Description
Latin name
Diclovitum
Release form
Gel for external use 1%. 20, 30, 40 and 50 g each in aluminum or polyethylene laminate tubes. 1 tube is placed in a cardboard box with instructions for medical use of the drug.
Packing
Tube 20 g.
Pharmacological action
The active ingredient diclofenac is a non-steroidal anti-inflammatory drug with pronounced analgesic and anti-inflammatory properties. Indirectly inhibiting types 1 and 2 cyclooxygenase, it violates the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.
Diclovit ® is used to eliminate pain and reduce swelling associated with the inflammatory process. For external use, it causes the weakening or disappearance of pain in the joints at rest and during movement. Reduces morning stiffness and swelling of the joints, helps to increase the range of motion in the affected joints. The water-alcohol base of the gel additionally has a local anesthetic effect.
Indications
Inflammatory diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis, rheumatic soft tissue lesions gouty arthritis).
Pain and inflammation of tendons, ligaments, muscles and joints as a result of sprains, with exertion and bruises.
Pain and swelling associated with diseases of the muscles and joints (lumbago, sciatica, neuralgia, myalgia, tendovaginitis, bursitis degenerative diseases of the musculoskeletal system: deforming osteoarthritis, osteochondrosis).
Contraindications
Hypersensitivity, including to aspirin or other NSAIDs, peptic ulcer of the stomach or duodenum in the phase of exacerbation of hematopoiesis disorders of unknown etiology erosive and ulcerative gastrointestinal tract (in the acute stage) aspirin asthma, aspirin triad pregnancy children under 6 years old. Precautions: induced hepatic porphyria impaired renal and hepatic function.
Special instructions
Gel is applied only to intact skin. After application, an occlusive dressing should not be applied.
Avoid contact with eyes, mucous membranes, or open wounds.
When using the drug in conjunction with other dosage forms of diclofenac, the maximum daily dose should be considered.
When applied to large surfaces of the skin and / or for a long time, the risk of developing systemic side effects characteristic of non-steroidal anti-inflammatory drugs is increased.
Composition
Active ingredient – diclofenac sodium – 10 mg
Excipients – lactic acid – 0.44 mg (in terms of 100% substance), isopropanol – 150 mg, ethanol – 150 mg, sodium – 0.5 mg, carbomer – up to 15 mg, trolamine up to 30 mg (to obtain a gel with a pH from 7.0 to 8.5), water – up to 1 g.
Dosage and Administration
Externally. For adults and children over 12 years of age, the drug is applied a thin layer over the focus of inflammation 3-4 times a day and rubbed lightly. The required amount of the drug depends on the size of the painful area. A single dose of the gel is 2-4 g (which is comparable in volume to the size of a large cherry or walnut).
For children from 6 to 12 years old, use no more than 2 times a day, a single dose of the drug up to 2 g.
After applying the gel, wash your hands.
The duration of treatment depends on the indications and the observed effect. After 2 weeks of using the drug, consult your doctor.
To enhance the effect, on the recommendation of a doctor, Diklovit ® gel can be used in conjunction with systemic non-steroidal anti-inflammatory drugs (for example, with other Diclovit ® dosage forms).
Side effects
Emerging side effects depend on the individual sensitivity, the size of the dose used and the duration of treatment. When using the drug, a local irritating effect on the mucous membrane of the large intestine, mucous discharge with an admixture of blood, pain during bowel movements, gastrointestinal disorders: nausea, vomiting, anorexia, flatulence, constipation, diarrhea, interstitial nephritis (rarely nephrotic syndrome, papillary necrosis, acute renal disease) is possible failure) headache, dizziness, agitation, insomnia, irritability, fatigue allergic skin reactions: exanthema, erythema, eczema, erythema multiforme, Steve syndrome ns-Johnson, Lyell’s syndrome, erythroderma, Quincke’s edema, photosensitivity bronchospasm, hematopoiesis purpura: anemia – hemolytic and aplastic, leukopenia, agranulocytosis, thrombocytopenia, increased blood pressure, impaired sensitivity and vision convulsions.
Drug interaction
With the simultaneous use of the drug “Diclovit” and: – digoxin, phenytoin or lithium preparations can increase the plasma levels of these drugs – diuretics and antihypertensive drugs – the effect of these drugs – potassium-sparing diuretics decreases – hyperkalemia may occur – other NSAIDs or glucocorticoids – the risk of side effects from the gastrointestinal tract – acetylsalicylic acid increases – the concentration level of diclofenac in the blood serum decreases – cyclosporine – the toxic effect of the latter on the kidneys increases – antidiabetes natural means – hypo or hyperglycemia may occur. With this combination of drugs, it is necessary to control the level of sugar in the blood – methotrexate within 24 hours before or after its intake – can lead to an increase in the concentration of methotrexate and to increase its toxic effect – anticoagulants – regular monitoring of blood coagulation is necessary.
Storage Conditions
At a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Expiration
2 years.
active substance
Diclofenac
Pharmacy conditions
without prescription
Dosage form
gel for external use
Nizhf rm, Russia
