Instruction for use: Diclonac

Active substance Diclofenac

ATX Code M01AB05 Diclofenac

Pharmacological group

NSAIDs - Acetic acid derivatives and related compounds

Nosological classification (ICD-10)

M05 Seropositive rheumatoid arthritis

Rheumatoid arthritis seropositive

M10 Gout

Exacerbation of gout, Acute articular attack with gout, Acute gouty attack, Gouty attack, Recurrent gout attacks, Chronic gout

M45 Ankylosing spondylitis

Ankylosing spondylarthrosis, Marie-Strumpel disease, Ankylosing spondylitis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Bechterew's disease, Ankylosing spondylitis, Diseases of the spinal column, Rheumatic spondylitis, Bechterew-Marie-Strumpel disease

N23 Renal colic unspecified

Pain in renal colic, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), renal Colic, ureteral colic, Renal colic, Renal colic with urolithiasis, Kidney disease, Spasm of smooth muscle in diseases of the urinary system, The spasm of the urinary tract, The spasm of the ureter, The spasm of the ureters, Spasms of the urinary tract, Spasms of the urinary tract

R52.2 Other constant pain

Pain syndrome, rheumatic origin, Pain at vertebral lesions, Pain in the chamber, Pain for burns, Pain syndrome weak or moderate, Perioperative pain,Moderate to severe pain, Moderately or weakly expressed pain syndrome, Moderate to severe pain, Ear pain of otitis, Neuropathic pain, neuropathic pain

Composition and form of release

1 tablet, coated with enteric coating, contains 50 mg of diclofenac sodium, 20 units in a contiguous cell package, 5 packs in a cardboard bundle.

1 ampoule with 3 ml solution for injection - 75 mg, in a package of 20 pcs.

pharmachologic effect

Pharmacological action - anti-inflammatory, antipyretic, analgesic.

Pharmacokinetics

After a / m (intramuscular) injection of Cmax in the plasma is achieved after 10-30 minutes. It binds to blood plasma proteins; penetrates (with inflammation) into the synovial fluid, where it accumulates in a concentration higher than in the plasma. Metabolized mainly in the liver. The main product of metabolism is 4-hydroxydiclofenac. It is excreted through the urinary and biliary tract. In healthy patients, the average Cl of diclofenac from plasma was 16 l / h. The average half-life in the final phase is 1.1-1.8 hours. The patient's age and renal function impairment do not significantly affect the pharmacokinetic parameters.

indications

Acute inflammatory diseases of the musculoskeletal system, rheumatoid arthritis, ankylosing spondylitis, gout, renal and biliary colic, dental and perioperative pain.

Contraindications

Hypersensitivity, peptic ulcer, anamnestic information about asthma attacks, hives and other allergic reactions associated with the use of nonsteroidal anti-inflammatory drugs; childhood.

pregnancy and lactation

In the I and II trimesters of pregnancy - only according to strict indications, in the third trimester (due to the known action of PG inhibitors (prostaglandins) on the fetal cardiovascular system) - is contraindicated. Since diclofenac penetrates, although in small amounts, into the mother's milk, during breastfeeding is not recommended.

Side effects

Pain in the abdomen, changes in appetite, dry mouth, indigestion, nausea, vomiting, flatulence, constipation, diarrhea, aphthous stomatitis, peptic ulcer with bleeding; dizziness, headache, drowsiness, depression, insomnia, anxiety, fluid retention, tinnitus, weakness, weight loss, impaired vision and taste, impaired renal function, hepatitis, pruritus, rashes.

Dosing and Administration

Inside - 75-150 mg per day in 2-3 divided doses.

In / m (intramuscular) (with acute pain) - 75 mg, if necessary, the next dose is administered after 30 minutes; the maximum daily dose is 150 mg.

Overdose

In case of an overdose, the stomach is washed, activated charcoal is prescribed and symptomatic therapy is performed.

storage conditions

In the dark place at a temperature below 30 ° C.

Keep out of the reach of children.

Shelf life

solution for intramuscular injection of 25 mg / ml - 3 years.

tablets, coated with enteric coating 50 mg - 5 years.

Do not use after the expiry date printed on the package.