Ketonal cream d / nar. approx. 5% tube 100g

Release form, composition and packaging

Gel for external use 2.5% homogeneous, colorless, transparent.

pharmachologic effect

NSAIDs.

It has an analgesic, anti-inflammatory and anti-edema effect.

Inhibits the activity of COX, which leads to inhibition of the synthesis of prostaglandins.

In addition, ketoprofen inhibits lipoxygenase, bradykinin synthesis, stabilizes lysosomal membranes and prevents the release of enzymes involved in the inflammatory process.

Ketoprofen does not adversely affect the condition of the articular cartilage.

Pharmacokinetics

Suction

Ketoprofen is absorbed very slowly and practically does not accumulate in the body.

Bioavailability is 5%.

Ketoprofen penetrates into the synovial fluid and reaches therapeutic concentrations there.

The concentration of the drug in blood plasma is extremely low.

Metabolism and excretion

Ketoprofen is metabolized in the liver to form conjugates, which are mainly excreted in the urine.

Ketoprofen is characterized by slow urinary excretion.

Pharmacokinetics in special clinical situations

Metabolism of ketoprofen does not depend on age, the presence of renal failure or liver cirrhosis.

Indications

Symptomatic therapy of painful and inflammatory processes of various origins, including:

rheumatoid arthritis and periarthritis

ankylosing spondylitis (ankylosing spondylitis)

psoriatic arthritis

reactive arthritis (Reiter's syndrome)

osteoarthritis of various localization

tendinitis, bursitis

myalgia

neuralgia

radiculitis

injuries of the musculoskeletal system (including sports), bruises of muscles and ligaments, sprains, ruptures of ligaments and muscle tendons.

Dosage regimen

For external use.

A small amount of gel (about 3-5 cm) is applied with a thin layer on the skin over the lesion 1-2 times / day with light rubbing movements.

It should be borne in mind that 5 cm of the gel corresponds to 100 mg of ketoprofen, 10 cm - 200 mg of ketoprofen.

The maximum daily dose when using the gel is 200 mg.

An occlusive dressing is not recommended.

Ketonal® gel can be used in combination with other forms of Ketonal (capsules, tablets, rectal suppositories).

The duration of treatment without consulting a doctor should not exceed 14 days.

Side effect

Local reactions are the most common.

Determination of the frequency of adverse reactions: very often (? 1/10), often (? 1/100 and < 1/10), infrequently (? 1/1000 and < 1/100), rarely (? 1/10 000 and < 1 / 1000), very rarely (< 10,000).

Allergic reactions: very rarely - angioedema, anaphylaxis.

On the part of the skin and skin appendages: infrequently - erythema, itching, burning, eczema, transient dermatitis of mild severity

rarely - urticaria, rash, photosensitivity, bullous dermatitis, purpura, erythema multiforme, lichenoid dermatitis, skin necrosis, Stevens-Johnson syndrome

very rarely - a single case of severe contact dermatitis (against the background of poor hygiene and insolation), a single case of severe generalized photodermatitis, toxic epidermal necrolysis.

From the respiratory system: very rarely - asthmatic attacks (as a variant of an allergic reaction).

From the urinary system: very rarely - a single case of deterioration of renal function in a patient with chronic renal failure

in isolated cases - interstitial nephritis.

Contraindications for use

hypersensitivity to drug components

hypersensitivity to salicylates, tiaprofenic acid or other NSAIDs, fenofibrate, UV blockers, fragrances

violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound)

a history of indications of bronchial asthma attacks caused by taking NSAIDs and salicylates

a history of photosensitivity reactions

exposure to solar

Name ENG

KETONAL

Clinical and pharmacological group

NSAIDs for external use

ATX code

Ketoprofen

Dosage

5% x 100g

Structure

ketoprofen

Indications

Symptomatic therapy of painful and inflammatory processes of various origins, including:

rheumatoid arthritis and periarthritis

ankylosing spondylitis (ankylosing spondylitis)

psoriatic arthritis

reactive arthritis (Reiter's syndrome)

osteoarthritis of various localization

tendinitis, bursitis

myalgia

neuralgia

radiculitis

injuries of the musculoskeletal system (including sports), bruises of muscles and ligaments, sprains, ruptures of ligaments and muscle tendons.

INN / Active ingredient

ketoprofen

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 5 years

Contraindications

hypersensitivity to drug components

hypersensitivity to salicylates, tiaprofenic acid or other NSAIDs, fenofibrate, UV blockers, fragrances

violation of the integrity of the skin (eczema, weeping dermatitis, open or infected wound)

a history of indications of bronchial asthma attacks caused by taking NSAIDs and salicylates

a history of photosensitivity reactions

exposure to sunlight, incl.

indirect sunlight and UV irradiation in a solarium throughout the entire treatment period and for another 2 weeks after stopping treatment

III trimester of pregnancy

children under 15 years of age.

With care: impaired liver and / or kidney function, erosive and ulcerative lesions of the gastrointestinal tract, blood diseases, bronchial asthma, chronic heart failure.

Specifications

Category

Bruises, sprains

Scope of the drug

General

Release form

Gel

Manufacturer country

Germany

Package quantity, pcs

one

Way of introduction

Outwardly

Vacation conditions

Without recipe

Brand name

LEK

The amount of the dosage form in the primary package

100 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M02AA10 Ketoprofen

Dosage form

Cream for external use

Item weight, g

one hundred

Expiration date in days

1826

Dosage (volume) of the substance in the preparation

In 1 g: ketoprofen 50 mg

Package weight, g

115

Mode of application

:

For external use.

A small amount of gel (about 3-5 cm) is applied with a thin layer on the skin over the lesion 1-2 times / day with light rubbing movements.

It should be borne in mind that 5 cm of the gel corresponds to 100 mg of ketoprofen, 10 cm - 200 mg of ketoprofen.

The maximum daily dose when using the gel is 200 mg.

An occlusive dressing is not recommended.

Ketonal® gel can be used in combination with other forms of Ketonal (capsules, tablets, rectal suppositories).

The duration of treatment without consulting a doctor should not exceed 14 days

Drug action

:

Pain reliever

,

Anti-inflammatory

,

Analgesic

,

Decongestant

Information on technical characteristics, delivery set, country of manufacture