Oka granules for susp. 80mg / 2g 12 Pcs

Description

Composition
Active substance:
Ketoprofen lysine (ketoprofen lysine salt) 80 mg (equivalent to 50 mg ketoprofen).
Excipients:
1700 mg of mannitol, 132 mg of povidone, colloidal silicon dioxide 3 mg sodium chloride 20 mg sodium saccharinate 15 mg Ammonium glycyrrhizinate 20 mg, 30 mg peppermint flavor.
Description:
Pellets from white to pale yellow color with a characteristic odor of mint.
Product form:
Granules for oral solution 80 mg / 2 Years
2 g of the drug in the dual chamber sachet (1.0 g – in each screen) of three-layer material: low-density polyethylene (inner part), aluminum (intermediate portion), paper (outer part).
Bags 12 together with instructions for use placed into cardboard pack.
Contraindications
Hypersensitivity to the active substance and other ingredients, as well as other non-steroidal anti-inflammatory drugs.
Full or partial combination of asthma, recurrent nasal polyposis and paranasal sinuses and intolerance to acetylsalicylic acid or other NSAIDs (including history).
Erosive-ulcerous lesions of the gastrointestinal tract and duodenal ulcers (acute phase), active gastrointestinal, cerebrovascular or other bleeding, inflammatory bowel disease (ulcerative colitis, Crohn’s disease) (acute phase), hemophilia and other bleeding disorders, decompensated heart failure, since the aortocoronary bypass, severe hepatic impairment or active liver disease, severe renal impairment (creatine clearance and less than 30 ml / min), progressive renal disease, confirmed hyperkalemia, children (under 6 years), pregnancy (III trimester), lactation.
Carefully
Peptic ulcer and duodenal ulcer, ulcerative colitis, Crohn’s disease, liver disease (disorder), hepatic porphyria, chronic renal failure (creatinine clearance of 30-60 ml / min), chronic heart failure, arterial hypertension, a significant reduction in circulating blood volume ( including after surgery), elderly patients (including those receiving diuretics, debilitated patients with low body weight), bronchial asthma, concomitant use of corticosteroids (in chi le prednisolone), anticoagulants (including warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (including citalopram, fluoxetine, paroxetine, sertraline), coronary heart disease, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, the presence of Helicobacter pylori infection, long-term use of NSAIDs, tuberculosis, marked osteoporosis, alcoholism, severe somatic diseases, pregnancy (I, II trimester).
Indications
adults:
Symptomatic treatment of inflammatory processes of various origins, accompanied by pain syndrome, including:
– tendinitis, bursitis, myalgia, neuralgia, sciatica;
– headache;
– toothache;
– painful menstruation (algomenorrhea);
– post-traumatic and postoperative pain;
– for cancer pain syndrome;
– inflammatory and degenerative diseases of the musculoskeletal system:
– rheumatoid arthritis, seronegative arthritis, ankylosing spondylitis (Bechterew’s disease), gout, pseudogout, osteoarthritis, psoriatic arthritis, reactive arthritis (Reiter’s syndrome).
Children (over 6 years):
Short-term symptomatic treatment of inflammatory processes accompanied by pain in combination with heat or without him in diseases of supporting – motor apparatus, otitis.
Relief of postoperative pain.
The drug is intended for the symptomatic therapy reduce pain and inflammation at the time of use, does not affect the progression of the disease.
Interaction with other drugs
Combinations to be avoided • Corticosteroids: increased risk of ulcers and gastrointestinal bleeding.
• Anticoagulants (parenteral heparin, warfarin): increased risk of bleeding due to inhibition of platelet function and damage to the mucous membrane of the stomach and intestines. NSAIDs can enhance the effects of anticoagulants, such as warfarin.
• Antiplatelet drugs (clopidogrel, ticlopidine) and selective serotonin reuptake inhibitor: increased risk of bleeding,
induced inhibition of platelet aggregation and damage the mucous membrane of the stomach and intestines. Patients should be monitored, if the combined use can not be avoided.
• Other NSAIDs, including high doses of salicylates (> 3 g / day): concomitant several NSAIDs may increase the risk of ulcers and gastrointestinal bleeding due to synergistic effect.
• Lithium: NSAIDs increase in the plasma level of lithium (lithium decreases excretion in the kidney) that can reach toxic levels. This parameter is necessary to control the beginning of treatment, the regulation of the dose and after treatment discontinuation ketoprofen.
• Methotrexate in high doses (higher than 15 mg per week) increases hematotoxicity methotrexate, since it reduces the excretion by the kidneys, which occurs when taking anti-inflammatory drugs. When combined with methotrexate application at low doses (less than 15 mg per week) it is necessary to carry out complete blood count once a week during the first few weeks of treatment. Be sure to conduct more frequent monitoring of the clinical condition of the presence of even a slight deterioration in renal function, as well as in elderly patients.
• Hydantoin and sulphonamides: the toxic effects of these substances may be increased.
Combinations that require precautions • Diuretics, ACE inhibitors and angiotensin II: NSAIDs may reduce the effectiveness of diuretics and antihypertensive drugs. Patients with impaired renal function (e.g., patients with dehydration or elderly patients) concomitant ACE inhibitors or angiotensin II antagonists with drugs that inhibit cyclooxygenase system may cause additional impaired renal function, including acute renal failure, usually reversible.
Patients should be sufficiently hydrated, and after initiation of concomitant therapy is necessary to monitor renal function.
• Pentoxifylline: increased risk of bleeding. Be sure to conduct more frequent monitoring of the clinical condition and the control of blood clotting time.
• Zidovudine: increased risk of toxicity to red blood cells through the effects on reticulocytes with the emergence of severe anemia, a week after the NSAID treatment. It is necessary to conduct a complete blood count and reticulocyte count control once or twice a week after the start of NSAID treatment.
• Sulfonylurea: NSAIDs may enhance the effect of hypoglycemic sulfonylureas, reducing its association with plasma proteins.
Combinations to be taken into account:
• Beta-blockers: NSAIDs may reduce the antihypertensive effect of beta-blockers due to inhibition of prostaglandin synthesis.
• Tacrolimus and tacrolimus: NSAID nephrotoxicity may increase due to effects associated with prostaglandins kidneys. When the joint application must monitor renal function.
• Thrombolytics: increased risk of bleeding.
• Probenecid: the concentration of ketoprofen in plasma can be increased. This increase may be due to an inhibitory mechanism at the site of renal tubular secretion and glyukuronokonyugatsii and require dose adjustment of ketoprofen.
Overdose
overdoses doses up to 2.5 g of ketoprofen were reported. In most cases, the symptoms were limited to lethargy, drowsiness, nausea, vomiting and pain in the epigastric region.
Measures to assist in overdose
A specific antidote is not known. As in providing symptomatic measures vital signs (blood flow stabilization, alignment acidosis or resuscitation) shows the measures for reducing resorption and accelerating elimination (medical charcoal, diuresis).
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
It has anti-inflammatory, analgesic and antipyretic effect. Inhibiting cyclooxygenase type I and II, inhibits the synthesis of prostaglandins. Antibradikininovoy possesses activity stabilizes lysosomal membranes and inhibits the release of these enzymes that contribute to tissue destruction in chronic inflammation. It reduces the release of cytokines, inhibits the activity of neutrophils.
Reduce morning stiffness and swelling of joints, increases range of motion.
Ketoprofen lysine salt, unlike ketoprofen is rapidly dissolving molecule with a neutral pH and almost no irritation to the gastrointestinal tract
Pharmacokinetics:
Suction.
Assign inside, ketoprofen quickly and adequately absorbed from the gastrointestinal tract, its bioavailability is about 80%. Maximum plasma concentration at intake observed after 0.5-2 hours, its value is directly dependent on the dose. The equilibrium concentration of ketoprofen is reached 24 hours after the start of its regular intake.
Distribution.
Up to 99% of absorbed ketoprofen bound to plasma proteins, mainly albumin. The volume of distribution – 0.1-0.2 l / kg. Easily it passes through the blood-tissue barriers and distributed in the tissues and organs. Ketoprofen is well into the synovial fluid and connective tissue. While ketoprofen concentration in synovial fluid is somewhat lower than in the plasma, they are more stable (stored up to 30 hours).
Metabolism.
Ketoprofen is mainly metabolized by the liver, where it undergoes glucuronidation to form esters with glucuronic acid.
Withdrawal.
Metabolites are excreted by the kidneys. The drug is not cumulated.
Pregnancy and breast-feeding
In the third trimester of pregnancy, the use of ketoprofen is contraindicated.
In the first and second trimesters of pregnancy, use of the drug is only possible if the intended benefits to the mother outweighs the potential risk to the fetus.
The drug should not be used during breastfeeding
Conditions of supply of pharmacies
On prescription
side effects
According to the World Organization (WHO) undesirable effects are classified according to their frequency of as follows: very often (1/10), often (from 1/100 to
In connection with the use of ketoprofen the following side effects were noted.
Violations by the side of blood and lymphatic system
Rare: haemorrhagic anemia.
Frequency unknown: anemia, thrombocytopenic purpura, agranulocytosis, impaired bone marrow function, leykotsitopeniya, leukocytosis, inflammation of the lymphatic vessels, vasculitis.
Violations by the immune system
Frequency unknown: anaphylactic reactions (including anaphylactic shock).
Violations of the central nervous system and sensory organs
Uncommon: headache, dizziness, drowsiness.
Rare: paresthesia, blurred vision, tinnitus.
Frequency not known: convulsions, dysgeusia, mood changes, irritability, insomnia.
Cardio-vascular system
Frequency unknown: cardiac failure, tachycardia, palpitations, hypertension, hypotension, vasodilatation.
The respiratory system
Rare: asthma.
Frequency unknown: bronchospasm (particularly in patients with confirmed hypersensitivity to aspirin and other NSAIDs), rhinitis, dyspnea, edema, and spasm of the larynx.
From the digestive system
Common: nausea, vomiting, dyspepsia, abdominal pain.
Uncommon: constipation, diarrhea, bloating, gastritis.
Rare: stomatitis, gastric ulcer and duodenal ulcer, hepatitis, increased liver transaminases and increased serum bilirubin, caused by impaired hepatic function.
Frequency unknown: exacerbation of ulcerative colitis and Crohn’s disease, gastrointestinal bleeding, perforation, heartburn.
For the skin and subcutaneous fat
Uncommon: rash, pruritus.
Frequency unknown: photosensitivity reactions, alopecia, urticaria, angioneurotic edema, bullous skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell’s syndrome), erythema and rash, maculopapular rash, dermatitis.
From the urinary system
Frequency unknown: acute renal failure, tubulointerstitial nephritis and nephritic syndrome, abnormal values ​​of parameters of renal function.
other
Uncommon: edema, fatigue.
Unknown: allergic and anaphylactoid reactions, swelling of the mouth, periorbital edema.
In case of any side effects, stop taking the drug and seek medical advice
special instructions
Early treatment is necessary to monitor patterns of peripheral blood and functional state of the liver and kidneys.
After 2 weeks of drug application necessary to monitor liver function tests (transaminase levels).
Use of ketoprofen patients suffering from bronchial asthma, can lead to attacks of bronchial asthma.
If necessary, definition of 17-ketosteroids drug should be discontinued 48 hours before the study.
The preparation may modify the properties of platelets, but does not replace the preventive action of acetylsalicylic acid in cardiovascular diseases.
The drug may mask signs of infection.
Elderly patients, patients with ulcer history and in patients receiving low-dose aspirin or other drugs that may increase the risk of gastrointestinal reactions shown combined use of protective agents (misoprostol or proton pump inhibitors).
Use of the drug can impair female fertility and is not recommended for women planning pregnancy.
Use of the drug should be discontinued in women with problems of fertility or undergoing fertility study.
The drug has no effect on low-calorie diets and controlled and can be used in patients with diabetes mellitus.
The preparation does not contain gluten, so the drug is not contraindicated in patients with celiac disease.
The drug does not contain aspartame, and the drug can be used in patients with phenylketonuria.
Cardiovascular and cerebrovascular effects
Patients with hypertension and / or cardiac insufficiency moderate severity, accompanied by fluid retention and edema (disorder) associated with taking NSAIDs, careful monitoring and consultation.
Clinical trials and epidemiological data indicate that the use of certain NSAIDs (particularly at high doses for a prolonged time) may be associated with a small increase in the risk of arterial thrombotic events (e.g., myocardial infarction or stroke). Data to eliminate the above said risk of ketoprofen lysine salt insufficient.
Patients with uncontrolled hypertension, heart failure, ischemic heart disease installed, peripheral arterial disease and / or cerebrovascular diseases should be applied ketoprofen lysine salt only after careful examination. The same examination patients must undergo before long-term treatment with risk factors for cardiovascular diseases (e.g., hypertension, hyperlipidemia, diabetes, smoking).
Impact on the ability of management and road machinery
The drug has a limited and moderate influence on the ability to drive vehicles or machinery due to the possible occurrence of dizziness and drowsiness.
If after the drug is marked drowsiness, dizziness, or seizures, vehicles and management mechanisms should be avoided, as well as other activities that require concentration.
Storage conditions
At temperatures above 25 ° C.
Keep out of the reach of children
Dosing and Administration
adults:
Content 1 double sachet (full dose) dissolved in drinking half a glass of water and taken orally up to 3 times a day at meal time. To obtain a full dose (80 mg) to open the double bag along the line marked “full dose”.
Older patients physician sets the dose, it is desirable to decrease the dosage to 2 times.
Children (6 to 14 years):
Content 1/2 double sachet (half dose) is dissolved in half a glass of drinking water and taken orally up to 3 times a day at meal time.
For half dose (40 mg) to open the double bag along with the word “half-dose” line.
Children (from 14 to 18 years):
The dosage of the drug correspond to those in adults.
To reduce the risk of adverse effects from the gastrointestinal tract should use the lowest effective dose for the shortest possible course.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist