Glucose-tolerance test

Ukraine
Brand name Glucose-tolerance test
Form powder, dosed
Active substance / Dosage
glucose · 75 g
Prescription type over-the-counter (OTC)
ATC code
Registration number UA/0758/01/01
Manufacturer Farmak JSC
Glucose-tolerance test powder, dosed

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GLUCOSE TOLERANCE TEST

Composition:

Active ingredient: glucose monohydrate;

1 sachet contains: glucose monohydrate 75.0 g;

Excipient: citric acid monohydrate – 0.75 g.

Pharmaceutical form. Dosage powder.

Main physicochemical properties: granular powder of white or almost white color, odorless.

Pharmacotherapeutic group. Diagnostic agents. ATC code V04CA02.

Pharmacological Properties.

Pharmacodynamics.

The oral glucose tolerance test is used as a laboratory method in endocrinology for diagnosing impaired glucose tolerance (prediabetes) and diabetes mellitus.

Pharmacokinetics.

The drug is well absorbed in the gastrointestinal tract, enters the bloodstream, and subsequently penetrates all organs and tissues; metabolites are excreted in the urine.

Clinical characteristics.

Indications.

Used for performing the glucose tolerance test when blood glucose levels do not allow establishing a diagnosis of impaired glucose tolerance or diabetes mellitus.

Contraindications.

Increased individual sensitivity to dextrose.

Interaction with other medicinal products and other forms of interactions.

Not established.

Special precautions.

During the test, the patient should lie or sit quietly. Smoking, exposure to cold, and engaging in physical activity should be avoided immediately prior to the test.

The test is not recommended following severe illnesses, surgery, or childbirth; during inflammatory processes, infectious diseases, fever, malignant conditions, alcoholic liver cirrhosis, hepatitis, menstruation, or gastrointestinal disorders associated with impaired glucose absorption.

Medications (diuretics, morphine, diphenylhydantoin, adrenaline, glucocorticoids, contraceptives, caffeine, thiazide diuretics, psychotropic agents, and antidepressants) as well as therapeutic procedures that may affect blood glucose levels should be discontinued prior to and on the day of the test.

False-positive results may occur in cases of hypokalemia, liver dysfunction, and endocrinopathies.

Use during pregnancy or breastfeeding.

Oral glucose tolerance testing is not contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate when driving or operating machinery.

The Glucose Tolerance Test does not impair the ability to drive or operate machinery.

Dosage and Administration.

The patient should not reduce food intake for 3 days prior to the test. Immediately before the test, the patient must not eat for 10–16 hours. The test should be performed in the morning. First, the fasting blood glucose level is measured. Then, the contents of 1 sachet dissolved in 250 ml of water should be consumed within 5 minutes. When performing the test in individuals with excess body weight, add glucose monohydrate at a dose of 1 g per 1 kg of body weight, but not exceeding 100 g. Two hours later, measure the blood glucose level.

In children, after the first blood sample is taken from the finger, an aqueous solution of glucose monohydrate should be administered orally within 5 minutes at a dose of 1.75 g per 1 kg of body weight, but not exceeding 75 g.

Interpretation of Results. The test results can be evaluated using the table below (data refer to glucose levels in capillary blood).

Normal

Impaired glucose tolerance

Diabetes mellitus

2-hour value, SI units

< 7.8 mmol/L

7.8 – 11.0 mmol/L

≥ 11.1 mmol/L

2-hour value, mg/dL

< 140 mg/dL

140 – 199 mg/dL

≥ 200 mg/dL

For venous blood, threshold values will be approximately 1 mmol/L (18 mg/dL) lower.

Children. The test can be performed in children as indicated, without age restrictions.

Overdose.

After a single administration of a large amount of the drug, digestive disturbances (nausea, bloating, diarrhea) are possible. Symptomatic therapy is recommended.

Side effects.

Allergic reactions are possible in individuals with hypersensitivity.

Shelf life.

4 years. Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºС.

Keep out of reach of children.

Packaging. 75.75 g of powder in a sachet. 1 sachet per carton.

Category of supply. Over-the-counter.

Manufacturer: JSC "Farmak".

Manufacturer's name and address of the place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.