DICLOFENAC RETARD

Manufacturer: OZONE LLC (Russia)

tab. prolong. actions, covering enteric coated, 100 mg: 10, 20, 30, 40, 50, 60, 80, 100, 120, 150, 160, 200, 250, 300, 400, 500, 600, 800, 1000, 1200, 1600 or 2000 pcs. . Reg. No.: LP-001592

Clinical and pharmacological group:

NSAIDs

Release form, composition and packaging

Extended-release tablets, enteric-coated	1 tab.
diclofenac	100 mg

10 pieces. — cellular contour packages (1) — cardboard packs. 10 pieces. — contour cell packaging (2) — cardboard packs. 10 pieces. — cellular contour packages (3) — cardboard packs. 10 pieces. — contour cell packaging (4) — cardboard packs. 10 pieces. — contour cell packaging (5) — cardboard packs. 10 pieces. — contour cell packaging (6) — cardboard packs. 10 pieces. — contour cell packaging (8) — cardboard packs. 10 pieces. — contour cell packaging (10) — cardboard packs. 20 pcs. — cellular contour packages (1) — cardboard packs. 20 pcs. — contour cell packaging (2) — cardboard packs. 20 pcs. — cellular contour packages (3) — cardboard packs. 20 pcs. — contour cell packaging (4) — cardboard packs. 20 pcs. — contour cell packaging (5) — cardboard packs. 20 pcs. — contour cell packaging (6) — cardboard packs. 20 pcs. — contour cell packaging (8) — cardboard packs. 20 pcs. — contour cell packaging (10) — cardboard packs. 10 pieces. — polymer containers (1) — cardboard packs. 20 pcs. — polymer containers (1) — cardboard packs. 30 pcs. — polymer containers (1) — cardboard packs. 40 pcs. — polymer containers (1) — cardboard packs. 50 pcs. — polymer containers (1) — cardboard packs. 100 pieces. — polymer containers (1) — cardboard packs. 10 pieces. — polymer containers (5) — cardboard packs. 10 pieces. — polymer containers (10) — cardboard packs. 10 pieces. — polymer containers (20) — cardboard packs. 20 pcs. — polymer containers (5) — cardboard packs. 20 pcs. — polymer containers (10) — cardboard packs. 20 pcs. — polymer containers (20) — cardboard packs. 30 pcs. — polymer containers (5) — cardboard packs. 30 pcs. — polymer containers (10) — cardboard packs. 30 pcs. — polymer containers (20) — cardboard packs. 40 pcs. — polymer containers (5) — cardboard packs. 40 pcs. — polymer containers (10) — cardboard packs. 40 pcs. — polymer containers (20) — cardboard packs. 50 pcs. — polymer containers (5) — cardboard packs. 50 pcs. — polymer containers (10) — cardboard packs. 50 pcs. — polymer containers (20) — cardboard packs. 100 pieces. — polymer containers (5) — cardboard packs. 100 pieces. — polymer containers (10) — cardboard packs. 100 pieces. — polymer containers (20) — cardboard packs. 10 pieces. — contour cell packaging (20) — cardboard packs. 10 pieces. — contour cell packaging (40) — cardboard packs. 10 pieces. — contour cell packaging (60) — cardboard packs. 10 pieces. — blister contour packages (80) — cardboard packs. 10 pieces. — contour cell packaging (100) — cardboard packs. 20 pcs. — contour cell packaging (20) — cardboard packs. 20 pcs. — contour cell packaging (40) — cardboard packs. 20 pcs. — contour cell packaging (60) — cardboard packs. 20 pcs. — blister contour packages (80) — cardboard packs. 20 pcs. — contour cell packaging (100) — cardboard packs.

Description of the active components of the drug "Diclofenac"

pharmachologic effect

NSAID, phenylacetic acid derivative. It has a pronounced anti-inflammatory, analgesic and moderate antipyretic effect. The mechanism of action is associated with inhibition of the activity of COX, the main enzyme in the metabolism of arachidonic acid, which is a precursor of prostaglandins, which play a major role in the pathogenesis of inflammation, pain and fever. The analgesic effect is due to two mechanisms: peripheral (indirectly, through suppression of prostaglandin synthesis) and central (due to inhibition of prostaglandin synthesis in the central and peripheral nervous system).

Inhibits proteoglycan synthesis in cartilage.

For rheumatic diseases, it reduces pain in the joints at rest and during movement, as well as morning stiffness and swelling of the joints, and helps to increase range of motion. Reduces post-traumatic and postoperative pain, as well as inflammatory swelling.

Suppresses platelet aggregation. With long-term use it has a desensitizing effect.

When applied topically in ophthalmology, it reduces swelling and pain during inflammatory processes of non-infectious etiology.

Indications

Articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout), degenerative and chronic inflammatory diseases of the musculoskeletal system (osteochondrosis, osteoarthritis, periarthropathy), post-traumatic inflammation of soft tissues and the musculoskeletal system (sprains, bruises). Pain in the spine, neuralgia, myalgia, arthralgia, pain and inflammation after operations and injuries, pain with gout, migraine, algodismenorrhea, pain with adnexitis, proctitis, colic (bilious and renal), pain with infectious and inflammatory diseases of the ENT -organs

For local use: inhibition of miosis during cataract surgery, prevention of cystoid macular edema associated with removal and implantation of the lens, inflammatory processes of the eye of a non-infectious nature, post-traumatic inflammatory process in penetrating and non-penetrating wounds of the eyeball.

Dosage regimen

For oral administration for adults, a single dose is 25-50 mg 2-3 times a day. The frequency of administration depends on the dosage form used, the severity of the disease and is 1-3 times a day, rectally - 1 time a day. For the treatment of acute conditions or relief of exacerbation of a chronic process, a dose of 75 mg is used intramuscularly.

For children over 6 years of age and adolescents, the daily dose is 2 mg/kg.

Apply externally in a dose of 2-4 g (depending on the area of the painful area) to the affected area 3-4 times a day.

When used in ophthalmology, the frequency and duration of administration are determined individually.

Maximum daily dose

for adults when taken orally it is 150 mg/day.

Side effect

From the digestive system:

nausea, vomiting, anorexia, pain and discomfort in the epigastric region, flatulence, constipation, diarrhea; in some cases - erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract; rarely - liver dysfunction. When administered rectally, in isolated cases, inflammation of the colon with bleeding and exacerbation of ulcerative colitis were observed.

From the central nervous system and peripheral nervous system:

dizziness, headache, agitation, insomnia, irritability, feeling tired; rarely - paresthesia, visual impairment (blurredness, diplopia), tinnitus, sleep disorders, convulsions, irritability, tremor, mental disorders, depression.

From the hematopoietic system:

rarely - anemia, leukopenia, thrombocytopenia, agranulocytosis.

From the urinary system:

rarely - renal dysfunction; swelling may occur in predisposed patients.

Dermatological reactions:

rarely - hair loss.

Allergic reactions:

skin rash, itching; when used in the form of eye drops - itching, redness, photosensitivity.

Local reactions:

at the site of intramuscular injection, a burning sensation is possible, in some cases - the formation of infiltrate, abscess, necrosis of adipose tissue; with rectal administration, local irritation, the appearance of mucous discharge mixed with blood, and painful defecation are possible; when used externally in rare cases - itching, redness, rash, burning; when applied topically in ophthalmology, a transient burning sensation and/or temporary blurred vision may occur immediately after instillation.

With prolonged external use and/or application to large surfaces of the body, systemic side effects are possible due to the resorptive effect of diclofenac.

Contraindications

Erosive and ulcerative lesions of the gastrointestinal tract in the acute phase, “aspirin triad”, hematopoietic disorders of unknown etiology, hypersensitivity to diclofenac and components of the dosage form used, or other NSAIDs.

Pregnancy and lactation

Use during pregnancy and lactation is possible in cases where the potential benefit to the mother outweighs the potential risk to the fetus or newborn.

Use for liver dysfunction

Use with extreme caution if you have a history of liver disease.

Use for renal impairment

Use with extreme caution if you have a history of kidney disease.

Use in old age

Use with extreme caution in elderly patients.

Application for children

Not recommended for use in children under 6 years of age.

special instructions

Use with extreme caution in patients with a history of liver, kidney, gastrointestinal diseases, dyspeptic symptoms, bronchial asthma, arterial hypertension, heart failure, immediately after major surgical interventions, as well as in elderly patients.

If there is a history of allergic reactions to NSAIDs and sulfites, diclofenac is used only in emergency cases. During treatment, systematic monitoring of liver and kidney function and peripheral blood patterns is necessary.

Rectal use is not recommended in patients with diseases of the anorectal region or a history of anorectal bleeding. It should be used externally only on undamaged areas of the skin.

Avoid contact of diclofenac with the eyes (except for eye drops) or mucous membranes. Patients using contact lenses should use eye drops no earlier than 5 minutes after removing the lenses.

Not recommended for use in children under 6 years of age.

During treatment with dosage forms for systemic use, alcohol consumption is not recommended.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, the speed of psychomotor reactions may decrease. If your vision becomes blurred after using eye drops, you should not drive a car or engage in other potentially hazardous activities.

Drug interactions

When used simultaneously with diclofenac, antihypertensive drugs may weaken their effect.

There are isolated reports of the occurrence of seizures in patients taking NSAIDs and quinolone antibacterial drugs simultaneously.

When used simultaneously with GCS, the risk of side effects from the digestive system increases.

With simultaneous use of diuretics, the diuretic effect may be reduced. When used simultaneously with potassium-sparing diuretics, it is possible to increase the concentration of potassium in the blood.

When used simultaneously with other NSAIDs, the risk of side effects may increase.

There are reports of the development of hypoglycemia or hyperglycemia in patients with diabetes mellitus who used diclofenac simultaneously with hypoglycemic drugs.

When used simultaneously with acetylsalicylic acid, the concentration of diclofenac in the blood plasma may decrease.

Although clinical studies have not established the effect of diclofenac on the action of anticoagulants, isolated cases of bleeding have been described with the simultaneous use of diclofenac and warfarin.

With simultaneous use, it is possible to increase the concentration of digoxin, lithium and phenytoin in the blood plasma.

The absorption of diclofenac from the gastrointestinal tract is reduced when used simultaneously with cholestyramine, and to a lesser extent with colestipol.

With simultaneous use, it is possible to increase the concentration of methotrexate in the blood plasma and increase its toxicity.

With simultaneous use, diclofenac may not affect the bioavailability of morphine, however, the concentration of the active metabolite of morphine may remain elevated in the presence of diclofenac, which increases the risk of developing side effects of the morphine metabolite, incl. respiratory depression.

When used simultaneously with pentazocine, a case of the development of a grand mal seizure has been described; with rifampicin - a decrease in the concentration of diclofenac in the blood plasma is possible; with ceftriaxone - the excretion of ceftriaxone in bile increases; with cyclosporine - increased nephrotoxicity of cyclosporine is possible.