Isodibut

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT ISODIBUT® (ISODIBUT)

Composition:

Active substance: isodibut;

1 tablet contains isodibut® 500 mg (0.5 g);

Excipients: potato starch, lactose monohydrate, hypromellose (15), sodium starch glycolate, calcium stearate.

Pharmaceutical form. Tablets.

Main physicochemical properties: tablets from white to yellowish-white, round-shaped with flat surface, with a score line and chamfer. Mottling on the surface of tablets is permissible.

Pharmacotherapeutic group.

Medicinal products used in diabetes mellitus. Aldose reductase inhibitors.

ATC code A10XA.

Pharmacological properties.

Pharmacodynamics.

Izodibut® is an inhibitor of the enzyme aldose reductase. Izodibut® reduces the activity of aldose reductase by 1.5–3 times and increases the activity of sorbitol dehydrogenase by 1.2–1.4 times, thereby suppressing the sorbitol pathway of glucose metabolism (its activity is significantly increased in patients with diabetes mellitus) and preventing sorbitol accumulation in vascular walls, nerves, and lens. It inhibits protein glycation processes. Izodibut® prevents tissue swelling and damage, primarily in blood vessels, nerves, and the lens. It reduces the content of glycated proteins in blood and cellular membranes. The drug improves functional status, metabolism, and microcirculation in the brain, enhancing memory. It increases visual acuity and improves blood supply to the conjunctiva and retina. It enhances renal blood flow and reduces albuminuria. Izodibut® restores sensitivity and relieves pain in the lower limbs, accelerating ulcer healing. It reduces symptoms of peripheral neuropathy.

Pharmacokinetics.

After oral administration, the drug is almost completely absorbed from the gastrointestinal tract. Maximum blood concentration is reached within 3 hours; the elimination half-life is 6.5 hours. It does not accumulate in the body. Maintaining a constant therapeutic concentration is achieved by administering the drug three times daily. The drug is completely excreted by the kidneys in urine.

Clinical characteristics.

Indications.

As a preventive and therapeutic agent for complications of diabetes mellitus, such as: diabetic angiopathy of the lower extremities, retinopathy, nephropathy, polyneuropathy, encephalopathy, diabetic cataract.

Contraindications.

Hypersensitivity to the components of the drug. Renal and hepatic insufficiency.

Interaction with other medicinal products and other types of interactions.

Isodybute® potentiates the effects of angiotropic agents, antihypertensive drugs, insulin, oral hypoglycemic agents, α-lipoic acid, and sulfur-containing compounds (sodium thiosulfate, unithiol).

Special precautions for use

In gastrointestinal disorders, the drug should preferably be taken after meals.

The drug contains lactose; therefore, it should not be administered to patients with rare hereditary forms of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome.

Use during pregnancy or breastfeeding

Since the safety of the drug has not been studied in these patient groups, Izodibut® should be prescribed only when the expected therapeutic benefit for the mother outweighs the potential risk of adverse effects on the fetus/child.

Ability to affect reaction rate while driving or operating machinery

Izodibut® does not affect reaction speed while driving or operating machinery, as monotherapy with the drug does not cause hypoglycemia. However, caution should be exercised when using Izodibut® in combination with other hypoglycemic agents due to the risk of developing hypoglycemia.

Dosage and Administration

Take Isodyb® orally, one tablet (500 mg) three times daily, to adults and children aged 14 years and older. The maximum daily dose is 4 g. Treatment duration is 2–3 months. Repeat the course after 6 months. For prevention of diabetic complications, it is recommended to carry out two-month treatment courses twice a year.

Children

The drug is contraindicated in children under 14 years of age.

Overdose

In case of overdose, symptoms of hypoglycemia occur: sensation of hunger, increased sweating, weakness, palpitations, pallor of the skin, perioral paresthesia, tremor, anxiety, headache, abnormal drowsiness, sleep disturbances, fear, impaired motor coordination, and transient neurological disorders (speech and visual disturbances, development of paralysis or sensory disturbances). With progression of hypoglycemia, loss of self-control and consciousness may occur.

Treatment: gastric lavage (if the patient is conscious); in cases of mild or moderate hypoglycemia, administer glucose or sugar solution orally. In case of severe hypoglycemia (loss of consciousness), administer 40% glucose solution intravenously, or glucagon intravenously, intramuscularly, or subcutaneously. After recovery of consciousness, the patient should be given carbohydrate-rich food to prevent recurrence of hypoglycemia.

Side effects

The drug is usually well tolerated. In some patients, allergic reactions (skin rash, urticaria) are possible. These reactions occur more frequently in patients with polyvalent allergy. In such cases, the drug should be discontinued.

Shelf life

3 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions

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

Keep out of reach of children.

Packaging 10 tablets per blister. 3 or 5 blisters per carton.

Prescription status Prescription only.

Manufacturer

JSC "Farmak".

Manufacturer's address and place of business

74, Kyrylivska Street, Kyiv, 04080, Ukraine.