Glucosamine sulfate 750 (Tablets) Instructions for Use

Marketing Authorization Holder

Unipharm, Inc. (USA)

ATC Code

M01AX05 (Glucosamine)

Active Substance

Glucosamine (Rec.INN registered by WHO)

Dosage Form

Glucosamine sulfate 750

Coated tablets, 750 mg: 10, 12, 15, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Coated tablets from light yellow to dark yellow in color, oval, biconvex, with an engraving “S 750” on one side.

Excipients: calcium carbonate, microcrystalline cellulose, stearic acid, colloidal silicon dioxide, magnesium stearate, croscarmellose sodium, hypromellose, titanium dioxide, triacetin, propylene glycol, E110.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
30 pcs. – polyethylene bottles (1) – cardboard packs.
60 pcs. – polyethylene bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating metabolism in cartilage tissue

Pharmacotherapeutic Group

Tissue regeneration stimulant

Pharmacological Action

Glucosamine helps prevent cartilage destruction processes, stimulates the restoration of cartilage tissue, has an anti-inflammatory and analgesic effect, and normalizes the production of synovial fluid.

It improves joint mobility and reduces the need for NSAIDs.

Indications

• Osteoarthritis of peripheral joints and spine.

ICD codes

Dosage Regimen

Administer orally for adults at a dosage of 1 tablet twice daily.

Take with meals to improve gastrointestinal tolerability.

Achieve a sustained therapeutic effect by continuing the course of treatment for a duration of at least 6 months.

Adverse Reactions

Observe primarily gastrointestinal adverse reactions, including epigastric pain, flatulence, diarrhea, and constipation.

Monitor for potential skin allergic reactions such as rash, pruritus, and urticaria. These reactions are generally infrequent and mild in nature.

Contraindications

• Do not use in patients with phenylketonuria due to the presence of aspartame.
• Contraindicated in cases of severe renal impairment (creatinine clearance less than 30 ml/min).
• Avoid use during pregnancy and throughout the lactation period due to a lack of safety data.
• Do not administer to individuals with a known hypersensitivity to glucosamine, other shellfish-derived ingredients, or any excipient of the formulation.

Special Precautions

Not recommended for children under 15 years of age due to the lack of scientific data for this patient category.

Overdose

Symptoms: cases of overdose are unknown.

Treatment: gastric lavage, symptomatic therapy.

Drug Interactions

Be aware that this agent increases the absorption of tetracycline antibiotics, potentially elevating their plasma levels.

Concomitant use may reduce the antibacterial effect of semisynthetic penicillins and chloramphenicol.

The drug is considered compatible with paracetamol, NSAIDs, and glucocorticosteroids. It may enhance the anti-inflammatory and analgesic effects of NSAIDs when used together.

Storage Conditions

Store in a dry place, out of reach of children, at a temperature of 10-30°C (50-86°F).

Shelf Life

Shelf life – 5 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.