Диклоген®
Producer: Agio Pharmaceuticals Ltd. (Adzhio Pharmasyyutikals Ltd.) India
Code of automatic telephone exchange: M02AA15
Release form: Soft dosage forms. Gel for external use.
General characteristics. Structure:
Active ingredient: 1,6 mg of diclofenac of diethyl amine that is equivalent to 10 mg of diclofenac of sodium.
Excipients: chlorocresol, liquid paraffin, carbomer 940, dinatrium эдетат, propylene glycol, isopropanol, petrol alcohol, sodium sulfite, polysorbate 80, lavenders oil, троламин, the water purified.
Pharmacological properties:
Pharmakdinamika. Active component of drug diclofenac - the non-steroidal anti-inflammatory drug (NPVP) possessing the expressed analgeziruyushchy (anesthetics) and antiinflammatory properties. Not selectively oppressing type cyclooxygenase 1 and 2, breaks metabolism of arachidonic acid and synthesis of prostaglandins which are the main link in development of an inflammation.
Диклоген® it is used for elimination of a pain syndrome and reduction of the puffiness connected with inflammatory process. At topical administration causes easing or disappearance of joint pains at rest and at the movement. Reduces morning constraint and a swelling of joints, promotes increase in volume of movements.
Pharmacokinetics. At application system absorption makes no more than 6%. Communication with proteins - 99.7%. It is removed by kidneys.
Indications to use:
• A posttraumatic inflammation of soft tissues and joints, for example owing to stretchings, retension and bruises.
• Rheumatic diseases of soft tissues (tendovaginitis, bursitis, defeat of periartikulyarny fabrics).
• The pain syndrome and puffiness connected with a disease of muscles and joints (a pseudorheumatism, an osteoarthrosis, radiculitises, a lumbago, a sciatica, muscular pains of a rheumatic and not rheumatic origin).
Route of administration and doses:
Outwardly. To adults and children 12 years drug are more senior apply on skin 2 times a day and slightly rub. The necessary amount of drug depends on the size of a painful zone. A single dose of drug - to 2 g (about 4 cm at completely open mouth of a tuba). To children from 6 to 12 years to apply not more often than 2 times a day, a single dose of drug up to 1 g (about 2 cm at completely open mouth of a tuba).
After putting drug of a hand it is necessary to wash up. Duration of treatment depends on indications and medical effect. After 2 weeks of use of drug it is necessary to consult with the doctor.
Features of use:
Use at pregnancy and during breastfeeding. Drug cannot be used in the III trimester of pregnancy. Experience of use of drug in the period of a lactation is not available. Use in I and II trimesters is possible only after consultation with the doctor.
Gel should be applied only on the unimpaired skin, avoiding hit on open wounds. After drawing it is not necessary to apply an occlusive bandage. It is not necessary to allow hits of drug on eyes and mucous membranes.
At long use of large amounts of drug it is impossible to exclude emergence of the system side effects characteristic of NPVP.
Side effects:
Local reactions: eczema, a photosensitization, contact dermatitis (an itch, reddening, puffiness of the processed site of skin, a papule, a vesicle, a peeling).
System reactions: generalized skin rash, allergic reactions (small tortoiseshell, Quincke's disease, bronkhospastichesky reactions), photosensitization.
Interaction with other medicines:
Drug can strengthen effect of the drugs causing a photosensitization. Clinically significant interaction with other medicines is not described.
Contraindications:
Hypersensitivity to diclofenac or other components of drug, acetylsalicylic acid or other NPVP, anamnestic data on an attack of a bronkhoobstruktion, rhinitis, urticaria after reception of acetylsalicylic acid or other NPVP, pregnancy (the III trimester), the lactation period, children's age (up to 6 years), disturbance of integrity of integuments.
With care: hepatic porphyria (aggravation), digestive tract erosive cankers, heavy abnormal liver functions and kidneys, disturbance of coagulability of blood (including hemophilia, lengthening of a bleeding time, tendency to bleedings), chronic heart failure, bronchial asthma, advanced age, pregnancy I and II trimesters.
Overdose:
Extremely low system absorption of active components of drug makes overdose almost impossible. At an accidental proglatyvaniye of large amounts of gel (more than 20 g) emergence of the system undesirable reactions characteristic of NPVP is possible. The gastric lavage, reception of absorbent carbon is necessary.
Storage conditions:
To store in the dry, protected from light place at a temperature not above 25 °C. Not to freeze. To store in the place, unavailable to children. A period of validity - 3 years. Not to use after a period of validity.
Issue conditions:
Without recipe
Packaging:
Gel for external use of 1%. 30 g or 50 g of gel in the aluminum or aluminum laminated tuba. On 1 tuba with the application instruction in a cardboard pack.