Diclofenac-Akos injection 25 mg / ml 3 ml Amp. 5 pieces


Diclofenac-Akos injection 25 mg / ml 3 ml Amp. 5 pieces



Active substance:
1 ml of solution contains: diclofenac sodium – 25 mg.
Benzyl alcohol (benzyl alcohol) – 40 mg Propylene Glycol – 200 mg, mannitol (mannitol) – 6 mg, sodium disulfite (sodium metabisulfite) – 3 mg, 1 M sodium hydroxide solution – 25 mg Water for injection – up to 1 ml.
Product form:
Solution for intramuscular administration of 25 mg / ml.
3 ml ampoule with a capacity of 5 ml of neutral glass. 5 or 10 ampoules in a cardboard box.
5 ampoules in blisters of PVC film and aluminum foil printing patent or without foil. 1, 2 blisters in a pack made of cardboard.
In each pack, and put the box and the instructions for use scarifier ampoule. In the case of ampules with a ring or a break-point and notched scarifier ampoule not invest.
Hypersensitivity to diclofenac or to any other therapeutic agent from the group of nonsteroidal anti-inflammatory drugs (NSAIDs), and any of the excipients of the formulation; erosive-ulcerous lesions of the gastrointestinal tract (exacerbation), bleeding from the gastrointestinal tract, inflammatory bowel disease (ulcerative colitis, Crohn’s disease); severe hepatic failure, liver disease during acute period; severe renal impairment (creatinine clearance less than 30 mL / min), hyperkalemia; complete or incomplete syndrome intolerance of acetylsalicylic acid (rhinosinusitis, urticaria, polyps, nasal mucosa, bronchial asthma, arising when taking aspirin or any other NSAID); violations of blood, hemostatic disorders (including hemophilia); pregnancy, lactation, children under 18 years of age; since the aortocoronary bypass surgery; at increased risk of arterial thrombosis and thromboembolism; chronic heart failure, functional class II-IV at NYHA classification; clinically confirmed ischemic heart disease; peripheral artery disease and cerebrovascular disease; uncontrolled hypertension.
25 mg / ml
For short-term treatment of pain of various genesis, moderate intensity: diseases of the musculoskeletal system (rheumatoid arthritis, psoriatic, juvenile chronic arthritis, ankylosing spondylitis, gouty arthritis, rheumatic soft tissue, osteoarthritis peripheral joints and spine (including radicular syndrome).
The drug is intended for the symptomatic therapy reduce pain and inflammation at the time of use, does not affect the progression of the disease;
lumbago, sciatica, neuralgia; algomenorrhea, inflammation of the pelvic organs, including adnexitis; posttraumatic pain, accompanied by inflammation; post-operative pain.
Interaction with other drugs
Increasing the concentration of digoxin in plasma of methotrexate drugs lithium and cyclosporine. Reduces the effect of diuretics, potassium-sparing diuretics in the background increases the risk of hyperkalemia; against the background of anticoagulants, thrombolytic agents (alteplase, streptokinase, urokinase) – The risk of bleeding (usually from the gastrointestinal tract). Reduces the effect of antihypertensive and hypnotic drugs. It increases the likelihood of side effects of other nonsteroidal anti-inflammatory drugs and glucocorticosteroid means (bleeding in the gastrointestinal tract), the toxicity of methotrexate and cyclosporine nephrotoxicity. Acetylsalicylic acid reduces the concentration of diclofenac in the blood. Simultaneous use of paracetamol increases the risk of nephrotoxic effects of diclofenac. Reduces the effect of hypoglycemic agents. Cefamandole, cefoperazone, cefotetan, valproic acid and increase the incidence plicamycin hypoprothrombinemia. Cyclosporine and preparations of gold increases the effect of diclofenac on the synthesis of prostaglandins in the kidneys, which increases the nephrotoxicity. Simultaneous with the appointment ethanol, colchicine, corticotropin, selective serotonin reuptake inhibitors, and drugs St. John’s wort increases the risk of bleeding in the gastrointestinal tract. Diclofenac enhances the action of drugs that cause photosensitization. Drugs that block tubular secretion, increase the concentration of diclofenac in plasma, thereby increasing its toxicity. Antibacterial drugs from the group of quinolone – the risk of seizures.
Symptoms: vomiting, dizziness, headache, shortness of breath, dizziness, children – myoclonic seizures, nausea, vomiting, abdominal pain, bleeding, abnormal liver function and kidney.
Treatment: symptomatic therapy, forced diuresis. Hemodialysis is ineffective.
pharmachologic effect
Pharmacological properties:
Diclofenac possesses anti-inflammatory, analgesic and antipyretic action. Non-selectively inhibiting cyclooxygenase 1 and 2, it gives the arachidonic acid metabolism, reduces the amount of prostaglandins in inflammation. In rheumatic diseases inflammatory and analgesic effect of diclofenac contributes to a significant reduction in the severity of pain, morning stiffness, swelling of the joints, which improves the functional state of the joint. When trauma, postoperative diclofenac reduces pain and inflammatory edema.
The time to reach maximum concentration in the intramuscular application of 75 mg – 15-30 min, the maximum concentration value – 1,9-4,8 (average 2.7) mcg / ml. After 3 h after administration plasma concentration averaged 10% of the maximum. Relationship to plasma proteins – more than 99% (most associated with albumin). Metabolism occurs as a result of single or multiple hydroxylation and conjugation with glucuronic acid. The metabolism of the drug is involved enzyme system P450 CYP2C9. The pharmacological activity of the metabolites is lower than diclofenac. Systemic clearance is 350 ml / min, the volume of – 550 ml / kg. . The half-life of plasma – 2 hours 65% of the administered dose excreted by the kidneys as metabolites; less than 1% is excreted in unaltered form, the remainder of the dose excreted in bile as metabolites. In patients with renal failure (less than 10 ml / min creatinine clearance) increases the excretion of metabolites in the bile, thus increasing their concentration in the blood is not observed. In patients with chronic hepatitis or compensated cirrhosis pharmacokinetic parameters of diclofenac are not changed. Diclofenac passes into breast milk.
Conditions of supply of pharmacies
On prescription.
side effects
To reduce the risk of adverse events, use the lowest effective dose short course. Often – 1-10%; sometimes – 0.1-1%; rarely – 0,01-0.1%; very rarely – less than 0.001%, including some cases.
From the digestive system: – often – epigastric pain, nausea, vomiting, diarrhea, dyspepsia, flatulence, anorexia, increased transaminases; – rarely – gastritis, proctitis, bleeding from the gastrointestinal (vomiting blood, melena, diarrhea mixed with blood), ulcers of the gastrointestinal tract (with or without bleeding or perforation), hepatitis, jaundice, liver dysfunction; – very rarely – stomatitis, glossitis, esophageal injuries, bowel diafragmopodobnye stiktury (nonspecific hemorrhagic colitis, exacerbation of ulcerative colitis or Crohn’s disease), constipation, pancreatitis, fulminant hepatitis.
From the nervous system: – common – headache, dizziness; – rarely – drowsiness; – very rarely – a violation of the sensitivity, including paresthesia, memory disturbances, tremors, convulsions, anxiety, cerebrovascular disorders, aseptic meningitis, confusion, depression, insomnia, night “nightmares”, irritability, personality disorders.
From the senses: – often – vertigo; – very rarely – visual disturbances (blurred vision, diplopia), impaired hearing, tinnitus, taste disturbance.
From the urinary system: – very rarely – acute renal failure, hematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.
From the side of hematopoiesis: – very rarely – thrombocytopenia, leukopenia, hemolytic and aplastic anemia, agranulocytosis.
Allergic reactions: – anaphylactic / anaphylactoid reactions, including marked reduction of blood pressure and shock; – very rarely – angioneurotic edema (including face).
Cardio-vascular system: – very rarely – palpitations, chest pain, high blood pressure, vasculitis, heart failure, myocardial infarction. The respiratory system: – rarely – bronchial asthma (including shortness of breath); – very rarely – pneumonitis.
For the skin – often – skin rash; – rarely – urticaria; – very rare – bullous rash, eczema, including multiforme and Stevens-Johnson syndrome, Lyell syndrome, exfoliative dermatitis, itching, loss of hair, photosensitivity, purpura, including allergic.
Local reactions when administered intramuscularly: – burning, infiltration, aseptic necrosis, necrosis of adipose tissue.
special instructions
To reduce the risk of adverse events, use the lowest effective dose of diclofenac lowest possible short course. Long-term therapy with diclofenac and therapy with the use of high doses can lead to an increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke). Patients treated with the drug, you must abstain from alcohol.
The effect on the ability to operate vehicles, machinery
Patients suffering from vertigo and other disorders of the central nervous system, in the period of treatment should refrain from driving vehicles and other classes of potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
In the dark place at a temperature not higher than 25 C. The freezing is allowed. Keep out of the reach of children.
Dosing and Administration
Injected deep intramuscularly.
The single dose for adults – 75 mg (1 ampoule). If necessary, repeated administration is possible, but not sooner than 12 hours. When using other diclofenac formulations should not exceed the maximum daily dose – 150 mg.
Duration of not more than 2 days, if necessary, further switching to oral, rectal or diclofenac.
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg


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