Index of drugs

Symptomatic treatment of acute severe pain in: acute arthritis; chronic arthritis, especially rheumatoid arthritis; ankylosing spondylitis (Bechterew's disease) and other rheumatoid inflammations of the spine; exacerbation of osteoarthritis of the joints and spine (cases of osteoarthritis and arthritis of the spine). Parenteral administration is indicated in case of urgent action or when oral or rectal administration is not possible. In this situation, the use of Ketoprofen in parenteral form should be limited to a single injection in order to start treatment.

1 amp. 2 ml contains 100 mg ketoprofen. The drug contains 25 mg / ml of benzyl alcohol.

A non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and antipyretic effects. The mechanism of action is the inhibition of cyclooxygenase, the enzyme responsible for the synthesis of prostaglandins. In addition, ketoprofen inhibits collagen-induced platelet aggregation. C_max in plasma takes place 20-30 minutes after intramuscular administration. Bioavailability is 70%. It is metabolised in the liver, and then inactive metabolites are mainly removed by the kidneys (92-98%). T_0,5 is 1.5-2.5 h. It binds 99% of plasma proteins. In patients with impaired renal function, excretion may be prolonged in proportion to the degree of the disorder.

Hypersensitivity to the active substance or to any of the excipients. Past hypersensitivity reactions such as bronchospasm, asthma attack, rhinitis, urticaria or other allergic reactions caused by Ketoprofen, salicylates (including acetylsalicylic acid) or other NSAIDs. Known photoallergic or phototoxic reactions when using ketoprofen or fibrates. Active gastric ulcer or any cases of gastrointestinal bleeding, ulcer or perforation of the gastrointestinal tract. Unexplained hematopoietic disorders. Hemorrhagic diathesis. Haemostatic disorders or treatment with anticoagulants. Bleeding from cerebral vessels or other active bleeding. Severe heart failure. Severe hepatic failure. Severe renal failure. Third trimester of pregnancy. Children and adolescents <18 years.

Due to the possibility of anaphylactic reactions (including anaphylactic shock), the patient should be observed for at least 1 hour after administration of the preparation and a rescue kit should be prepared. Taking the preparation at the lowest effective dose for the shortest period necessary to relieve symptoms reduces the risk of side effects. The combination with other NSAIDs, including selective COX-2 inhibitors, should be avoided. When using NSAIDs, the risk of side effects, especially gastrointestinal bleeding or gastrointestinal perforation (with or without warning symptoms) that may end in death, is higher in the elderly. The use of ketoprofen may be associated with increased, when compared to other NSAIDs, gastrointestinal toxicity, especially at higher doses. The risk of gastrointestinal bleeding, ulceration or perforation is greater when using higher doses of NSAIDs in patients with a history of peptic ulcer disease, in particular when complicated by bleeding or perforation - in these patients and the elderly, treatment should be started at the lowest available dose . In these patients and in the group of patients requiring concomitant treatment with low-dose Acetylsalicylic acid or other drugs that increase the risk of gastrointestinal adverse reactions, combination therapy with protective drugs (eg misoprostol or proton pump inhibitors) should be considered. Patients with a history of toxicity to the digestive system, especially in the elderly, should report any unusual abdominal symptoms (especially bleeding from the gastrointestinal tract), especially at the beginning of treatment. Caution is advised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as Warfarin, SSRIs or drugs that inhibit platelet aggregation (including acetylsalicylic acid). The relative risk of gastrointestinal bleeding is greater in patients with low body weight.In the case of gastrointestinal bleeding or gastrointestinal ulceration, the drug should be immediately discontinued. NSAIDs should be used with caution in patients with a history of a history of gastrointestinal (ulcerative colitis, Crohn's disease). Patients with hypertension and / or mild to moderate congestive heart failure should be monitored appropriately (risk of fluid retention and edema). The intake of some NSAIDs (especially long-term at high doses) is associated with an increased risk of thrombotic disorders in the arteries (eg myocardial infarction or stroke). Particularly cautiously used in patients with ischemic heart disease, peripheral artery disease and / or cerebrovascular disease. Caution should be exercised before initiating long-term treatment of patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidemia, diabetes, or smoking). For the first symptoms of skin rash, mucosal lesions and any other signs of hypersensitivity reactions, the preparation should be discontinued (risk of severe skin reactions). Probably the greatest risk of these side effects in patients occurs at the beginning of treatment. Ketoprofen causes an increased risk of photoallergic contact dermatitis. Relief of skin symptoms after discontinuation of the drug may last several months. Cross-hypersensitivity reactions with other arylpropionic acid compounds, fenofibrates or benzoyl or benzophenone compounds protected with oxybenzone may occur. If a photoallergic reaction occurs, ketoprofen should be discontinued. Ketoprofen should only be used after careful consideration of the benefit / risk ratio in cases of acquired porphyria. Particularly in the following cases, careful medical supervision is required: pre-existing kidney damage, abnormal liver function, immediately after major surgery, patients with hay fever, nasal polyps and COPD (due to an increased risk of initiating an allergic reaction, this can be seen in asthma attacks, vasomotor edema or urticaria), in patients with an allergic reaction to other substances, because there is also a risk of hypersensitivity reactions when using ketoprofen, intensive diuretic treatment, NSAID treatment or other analgesics, blood coagulation disorders, treatment with anticoagulants. If the first signs of serious hypersensitivity reactions occur after using ketoprofen, the preparation should be discontinued. In patients with asthma in combination with chronic rhinitis, chronic sinusitis and / or nasal polyposis, the risk of sensitization to acetylsalicylic acid and / or NSAIDs is greater than in the rest of the population. Taking this medicine may cause asthma attacks or bronchospasm, especially in people who are allergic to acetylsalicylic acid or NSAIDs. In the case of disorders such as blurred vision, the preparation should be discontinued. During an infectious disease, ketoprofen may mask the symptoms of infection, such as fever. In patients, particularly the elderly, with heart failure, cirrhosis and nephrosis, using diuretics and with chronic renal impairment, the renal function should be carefully monitored at the beginning of treatment (risk of kidney damage). Patients with impaired blood coagulation should be closely monitored (ketoprofen may temporarily inhibit platelet aggregation). Patients with abnormal liver function tests or a history of liver disease should have their transaminase tested periodically, especially during long-term treatment. Long-term use of ketoprofen requires regular monitoring of liver enzymes, renal function and blood counts with a smear. Diabetes or concomitant use of potassium-sparing drugs may lead to hyperkalemia (regular monitoring of potassium levels in the blood). During long-term use of analgesics, a headache may occur which should not be treated by increasing the dose of the preparation. Compulsive intake of analgesics, in particular when several analgesics are administered simultaneously, can lead to permanent kidney damage, including renal failure (drug-induced nephropathy). When taking NSAIDs, side effects, especially those related to the gastrointestinal tract and o.u.n. they intensify when alcohol is consumed at the same time. The preparation contains benzyl alcohol (25 mg / ml), therefore it must not be used in premature babies and newborns (risk of anaphylactoid reactions in infants and children up to 3 years).

In the I and II trimesters, ketoprofen should only be used in cases of extreme necessity. In the third trimester of pregnancy, the preparation is contraindicated. There is an increased risk of miscarriage, heart defects and exaggeration after the use of prostaglandin synthesis inhibitors in early pregnancy; the total risk of developing cardiovascular malformations increases from less than 1% to about 1.5%; the risk increases with the dose and duration of treatment. If ketoprofen is administered to a woman who intends to become pregnant or when it is administered during the first or second trimester of pregnancy, the dose should be as low as possible and the treatment time as short as possible. Prostaglandin inhibitors used during the third trimester may cause renal dysfunction in the fetus (which may lead to kidney failure with olihydramnios), cardiovascular and pulmonary function (premature closure of the ductus arteriosus and pulmonary hypertension) and expose mother and baby to prolonged bleeding time and inhibition of spasms the uterus. The use of the drug during breastfeeding is not recommended. Ketoprofen may affect fertility in women, therefore it is not recommended for women planning pregnancy. For women who have difficulty conceiving or who are being tested for infertility, the end of ketoprofen should be considered.

Very common: disorders of the digestive tract (nausea, vomiting, heartburn, stomach pain, bloating, constipation or diarrhea, and minor gastrointestinal bleeding that may cause anemia). Common: hypersensitivity reactions in the form of skin rash and pruritus; insomnia, agitation, irritability, headache, dizziness or fatigue, gastrointestinal ulcer with bleeding and perforation, peripheral edema (in particular in patients with hypertension), injection site reactions (pain and burning sensation) or tissue damage (formation of abscess, destruction of adipose tissue). Uncommon: drowsiness, visual disturbances, tinnitus, bloody vomiting, tarry stools, oral mucositis, gastritis, liver dysfunction, hypersensitivity to light, rash, pruritus, renal dysfunction, acute renal failure, nephrotic syndrome or interstitial syndrome nephritis, edema. Rare: hemorrhagic anemia, leukopenia, asthma, colitis, hepatitis, increased transaminases, increased bilirubin in the blood due to liver dysfunction, hyperkalemia, hypersensitivity reactions due to the benzyl alcohol content. Very rare: deterioration of infectious inflammatory states (eg necrotizing fasciitis), hemolytic anemia, aplastic anemia, thrombocytopenia, pancytopenia, agranulocytosis, acute general hypersensitivity reactions (swelling of the face, tongue edema, laryngeal internal edema with narrowing of the airways, dyspnea) , palpitations, hypotension, life-threatening anaphylactic shock), heart failure, myocardial infarction, hypertension, pancreatitis, liver damage (especially during long-term treatment), essentially reversible photoallergic or phototoxic reactions in the form of erythema, pruritus, alveolar or changes lichenoid after a few months of use without complications; alopecia (most often reversible), bullous skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis), kidney damage (necrosis of the warts, especially during long-term treatment), increase in uric acid, acute tubular necrosis. Not known: mood changes, convulsions, bronchospasm (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, urticaria, worsening of chronic urticaria, angioneurotic edema. In addition, the following were observed: ulcerative stomatitis and gastritis.

Intramuscularly. Adults. The maximum daily dose is 200 mg. Before starting treatment with a daily dose of 200 mg, the benefit / risk ratio should be carefully considered. The product should be given as a single injection, in severe cases it can be given twice daily (each time changing the injection site), at the same time the daily dose should not exceed 200 mg. When a change in treatment is required, oral or rectal administration should be used.Special groups of patients. Because of possible side effects, elderly patients require special observation. In elderly patients with impaired renal function it is recommended to reduce the initial dose and use the lowest effective dose; individual dose adjustments should only be considered after ensuring good tolerance of the preparation. Patients with hepatic impairment should be closely monitored and the lowest effective doses administered to them. The drug is not recommended for use in children and adolescents.Way of giving. Inject slowly and deeply into the buttock.