Flamadex
Flamadex: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. In case of impaired liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Flamadex
ATX code: M01AE17
Active ingredient: Dexketoprofen (Dexketoprofen)
Producer: PharmFirma SOTEX CJSC (Russia)
Description and photo update: 19.10.2018
Prices in pharmacies: from 152 rubles.
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Flamadex is a non-steroidal anti-inflammatory drug (NSAID).
Release form and composition
Dosage forms:
- film-coated tablets: round, biconvex, with a dividing line on each side, white, when broken - the core is almost white or white (10 pieces in a blister strip; in a cardboard box 1, 3 or 5 packs);
- solution for intravenous (i / v) and intramuscular (i / m) administration: clear, colorless liquid (2 ml in glass light-protective ampoules with a colored dot and a notch or a colored break ring, 5 pcs. in a blister strip, in a cardboard box 1 or 2 packs).
1 tablet contains:
- active substance: dexketoprofen trometamol - 36.9 mg, which is equivalent to the content of 25 mg of dexketoprofen;
- auxiliary components: pregelatinized starch, magnesium stearate, sodium starch glycolate (sodium carboxymethyl starch), microcrystalline cellulose;
- shell composition: macrogol, hypromellose (hypromellose 2910), titanium dioxide.
1 ampoule contains:
- active substance: dexketoprofen - 50 mg (in the form of dexketoprofen trometamol);
- auxiliary components: water for injection, ethyl alcohol 95% (ethanol), sodium chloride, sodium hydroxide, sodium disulfite.
Pharmacological properties
Pharmacodynamics
Flamadex is a propionic acid derivative that has anti-inflammatory, analgesic and antipyretic effects. The mechanism of its action is associated with inhibition of prostaglandin synthesis at the level of cyclooxygenase enzymes (COX-1 and COX-2).
The analgesic effect occurs within half an hour after the use of dexketoprofen and lasts: after taking the pill - 4–6 hours; after parenteral administration of 50 mg - 4-8 hours.
The use of dexketoprofen in combination with opioid analgesics can reduce the dose of opioids by up to 45%.
Pharmacokinetics
The maximum concentration of dexketoprofen in the blood serum after taking the Flamadex tablet occurs within an hour, with the simultaneous intake of food, the absorption of the drug slows down. There is no accumulation of the drug, since its total concentration in the blood plasma does not change after repeated administration.
Plasma protein binding of dexketoprofen is 99%. The half-life of the drug in the blood is about 0.35 hours. Dexketoprofen is excreted mainly by the kidneys after conjugation with glucuronic acid, its half-life (T 1/2) is from 1 to 2.7 hours.
With a single or repeated intramuscular or intravenous administration of the solution in elderly patients, the total clearance of the drug decreases, T 1/2 increases to 48%.
Indications for use
According to the instructions, Flamadex is used for symptomatic therapy, reducing inflammation and pain in the following conditions:
- relief of pain in the postoperative period, with bone metastases, trauma, renal colic, algodismenorrhea, neuralgia, sciatica, sciatica, toothache and pain syndrome of another genesis;
- symptomatic therapy of inflammatory, inflammatory-degenerative and metabolic diseases of the musculoskeletal system in acute and chronic form, including osteoarthritis, rheumatoid arthritis, spondyloarthritis (reactive arthritis, ankylosing spondylitis, psoriatic arthritis).
The drug does not affect the progression of the disease, since it only acts on the manifestations of symptoms at the time of application.
Contraindications
- erosive and ulcerative lesions of the gastrointestinal tract (GIT) and duodenum;
- period of exacerbation of inflammatory bowel diseases (Crohn's disease, ulcerative colitis);
- a history of gastrointestinal bleeding;
- blood clotting disorders, including hemophilia;
- incomplete or complete combination of recurrent polyposis of the nose and paranasal sinuses, bronchial asthma and intolerance to acetylsalicylic acid and other NSAIDs (including history);
- active bleeding of various origins, including suspicion of intracranial bleeding;
- concomitant anticoagulant therapy;
- severe (10-15 points on the Child - Pugh scale) liver dysfunction;
- severe renal dysfunction with creatinine clearance (CC) less than 30 ml / min, progressive renal pathology;
- confirmed hyperkalemia;
- period after coronary artery bypass grafting;
- decompensated heart failure;
- period of pregnancy;
- breast-feeding;
- age up to 18 years;
- hypersensitivity to NSAIDs (including sulfites) and drug components.
The use of Flamadex in the form of a solution for intravenous and intramuscular administration for neuraxial (intrathecal or epidural) administration is contraindicated due to the presence of ethanol in its composition.
Care should be taken when prescribing Flamadex for chronic heart failure [NYHA functional class I-II], coronary heart disease, arterial hypertension, gastric ulcer and duodenal ulcer, Crohn's disease, ulcerative colitis, history of liver disease, hepatic porphyria, chronic renal failure (CC 30-60 ml / min), a significant decrease in the volume of circulating blood (including conditions after surgery), bronchial asthma, cerebrovascular diseases, diabetes mellitus, dyslipidemia or hyperlipidemia, peripheral arterial diseases, systemic connective tissue, the presence of Helicobacter pylori infection, tuberculosis, prolonged use of NSAIDs, severe osteoporosis, severe somatic diseases, alcoholism,smoking, concomitant use of glucocorticosteroids (including prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, paroxetine, sertraline, fluoxetine (including age), including body weight, concomitant diuretic therapy or a debilitated condition) and a history of allergic reactions.concomitant diuretic therapy or a weakened condition) and a history of allergic reactions.concomitant diuretic therapy or a weakened condition) and a history of allergic reactions.
Instructions for the use of Flamadex: method and dosage
Film-coated tablets
Flamadex tablets are taken orally with meals.
The dose and the period of treatment are prescribed by the doctor, taking into account the clinical indications and the intensity of the pain syndrome.
Recommended dosage: 12.5 mg 4 to 6 times a day or 25 mg 3 times a day. The daily dose should not exceed 75 mg.
In case of impaired liver, kidney function or treatment of elderly patients, therapy should be started with lower doses. For this category of patients, the maximum dose is no more than 50 mg of the drug per day.
The duration of treatment is 3-5 days.
Solution for i / v and i / m administration
The solution is intended for intramuscular injection - slow, deep and intravenous injection - slow jet or drip (within half an hour).
To prepare a solution for infusion, dilute 2 ml of the drug in 30-100 ml of 0.9% sodium chloride solution, Ringer's solution or glucose solution under aseptic conditions and protected from exposure to daylight. The resulting solution should have a clear, colorless structure.
The use of the solution is indicated only for the removal of acute symptoms of the disease, within no more than 48 hours.
Recommended dosage: usually - 50 mg 2-3 times a day, with an interval between infusions of 8 or 12 hours. If necessary, re-administration of the drug can be carried out after 6 hours. The maximum daily dose is not more than 150 mg.
With mild and moderately severe liver dysfunction (5-9 points on the Child-Pugh scale), the total daily dose should not exceed 50 mg. Treatment should be accompanied by frequent monitoring of liver function indicators.
In case of mild renal dysfunction (CC from 30 to 60 ml / min), the usual daily dose of the drug should be reduced to 50 mg.
In elderly patients without a physiological decrease in renal function, dose adjustment is usually not required.
Side effects
- from the digestive system: often - nausea, vomiting; infrequently - dry mouth, dyspepsia, abdominal pain, constipation, diarrhea, hematemesis; rarely - anorexia, erosive and ulcerative lesions of the gastrointestinal tract (including bleeding and perforation), jaundice, increased activity of liver enzymes; very rarely - liver damage, pancreas damage;
- general and local reactions: often - pain at the injection site; infrequently - a feeling of heat, hematoma, an inflammatory reaction, hemorrhages at the injection site, chills, fatigue; rarely - back pain, fever, fainting;
- on the part of the hematopoietic system: rarely - anemia; very rarely - thrombocytopenia, neutropenia;
- from the senses: infrequently - blurred vision; rarely - tinnitus;
- from the nervous system: infrequently - insomnia, headache, drowsiness, dizziness; rarely - paresthesia;
- on the part of the cardiovascular system: infrequently - hyperemia of the skin, arterial hypotension, feeling of heat; rarely - tachycardia, peripheral edema, arterial hypertension, extrasystole, superficial thrombophlebitis;
- from the urinary system: rarely - renal colic, polyuria; very rarely - nephrotic syndrome or nephritis;
- on the part of the musculoskeletal system: rarely - muscle spasm, difficult movement of the joints;
- from the respiratory system: rarely - bradypnea; very rarely - dyspnea, bronchospasm;
- from the reproductive system: rarely - menstrual irregularities, dysfunction of the prostate gland;
- dermatological reactions: sometimes - sweating, dermatitis, rash; rarely - acne rash; very rarely - photosensitivity;
- allergic reactions: rarely - urticaria; very rarely - allergic dermatitis, Lyell's syndrome, Stevens-Johnson syndrome, facial edema, angioedema, anaphylactic shock;
- from the side of metabolism: rarely - hypertriglyceridemia, hyperglycemia, hypoglycemia;
- laboratory parameters: rarely - proteinuria, ketonuria;
- others: aseptic meningitis (mainly against the background of existing systemic lupus erythematosus or mixed connective tissue diseases), hematological disorders in the form of purpura, aplastic or hemolytic anemia, in rare cases - agranulocytosis and bone marrow hypoplasia.
Overdose
Possible symptoms of an overdose are: drowsiness, abdominal pain, disorientation, headache, nausea, vomiting, anorexia, dizziness.
Treatment: symptomatic therapy should be used; in severe cases, hemodialysis is indicated.
special instructions
If signs of ulcers or gastrointestinal bleeding appear, the drug should be discontinued immediately.
It has been clinically proven that blood clotting indices do not change when dexketoprofen is combined in the postoperative period with prophylactic doses of low molecular weight heparin drugs. But with the simultaneous use of Flamadex with other agents that affect blood clotting, careful monitoring of the blood coagulation system is required. Against the background of drug therapy, the development of reversible inhibition of platelet aggregation is possible.
The action of the drug can increase the level of nitrogen content and the concentration of creatinine in blood plasma. Since dexketoprofen is an inhibitor of prostaglandin synthesis, adverse events from the urinary system may occur in the form of interstitial nephritis, glomerulonephritis, nephrotic syndrome, papillary necrosis, or acute renal failure.
A significant increase in the activity of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in the blood serum, a transient slight increase in certain indicators of liver function is possible. Therefore, in elderly patients, it is necessary to monitor the function of the liver and kidneys in order to cancel the use of Flamadex with a pronounced increase in the corresponding indicators.
Against the background of NSAID therapy, an exacerbation of infectious processes in soft tissues is possible. As a result, if the condition worsens or signs of a bacterial infection appear during dexketoprofen treatment, a thorough additional examination of the patient is required.
One ampoule with a solution for intravenous and intramuscular administration contains 200 mg of ethanol.
Influence on the ability to drive vehicles and complex mechanisms
Treatment with the drug can cause the development of dizziness and drowsiness, there is a risk of a decrease in the speed of psychomotor reactions and concentration. In this regard, it is recommended to be careful when driving vehicles and complex mechanisms.
Application during pregnancy and lactation
The use of Flamadex is contraindicated during pregnancy and lactation.
Pediatric use
Due to the lack of data from clinical studies on the safety and efficacy of Flamadex, in pediatric practice, the appointment of the drug in children and adolescents under 18 years of age is contraindicated.
With impaired renal function
The appointment of the drug is contraindicated in moderate and severe renal failure with CC less than 30 ml / min.
In case of mild renal dysfunction (CC from 30 to 60 ml / min), the usual daily dose of the drug should be reduced to 50 mg.
If liver function is impaired
The use of dexketoprofen is contraindicated in patients with severe (10-15 points on the Child - Pugh scale) liver dysfunction.
With mild and moderate severity (5-9 points on the Child-Pugh scale) liver dysfunction, the total daily dose of the drug should not exceed 50 mg. Treatment should be accompanied by frequent monitoring of liver function indicators.
Use in the elderly
In elderly patients without a physiological decrease in renal function, dose adjustment is usually not required.
With a mild degree of renal dysfunction, the daily dose should not exceed 50 mg.
Drug interactions
With the simultaneous use of Flamadex:
- high (more than 3 g per day) doses of salicylates, other NSAIDs, oral anticoagulants, heparin (in a dose higher than prophylactic), ticlopidine: increase the risk of manifestations of the mucous membrane of the digestive tract and gastrointestinal bleeding;
- lithium preparations: cause a decrease in renal excretion and an increase in the concentration of lithium in the blood plasma; in order to exclude the achievement of a toxic level, the indicators of lithium in the blood should be monitored when prescribing, changing the dose and canceling dexketoprofen;
- methotrexate (at a dose of 15 mg per week or more): NSAIDs reduce its renal clearance, thereby increasing toxicity;
- glucocorticosteroids: increase the risk of developing ulcers and gastrointestinal bleeding;
- hydantoin derivatives and sulfonamides: can increase the severity of toxicity;
- diuretics, angiotensin-converting enzyme inhibitors, antibacterial agents from the group of angiotensin II receptor antagonists and aminoglycosides: their therapeutic effect decreases;
- pentoxifylline: causes an increased risk of bleeding, monitoring and regular monitoring of blood clotting time is required;
- zidovudine: may have a toxic effect on reticulocytes and after 7 days of this combination cause the development of severe anemia;
- oral hypoglycemic agents: the degree of their binding to blood plasma proteins decreases and the hypoglycemic effect may increase;
- beta-blockers: it is possible to reduce their antihypertensive effect due to the inhibition of prostaglandin synthesis by dexketoprofen;
- cyclosporine, tacrolimus: the risk of increased nephrotoxicity increases;
- thrombolytic agents: the likelihood of bleeding increases;
- probenecid: causes an increase in the concentration of dexketoprofen in the blood plasma;
- cardiac glycosides: their concentration in blood plasma may increase;
- mifepristone: may lose its therapeutic effect, therefore, NSAIDs are allowed to be prescribed only 8-12 days after taking it;
- quinolone antibiotics: high doses may cause seizures.
- Due to the formation of a precipitate, Flamadex solution is pharmaceutically incompatible with dopamine, pentazocine, promethazine, pethidine or hydroxyzine, therefore, they cannot be mixed in the same syringe.
- In one syringe, the drug can be mixed with a solution of lidocaine, heparin, theophylline or morphine.
The ready-made solution of Flamadex for infusion is incompatible with the drugs promethazine or pentazocine, it is compatible with solutions for injections of dopamine, hydroxyzine, heparin, lidocaine, pethidine, morphine and theophylline.
Analogs
Flamadex analogues are: solution - Dexalgin, Ketodeksal, tablets - Dexalgin.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C in a dark place.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Flamadex
The few reviews about Flamadex indicate the high effectiveness of the drug. Patients note its rapid analgesic effect, high efficacy in moderate pain, as well as its affordability.
As disadvantages, the presence of a large number of contraindications and side effects, a short action and painfulness of injections are indicated.
Price for Flamadex in pharmacies
The estimated price for Flamadex can be: pack of tablets (25 mg each) 10 pcs. - from 185 rubles; solution for injection (25 mg / ml, 2 ml in an ampoule) 5 ampoules per package - from 268 rubles.
Flamadex: prices in online pharmacies
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Drug name Price Pharmacy |
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Flamadex 25 mg / ml solution for intravenous and intramuscular administration 2 ml 5 pcs. 152 RUB Buy |
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Flamadex 25 mg film-coated tablets 10 pcs. RUB 176 Buy |
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Flamadex tablets p.o. 25mg 10 pcs. 195 RUB Buy |
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Flamadex solution for intravenous and intramuscular injection 25mg / ml 2ml 5 pcs. 217 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
