Sodium diclofenac

General characteristics. Structure:

Active ingredient: diclofenac;

100 g of gel contain diclofenac of sodium 1 g in terms of dry matter;

excipients: carbomer 940, ammonia solution of 15%, propylene glycol, glycerin, ethanol (96%), methylparahydroxybenzoate (Е 218), the water purified.

Pharmacological properties:

Diclofenac of sodium concerns to group of nonsteroid antiinflammatory medicines (NPVLS). Has the febrifugal activity expressed antiinflammatory, and also moderately expressed. The mechanism of action is caused by inhibition of synthesis of prostaglandins. By braking of activity of enzyme of cyclooxygenase (TsOG-1) reduces aggregation of thrombocytes. Drug is effective at treatment of rheumatic diseases and a nonspecific inflammation, reduces pain, removes the inflammatory phenomena and hypostases at rheumatic or traumatic inflammations, improves or normalizes function of a musculoskeletal system. At course treatment of a pseudorheumatism drug intensively gets into a cavity of joints, reduces pain at rest and at the movement, promotes increase in volume of movements in the affected joints, reduces morning constraint and puffiness of joints. The lasting effect develops in 1-2 weeks of treatment.

When drawing on skin it is partially soaked up (3,3% of locally used dose) and it is found in a blood plasma. Sodium diclofenac well gets into fabrics and synovial fluid where its concentration can exceed concentration in a blood plasma. Plasma elimination half-life of blood makes 1-2 hours, of synovial fluid – 3-6 hours.

Indications to use:

Symptomatic treatment of pain, inflammation and hypostasis at:

– damage of soft tissues: to an injury of sinews, sheaves, muscles and joints (for example owing to dislocation, stretching, bruises); sports injuries;

– the localized forms of rheumatism of soft tissues: a tendinitis (including "a tennis elbow"), a bursitis, a humeral syndrome and a periartropatiya, the localized forms of degenerative rheumatism (an osteoarthritis of peripheral joints and a backbone).

Route of administration and doses:

Drug is used outwardly to adults and children 12 years are more senior. The dose of gel depends on the sizes of an affected area. Usually to apply 2-4 g of gel (of the size of cherry or walnut) on skin in the place of an inflammation (the affected joints or other body parts with an inflammation and pain) 3-4 times a day and to rub slightly. After application of drug it is necessary to wash up hands, except cases when hands are subject to treatment.

Duration of therapy depends on the indication and efficiency of treatment. Indications for use are recommended to be revised in 2 weeks.

It is longer not necessary to use drug 14 days in a row – at defeat of soft tissues or rheumatic diseases of a soft tissue, or longer than 21 days – in case of the pain caused by arthritis if the doctor did not appoint another.

In case of drug use not on doctor's orders it is necessary to see behind consultation a doctor if after 7 days of treatment the condition of the patient did not improve or worsened.

Patients of advanced age, patients with an abnormal liver function and kidneys do not need dose adjustment.

Features of use:

Use during pregnancy or feeding by a breast.

Use of drug is contraindicated in the III trimester of pregnancy in connection with a possibility of development of weakness of patrimonial activity and/or premature closing of an arterial channel, in I and II trimesters use of gel is possible only on doctor's orders in case the expected advantage for mother exceeds potential risk for a fruit. During the researches on animals any manifestation of an adverse effect of diclofenac on pregnancy or embryonic development, childbirth or post-natal development was not revealed.

Diclofenac of sodium gets in insignificant quantity into breast milk therefore in the presence of the essential bases for use of gel during feeding by a breast it should not be applied on mammary glands or big sites of skin and to apply throughout a long time.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

Does not influence.

Children.

Drug is not used to children up to 12 years.

Side effects:

Assessment of side reactions is given on the frequency of manifestations: very often (≥ 1/10), it is frequent     (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), is rare (≥ 1/10 000, <1/1000), is very rare (<1/10 000).

From skin: infrequently – the itch, reddening, a dieback, burning, swelled, rash (vesicular, papular, pustular), a peeling and a xeroderma, dermatitis (including contact dermatitis); seldom – violent dermatitis; very seldom – reactions of a photosensitivity, generalized skin rashes, eczema.

From immune system: very seldom – hypersensitivity reactions, a Quincke's disease, a bronchospasm.

From respiratory system: very seldom – bronchial asthma.

From a digestive tract: side reactions arise very seldom after topical administration of the drugs containing diclofenac.

At use of gel in high doses or its drawing on big sites of skin it is impossible to exclude possibility of system side reactions, and also reactions of hypersensitivity in the form of an angioedema, диспноэ.

Interaction with other medicines:

As system absorption of diclofenac at topical administration of drug very low, emergence of interactions is improbable.

Contraindications:

Hypersensitivity to diclofenac and/or to other components of drug. Existence in the anamnesis of the attacks of bronchial asthma, small tortoiseshell or acute rhinitis caused by reception by acetylsalicylic acid or other non-steroidal anti-inflammatory drugs.

Appropriate security measures at use.

 

With care to apply with peroral non-steroidal anti-inflammatory drugs.

The probability of development of system side effects at topical administration of diclofenac is insignificant in comparison with use of its peroral forms, but it is not excluded at use of drug on rather big sites of skin throughout a long time.

Sodium diclofenac gel is recommended to be applied only on intact sites of skin, avoiding hit on the inflamed, injured or infected skin. It is necessary to avoid contact of drug with eyes and mucous membranes. It is impossible to swallow of drug.

At emergence of any skin rashes treatment by drug needs to be stopped.

Sodium diclofenac gel should not be applied under an air-tight occlusive bandage. In case of sprain the struck area can be tied up bandage.

Sodium diclofenac gel contains propylene glycol which can cause the slight localized irritation of skin.

At the states which are followed by reddening or swelling of joints, an acute pain in the waist giving to the lower extremities and/or which is followed by neurologic disturbances (feeling of numbness, a pricking) it is necessary to consult with the doctor.

Overdose:

The overdose is improbable in connection with low absorption of diclofenac in a system blood stream at topical administration.

At an accidental proglatyvaniye of drug it is necessary to clear a stomach at once and to accept adsorbent. The symptomatic treatment using the therapeutic measures applied at treatment of poisoning with non-steroidal anti-inflammatory drugs is shown.

Storage conditions:

Period of validity. 3 years. Not to use drug after the termination of the period of validity specified on packaging. To store at a temperature not above 18 °C. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 40 g in a tuba. On 1 tuba in a pack.