Dona^® (Tablets, Solution, Powder) Instructions for Use

ATC Code

M01AX05 (Glucosamine)

Active Substance

Glucosamine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug affecting metabolism in cartilage tissue. Proteoglycan biosynthesis stimulator

Pharmacotherapeutic Group

Tissue repair stimulant

Pharmacological Action

It has anti-inflammatory and analgesic action, replenishes the endogenous deficiency of glucosamine, stimulates the synthesis of proteoglycans of the articular cartilage and hyaluronic acid of the synovial fluid, thereby stimulating the regeneration of cartilage tissue; increases the permeability of the joint capsule, restores enzymatic processes in the cells of the synovial membrane and articular cartilage.

It promotes the fixation of sulfur in the process of chondroitin sulfuric acid synthesis, facilitates the normal deposition of calcium in bone tissue, inhibits the development of degenerative processes in the joints, restores their function, and reduces joint pain.

The efficacy of glucosamine sulfate has been proven after just 2-3 weeks from the start of use, with the duration of the effect ranging from 6 months to 3 years, unlike NSAIDs.

Daily continuous treatment with glucosamine sulfate for 3 years showed progressive improvement of symptoms and delay of structural changes in the joint, as determined by conventional radiography.

Glucosamine sulfate demonstrated good tolerability in both short and long courses of treatment.

Pharmacokinetics

Absorption from the gastrointestinal tract – 90%, bioavailability 25%, T_1/2 – 70 h.

Indications

• Osteoarthritis of peripheral joints and spine;
• Osteochondrosis.

ICD codes

Dosage Regimen

Tablets

Orally, 1500 mg once a day, preferably with meals, with a glass of water. The symptomatic effect occurs 2-3 weeks after using the drug. The minimum course of therapy is 4-6 weeks.

If necessary, the course of treatment is repeated at 2-month intervals. The duration and regimen of treatment are prescribed by the attending physician.

Solution, Powder

Orally, intramuscularly, externally.

The dose and duration of treatment are set individually.

Adverse Reactions

The frequency of adverse effects is defined as follows: very common (>1/10); common (<1/10, >1/100); uncommon (<1/100, >1/1000); rare (<1/1000, >1/10000); very rare (<1/10000); frequency unknown.

The most common adverse reactions associated with oral administration are nausea, abdominal pain, dyspepsia, flatulence, constipation, and diarrhea.

The described adverse reactions are usually mild and transient.

Immune system disorders: frequency unknown – allergic reactions (hypersensitivity).

Metabolism and nutrition disorders: frequency unknown – inadequate control of diabetes.

Nervous system disorders: common – headache, drowsiness; frequency unknown – insomnia, dizziness.

Gastrointestinal disorders : common – diarrhea, constipation, nausea, flatulence, abdominal pain, dyspepsia; frequency unknown – vomiting.

Skin and subcutaneous tissue disorders: uncommon – erythema, pruritus, rash; frequency unknown – angioedema, urticaria.

Hepatobiliary disorders: frequency unknown – jaundice.

Eye disorders: frequency unknown – visual impairment.

Respiratory, thoracic and mediastinal disorders: frequency unknown – asthma/exacerbation of asthma.

Cardiac disorders: uncommon – flushing; frequency unknown – cardiac rhythm disorder, tachycardia.

General disorders and administration site conditions: common – fatigue; frequency unknown – edema/peripheral edema.

Investigations: increased liver enzymes, increased blood glucose levels, increased blood pressure. Cases of hypercholesterolemia have been reported, but a causal relationship has not been established.

Contraindications

• Individual hypersensitivity to the active substance and other components of the drug;
• Severe chronic renal failure.

Due to the lack of scientific clinical data, it is not recommended to prescribe during

• Pregnancy;
• Breastfeeding period;
• Children under 18 years of age.

With caution

Patients with allergy to seafood (shrimp, shellfish), with bronchial asthma, diabetes mellitus.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and breastfeeding due to the lack of scientific clinical data in this category of patients.

Use in Hepatic Impairment

When used in patients with severe hepatic insufficiency, medical supervision is necessary.

Use in Renal Impairment

Contraindicated in severe chronic renal failure. When used in patients with severe renal insufficiency, medical supervision is necessary.

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

When used in patients with impaired glucose tolerance, with severe hepatic and renal insufficiency, medical supervision is necessary.

Not recommended for use in children and adolescents under 18 years of age due to the lack of scientific data for this category of patients.

The risk of allergic reactions increases with intolerance to seafood.

Effect on ability to drive vehicles and operate machinery

There are no data on the effect of this agent on the central nervous system or motor system that could affect the ability to drive vehicles and engage in activities requiring increased concentration and speed of psychomotor reactions. However, if dizziness occurs, caution should be exercised.

Drug Interactions

Compatible with NSAIDs, paracetamol and corticosteroids.

When used concomitantly with NSAIDs, it enhances the anti-inflammatory and analgesic effect of the latter.

Increases the absorption of tetracyclines, decreases the absorption of semi-synthetic penicillins, chloramphenicol; enhances the effect of coumarin anticoagulants.

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

Over-the-Counter

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.