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.
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.
Diclofenac 100 mg (extended release tablets)
In order to reduce the risk of adverse events, the drug should be used at the lowest effective dose for the shortest period necessary to relieve symptoms.
Therapy with NSAIDs, including diclofenac, particularly long-term and high-dose therapy, may be associated with a small increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke).
In patients with significant risk factors for cardiovascular events (eg hypertension, hyperlipoproteinemia, diabetes mellitus and smoking), treatment with diclofenac-containing products should only be initiated after careful evaluation and analysis.
Because of the important role of prostaglandins in maintaining renal blood flow, special caution should be exercised when prescribing the drug to patients with cardiac or renal failure, hypertension, elderly patients, patients taking diuretics or other drugs that affect renal function, and patients with For some reason, there is a decrease in circulating blood volume (for example, after extensive surgery). If diclofenac is prescribed in such cases, monitoring of renal function is recommended as a precaution. After cessation of drug therapy, normalization of renal function indicators to initial values is usually observed.
When using diclofenac, phenomena such as bleeding or ulceration/perforation of the gastrointestinal tract, in some cases fatal, were observed. These phenomena may occur at any time when using the drug in patients with or without previous symptoms and a history of serious gastrointestinal diseases. In elderly patients, such complications can have serious consequences. If patients receiving diclofenac develop bleeding or ulceration of the gastrointestinal tract, the drug should be discontinued. To reduce the risk of toxic effects on the gastrointestinal tract, the drug should be used in the minimum effective dose for the shortest possible time, especially for patients with gastrointestinal ulcers, especially complicated by a history of bleeding or perforation, as well as elderly patients.
Patients with an increased risk of developing gastrointestinal complications, as well as those receiving therapy with low doses of acetylsalicylic acid or other drugs that can increase the risk of damage to the gastrointestinal tract, should take gastroprotectors.
Patients with a history of gastrointestinal disorders, especially the elderly, should report all symptoms of the digestive system to their doctor.
When carrying out long-term therapy, it is necessary to monitor liver function, peripheral blood patterns, and stool analysis for occult blood.
With long-term use of diclofenac, there may be an increase in the activity of one or more liver enzymes. If liver dysfunction persists or progresses or signs of liver disease or other symptoms occur (for example, eosinophilia, rash, etc.), the drug should be discontinued. It should be borne in mind that hepatitis during the use of diclofenac can develop without prodromal phenomena.
Caution must be exercised when using diclofenac in patients with hepatic porphyria, since the drug can provoke attacks of porphyria.
Diclofenac can reversibly inhibit platelet aggregation, therefore, in patients with hemostasis disorders with long-term use, careful monitoring of relevant laboratory parameters is necessary.
In patients with bronchial asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (including nasal polyps), chronic obstructive pulmonary disease, chronic respiratory tract infections (especially those associated with allergic rhinitis-like symptoms), as well as in patients with allergies to other medications (rash, itching, urticaria) when prescribing diclofenac, special care should be taken (preparedness for resuscitation measures).
Severe, in some cases fatal, skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been very rarely reported with the use of diclofenac. The highest risk and incidence of severe dermatological reactions were observed in the first month of treatment with diclofenac. If patients receiving the drug develop the first signs of skin rash, damage to the mucous membranes or other symptoms of hypersensitivity, diclofenac should be discontinued.
The anti-inflammatory effect of NSAIDs, including diclofenac, may complicate the diagnosis of infectious processes.
Due to the negative effect on fertility, the drug is not recommended for women planning pregnancy. In patients with infertility (including those undergoing examination), it is recommended to discontinue the drug.
When taking 100 mg tablets, patients with diabetes should take into account the sucrose content in the drug (1 tablet contains 94.7880 mg of sucrose).
Diclofenac-Akrikhin retard tab.prolonged.d.p.p.o. 100 mg N20 ext.
Indications for use Symptomatic treatment of diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (Bechterew's disease); gouty arthritis, rheumatic soft tissue lesions, osteoarthritis of peripheral joints and spine, including with radicular syndrome, tenosynovitis , bursitis). The drug relieves or reduces pain and inflammation during the treatment period, but does not affect the progression of the disease. Pain syndrome of mild or moderate severity: neuralgia, myalgia, lumboischialgia, post-traumatic pain syndrome accompanied by inflammation, postoperative pain, headache, migraine, algomenorrhea, adnexitis, proctitis, toothache. As part of complex therapy for infectious and inflammatory diseases of the ear, nose and throat with severe pain (pharyngitis, tonsillitis, otitis media). Contraindications - Hypersensitivity to the active substance (including other NSAIDs) or auxiliary components; — Anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or other NSAIDs (complete or incomplete acetylsalicylic acid intolerance syndrome - rhinosinusitis, urticaria, nasal polyps, asthma); — Erosive and ulcerative changes in the mucous membrane of the stomach or duodenum, active gastrointestinal bleeding; - Inflammatory bowel diseases (ulcerative colitis, Crohn's disease) in the acute phase; — The period after coronary artery bypass surgery; — III trimester of pregnancy, breastfeeding period; — Decompensated heart failure; — Hematopoietic disorders, hemostasis disorders (including hemophilia); — Severe liver failure or active liver disease; — Severe renal failure (creatinine clearance less than 30 ml/min); progressive kidney diseases, incl. confirmed hyperkalemia; - Children under 15 years of age - for tablets of 50 mg and up to 18 years of age - for tablets of 100 mg; — Patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption are contraindicated to take the drug (50 mg tablets).
With caution Anemia, bronchial asthma, cerebrovascular diseases, coronary heart disease, congestive heart failure, arterial hypertension, peripheral arterial disease, edema syndrome, liver or renal failure (creatinine clearance less than 60 ml/min), dyslipidemia/hyperlipidemia, diabetes mellitus, smoking , inflammatory bowel diseases, condition after major surgical interventions, inducible porphyria. diverticulitis, systemic connective tissue diseases, pregnancy I–II trimester. Anamnestic data on the development of peptic ulcer disease of the gastrointestinal tract, the presence of Helicobacter pylori infection, old age, long-term use of NSAIDs, frequent alcohol consumption, severe somatic diseases. Concomitant therapy with anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid, clopidogrel), oral glucocorticosteroids (for example, prednisolone), selective serotonin reuptake inhibitors (for example, citalopram, fluoxetine, paroxetine, sertraline).
