Pentalgin extra-gel gel d / nar. approx. 5% tube 50g

Dosage form

Transparent or translucent homogeneous gel from yellowish to reddish-brown color with a characteristic odor.

Opalescence and air bubbles are allowed.

Structure

Composition for 1 g of gel:

Active ingredient: ketoprofen - 50.0 mg.

Excipients:

paprika tincture (peppermint tincture) - 40.0 mg, dimethyl sulfoxide (dimexide) - 30.0 mg, camphor - 30.0 mg, peppermint 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.

pharmachologic effect

Ketoprofen is a non-steroidal anti-inflammatory agent that, when applied topically, has an analgesic, anti-inflammatory and anti-edema effect.

The mechanism of action is associated with the suppression of the activity of enzymes cyclooxygenase 1 and cyclooxygenase 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.

It has no damaging effect on the 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 μg / ml.

Side effects

Adverse reactions are listed with an indication of 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 not less than 1/10000, but less than 1/1000), very rarely (with a frequency of less than 1/10000, including single messages), the frequency is unknown (cannot be established from the available data ).

From the side of the skin:

infrequently: erythema, pruritus, eczema

rarely: photosensitivity, bullous dermatitis, urticaria

very rare: contact dermatitis, angioedema.

From the gastrointestinal tract:

very rare: peptic ulcer, bleeding, diarrhea.

From the immune system:

very rare: anaphylactic reactions, hypersensitivity reactions.

From the urinary system:

very rare: worsening of the course of renal failure.

If these or other side effects appear, you must stop using the drug and consult a doctor.

Selling features

Available without a prescription

Special conditions

The gel should only be applied 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.

Long-term 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 of the skin to direct sunlight during the course of treatment, as well as two 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, disorders of the gastrointestinal tract, aggravation of the course of renal failure) may occur.

Patients with severe renal, heart or hepatic insufficiency should be careful when using ketoprofen.

The risk of systemic side effects increases with the amount

Name ENG

PENTALGIN EXTRA-GEL

Clinical and pharmacological group

NSAIDs for external use

ATX code

Ketoprofen

Dosage

1 g gel - 50 mg

Structure

Active ingredient: ketoprofen - 50.0 mg.

Excipients: paprika tincture (peppermint tincture) - 40.0 mg, dimethyl sulfoxide (dimexide) - 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.

Indications

Acute and chronic inflammatory diseases of the musculoskeletal system (inflammatory lesions of 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 musculoskeletal system (injuries and ruptures 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.

INN / Active ingredient

Ketoprofen

Contraindications

Individual hypersensitivity to ketoprofen or other components of the drug

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

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)

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

a history of skin allergies to sunscreens or perfumes

exposure to sunlight on the treated areas, including the 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

pregnancy (III trimester), breastfeeding period

children under 18 years of age.,

Carefully: ,

Erosive and ulcerative lesions of the gastrointestinal tract, severe renal and liver dysfunction, hepatic porphyria, chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).,

If you have one of the listed diseases / conditions, be sure to consult your doctor before taking the drug.

Storage conditions and periods

At a temperature not higher than 25 ° C.

Keep out of the reach of children.

Shelf life is 2 years.

Specifications

Scope of the medicinal product

General

Release form

Gel

Manufacturer country

Russia

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

OTCPharm

The amount of the dosage form in the primary package

50 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Anatomical and therapeutic characteristics

M02AA10 Ketoprofen

Dosage form

Gel for external use

Drug action

Pain reliever

,

Anti-inflammatory

,

Decongestant

Dosage (volume) of the substance in the preparation

ketoprofen 50 mg

Expiration date in days

24

Package weight, g

70

Category

:

Bruises, sprains

,

Joints

,

Treatment of diseases of the musculoskeletal system

,

Synovial fluid

,

Bone metabolism

Mode of application

:

The drug is intended for external use.

< br> 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.

Pharmaco-therapeutic group

:

Topical non-steroidal anti-inflammatory agent

Information on technical characteristics, delivery set, country of manufacture