Diklogen

Diklogen – non-steroidal anti-inflammatory drug (NPVS) with anesthetic and febrifugal action.

Form of release and structure

• Gel for external use of 1% and 5%: almost white color, translucent, with a specific smell (on 30 and 50 g in tubas an aluminum, 1 tuba in a cardboard pack);
• The tablets covered with a kishechnorastvorimy cover: round, biconvex, light brown color, with slanted edges (on 10 pieces in blisters or blister strip packagings, in a cardboard pack of 5 blisters or packagings);
• The tablets of the prolonged action covered with a kishechnorastvorimy cover: round, biconvex, pink color, with slanted edges (on 10 pieces in planimetric bezjyacheykovy packagings, in a cardboard pack 2 packagings);
• Solution for intramuscular and intravenous administration: transparent, from colourless till yellowish color (on 3 ml in ampoules: on 5 ampoules in planimetric plastic packagings, in a cardboard pack 1 or 2 packagings; on 10 ampoules in planimetric plastic packagings, in a cardboard pack 1 packaging).

Active agent of Diklogen – sodium diclofenac:

• 1 g of gel – 10 or 50 mg;
• 1 tablet covered with a kishechnorastvorimy cover – 50 mg;
• 1 tablet of the prolonged action – 100 mg;
• 1 ml of solution for injections – 25 mg.

Excipients:

• Gel: liquid paraffin, isopropanol, троламин, dinatrium эдетат, carbomer, chlorocresol, polysorbate 80, propylene glycol, benzyl alcohol, sodium sulfite, the water purified oil lavender;
• The tablets covered with a kishechnorastvorimy cover: starch corn, povidone, calcium dihydrophosphate, starch glikolit sodium, lactose, the isopropyl alcohol, talc purified of a methylene chloride, magnesium stearate, dye yellow (Opadry Yellow mix/OY-P-5290);
• The tablets of the prolonged action covered with a kishechnorastvorimy cover: a gidroksipropilmetiltsellyuloza, guar gum, povidone, isopropyl alcohol, magnesium the stearate, talc purified a dextrose. Structure of a cover: a gidroksipropilmetiltsellyuloza, titanium the dioxide, propylene glycol, isopropyl alcohol, talc purified, ethyl cellulose, a methylene chloride, iron oxide red;
• Solution for injections: sodium sulfite anhydrous, benzyl alcohol, Mannitolum, Acidum hydrochloricum, propylene glycol, water for injections.

Indications to use

Gel for external use

• The pain syndrome and puffiness caused by diseases of muscles and joints: radiculitises, osteoarthrosis, sciatica, lumbago, pseudorheumatism and muscular pains, including rheumatic origin;
• Rheumatic diseases of soft tissues: bursitis, tendovaginitis, defeat of periartikulyarny fabrics;
• Posttraumatic inflammation of soft tissues and joints (for example, owing to bruises, retension and stretchings).

Tablets and solution for injections

• The pain syndrome and puffiness caused by diseases of muscles and joints: mialgiya, neuralgia, lumbago, sciatica;
• Inflammatory diseases of circumarticular fabrics: bursitis, tendovaginitis, rheumatic defeat of soft tissues;
• Degenerative diseases of a musculoskeletal system: the osteochondrosis deforming an osteoarthrosis;
• Inflammatory diseases of a musculoskeletal system: ankylosing spondylitis, gout, arthritises (rhematoid, juvenile, psoriasis, gouty);
• Posttraumatic pain syndrome with an inflammation, postoperative pain;
• Renal/hepatic colic;
• Migraine;
• Adnexitis, proctitis, primary альгодисменорея;
• Complex therapy of infectious and inflammatory diseases of the ENT organs which are followed by the expressed pain syndrome: otitis, tonsillitis, pharyngitis.

Contraindications

For all dosage forms:

• Aspirinovy asthma in the anamnesis (a bronkhoobstruktion attack, rhinitis and a small tortoiseshell after reception of acetylsalicylic acid or other NPVS);
• Pregnancy and lactation;
• Individual hypersensitivity to components of drug or other NPVS.

In addition for gel:

• Disturbance of integrity of integuments;
• Children's age up to 6 years;
• III trimester of pregnancy.

In addition for tablets and solution for injections:

• Digestive tract erosive cankers in an aggravation phase;
• Hemopoiesis disturbances;
• Children's age up to 6 years – for tablets, coated, up to 18 years – for tablets of the prolonged action and solution for injections;
• Pregnancy and lactation.

With care Diklogen it is necessary to apply in the following cases:

• Gel: heavy abnormal liver functions and/or kidneys, aggravation of a hepatic porphyria, digestive tract erosive cankers, bronchial asthma, chronic heart failure, disturbance of coagulability of blood (including tendency to bleedings, lengthening of a bleeding time, hemophilia), I and II trimesters of pregnancy, advanced age;
• Tablets: heart failure, heavy abnormal liver functions and/or kidneys, the induced acute hepatic porphyria, and also the patient at advanced age and to patients at whom for any reason decrease in volume of the circulating liquid is noted (for example, after extensive surgical intervention);
• Solution for injections: heart failure, heavy abnormal liver functions and/or kidneys.

Route of administration and dosage

Gel for external use

In the form of gel Diklogen put outwardly, slightly rubbing, 2 times a day.

The necessary amount of drug depends on the size of painful area. The most admissible single doses: children are more senior than 12 years and adult – 2 g, children of 6-12 years – 1 g.

Duration of treatment is defined individually depending on indications and efficiency of the carried-out therapy. After 2 weeks of use of drug it is necessary to consult with the doctor.

The tablets covered with a kishechnorastvorimy cover

Diklogen it is necessary to accept inside, swallowing of tablets entirely and washing down with enough water. For bystry achievement of therapeutic effect it is recommended to accept drug in 30 minutes prior to food, in other cases – in time or after meal.

The adult appoint on 1 tablet 2-3 times a day. After achievement of optimum therapeutic effect gradually reduce a dose and transfer the patient to a maintenance therapy in a daily dose of 50 mg (1 tablet).

To children 12 years are more senior appoint no more than 2 mg/kg of body weight. At a juvenile pseudorheumatism the dose of drug can be increased to 3 mg/kg.

Tablets of the prolonged action

Diklogen it is necessary to accept inside, swallowing of tablets entirely and washing down with enough water. For bystry achievement of therapeutic effect it is recommended to accept drug in 30 minutes prior to food, in other cases – regardless of meals.

Doses are selected individually depending on a look and weight of a course of a disease.

The adult usually appoint on 1 tablet (100 mg) of 1 times a day. Duration of treatment is defined by the doctor.

Solution for intramuscular and intravenous administration

Intravenously the drug is administered in the drop way in a daily dose by no more than 150 mg. Just before introduction contents of 1 ampoule of Diklogen are parted by 100-500 ml of solution of glucose of 5% or solution of sodium of chloride of 0,9%, previously having added to infusion solutions of sodium of bicarbonate solution – 1 ml of 4,2% or 0,5 ml of 8,4%. Infusion duration depending on degree of manifestation of a pain syndrome can make from 30 to 180 minutes. Intravenously it is possible to administer the drug no more than 2 days.

For prevention of postoperative pains Diklogen's infusion is performed in a "shock" dose – 25-50 mg within 15-60 minutes, further introduction continue with a speed of 5 mg/hour before achievement of the most admissible daily dose 150 mg.

For stopping of the pain syndrome caused by an exacerbation of chronic diseases and for treatment of acute states it is possible to administer 1-2 times the drug intramusculary then to transfer the patient to a peroral form of Diklogen (the total daily dose should not exceed 150 mg). Solution is entered deeply intramusculary by no more than 2 days.

Side effects

At Diklogen's use in the form of gel:

• Local reactions: a photosensitization, eczema, contact dermatitis (papules, puffiness of the processed site of skin, a vesicle, reddening, a peeling, an itch);
• System reactions: photosensitization, generalized skin rash, allergic reactions (small tortoiseshell, bronkhospastichesky reactions, Quincke's disease).

At Diklogen's use in the form of tablets and solution for injections:

• Alimentary system: anorexia, a meteorism, nausea, vomiting, a gastralgia, abdominal pain, diarrhea, a lock, gastrointestinal bleeding (a melena, a hematemesis), increase in activity of hepatic transaminases, dryness in a mouth, a glossitis, aphthous stomatitis, digestive tract erosive cankers, pancreatitis, hepatitis (including with jaundice), nonspecific colitis with bleeding, fulminant hepatitis;
• Nervous system: decrease in memory, hearing and visual acuity, sonitus, diplopia, perception disturbance, dizziness, orientation loss, headache, uneasiness, sleeplessness, paresthesias, irritability, increased fatigue, psychotic reactions, tremor, disturbance of flavoring feelings, scotoma, dreadful dreams, depression, spasms, aseptic meningitis;
• Bodies of a hemopoiesis: hemolitic and aplastic anemia, leukopenia, thrombocytopenia, agranulocytosis;
• Cardiovascular system: stethalgia, heartbeat, increase in arterial pressure, arrhythmia;
• Urinary system: papillary necrosis, nephrotic syndrome, oliguria, proteinuria, hamaturia, cystitis, intersticial nephrite, acute renal failure;
• Skin: photosensitization, alopecia, skin rash (preferential urtikarny and erythematic), skin itch, eczema, erythrosis, allergic purpura, Quincke's disease, toxic epidermal necrolysis, mnogoformny exudative erythema;
• Others: system anaphylactic reactions (including shock), hypostases, a bronchospasm, impotence.

Special instructions

Gel Diklogen should be applied only on the unimpaired sites of skin, avoiding hit on open wounds. Not to apply an occlusive bandage. After drawing carefully to wash hands. Not to allow hit in eyes and on mucous membranes.

At purpose of drug in the form of tablets and solution for injections the elderly people (who are especially receiving diuretics), patients with renal or heart failure, and also the patient at which decrease in volume of the circulating liquid is observed need to control function of kidneys. Patients with a liver failure when performing long therapy need control of a picture of peripheral blood and function of a liver, carrying out analyses a calla on the occult blood.

At treatment by Diklogen in the form of tablets or solution for injections it is necessary to refrain from driving and occupations potentially dangerous types of activity demanding the high speed of reactions and special attention.

Medicinal interaction

Gel for external use

Diklogen can strengthen effect of the medicines causing a photosensitization.

Information on clinically significant interactions with other drugs is absent.

Tablets and solution for injections

• Lithium drugs, cyclosporine, digoxin: their concentration in plasma increases;
• Kaliysberegayushchy diuretics: the risk of development of a hyperpotassemia increases;
• Diuretics, hypnotic drugs and hypotensive drugs: their efficiency decreases;
• Anticoagulants, thrombolytic means (Streptokinasa, alteplaza, urokinase): the risk of bleedings increases;
• Acetylsalicylic acid: concentration of diclofenac in blood decreases;
• Methotrexate: its toxicity increases;
• Other NPVS, glucocorticosteroids: the probability of development of side effects, including gastrointestinal bleedings increases;
• Peroral antidiabetic drugs: the risk of development hyper - or a hypoglycemia increases;
• Cyclosporine: its nephrotoxicity increases;
• Valproic acid, цефоперазон, пликамицин, цефамандол, цефотетан: frequency of development of a prothrombinopenia increases;
• Gold drugs, cyclosporine, paracetamol: Diklogen's nephrotoxicity increases;
• Glucocorticosteroids, corticotropin, St. John's Wort drugs, colchicine, alcohol: the risk of development of the gastrointestinal complications accompanied with bleedings increases;
• Vazodilatatora: their hypotensive activity decreases.

Terms and storage conditions

To store in protected from light, the place, dry and unavailable to children, at a temperature up to 25 ºС. Not to freeze.

Period of validity – 3 years.