Aldospray (Aerosol) Instructions for Use

Marketing Authorization Holder

Aldo-Union, S.A. (Spain)

ATC Code

M02AA (Topical non-steroidal anti-inflammatory drugs)

Active Substance

Mabuprofen (Rec.INN registered by WHO)

Dosage Form

Aldospray

Aerosol for external use 10%: canister 90 g

Dosage Form, Packaging, and Composition

Aerosol for external use 10% in the form of a homogeneous foamy mass of white color.

Excipients: dimethyl sulfoxide, cetyl alcohol, Siegert L-2-SM esterin, polyethylene 23 lauryl ether, sorbitan monostearate, sorbitan monooleate, triethanolamine, propylene glycol, povidone, benzyl alcohol, 1,1,1,2-tetrafluoroethane (propellant 134a), purified water.

90 g – aluminum canisters (1) with a polypropylene sprayer and a cap – cardboard packs.

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

NSAID

Pharmacological Action

NSAID for external use, an ibuprofen derivative. It has a pronounced anti-inflammatory and analgesic effect. The mechanism of action is associated with inhibition of prostaglandin synthesis due to non-selective blockade of COX₁ and COX₂.

Pharmacokinetics

When applied externally, Mabuprofen is absorbed and undergoes hydrolysis, resulting in the release of ibuprofen. Systemic bioavailability is up to 18%.

The binding of ibuprofen to plasma proteins is 90%. During biotransformation, 4 metabolites are formed: 2-p-(2-hydroxy-2-methylpropyl) phenylpropionic acid, 2-p-(carboxypropyl) phenylpropionic acid), 2-4-(2-hydroxymethylpropyl) phenylpropionic acid, 2-4-(1-hydroxy-2-methylpropyl) phenylpropionic acid.

Up to 60% is excreted by the kidneys: about 9% as oxidized metabolites, up to 17% as conjugated oxidized metabolites, 16% as carboxylated metabolites, 19% as conjugated carboxylated metabolites.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system (including rheumatoid arthritis in remission stage, arthralgia in rheumatism, gout /as part of complex therapy/, psoriatic arthritis, shoulder periarthritis, ankylosing spondylitis, deforming osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, sciatic nerve neuritis, tendonitis, tenosynovitis, bursitis, low back pain).

Injuries (including sports, occupational, domestic) without violation of the integrity of soft tissues (including dislocations, sprains or ruptures of muscles and ligaments, contusions, post-traumatic soft tissue edema).

Pain syndrome of various origins (postoperative pain, neuralgia, tendonitis, bursitis, radiculitis, traumatic inflammation of soft tissues and the musculoskeletal system).

Myalgia of various origins.

Superficial phlebitis, periphlebitis (as part of combination therapy).

ICD codes

Dosage Regimen

For external use only. Apply the aerosol to intact skin over the painful area.

Shake the canister vigorously immediately before each use.

Hold the canister upright and spray from a distance of approximately 10-15 cm (4-6 inches).

Apply a sufficient amount to cover the entire affected area with a thin, uniform layer.

Administer the spray two to three times daily. The interval between applications should be at least four hours.

Gently massage the foam into the skin until fully absorbed.

Wash hands thoroughly with soap and water after application, unless the hands are the treated area.

The duration of continuous use should not exceed ten days for analgesia or fourteen days for anti-inflammatory effect without medical consultation.

Discontinue use and consult a physician if symptoms persist or worsen.

Avoid covering the treated area with occlusive dressings or tight bandages unless directed by a physician.

Adverse Reactions

Rarely erythema, burning sensation at the application site.

Contraindications

Hypersensitivity to mabuprofen.

Special Precautions

During application, avoid contact of the active substance with open wound surfaces and mucous membranes.

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.