Ketoprofen, 50 mg capsules 20 pcs

Pharmgroup:

NSAIDs.

Pharmic action:

PNP, has anti-inflammatory, analgesic and antipyretic effects associated with inhibition of COX1 and COX2 activity, regulating the synthesis of Pg.

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

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

Indications

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

It is intended for symptomatic therapy, to reduce pain and inflammation at the time of use, has no effect on the progression of the disease.

Pain syndrome: myalgia, osalgia, neuralgia, tendinitis, arthralgia, bursitis, sciatica, adnexitis, otitis, headache and toothache, with cancer, post-traumatic and postoperative pain syndrome accompanied by inflammation. Algodysmenorrhea, childbirth (as an analgesic and tocolytic agent).

Active ingredient

Composition

Capsules. 1 capsule – ketoprofen 50 mg.

Excipients:

Hyprolose (hydroxypropyl cellulose clucel 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 (E110) or Sunset Yellow – 2%, gelatin – up to 100%.

How to take, the dosage

Overly, during or immediately after a meal, without chewing, with enough water.

Adults and adolescents (15-18 years) are prescribed 4 capsules of the preparation daily, which can be divided into 3 doses (depending on the severity of the pain syndrome), but not more than 2 capsules once.

The maximum daily dose should not exceed 200 mg.

Interaction

Pharmaceutically incompatible with tramadol solution. Reduces the effectiveness of uricosuric drugs, increases the effect of anticoagulants, antiaggregants, fibrinolytics, ethanol, side effects of GCS and MKS, estrogens; reduces the effectiveness of hypotensive drugs and diuretics.

Mixed administration with other NSAIDs, GCS, ethanol, corticotropin may cause ulceration and gastrointestinal bleeding, increased risk of renal dysfunction. Concomitant administration with oral anticoagulants, heparin, thrombolytics, antiaggregants, cefaperazone, cefamandole and cefotetan increases the risk of bleeding.

Induces hypoglycemic effect of insulin and oral hypoglycemic drugs (recalculation of the dose 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 impairment of platelet aggregation. Increases the plasma concentration of verapamil and nifedipine, Li+ drugs, methotrexate. Antacids and colestyramine reduce absorption. Myelotoxic drugs increase manifestations of hematotoxicity of the drug.

Special Instructions

At the time of treatment, peripheral blood counts and liver and kidney function should be monitored. If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the study. Administration of ketoprofen may mask the signs of infectious disease.

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

During treatment, caution should be exercised when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and rapid psychomotor reactions.

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

Contraindications

Hypersensitivity (including to other NSAIDs), history of bronchial asthma, rhinitis or urticaria caused by taking ASA or other NSAIDs. NSAIDs, gastric and duodenal ulcer (exacerbation), ulcerative colitis (exacerbation), Crohn’s disease, diverticulitis, peptic ulcer, hemophilia, etc. clotting disorders, active gastrointestinal bleeding; severe renal failure (CKR less than 30 ml/min), advanced renal disease, severe liver failure or active liver disease, condition after coronary artery bypass surgery, confirmed hyperkalemia, inflammatory bowel disease, childhood age (under 6 years), pregnancy (III trimester).

With caution. Anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic cirrhosis, hyperbilirubinemia, hepatic insufficiency, dehydration, sepsis, CHF, edemas, arterial hypertension, blood diseases (including leukopenia), stomatosis. leukopenia), stomatitis, CHD, cerebrovascular disease, dyslipidemia/hyperlipidemia, diabetes mellitus, peripheral artery disease, CKD (CK 30-60 ml/min), history of GI ulcers, Helicobacter pylori infection, long-term use of NSAIDs, severe medical conditions, simultaneous use of oral GCS (including prednisolone).Prednisolone), anticoagulants (including warfarin), antiplatelet agents (including clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), older age, pregnancy (I, II trimester), lactation.

Side effects

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

Digestive system disorders: NSAID gastropathy, abdominal pain, dyspepsia (nausea, vomiting, heartburn, flatulence, decreased appetite, diarrhea), stomatitis, liver dysfunction; rare – erosive ulcerative lesions, bleeding and perforation of the GI tract, changes in taste.

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

Senses: tinnitus or ringing in the ears, blurred vision; rarely – conjunctivitis, dry mucous membrane of the eye, eye pain, conjunctival hyperemia, decreased hearing, dizziness; additionally for capsules – vertigo.

Systemic system disorders: edema, increased BP; rarely – tachycardia.

Respiratory system disorders: hemoptysis, dyspnea, pharyngitis, rhinitis, bronchospasm, laryngeal edema (signs of anaphylactic reactions); rarely – asthma attacks.

Hematopoietic organs: rarely – agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, leukopenia. High doses of ketoprofen may inhibit platelet aggregation, prolonging bleeding time, and cause nasal bleeding and hematoma formation.

Urinary system disorders: edema syndrome; rarely – cystitis, urethritis, renal dysfunction, interstitial nephritis, nephrotic syndrome; rarely – hematuria.

The immune system: reactive respiratory system, including bronchial asthma, its exacerbation; 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), skin itching, rhinitis; rarely – exfoliative dermatitis.

Others: increased sweating; rarely – hemoptysis, nasal bleeding, myalgia, muscle twitching, shortness of breath, thirst, photosensitization; with prolonged use in high doses – vaginal bleeding.

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