Ketonal DUO modified-release capsules 150mg, 30pcs

Composition

1 capsule contains:

Active ingredient:

ketoprofen – 50 mg.

Auxiliary substances:

lactose,

magnesium stearate,

colloidal silicon dioxide.

Capsule shell composition:

gelatin,

titanium dioxide,

dye blue patent “Patent blue V”.

Pharmacological action

of NSAIDs derived from propionic acid.

It has analgesic, anti-inflammatory and antipyretic effects.

Due to the inhibition of COX-1 and COX-2 and, partially, lipoxygenase, ketoprofen suppresses the synthesis of prostaglandins and bradykinin, and stabilizes lysosomal membranes.

Ketoprofen does not have a negative effect on the condition of 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 / ankylosing spondylitis / psoriatic arthritis, reactive arthritis /Reiter’s syndrome/),
• gout, pseudogout,
• osteoarthritis.

Pain syndrome:

• headache,
• tendinitis, bursitis, myalgia, neuralgia, sciatica,
• post-traumatic and postoperative pain syndrome,
• algodismenorrhea,
• pain syndrome in oncological diseases.

Use during pregnancy and lactation

The use of ketoprofen in the third trimester of pregnancy is contraindicated. In the first and second trimesters of pregnancy, the drug can only be prescribed if the intended benefit to the mother exceeds the potential risk to the fetus.

When taking the drug during lactation, you should decide whether to stop breastfeeding.

Contraindicated in children under 15 years of age.

Contraindications

• bronchial asthma, rhinitis, urticaria in the anamnesis caused by taking acetylsalicylic acid or other NSAIDs,
• peptic ulcer of the stomach and duodenum in the acute phase,
• Ulcerative colitis, Crohn’s disease,
• hemophilia and other blood clotting,
• severe hepatic insufficiency,
• renal insufficiency,
• progressive kidney disease,
• uncompensated congestive heart failure,
• postoperative period after coronary artery bypass surgery,
• gastrointestinal, cerebrovascular, and other bleeding (or suspected bleeding),
• chronic dyspepsia,
• hypersensitivity to Ketoprofen or other components of the drug, as well as salicylates or other NSAIDs.

With caution:  the drug should be prescribed for a history of peptic ulcer disease, a history of bronchial asthma, clinically expressed cardiovascular, cerebrovascular diseases, peripheral artery diseases, dyslipidemia, liver failure, hyperbilirubinemia, alcoholic cirrhosis of the liver, renal failure, chronic heart failure, arterial hypertension, blood diseases, dehydration, diabetes mellitus, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, smoking, concomitant therapy with anticoagulants (for example, warfarin), antiplatelet agents (for example, acetylsalicylic acid), oral corticosteroids (for example, prednisone), selective serotonin reuptake inhibitors (for example, citalopram, sertraline).

Side effects

Frequency of adverse reactions:

• Very common (>10%).
• Common ( > 1%, but >
• Non-distributed (> 0.1%, but >
• Rare ( > 0.01%, but >
• Very rare (

From the digestive system:  common – dyspepsia (nausea, flatulence, diarrhea or constipation, vomiting, decreased or increased appetite), abdominal pain, stomatitis, dry mouth; uncommon (with prolonged use in large doses – ulceration of the gastrointestinal mucosa, impaired liver function); rare-perforation of the gastrointestinal tract, exacerbation of Crohn’s disease, melena, bleeding from the gastrointestinal tract, transient increase in liver enzymes.

From 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 side of the senses:  rare – tinnitus, taste changes, blurred vision, conjunctivitis.

From the cardiovascular system:  non-common – tachycardia, arterial hypertension, peripheral edema.

From the hematopoietic system:  reduced platelet aggregation; rare-anemia, thrombocytopenia, agranulocytosis, purpura.

From the urinary system:  rare – impaired renal function, interstitial nephritis, nephrotic syndrome, hematuria (with prolonged use of NSAIDs and diuretics).

Allergic reactions:  common – pruritus, urticaria; uncommon-rhinitis, shortness of breath, bronchospasm, angioedema, anaphylactoid reactions.

Other services:  rare – hemoptysis, metrorrhagia.

Interaction

Ketoprofen reduces the effect of diuretics, antihypertensive agents.

Enhances the effect of oral hypoglycemic drugs.

Increases the effect of some anticonvulsants (for example, phenytoin).

Concomitant use with other NSAIDs, salicylates, corticosteroids, and ethanol increases the risk of gastrointestinal bleeding.

When used concomitantly with anticoagulants, thrombolytics, and antiplatelet agents, the risk of bleeding increases.

The risk of developing impaired renal function is increased when taken concomitantly with diuretics or ACE inhibitors.

When used concomitantly, it increases the concentration of cardiac glycosides, slow calcium channel blockers, lithium preparations, cyclosporine, and methotrexate.

Ketoprofen may reduce the effectiveness of mifepristone. NSAIDs should be started no earlier than 8-12 days after mifepristone is discontinued.

How to take, course of use and dosage

For adults, the drug is prescribed 1-2 capsules 2-3 times/day; or 1 tab. forte 2-3 times/day; or 1 tab. retard 1-2 times/day.

Capsules and tablets should be taken during or immediately after a meal, without chewing, with a sufficient amount of water.

Overdose

Symptoms:  nausea, vomiting, abdominal pain, vomiting with blood, melena, impaired consciousness, respiratory depression, convulsions, impaired renal function, renal failure.

Treatment:  gastric lavage, use of activated charcoal, and symptomatic therapy are performed.

The use of histamine H2-receptor blockers, proton pump inhibitors, and prostaglandin inhibitors is indicated. There is no specific antidote.

Special instructions

Ketonal can be washed down with milk or taken with antacids to reduce the frequency of gastrointestinal disorders (milk and antacids do not affect the absorption of ketoprofen).

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 exercise caution and monitor blood pressure more often when using ketoprofen for the treatment of patients with arterial hypertension, cardiovascular diseases that lead to fluid retention.

Like other NSAIDs, ketoprofen may mask the symptoms of infectious diseases.

Influence on the ability to drive motor vehicles and manage mechanisms

There are no data on the negative effect of Ketonal in the recommended doses on the ability to drive a car or work with mechanisms. At the same time, patients who report non-standard effects when taking Ketonal® should be careful when engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Capsules

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Ketoprofen

Conditions of release from pharmacies

By prescription

Dosage form

long-acting capsule