Diclofenac gel 5% 100gr

Diclofenac instruction for use

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Clinical and pharmacological group

NSAIDs for external use

Form of release, composition and packaging

Gel for external use 5% white or white with a yellowish or creamy hue, uniform, with a specific odor.
1 g
diclofenac sodium 50 mg
Excipients: ethanol, propylene glycol, carbomer (carbopol), methyl parahydroxybenzoate, triethanolamine (trolamine), lavender oil, purified water.
30 g - aluminum tubes (1) - cardboard packs.
50 g - aluminum tubes (1) - packs of cardboard.

pharmachologic effect

NSAIDs for external use.
Diclofenac has pronounced analgesic and anti-inflammatory properties. By indiscriminately inhibiting the enzymes of COX-1 and COX-2, it breaks the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.
Used to eliminate the pain syndrome and reduce the swelling associated with the inflammatory process. When topical application causes weakening or disappearance of pain in joints at rest and during movement. Reduces the morning stiffness and swelling of the joints, contributes to an increase in the volume of movements.

Pharmacokinetics

With the recommended method of applying the drug, no more than 6% of diclofenac is absorbed.

Indications

- Post-traumatic inflammation of soft tissues and joints due to stretching, overstrain and bruises;
- rheumatic diseases of soft tissues (including tendovaginitis, bursitis, lesion of periarticular tissues);
- Pain syndrome and puffiness associated with diseases of muscles and joints (including rheumatoid arthritis, osteoarthritis, radiculitis, lumbago, sciatica);
- muscular pain of rheumatic and non-rheumatic origin (for a 5% gel).

Contraindications

- violation of the integrity of the skin;
- indication in an anamnesis for seizures of bronchial asthma after application of NSAIDs and salicylates (including acetylsalicylic acid);
- III trimester of pregnancy;
- lactation period;
- children's age till 6 years;
- hypersensitivity to diclofenac or other components of the drug;
- Hypersensitivity to salicylates (including to acetylsalicylic acid) or other NSAIDs.
With caution should be used in patients with hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of liver and kidney function, chronic heart failure, bronchial asthma, in the first and second trimesters of pregnancy, in elderly patients.
Additionally for the preparation in the form of a gel 5%: with caution should be used for violations of blood clotting (including hemophilia, lengthening bleeding time, a tendency to bleeding).

Dosage

Outwardly. The amount of the drug depends on the size of the painful area. A single dose of 1% gel is 2-4 g (comparable in volume to the size of a cherry or walnut). A single dose of the gel is 5% - up to 2 g (about 4 cm with the tube open completely open).
Adults and children over the age of 12 years, the drug should be applied to the skin 3-4 times / day and lightly rub.
For children aged 6 to 12 years, the preparation in the form of a gel 1% should be applied to the skin no more than 2 g (per application) up to 2 times / day; the preparation in the form of a gel 5% - no more than 1 g (about 2 cm with a fully open neck of the tube) for one application up to 2 times / day.
After applying the product, the hands should be washed.
The duration of treatment depends on the indications and the effect observed. After 2 weeks of use, consult a physician.

Side effects

Local reactions: eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated area of ​​the skin, papules, vesicles, peeling).
Systemic reactions: generalized skin rash, allergic reactions (hives, angioedema, bronchospastic reactions), photosensitization.

Overdose

Extremely low systemic absorption of active components of the drug with external application makes an overdose almost impossible.
Symptoms: with the accidental ingestion of large amounts of gel (more than 20 g), there may be systemic adverse reactions that are characteristic of NSAIDs.
Treatment: should wash the stomach, take activated charcoal.

Drug Interactions

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

special instructions

The gel should only be applied to intact skin, avoiding contact with open wounds.
After applying, do not apply an occlusive dressing.
Do not allow the product to get into the eyes and mucous membranes.
With prolonged use of large amounts of the drug, it is impossible to exclude the occurrence of systemic side effects, characteristic for NSAIDs.

Pregnancy and lactemia

Contraindicated use of the drug in the III trimester of pregnancy. Use in I and II trimesters is possible only after consultation with a doctor.
Experience in using the drug during lactation is not available.

Application in childhood

Contraindicated in children under 6 years.

In case of violations of kidney function

With caution should apply the drug in severe violations of kidney function.

With violations of liver function

With caution should be used in patients with hepatic porphyria, severe violations of liver function.

Conditions of leave from pharmacies

The drug is approved for use as a means of OTC.

Terms and conditions of storage

The drug should be stored in a dry place inaccessible to children at a temperature of 15 ° to 25 ° C; Do not freeze. Shelf life - 2 years.