Dolgit, gel 5% 100 g

NSAIDs

ATH code

M01AE01

Pharmacodynamics:The drug has a local analgesic and anti-inflammatory effect. Suppresses the production of inflammatory mediators. It selectively blocks cyclooxygenase (COX-1 and COX-2) and has an inhibitory effect on the synthesis of prostaglandin prostacyclin and thromboxane.

Analgesic effect is most pronounced for pain of inflammatory nature: the drug reduces pain at rest and during movement; reduces morning stiffness and joint swelling; helps to increase range of motion.

In addition to anti-inflammatory effect ibuprofen reduces platelet aggregation in the inflamed area, as well as migration of leukocytes and the release of lysosomal enzymes in the inflamed area.
Pharmacokinetics:

In application of gel on skin ibuprofen penetrates into deeper tissues (subcutaneous tissue, muscles, joint synovial fluid) and reaches therapeutic concentrations in them. The therapeutic effect in the area of application is achieved by direct distribution through the skin to the target tissues. In a small amount is determined in blood plasma. With the recommended method of application, the concentration in synovial fluid is about 2 µg/ml.

Indications

– Inflammatory and degenerative diseases of the musculoskeletal system: articular syndrome with exacerbation of gout, arthritis (rheumatoid psoriatic gout), humeroscapular periarthritis, ankylosing spondylitis (Bechterew’s disease), deforming osteoarthritis, osteochondrosis with radicular syndrome, radiculitis, tendinitis, tendovaginitis, bursitis, lumbago, sciatica.

– Muscle pain (myalgia) of rheumatic and non-rheumatic origin.

– Injuries (sports, industrial, household, etc.) without violating the integrity of the skin (dislocations, sprains or tears of muscles and ligaments, bruises, post-traumatic swelling of soft tissues, etc.).

Pharmacological effect

NSAIDs

ATX code

M01AE01

Pharmacodynamics:
The drug has a local analgesic and anti-inflammatory effect. Suppresses the production of inflammatory mediators. It does not selectively block cyclooxygenase (COX-1 and COX-2) and has an inhibitory effect on the synthesis of prostaglandin prostacyclin and thromboxane.

The analgesic effect is most pronounced for pain of an inflammatory nature: the drug weakens the pain syndrome during pain at rest and during movement; reduces morning stiffness and swelling of joints; helps increase range of motion.

In addition to the anti-inflammatory effect, ibuprofen reduces platelet aggregation at the site of inflammation, as well as the migration of leukocytes and the release of lysosomal enzymes in the area of ​​inflammation.
Pharmacokinetics:

When the gel is applied to the skin, ibuprofen penetrates into deeper tissues (subcutaneous tissue, muscles, joints, synovial fluid) and reaches therapeutic concentrations there. The therapeutic effect in the area of ​​application is achieved by direct distribution through the skin into the target tissue. It is detected in small quantities in blood plasma. With the recommended method of application, the concentration in the synovial fluid is about 2 μg/ml.

Special instructions

In severe cases, combined use of the gel externally with the administration of other dosage forms of NSAIDs (parenterally or rectally) is recommended.

Avoid contact of the gel with the eyes and mucous membranes.

Impact on the ability to drive vehicles. Wed and fur.:

The use of the drug does not affect activities that require increased attention to coordination of movements, high speed mental and physical reactions (for example, transport drivers, people working with complex mechanisms, etc.).

Active ingredient

Ibuprofen

Composition

100 g of gel contains:

active substance: ibuprofen 5 g;

excipients: isopropapol, dimethylhydroxymethyldioxolane (Solketal), poloxamer a;b;c =101; 56; 101 (Poloxamer 407, Pluronic F 127), medium chain triglycerides (Miglyol 812), purified water, lavender oil, orange flower oil (nerol oil).

Contraindications

Hypersensitivity to ibuprofen components of the drug and other NSAIDs; bronchial asthma, urticaria, rhinitis provoked by taking acetylsalicylic acid; weeping dermatoses eczema violations of the integrity of the skin at the site of application of the gel, including infected wounds and abrasions; pregnancy (III trimester) children up to 12 years of age.

With caution:

Pregnancy (I-II trimester) lactation period.

Side Effects

Usually the drug is well tolerated. In rare cases, signs of local irritation of the skin may temporarily appear in the form of redness, swelling, rashes, itching of the skin, burning and tingling sensations. In case of hypersensitivity to NSAIDs, bronchospasm may occur. Long-term use of the drug in particularly sensitive patients may lead to the development of systemic side effects, if these occur, you should stop taking the drug and consult a doctor.

Interaction

Drug interactions with other drugs have not been described.

However, it should be borne in mind that even when applied topically, ibuprofen has a systemic effect and theoretically, when using the gel simultaneously with other NSAIDs, side effects may increase.

Overdose

Cases of drug overdose have not been described.

In case of accidental ingestion of the drug, it is necessary to induce vomiting, gastric lavage, and take activated charcoal. Further treatment, if necessary, is symptomatic.

Storage conditions

Store in a dry place at a temperature of 15-25 °C.

Keep out of the reach of children.

Shelf life

3 years.

Do not use after the expiration date.

Manufacturer

Dolorgit GmbH and Co. KG, Germany