Pentalgin Extra gel 5%, 50 g

• Acute and chronic inflammatory diseases of the musculoskeletal system (inflammation of the ligaments and tendons, osteoarthritis, osteochondrosis with radicular syndrome, sciatica, bursitis, sciatica, lumbago, articular syndrome with exacerbation of gout);

• muscle pains of rheumatic and non-rheumatic origin;

• post-traumatic inflammation of soft tissues and the musculoskeletal system (damage and rupture of ligaments, bruises).

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

The drug 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 gentle rubbing into the inflamed or painful areas of the body. The drug should be applied 2-3 times / day.

The duration of the course of treatment should not exceed 14 days.

Gel for external use is transparent or translucent, homogeneous, from yellowish to reddish-brown color, with a characteristic odor; opalescence and air bubbles are allowed.

1 g

ketoprofen 50 mg

Excipients: tincture of paprika fruits (tincture of paprika) - 40 mg, dimethyl sulfoxide (dimexide) - 30 mg, camphor - 30 mg, peppermint leaf oil (peppermint oil) - 9 mg, hypromellose - 20 mg, sodium hydroxide - 7.5 mg, ethanol 96% - 350 mg, purified water - up to 1000 mg

• Complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including a history);

• a history of increased sensitivity of the skin to the effects of solar radiation (photosensitivity);

• a history of skin allergies to sunscreens or perfumes;

• exposure to sunlight on the treated areas, including a solarium, during the course of the drug and 2 weeks after; damage to the skin (weeping dermatoses, eczema, infected abrasions, wounds) at the site of the intended application;

• III trimester of pregnancy; breastfeeding period; age up to 18 years.

• hypersensitivity to acetylsalicylic acid or other NSAIDs (a history of bronchospasm, urticaria or rhinitis caused by taking acetylsalicylic acid), tiaprofenic acid and fenofibrate;

• individual hypersensitivity to ketoprofen or other components of the drug.

• With care: erosive and ulcerative lesions of the gastrointestinal tract, severe renal and liver dysfunction, hepatic porphyria, chronic heart failure, bronchial asthma, old age, I and II trimesters of pregnancy.

Pharmacological action of NSAIDs.

When applied topically, it has anesthetic, anti-inflammatory and anti-edema effect. The mechanism of action is associated with the suppression of the activity of the enzymes COX-1 and COX-2, which regulate the synthesis of prostaglandins. When applied in the form of a gel, it provides a local therapeutic effect on the affected joints, tendons, ligaments, muscles. With articular syndrome, it reduces joint pain at rest and during movement, morning stiffness and swelling of the joints. Does not damage articular cartilage.

Pharmacokinetics

When applied topically in the form of a gel, it penetrates into the focus of inflammation through the skin and is absorbed from the focus of inflammation extremely slowly and practically does not accumulate in the body. The bioavailability of ketoprofen is about 5%. After external use at a dose of 50-150 mg, the plasma concentration after 5-8 hours is 0.08-0.15 ?g / ml.

Side effect

On the part of the skin: infrequently - erythema, itching, eczema; rarely - photosensitivity, bullous dermatitis, urticaria; very rarely - contact dermatitis, angioedema. From the digestive system: very rarely - peptic ulcer, bleeding, diarrhea. From the immune system: very rarely - anaphylactic reactions, hypersensitivity reactions. From the urinary system: very rarely - worsening of the course of renal failure. If these or other side effects appear, the patient should stop using the drug and consult a doctor.

Application during pregnancy and lactation

The use of the drug is contraindicated in the third trimester of pregnancy. In the first and second trimesters of pregnancy, the use of the drug is possible only after consulting a doctor, if the intended benefit to the mother outweighs the potential risk to the fetus. If it is necessary to use the drug during breastfeeding, breastfeeding should be discontinued.

Application for violations of liver function

The drug should be used with caution in severe liver dysfunction, hepatic porphyria.

Application for impaired renal function

The drug should be used with caution in severe renal impairment.

Application in children

The use of the drug under the age of 18 is contraindicated.

Use in elderly patients

The drug should be used with caution in old age.

special instructions

The gel should be applied only to intact skin areas, avoiding contact with open wounds, eyes and mucous membranes. After applying the drug, you must wash your hands. The formation of a transparent film on the skin at the site of application of the gel is allowed. Do not use with occlusive dressings. Can be used for phonophoresis. Prolonged use of topical agents can lead to increased sensitivity and symptoms of skin irritation at the site of application. In order to avoid the manifestations of photosensitivity, it is recommended to avoid exposure to the skin of direct sunlight during the course of treatment, as well as after 2 weeks after the last use of the drug (including not visiting the solarium).With prolonged use of the drug in large quantities, in very rare cases, systemic side effects (hypersensitivity reactions, gastrointestinal disturbances, aggravation of the course of renal failure) may occur. Patients with severe renal, heart or hepatic impairment should be careful when using ketoprofen. The risk of systemic side effects increases depending on the amount of gel applied, the area of ??the treated skin area, the condition of the skin, and the duration of use. Discontinue use of the drug if any skin reaction occurs, including reactions while applying sunscreens or other cosmetics containing octocrylene organic sunscreen filter.worsening of the course of renal failure). Patients with severe renal, heart or hepatic impairment should be careful when using ketoprofen. The risk of systemic side effects increases depending on the amount of gel applied, the area of ??the treated skin area, the condition of the skin, and the duration of use. Discontinue use of the drug if any skin reaction occurs, including reactions while applying sunscreens or other cosmetics containing octocrylene organic sunscreen filter.worsening of the course of renal failure). Patients with severe renal, heart or hepatic impairment should be careful when using ketoprofen. The risk of systemic side effects increases depending on the amount of gel applied, the area of ??the treated skin area, the condition of the skin, and the duration of use. Discontinue use of the drug if any skin reaction occurs, including reactions while applying sunscreen or other cosmetic products containing octocrylene organic sunscreen filter.The risk of systemic side effects increases depending on the amount of gel applied, the area of ??the treated skin area, the condition of the skin, and the duration of use. Discontinue use of the drug if any skin reaction occurs, including reactions while applying sunscreen or other cosmetic products containing octocrylene organic sunscreen filter.The risk of systemic side effects increases depending on the amount of gel applied, the area of ??the treated skin area, the condition of the skin, and the duration of use. Discontinue use of the drug if any skin reaction occurs, including reactions while applying sunscreens or other cosmetics containing octocrylene organic sunscreen filter.

Influence on the ability to drive vehicles and use mechanisms

The drug does not affect the ability to drive vehicles and work with mechanisms.

Overdose

In case of accidental use of the drug in a dose exceeding the recommended, the risk of overdose symptoms is minimal due to the extremely low systemic absorption of ketoprofen when used externally. Treatment: if local side effects appear, the drug should be discontinued and the site of application should be rinsed. In case of accidental ingestion of large amounts of gel, systemic adverse reactions characteristic of NSAIDs may occur. It is necessary to wash the stomach, take activated charcoal.

Drug interactions

The drug can enhance the effect of drugs that cause photosensitization. Despite the insignificant 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 used together with other NSAIDs, GCS, ethanol, corticotropin, ulcers in the gastrointestinal tract and the development of gastrointestinal bleeding are possible. Patients taking coumarin anticoagulants are advised to regularly monitor their INR. When used together, ketoprofen increases the toxicity of methotrexate. Dimethyl sulfoxide, which is part of the excipients, enhances the penetration of drugs through the skin.