Flamadex, 10 pcs., 25 mg, film-coated tablets
The following interactions are common to all NSAIDs.
Undesirable combinations
- with other NSAIDs, including salicylates in high doses (more than 3 g / day) - simultaneous use of several NSAIDs due to the synergistic effect increases the risk of gastrointestinal bleeding and ulcers;
- with oral anticoagulants, heparin in doses exceeding prophylactic ones - the risk of bleeding increases;
- with ticlopidine - the risk of bleeding increases due to inhibition of platelet aggregation and damage to the gastrointestinal mucosa;
- with lithium preparations - NSAIDs increase the concentration of lithium in the blood, up to toxic levels, and therefore this indicator must be monitored when using, changing the dose and after discontinuation of NSAIDs;
- with methotrexate in high doses (15 mg/week or more) - the hematological toxicity of methotrexate increases due to a decrease in its renal clearance during NSAID therapy;
- with hydantoins and sulfonamides - the risk of increasing the toxic effect of these drugs.
Combinations requiring caution
- with diuretics, ACE inhibitors - NSAID therapy is associated with the risk of developing acute renal failure in dehydrated patients (decreased CP due to reduced PG synthesis). NSAIDs may reduce the antihypertensive effect of some drugs;
- with methotrexate in low (less than 15 mg/week) doses - the hematological toxicity of methotrexate increases due to a decrease in its renal clearance during NSAID therapy. It is necessary to conduct weekly blood cell counts during the first weeks of concomitant therapy. In the presence of even mild renal dysfunction, as well as in elderly people, careful medical supervision is necessary;
- with serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline), oral corticosteroids - increased risk of developing gastrointestinal bleeding;
- with pentoxifylline - the risk of bleeding increases.
Intensive clinical monitoring and frequent monitoring of bleeding time or clotting time are necessary;
- with zidovudine - the risk of increased toxic effects on erythrocytes due to the effect on reticulocytes, with the development of severe anemia a week after the administration of NSAIDs. It is necessary to conduct a complete blood count with a reticulocyte count 1–2 weeks after starting NSAID therapy;
- with oral hypoglycemic agents - NSAIDs can enhance the hypoglycemic effect of sulfonylurea due to its displacement from sites of binding to blood plasma proteins;
- with low molecular weight heparin preparations - increased risk of bleeding.
Combinations to consider
- with β-blockers - NSAIDs can reduce the hypotensive effect of β-blockers, which is due to inhibition of PG synthesis;
- with cyclosporine and tacrolimus - NSAIDs can increase nephrotoxicity, which is mediated by the action of renal PGs. During concomitant therapy, renal function should be monitored;
- with thrombolytics - the risk of bleeding increases;
- with probenecid - plasma concentrations of NSAIDs may increase, which may be due to the inhibitory effect of probenecid on renal tubular secretion and/or conjugation with glucuronic acid, which requires dose adjustment of NSAIDs;
- with cardiac glycosides - NSAIDs can lead to an increase in the concentration of glycosides in the blood plasma;
- with mifepristone - due to the theoretical risk of changes in the effectiveness of mifepristone under the influence of PG synthesis inhibitors; NSAIDs should not be prescribed earlier than 8–12 days after discontinuation of mifepristone;
- with quinolones - data obtained from experimental studies in animals indicate a high risk of developing seizures when using NSAIDs during therapy with quinolones in high doses.
Flamadex tablets ppo 25 mg No. 10
Compound
For one tablet:
active ingredient:
dexketoprofen trometamol 36.90 mg, equivalent to dexketoprofen 25.00 mg,
Excipients:
microcrystalline cellulose 181.89-183.84 mg, pregelatinized starch 26.26 mg, sodium carboxymethyl starch (sodium starch glycolate) 10.40 mg, magnesium stearate 2.60-4.55 mg,
shell composition:
titanium dioxide 2.5 mg, hypromellose (hypromellose 2910) 2.5 mg, polydextrose 2.5 mg, macrogol 0.5 mg.
Pharmacokinetics
Suction
After taking the drug orally, the maximum serum concentration (Cmax) of dexketoprofen in humans is achieved on average after 30 minutes (15-60 minutes). Concomitant food intake slows down the absorption of the drug. The areas under the concentration-time curve (AUC) after single and repeated doses are similar, indicating the absence of drug accumulation.
Distribution
Plasma protein binding is 99%, the average volume of distribution is less than 0.25 l/kg, the half-life is about 0.35 hours.
Removal
The main route of excretion of dexketoprofen is its conjugation with glucuronic acid, followed by excretion by the kidneys. The half-life (T1/2) is 1.65 hours. In elderly people, an increase in T1/2 is observed on average to 48% and a decrease in the overall clearance of the drug.
Indications for use
— Relief of pain syndrome of various origins (including postoperative, post-traumatic pain, pain with bone metastases, renal colic, algomenorrhea, sciatica, sciatica, neuralgia, toothache, etc.),
- symptomatic treatment of acute and chronic inflammatory, inflammatory-degenerative and metabolic diseases of the musculoskeletal system (including rheumatoid arthritis, osteoarthritis, spondyloarthritis: ankylosing spondylitis, reactive arthritis, psoriatic arthritis).
The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.
Contraindications
Symptoms:
nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia.
Treatment:
symptomatic therapy, if necessary - gastric lavage, hemodialysis.
Directions for use and doses
Flamadex is taken orally with meals.
Depending on the intensity of the pain syndrome, the recommended dose for adults is 12.5 mg (1/2 tablet) every 4-6 hours or 25 mg (1 tablet) every 8 hours.
The maximum daily dose is 75 mg.
For patients with impaired liver and/or kidney function and the elderly, therapy with Flamadex should be started with lower doses. The maximum daily dose is 50 mg per day.
Flamadex is not intended for long-term therapy; the course of treatment with the drug should not exceed 3-5 days.
Storage conditions
In a dry place, protected from light, at a temperature not exceeding 25 C.
Keep out of the reach of children.
Best before date
2 years.
Do not use after the expiration date stated on the packaging.
special instructions
Caution should be exercised when prescribing Flamadex to patients with gastrointestinal disorders or a history of gastrointestinal diseases. If gastrointestinal bleeding or ulcers occur, therapy with Flamadex should be discontinued.
It has been clinically proven that the simultaneous use of dexketoprofen and low molecular weight heparin drugs in prophylactic doses in the postoperative period does not change coagulation rates. However, when using Flamadex with other drugs that affect blood clotting, careful medical monitoring of the blood clotting system is necessary. Dexketoprofen may cause reversible inhibition of platelet aggregation.
Like other NSAIDs, Flamadex can lead to increased concentrations of creatinine and nitrogen in the blood plasma. Like other prostaglandin synthesis inhibitors, Flamadex can have side effects on the urinary system, which can lead to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure.
As with the use of other NSAIDs, during therapy with Flamadex, a slight transient increase in some liver parameters, as well as a significant increase in the activity of AST and ALT in the blood serum, may be observed. At the same time, monitoring liver and kidney function is necessary in elderly people. In case of a significant increase in the corresponding indicators, Flamadex should be discontinued.
Flamadex is prescribed with caution to patients with chronic heart failure of functional class I-II according to the NYHA classification.
Like other NSAIDs, dexketoprofen may mask the symptoms of infectious diseases. If signs of infection or deterioration of health are detected during therapy with Flamadex, the patient should immediately consult a doctor.
Description
Round, biconvex tablets, white film-coated, scored on both sides. On a cross section, the core is white or almost white.
Conditions for dispensing from pharmacies
On prescription
Dosage form
film-coated tablets
Manufacturer and organization accepting consumer complaints
PharmFirma SOTEX, JSC
Pharmacodynamics
Non-steroidal anti-inflammatory drug (NSAID).
It has analgesic, anti-inflammatory and antipyretic effects. The mechanism of action is associated with inhibition of prostaglandin synthesis at the level of COX-1 and COX-2.
The analgesic effect occurs 30 minutes after oral administration, the duration of action is 4-6 hours.
When combined with opioid analgesics dexketoprofen, trometamol significantly (up to 30-45%) reduces the need for opioids.
Side effects
The frequency of side effects noted when taking dexketoprofen is given in accordance with the World Health Organization (WHO) classification: very often (more than 10%), often (1-10%), infrequently (0.1-1%), rarely (0 .01-0.1%), very rarely (less than 0.01%), including isolated reports.
From the blood and lymphatic system:
very rarely - neutropenia, thrombocytopenia.
From the nervous system:
infrequently - headache, dizziness, insomnia, drowsiness, rarely - paresthesia.
From the senses:
rarely - tinnitus, very rarely - blurred vision.
From the cardiovascular system:
infrequently - feeling of heat, hyperemia of the skin, rarely - extrasystole, increased blood pressure, very rarely - tachycardia, decreased blood pressure.
From the respiratory system:
rarely - bradypnea, very rarely - bronchospasm, shortness of breath.
From the gastrointestinal tract
: often - nausea, vomiting, abdominal pain, dyspepsia, diarrhea, infrequently - constipation, dry mouth, flatulence, rarely - erosive and ulcerative lesions of the gastrointestinal tract, bleeding from an ulcer or its perforation, anorexia, very rarely - damage to the pancreas.
From the liver and biliary tract:
rarely - increased activity of liver enzymes, including aspartate aminotransferase and alanine aminotransferase (AST and ALT, jaundice, very rarely - liver damage.
From the kidneys and urinary tract:
rarely - polyuria, very rarely - nephritis or nephrotic syndrome.
From the reproductive system:
rarely - in women, menstrual irregularities; in men - transient dysfunction of the prostate gland with long-term use.
From the musculoskeletal system:
rarely - back pain, muscle spasm, difficulty moving the joints.
For the skin and subcutaneous tissues:
infrequently - dermatitis, rash, rarely - urticaria, acne, sweating, very rarely - severe skin reactions (Stevens-Johnson syndrome, Lyell's syndrome). angioedema, allergic dermatitis, photosensitivity.
From the side of metabolism:
rarely - hyperglycemia, hypoglycemia, hypertriglyceridemia.
Laboratory data:
rarely - ketonuria, proteinuria.
In terms of general status:
infrequently - fever, fatigue; very rarely - anaphylactic shock, facial swelling.
Other:
uncommon - aseptic meningitis, occurring mainly in patients with systemic lupus erythematosus or mixed connective tissue diseases, hematological disorders (purpura, aplastic and hemolytic anemia), rarely - agranulocytosis and bone marrow hypoplasia.
Use during pregnancy and breastfeeding
Flamadex is contraindicated during pregnancy and breastfeeding due to the lack of reliable clinical data confirming the safety of its use.
Interaction
The following interactions are common to all NSAIDs.
Undesirable combinations
With other NSAIDs, including salicylates in high doses (more than 3 g/day):
simultaneous use of several NSAIDs due to the synergistic effect increases the risk of gastrointestinal bleeding and ulcers.
With oral anticoagulants, heparin in doses exceeding prophylactic doses, and ticlopidine
: increased risk of bleeding due to inhibition of platelet aggregation and damage to the gastrointestinal mucosa.
With lithium preparations:
NSAIDs increase the concentration of lithium in the blood, up to toxic levels, and therefore this indicator must be monitored when using, changing the dose and after discontinuation of NSAIDs.
With methotrexate in high doses (15 mg/week or more):
increased hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy.
With hydantoins and sulfonamides:
the risk of increased toxic effects of these drugs.
Combinations requiring caution
With diuretics, angiotensin-converting enzyme inhibitors:
NSAID therapy is associated with a risk of acute renal failure in dehydrated patients (decreased glomerular filtration rate due to decreased prostaglandin synthesis). NSAIDs may reduce the antihypertensive effect of some drugs.
With methotrexate in low doses (less than 15 mg/week):
increased hematological toxicity of methotrexate due to a decrease in its renal clearance during NSAID therapy. It is necessary to conduct weekly blood cell counts during the first weeks of concomitant therapy. In the presence of even mild renal dysfunction, as well as in elderly people, careful medical supervision is necessary.
With serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline), oral glucocorticosteroids:
increased risk of developing gastrointestinal bleeding.
With pentoxifylline:
increased risk of bleeding. Intensive clinical monitoring and frequent checking of bleeding time (blood clotting time) is necessary.
With zidovudine
: risk of increased toxicity to red blood cells due to effects on reticulocytes, with the development of severe anemia one week after administration of NSAIDs. It is necessary to conduct a complete blood count with a reticulocyte count 1-2 weeks after starting NSAID therapy.
With oral hypoglycemic agents
: NSAIDs may enhance the hypoglycemic effect of sulfonylureas due to their displacement from sites of binding to plasma proteins.
With low molecular weight heparin preparations:
increased risk of bleeding.
Combinations to consider
With -adrenergic blockers:
NSAIDs may reduce the hypotensive effect of beta-blockers due to inhibition of prostaglandin synthesis.
With cyclosporine and tacrolimus:
NSAIDs may increase nephrotoxicity, which is mediated by the action of renal prostaglandins. During concomitant therapy, renal function should be monitored.
With thrombolytics:
increased risk of bleeding.
With probenecid:
NSAID plasma concentrations may increase, which may be due to the inhibitory effect of probenecid on renal tubular secretion and/or conjugation with glucuronic acid, which requires NSAID dose adjustment.
With cardiac glycosides:
NSAIDs may lead to increased plasma concentrations of glycosides.
With mifepristone
: Due to the theoretical risk of changes in the effectiveness of mifepristone under the influence of prostaglandin synthesis inhibitors, NSAIDs should not be prescribed earlier than 8-12 days after discontinuation of mifepristone.
With quinolones:
Data obtained from experimental studies in animals indicate a high risk of seizures when using NSAIDs during high-dose quinolone therapy.
Overdose
Symptoms:
nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia.
Treatment:
symptomatic therapy, if necessary - gastric lavage, hemodialysis.
Impact on the ability to drive vehicles and operate machinery
Due to the possible occurrence of dizziness and drowsiness while taking dexketoprofen, it should be used with caution in patients engaged in potentially hazardous activities that require increased attention and speed of psychomotor reactions.
