Flamax solution for intravenous intramuscular administration 50 mg/ml 2 ml ampoules 5 pcs. in Astrakhan

Release form, composition, packaging

The drug is available in three pharmaceutical forms: gelatin capsules, suppositories and solution for injection. The main active ingredient in both versions is ketoprofen. Capsules are packaged in plastic bottles with a control for the first opening in the cap, 25 pieces each. Next, the bottle is placed in a cardboard box along with the annotation. In addition to ketoprofen (50 mg), the drug contains additional components: microcrystalline cellulose, silicon dioxide, sodium lauryl sulfate and croscarmellose, lactose monohydrate, povidone.

The injection composition is packaged in glass ampoules. In addition to 50 mg of ketoprofen, it contains benzyl alcohol, ethanol, sodium hydroxide, propylene glycol, and purified water. Ampoules are packed in cardboard packs of 10 pcs.

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Candles are packaged in plastic cell packaging of 5 pieces. Placed in cardboard boxes along with annotations. Suppositories are intended for intravaginal or rectal administration.

Flamax cost

The solution in ampoules is dispensed only with a doctor's prescription. Depending on where you live, the average cost of Flamax for injections will vary. The price is about 250 rubles for 10 2 ml ampoules with a concentration of 50 mg of the main component.

Some drugs have a similar effect. They also contain the main active ingredient ketoprofen. Structural analogues include:

• Ketonal;
• Artrum;
• Ketoprofen;
• Valusal;
• Profenid.

Only the attending physician selects a similar medication. He will be able to indicate the exact dosage and duration of treatment with the replacement drug.

Pharmacokinetics and pharmacodynamics

Ketoprofen, the active component of the drug Flamax, is a derivative of propionic acid and belongs to the group of non-steroidal anti-inflammatory drugs. The medication is prescribed for the treatment of pathologies accompanied by acute pain, inflammation, and high fever.

Ringer's solution belongs to a group of agents that have a powerful detoxification effect. It belongs to the group of drugs that normalize electrolyte levels and are often used for emergency care. Read more in the article: “Ringer's solution: indications for use.”

The active component affects the lipoxygenase and cyclooxygenase pathways of arachidonic acid metabolism. The drug prevents the formation of prostaglandins - special mediators of inflammation, thromboxanes, leukotrienes. As a result, the anti-inflammatory and analgesic effect of Flamax is manifested. In addition, Ketoprofen has an antipyretic effect.

The described drug is characterized by fairly rapid absorption. Almost the entire volume of the absorbed drug binds to blood proteins, penetrates the connective tissue, and is found in the synovial fluid. Although in the joints the concentration of the active substance is still slightly less than in the plasma. The concentration required for the therapeutic effect is observed after 15 minutes. The effect of the drug can last for 24 hours.

Flamax is available from the pharmacy chain with a prescription.

Metabolism of the active substance occurs in the liver, and removal from the body is carried out by the renal system. A small amount of the substance may be excreted in the stool. The half-life is 1.5-2 hours.

Pharmacological properties

The main substance in Flamax, ketoprofen, is distinguished by its ability to inhibit active enzymes in the body that are responsible for inflammation. When it gets inside, it begins to interact with albumin and plasma proteins. The main component actively penetrates liquid and tissue.

After about 15 minutes it reaches its maximum effect. Over the next half hour, ketoprofen works very actively, reducing pain and inflammation in the body. It does not accumulate in tissues, and its biotransformation occurs in the liver. It is excreted through the kidneys and only 1% finds its way out of the intestines. The substance significantly reduces inflammation and stiffness of joints and provides an analgesic effect.

Indications for use

Flamax helps against a number of diseases and conditions associated with inflammatory processes and pain. It is used in various branches of medicine as an analgesic and anti-inflammatory agent, but does not affect the progress of pathology. Indications for prescribing the medication are:

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• pain that develops after the end of anesthesia in the postoperative period;
• pain syndrome in oncological pathologies;
• post-traumatic pain;
• rheumatoid, gouty, psoriatic arthritis;
• osteochondrosis;

• lumbago, sciatica;
• painful menstruation;
• inflammatory processes of the pelvic organs;
• headaches, including migraines;
• various neuralgia.

It should be noted that the use of the drug Flamax is necessary to eliminate pain of varying intensity. Therapy in most cases is a course of treatment, but it is aimed only at eliminating symptoms and does not affect the disease process.

Pain syndrome is a common symptom of the development of a systemic disease, fatigue and some other conditions of the body. Painkillers such as Spazmalgon do not cure the lesion, but can significantly improve the patient’s well-being at the time of therapy. Read more in the article: “What do spasmalgon tablets help with?”

Flamax

Trade name: Flamax International name: Ketoprofen Pharmacological group: NSAID (non-steroidal anti-inflammatory drug) Pharmacological group for ATC: M01AE03. Ketoprofen Pharmacological action: analgesic, antiplatelet, antipyretic, anti-inflammatory Pharmacodynamics: NSAID, has anti-inflammatory, analgesic and antipyretic effects associated with the suppression of the activity of COX1 and COX2, which regulate the synthesis of Pg. The anti-inflammatory effect occurs by the end of 1 week of use.

Pharmacokinetics: Absorption is rapid, bioavailability is more than 90%. Communication with plasma proteins - 99%. TCmax - 1-2 hours after oral administration, 1.4-4 hours - with rectal administration, 15-30 minutes - with parenteral administration. When taking retard tablets, the minimum effective concentration is determined after 45-60 minutes. Css in plasma is achieved 24 hours after the start of regular use. The therapeutic concentration in the synovial fluid lasts 6-8 hours. It does not penetrate the BBB in a significant amount. It is almost completely metabolized in the liver by glucuronidation and has a “first pass” effect through the liver. Excreted by the kidneys (mainly) and intestines (1%). T1/2 - 1.6-1.9 hours - for regular tablets and 5.4 hours - for extended-release tablets. Does not accumulate.

Indications for use: Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid, psoriatic arthritis, ankylosing spondylitis (ankylosing spondylitis), gouty arthritis (in case of an acute attack of gout, fast-acting dosage forms are preferred), osteoarthritis. Intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease. Pain syndrome: myalgia, ossalgia, neuralgia, tendonitis, arthralgia, bursitis, radiculitis, adnexitis, otitis media, headache and toothache, in cancer, post-traumatic and postoperative pain syndrome accompanied by inflammation. Algodysmenorrhea, childbirth (as an analgesic and tocolytic agent).

Contraindications: Hypersensitivity (including to other NSAIDs), a history of bronchial asthma, rhinitis or urticaria caused by taking ASA or other NSAIDs, gastric and duodenal ulcers (exacerbation), ulcerative colitis (exacerbation), Crohn's disease, diverticulitis, peptic ulcer, hemophilia and other coagulation disorders, active gastrointestinal bleeding, severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, severe liver failure or active liver disease, condition after aortocoronary bypass surgery, confirmed hyperkalemia, inflammatory bowel diseases, children (up to 6 years), pregnancy (III trimester).

With caution: Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver, hyperbilirubinemia, liver failure, dehydration, sepsis, CHF, edema, arterial hypertension, blood diseases (including leukopenia), stomatitis, ischemic heart disease, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral arterial disease, chronic renal failure (creatinine clearance 30-60 ml/min), a history of ulcerative lesions of the gastrointestinal tract, the presence of Helicobacter pylori infection, long-term use of NSAIDs, severe somatic diseases, simultaneous use of oral corticosteroids (including . prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), old age, pregnancy (I , II trimester), lactation period.

Dosage regimen: Inside, intramuscularly, intravenously.

Tablets, drops for oral administration - 100 mg 3 times a day or 150 mg / day (retard) with an interval of 12 hours. Capsules - 50 mg in the morning and afternoon, 100 mg in the evening. The combined use of dosage forms is possible.

IM - 100 mg 1-2 times a day. IV, drip - 100-200 mg in 100-500 ml of 0.9% NaCl solution. Infusions are carried out only in a hospital, no more than 300 mg over 0.5-1 hour.

Side effects: From the digestive system: NSAID gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, loss of appetite, diarrhea), stomatitis, impaired liver function, rarely - change in taste. With long-term use in large doses - ulceration of the gastrointestinal mucosa, gingival, gastrointestinal, and hemorrhoidal bleeding. From the nervous system: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, rarely - confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy. From the senses: noise or ringing in the ears, blurred vision, rarely - conjunctivitis, dry mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss, vertigo. From the cardiovascular system: increased blood pressure, rarely - tachycardia. From the hematopoietic organs: rarely - agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia. From the urinary system: edematous syndrome, rarely - cystitis, urethritis, impaired renal function, interstitial nephritis, nephrotic syndrome, rarely - hematuria. Allergic reactions: skin rash (including erythematous, urticaria), skin itching, rhinitis, angioedema, rarely - bronchospasm, exfoliative dermatitis, anaphylactic shock. Other: increased sweating, rarely - hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitivity, with prolonged use in large doses - vaginal bleeding. The lysine salt of ketoprofen in comparison with ketoprofen (due to its neutral reaction and less local irritant effect on the gastrointestinal mucosa) is less likely to cause side effects from the gastrointestinal tract.

Interaction: Pharmaceutically incompatible with tramadol solution. Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of GCS and MCS, estrogens, reduces the effectiveness of antihypertensive drugs and diuretics. Combined use with other NSAIDs, corticosteroids, ethanol, corticotropin can lead to the formation of ulcers and the development of gastrointestinal bleeding, increasing the risk of developing renal dysfunction. Co-administration with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefaperazone, cefamandole and cefotetan increases the risk of bleeding. Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary). Inducers of microsomal liver enzymes (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites. Co-administration with valproic acid causes disruption of platelet aggregation. Increases plasma concentrations of verapamil and nifedipine, Li+ drugs, methotrexate. Antacids and cholestyramine reduce absorption. Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

Special instructions: During treatment, it is necessary to monitor the peripheral blood picture and the functional state of the liver and kidneys. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Taking ketoprofen can mask the signs of an infectious disease. If renal or liver function is impaired, dose reduction and careful monitoring are necessary. During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions. To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used for the shortest possible short course.

Manufacturer: Replek Pharm LLC Skopje, Macedonia Registration certificate holder: Sotex PharmFirma CJSC, Russia Release form: 50 mg capsules, plastic container Belongs to VED Conditions of release: by prescription Preferential release: DLO Registration data: LSR-000013 dated 03/21/2007 Status registration certificate: valid Pharmaceutical article number: LSR-000013-251108

Manufacturer: Replekpharm AD, Republic of Macedonia Registration certificate holder: Replekpharm AD, Republic of Macedonia Release form: 50 mg capsules, plastic containers Ingredients: ketoprofen 50 mg Belongs to VED Dispensing conditions: by prescription Preferential release: DLO Shelf life: 3 years Registration information : LSR-000013 dated 03/21/2007 Status of the registration certificate: valid Pharmaceutical article number: ND 42-14380-06

Manufacturer: Sotex PharmFirma ZAO, Russia Registration certificate holder: Sotex PharmFirma ZAO, Russia Forms of release: solution for intravenous and intramuscular administration 50 mg/ml, ampoule, solution for intravenous and intramuscular administration 50 mg/ml, dark glass ampoules Composition: ketoprofen 100 mg - 2 ml Belongs to VED Conditions of release: by prescription Preferential release: DLO Expiration date: 3 years Registration data: LS-000429 dated 05/06/2010 Status of the registration certificate: valid Pharmaceutical article number: LS-000429-291110, FSP 42-0557 -6443-05

Contraindications to drug treatment

The use of different medicinal variants of Flamax is impossible in some patients due to the presence of strict contraindications. The described medication is not prescribed if the patient is diagnosed with:

• erosive and ulcerative lesions of the digestive system in the acute period;

• bleeding from the gastrointestinal tract, inflammation of the intestines;
• renal failure;
• violations of the basic functions of the liver and diseases of this organ;
• progressive pathologies of the renal system;
• excess potassium in the body;
• abnormalities in the functioning of the hematopoietic organs, hemostasis, hemophilia;
• postoperative period after coronary artery bypass surgery;
• problems with the urinary system;
• lactation period, last trimester of pregnancy;

• children under 14 years of age;
• individual excessive sensitivity to the components of the drug or intolerance to them.

The use of Flamax is not recommended if there is a history of intolerance to other NSAID drugs. A previously developed allergic reaction to such drugs is also a contraindication.

Ketoprofen therapy is prescribed with caution for bronchial asthma, chronic cardiac failure, and arterial hypertension. Treatment should be carried out under the supervision of doctors if the patient is diagnosed with diabetes mellitus and ischemia. When prescribing the drug to patients with impaired renal function or patients over 65 years of age, a mandatory adjustment of the daily dose is required.

Contraindications

Without consulting a specialist, you should not give injections or drink Flamax capsules. Its use is contraindicated if you have the following diseases:

• gastric and duodenal ulcers of a chronic form or in the acute stage;
• problems in the liver and kidneys with impaired function;
• bronchial asthma;
• ulcerative colitis;
• Crohn's disease;
• if the blood contains high amounts of potassium;
• recent heart surgery;
• individual intolerance to the components of the medicine;
• polyposis in the sinuses.

The drug is not recommended during pregnancy, the 1st and 3rd trimesters and during lactation. It should not be prescribed to children under 12 years of age. Flamax in injections or capsules should be taken with great caution by patients with diabetes mellitus and coronary heart disease, suffering from high blood pressure. People over 65 years of age should also take the medication in limited doses.

In the first 3 months of gestation, pregnant women should not use Flamax. It negatively affects the mother's body, which can lead to birth defects in many organs, such as the heart, lungs, and face. In the second trimester, the attending physician may prescribe the drug when there is a threat to the expectant mother that exceeds the risks to the fetus.

The medication is not recommended in the 3rd trimester of pregnancy, since the main component ketoprofen has a negative effect on the woman’s body. After use, it can cause termination of pregnancy, the development of internal bleeding, and dysfunction of the respiratory organs in the fetus and newborn.

Since ketoprofen can be excreted in breast milk during lactation, it should not be used during this period. If the attending physician decides to prescribe medication to the patient, then breastfeeding should be stopped.

Negative phenomena that develop while taking

Flemax based on ketoprofen is generally well tolerated by different groups of patients. However, during therapy, unwanted side effects may occur. If unpleasant symptoms intensify, you must stop taking the drug and contact a medical facility to replace it or adjust the dose. Treatment with Flamax may be accompanied by the following symptoms:

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1. Disorders of the hematopoietic organs
   . The development of anemia, including hemolytic, leukopenia, and agranulocytosis is possible.

2. Functional abnormalities of the nervous system
   . During course therapy with ketoprofen, dizziness, nervous, and asthenic conditions may occur. Sometimes memory impairment and confusion of thoughts are recorded, and there is a risk of developing depressive disorders.

3. Digestive system
   . There is a possibility of developing dyspeptic pain, vomiting, and nausea. Treatment may be accompanied by diarrhea, excessive flatulence, and increased acidity. There may be a change in taste sensations.

4. Urinary organs
   . During therapy, the occurrence of disorders of the genitourinary system cannot be ruled out. The risk of developing cystitis, nephritis and other abnormalities in kidney function increases.

5. The cardiovascular system
   . Taking the drug is sometimes accompanied by tachycardia and surges in blood pressure. If such symptoms intensify, continuation of treatment is impossible without dosage adjustment.

The risk of an allergic reaction cannot be excluded. It can be expressed as a reddish rash, itching, and swelling. Allergic bronchospasms, Quincke's edema, and anaphylactic shock were rarely recorded during the use of Flamax.

Side effects

While taking the medication, patients may experience side effects of varying severity and manifestations. Undesirable effects in the body:

• malfunction of the gastrointestinal tract in the form of discomfort, pain, nausea, vomiting, intestinal upset, flatulence;
• stomatitis and dizziness;
• bleeding in the intestines and stomach;
• headache and depression;
• emotional instability;
• fainting and difficulty falling asleep;
• rapid heartbeat and exacerbation of hypertension;
• peripheral edema;
• allergic reaction in the form of itching, rhinitis, bronchospasm, skin rashes;
• instability in the function of the urinary tract (the appearance of blood during urination, urethritis, cystitis, etc.).

The use of Flamax sometimes leads to the development of diseases of the hematopoietic system. These are anemia, leukopenia, thrombocytopenia and others. Women are at risk of vaginal bleeding. Also, when taking the drug intravenously and intramuscularly, muscle pain, hemoptysis and nosebleeds, and shortness of breath occur.

In cases of longer course of treatment with these medications, the risk of side effects increases. To avoid such a reaction, experts advise taking the medicine in short courses and in limited dosages.

During drug therapy, concentration decreases, so it is better for motorists to stop driving vehicles while taking the drug. This also applies to patients who work at potentially hazardous sites.

Instructions for use

Due to the likelihood of developing negative phenomena, therapy with Flamax should be carried out in the shortest possible course and begin with low doses. To reduce pain, the drug is taken for no more than 5 days. Below are the uses of various dosage forms.

Injection

Treatment, depending on the severity of the patient’s condition, can be carried out either intravenously or intramuscularly. The drug must be injected into the muscle twice a day, 100 mg. One injection is enough to reduce pain once.

For intravenous infusions, the contents of the ampoule are diluted in 100 ml of physiological solution and administered slowly over 50-60 minutes. A longer administration of the medication is possible. To do this, 100-200 mg of Flamax are diluted in 0.5 liters of Ringer's solution or sodium chloride 9% and dripped for 8 hours.

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Capsules

The drug in capsule form is taken simultaneously with meals, with the required amount of liquid. Treatment regimens may vary. If Flamax is prescribed for pain due to pathologies of the musculoskeletal system, depending on the severity of the disease, one tablet may be prescribed in the morning and lunchtime and two at night. The usual four-fold application is no less effective. Sometimes it is necessary to use Flamax Forte with an increased dosage.

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Candles

According to the instructions, Flamax suppositories are used to treat certain gynecological pathologies and diseases of the rectum. The average daily dosage is 100-200 mg. Prescribe twice the use of the drug in the morning and evening hours. It can be used in childhood, but the dose in this case is selected by the attending physician.

Compatibility with other drugs

Flamax is completely compatible with centrally acting analgesics and is well accepted by the body. Mixing with morphine is acceptable. It cannot be combined with tramadol, as this will cause sediment to appear in the bottle.

In complex therapy, Flamax can be combined with itself only in a different form of release. Depending on the severity of the disease, the daily dosage can be increased to 300 mg of ketoprofen, or reduced to 100 mg. The dose per day will depend on the patient’s tolerability of the drug.

The active component of Flamax may react with certain groups of medications. It cannot be combined with loop diuretics, as increased nephrotoxicity is observed. Ketoprofen enhances the effectiveness of insulin, hypoglycemic drugs, fibrinolytics. In combination with diuretics, it reduces their effectiveness, as well as drugs for hypertension.

Drug overdose

There are no data on the occurrence of overdose during the treatment of Flamax drugs. With long-term use in high doses, increased side effects are likely. If you accidentally swallow a large number of capsules, induce vomiting, rinse your stomach, and then contact a medical facility.

In hospital settings, if an overdose is suspected, gastric lavage is also performed and symptomatic therapy is prescribed. No specific antidotes have been developed for the drug.

Drug interactions, special instructions

The combined use of Flamax with other analgesics is not prohibited. When ketoprofen is prescribed simultaneously with myelotoxic drugs, its hemotoxicity increases. During treatment with Flamax, the effect of insulin and other hypoglycemic drugs may be enhanced. In this case, the dose of the latter will need to be adjusted.

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When treated with ketoprofen, the effect of diuretics, antihypertensive and uricosuric drugs may be weakened. The toxicity of the active substance increases when taken together with estrogens and loop diuretics.

Ketoprofen enhances the effect of fibrinolytics, antiplatelet agents and anticoagulants.

When combined with glucocorticosteroids, the likelihood of ulcers and erosions increases.

During treatment with Flamax, you should avoid drinking alcohol. Since ketoprofen affects the ability to concentrate, caution must be used when driving vehicles.

Analogs of the drug Flamax

Since the described drug has many contraindications, in some cases, when treating a patient, a change in drug is required. Modern pharmaceutical companies offer a wide range of medications that have a similar effect on the body. Most often, instead of Flamax, patients are prescribed the following analogues:

Reviews from patients and doctors

The opinions of patients and doctors about the use of the drug are different, but in most cases they are positive. One of the advantages of such products is their gentle effect on the gastrointestinal tract. The use of Flamax for pain relief is indicated even if there is a history of stomach or intestinal pathology. However, in this case you need to carefully choose the dosage.

The drug should not be used for more than 3 days in accordance with the instructions without consulting a doctor.

The described drug can be used in complex therapy of diseases of the joints and spine as an analgesic and anti-inflammatory agent. It quickly reduces the severity of pain and helps with inflammation. In rare cases, it is possible to prescribe a drug to reduce fever.