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Ibuprofen (Gel) Instructions for Use

ATC Code

M02AA13 (Ibuprofen)

Active Substance

Ibuprofen (Rec.INN registered by WHO)

Clinical-Pharmacological Group

NSAIDs for external use

Pharmacotherapeutic Group

Drugs for external use for muscle and joint pain; non-steroidal anti-inflammatory drugs for external use

Pharmacological Action

NSAID, a derivative of phenylpropionic acid. When applied externally, it has an anti-inflammatory and analgesic effect. It reduces morning stiffness and helps to increase the range of motion in the joints.

The mechanism of action is associated with the inhibition of COX activity, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins that play a major role in the pathogenesis of inflammation, pain, and fever. The analgesic effect is due to both a peripheral mechanism (indirectly, through the suppression of prostaglandin synthesis) and a central mechanism (by inhibiting the synthesis of prostaglandins in the central and peripheral nervous system).

Pharmacokinetics

After application to the skin, Ibuprofen is detected in the epidermis and dermis after 24 hours. It reaches a high therapeutic concentration in the underlying soft tissues, joints, and synovial fluid. Clinically significant systemic absorption practically does not occur. The Cmax of ibuprofen in blood plasma with external use is 5% of the Cmax level with oral administration of ibuprofen.

80% of the dose is excreted in the urine, mainly in the form of metabolites (70%), 10% – unchanged; 20% is excreted through the intestines in the form of metabolites.

Indications

As an analgesic and anti-inflammatory agent for conditions such as muscle pain, back pain, arthritis, pain from ligament injuries and sprains, sports injuries, neuralgia.

ICD codes

ICD-10 code Indication
M05 Seropositive rheumatoid arthritis
M13.9 Arthritis, unspecified
M15 Polyosteoarthritis
M19.9 Unspecified arthrosis
M25.5 Pain in joint
M42 Spinal osteochondrosis
M45 Ankylosing spondylitis
M47 Spondylosis
M54 Dorsalgia
M54.1 Radiculopathy
M54.3 Sciatica
M54.4 Lumbago with sciatica
M65 Synovitis and tenosynovitis
M70 Soft tissue disorders related to use, overuse, and pressure
M71 Other bursopathies
M79.1 Myalgia
M79.2 Neuralgia and neuritis, unspecified
T14.3 Dislocation, sprain and strain of joint and ligament of unspecified body region
ICD-11 code Indication
8B93.Z Radiculopathy, unspecified
8E4A.1 Paraneoplastic or autoimmune diseases of the peripheral or autonomic nervous system
FA05 Polyosteoarthritis
FA0Z Osteoarthritis, unspecified
FA20.0 Seropositive rheumatoid arthritis
FA2Z Inflammatory arthropathies, unspecified
FA85.Z Defects of vertebral end-plates, unspecified
FA8Z Degenerative disease of spine, unspecified
FA92.0Z Ankylosing spondylitis, unspecified
FB40.Z Tenosynovitis, unspecified
FB50.1 Bursitis associated with use, overuse or pressure
FB50.Z Bursitis, unspecified
FB56 Specified soft tissue diseases, not elsewhere classified
FB56.2 Myalgia
ME82 Pain in joint
ME84.20 Lumbago with sciatica
ME84.3 Sciatica
ME84.Z Back pain, unspecified
ND56.3 Dislocation, sprain or strain of unspecified body region

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

For external use only. Apply a strip of gel 5 to 10 cm (2 to 4 inches) long to the affected area.

Gently massage the gel into the skin until fully absorbed.

Apply the gel two to three times daily. Maintain a minimum interval of four hours between applications.

Use the lowest effective dose for the shortest duration necessary to relieve symptoms.

Do not exceed the maximum daily application area. Avoid using on large areas of the body simultaneously.

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

Avoid contact with eyes, mucous membranes, and open wounds. If accidental contact occurs, rinse immediately with plenty of water.

Do not apply with an occlusive dressing or airtight bandage.

Treatment duration should not exceed two to three weeks without medical consultation. Discontinue use if symptoms persist or worsen.

Adverse Reactions

Local reactions with external use may include skin hyperemia, a sensation of burning or tingling.

Contraindications

Hypersensitivity to ibuprofen; “aspirin triad” (including in history); impaired skin integrity at the application site (including infected wounds and abrasions, weeping dermatitis, eczema); children under 14 years of age; pregnancy, lactation period.

Use with caution

In the presence of concomitant liver and kidney diseases, gastrointestinal tract diseases, exacerbation of hepatic porphyria, in bronchial asthma, urticaria, rhinitis, nasal mucosal polyps, chronic heart failure, as well as in elderly patients.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is contraindicated.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction. Use with caution in concomitant liver diseases.

Use in Renal Impairment

Contraindicated in severe renal dysfunction. Use with caution in concomitant kidney diseases.

Pediatric Use

Ibuprofen is contraindicated for external use in children under 14 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

When applying externally, avoid contact with eyes and lips.

Do not use under an occlusive (airtight) bandage.

Avoid exposure of the application area to sunlight.

Drug Interactions

Theoretically, with simultaneous use with other NSAIDs, an increase in side effects is possible.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

PFKO-1, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle OTC Icon Ibuprofen Renewal Gel for external use 50 mg/g

Dosage Form, Packaging, and Composition

Gel for external use

1 g
Ibuprofen 50 mg

100 g – tubes – cardboard packs – Over-the-Counter
120 g – tubes – cardboard packs – Over-the-Counter
15 g – tubes – cardboard packs – Over-the-Counter
150 g – tubes – cardboard packs – Over-the-Counter
180 g – tubes – cardboard packs – Over-the-Counter
20 g – tubes – cardboard packs – Over-the-Counter
200 g – tubes – cardboard packs – Over-the-Counter
25 g – tubes – cardboard packs – Over-the-Counter
30 g – tubes – cardboard packs – Over-the-Counter
35 g – tubes – cardboard packs – Over-the-Counter
40 g – tubes – cardboard packs – Over-the-Counter
50 g – tubes – cardboard packs – Over-the-Counter
60 g – tubes – cardboard packs – Over-the-Counter

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Ibuprofen-Vertex Gel for external use 5%: tubes 20 g, 30 g, 50 g, or 100 g

Dosage Form, Packaging, and Composition

Gel for external use colorless or with a light yellow tint, transparent, with a specific odor; the presence of opalescence and air bubbles is allowed.

1 g
Ibuprofen 50 mg

Excipients : ethanol 95% (ethyl alcohol 95%) – 150 mg, propylene glycol – 100 mg, trolamine (triethanolamine) – 60 mg, dimethyl sulfoxide – 25 mg, carbomer – 15 mg, methylparahydroxybenzoate (methylparaben) – 1.5 mg, lavender oil – 1 mg, orange flower oil (neroli oil) – 0.5 mg, purified water – up to 1 g.

20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle OTC Icon Ibuprofen-Verte Gel for external use 5%: tubes 20 g, 30 g, 50 g, or 100 g

Dosage Form, Packaging, and Composition

Gel for external use 5% colorless or with a light yellow tint, transparent, with a specific odor; the presence of opalescence is allowed.

1 g
Ibuprofen 50 mg

Excipients : propylene glycol, ethanol, carbomer 940, dimexide, triethanolamine, methylparahydroxybenzoate, neroli oil, lavender oil, purified water.

20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
100 g – aluminum tubes (1) – cardboard packs.

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