Pentalgin Extra, gel 5% 100 g

A nonsteroidal anti-inflammatory agent for topical use.

ATX CODE: M02AA10

Pharmacodynamics

Ketoprofen is a non-steroidal anti-inflammatory drug, when used topically it has analgesic, anti-inflammatory and anti-edema effects. The mechanism of action is related to the inhibition of the activity of cyclooxygenase 1 and cyclooxygenase 2 enzymes that regulate the synthesis of prostaglandins. When used as a gel, it provides local therapeutic effect on the affected joints, tendons, ligaments, muscles. In joint syndrome, it reduces joint pain at rest and when moving, morning stiffness and joint swelling. Does not have a damaging effect on joint cartilage.

Indications

The drug is intended as symptomatic therapy, to reduce pain and inflammation at the time of use, does not affect the progression of the disease.

Active ingredient

Composition

Tincture of chilli pepper fruit (chilli pepper tincture) – 40.0 mg, dimethyl sulfoxide (dimethoxide) – 30.0 mg, camphor – 30.0 mg, peppermint leaf oil (peppermint oil) – 9.0 mg, hypromellose – 20.0 mg, sodium hydroxide – 7.5 mg, ethanol 96% – 350.0 mg, purified water – up to 1000.0 mg.

How to take, the dosage

The product is intended for external use. The gel should be applied to clean dry skin. A small amount of gel (3-5 cm) is applied in a thin layer, followed by careful rubbing into the inflamed or painful areas of the body.

The drug should be applied 2-3 times a day. The course of treatment should not exceed 14 days.

Interaction

The drug may increase the effect of drugs causing photosensitization. Despite the low degree of absorption of ketoprofen through the skin, with frequent and prolonged use symptoms of interaction with other drugs may appear (the same as with systemic use).

When co-administered with other NSAIDs, glucocorticoids, ethanol, corticotropin, gastrointestinal ulceration and gastrointestinal bleeding may occur.

Patients taking coumarin anticoagulants are recommended to have regular monitoring of the international normalized ratio (INR).

Ketoprofen increases the toxicity of methotrexate when used together.

The excipients in the formulation of dimethyl sulfoxide increase penetration of drugs through the skin.

Special Instructions

The gel should be applied only to intact skin, avoiding contact with open wounds, eyes and mucous membranes.
After applying the drug you should wash your hands.
The formation of a transparent film on the skin in the gel application area is allowed.
Do not use with occlusive dressings.
Can be used in phonophoresis.

Long-term use of topical products may result in increased sensitivity and symptoms of skin irritation at the site of application.

In order to avoid photosensitivity, it is recommended to avoid exposing the skin to direct sunlight during treatment and for two weeks after the last treatment (including not using a sunbed).

In prolonged and large doses of the drug, systemic side effects (hypersensitivity reactions, gastrointestinal disorders, worsening of renal failure) may occur in very rare cases.

Patients with severe renal, cardiac or hepatic failure should use ketoprofen with caution.

The risk of systemic side effects increases depending on the amount of gel applied, the area of skin treated, the condition of the skin, and the duration.

The product should be discontinued if any skin reaction occurs, including reactions if sunscreens or other cosmetics containing the organic sunscreen octocrylene are applied at the same time.

Influence on ability to drive and operate machinery: The drug does not affect the ability to drive vehicles and operate machinery.

Synopsis

Contraindications

– individual hypersensitivity to ketoprofen or other components of the drug;
– hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (indication in the history of bronchospasm, urticaria or rhinitis, caused by taking acetylsalicylic acid), thiaprofenic acid and fenofibrate;
– complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis and intolerance to acetylsalicylic acid or other NSAIDs (incl.ч.
– skin hypersensitivity to the effects of solar radiation (photosensitization) in the anamnesis;
– skin allergy to sunscreen or perfume in the anamnesis;
– exposure to sunlight on the treated areas, including tanning beds, during the course of the preparation and 2 weeks after;
– skin lesions (oozing dermatoses, eczema, infected abrasions, wounds) in the place of the supposed application;
– pregnancy (III trimester), breast-feeding period;
– children under 18 years old.

With caution – erosive-ulcerous lesions of the gastrointestinal tract, severe renal and hepatic function disorders, hepatic porphyria, chronic heart failure, bronchial asthma, older age, pregnancy (I and II trimester).

If you have any of the above diseases/conditions, be sure to talk to your doctor before taking this medication.

Side effects

Overdose

Pregnancy use

The use of the drug is contraindicated in the III trimester of pregnancy. In I and II trimesters of pregnancy the drug may be used only after consultation with a physician if the estimated benefits to the mother exceed the potential risk to the fetus.

If it is necessary to use the drug during breastfeeding, breastfeeding must be stopped.

Similarities