Diclofenac Acri (ointment, gel) – instructions for use. What does Diclofenac ointment and gel form help with? Diclofenac injections: instructions for use
Used for inflammatory processes in soft tissues and joints. Suppresses pain in diseases of muscles and joints.
Release form, composition
Ointment for external use 1% white to white with a grayish or yellowish tint, color with a weak specific odor, pearlescent stains are allowed.
1 g contains diclofenac sodium 10 mg
Excipients: polyethylene oxide 1500, polyethylene oxide 400, propylene glycol, succinic acid, dimexide.
Indications
- post-traumatic inflammation of soft tissues and joints, for example, as a result of sprains, strains and bruises;
- rheumatic diseases of soft tissues;
- pain and swelling associated with diseases of muscles and joints (rheumatoid arthritis, osteoarthritis, radiculitis, muscle pain of rheumatic and non-rheumatic origin).
Directions for use and doses
Externally. For adults and children over 12 years of age, the drug is applied thin layer over the source of inflammation 3-4 times a day and rub lightly. Required amount The drug depends on the size of the painful area. A single dose of the drug is 2-4 g (in volume comparable to the size of a large cherry). For children from 6 to 12 years of age, use no more than 2 times a day, a single dose of the drug - up to 2 g.
After applying the drug, hands must be washed.
The duration of treatment depends on the indications and the observed effect. After 2 weeks of using the drug, you should consult your doctor.
Side effect
Local reactions: eczema, contact dermatitis(itching, redness, swelling of the treated area of skin, peeling).
Systemic reactions: skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions).
Contraindications for use
- anamnestic data on an attack of bronchial obstruction, rhinitis, urticaria after taking acetylsalicylic acid or another NSAID;
- pregnancy (III trimester);
- lactation period;
- childhood up to 6 years;
- integrity violation skin;
- hypersensitivity to diclofenac or other components of the drug, to acetylsalicylic acid or other NSAIDs.
special instructions
The ointment should be applied only to intact skin, avoiding contact with open wounds. After application, do not apply an occlusive dressing. The drug should not come into contact with the eyes and mucous membranes.
When using the drug together with other dosage forms of diclofenac, the maximum daily dose should be taken into account.
When applied to large surfaces of the skin for a long time, the risk of developing systemic side effects, characteristic of non-steroidal anti-inflammatory drugs.
Overdose
The extremely low systemic absorption of the active components of the drug when used externally makes overdose almost impossible.
*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)
Registration number:
P N002146/01Trade name of the drug:
Diclofenac-AkrikhinInternational nonproprietary name:
diclofenacDosage form:
ointment for external useCompound
100 g ointment contains:active substance: diclofenac sodium in terms of 100% substance - 1 g;
Excipients: dimethyl sulfoxide (dimexide), macrogol (polyethylene oxide 1500), macrogol (polyethylene oxide 400), propylene glycol, succinic acid.
Description
The ointment is white to white with a grayish or yellowish tint with a weak specific odor.
The presence of pearlescent stains is allowed.
Pharmacotherapeutic group:
non-steroidal anti-inflammatory drug (NSAID).CodeATX: M02AA15
Pharmacological properties
Pharmacodynamics.
The active component diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) with pronounced analgesic and anti-inflammatory properties. Indiscriminately inhibiting cyclooxygenase types 1 and 2, it disrupts the metabolism of arachidonic acid and the synthesis of prostaglandins, which are the main link in the development of inflammation.
Diclofenac-Akrikhin is used to eliminate pain and reduce swelling associated with the inflammatory process. At local application causes weakening or disappearance of joint pain at rest and during movement. Reduces morning stiffness and swelling of joints, helps increase range of motion.
Pharmacokinetics.
When applied, systemic absorption is no more than 6%. When applied to the area of the affected joint, the concentration in the synovial fluid is higher than in the plasma.
Indications for use
- Post-traumatic inflammation of soft tissues and joints, for example, as a result of sprains, strains and bruises.
- Rheumatic diseases of soft tissues (tenosynovitis, bursitis, damage to periarticular tissues).
- Pain and swelling associated with diseases of muscles and joints (rheumatoid arthritis, osteoarthritis, radiculitis, lumbago, sciatica, muscle pain of rheumatic and non-rheumatic origin).
Contraindications
Increased sensitivity to diclofenac or other components of the drug, to acetylsalicylic acid or other NSAIDs, anamnestic data on an attack of bronchial obstruction, rhinitis; urticaria after taking acetylsalicylic acid or other NSAIDs, pregnancy (III trimester), lactation period, children (up to 6 years), violation of the integrity of the skin.Carefully.
Hepatic porphyria (exacerbation), erosive and ulcerative lesions of the gastrointestinal tract, severe dysfunction of the liver and kidneys, chronic heart failure, old age, bronchial asthma, pregnancy (I and II trimester).Use during pregnancy and lactation
The drug should not be used in the third trimester of pregnancy. There is no experience with the use of the drug during lactation.Use in the first and second trimesters is possible only after consultation with a doctor.
Directions for use and doses
Externally.For adults and children over 12 years of age, the drug is applied in a thin layer over the area of inflammation 3-4 times a day and lightly rubbed in.
The required amount of the drug depends on the size of the painful area.
A single dose of the drug is 2-4 g (in volume comparable to the size of a large cherry).
For children from 6 to 12 years of age, use no more than 2 times a day, a single dose of the drug is up to 2 g.
After applying the drug, hands must be washed.
The duration of treatment depends on the indications and the observed effect. After 2 weeks of using the drug, you should consult your doctor.
Side effect
Local reactions: eczema, photosensitivity, contact dermatitis (itching, redness, swelling of the treated skin area; papules, vesicles, peeling).
Systemic reactions: generalized skin rash, allergic reactions (urticaria, angioedema, bronchospastic reactions).
Overdose
The extremely low systemic absorption of the active components of the drug when used externally makes overdose almost impossible.
Interaction with other drugs
The drug may enhance the effect of drugs that cause photosensitivity. Clinically significant interactions with others medicines not described.
special instructions
The ointment should be applied only to intact skin, avoiding contact with open wounds. After application, do not apply an occlusive dressing.
The drug should not come into contact with the eyes and mucous membranes.
When using the drug together with other dosage forms of diclofenac, the maximum daily dose should be taken into account.
When applied to large surface areas of the skin for a long time, the risk of developing systemic side effects characteristic of NSAIDs increases.
Release form
Analogs of the drug diclofenac-acri are presented, in accordance with medical terminology, called “synonyms” - drugs that are interchangeable in their effects on the body, containing one or more identical active ingredients. When selecting synonyms, consider not only their cost, but also the country of production and the reputation of the manufacturer.
Description of the drug
Diclofenac-Acree- Non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid. It has anti-inflammatory, analgesic, antipyretic and antiplatelet effects. By indiscriminately inhibiting cycloxygenases 1 and 2, it disrupts the metabolism of arachidonic acid and reduces the amount of prostaglandins. at the site of inflammation, suppresses the exudative and proliferative phases of inflammation.At rheumatic diseases The anti-inflammatory and analgesic effect of diclofenac helps to significantly reduce the severity of pain, morning stiffness, and swelling of the joints, which improves the condition of the joint.
In case of injuries, postoperative period diclofenac reduces painful sensations and inflammatory edema.
List of analogues
Note! The list contains synonyms of Diclofenac-Acri, having similar composition, so you can choose a replacement yourself, taking into account the form and dose of the medicine prescribed by your doctor. Give preference to manufacturers from the USA, Japan, Western Europe, as well as well-known companies from of Eastern Europe: KRKA, Gedeon Richter, Actavis, Aegis, Lek, Hexal, Teva, Zentiva.
| Release form(by popularity) | price, rub. |
| Diclofenac-Acree | |
| Ointment 1% - 30g (Akrikhin KhFK OJSC (Russia) | 84 |
| Arguette Duo | |
| Arguette Rapid | |
| Arthrex | |
| Bioran | |
| Veral | |
| Voltaren | |
| 15 mg/day No. 2 TTC (Dojin Iyaku - Kako Co. LTD (Japan) | 169.50 |
| 30 mg/day No. 2 TTC (Dojin Iyaku - Kako Co. LTD (Japan) | 252.70 |
| Tab 25mg N30 (Novartis Pharma S.p.A. (Italy) | 256.70 |
| Amp 75mg / 3ml No. 5. (Novartis Pharma AG (Switzerland) | 281.90 |
| Suppositories 100 mg N5 (Novartis Pharma SAS (France) | 295.10 |
| Amp 75mg / 3ml N1 (Novartis Pharma AG (Switzerland) | 305 |
| Tab 50mg N20 (Novartis Pharma S.p.A. (Italy) | 313.30 |
| 15 mg/day No. 5 TTC (Dojin Iyaku - Kako Co. LTD (Japan) | 350.90 |
| Suppositories 50 mg N10 (Novartis Pharma SAS (France) | 351.30 |
| Emulgel 1% - 50g (Novartis Pharma Productions Gmb (Germany) | 375 |
| Emulgel for joint pain 1% - 100g (Novartis Pharma Productions Gmb (Germany) | 401.90 |
| Emulgel 1% - 100g (Novartis Pharma Productions Gmb (Germany) | 561.70 |
| Emulgel 1% 150g external gel (Novartis Consumer Health S.A. (Switzerland) | 774.20 |
| Voltaren Akti | |
| Tablet p/o 12.5 mg N10 (Novartis Pharmaceuticals S.A. (Spain) | 126 |
| Voltaren Ofta | |
| Voltaren Rapid | |
| Diklak | |
| Tab 75mg N10 (Hexal AG (Germany) | 69.80 |
| Gel 5% 50g (Salutas Pharma GmbH (Germany) | 260.30 |
| Gel 5% 100g (Salutas Pharma GmbH (Germany) | 379.80 |
| Diklak Lipogel | |
| Diklo-F | |
| Eye drops 0.1% - 5ml | 161.30 |
| Diclobene | |
| Dikloberl N 75 | |
| Diklovit | |
| Gel 1% 20g (Nizhpharm OJSC (Russia) | 136 |
| Rectal suppositories N10 (Nizhpharm OJSC (Russia) | 153.20 |
| Diclogen | |
| Ampoules 75 mg, 3 ml, 5 pcs. (Ajio Pharmaceuticals Ltd, India) | 6 |
| Diclomax | |
| Diclomax-25 | |
| Diclomax-50 | |
| Diclomax™ | |
| Diclomax™-25 | |
| Diclomax™-50 | |
| Diclomelan | |
| Diclonak | |
| Diclonate P | |
| 37.5 mg/ml 2ml No. 5 r - r i/m (Merkle GmbH (Germany) | 95.20 |
| Dicloran | |
| Gel, 30 g (Unic Pharmaceutical, India) | 265 |
| Dicloran SR | |
| Diclorium | |
| Diclofen | |
| Diclofenac | |
| 0.1% 5ml eye drops MEZ (Moscow Endocrine Plant (Russia) | 30.10 |
| 0.1% 5ml eye drops Synthesis (Sintez OJSC (Russia) | 30.10 |
| Amp 75mg / 3ml No. 5 Hemofarm. (Hemofarm A.D. (Serbia) | 48.30 |
| Amp 75mg / 3ml N5 Hemofarm (Hemofarm A.D. (Serbia) | 48.80 |
| 100 mg No. 10 suppository rect. (Biokhimik JSC (Russia) | 53.30 |
| Gel 1% - 30g (Indus Pharma Pvt Ltd (India) | 55.60 |
| 0.1% 5ml eye drops Rompharm (K.O. Rompharm Company S.R.L. (Romania) | 57 |
| Amp 75mg / 3ml N1 Sotex (Sotex PharmFirma CJSC (Russia) | 62.60 |
| 100 mg No. 10 suppository rectal DHF (Dalkhimpharm OJSC (Russia) | 62.30 |
| 1% 30g gel Synthesis (Synthesis AKOMPI OJSC (Russia) | 69.70 |
| Amp 75mg / 3ml N5 Sotex (Sotex PharmFirma CJSC (Russia) | 75.50 |
| Gel 1% - 40g (Hemofarm A.D. (Serbia) | 103 |
| 5% 50g gel Synthesis (Synthesis ACOMPI OJSC (Russia) | 103.20 |
| Suppositories 50 mg N10 Poland (GlaxoSmithKline Pharmaceuticals (Poland) | 184.30 |
| 5% 100g gel Synthesis (Synthesis ACOMPI OJSC (Russia) | 207.80 |
| Diclofenac (Biclopan) | |
| Diclofenac (Ortofen) | |
| Diclofenac Bufus | |
| Diclofenac Welfarm | |
| Diclofenac Grindeks | |
| Diclofenac potassium | |
| Diclofenac sodium | |
| Diclofenac retard | |
| 100 mg No. 20 tablet prolong.p/cr.o Ozon (Ozon LLC (Russia) | 39.10 |
| Diclofenac retard Obolenskoye | |
| 100 mg No. 20 tab prol.p/kr.o (Obolenskoye FP CJSC (Russia) | 51.90 |
| Diclofenac retard-Akrikhin | |
| 41 | |
| Diclofenac Sandoz | |
| Diclofenac Stada | |
| Diclofenac Elfa | |
| Diclofenac* | |
| Diclofenac-AKOS | |
| 25mg/ml 3ml No. 1 solution i/m (Sintez OJSC (Russia) | 20.40 |
| 25 mg / ml 3 ml No. 5 solution in / m (Sintez OJSC (Russia) | 22.70 |
| 1% - 30g ointment (Sintez OJSC (Russia) | 31.90 |
| 25 mg / ml 3 ml No. 10 r - r v / m (5x2) (Sintez OJSC (Russia) | 42.50 |
| Diclofenac-Acre retard | |
| 100 mg No. 20 tab p/pl.o prolong (Akrikhin KhFK OJSC (Russia) | 39.70 |
| Diclofenac-Akrikhin | |
| 1% 30g ointment (Akrikhin KhFK OJSC (Russia) | 85.90 |
| 1% 40g gel (Akrikhin KhFK OJSC (Russia) | 132.20 |
| Diclofenac-Altpharm | |
| Suppositories 50 mg N10 (Altfarm LLC (Russia) | 108.40 |
| Suppositories 100 mg N10 (Altfarm LLC (Russia) | 138.50 |
| Diclofenac-long | |
| Diclofenac-MFF | |
| Ointment 2% - 30g (Moscow Pharmaceutical Factory CJSC (Russia) | 23.60 |
| Candles 50 mg N10 (Moscow Pharmaceutical Factory CJSC (Russia) | 30 |
| Diclofenac-ratiopharm | |
| Diclofenac-Solopharm | |
| R - r for v/mice. injected 25 mg/ml 3 ml ampoules, 5 pcs. | 46 |
| Eye drops 0.1%, 5 ml | 47 |
| Diclofenac-Teva | |
| 1% 100g gel (Merkle GmbH (Germany) | 308.10 |
| Diclofenac-UBF | |
| Diclofenac-Farcos | |
| Diclofenac-FPO | |
| Tablets coated quiche - dissolved vol. 50 mg, 20 pcs | 39 |
| Diclofenac-Eskom | |
| Diclofenaclong | |
| Main drops 0.1% 10ml (Firn M (Russia) | 100.90 |
| Diclofenacol | |
| Cream 1%, 20 g | 90 |
| Difen | |
| Dorosan | |
| Spray 1% 50ml (Aerosol Service Italiana S.r. (Italy) | 200 |
| Naklof | |
| Naklofen | |
| Amp 75mg / 3ml - 3ml N1 KRKA (KRKA, novo mesto (Slovenia) | 49.90 |
| Tablet p/o 50 mg N20 (Krka, d.d. Novo Mesto (Slovenia) | 64.10 |
| Candles 50 mg N10 (KRKA, Novo Mesto (Slovenia) | 104.50 |
| Naklofen Duo | |
| Capsules with mod. vysv. 75 mg, 20 pcs. | 131 |
| Naklofen SR | |
| Retard tablets 100 mg, 20 pcs. (KRKA, Slovenia) | 98 |
| Diclofenac sodium | |
| Ortofen | |
| 25 mg No. 20 tab p/kr.o THF (Tathimpharmpreparaty OJSC (Russia) | 40.20 |
| Ointment 2% 30g Vertex (Vertex JSC (Russia) | 84.50 |
| Ointment 2% 50g Vertex (Vertex JSC (Russia) | 117.50 |
| Gel 5% 50g Vertex (Vertex JSC (Russia) | 204.60 |
| Ortofena ointment 2% | |
| Ortofena solution for injection 2.5% | |
| Ortofena film-coated tablets, 0.025 g | |
| Ortofena film-coated tablets for children 0.015 g | |
| Orthofer | |
| Orthoflex | |
| Pensaid | |
| Rapten Duo | |
| Rapten rapid | |
| Tab b. 50 mg N10 (HEMOFARM (Serbia) | 47.30 |
| Tab p/o. 50 mg N10 (HEMOFARM (Serbia) | 54.60 |
| Revmavec | |
| Revodina retard | |
| Remetan | |
| Sanfinak | |
| SwissJet | |
| SwissJet Duo | |
| Tabuk-Di | |
| Uniclofen | |
| Feloran | |
| Feloran 25 | |
| Feloran retard | |
| Flector | |
| Flotak | |
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Official instructions for use
There are contraindications! Read the instructions before useDiclofenac-Acree
Registration number:
P N011648/01/02Tradename drug: Diclofenac-Acree
International generic name(INN): Diclofenac-Acri.
Dosage form:
enteric-coated tablets; extended-release tablets, coated film-coated.Compound
1 enteric-coated tablet contains: active substance: Diclofenac-Acri sodium 50 mg; Excipients: lactose monohydrate - 46.6 mg, corn starch - 59.2 mg, povidone-K30 - 10.0 mg, sodium lauryl sulfate - 10.0 mg, sodium carboxymethyl starch - 20.0 mg, colloidal silicon dioxide - 3.0 mg, magnesium stearate - 1.2 mg; shell: methacrylic acid and methyl methacrylate copolymer - 4.1379 mg, macrogol-6000 - 1.0345 mg, talc - 6.7241 mg, titanium dioxide E 171 - 1.0345 mg, sunset yellow dye - 2.0670 mg.
1 extended-release film-coated tablet contains: active substance: Diclofenac-Acri sodium 100 mg; Excipients: sucrose - 94.7880 mg, cetyl alcohol - 54.8200 mg, colloidal silicon dioxide, anhydrous - 0.7900 mg, talc - 3.9500 mg, povidone K-25 - 1.053 mg, magnesium stearate - 7.8990 mg; shell: hypromellose - 3.4355 mg, titanium dioxide E 171 - 0.8649 mg, talc - 2.4178 mg, polysorbate 80 - 0.3826 mg, macrogol 6000 - 0.6894 mg, crimson dye [Ponceau 4R] [E124] - 0.0441 mg, brown dye [sunset yellow dye [E110] + azorubine dye [E122] + brilliant black dye [E151]] - 0.0147 mg, aluminum varnish based on sunset yellow dye [E110] -0.0500 mg.
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Description
Enteric-coated tablets, 50 mg
- round biconvex tablets, enteric-coated, orange in color, white to almost white at the break white.
Extended-release film-coated tablets, 100 mg
- round biconvex tablets, pink-coated, white to almost white at the break. Pharmacotherapeutic group:
Nonsteroidal anti-inflammatory drug (NSAID)
ATX code:М01АВ05
Pharmacological properties
Non-steroidal anti-inflammatory drug (NSAID), a derivative of phenylacetic acid. Diclofenac-Acri has anti-inflammatory, analgesic, antiplatelet and antipyretic effects. By indiscriminately inhibiting cyclooxygenase 1 and 2 (COX1 and COX2), it disrupts the metabolism of arachidonic acid and reduces the amount of prostaglandins at the site of inflammation. Most effective for inflammatory pain.In rheumatic diseases, the anti-inflammatory and analgesic effect of diclofenac helps to significantly reduce the severity of pain, morning stiffness, and swelling of the joints, which improves functional state joint
For injuries, in the postoperative period, Diclofenac-Acri reduces pain and inflammatory swelling.
Pharmacokinetics
Absorption is rapid and complete, food slows the rate of absorption by 1–4 hours and reduces the maximum concentration (Cmax) by 40%. After oral administration of 50 mg, the maximum concentration (Cmax) of 1.5 μg/ml is achieved after 2–3 hours. The plasma concentration is linearly dependent on the size of the administered dose.After oral administration of 100 mg tablets, C max - 0.5 mcg/ml is achieved in - 4–5 hours.
There are no changes in the pharmacokinetics of diclofenac following repeated administration. Does not accumulate if the recommended interval between meals is observed.
Bioavailability - 50%. Communication with plasma proteins is more than 99% (most of it is associated with albumin). Penetrates into synovial fluid; Cmax in synovial fluid is observed 2–4 hours later than in plasma. Half-life (T 1/2) from synovial fluid 3–6 hours (concentration active substance in the synovial fluid 4–6 hours after administration of the drug is higher than in plasma, and remains higher for another 12 hours).
The relationship between the concentration of the drug in the synovial fluid and the clinical effectiveness of the drug has not been clarified.
Metabolism: 50% of the active substance is metabolized during the “first pass” through the liver. Metabolism occurs as a result of multiple or single hydroxylation and conjugation with glucuronic acid. The enzyme system P450 CYP2C9 takes part in the metabolism of the drug.
The pharmacological activity of the metabolites is lower than that of diclofenac.
Systemic clearance is approximately 260 ± 50 ml/min, volume of distribution is 550 ml/kg. T 1/2 from plasma averages about 2.5 hours. 65% of the administered dose is excreted as metabolites by the kidneys; less than 1% is excreted unchanged, the rest of the dose is excreted as metabolites in the bile.
In patients with severe renal failure (creatinine clearance less than 10 ml/min), the excretion of metabolites in bile increases, but no increase in their concentration in the blood is observed,
In patients with chronic hepatitis or compensated liver cirrhosis, the pharmacokinetic parameters of diclofenac do not change.
Diclofenac-Acri penetrates into breast milk.
Indications for use
Symptomatic treatment of diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic arthritis, juvenile chronic arthritis, ankylosing spondylitis (ankylosing spondylitis); gouty arthritis, rheumatic lesion soft tissue, osteoarthritis peripheral joints and spine, including those 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, algodismenorrhea, adnexitis, proctitis, toothache.
As part of complex therapy for infectious and inflammatory diseases of the ear, nose and throat with severe pain syndrome(pharyngitis, tonsillitis, otitis).
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;
- 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;
- Expressed renal failure(creatinine clearance less than 30 ml/min); progressive kidney diseases, incl. confirmed hyperkalemia;
- Children under 15 years of age - for 50 mg tablets and up to 18 years of age - for 100 mg tablets;
- Patients with rare hereditary diseases such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption, take the drug ( tablets 50 mg) is contraindicated.
Carefully
Anemia, bronchial asthma, cerebrovascular diseases, ischemic disease heart disease, congestive heart failure, arterial hypertension, peripheral arterial disease, edema syndrome, liver or kidney failure (creatinine clearance less than 60 ml/min), dyslipidemia/hyperlipidemia, diabetes mellitus, smoking, inflammatory diseases intestines, condition after extensive surgery, inducible porphyria. diverticulitis, systemic diseases connective tissue, pregnancy I–II trimester.
Anamnestic data on development peptic ulcer gastrointestinal tract, presence of infection Helicobacter pylori, old age, long-term use of NSAIDs, frequent use alcohol, heavy 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).
Directions for use and doses
Tablets 50 mg.Orally, without chewing, during or after meals, with a small amount of water.
Adults and adolescents over 15 years old - 50 mg 2-3 times a day. Upon reaching the optimal therapeutic effect the dose is gradually reduced and switched to maintenance treatment at a dose of 50 mg/day. Maximum daily dose- 150 mg.
Tablets 100 mg.
1 tablet 1 time per day. If additional drug intake is necessary, use 50 mg tablets.
Side effects
Often - 1–10%; sometimes - 0.1–1%; rarely - 0.01–0.1%; very rarely - less than 0.001%, including isolated cases.From the outside digestive system: often - epigastric pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased aminotransferase activity; rarely - gastritis, proctitis, bleeding from the gastrointestinal tract (gastrointestinal tract) (vomiting with blood, melena, diarrhea mixed with blood), gastrointestinal ulcers (with or without bleeding or perforation), hepatitis, jaundice, impaired liver function; very rarely - stomatitis, glossitis, esophagitis, nonspecific hemorrhagic colitis, exacerbation ulcerative colitis or Crohn's disease, constipation, pancreatitis, fulminant hepatitis.
From the outside nervous system: often - headache, dizziness; rarely - drowsiness; very rarely - sensory disturbance, incl. paresthesia, memory disorders, tremor, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, disorientation, depression, insomnia, nightmares, irritability, mental disorders.
From the senses: often - vertigo; very rarely - visual impairment (blurred vision, diplopia), hearing impairment, tinnitus, impaired taste sensations.
From the urinary system: very rarely - acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.
From the hematopoietic organs: very rarely - thrombocytopenia, leukopenia, hemolytic and aplastic anemia, agranulocytosis.
Allergic reactions: anaphylactic/anaphylactoid reactions, including marked decrease blood pressure(BP) and shock; very rarely - angioedema (including the face).
From the outside of cardio-vascular system: very rarely - palpitations, chest pain, increased blood pressure, vasculitis, heart failure, myocardial infarction.
From the outside respiratory system: rarely - exacerbation bronchial asthma; very rarely - pneumonitis.
From the skin: often - skin rash; rarely - urticaria; very rarely - bullous rashes, eczema, incl. multiforme and Stevens-Johnson syndrome, Lyell's syndrome, exfoliative dermatitis, itching, hair loss, photosensitivity, purpura, incl. allergic.
Overdose
Symptoms: vomiting, bleeding from the gastrointestinal tract, diarrhea, dizziness, tinnitus, convulsions, increased blood pressure, respiratory depression, in case of significant overdose - acute renal failure, hepatotoxic effect.Treatment: gastric lavage, activated carbon, symptomatic therapy, aimed at eliminating increased blood pressure, renal dysfunction, seizures, gastrointestinal irritation, and respiratory depression. Forced diuresis and hemodialysis are ineffective (due to the significant connection with proteins and intensive metabolism).
Interaction with other drugs
Increases plasma concentrations of digoxin, methotrexate, lithium and cyclosporine.Reduces the effect of diuretics; against the background of potassium-sparing diuretics, the risk of hyperkalemia increases; against the background of anticoagulants, thrombolytic agents (alteplase, streptokinase, urokinase) - the risk of bleeding (usually from the gastrointestinal tract).
Reduces the effects of antihypertensive and sleeping pills.
Increases the likelihood of side effects of other NSAIDs and glucocorticosteroids (bleeding in gastrointestinal tract), toxicity of methotrexate and nephrotoxicity of cyclosporine.
Acetylsalicylic acid reduces the concentration of diclofenac in the blood.
Concomitant use with paracetamol increases the risk of developing nephrotoxic effects of diclofenac.
Reduces the effect of hypoglycemic drugs.
Cefamandole, cefoperazone, cefotetan, valproic acid and plicamycin increase the incidence of hypoprothrombinemia.
Cyclosporine and gold preparations increase the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which increases nephrotoxicity.
Simultaneous administration with ethanol, colchicine, corticotropin, serotonin reuptake inhibitors and St. John's wort preparations increases the risk of bleeding in the gastrointestinal tract.
Diclofenac-Acri enhances the effect of drugs that cause photosensitivity.
Drugs that block tubular secretion increase the plasma concentration of diclofenac, thereby increasing its toxicity.
Antibacterial drugs from the quinolone group - the risk of developing seizures.
Impact on results laboratory tests: Diclofenac-Acri may affect serum transaminases (if this effect is long-lasting or if complications occur, treatment should be discontinued) and may also cause an increase in potassium concentrations.
special instructions
In order to quickly achieve the desired therapeutic effect, Diclofenac-Acri is taken 30 minutes before meals. In other cases, take before, during or after meals, without chewing, with a sufficient amount of water.Because of the important role of prostaglandins in maintaining renal blood flow, careful attention should be paid to special caution when prescribed to patients with heart or renal failure, as well as when treating elderly patients taking diuretics, and patients who, for any reason, have a decrease in circulating blood volume (for example, after extensive surgical intervention).
If Diclofenac-Acri is prescribed in such cases, it is recommended to monitor renal function as a precaution.
In patients with renal failure with CC less than 10 ml/min, Css of metabolites in plasma should theoretically be significantly higher than in patients with normal function kidneys, but this is not really observed, since in this situation the excretion of metabolites with bile increases.
In patients with liver failure (chronic hepatitis, compensated cirrhosis of the liver) kinetics and metabolism do not differ from similar processes in patients with normal liver function. When conducting long-term therapy it is necessary to monitor liver function, peripheral blood picture, stool analysis occult blood.
Due to the negative effect on fertility, the drug is not recommended for women wishing to become pregnant. In patients with infertility (including those undergoing examination), it is recommended to discontinue the drug.
Care must be taken when owls local use With ACE inhibitors, beta blockers; digoxin; during treatment with nephrotoxic drugs, zidovudine.
During the treatment period, the speed of mental and motor reactions may decrease, so it is necessary to refrain from driving vehicles and engaging in other potentially dangerous activities. dangerous species activities requiring increased concentration attention and speed of psychomotor reactions.
To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.
When taking 100 mg tablets to patients diabetes mellitus the content of sucrose in the preparation should be taken into account (in 1 tablet - 94.7880 mg of sucrose).
Patients taking the drug must refrain from drinking alcohol.
Release form
Enteric-coated tablets, 50 mg.10 tablets per PVC/AL blister. 2 blisters along with instructions for use in a cardboard box.
Extended-release film-coated tablets, 100 mg.
10 tablets per blister made of PVC/PVDC/AL. 2 blisters along with instructions for use in a cardboard box.
Storage conditions
List B.Store in a dry place, protected from light, at a temperature of 15 to 25 °C.
Keep out of the reach of children!
Best before date
Enteric-coated tablets - 3 years.Extended-release film-coated tablets - 4 years.
Do not use after the expiration date stated on the package.
Vacation conditions
On prescription.Manufacturer
1. ManufacturerHemofarm A.D., Serbia
26300 Vršac, Beogradski put bb, Serbia
Consumer complaints should be sent to:
Russia, 603950, Nizhny Novgorod GSP-458, st. Salganskaya, 7.
In the case of packaging at Hemofarm LLC. Russia:
Manufactured by: Hemofarm A.D., Vršac, Serbia
Packed:
Hemofarm LLC, 249030, Russia, Kaluga region, Obninsk, Kyiv highway, 62.
OR
2. Manufacturer
Hemofarm LLC, 249030, Russia, Kaluga region, Obninsk, Kyiv highway, 62.
Organizations accepting complaints from consumers:
Hemofarm LLC, 249030, Russia, Kaluga region, Obninsk, Kyiv highway, 62.
The information on the page was verified by physician-therapist E.I. Vasilyeva.
Diclofenac Acri is a medicine with an analgesic effect and an anti-inflammatory effect. Used in neurology, traumatology, surgery and other areas of medicine. Prescribed for pain in the joints, muscles or bone tissue. As part of a complex course, it can be used in therapy respiratory tract, in sports medicine, ophthalmology, gynecology.
Release form, composition and packaging
The drug is available in the form of a light gel and a thicker ointment. 1 g of medicines contains 10 mg of the main active component- diclofenac sodium, a NSAID.
Diclofenac is packaged in aluminum tubes with membrane protection. Each package contains medicine and detailed guide for use.
Ointment
The drug in the form of an ointment has a dense texture that is slowly absorbed into the skin. Similar form Suitable for application under bandages. Color - white or white-gray, a pearlescent tint may appear. The smell is faint. Available in tubes of 30 g.
Gel
The product in the form of a gel has a light texture that is well absorbed and leaves no residue. The color is from white to white-yellow, the smell is specific, but unobtrusive. Available in tubes of 40 g.
Pills
Diclofenac retard - tablets based on diclofenac. 1 dose contains 100 mg active ingredient. The drug is packaged in blister packs of 10 pcs. Tablets are incompatible with some medicines, have many contraindications, wide range side effects.
Before taking diclofenac orally, you should consult your doctor.
Pharmacological action of Diclofenac Acri
The main active component of the drug - diclofenac - has a complex effect. The substance interferes with the metabolism of acids and hormone-like substances that provoke the development inflammatory processes. Suppresses platelet aggregation, improves blood microcirculation. The water-ethanol base of the ointment and gel has an additional analgesic effect.
When applied to the skin, the absorption of diclofenac does not exceed 6%. The drug easily and quickly penetrates the dermis and gradually accumulates in the tissues.
What does Diclofenac Acri help with?
The drug is intended to reduce pain and inflammation of connective or soft tissues. Effective in the treatment of traumatic or rheumatic syndromes. Good for increasing joint mobility. Prescribed for the following conditions:
- radiculitis, osteoarthritis and other diseases of the spine;
- muscle strains;
- bruises and injuries of various types;
- joint pain.
The product is effective in complex treatment with other medications and therapeutic procedures for upper respiratory tract infections, diseases of the anorectal region, inflammation of the urinary system. Can be used to eliminate negative consequences appeared after operations and injuries.
Dosage regimen
The drug is applied to the painful or inflamed area and gently rubbed in a circular motion. The frequency of use of the ointment is 2-3 times a day, the gel is 3-4. The amount of dose applied is determined by the size of the treated surface, and the duration of treatment is determined by the progress of therapy and medical indications. The maximum course is 14 days.
After each application of the gel and ointment, you must wash your hands to avoid getting the composition on the skin or mucous membranes.
If after 7 days from the start of treatment the condition does not improve or worsens, you should consult a doctor.
Side effects of Diclofenac Acri
According to available data, the drug rarely causes adverse reactions. The likelihood of negative consequences of using a cream or gel increases if the recommended dosages and course of treatment are not followed.
In rare cases, the medicine provokes the following adverse reactions:
- pustular rashes;
- rash;
- allergies;
- dermatitis and its symptoms (itching, swelling, peeling, etc.);
- development of sensitivity to the sun;
- bronchospastic reactions;
- impaired vision and taste.
When found undesirable consequences treatment, it is recommended to stop using the drug and consult a doctor.
Contraindications for use
The drug is not prescribed to people sensitive to diclofenac or other components of the drug. Its use is unacceptable in the following cases:
- Availability adverse reactions when taking other NSAIDs;
- last trimester of pregnancy;
- age up to 6 years.
For chronic heart failure, stomach diseases, gastrointestinal lesions in the acute phase, Diclofenac is used with caution.
special instructions
Do not apply the product to damaged skin or wounds. Do not allow the composition to get into the mucous membranes. The drug does not affect the speed of reactions and concentration.
To enhance the effectiveness of treatment, the medicine is applied under a bandage that allows air to pass through.
When using several forms of Diclofenac simultaneously (for example, ointments and tablets), restrictions must be taken into account. daily dosage substances.
When Retard is taken orally, diclofenac is detected in the blood plasma and can cause an increase in the activity of liver transaminases. At long-term treatment control of laboratory tests is necessary.
The tablets are taken as prescribed by the doctor separately from meals - when eating, the rate of absorption of the active ingredient may decrease.
Use during pregnancy and breastfeeding
There are no data on the topical use of Diclofenac among pregnant patients. Therefore, the medicine is used only after consulting the attending physician, who will compare potential harm for the fetus and benefits for the mother.
Women in the last trimester of pregnancy are not prescribed Diclofenac. The limitation is due to the possible negative impact the drug on uterine tone and increased bleeding during childbirth.
There is no information about whether the active substance can pass into breast milk. If you need to use the drug during lactation, you should not apply the composition to the mammary glands or use the product for a long time.
Use in children
Diclofenac is prescribed to children over 6 years of age. For the treatment of patients 6-12 years old, the dosage recommended for adults is halved.
Use for renal impairment
At severe violations renal function Diclofenac is used with caution and under the supervision of a physician.
Overdose
When using the drug topically, there is low level absorption, so the likelihood of overdose is practically absent. When taking Diclofenac orally, systemic adverse reactions may occur.
Diclofenac | instructions for use (ointment)
The result of treatment with diclofenac
Diclofenac Analogues
Storage conditions and periods
The drug should be stored at room temperature (+15...+25°C). If storage conditions are met, the shelf life is 3 years. The tube must be hidden from children.
Conditions for dispensing from pharmacies
The medicine can be purchased at any pharmacy in the city or online stores specializing in the delivery of medical goods. The drug is sold without a prescription.
Price
The cost of Diclofenac may vary depending on the area of sale and the conditions of the seller. The price of ointment with a volume of 30 g is from 80 rubles, gel (40 g) - from 130 rubles.
Analogs
Structural analogues of Diclofenac include drugs such as Dicloran, Voltaren, Naklofen, etc. The action of such drugs is ensured by the general active substance- diclofenac, and the difference lies in the manufacturers, the concentration of the active component and the cost.
If treatment is ineffective or individual sensitivity to diclofenac, patients may be prescribed the following analogues:
- Dolgit (ibuprofen);
- Ibalgin (ibuprofen);
- Indomethacin (indomethacin);
- Indovazin (indomethacin and troxevasin).
The drugs help eliminate swelling, relieve painful sensations, prevent the development of inflammation. Prescribed for injuries, sprains, acute inflammations musculoskeletal system, joint and tissue lesions.
1 retard film-coated tablet contains diclofenac sodium 100 mg; 10 pcs in a blister pack, 2 packs in a cardboard box.pharmachologic effect
Pharmacological effects - analgesic, antiaggregation, antipyretic, anti-inflammatory.
Inhibits cyclooxygenase, disrupts the metabolism of arachidonic acid, reduces the amount of PG both in the site of inflammation and in healthy tissues, suppresses the exudative and proliferative phases of inflammation.
Pharmacokinetics
After oral administration, it is quickly and completely absorbed (food slows down the rate of absorption). As a result of the delayed release of the active substance after taking a dose of 100 mg, Cmax - 0.5-1 μg/ml is achieved after 5 hours. The plasma concentration depends linearly on the size of the administered dosage. Bioavailability - 50%. Communication with plasma proteins, mainly with albumin, is 95-98%. Penetrates into the synovial fluid, where its concentration grows more slowly, but after 4-6 hours it reaches more than high values than in plasma and remains at this level for 12 hours. 50% of the administered dosage undergoes the effect of the first passage through the liver. Metabolized by single or multiple hydroxylation and conjugation with glucuronic acid to form metabolites that are pharmacologically less active than diclofenac. Systemic Cl is 260 ml/min. Excreted through the kidneys (60% of the administered dosage), less than 1% - unchanged, the rest - in the form of metabolites with bile. If the recommended interval between doses is observed, it does not accumulate. When renal function is impaired, the excretion of metabolites with bile increases, but their concentration in the blood is not noticed.Indications of the drug Diclofenac-Acri® retard
Inflammatory diseases of the musculoskeletal system (rheumatoid, psoriatic, juvenile and chronic arthritis, ankylosing spondylitis, chronic and acute gouty arthritis); degenerative diseases musculoskeletal system (deforming osteoarthritis, osteochondrosis); lumbago, sciatica, neuralgia, myalgia; diseases of periarticular tissues (tenosynovitis, bursitis); post-traumatic pain syndrome accompanied by inflammation; postoperative pain, migraine, renal colic, primary algodismenorrhea, adnexitis, proctitis; infectious diseases ENT organs with severe pain syndrome (pharyngitis, tonsillitis, otitis media), residual effects of pneumonia; febrile syndrome.Contraindications
Hypersensitivity (including to other NSAIDs), ulcerative-erosive lesions of the gastrointestinal tract (in the acute phase), “aspirin” asthma, hematopoietic disorders, pregnancy, breast-feeding, younger children's age.Use during pregnancy and breastfeeding
Contraindicated during pregnancy. Breastfeeding should be stopped during treatment.Side effects
From the nervous system and sensory organs:> 1% - headache, dizziness, increased fatigue, insomnia, anxiety, “nightmarish” dreams, impaired taste; > 0.1-< 1% — парестезии, снижение памяти, дезориентация, раздражительность, депрессия, психотические реакции, анорексия, снижение остроты зрения, диплопия, скотома, снижение слуха, шум в ушах; < 0,1% — судороги, тремор, асептический менингит.From the cardiovascular system and blood (hematopoiesis, hemostasis):> 1% - palpitations, chest pain, arrhythmias; > 0.1-< 1% — повышение АД, системные anaphylactic reactions, including shock, thrombocytopenia, leukopenia, anemia;< 0,1% — агранулоцитоз, гемолитическая анемия.From the respiratory system: > 0,1- < 1% — бронхоспазм.From the gastrointestinal tract:> 1% - NSAID gastropathy (gastralgia, nausea, vomiting, diarrhea, abdominal pain, flatulence), erosive and ulcerative lesions of the gastrointestinal tract, gastric or intestinal bleeding, nonspecific colitis, dry mouth, constipation; > 0.1-< 1% — панкреатит, афтозный стоматит, глоссит, повышение активности печеночных трансаминаз, токсический гепатит, фульминантный гепатит.From the outside genitourinary system: > 1% - nephrotic syndrome (edema). > 0.1-< 1% — острая почечная недостаточность, гематурия, протеинурия, олигурия, интерстициальный нефрит, сосочковый некроз, цистит; < 0,1% — импотенция.From the skin: > 1% — itchy skin, skin rash (mostly erythematous, urticarial), angioedema; > 0.1-< 1% — экзема, фотосенсибилизация, аллергическая пурпура, многоформная exudative erythema(including Steven-Johnson syndrome);< 0,1% — эритродермия, алопеция, токсический эпидермальный некролиз (синдром Лайелла).Interaction
Increases plasma concentrations of digoxin, lithium, and cyclosporine. Reduces the effects of diuretics, antihypertensives and hypnotics, increases the likelihood of side effects of other NSAIDs, the toxicity of methotrexate, the nephrotoxicity of cyclosporine and gold preparations. When used simultaneously with oral antidiabetic drugs, both hypo- and hyperglycemia are possible, with potassium-sparing diuretics - the risk of hyperkalemia increases, with anticoagulants - the risk of bleeding. Acetylsalicylic acid reduces the concentration of diclofenac in the blood, cefamandole, cefaperazone, cefotetan, valproic acid, plicamycin increase the frequency development of hypoprothrombinemia. Simultaneous use with ethanol, colchicine, corticotropin, St. John's wort, glucocorticoids will increase the risk of developing gastric - intestinal bleeding.Directions for use and doses
Orally, without chewing, before, during or after meals, with a small amount of water. For adults- 100 mg 1 time per day. For dysmenorrhea and migraine attacks - up to 200 mg/day. If it is necessary to increase the dosage to 150 mg/day, it is possible to combine the prolonged form and the drug short acting(50 mg tablet).Overdose
Symptoms: dizziness, increased blood pressure, headache, hyperventilation, clouding of consciousness, in children - myoclonic convulsions, nausea, vomiting, abdominal pain, bleeding, impaired liver and kidney function. Treatment: symptomatic, gastric lavage, administration activated carbon. Forced diuresis and hemodialysis are ineffective.Precautionary measures
It should be used with caution in cases of induced acute hepatic porphyria, severe impairment of liver and kidney function, heart failure, elderly people taking diuretics, and patients who experience a decrease in blood volume (after major surgery). In these cases, renal function should be monitored. When carrying out long-term therapy, monitoring of liver function, peripheral blood patterns, and stool analysis for occult blood is necessary (especially in patients with a history of liver failure). To quickly achieve the desired effect, the tablet can be taken 30 minutes on an empty stomach. It is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.Storage conditions for Diclofenac-Acri® retard
In a dry place, protected from light, at a temperature not exceeding 25 °C.
Keep out of the reach of children.
Shelf life of Diclofenac-Acri® retard
Do not use after the expiration date stated on the package.