – carton packs.

Pharmacotherapeutic Group

Other diagnostic agents

Pharmacological Action

Diagnostic agent. It is a disaccharide (4-galactosyl-xylose) that undergoes hydrolysis in the intestine by lactase to form galactose and xylose. Galactose enters the liver via the bloodstream, where it is converted into glucose.

Pharmacokinetics

After oral administration, Gaxilose is hydrolyzed by intestinal lactase to form galactose and xylose, which are absorbed in the small intestine. Unhydrolyzed Gaxilose is excreted by the intestine unchanged.

Clinical studies have shown that after oral administration of gaxilose in the dose range of 113 – 5400 mg, D-xylose is detected in blood and urine. The minimum dose of gaxilose for reliable detection of D-xylose in urine is 450 mg.

Indications

Diagnosis of lactase deficiency.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z03	Medical observation and evaluation for suspected disease or pathological condition

ICD-11 code	Indication
QA02	Medical observation or examination for suspected diseases or conditions that were ruled out

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally as a single dose for diagnostic purposes.

For adult patients, administer the entire contents of one 0.45 g sachet.

Dissolve the powder in a glass containing approximately 200 ml of water immediately before administration.

Ensure the patient has fasted overnight prior to administration.

Collect a baseline urine sample immediately before the dose is administered.

Instruct the patient to empty their bladder completely at the time of dosing.

Collect all urine produced over the subsequent 5-hour period following administration.

Ensure the total urine volume collected over this 5-hour period is measured and recorded for analysis.

Do not administer to patients with impaired renal function (GFR less than 90 ml/min/1.73 m²).

Discontinue drugs such as acetylsalicylic acid and indomethacin at least 48 hours prior to testing.

Adverse Reactions

Gastrointestinal disturbances are possible, including nausea, vomiting, abdominal pain, diarrhea, and bloating.

Other potential reactions include migraine, itching, and urticaria.

Contraindications

History of gastric resection and/or vagotomy.
Renal impairment with GFR less than 90 ml/min/1.73 m².
Hepatic impairment, portal hypertension (ascites, cirrhosis).
Diabetes mellitus.
Myxedema (severe hypothyroidism).
Hypersensitivity to gaxilose.
Pentosuria, galactosemia.
Children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is possible only if the intended benefit to the mother outweighs the potential risk to the fetus or child.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Use of gaxilose is possible only under strict medical supervision.

Before using gaxilose, an assessment of renal function must be performed.

For 48 hours before using gaxilose, the use of acetylsalicylic acid and indomethacin preparations should be excluded.

If the patient vomits during the study, the study can be repeated no earlier than 3 days later.

Drug Interactions

Discontinue preparations containing acetylsalicylic acid and indomethacin at least 48 hours prior to the test.

These substances can reduce the renal excretion of xylose, potentially leading to false-positive results.

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.

Medical Disclaimer