Ketonal duo caps. with modif.vysv. 150mg 30 pieces

Description

Composition
Active substance:
1 capsule contains: Ketoprofen – 150,00 mg ;.
Excipients:
Microcrystalline Cellulose – 34.00 mg; lactose monohydrate – 20.00 mg; Povidone – 5.00 mg; Croscarmellose sodium – 10.00 mg; Polysorbate 80 – 1.00 mg; shell pellet1: Eudragit RS 30 D (ethyl acrylate, methyl methacrylate and copolymer trimetilammonioetilmetakrilata [1: 2: 0.1]) – 4.908 mg; Eudragit RL 30 D (ethyl acrylate, methyl methacrylate and copolymer trimetilammonioetilmetakrilata [1: 2: 0.2]) – 4.908 mg; triethyl citrate – 0,880 mg; polysorbate 80 – 0,008 mg; talc – 1,760 mg; iron (III) oxide yellow (E 172) – 0.080 mg; talk2 – 0,200 mg; kolloidnyy2 silicon dioxide – 0,200 mg; capsule capsule 1 L 970 / 53.051: 1 unit; gelatin – up to 100%; indigo carmine (E 132) – 0.4%; titanium dioxide (E 171) – 0.9%.
Description:
№ capsule 1 with a transparent body and blue cap. The contents of the capsule is a white and yellow pellets.
Product form:
Capsules with 150 mg of modified release
10 capsules in blister aluminum / PVC / TE / PVDC.
1, 2 or 3 blisters with instruction for use in a cardboard box.
Contraindications
Hypersensitivity to ketoprofen or other components of the drug as well as salicylates and other nonsteroidal anti-inflammatory drugs; complete or incomplete combination of asthma, recurrent nasal polyposis mucous membrane and paranasal sinuses and intolerance to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs) (including history); gastric ulcer or duodenal ulcer in the acute stage, ulcerative colitis, Crohn’s disease in the acute phase inflammatory bowel disease in the acute stage; hemophilia and other bleeding disorders; children’s age (15 years); severe hepatic failure; severe renal failure (creatinine clearance (CC) of less than 30 ml / min), progressive renal disease; decompensated heart failure; postoperative period after coronary artery bypass surgery; gastrointestinal, and other cerebrovascular bleeding (bleeding or suspected); lactase deficiency, lactose intolerance, glucose-galactose malabsorption; chronic dyspepsia; III of trimester of pregnancy; lactation.
Precautions: ulcer history, bronchial asthma history, symptomatic cardiovascular disease, cerebrovascular disease and peripheral arterial disease, dyslipidemia, progressive liver disease, hyperbilirubinemia, alcoholic cirrhosis, renal failure (creatinine clearance 30 – 60 ml / min) chronic heart failure, arterial hypertension, blood disorders, dehydration, diabetes, medical history of the development of ulcerative lesions of the gastrointestinal tract, smoking, with comorbid anticoagulation therapy (e.g. warfarin), antiplatelet agents (for example, acetylsalicylic acid), glucocorticosteroids for ingestion (e.g., prednisone), selective serotonin reuptake inhibitors (e.g., citalopram, sertraline), prolonged use of NSAIDs, the presence of Helicobacter pylori infection, hepatic failure, older age.
Indications
Symptomatic treatment 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; pain in cancer syndrome; algomenorrhea.
Interaction with other drugs
Ketoprofen may weaken the effect of diuretics and antihypertensives and potentiate hypoglycemic agents for oral and some anticonvulsants (phenytoin).
The simultaneous use of other NSAIDs, salicylates, glyukokorti- kosteroidami, ethanol increases the risk of adverse effects on the gastrointestinal tract.
The simultaneous use of anticoagulants (heparin, warfarin), thrombolytics, antiplatelet agents (ticlopidine, clopidogrel), pentoxifylline increases the risk of bleeding.
The simultaneous use of potassium salts, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, NSAIDs, low molecular weight heparin, cyclosporin, tacrolimus and trimethoprim increases the risk of hyperkalemia.
Increasing the concentration in the blood plasma of cardiac glycosides, blockers “slow” calcium channels, lithium drugs, cyclosporine, methotrexate and digoxin.
Increases the toxicity of methotrexate and cyclosporine nephrotoxicity.
The simultaneous use of probenecid significantly reduces the clearance of ketoprofen in plasma.
A combined reception with corticosteroids and other NSAIDs (including selective inhibitors TSOG2) increases the likelihood of side effects (in particular, from the gastrointestinal tract).
NSAIDs can reduce the effectiveness of mifepristone. NSAIDs should be started no earlier than 8-12 days after withdrawal of mifepristone.
Overdose
As with the other NSAIDs, ketoprofen overdose may experience nausea, vomiting, abdominal pain, vomiting of blood, melena, disturbance of consciousness, respiratory depression, convulsions, impaired kidney function and kidney failure.
In overdose shown gastric lavage, and the use of activated carbon.
Treatment – symptomatic; ketoprofen effect on the gastrointestinal tract (GIT) may be reduced using H2-blockers, histamine receptors, proton pump inhibitors and prostaglandins.
pharmachologic effect
Pharmacological group:
Nonsteroidal anti-inflammatory drug (NSAID).
Pharmacodynamics:
Ketoprofen is a non-steroidal anti-inflammatory drug. Ketoprofen has anti-inflammatory, analgesic and antipyretic action.
Ketoprofen blocks the action of the enzyme cyclooxygenase 1 and 2 (and TSOG1 TSOG2) and partially lipoxygenase, leading to the suppression of prostaglandin synthesis (including in the central nervous system, probably in the hypothalamus).
Stabilizes in vitro and in vivo liposomal membrane at high concentrations in vitro ketoprofen inhibits the synthesis of leukotrienes and bradykinin.
Ketoprofen has no negative impact on the status of the articular cartilage.
Pharmacokinetics:
Suction
Ketonal® DUO is a new dosage form that is different from conventional capsules way the release of active substance. Capsules c modified release comprise two types of pellets: white (about 60% of the total) and yellow (40% of the total, coated). Ketoprofen is rapidly released from the white pellets and slowly from yellow, which makes the combination of fast and long-acting drug.
The drug is well absorbed after oral administration. Bioavailability as a conventional capsule or capsule modified release same and amounts to 90%.
Food intake has no effect on overall bioavailability (AUC) of ketoprofen, but reduces the rate of absorption.
After oral administration of ketoprofen in the form of capsules with 150 mg of modified release maximum plasma concentration (Cmax) = 9036,64 ng / ml is reached within 1.76 hours.
Distribution
Ketoprofen is 99% bound to plasma proteins, mainly to albumin fraction.
The volume of distribution in tissues was 0.1-0.2 l / kg. The drug penetrates well into the synovial fluid and it reaches a concentration of 30% plasma. Significant concentration of ketoprofen in synovial fluid stable and maintained until 30 hours, resulting in a long time decreases pain and joint stiffness.
Metabolism and excretion
Ketoprofen undergoes extensive metabolism by means of microsomal liver enzymes half-life (T1 / 2) ketoprofen less than 2 hours. It binds to glucuronic acid and excreted as glucuronide. No active metabolites of ketoprofen.
To 80% ketoprofen excreted by the kidneys within 24 hours, mostly in the form of ketoprofen glucuronide. In applying the drug in a dosage of 100 mg or more renal excretion may be difficult. In patients with severe renal insufficiency, most of the drug is released through the intestines. When receiving high doses of hepatic clearance also increases. Through the intestine is output to 40% of the formulation.
Patients with liver failure plasma concentration of ketoprofen doubled (possibly due to hypoalbuminemia, and therefore a high level of unbound ketoprofen active); such patients should be the appointment of the drug in the minimum therapeutic dose.
In patients with renal insufficiency, the clearance of ketoprofen reduced, which also requires reducing the dosage.
Elderly patients metabolism and excretion of ketoprofen are slower, but it has clinical significance only for patients with reduced renal function.
Pregnancy and breast-feeding
Inhibition of prostaglandin synthesis may have an undesirable influence on the pregnancy and / or fetal development. The data obtained in epidemiological studies in the application of a prostaglandin synthesis inhibitor in early pregnancy, confirm an increased risk of spontaneous abortion and the formation of heart disease (~ 1-1.5%).
Prescribed the drug to pregnant women in I and II trimesters of pregnancy is possible only when the benefits to the mother justifies the potential risk to the fetus.
Contraindicated the use of ketoprofen in pregnant women during the III trimester of pregnancy due to the possibility of uterine weakness generic activities and / or premature closure of the ductus arteriosus, a possible increase in bleeding time, water scarcity, and renal failure.
To date, no data on the allocation of ketoprofen into breast milk, so the need for appointing ketoprofen nursing mothers should decide the issue of termination of breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
According to the World Health Organization (WHO), undesirable effects are classified according to their rate of development as follows: very common (> 1/10), common (> 1/100,
special instructions
Not to be combined with the reception of ketoprofen taking other NSAIDs and / or TSOG2 inhibitors. With prolonged use of NSAIDs is necessary to periodically evaluate the clinical analysis of blood, control kidney and liver function, especially in elderly patients (65 years), to analyze the fecal occult blood.
Care should be taken more frequently monitor blood pressure during application of ketoprofen to treat patients suffering from hypertension, cardiovascular diseases, which result in fluid retention.
In the event of violations of the organs of vision, treatment should be immediately discontinued.
Like other NSAIDs, ketoprofen may mask the symptoms of infectious-inflammatory diseases. In the event of evidence of infection or degradation being against application of the drug to immediately seek medical attention.
With a history of contraindications of the gastrointestinal tract (bleeding, perforation, ulcers), conducting long-term therapy and the use of high doses of ketoprofen patient should be under close medical supervision.
Due to the importance of prostaglandins in maintaining renal blood flow should be particularly careful in the appointment of ketoprofen in patients with cardiac or renal insufficiency as well as in the treatment of elderly patients taking diuretics, and patients who, for whatever reason, the decrease in the volume of circulating observed blood. Use of the drug should be discontinued prior to major surgery.
Use of ketoprofen can affect female fertility, so patients with infertility (including passing examination) is not recommended to use a preparation.
Information about the negative impact Ketonal® DUO at recommended doses on the ability to drive a car or operate machinery is not. When driving and busy with other potentially hazardous activities that require high concentration and psychomotor speed reactions, need to be careful, because the drug can cause dizziness and other side effects that may affect these abilities.
Storage conditions
In the dark place at a temperature not higher than 25 C.
In the reach of children.
Dosing and Administration
Inside.
DUO Ketonal® standard dose for adults and children over 15 years of age is 150 mg / day (1 capsule with a modified release). The capsules should be taken during or after eating, drinking water or milk (fluid volume must be not less than 100 ml).
The maximum dose of ketoprofen is 200 mg / day.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist