Flamax - Instructions For Using The Medicine, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Flamax

Flamax: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Flamax

ATX code: M01AE03

Active ingredient: Ketoprofen (Ketoprofen)

Producer: Sotex PharmFirma (Russia)

Description and photo update: 19.10.2018

Prices in pharmacies: from 87 rubles.

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Flamax is a drug with antipyretic, anti-inflammatory and analgesic effects.

Release form and composition

Dosage forms of release:

• solution for intravenous and intramuscular administration: transparent, with a yellowish tinge or colorless (in 2 ml ampoules, in blisters of 5 ampoules, in a cardboard box 1 or 2 packages);
• capsules: gelatinous hard, size No. 2, white body, blue cap; the capsules contain a white homogeneous powder (25 pcs. in plastic containers, 1 container in a cardboard box).

Composition of 1 ml injection solution:

• active substance: ketoprofen - 50 mg;
• auxiliary components: propylene glycol - 400 mg; ethanol (95% ethyl alcohol in terms of 100% substance) - 100 mg; benzyl alcohol - 20 mg; sodium hydroxide - up to pH 6.5–7.5; water for injection - up to 1 ml.

Composition of 1 capsule:

• active substance: ketoprofen - 50 mg;
• auxiliary components: sodium lauryl sulfate - 2.4 mg; microcrystalline cellulose - 90.17 mg; croscarmellose sodium - 4.8 mg; colloidal silicon dioxide - 1.43 mg; lactose monohydrate - 84 mg; povidone - 7.2 mg;
• shell: titanium dioxide, gelatin, FD&C indigo blue indigo carmine.

Pharmacological properties

Pharmacodynamics

Ketoprofen belongs to the number of NSAIDs (non-steroidal anti-inflammatory drugs), propionic acid derivatives. Suppresses platelet aggregation, has antipyretic, anti-inflammatory and analgesic effects.

Acts on the lipoxygenase and cyclooxygenase link of the metabolism of arachidonic acid, as a result of which it inhibits the synthesis of prostaglandins, thromboxanes and leukotrienes. The analgesic effect is due to the central and peripheral mechanisms.

Pharmacokinetics

• distribution: up to 99% of ketoprofen binds to plasma proteins (mainly albumin). Due to the low volume of distribution (Vd) - 0.1–0.2 l / kg, the maximum concentration of the substance in the plasma is reached quickly, the stationary concentration of the substance in the blood (Css) is reached 24 hours after the start of its regular use. Ketoprofen penetrates well into connective tissues and synovial fluid, reaching a significant concentration in the articular exudate within 15 minutes after a single use of 100 mg. The concentration of ketoprofen in the synovial fluid is slightly lower than the plasma concentration, while it is more stable (lasts up to 30 hours), as a result of which joint stiffness and pain syndrome decreases for a long time. The substance does not cumulate; it does not penetrate the blood-brain barrier in a significant amount;
• metabolism: occurs mainly in the liver, where ketoprofen undergoes glucuronidation, followed by the formation of esters with glucuronic acid, which are excreted mainly by the kidneys. It is metabolized before entering the systemic circulation, when passing through the wall of the gastrointestinal tract and the liver (the effect of the first passage through the liver);
• excretion: occurs mainly with urine. Less than 1% of the substance is excreted with feces. The half-life of ketoprofen is in the range of 1.6-1.9 hours.

Indications for use

According to the instructions, Flamax is prescribed for the symptomatic treatment of pain and inflammation of various etiologies of moderate intensity (it has no effect on the progression of the disease), including the following diseases / conditions:

• pain syndrome against the background of oncological diseases;
• postoperative pain;
• post-traumatic pain syndrome with inflammation;
• diseases of the musculoskeletal system of inflammatory / degenerative etiology: psoriatic, rheumatoid, juvenile chronic arthritis, gouty arthritis, ankylosing spondylitis (ankylosing spondylitis), osteoarthritis of the spine and peripheral joints (including with radicular syndrome), rheumatic lesions of soft tissues
• algodismenorrhea;
• sciatica, lumbago;
• migraine;
• toothache;
• inflammatory processes of the pelvic organs, including adnexitis;
• neuralgia.

Contraindications

Injection solution

Absolute:

• erosive and ulcerative lesions of the gastrointestinal tract (with exacerbation);
• bleeding from the gastrointestinal tract, inflammatory bowel disease (with exacerbation, including Crohn's disease, ulcerative colitis);
• renal failure in severe course (with creatinine clearance <30 ml / min);
• liver failure in severe or acute period of liver disease;
• hyperkalemia;
• progressive kidney disease;
• bronchial asthma, recurrent polyposis of the nose and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (complete or incomplete combination, including a burdened history);
• disorders of hematopoiesis and hemostasis (including hemophilia);
• period after coronary artery bypass grafting;
• III trimester of pregnancy and breastfeeding period;
• age up to 15 years;
• individual intolerance to the components of the drug, including hypersensitivity to other NSAIDs.

Relative (diseases / conditions in the presence of which the appointment of ketoprofen requires caution):

• bronchial asthma;
• cholecystitis, alcoholism and other factors that increase toxicity in the gastrointestinal tract;
• chronic heart failure;
• edematous syndrome;
• arterial hypertension;
• impaired renal function;
• cholestasis;
• sepsis;
• combined use with other NSAIDs, long-term use of NSAIDs;
• cardiac ischemia;
• cerebrovascular diseases;
• dyslipidemia / hyperlipidemia;
• diabetes;
• peripheral arterial disease;
• chronic renal failure (with creatinine clearance of 30-60 ml / min);
• burdened history of ulcerative lesions of the gastrointestinal tract;
• Helicobacter pylori infection (confirmed);
• severe somatic diseases;
• concomitant use of the following drugs: anticoagulants, antiplatelet agents, selective serotonin reuptake inhibitors, glucocorticosteroids;
• smoking;
• age over 65;
• I – II trimester of pregnancy.

Capsules

Absolute:

• hemophilia and other blood clotting disorders;
• burdened history of bronchial asthma caused by ketoprofen, other NSAIDs or acetylsalicylic acid;
• peptic ulcer;
• recurrent peptic ulcer of the stomach and duodenum;
• severe renal / hepatic impairment;
• insufficiency of the circulatory system;
• cerebrovascular, gastrointestinal and other bleeding (or suspected bleeding);
• Crohn's disease, ulcerative colitis, diverticulitis;
• pregnancy and the period of breastfeeding;
• age up to 15 years;
• individual intolerance to the components of the drug.

Relative (diseases / conditions in the presence of which the appointment of ketoprofen requires caution):

• bronchial asthma;
• anemia;
• smoking;
• alcoholism;
• hyperbilirubinemia;
• alcoholic cirrhosis of the liver;
• diabetes;
• hepatic / renal failure;
• sepsis;
• dehydration;
• swelling;
• chronic heart failure;
• cardiac ischemia;
• arterial hypertension;
• stomatitis;
• blood diseases (including leukopenia);
• adolescence 15-18 years old;
• advanced age over 65 years.

Instructions for the use of Flamax: method and dosage

Flamax should be used in the smallest doses with a minimum course. Combined use of dosage forms is possible.

Injection solution

Method of administration:

• intramuscularly: 1–2 times a day, 100 mg;
• intravenous infusion (only in stationary conditions): the average infusion time is 30-60 minutes (short-term - 100-200 mg, diluted in 100 ml of 0.9% sodium chloride solution) or 8 hours (long-term - 100-200 mg, diluted in 500 ml of 0.9% sodium chloride solution, Ringer's solution, 5% dextrose solution); the introduction can be repeated after 8 hours. The maximum duration of the infusion is 48 hours, the maximum daily dose is 300 mg.

Capsules

Flamax is taken orally, preferably during meals.

Recommended dosage regimen:

• rheumatic diseases: 1 capsule in the morning and afternoon and 2 capsules in the evening, or 1 capsule 4 times a day;
• pain syndrome and algodismenorrhea: 1 capsule every 6-8 hours.

The maximum is 300 mg per day.

In renal insufficiency, the dose is reduced to 33-50%; in elderly patients, the dose should be adapted to age.

Side effects

• hematopoietic system: anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, leukopenia;
• nervous system: peripheral neuropathy, nervousness, headache, insomnia, dizziness, agitation, drowsiness, depression, memory impairment, asthenia, loss or confusion, migraine;
• digestive system: abdominal pain, dyspepsia (in the form of decreased appetite, nausea, vomiting, heartburn, flatulence, diarrhea), stomatitis, change in taste, impaired liver function; with prolonged use of large doses - ulceration of the mucous membrane of the gastrointestinal tract; gastrointestinal, gingival, hemorrhoidal bleeding;
• urinary system: hematuria, cystitis, edematous syndrome, urethritis, renal dysfunction, nephrotic syndrome, interstitial nephritis;
• sense organs: ringing / tinnitus, conjunctivitis, blurred vision, dryness of the mucous membrane of the eye, conjunctival hyperemia, eye pain, hearing loss, vertigo;
• cardiovascular system: tachycardia, increased blood pressure;
• allergic reactions: skin rash (including erythematous rash, urticaria), rhinitis, pruritus, anaphylactic shock, angioedema, exfoliative dermatitis, bronchospasm;
• others: photosensitivity, increased sweating, nosebleeds, hemoptysis, myalgia, muscle twitching, thirst, shortness of breath; when carrying out a long course in high doses - vaginal bleeding.

Overdose

Overdose cases are not described.

The main possible symptoms are: dizziness, vomiting, headache, shortness of breath, abdominal pain, bleeding, impaired renal / hepatic function.

Therapy: symptomatic; there is no specific antidote.

special instructions

With the combined use of ketoprofen with warfarin or lithium preparations, the patient's condition should be monitored.

Flamax can mask the signs of infectious diseases.

During therapy, it is necessary to monitor the peripheral blood picture and the functional state of the kidneys / liver.

If it is necessary to determine 17-ketosteroids, Flamax should be canceled 48 hours before the start of the study.

Influence on the ability to drive vehicles and complex mechanisms

Patients should be careful while driving vehicles during therapy.

Application during pregnancy and lactation

The use of ketoprofen during pregnancy:

• injection solution: III trimester - contraindicated; I – II trimester - use is possible with caution after assessing the balance of benefits with risks;
• capsules: the entire period of pregnancy is contraindicated.

Flamax in all dosage forms is contraindicated during lactation.

Pediatric use

The drug is not prescribed for children under 15 years of age. Capsules in children 15-18 years old should be used with caution.

With impaired renal function

• injection solution: severe renal failure (with creatinine clearance <30 ml / min); progressive kidney disease - contraindicated; renal dysfunction, chronic renal failure (with creatinine clearance 30-60 ml / min) - with caution;
• capsules: severe renal failure - contraindicated; renal failure - with caution.

For violations of liver function

• injection solution: severe hepatic failure, exacerbation of liver disease - contraindicated;
• capsules: severe hepatic failure - contraindicated; liver failure - with caution.

Use in the elderly

Patients over 65 years of age should be prescribed Flamax with caution. The dose should be adapted to age.

Drug interactions

Possible combined use with central analgesics.

A solution of ketoprofen in one bottle can be mixed with morphine, but not with tramadol (due to precipitation).

Parenteral administration of Flamax can be combined with oral or rectal administration of the drug, while, depending on the nature of the disease and the patient's condition, the total daily dose can be increased to 300 mg or reduced to 100 mg.

With the combined use of Flamax with certain drugs / substances, the following effects may develop:

• uricosuric drugs: decrease in their effectiveness;
• loop diuretics: increasing the nephrotoxic effect of both drugs;
• glucocorticosteroids, mineralocorticosteroids, estrogens: increased severity of their side reactions;
• anticoagulants, antiplatelet agents, fibrinolytics, ethanol: enhancing their action;
• diuretics and drugs with antihypertensive action: decrease in their effectiveness;
• ethanol, phenytoin, barbiturates, phenylbutazone, rifampicin, tricyclic antidepressants and other inducers of microsomal oxidation enzymes in the liver: increased production of hydroxylated active metabolites;
• other NSAIDs, glucocorticosteroids, ethanol, corticotropin: ulceration and development of gastrointestinal bleeding, an increase in the likelihood of impaired renal function;
• oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandol, cefotetan: increased risk of bleeding;
• myelotoxic drugs: increased manifestation of ketoprofen hematotoxicity;
• cholestyramine, antacids: decreased absorption of ketoprofen;
• insulin, oral forms of hypoglycemic drugs: increased hypoglycemic action (dose adjustment is required);
• sodium valproate: reduced platelet aggregation;
• verapamil, nifedipine, lithium preparations, methotrexate: an increase in their plasma concentration.

Analogs

Flamax analogues are: Arketal Rompharm, Artrozilen, Artrum, Febrofid, Bystrumgel, Flexen, Flamax forte, Bystrumkaps, VALUSAL, Ketonal, Ketoprofen, OKI.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life: solution - 5 years; capsules - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Flamax

According to reviews, Flamax has a pronounced analgesic effect, including the effectiveness of its use in the postoperative period. The development of side effects, including allergic and dermatological reactions, is rarely reported.

Price for Flamax in pharmacies

Approximate price for Flamax:

• injection solution (5 or 10 ampoules per package): 110-125 or 225-235 rubles;
• capsules (25 pcs. in a package): 100-110 rubles.

Flamax: prices in online pharmacies

Drug name Price Pharmacy

Flamax 50 mg capsule 25 pcs. RUB 87 Buy

Flamax 50 mg / ml solution for intravenous and intramuscular administration 2 ml 5 pcs. RUB 105 Buy

Flamax forte 100 mg film-coated tablets 20 pcs. 129 RUB Buy

Flamax Forte tablets p.o. 100mg 20 pcs. 133 rbl. Buy

Flamax 50 mg / ml solution for intravenous and intramuscular administration 2 ml 10 pcs. 136 RUB Buy

Flamax solution for intravenous and intramuscular injection. 50mg / ml 2ml 10 pcs. 256 RUB Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, 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!