Ultrafastin (ketoprofen) coated tablets 100 mg. №20

Description

Ultrafastin (ketoprofen) coated tablets 100 mg. №20

Composition

active substance: ketoprofen;

1 tablet contains ketoprofen 100 mg;

excipients:

tablet core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate;

shell: hypromellose, lactose monohydrate, triacetin, titanium dioxide (E 171), macrogol 3000, quinoline yellow (E 104), iron oxide yellow (E 172), iron oxide red (E 172).

Dosage form

Coated tablets.

Main physical and chemical properties: pale yellow round biconvex tablets.

Pharmacotherapeutic group

Non-steroidal anti-inflammatory and anti-rheumatic drugs. Derivatives of propionic acid. Ketoprofen. ATX code M01A E03.

Pharmacological properties

Ketoprofen, a derivative of phenylpropionic acid, belongs to a group of non-steroidal drugs with anti-inflammatory and antirheumatic effects.
The mechanism of action Ultrafastin coated tablets is due to the inhibition of cyclooxygenase, the enzyme responsible for the synthesis of prostaglandins. Ketoprofen is also a bradykinin antagonist. Inhibits leukotriene synthesis, reduces blood platelet aggregation, affects lysosomal membranes.
In women, ketoprofen reduces the symptoms of primary dysmenorrhea due to inhibition of prostaglandin synthesis.

Indication

Rheumatoid arthritis; seronegative spondyloarthritis (ankylosing spondylitis, psoriatic arthritis, reactive arthritis); gout, pseudogout; osteoarthritis; extra-articular rheumatism (tendinitis, bursitis, capsulitis of the shoulder joint);
pain of various etiologies, mild and moderate (lumbago; post-traumatic pain in joints, muscles);
algodysmenorrhea.

Contraindication

• hypersensitivity to ketoprofen or to any of the excipients;
• contraindicated in patients in whom the use of ketoprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs) provokes bronchospasm, asthma attacks, urticaria, angioneurotic edema, acute rhinitis or other allergic reactions;
• active phase or recurrence of peptic ulcer of the stomach and / or duodenum;
• history of gastrointestinal bleeding / perforation / ulcer, cerebrovascular or other bleeding;
• patients prone to hemorrhage;
• severe hepatic or renal failure;
• severe heart failure;
• treatment of postoperative pain during coronary artery bypass graft surgery;
• history of chronic dyspepsia.

Method of application and dosage

Doses should be selected individually, depending on the patient’s condition and his response to treatment.
The recommended dose for adults is 1 tablet 2 times a day.
The recommended dose for the treatment of rheumatoid arthritis and osteoarthritis is 1 tablet 2 times a day.
The recommended dose for mild, moderate pain and dysmenorrhea – 1 tablet 1 time per day.
The duration of treatment depends on the severity and course of the disease, but side effects can be minimized by using the lowest effective dose for as short a time as possible to relieve symptoms.
The maximum daily dose of ketoprofen is 200 mg. The risk / benefit ratio should be carefully considered before prescribing a maximum daily dose of 200 mg. The use of a higher dose is not recommended.
Take tablets with food, washed down with water. The tablets should be swallowed whole without chewing.
To prevent the negative effects of ketoprofen on the mucous membranes of the gastrointestinal tract, you can take antacids at the same time.
Use Ultrafastin coated tablets in elderly patients.
Elderly patients have an increased risk of adverse reactions. If NSAIDs are required, the minimum effective dose should be used for as short a time as possible. Also, NSAID therapy should be monitored regularly for signs of gastrointestinal bleeding.

Children

The safety of ketoprofen in children has not been established, so the drug should not be prescribed to children.

Overdose

Symptoms. In case of ketoprofen overdose, the following symptoms were observed: headache, drowsiness, nausea, vomiting, diarrhea, abdominal pain, decreased renal function and impaired renal function. In case of significant overdose: arterial hypotension or arterial hypertension, shortness of breath, respiratory depression, disturbance of consciousness, gastrointestinal bleeding; rarely – coma, convulsions, acute renal failure.
Treatment. In case of overdose, Ultrafastin should be discontinued immediately. If no more than 1 hour has elapsed since the overdose, gastric lavage should be performed and activated charcoal at a dose of 60-100 g for adults and 1-2 g / kg body weight for children should be taken and symptomatic treatment aimed at maintaining vital functions should be initiated. An increase in diuresis may be indicated. In case of renal failure, hemodialysis can be used to remove the drug from the body. H2-receptor antagonists, proton pump inhibitors and prostaglandins alleviate the dangerous effects of ketoprofen on the digestive tract. There is no specific antidote.

Side effects:

• from the digestive tract – dyspepsia, nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, anorexia, stomatitis;
• from the immune system – exacerbation of asthma, bronchospasm or shortness of breath (especially in patients with hypersensitivity to acetylsalicylic acid and other NSAIDs);
• mental disorders – depression, nervousness, nightmares, drowsiness;
• from the nervous system – headache, asthenia, discomfort, fatigue, weakness, dizziness, paresthesia, mood swings, weight gain; rare – dysgeusia;
• on the part of the visual organs – visual impairment;
• from the hearing organs – tinnitus;
• from the cardiovascular system – edema.