Ketoprofen
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Clinical Pharmacology
NSAIDs, a derivative of propionic acid. It has analgesic, anti-inflammatory and antipyretic effect. By inhibiting COX-1 and COX-2 and, in part, lipoxygenase, ketoprofen inhibits the synthesis of prostaglandins and bradykinin, stabilizes lysosomal membranes.
Ketoprofen does not adversely affect the state of the articular cartilage.
Indications
Symptomatic therapy of painful and inflammatory processes of various origins, including:
Inflammatory and degenerative diseases of the musculoskeletal system:
- Rheumatoid arthritis.
- Seronegative arthritis (ankylosing spondylitis / Bechterew's disease /, psoriatic arthritis, reactive arthritis / Reiter's syndrome /).
- Gout, pseudogout.
- Osteoarthritis.
Pain syndrome:
- Headache.
- Tendonitis, bursitis, myalgia, neuralgia, sciatica.
- Post-traumatic and postoperative pain syndrome.
- Algomenorrhea.
- Pain syndrome in cancer.
Composition
1 tablet contains:
Active substance: Ketoprofen - 100 mg.
Excipients: magnesium stearate, colloidal silicon dioxide, corn starch, povidone, talc, lactose.
Shell composition: hypromellose, macrogol 400, indigo carmine (E132), titanium dioxide, talc, carnauba wax.
Ketoprofen is marketed under different brands and generic names, and comes in different dosage forms:
Brand name | Manufacturer | Country | Dosage form |
---|---|---|---|
Ketonal | Sandoz | Switzerland | pills |
Ketonal | Sandoz | Switzerland | rectal suppositories |
Ketonal | Sandoz | Switzerland | capsules |
Ketonal | Sandoz | Switzerland | solution |
Ketonal | Salyutas Pharma GmbH | Switzerland | cream |
Ketoprofen | Vertex | Russia | gel |
Ketoprofen | TEVA | Israel | gel |
solution | |||
Ketonal | Sandoz | Switzerland | cream |
Pentalgin | Lecco | Russia | gel |
Arketal | K.O.Romparm Company S.R.L | Romania | solution |
Ketoprofen | Organica | Russia | capsules |
Flamax | Sotex | Russia | capsules |
Ketoprofen | Organica | Russia | pills |
Ketoprofen | Synthesis AKOMP | Russia | ampoules |
Ketonal | Sandoz | Switzerland | gel |
Ketoprofen | VetProm AD | Bulgaria | gel |
Fastcaps | Valfarma | San marino | capsules |
Ketoprofen | Biocom | Russia | pills |
Flamax | Sotex | Russia | ampoules |
Ketonal | Sandoz | Switzerland | patch |
Flamax | Sotex | Russia | pills |
Fastum gel | Berlin-Chemie/Menarini | Germany | gel |
Artrosilene® | Dompe | Italy | gel |
OKI® | Dompe | Italy | tea bags |
Flexen gel | Italfarmaco | Italy | gel |
Flexen rectal suppositories | Italfarmaco | Italy | rectal suppositories |
OKI® | Dompe | Italy | vials |
OKI® | Dompe | Italy | rectal suppositories |
Artrosilene® | Dompe | Italy | spray can |
Artrosilene® | Dompe | Italy | solution |
Artrosilene® | Dompe | Italy | capsules |
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Dosage and Administration
Oral forms can be combined with the use of rectal suppositories or Ketonal dosage forms for external use (cream, gel).
The maximum daily dose (including the use of various dosage forms) is 200 mg.
Adverse reactions
Incidence of adverse reactions:
- Very common (> 10%).
- Common (> 1%, but <10%).
- Undistributed (> 0.1%, but <1%).
- Rare (> 0.01%, but <0.1%).
- Very rare (<0.01%).
From the digestive system: common - dyspepsia (nausea, flatulence, diarrhea or constipation, vomiting, decreased or increased appetite), abdominal pain, stomatitis, dry mouth; undistributed (with long-term use in large doses - ulceration of the gastrointestinal mucosa, impaired liver function); rare - perforation of the digestive tract, exacerbation of Crohn's disease, melena, bleeding from the gastrointestinal tract, transient increase in the level of liver enzymes.
From the side of the central nervous system and peripheral nervous system: common - headache, dizziness, drowsiness, fatigue, nervousness, nightmares; rare - migraine, peripheral neuropathy; very rare - hallucinations, disorientation, speech disorder.
From the senses: rare - tinnitus, change in taste, blurred vision, conjunctivitis.
Since the cardiovascular system: not common - tachycardia, arterial hypertension, peripheral edema.
From the hemopoietic system: decreased platelet aggregation; rare - anemia, thrombocytopenia, agranulocytosis, purpura.
From the urinary system: rare - renal dysfunction, interstitial nephritis, nephrotic syndrome, hematuria (with long-term use of NSAIDs and diuretics).
Allergic reactions: common - itching, urticaria; not common - rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions.
Other: rare - hemoptysis, metrorrhagia.
Contraindications
- Bronchial asthma, rhinitis, urticaria in history, caused by taking acetylsalicylic acid or other NSAIDs.
- Peptic ulcer and duodenal ulcer in the acute phase.
- UCR, Crohn's disease.
- Hemophilia and other bleeding disorders.
- Severe liver failure.
- Severe renal failure.
- Progressive kidney disease.
- Uncompensated heart failure.
- The postoperative period after coronary artery bypass surgery.
- Gastrointestinal, cerebrovascular and other bleeding (or suspected bleeding).
- Chronic dyspepsia.
- Children's age up to 15 years.
- III trimester of pregnancy.
- Lactation period (breastfeeding).
- Hypersensitivity to ketoprofen or other components of the drug, as well as salicylates or other NSAIDs.
Carefully: It should be prescribed for a history of peptic ulcer disease, a history of bronchial asthma, clinically significant cardiovascular, cerebrovascular diseases, diseases of the peripheral arteries, dyslipidemias, hepatic insufficiency, hyperbilirubinemia, alcoholic cirrhosis of the liver, renal failure, chronic heart failure, and for example, hepatic insufficiency, renal failure, chronic hepatitis, and hyperbilirubinemia. , dehydration, diabetes mellitus, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, smoking, concomitant therapy of anti agulyantami (e.g., warfarin), antiplatelet agents (for example, acetylsalicylic acid), oral corticosteroids (e.g., prednisone), selective serotonin reuptake inhibitors (e.g., citalopram, sertraline).
Drug interactions
Ketoprofen reduces the effect of diuretics, antihypertensive agents.
Enhances the action of oral hypoglycemic drugs.
Enhances the effect of some anticonvulsants (for example, phenytoin).
With simultaneous use with other NSAIDs, salicylates, corticosteroids and ethanol increases the risk of gastrointestinal bleeding.
When used simultaneously with anticoagulants, thrombolytics, antiplatelet agents, the risk of bleeding increases.
The risk of developing impaired renal function is increased when taken simultaneously with diuretics or ACE inhibitors.
With simultaneous use increases the concentration of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, methotrexate.
Ketoprofen may decrease the effectiveness of mifepristone. Acceptance of NSAIDs should begin no earlier than 8-12 days after the abolition of mifepristone.
Pregnancy and Lactation
The use of ketoprofen in the third trimester of pregnancy is contraindicated. In the first and second trimesters of pregnancy, prescribing is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.
When taking the drug during lactation should decide on the termination of breastfeeding.
Special instructions
Ketonal® can be taken with milk or taken with antacids to reduce the frequency of gastrointestinal disorders (milk and antacids do not affect ketoprofen absorption). With prolonged use of NSAIDs, it is necessary to monitor the condition of the blood, as well as liver and kidney function, especially in elderly patients.
It is necessary to be careful and more often to control blood pressure when using ketoprofen for the treatment of patients with arterial hypertension, cardiovascular diseases that lead to fluid retention.
Like other NSAIDs, ketoprofen can mask the symptoms of infectious diseases.
Influence on ability to drive motor transport and control mechanisms
There are no data on the negative effect of Ketonal in recommended doses on the ability to drive a car or work with mechanisms. At the same time, patients who notice non-standard effects while taking Ketonal® should be careful when practicing potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions.
Overdosage
Symptoms: nausea, vomiting, abdominal pain, vomiting with blood, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function, renal failure.
Treatment: gastric lavage, the appointment of Activated charcoal, conduct symptomatic therapy. The use of histamine H blockers is shown.2-receptors, proton pump inhibitors, prostaglandin inhibitors. There is no specific antidote.
- Brand name: Ketonal
- Active ingredient: Ketoprofen
- Dosage form: pills, film coated.
- Manufacturer: Sandoz
- Country of Origin: Switzerland
Studies and clinical trials of Ketoprofen (Click to expand)
- Determination of (R)- and (S)-ketoprofen in human plasma by liquid chromatography/tandem mass spectrometry following automated solid-phase extraction in the 96-well format
- Direct HPLC analysis of ketoprofen in horse plasma applying an ADS-restricted access-phase
- Large Scale Safety Study of Ketoprofen 25 mg (Toprec®) in Febrile and Painful Conditions
- Stereoselective metabolic pathways of ketoprofen in the rat: Incorporation into triacylglycerols and enantiomeric inversion
- Bi-directional chiral inversion of ketoprofen in CD-1 mice
- Chiral discrimination in the transport of ketoprofen and ibuprofen esters through an aqueous phase mediated by various serum albumins
- Stereoselective drug release from Ketoprofen and Ricobendazole matrix tablets
- An Efficient and Practical Sequential One-Pot Synthesis of Suprofen, Ketoprofen and Other 2-Arylpropionic Acids
- Ketoprofen nanoparticle gels formed by evaporative precipitation into aqueous solution
- Preparation of ketoprofen-loaded high-molecular-weight poly(vinyl alcohol) gels
- Release of ketoprofen from dermal bases in presence of cyclodextrins: Effect of the affinity constant determined in semisolid vehicles
- Pharmacokinetic characteristics of ketoprofen suppositories
- Comparative pharmacokinetics of ketoprofen derived from single oral doses of ketoprofen capsules or a novel sustained-release pellet formulation
- Single dose pharmacokinetics of ketoprofen, indomethacin, and naproxen taken alone or with sucralfate
- Pharmacokinetics of ketoprofen in rats: Effect of age and dose
- Intestinal absorption characteristics of ketoprofen in rats
- Pharmacokinetics and pharmacodynamics of ketoprofen plasters
- Drug–excipient interactions in ketoprofen: A vibrational spectroscopy study
- Comparative chromatographic study on the chiral separation of the 1-naphthylamine derivative of ketoprofen on cellulose-based columns of different sizes
- Resolution of enantiomers of ketoprofen by HPLC: a review
- Simultaneous quantitation of etoricoxib, salicylic acid, valdecoxib, ketoprofen, nimesulide and celecoxib in plasma by high-performance liquid chromatography with UV detection
- High-performance liquid chromatography method development and validation for simultaneous determination of five model compounds, antipyrine, metoprolol, ketoprofen, furosemide and phenol red, as a tool for the standardization of rat in situ intestinal permeability studies using timed wavelength detection