Pentalgin extra-gel - instructions for use, dose, side effects, contraindications

pepper flavors tincture (pepper tincture) - 40.0 mg, dimethylsulfoxide (dimime) - 30.0 mg, camphor 30.0 mg, peppermint mint 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.

Description:

Transparent or translucent homogeneous gel from yellowish to reddish-brown color with a characteristic smell. Opalescence and air bubbles are allowed.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory agent for topical application

ATX: & nbsp

M.02.A.A.10 Ketoprofen

Pharmacodynamics:

Ketoprofen - non-steroidal anti-inflammatory drug, with local application, it has analgesic, anti-inflammatory and anti-edematous effect. The mechanism of action is associated with the suppression of the activity of cyclooxygenase 1 and cyclooxygenase 2, regulating the synthesis of prostaglandins.When applied in the form of a gel provides a local therapeutic effect in relation to affected joints, tendons, ligaments, muscles. With articular syndrome reduces joint pain at rest and during movement, morning stiffness and swelling of the joints. Does not have a damaging effect on articular cartilage.

Pharmacokinetics:

With topical application in the form of a gel, it penetrates into the focus of inflammation through the skin and is absorbed from the inflammatory focus extremely slowly and practically does not accumulate in the body. Bioavailability of ketoprofen is about 5%. After external use in a dose of 50-150 mg concentration in the plasma after 5-8 hours - 0.08-0.15 μg / ml.

Indications:

- Acute and chronic inflammatory diseases of the musculoskeletal system (inflammatory defeat of ligaments and tendons, osteoarthrosis, osteochondrosis with radicular syndrome, radiculitis, bursitis, sciatica, lumbago, articular syndrome with exacerbation of gout);

- muscular pain of rheumatic and non-rheumatic origin;

- Post-traumatic inflammation of soft tissues and musculoskeletal system (injuries and ruptures of ligaments, bruises).

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

Contraindications:

- Individual hypersensitivity to ketoprofen or other components of the drug;

- hypersensitivity to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) (history of bronchospasm, urticaria or rhinitis caused by acetylsalicylic acid), tiaprofenic acid and fenofibrate;

- complete or incomplete combination of bronchial asthma, recurrent nasal polyposis and paranasal sinuses, and intolerance to acetylsalicylic acid or other NSAIDs (including in anamnesis);

- increased sensitivity of the skin to the effects of solar radiation (photosensitization) in the anamnesis;

- skin allergy in a history of sunscreen or perfume;

- exposure to sunlight on the treated areas, including the solarium, during the course of the drug and 2 weeks after;

- damage to the skin (wet dermatoses, eczema, infected abrasions, wounds) at the site of the intended application;

- pregnancy (III trimester), the period of breastfeeding;

- Children under 18 years.

Carefully:

Erosive-ulcerative lesions of the gastrointestinal tract,severe impairment of renal and hepatic function, hepatic porphyria, chronic heart failure, bronchial asthma, elderly age, pregnancy (I and II trimester).

If you have any of the listed diseases / conditions, always consult a doctor before taking the drug.

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 drug can be used only after consulting a doctor, if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to use the drug during breastfeeding, breastfeeding should be stopped.

Dosing and Administration:

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 a day.

The duration of treatment should not exceed 14 days.

Side effects:

Adverse reactions are listed with the frequency of occurrence in accordance with the WHO classification: very often (with a frequency of more than 1/10), often (with a frequency of at least 1/100, but less than 1/10),infrequently (with a frequency of at least 1/1000 but less than 1/100), rarely (with a frequency of at least 1/10000 but less than 1/1000), very rarely (with a frequency of less than 1/10000, including single messages), frequency unknown (can not be determined from available data).

From the skin:

infrequently: erythema, itching, eczema; rarely: photosensitivity, bullous dermatitis, hives; rarely: contact dermatitis, angioedema.

From the gastrointestinal tract:

rarely: peptic ulcer, bleeding, diarrhea.

From the immune system:

rarely: anaphylactic reactions, hypersensitivity reactions.

From the urinary system:

rarely: aggravation of the course of renal failure.

If these or other side effects occur, discontinue use and consult a doctor.

Overdose:

In case of accidental use of the drug at a dose exceeding the recommended dose, the risk of developing overdose symptoms is minimal due to the extremely low systemic absorption of ketoprofen when applied externally.

If local side effects occur, discontinue the drug and rinse the application site.

If the large amounts of the gel are accidentally swallowed, the systemic undesirable reactions characteristic of NSAIDs may occur. It is necessary to wash the stomach, taking activated charcoal.

Interaction:

The drug may enhance the effect of drugs that cause photosensitivity. Despite the small degree of absorption of ketoprofen through the skin, frequent and prolonged use may cause symptoms of interaction with other drugs (same as in systemic use).

When combined with other NSAIDs, glucocorticoids, ethanol, corticotropin, ulceration in the gastrointestinal tract and the development of gastrointestinal bleeding may occur.

Patients who take anticoagulants coumarinic series, it is recommended to conduct regular monitoring of the international normalized relationship (INR).

When combined ketoprofen increases the toxicity of methotrexate.

Composed of auxiliary substances dimethylsulfoxide enhances the penetration of drugs through the skin.

Special instructions:

The gel should only be applied to intact skin areas, avoiding exposure to open wounds, eyes and mucous membranes.

After applying the product, you should wash your hands.

It is allowed to form a transparent film on the skin at the site of application of the gel.

Do not use with occlusive dressings.

Can be used in phonophoresis.

Long-term use of local remedies can lead to increased sensitivity and the appearance of skin irritation symptoms at the site of application.

To avoid photosensitivity, it is recommended to avoid exposure to the skin of direct sunlight during the course of treatment, and also after two weeks after the last use of the drug (including not to visit the solarium).

With prolonged use of the drug in large quantities in very rare cases, the occurrence of systemic side effects (hypersensitivity reactions, disorders of the gastrointestinal tract, aggravation of the course of renal failure).

Patients with severe renal, cardiac or liver failure should be careful with ketoprofen.

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

Discontinue use of the drug in the event of any skin reaction, including reactions with simultaneous application of sunscreen or other cosmetic products containing an organic sunscreen, octocrylene.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Gel for external use, 5%.

Packaging:

Gel for 30 g, 50 g or 100 g in tubes of aluminum with bush polymers, according to TU 9467-004- 32807885-2008.

Tubu together with instructions for use are placed in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:LP-004277

Date of registration:28.04.2017

Expiration Date:28.04.2022

The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia

Manufacturer: & nbsp

LEKKO, ZAO Russia

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Representation: & nbspOtisipharm, PAOOtisipharm, PAORussia

Information update date: & nbsp23.05.2017

Illustrated instructions

Instructions

Pentalgin® extra-gel (Pentalgin® extra-gel)