Flamadex, pills 25mg 10pcs

Composition

Per tablet:

Active ingredient:

dexketoprofen trometamol 36.90 mg, based on 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

Pharmacological action

Pharmacotherapy group:

NSAIDs

ATX:  

M. 01. A. E Propionic acid Derivatives

M. 01. A. E. 17 Dexketoprofen

Pharmacodynamics :

Nonsteroidal 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 use, the duration of action is 4-6 hours.

When combined with dexketoprofen opioid analgesics, trometamol significantly reduces the need for opioids (up to 30-45%).

Pharmacokinetics:

Suction

After oral use, the maximum serum concentration (Cmax) of dexketoprofen in humans is reached on average in 30 minutes (15-60 minutes). Simultaneous food intake slows down the absorption of the drug. The areas under the concentration – time curve (AUC) after single and repeated doses are similar, which indicates that there is no accumulation of the drug.

Distribution

Binding to plasma proteins is 99%, the average volume of distribution is less than 0.25 l / kg, and the half-life is about 0.35 hours.

Deduction

The main route of dexketoprofen elimination is its conjugation with glucuronic acid, followed by renal elimination. The elimination half-life (T 1/2) is 1.65 hours. In the elderly, there is an average prolongation of T 1/2 up to 48% and a decrease in the total clearance of the drug.

Indications

– Relief of the pain syndrome of different Genesis (including post-operative, post-traumatic pain, pain in bone metastases, renal colic, algomenorrhea, sciatica, radiculitis, 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

– Hypersensitivity to dexketoprofen or other NSAIDs or to any of the excipients included in the composition of the drug;

– erosive-ulcerative lesions of the gastrointestinal tract and duodenum in the acute phase;

gastro – intestinal bleeding, a history of other active bleeding (including suspected intracranial bleeding), anticoagulant therapy;

inflammatory bowel disease (Crohn’s disease, ulcerative colitis) in the acute phase;

– severe liver dysfunction (10-15 points on a scale child-Pugh);

– moderate or severe renal dysfunction (creatinine clearance less than 30 ml/min);

– complete or incomplete combination of bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance of acetylsalicylic acid or other NSAIDs (in the anamnesis);

– anticoagulant therapy;

decompensated heart failure;

– after the coronary artery bypass grafting;

– hemophilia and other blood clotting;

– degenerative diseases of the kidneys;

– confirmed hyperkalemia;

– children up to age 18 years (there are no clinical data on the efficacy and safety of the drug in pediatric practice);

– pregnancy and breastfeeding.

With caution:

Peptic ulcer of the stomach and duodenum, ulcerative colitis, Crohn’s disease, a history of liver disease, hepatic porphyria, chronic renal failure (creatinine clearance 30-60 ml/min), chronic heart failure of NYHA functional class I-II, arterial hypertension, significant decrease in the volume of circulating blood (including after surgery), elderly patients (including those receiving diuretics, weakened patients and low body weight concomitant use of glucocorticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery diseases, smoking, presence of Helicobacter pylori infection, systemic connective tissue diseases, long-term use of nonsteroidal anti-inflammatory drugs, tuberculosis, severe osteoporosis, alcoholism, severe somatic diseases.

Side effects

the Frequency of side effects observed when taking dexketoprofen given in accordance with the classification of the world health organization (who): very often (>10%), often (1-10%), infrequently (0,1-1%), rarely (0,01-0,1%), very rarely (less than 0.01%), including individual messages. From the blood and lymphatic system: very rarely – neutropenia, thrombocytopenia. From the nervous system: infrequently-headache, dizziness, insomnia, drowsiness; rarely – paresthesia. From the side of the senses: rarely-tinnitus; very rarely-blurred vision. From the cardiovascular system: infrequently-a 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 the ulcer or its perforation, anorexia; very rarely-pancreatic damage. From the liver and biliary tract: rarely-increased activity of “liver” enzymes, including aspartate aminotransferase and alanine aminotransferase (ACT and ALT, jaundice; very rarely-liver damage. From the side of the kidneys and urinary tract: rarely-polyuria; very rarely-nephritis or nephrotic syndrome. On the part of the reproductive system: rarely-in women, menstrual disorders, in men-transient disorders of the prostate gland with prolonged use. From the musculoskeletal system: rarely-back pain, muscle spasm, difficulty moving in the joints. From 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. From the general status side: infrequently-fever, fatigue; very rarely-anaphylactic shock, facial edema. Other: infrequently-aseptic meningitis, which occurs 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.

Interaction

The following interactions are common to all NSAIDs.

Unwanted 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 higher than prophylactic, 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, and therefore this indicator should 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 increasing the toxic effect of these drugs.

Combinations that require caution

With diuretics, angiotensin-converting enzyme inhibitors: NSAID therapy is associated with the risk of acute renal failure in dehydrated patients (reduced glomerular filtration rate due to reduced prostaglandin synthesis). NSAIDs may reduce the antihypertensive effect of certain medications.

With low-dose methotrexate (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 carry out a weekly blood cell count in the first weeks of simultaneous therapy. In the presence of impaired renal function, even in a mild degree, as well as in the elderly, careful medical supervision is necessary.

With serotonin reuptake inhibitors (citalopram, fluoxetine, sertraline), oral glucocorticosteroids: increased risk of gastrointestinal bleeding.

With pentoxifylline: increased risk of bleeding. Intensive clinical monitoring and frequent checking of the bleeding time (blood clotting time) is required.

With zidovudine: the risk of increased toxic effects on red blood cells due to exposure to reticulocytes, with the development of severe anemia one week after the appointment of NSAIDs. It is necessary to perform a general blood test with a reticulocyte count 1-2 weeks after the start of NSAID therapy.

With oral hypoglycemic agents: NSAIDs can increase the hypoglycemic effect of sulfonylureas due to its displacement from the sites of binding to plasma proteins.

With low-molecular-weight heparin preparations: increased risk of bleeding.

Combinations to take into account

With beta-blockers: NSAIDs may reduce the antihypertensive 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: 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 changing the effectiveness of mifepristone under the influence of prostaglandin synthesis inhibitors, NSAIDs should not be prescribed earlier than 8-12 days after mifepristone withdrawal.

With quinolones: data obtained in experimental animal studies indicate a high risk of seizures when using NSAIDs against the background of high-dose quinolone therapy.

How to take, course of use and dosage

of 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, the elderly, therapy with Flamadex® should begin 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.

Overdose

Symptoms: nausea, anorexia, abdominal pain, headache, dizziness, disorientation, insomnia. Treatment: symptomatic therapy; if necessary – gastric lavage, hemodialysis.

Special instructions

Caution should be exercised when prescribing Flamadex® to patients with gastrointestinal disorders or a history of gastrointestinal diseases. If gastrointestinal bleeding or ulceration occurs, treatment with Flamadex® should be discontinued.

It has been clinically proven that the simultaneous use of dexketoprofen and low-molecular-weight heparin preparations in prophylactic doses in the postoperative period does not change clotting parameters. However, careful medical monitoring of the blood clotting system is necessary when the drug Flamadex® is co-administered with other drugs that affect blood clotting. Dexketoprofen may cause reversible inhibition of platelet aggregation.

Like other NSAIDs, Flamadex® can lead to an increase in the concentration of creatinine and nitrogen in blood plasma. Like other prostaglandin synthesis inhibitors, Flamadex® can have a side effect on the urinary system, which can lead to the development of glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome and acute renal failure.

As with other NSAIDs, there may be a slight transient increase in some hepatic parameters, as well as a significant increase in the activity of ACT and ALT in the blood serum, against the background of therapy with Flamadex®. At the same time, monitoring of liver and kidney function is necessary in the elderly. In case of a significant increase in the corresponding indicators, Flamadex® should be discontinued.

Flamadex® should be used with caution in patients with chronic heart failure of NYHA functional class I-II.

Like other NSAIDs, dexketoprofen may mask the symptoms of infectious diseases. If signs of infection or deterioration of health are detected during treatment with Flamadex®, the patient should immediately consult a doctor.

Influence on the ability to drive vehicles and mechanisms:

Due to the possible occurrence of dizziness and drowsiness while taking dexketoprofen, it should be used with caution in patients engaged in potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Form of production

Film-coated tablets,25 mg.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Dexketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Rheumatoid Arthritis, Sciatica, Osteochondrosis, Sciatica, Lumbago, Arthritis, Trigeminal Neuralgia, Osteoarthritis