Ibuprofen, gel 5% 50 g

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID).

ATC code

M02AA13

Pharmacological properties

The drug in the dosage form gel for external use is easy to apply and quickly absorbed into the skin.

Pharmacodynamics

Ibuprofen belongs to the group of non-steroidal anti-inflammatory drugs. It has a dual action: analgesic and anti-inflammatory. Ibuprofen, as a derivative of propionic acid, non-selectively blocks cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), and as a result inhibits the synthesis of prostaglandins – mediators of pain, inflammation and hyperthermia.

In application to the skin the gel has an additional cooling effect due to rapid evaporation of the ethyl alcohol contained in its composition.

Pharmacokinetics

After application to the skin, ibuprofen is detectable in the epidermis and dermis after 24 hours. Maximum concentration in blood plasma of ibuprofen when administered topically is 5% of the maximum concentration level when using oral forms of ibuprofen. There is practically no clinically significant systemic absorption.

It is metabolized in the liver. It is excreted by the kidneys (not more than 1% unchanged) and, to a lesser extent, in the bile.

Indications

Active ingredient

Composition

1 g of the gel contains:

acting substance: ibuprofen – 50.0 mg;

excipients: Ethyl alcohol 95% (ethanol 95%), 150.0 mg; propylene glycol, 100.0 mg; trolamine (triethanolamine), 60.0 mg; dimethyl sulfoxide, 25.0 mg; carbomer, 15.0 mg; methyl parahydroxybenzoate (methyl paraben) – 1.5 mg; lavender oil – 1.0 mg; orange blossom oil (neroli oil) – 0.5 mg; purified water – up to 1.0 g.

How to take, the dosage

For external use only.

Read the instructions carefully before using the drug. This product is for use in adults and children over 14 years of age.

The first time you use the tube: Open the cap and make sure the safety foil on the neck of the tube is intact. Open the foil by pressing the outer side of the cap down.

Please squeeze 4-10 cm of the product (equivalent to about 50-125 mg of ibuprofen) onto your hand and gently massage the gel into the skin until it absorbs.

Wash your hands immediately after application.

Repeat the product at least 4 hours afterwards. Do not use the drug more than four times within 24 hours. The maximum daily dose is 500 mg.

If symptoms persist or worsen after two weeks of use, you should stop treatment and see a doctor.

Do not exceed the stated dose.

Interaction

Special Instructions

Avoid contact with eyes, lips and other mucous membranes, inflamed or damaged skin.

Do not use in conjunction with an occlusive (sealed) medical dressing.

Prevent excessive exposure to sunlight on the area of application.

Impact on ability to drive, operate machinery

It does not affect activities requiring increased concentration and quick psychomotor reactions (driving or operating machinery).

Contraindications

Cautions

If you have any of the conditions listed in this section, consult a physician before using the drug.

Bronchial asthma or allergic diseases with acute or past history of bronchospasm, renal failure, hepatic failure, peptic ulcer including history, enteritis, colitis, hemorrhagic diathesis, pregnancy I-II trimester, breast-feeding period.

Side effects

The frequency of adverse reactions is estimated based on the following criteria:

very often ≥ 1/10;

often from ≥ 1/100 to <1/10;

infrequently from ≥ 1/1000 to <1/100;

rarely from ≥ 1/10000 to <1/1000;

very rare >1/10000;

frequency unknown (frequency cannot be determined from available data). The following adverse reactions have been reported with short-term use of ibuprofen at doses not exceeding 500 mg/day. When treating chronic conditions and with long-term use, other adverse reactions may occur.

Immune system disorders:

frequency unknown – hypersensitivity reactions: non-specific allergic reactions and anaphylactic reactions, respiratory reactions (bronchial asthma, including its exacerbation, bronchospasm, dyspnea), skin reactions (itching, urticaria, purpura, Quincke’s edema, exfoliative and bullous dermatoses, including toxic epidermal necrolysis (Lyell syndrome), Stevens-Johnson syndrome (erythema multiforme).

Gastrointestinal tract disorders:

frequency unknown – abdominal pain, dyspepsia.

Kidney and urinary tract disorders:

frequency unknown – impaired renal function.

If side effects occur, discontinue use of the drug immediately and consult a physician.

Overdose

Pregnancy use

Similarities