Diclofenac-Teva - instructions for use, dose, side effects, contraindications

Composition:100 g of the preparation contain: active substance: diclofenac sodium 1,000 g; auxiliary substances: diisopropyl adipate 5,000 g; giprolose 2,000 g; lactic acid 90% 0.044 g; sodium disulfite 0.050 g; isopropoyl 40,000 g; purified water 51.906 g.

Description:

Transparent colorless gel with a characteristic odor.

Pharmacotherapeutic group:Non-steroidal anti-inflammatory drug (NSAID).

ATX: & nbsp

S.01.B.C.03 Diclofenac

M.01.A.B.05 Diclofenac

Pharmacodynamics:Gel for external use, the active ingredient of which is diclofenac - a nonsteroidal anti-inflammatory drug that has pronounced analgesic, anti-inflammatory and antipyretic properties. Indiscriminately inhibiting cyclooxygenase 1 and 2 types, disrupts the metabolism of arachidonic acid and the formation of pro-inflammatory prostaglandins in the inflammatory focus. Diclofenac is used to eliminate pain syndrome and inflammation in the charters, muscles and ligaments of traumatic or rheumatic origin, contributing to the reduction of pain and swelling associated with the inflammatory process,increasing the mobility of the joints.

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

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. The maximum plasma concentrations were approximately 100 times lower than after oral administration of the same amount of diclofenac. 99.7% of diclofenac is bound by plasma proteins, mainly with albumins (99.4%). Diclofenac mainly distributed and retained deep in tissues susceptible to inflammation, such as joints, where its concentration is 20 times higher than in blood plasma.

The metabolism of diclofenac is partially realized by glucuronization of the unmodified molecule, mainly through single and multiple hydroxylation, which leads to the formation of several phenolic metabolites, most of which are converted into 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 final half-life is 1-2 hours. The half-life of metabolites, including two pharmacologically active metabolites, is also short-lived and is 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 the diclofenac and its metabolites are excreted in the urine.

Indications:

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

- pain in the joints (joints of the fingers, knees, etc.) with rheumatoid arthritis, osteoarthrosis;

- pain in muscles (due to stretching, overstrain, bruises, injuries);

- inflammation and puffiness of soft tissues and joints due to injuries and rheumatic diseases (tendovaginitis, bursitis, periarticular tissue lesions, wrist syndrome).

Contraindications:Hypersensitivity to diclofenac or other components of the drug; propensity to occurrence of attacks of a bronchial asthma, skin rashes or sharp rhinitis at application of an acetylsalicylic acid or other nonsteroid anti-inflammatory preparations; pregnancy (III trimester),breast-feeding; children's age (up to 12 years); violation of the integrity of the skin in the intended site of application.

Carefully:Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe violations of the liver and kidney function, blood clotting disorders (including hemophilia, prolonged bleeding time, a tendency to bleeding), chronic heart failure, bronchial asthma, advanced age, pregnancy (I and II trimester).

Pregnancy and lactation:

In connection with the lack of data on the use of diclofenac in pregnant women, the use of the drug during the first and second trimester of pregnancy is recommended only for the doctor's prescription, comparing the benefits to the mother and the risk to the fetus. Diclofenac contraindicated in the third trimester of pregnancy due to the possibility of lowering the tone of the uterus and / or premature closure of the arterial duct of the fetus.

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

Dosing and Administration:

It is applied externally.

Adults and children over 12 years of age, the drug is applied to the skin 2 times a day (every 12 hours: preferably in the morning and in the 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 - 2 - 4 g (which is comparable in volume to the size of a cherry or walnut, respectively) is sufficient for processing the area of 400-800 cm2. If the hands are not a zone of pain localization, then after applying the drug, they must be washed. The duration of treatment depends on the indications and the effect observed. The gel should not be used for more than 14 days with post-traumatic inflammations and rheumatic diseases of soft tissues without a doctor's recommendation. If after 7 days of application the therapeutic effect is not observed or the condition worsens, you should consult the rook.

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

Side effects:

The incidence of side effects is classified according to the recommendations of the World Health Organization: very often (> 1/10); often (> 1/100, but <1/10); infrequently (> 1/1000, but <1/100); rarely (> 1/10000, but <1/1000); very rarely (<1/10000), including individual messages; the frequency is unknown - the frequency can not be estimated from the available data.

Infectious and parasitic diseases: very rarely - pustular eruptions.

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

From the respiratory and thoracic and mediastinal organs: very rarely - attacks of suffocation, bronchospastic reactions.

From the skin: often - erythema, dermatitis, incl. contact dermatitis (symptoms: eczema, itching, swelling of the treated area of the skin, rash, papules, vesicles, peeling); rarely bullous dermatitis; very rarely photosensitization reactions.

Overdose:Due to low systemic absorption during the application of the gel, an overdose is unlikely. With accidental ingestion, it is possible to develop systemic adverse reactions. Treatment of an overdose with accidental ingestion: gastric lavage, induction of vomiting, Activated carbon, symptomatic therapy. Dialysis and forced diuresis are not effective due to the high degree of binding of diclofenac to plasma proteins (about 99%).

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

Special instructions:Diclofenac-Teva should be applied only to intact skin, avoiding getting open wounds. Do not allow the drug to enter the mouth, eyes and mucous membranes. After applying the drug, a bandage bandage is allowed, but no airtight occlusive dressings should be applied. In the case of development after application of the skin rash, its use should be discontinued.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to perform potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions (vehicle management, work with moving mechanisms).

Form release / dosage:

Gel for external use 1%.

Packaging:

For 40 g or 100 g of the drug in an aluminum tube, tightened with aluminum foil to control the first opening, with a screw cap.

1 tube together with the instruction, but the application is placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children!

Shelf life:

4 years.

After opening the tube, the drug is suitable for use for 1 year. Do not use after the expiration date!

Terms of leave from pharmacies:Without recipe

Registration number:П N015378 / 02

Date of registration:12.12.2008

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

MERCKLE, GmbH Germany

Representation: & nbspTeva Teva Israel

Information update date: & nbsp25.02.2016

Illustrated instructions

Instructions

Diclofenac-Teva (Diclofenac-Teva)