Ketoprofen capsules 50mg 20pcs

Composition

Capsules. 1 capsule-ketoprofen 50 mg.

Auxiliary substances:

giprolose (hydroxypropylcellulose klucel LF) – 1.2 mg,

mannitol (mannitol) – 10.5 g,

croscarmellose sodium (primellose) – 2.7 mg,

microcrystalline cellulose-24.2 mg,

colloidal silicon dioxide (aerosil) – 0.5 mg,

magnesium stearate-0.9 mg.

Capsule shell composition:

sunset yellow (E 110) or sunset yellow – 2%, gelatin – up to 100%.

Pharmacological action

Pharmaceutical Group:

NSAIDs.

Pharmaceutical action:

NSAIDs have anti-inflammatory, analgesic and antipyretic effects associated with the suppression of COX-1 and COX-2 activity, which regulate Pg synthesis.

The anti-inflammatory effect occurs by the end of 1 week of use.

The lysine salt of ketoprofen has an equally pronounced anti-inflammatory, analgesic, and antipyretic effect. It has no catabolic effect on articular cartilage.

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.

It is intended for symptomatic therapy, reducing pain and inflammation at the time of use, and does not affect the progression of the disease.

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, childbirth (as an analgesic and tocolytic agent).

Contraindications

Hypersensitivity (including to other NSAIDs), bronchial asthma, rhinitis or urticaria in the anamnesis caused by taking ASA or other NSAIDs, peptic ulcer of the stomach and duodenum (exacerbation), ulcerative colitis (exacerbation), Crohn’s disease, diverticulitis, peptic ulcer, hemophilia, etc. blood clotting disorders, active gastrointestinal bleeding; severe renal failure (creatinine clearance less than 30 ml/min), progressive kidney disease, severe hepatic insufficiency or active liver disease, condition after coronary artery bypass grafting, confirmed hyperkalemia, inflammatory bowel diseases, childhood (up to 6 years), pregnancy (third 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, CHD, cerebrovascular diseases, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery diseases, CRF (creatinine clearance 30-60 ml/min) history of gastrointestinal ulcers, Helicobacter pylori infection, long-term use of NSAIDs, severe somatic diseases, concomitant use of oral corticosteroids (including prednisone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), elderly age, pregnancy (I, II trimester), lactation period.

Side effects

The frequency is classified as rare-from 0.01 to 0.1%; very rare

From the digestive system: NSAIDs-gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, loss of appetite, diarrhea), stomatitis, liver dysfunction; rarely — erosive and ulcerative lesions, bleeding and perforation of the gastrointestinal tract, taste changes.

From the nervous system: headache, dizziness, insomnia, agitation, nervousness, drowsiness, depression, asthenia; rarely-confusion or loss of consciousness, forgetfulness, memory impairment, migraine, peripheral neuropathy.

From the sensory organs: noise or ringing in the ears, blurred visual perception; rarely-conjunctivitis, dryness of the mucous membrane of the eye, pain in the eyes, conjunctival hyperemia, hearing loss, dizziness; additionally for capsules-vertigo.

From the cardiovascular system: edema, increased blood pressure; rarely-tachycardia.

From the respiratory system: hemoptysis, shortness of breath, pharyngitis, rhinitis, bronchospasm, laryngeal edema (signs of anaphylactic reaction); rarely — asthma attacks.

Hematopoietic disorders: rarely-agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia. High doses of ketoprofen can inhibit platelet aggregation, thereby prolonging the bleeding time, and cause nosebleeds and bruising.

From the urinary system: edematous syndrome; rarely — cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome; rarely-hematuria.

Immune system disorders: respiratory reactivity, including acute asthma; bronchospasm or shortness of breath (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs); very rarely — angioedema and anaphylaxis.

Allergic reactions: skin rash (including erythematous, urticaria), itchy skin, rhinitis; rarely-exfoliative dermatitis.

Other: increased sweating; rarely-hemoptysis, nosebleeds, myalgia, muscle twitching, shortness of breath, thirst, photosensitization, with prolonged use in large doses — vaginal bleeding.

Interaction

Pharmacologically incompatible with tramadol solution. Reduces the effectiveness of uricosuric drugs, increases the effect of anticoagulants, antiplatelet agents, fibrinolytics, ethanol, side effects of corticosteroids and MCS, estrogens; reduces the effectiveness of antihypertensive drugs and diuretics.

Co-use with other NSAIDs, corticosteroids, ethanol, and corticotropin may lead to ulceration and gastrointestinal bleeding, and may increase the risk of developing renal dysfunction. Concomitant use with oral anticoagulants, heparin, thrombolytics, antiplatelet agents, cefaperazone, 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 liver enzymes (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants) increase the production of hydroxylated active metabolites.

Co-use with valproic acid causes a violation of platelet aggregation. Increases plasma concentrations of verapamil and nifedipine, Li+ 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 or immediately after a meal, without chewing, with enough water.

Adults and adolescents (15-18 years old) are prescribed 4 capsules of the drug per day, which can be divided into 3 doses (depending on the severity of the pain syndrome), but no more than 2 capsules. once.

The maximum daily dose should not exceed 200 mg.

Special instructions

During treatment, it is necessary to monitor the picture of peripheral blood 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 may mask the signs of an infectious disease.

In case of impaired renal and hepatic function, dose reduction and careful monitoring are necessary.

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

To reduce the risk of gastrointestinal adverse events, the minimum effective dose should be used in the shortest possible course.

Storage conditions

In a dark place, at a temperature not exceeding 30 °C. Keep out of reach of children.

Shelf

life is 2 years.

Active ingredient

Ketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

Capsules