Voltaren Emulgel gel for external use 1% 50g

pharmachologic effect

NSAIDs for external use, a derivative of phenylacetic acid.

It has anti-inflammatory and analgesic effects.

The mechanism of action is due to inhibition of the activity of COX-1 and COX-2, which leads to disruption of the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.

When applied externally, it leads to the disappearance or weakening of pain at the site of application, reduces pain in joints at rest and during movement, as well as morning stiffness and swelling of the joints.

Promotes increased range of motion in the affected joints.

Pharmacokinetics

The amount of diclofenac absorbed through the skin is proportional to the area of ��the treated surface and depends both on the total dose of the applied drug and on the degree of skin hydration.

The binding of diclofenac to plasma proteins is 99.7%, mainly to albumin (99.4%).

Diclofenac is predominantly distributed and retained deep in tissues prone to inflammation, such as joints, where its concentration is 20 times higher than in plasma.

Diclofenac metabolism is carried out in part by glucuronization of the unchanged molecule, but mainly through single and repeated hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted to glucuronide conjugates.

Two phenolic metabolites are biologically active, but to a significantly lesser extent than diclofenac.

The total systemic plasma clearance of diclofenac is 263 В± 56 ml / min.

The final T1 / 2 is 1-2 hours. T1 / 2 of metabolites, including two pharmacologically active ones, is also short and is 1-3 hours. One of the metabolites (3'-hydroxy-4'-methoxydiclofenac) has a longer T1 / 2, however, this metabolite is completely inactive.

Most of diclofenac and its metabolites are excreted in the urine.

Indications

Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica)

joint pain (including the joints of the fingers, knee) with rheumatoid arthritis, osteoarthritis

muscle pain (due to sprains, strains, bruises, injuries)

inflammation and swelling of soft tissues and joints due to trauma and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues).

ICD-10 codes

Dosage regimen

When applied externally, the amount of the drug depends on the size of the painful area.

A single dose depends on the dosage form used and the patient's age.

Gel, ointment, spray for external use

For adults and children over the age of 12 years, the drug should be applied to the skin over the area of ��inflammation 3-4 times / day, for children aged 6 to 12 years - up to 2 times / day.

The duration of use depends on the indications and the effectiveness of the treatment.

After 2 weeks of using the drug, the patient should consult a doctor.

Transdermal patch

Applied as a skin application.

For adults, elderly patients and adolescents over 15 years of age, the patch is glued to the skin over the painful area for 24 hours.

Only 1 patch is allowed per day.

In the treatment of soft tissue injuries, the patch is used for no more than 14 days, and in the treatment of diseases of the muscles and joints - no more than 21 days, if there are no special doctor's recommendations.

If there is no improvement in the condition after 7 days and if the state of health worsens, you should consult your doctor.

Side effect

Determination of the frequency of adverse reactions: very often (? 1/10), often (? 1/100, < 1/10), infrequently (? 1/1000, < 1/100), rarely (? 1/10 000, < 1 / 1000) and very rare (< 10,000), the incidence is unknown (the incidence cannot be determined from the available data).

Infectious and parasitic diseases: very rarely - pustular eruptions.

From the immune system: very rarely - generalized skin rash, allergic reactions (urticaria, hypersensitivity: angioedema).

On the part of the respiratory system and organs of the chest and mediastinum: very rarely - asthma attacks, bronchospastic reactions.

On the part of the skin: often - erythema, dermatitis, incl.

contact dermatitis (symptoms: eczema, itching, swelling of the treated skin area, rash, papules, vesicles, peeling)

rarely, bullous dermatitis

very rarely - photosensitivity reactions.

Contraindications for use

Aspirin triad" (attacks of bronchial asthma, urticaria and acute rhinitis while taking acetylsalicylic acid or other NSAIDs)

violation of the integrity of the skin at the site of application of the drug

III trimester of pregnancy

lactation period (breastfeeding)

children under 6 years of age and older, depending on the drug used

hypersensitivity to diclofenac, other NSAIDs or to any of the excipients of the drug used.

With care: hepatic porphyria (in the acute phase)

erosive and ulcerative lesions of the gastrointestinal tract

severe violations of liver and kidney function

chronic heart failure

bronchial asthma

bleeding disorder (including hemophilia, prolonged bleeding time, tendency to bleed)

I and II trimesters of pregnancy

elderly patients.

Application during pregnancy and lactation

Contraindicated in the third trimester of pregnancy due to the possibility of a decrease in the tone of the uterus and / or premature closure of the arterial duct of the fetus.

Application in the I and II trimesters of pregnancy is possible in cases where the potential benefit to the mother outweighs the potential risk to the fetus or infant.

Use during lactation (breastfeeding) is contraindicated.

Application for violations of liver function

Use with extreme caution in case of liver disease in history.

Application for impaired renal function

Use with extreme caution in case of a history of kidney disease.

Application in children

Not recommended for use in children under 6 years of age.

Use in elderly patients

Use with extreme caution in elderly patients.

special instructions

Apply only to intact skin.

Avoid getting the drug in the eyes, mucous membranes or open wounds.

Do not use under airtight (occlusive) dressings.

Care should be taken when applying large amounts of the drug to large surfaces of sensitive skin over an extended period of time.

When used with other dosage forms of diclofenac, the total maximum daily dose should be taken into account.

During the application period, prolonged exposure to the sun should be avoided.

Drug interactions

Drugs that cause photosensitization - an increase in the action of drugs that can cause photosensitization.

Name ENG

VOLTAREN EMULGEL

Clinical and pharmacological group

NSAIDs for external use

ATX code

Diclofenac

Dosage

1% x 50g

Structure

100 g of gel contains 1.16 g of diclofenac diethylamine, which is acc.

1 g diclofenac sodium

Gel base: fat emulsion in an aqueous gel with the addition of isopropanol and propylene glycol.

Other Ingredients: Diethylamine, Acrylic Acid Polymer, Cetomacrogol 1000, Caprylic / Capric Acid Alcohol Ester, Isopropyl Alcohol, Propylene Glycol, Liquid Paraffin, Fragrance, Water.

Indications

Back pain in inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica)

- pain in joints (joints of fingers, knees, etc.) with osteoarthritis

- muscle pain (due to sprains, overexertion, bruises, injuries)

- inflammation and swelling of soft tissues and joints due to trauma and rheumatic diseases (tendovaginitis, bursitis, lesions of periarticular tissues).

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

Contraindications

Hypersensitivity to diclofenac or other components of the drug

a tendency to develop attacks of bronchial asthma, skin rashes or acute rhinitis when using acetylsalicylic acid or other NSAIDs

pregnancy (III trimester), breastfeeding

children's age (up to 12 years old)

violation of the integrity of the skin at the intended site of application.

With care: Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe liver and kidney dysfunction, chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).

INN / Active ingredient

Diclofenac

Specifications

Category

Bruises, sprains

Scope of the medicinal product

Dermatology

Release form

Gel

Manufacturer country

Switzerland

Package quantity, pcs

one

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Voltaren

The amount of the dosage form in the primary package

50 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

NSAIDs

Anatomical and therapeutic characteristics

M02AA15 Diclofenac

Dosage form

Gel for external use

Expiration date in days

1095

Package weight, g

45

Mode of application

:

The amount of the drug used depends on the size of the painful area.

For example, 2-4 g of Voltaren Emulgel (which is comparable in volume to the size of a cherry or a walnut, respectively) is sufficient for application to an area of ��400-800 cm2.

The drug is applied to the skin 3-4 times / day and rubbed lightly. < br> After application of the drug, hands should be washed, unless this area is being treated. < br> The duration of treatment depends on the indications and effectiveness of therapy.

It is recommended to revise the indications for continuation of treatment after 2 weeks.

Drug action

:

Pain reliever

,

Anti-inflammatory

,

Analgesic

,

Decongestant

Information on technical characteristics, delivery set, country of manufacture "