Dolaren (diclofenac sodium) tablets №100

Description

DOLAREN COMPOSITION
active ingredients: 1 tablet contains diclofenac sodium 50 mg, paracetamol 500 mg
auxiliary substances: corn starch, talc, magnesium stearate, sodium starch (type A), gelatin, sodium methylparaben (E 219), sodium propylparaben (E 217), microcrystalline cellulose, dye Sunset Yellow FCF (E 110).

DOLAREN DOSAGE FORM.
Pills.

MAIN PHYSICAL AND CHEMICAL PROPERTIES:
round biconvex two-layer, two-color (white on one side, orange on the other) tablets. White and / or dark orange blotches are allowed on the surface of the tablets.

PHARMACOLOGICAL GROUP
Analgesics and antipyretics. Paracetamol, combinations without psycholeptics.
ATX code N02B E51.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics.

Dolaren is a combined drug that has a pronounced anti-inflammatory, analgesic and antipyretic effect. The pharmacological activity of the drug is due to the properties of diclofenac and paracetamol, which are part of the drug.

Diclofenac sodium has a pronounced anti-inflammatory and analgesic, as well as a moderate antipyretic effect. Paracetamol exhibits a pronounced analgesic, slight antipyretic and anti-inflammatory effect. The mechanism of action is associated with inhibition of prostaglandin synthesis.

Pharmacokinetics.

After oral administration, the drug is rapidly and completely absorbed. Food does not affect the absorption of the drug.

Concentrations of active substances in blood plasma have a linear dependence on the dose of the drug, the maximum levels are reached 60-90 minutes after administration.

The binding of diclofenac to blood plasma proteins (mainly albumin) reaches 99.7%. The expected volume of distribution is 0.12-0.17 l / kg. Diclofenac penetrates into the synovial fluid, where its maximum concentration is reached 2-4 hours later than in the blood plasma. The half-life of the synovial fluid is 3-6 hours.

Diclofenac metabolism is carried out by glucuronization of the unchanged molecule and methoxylation, which leads to the formation of several phenolic metabolites, the biological activity of which is significantly inferior to the activity of the parent substance.

The total systemic clearance of diclofenac is approximately 300 ml / min. The final half-life is 1-2 hours. 60% of the administered dose is excreted in the urine in the form of glucuronic conjugates of unchanged diclofenac, the rest – with bile and feces.

Paracetamol is metabolized in the liver and excreted mainly in the urine.

After repeated use of the drug, the pharmacokinetic parameters of the active substances do not change. Subject to the recommended intervals between taking the tablets, the accumulation of the drug is not observed.

DOLAREN INDICATIONS
Acute pain (muscle, head, toothache, localized in the spine), with non-articular rheumatism, rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, spondyloarthritis, acute attacks of gout, primary dysmenorrhea, adnexitis, pharyngitis.
Post-traumatic and postoperative pain syndrome.

CONTRAINDICATIONS
Hypersensitivity to diclofenac, paracetamol or any other component of the drug.
A history of active peptic ulcer / bleeding or recurrent peptic ulcer / bleeding (two or more separate episodes of established ulcer or bleeding).
Liver failure.
Renal failure
Congestive Heart Failure (NYHA II-IV)
Ischemic heart disease in patients with angina pectoris who have had myocardial infarction.
Patients in whom the use of diclofenac, paracetamol, acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs) provokes attacks of bronchial asthma, angioedema, urticaria or acute rhinitis.
Diseases of the blood, severe anemia, leukopenia.
Congenital hyperbilirubinemia.
Deficiency of glucose-6-phosphate dehydrogenase.
A history of bleeding or perforation of the gastrointestinal tract associated with previous treatment with non-steroidal anti-inflammatory drugs (NSAIDs).
Inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
Alcoholism.
Treatment of PERIOPERATIVE pain with coronary artery bypass grafting (or using a heart-lung machine).
Peripheral artery disease.
Cerebrovascular disease in patients who have had a stroke or have episodes of transient ischemic attacks.
High risk of postoperative bleeding, blood clotting, hemostasis disorders, hematopoietic disorders, or cerebrovascular bleeding.