Flamax, 50mg capsules 25pcs

Composition

Active ingredient:

50 mg of ketoprofen,

excipients:

lactose monohydrate,

microcrystalline cellulose,

croscarmelose sodium,

sodium lauryl sulfate,

povidone,

colloidal silicon dioxide.

Composition of the gelatin capsule:

titanium dioxide, gelatin, indigo carmine FD & C blue.

Pharmacological action

Pharmacodynamics

A nonsteroidal anti-inflammatory drug (NSAID) derived from propionic acid. It has anti-inflammatory, analgesic and antipyretic, antiplatelet effects.

Inhibits the activity of cyclooxygenases 1 and 2, which regulate prostaglandin synthesis. The analgesic effect is caused by both central and peripheral mechanisms. It has anti-radikinin activity, stabilizes lysosomal membranes.

Pharmacokinetics

Absorption-fast, bioavailability-90%. Up to 99% of absorbed ketoprofen binds to plasma proteins, mainly albumin. The maximum concentration of the drug in plasma (Cmax) is reached quickly (0.5-2 hours after oral use) due to the low volume of distribution (0.1-0.2 l / kg).

Steady – state plasma concentrations (Sss) of ketoprofen are reached 24 hours after the start of regular ketoprofen use. Ketoprofen penetrates well into synovial fluid and connective tissues.

The maximum concentration in synovial fluid is 30% of the serum concentration, and 4-6 hours after ingestion exceeds it. Ketoprofen penetrates the blood-brain barrier. It is almost completely metabolized in the liver by glucuronidation, and has a “first pass” effect through the liver. It is excreted by the kidneys (mainly) and intestines (1-8%).

The half-life of ketoprofen (T 1/2) is 1.6-1.9 h. In the elderly, the half-life increases to 3-5 h, in patients with renal insufficiency (creatinine clearance 20-60 ml / min) is about 3.5 h. It does not accumulate.

Indications

Inflammatory and degenerative diseases of the musculoskeletal system: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gouty arthritis (with an acute attack of gout, fast-acting dosage forms are preferred), osteoarthritis.

Pain syndrome: myalgia, ossalgia, neuralgia, tendinitis, arthralgia, bursitis, sciatica, adnexitis, otitis media, headache and toothache, cancer, post-traumatic and postoperative pain syndrome accompanied by inflammation. Algodismenorrhea.

Contraindications

– hypersensitivity to Ketoprofen or to any component of the drug;-bronchial asthma in history caused by Ketoprofen, other nonsteroidal anti-inflammatory drug or acetilsalicilico acid;- receiveready gastric ulcer and duodenal ulcer – a peptic ulcer;- severe liver failure;- severe renal failure;- failure of the circulatory system; gastrointestinal, cerebrovascular, and other bleeding (or suspected bleeding);- pregnancy and lactation period; – children’s age (up to 15 years);- hemophilia and other blood clotting disorders;- ulcerative colitis, Crohn’s disease, diverticulitis.

With caution Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis of the liver, hyperbilirubinemia, hepatic and renal insufficiency (since the drug is mainly excreted by the kidneys), diabetes mellitus, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, coronary heart disease, blood diseases (including leukopenia), stomatitis, children (older than 15 years), the elderly. Pregnancy and lactation The use of ketoprofen is contraindicated during pregnancy and lactation.

Side effects

From the digestive system: NSAID-gastropathy, stomach pain, dyspepsia (nausea, vomiting, heartburn, flatulence, decreased appetite, diarrhea), stomatitis; a change of taste, ulceration and perforation of the mucous membrane of the gastrointestinal tract, gingival, gastrointestinal, hemorrhoidal bleeding; increased activity of “liver” transaminases in the blood serum hepatitis.

Nervous system disorders: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia, confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy.

– From the sensory organs: noise or ringing in the ears, blurred vision, conjunctivitis, dryness of the mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss, vertigo.

– From the cardiovascular system: increased blood pressure, tachycardia.

– From the hematopoietic organs: rarely-agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia.

– From the urinary system: edematous syndrome, cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome, hematuria.

– From the respiratory system: hemoptysis, dyspnoea, bronchospasm, rhinitis, laryngeal edema, nosebleeds, shortness of breath.

– From the skin: skin rash, alopecia and eczema, exudative erythema, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), photodermatitis.

– Allergic reactions: skin rash (including erythematous, urticaria), itchy skin, rhinitis, angioedema, exfoliative dermatitis, anaphylactic shock.

– Other: increased sweating, myalgia, muscle twitching, shortness of breath, thirst, vaginal bleeding.

Overdose

Symptoms: drowsiness, nausea, vomiting, abdominal pain, bleeding, and impaired liver and kidney function may occur.

Treatment is symptomatic: gastric lavage and / or activated charcoal and / or other sorbents. There is no specific antidote.

Interaction

Reduces the effectiveness of uricosuric drugs, enhances the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of glucocorticosteroids and mineralocorticosteroids, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics.

Concomitant use with other NSAIDs, glucocorticosteroids, ethanol, and corticotropin may lead to ulceration and gastrointestinal bleeding, and increase the risk of developing renal dysfunction.

Concomitant use of oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefoperazone, cefamandol, and cefotetan increases the risk of bleeding.

Increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

Inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Co-use with sodium valproate causes a violation of platelet aggregation.

Increases plasma concentrations of verapamil and nifedipine, lithium preparations, and methotrexate. Antacids and colestyramine reduce absorption.

Myelotoxic drugs increase the manifestations of hematotoxicity of the drug.

How to take, course of use and dosage

Inside, during a meal. For rheumatic diseases,1 capsule in the morning,1 in the afternoon and 2 in the evening, or 4 times a day,1 capsule. Combined use of dosage forms is possible.

In patients with renal insufficiency, the dose is reduced to 33-50%, in elderly patients, the dose is adapted to age. In the treatment of pain syndrome and algodismenorrhea, the dose, if necessary, is 25-50 mg of ketoprofen every 6-8 hours. The maximum daily dose is 300 mg.

Special instructions

Patients with concomitant use of ketoprofen and warfarin, as well as coumarin anticoagulants or lithium salts, should be under strict medical supervision.

Caution should be exercised when prescribing the drug to patients with a history of gastrointestinal ulcers, renal or hepatic insufficiency. During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys. In patients with impaired renal and hepatic function (increased ALT activity is the most sensitive indicator of NSAID-induced liver dysfunction), dose reduction and careful monitoring are necessary. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study.

Like other drugs of this group, it can mask the signs of an infectious disease.

With the development of visual disorders, you need to consult an ophthalmologist.

During treatment, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Capsules

Storage conditions

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

Shelf

life is 3 years.

Active ingredient

Ketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

Capsules

Purpose

Children prescribed by a doctor, Nursing mothers prescribed by a doctor, Children over 15 years of age, For adults, Pregnant women prescribed by a doctor

Indications

Lumbago, Sciatica, Arthritis, Gout, Osteoarthritis, Swelling after injuries and operations, Bruises, Bursitis, Osteochondrosis, Rheumatoid Arthritis, Osteoarthritis, Myositis, Trigeminal Neuralgia