Pharmacy No. 84. Delivery of medicines to your home and office.

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DICLOGEN is a combined anti-inflammatory, antipyretic and analgesic drug.

Pharmacological properties

DICLOGEN® is a combined analgesic, antipyretic and anti-inflammatory drug. The mechanism of action is determined by the pharmacological properties of its constituent components. Diclofenac sodium, a derivative of phenylacetic acid, is a non-steroidal anti-inflammatory drug. The mechanism of action is associated with indiscriminate inhibition of cyclooxygenase (COX-1 and COX-2), which disrupts the metabolism of arachidonic acid and reduces the amount of prostaglandins at the site of inflammation. Most effective for inflammatory pain. It has anti-inflammatory, analgesic and antipyretic effects, and prevents platelet aggregation. Paracetamol is an aniline derivative that has an analgesic and antipyretic effect. The mechanism of the analgesic effect is associated with inhibition of prostaglandin synthesis mainly in the thermoregulation center in the hypothalamus, which explains the almost complete absence of anti-inflammatory effect. In the combined preparation DICLOGEN®, diclofenac sodium and paracetamol potentiate the clinical effects of each other.

Indications for use

Relief and elimination of pain in: - inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile and chronic arthritis, acute gouty arthritis, ankylosing spondylitis, osteoarthritis); — degenerative diseases of the musculoskeletal system (deforming osteoarthritis, osteochondrosis, arthrosis, spondyloarthrosis); - diseases of periarticular tissues (tenosynovitis, bursitis, tendinitis, tenosynovitis); - lumbago, sciatica, neuralgia, myalgia; — post-traumatic (sprains, dislocations, sports injuries) and postoperative pain; - diseases of the ENT organs (pharyngitis, tonsillitis, otitis media) as part of complex therapy; - headache and toothache; - diseases of the female genital organs (algodismenorrhea, adnexitis); - febrile syndrome.

Directions for use and doses

The drug is taken orally, without chewing, during or after meals, with a sufficient amount of water. At the beginning of treatment, adults and adolescents over 12 years of age weighing more than 60 kg are recommended to take 2-3 DICLOGEN® tablets per day.

For moderately severe symptoms of the disease, as well as for long-term therapy, as a rule, it is enough to take 2 tablets of the drug per day - one tablet in the morning and in the evening. The maximum single dose is 2 tablets. Children over 12 years old and weighing more than 30 kg are prescribed 1/2 tablet. 2-3 times/day. The interval between each next dose is at least 4 hours. The maximum duration of treatment for adults is 7 days, for children – 3 days. If you miss another dose of the drug, you must take the next dose as soon as possible. However, you should not double the dose to compensate for the missed dose.

With long-term use of the drug, it is necessary to carry out regular monitoring for the possible occurrence of erosion of the gastrointestinal mucosa with the subsequent development of gastrointestinal bleeding, as well as perform liver function tests for the purpose of early detection of possible hepatotoxicity of the drug.

Diclofenac gel

Dosage form

Gel for external use

Composition per 100 g:

Active substance

: diclofenac sodium – 1.00 g.

Excipients

: 2-propanol – 45.00 g, macrogol 7 glyceryl cocoate – 6.00 g, hypromellose 4000 – 3.00 g, Scots pine oil – 0.15 g, lavender oil – 0.05 g, purified water – up to 100 .00 g.

Description

Colorless or with a slight yellowish tint, transparent gel with a characteristic odor.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory drug (NSAID).

ATX code: M02AA15.

Pharmacological properties

Pharmacodynamics

The active component diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic, anti-inflammatory and antipyretic properties. Indiscriminately inhibiting cyclooxygenase types 1 and 2, it disrupts the metabolism of arachidonic acid.

Diclofenac 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.

Thanks to its hydroalcoholic base, Diclofenac has a calming and cooling effect.

Pharmacokinetics

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 drug applied and the degree of skin hydration. After applying Diclofenac, gel for external use 1% (4 applications per day) to a skin surface area of 400 cm2, the concentration of the active substance in the plasma corresponds to its concentration when using 2% diclofenac gel (2 applications per day). On day 7, the relative bioavailability of the drug (AUC ratio) is 4.5% (for an equivalent dose of diclofenac sodium salt). When wearing a moisture-permeable dressing, suction did not change. The concentration of diclofenac in plasma, synovial membrane and synovial fluid was measured when the drug was applied to the area of the affected joint. Maximum plasma concentrations were approximately 100 times lower than after oral administration of the same amount of diclofenac. 99.7% of diclofenac is bound to plasma proteins, mainly to albumin (99.4%).

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

The metabolism of diclofenac is carried out partly by glucuronidation of the 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 much lesser extent than diclofenac.

The total systemic plasma clearance of diclofenac is 263±56 ml/min. The terminal half-life is 1-2 hours. The half-life of metabolites, including two pharmacologically active ones, is also short and amounts to 1-3 hours. One of the metabolites (3′-hydroxy-4′-methoxydiclofenac) has a longer half-life, however, this the metabolite is completely inactive. Most of diclofenac and its metabolites are excreted in the urine.

Indications for use

• Back pain due to inflammatory and degenerative diseases of the spine (sciatica, osteoarthritis, lumbago, sciatica),

• Pain in the joints (joints of the fingers, knees, etc.) with osteoarthritis,

• Muscle pain (due to sprains, strains, bruises, injuries),

• Inflammation and swelling of soft tissues and joints due to injuries and rheumatic diseases (tenosynovitis, bursitis, lesions of periarticular tissues, wrist syndrome).

Contraindications

Hypersensitivity to diclofenac or other components of the drug; 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); violation of the integrity of the skin at the intended site of application.

Carefully

Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe dysfunction of the liver and kidneys, blood clotting disorders (including hemophilia, prolonged bleeding time, bleeding tendency), chronic heart failure, bronchial asthma, old age, pregnancy (I and II trimester).

Use during pregnancy and breastfeeding

Due to the lack of data on the use of Diclofenac in pregnant women, the use of the drug during the first and second trimesters of pregnancy is recommended only as prescribed by a doctor, weighing the benefits for the mother and the risk for the fetus.

The drug is contraindicated in the third trimester of pregnancy due to the possibility of decreased uterine tone, impaired fetal renal function with subsequent development of oligohydramnios and/or premature closure of the fetal ductus arteriosus.

Due to the lack of data on the penetration of Diclofenac into breast milk, the drug is not recommended for use during breastfeeding. If it is still necessary to use the drug, it should not be applied to the mammary glands or large surface areas of the skin and should not be used for a long time.

There are no data on the use of Diclofenac and its effect on fertility in humans.

Directions for use and doses

Externally.

For adults and children over 12 years of age, the drug is applied to the skin 2 times a day (every 12 hours: preferably morning and evening), lightly rubbing into the skin.

The required amount of the drug depends on the size of the painful area. A single dose of the drug - 4-8 g (which is comparable in volume to twice the size of a cherry or walnut) is enough to treat an area of 400-800 cm2. If your hands are not the area where pain is localized, then after applying the drug they should be washed. The duration of treatment depends on the indications and the observed effect. The gel should not be used for more than 14 days for post-traumatic inflammation and rheumatic diseases of soft tissues without a doctor’s recommendation. If after 7 days of use the therapeutic effect is not observed or the condition worsens, you should consult a doctor.

To remove the protective membrane, use the screw cap as a key (the recess with protrusions on the outside of the cap). Align the indentation on the outside of the cap with the shaped protective membrane of the tube and turn. The membrane should separate from the tube.

The tubes can have either a regular cap (round shape) or an innovative cap (triangular shape), which is especially convenient for use when the mobility of the hand joints is limited due to osteoarthritis or other joint diseases or injuries.

Side effect

Classification of the frequency of occurrence of adverse reactions:

very often (> 1/10); often (> 1/100, < 1/10); uncommon (> 1/1000, < 1/100); rare (> 1/10000, < 1/1000); very rare (< 1/10000), including isolated reports.

Infectious and parasitic diseases:

Very rare: pustular rash.

Immune system disorders:

Very rare: hypersensitivity reactions (including urticaria), angioedema. Respiratory, thoracic and mediastinal disorders: Very rare: asthma.

Disorders of the skin and subcutaneous tissues:

Common: dermatitis (including contact dermatitis), rash, erythema, eczema, itching.

Rarely: bullous dermatitis.

Very rare: photosensitivity reactions.

If any side effects occur, including those not indicated in the instructions, you must stop using the drug and consult a doctor.

Overdose

Due to the low systemic absorption when applying the gel, overdose is unlikely.

In case of accidental ingestion, systemic adverse reactions may develop. Treatment of overdose due to accidental ingestion: gastric lavage, induction of vomiting, activated charcoal, symptomatic therapy. Dialysis and forced diuresis are not effective due to the high degree of binding of diclofenac to plasma proteins (about 99%).

Interaction with other drugs

The drug may enhance the effect of drugs that cause photosensitivity. Clinically significant interactions with other drugs have not been described.

special instructions

Diclofenac should be applied only to intact skin, avoiding contact with open wounds. The drug should not come into contact with the mouth, eyes or mucous membranes. After applying the drug, a bandage may be applied, but airtight occlusive dressings should not be applied. If a skin rash develops after application of the drug, its use should be discontinued.

The effect of the drug on the ability to drive vehicles and machinery

Does not affect.

Release form

Gel for external use 1%.

5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100 g in orange glass jars with a triangular rim and a lid that is tensioned with a sealing element.

5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 70, 80, 90, 100 g in polymer jars complete with lids or in polyethylene terephthalate jars with closures.

20, 25, 30, 35, 40, 50, 60, 70, 80, 100 g in aluminum tubes, coated with BF-2 varnish, with caps made of high-density polyethylene or in polymer tubes with polyethylene screw caps.

Each jar and tube, along with instructions for use, is placed in a cardboard pack.

Storage conditions

At a temperature not higher than 25 °C.

Keep out of the reach of children.

Best before date

3 years.

Do not use after the expiration date stated on the packaging.

Vacation conditions

Available without a prescription.