Diklovit

Diklovit – non-steroidal anti-inflammatory drug (NPVS).

Form of release and structure

• Gel for external use: translucent, colourless or with a creamy or yellowish shade (on 20 or 30 g in aluminum tubas, 1 tuba in a cardboard pack);
• Suppositories rectal: a torpedo-shaped form, color, white or white with a cream shade (on 5 pieces in blister strip packagings, 2 packagings in a cardboard pack).

Active ingredient – sodium diclofenac:

• 1 g of gel – 10 mg;
• 1 suppository – 50 mg.

Gel excipients: sodium disulphite (sodium metabisulphite), isopropanol (2 propyl alcohol), lactic acid of 40%, троламин (2,2', 2' '-nitrilotrietanol), carbomer (карбопол), the water purified the alcohol rectified.

Excipient of suppositories: fat firm (витепсол – H15 and W35, суппосир – NA15 and NAS35).

Indications to use

For both dosage forms of Diklovit:

• The morbidity of muscles and joints caused by heavy exercise stresses;
• Rheumatic defeats of soft tissues;
• Inflammatory and degenerative diseases of a musculoskeletal system, including ankylosing spondylarthritis, rhematoid, juvenile, psoriasis, chronic and acute gouty arthritis;
• Posttraumatic pain syndrome (owing to bruises and sprain, sinews and muscles;
• Neuralgia;
• Sciatica;
• Lumbago.

Suppositories rectal, besides, are applied in the following cases:

• Migraine attacks;
• Postoperative pains;
• Fever;
• Bilious and renal gripes;
• Adnexitis;
• Primary альгодисменорея;
• The infectious and inflammatory diseases of ENT organs which are followed by the expressed pain syndrome (including tonsillitis, pharyngitis and otitis).

Contraindications

Absolute:

• Disturbance of a hemopoiesis of not clear genesis;
• Aggravation of a peptic ulcer of a stomach and 12-perstny gut;
• Pregnancy;
• Children's age up to 6 years;
• Individual hypersensitivity to drug components, acetylsalicylic acid or other NPVS.

In addition for gel:

• Disturbance of integrity of integuments;
• Lactation.

In addition for suppositories:

• Rectal bleedings;
• Bleedings from digestive tract;
• Proctitis;
• Hemorrhoids;
• Aspirinovy triad.

Relative (states/diseases at which it is necessary to apply Diklovit with extra care because of risk of development of complications):

• The induced acute hepatic porphyria;
• Heart failure;
• Renal failure and/or liver;
• The lactation period (for suppositories).

Route of administration and dosage

Gel for external use

In the form of gel of Diklovit apply outwardly: in a small amount (2-4 g, or a strip of gel of 1-2 cm) apply with a thin layer on the site of skin over the inflammation center, slightly rubbing before full absorption.

Frequency rate of applications – 2-3 times a day.

Treatment usually lasts up to 14 days, in some cases the doctor can prolong a therapy course.

Suppositories rectal

In the form of suppositories of Diklovit it is necessary to enter into a rectum after spontaneous purgation or a cleansing enema. After introduction within 20-30 minutes the patient has to be in a prone position.

The adult appoint on 1 suppository 2 times a day, in some cases the daily dose can be increased to 3 suppositories.

At the first symptoms of migraine administration of 2 suppositories is recommended. If there is a need, perhaps repeated use of drug for the same dose. If treatment needs to be continued in the next days, it is necessary to adhere to the most admissible daily dose – 3 suppositories.

Duration of treatment is defined individually depending on a look and weight of a course of a disease.

Side effects

At Diklovit's use in the form of gel development of allergic reactions is possible: local skin manifestations, including burning, rash, itch, hyperemia. At prolonged treatment and/or putting gel on sites of skin, extensive on the area, there is a probability of development of the system reactions which are shown including, generalized skin rash, a photosensitization, a bronchospasm, a Quincke's disease.

At Diklovit's use in the form of suppositories the following side effects are possible:

• Alimentary system: gastralgias, stomach aches, a diarrhea/lock, dyspepsia, a meteorism, nausea, vomiting, anorexia, an exacerbation of ulcer colitis or disease Krone, bleeding from digestive tract, increase in activity of hepatic transaminases, pancreatitis, hepatitis (including with jaundice), nonspecific colitis with bleeding, fulminant hepatitis;
• Central and peripheral nervous system: perception disturbance, increased fatigue, paresthesias, dizziness, decrease in memory, hearing and visual acuity, sonitus, diplopia, headache, orientation loss, uneasiness, sleeplessness, dreadful dreams, irritability, disturbance of flavoring feelings, tremor, spasms, psychotic reactions, depression;
• Urinary system: proteinuria, hamaturia, nephrotic syndrome, intersticial nephrite, acute renal failure, papillary necrosis;
• System of a hemopoiesis: hemolitic anemia, leukopenia, thrombocytopenia, agranulocytosis, aplastic anemia;
• Dermatological reactions: alopecia, rash, eczema, purpura, violent rashes, exfoliative dermatitis, mnogoformny erythema;
• Allergic reactions: small tortoiseshell, photosensitization, bronchospasm, allergic purpura, toxic epidermal necrolysis, Stephens-Johnson's syndrome, system anaphylactic reactions;
• Local reactions: irritation of a mucous membrane of a large intestine, pain at defecation, mucous allocations with blood impurity;
• Others: stethalgia, increase in arterial pressure, heart consciousness, hypostases, impotence.

Special instructions

When putting gel of Diklovit it is necessary to avoid hit on mucous membranes and in eyes. After application to wash up hands.

Medicinal interaction

At use of drug in the form of outside gel it is necessary to consider probability of medicinal interaction with other NPVS.

At Diklovit's use in the form of rectal suppositories along with other drugs the following reactions of interaction are possible:

• Digoxin, lithium drugs, Phenytoinum: their concentration in a blood plasma increases;
• Kaliysberegayushchy diuretics: risk of development of a hyperpotassemia;
• Diuretics, anti-hypertensive means: their action decreases;
• Glucocorticosteroids: risk of emergence of side effects from digestive tract;
• Acetylsalicylic acid: concentration of diclofenac in blood serum decreases;
• Cyclosporine: the probability of development of its nephrotoxic action increases;
• Antidiabetic means: the risk of development hypo - or a hyperglycemia increases (it is necessary to control concentration of glucose in blood);
• Methotrexate: its concentration in a blood plasma increases, toxic effects amplify;
• Anticoagulants: risk of developing of bleedings (it is necessary to control indicators of coagulability of blood);
• Hypnagogues: their efficiency decreases.

Terms and storage conditions

To store in the place, unavailable to children, protected from moisture and light at a temperature: gel – to 25 ºС, suppositories – to 20 ºС.

Period of validity – 2 years.