Voltaren emulgel 1% 20g

Release form, composition and packaging

?

Gel for external use 1% homogeneous, creamy, from white to yellowish.

100 g

diclofenac diethylamine 1.16 g,

which corresponds to the content of diclofenac sodium 1 g

carbomers (carbopol 974Р) - 1.2 g, macrogol cetostearate (cetomacrogol 1000) - 2 g, cocoyl caprilocaprate (cetiol LC) - 2.5 g, diethylamine - 0.9 g, isopropanol - 20 g, liquid paraffin - 2.5 g, aromatic cream 45 (contains benzyl benzoate) - 0.1 g, propylene glycol - 5 g, water - 64.64 g. 20 g - aluminum tubes (1) - cardboard packs.

50 g - aluminum tubes (1) - cardboard packs.

100 g - aluminum tubes (1) - cardboard packs.

20 g - laminated tubes (1) with a round lid - cardboard packs.

50 g - laminated tubes (1) with a round-shaped lid - cardboard packs.

100 g - laminated tubes (1) with a round-shaped lid - cardboard packs.

20 g - laminated tubes (1) with a triangular-shaped lid - cardboard packs.

50 g - laminated tubes (1) with a triangular-shaped lid - cardboard packs.

100 g - laminated tubes (1) with a triangular-shaped lid - cardboard packs.

pharmachologic effect

NSAIDs for external use.

Diclofenac has a pronounced analgesic and anti-inflammatory and antipyretic effect.

By indiscriminately inhibiting COX-1 and COX-2, it disrupts the metabolism of arachidonic acid.

Voltaren® Emulgel® is used to eliminate pain and inflammation in joints, muscles and ligaments of traumatic or rheumatic origin, helping to reduce pain and swelling associated with the inflammatory process, increasing joint mobility.

Pharmacokinetics

Absorption The amount of diclofenac absorbed through the skin is proportional to the area of ​​the treated surface and depends on both the total dose of the applied drug and the degree of skin hydration. After applying Voltaren® Emulgel®, 2% gel for external use (2 applications per day) to the skin surface of 400 cm2, the concentration of the active substance in the plasma corresponds to its concentration when using 1% diclofenac gel (4 applications per day). On the 7th day, the relative bioavailability of the drug (AUC ratio) is 4.5% (for the equivalent dose of diclofenac sodium salt). The absorption did not change when the moisture-permeable dressing was worn. Distribution When the drug was applied to the affected joint area, the concentration of diclofenac in plasma, synovial membrane and synovial fluid was determined.Cmax in plasma was approximately 100 times lower than after oral administration of the same amount of diclofenac. 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. Metabolism Diclofenac metabolism is carried out in part by glucuronidation of an unchanged molecule, but mainly through single and multiple 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.Withdrawal The total systemic plasma clearance of diclofenac is 263 ± 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 for use

- back pain in inflammatory and degenerative diseases of the spine (radiculitis, osteoarthritis, lumbago, sciatica)

- joint pain (including finger joints, knee joints) in rheumatoid arthritis

Name ENG

VOLTAREN EMULGEL

Clinical and pharmacological group

NSAIDs for external use

ATX code

Diclofenac

Dosage

1% x 20g

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 (radiculitis, osteoarthritis, lumbago, sciatica)

- joint pain (including the joints of the fingers, knee) with rheumatoid arthritis, 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, wrist syndrome).

Contraindications

anamnestic information about attacks of bronchial asthma, urticaria, acute rhinitis associated with the use of acetylsalicylic acid or other NSAIDs, as well as any drugs that suppress the production of prostaglandins

hypersensitivity to diclofenac and any other ingredients of the drug.

children up to age 14

The drug is not recommended for use in the third trimester of pregnancy (suppression of uterine contractility and premature closure of the arterial duct in the fetus is possible).

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

INN / Active ingredient

Diclofenac

Specifications

Scope of the medicinal product

Musculoskeletal system

Release form

Gel

Manufacturer country

Switzerland

Package quantity, pcs

one

Minimum age from

14 years old

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Voltaren

The amount of the dosage form in the primary package

20 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

The target audience

Children

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

0.01

Package weight, g

35

Category

:

Bruises, sprains

,

Joints

,

Treatment of diseases of the musculoskeletal system

,

Synovial fluid

,

Bone metabolism

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

:

Analgesic

,

Anti-inflammatory

,

Antipyretic

,

Decongestant

Information on technical characteristics, delivery set, country of manufacture