Universal reference book for medicines
Product name: BYSTRUMCAPS (BYSTRUMCAPS)

Active substance: ketoprofen

Type: NSAIDs

Manufacturer: MEDANA PHARMA (Poland) manufactured by VALPHARMA (Republic of San Marino)
Composition, form of production and packaging
Capsules of prolonged action
hard gelatinous, with a transparent case and a lid of white or white with a creamy shade of color, size 1;
the contents of the capsules are pellets of white or almost white color.
1 caps.

ketoprofen 200 mg

Excipients: Macrogol 4000, ethylcellulose, stearic acid, ammonium methacrylate copolymer, talc, neutral granules (sugar and corn starch (3: 1)).

The composition of the capsule shell: gelatin, titanium dioxide.

10 pieces.
- blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

NSAIDs from the group of propionic acid derivatives.
Has anti-inflammatory, analgesic, antipyretic effect. It inhibits the aggregation of platelets.
All of the above properties are a consequence of the reduction of prostaglandin synthesis, by a non-selective inhibition of the activity of COX-1 and COX-2.

PHARMACOKINETICS

Release of ketoprofen from granules with controlled release of the active substance occurs gradually in the digestive tract.

Suction

After oral administration ketoprofen is almost completely absorbed from the digestive tract, it has the effect of "first passage" through the liver.
C max in blood plasma is achieved 6-8 hours after ingestion of 200 mg of ketoprofen. Do not cum in the body. Eating does not affect the overall bioavailability of ketoprofen.
Distribution

Ketoprofen binds to plasma proteins by 99%.
Ketoprofen penetrates into the synovial fluid, where it reaches a higher concentration than in the plasma. In a small amount, it penetrates the placental barrier.
Metabolism and excretion

Metabolized by two main routes: by hydroxylation and by combining with glucuronic acid;
the latter is the main pathway of metabolism.
Less than 1% of the received dose of ketoprofen is found unchanged in urine, the rest are metabolites, of which 65-75% are metabolites of glucuronic acid.

It is excreted by the kidneys.
T 1/2 is about 8 hours. Within 5 days after taking 70-90% of the dose is excreted in the urine and 1-8% - with feces.
Pharmacokinetics in special clinical cases

In elderly patients, the elimination of ketoprofen decreases, and T 1/2 -
increases.
If the renal function T 1/2 increases, depending on the degree of renal dysfunction.

INDICATIONS

Diseases of the musculoskeletal system and pain syndrome of different genesis:

- symptomatic treatment of inflammatory-degenerative diseases of the musculoskeletal system (bursitis, synovitis, capsulitis, tendonitis, periarthritis);

- articular syndrome (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis) - for symptomatic therapy, pain and inflammation decrease at the time of use, the progression of the disease is not affected;

- Pain in the lower back and spine (neuralgia, myalgia, sciatica, lumbago);

- Post-traumatic pains (uncomplicated injuries, in particular sports, damage to ligaments and tendons, bruises);

- Postoperative pain;

- pain with dysmenorrhea.

DOSING MODE

Adults and adolescents over 15 years of age are prescribed 1 capsule (200 mg) 1 time / day during meals.

SIDE EFFECT

On the part of the digestive system: NSAIDs-gastropathy, heartburn, nausea, vomiting, diarrhea, constipation, flatulence, decreased appetite, stomatitis, abdominal pain and epigastric region, changes in transaminase activity;
rarely - a change in taste, hepatitis. With prolonged use in large doses - ulceration of the mucous membrane of the gastrointestinal tract, gingival, hemorrhoidal bleeding, intestinal perforation.
From the urinary system: rarely - cystitis, urethritis, renal dysfunction, acute renal failure, interstitial nephritis, nephrotic syndrome, hematuria, edema (especially in patients with arterial hypertension).

From the side of the nervous system: agitation, nervousness, drowsiness, depression, asthenia, headache, dizziness, sleep disturbance, insomnia, tinnitus;
rarely - confusion or loss of consciousness, forgetfulness, migraine, peripheral neuropathy.
From the cardiovascular system: heart failure, increased blood pressure;
rarely - tachycardia.
Allergic reactions: rhinitis, angioedema, anaphylactic shock, rash, itching, urticaria, asthmatic attack, especially in patients with hypersensitivity to acetylsalicylic acid, as well as to other drugs from the NSAID group.

Dermatological reactions: photosensitivity, alopecia, erythema multiforme, erythema multiforme exudative, incl.
Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome).
On the part of the organs of hematopoiesis: anemia, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia;
rarely - hemolytic anemia.
From the sense organs: reversible toxic amblyopia, vague vision or double vision;
rarely - conjunctivitis, dry eye mucosa, eye pain, conjunctival hyperemia, hearing loss.
Other: increased sweating;
rarely - hemoptysis, epistaxis, myalgia, muscle twitching, shortness of breath, thirst, with prolonged use in large doses - vaginal bleeding.
If any side effects occur, stop taking the medication immediately.

CONTRAINDICATIONS

- bronchial asthma, rhinitis or urticaria in history caused by ketoprofen, acetylsalicylic acid or other NSAIDs;

- Stomach ulcer and duodenal ulcer in the phase of exacerbation;

- ulcerative colitis in the phase of exacerbation;

- Crohn's disease;

- diverticulitis;

- peptic ulcer;

- hemophilia and other disorders of blood clotting;

- active gastrointestinal, cerebrovascular and other bleeding (or suspicion of bleeding);

- severe renal failure (CC less than 30 ml / min);

progressive kidney disease;

severe hepatic insufficiency or active liver disease;

- condition after aorto-coronary bypass surgery;

- confirmed hyperkalemia;

- Inflammatory bowel disease;

- children's age till 15 years;

- III trimester of pregnancy;

- lactation period;

- Hypersensitivity to ketoprofen, other NSAIDs or to any component of the drug.

With caution: anemia, bronchial asthma, alcoholism, tobacco smoking, alcoholic liver cirrhosis, hyperbilirubinemia, hepatic insufficiency, dehydration, sepsis, chronic heart failure, edema, arterial hypertension, blood diseases (including leukopenia), stomatitis, ischemic heart disease, cerebrovascular diseases, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, CC less than 60 ml / min, history of gastrointestinal lesions, presence of Helicobacter pylori infection, prolonged use of NSAIDs, severe somatic
(including prednisolone), anticoagulants (including warfarin), antiaggregants (including clopidogrel), selective inhibitors of serotonin reuptake (including citalopram, fluoxetine , paroxetine, sertraline), elderly age, pregnancy (I and II trimester).
PREGNANCY AND LACTATION

The drug is contraindicated in the third trimester of pregnancy and during lactation.

With caution should prescribe the drug in the I and II trimesters of pregnancy.

APPLICATION FOR FUNCTIONS OF THE LIVER

If the kidney and liver function is impaired, a dose reduction and careful monitoring is necessary.

During treatment, control of the functional state of the kidneys is necessary.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

With caution: alcoholic liver cirrhosis, hepatic insufficiency.

During treatment, it is necessary to monitor the functional state of the liver.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 15 years.

APPLICATION IN ELDERLY PATIENTS

With caution: the elderly.

SPECIAL INSTRUCTIONS

During treatment, it is necessary to monitor the picture of peripheral blood and the functional state of the liver and kidneys.

If it is necessary to determine 17-ketosteroids, the drug should be discontinued 48 hours before the test.

The use of ketoprofen can mask the signs of an infectious disease.

If the kidney and liver function is impaired, a dose reduction and careful monitoring is necessary.

To reduce the risk of developing adverse events from the gastrointestinal tract, the minimum effective dose should be used as short a course as possible.

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

OVERDOSE

In case of an overdose of ketoprofen, symptoms of acute poisoning may appear, such as: headache, dizziness, drowsiness, nausea, vomiting, diarrhea, epigastric pain, lowering blood pressure, bronchospasm, bleeding from the digestive tract.

Treatment: immediate discontinuation of the drug.
If no more than 1 hour has passed from an overdose of the drug, gastric lavage with activated charcoal in a dose of 60-100 g in adults, 1-2 g / kg of body weight in children. Conduct symptomatic therapy.
DRUG INTERACTION

When used simultaneously with
other NSAIDs (including salicylates in high doses), oral anticoagulants, heparin, ticlopidine increases the risk of bleeding. If ketoprofen is needed, careful monitoring of the patient's condition should be carried out.
With a simultaneous application with lithium, the toxic level of lithium in the plasma rises.
If necessary, during simultaneous use of lithium and ketoprofen preparations, and also after its termination, careful monitoring of lithium concentration in plasma should be made.
When used simultaneously with methotrexate (at a dose of more than 15 mg / week), the risk of hematotoxicity increases.
Intervals before and after taking methotrexate should be at least 12 hours from taking ketoprofen.
The drug enhances the effect of anticoagulants, antiaggregants, fibrinolytics, ethanol, side effects of GCS and ISS, estrogens.

Increases the concentration in the plasma of verapamil and nifedipine.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Reduces the hypotensive effect of beta-blockers.

Increases the risk of nephrotoxic effect of beta-blockers.

Increases the risk of nephrotoxic effect of cyclosporine and tacrolimus, especially in elderly patients.

Reduces the contraceptive effectiveness of intrauterine spirals.

Increases the risk of bleeding with thrombolytics.

With simultaneous use with diuretics and ACE inhibitors, it is possible to weaken diuretic and hypotensive effects and the risk of developing renal failure in patients with BCC deficiency.

When used simultaneously with pentoxifylline, the risk of bleeding increases.

With simultaneous use with zidovudin increases the risk of anemia (affects reticulocytes with the development of anemia).

With simultaneous use reduces the effectiveness of uricosuric drugs.

When used simultaneously with GCS, ethanol, corticotropin, the risk of ulceration and the development of gastrointestinal bleeding and the development of renal dysfunction increase.

With simultaneous use with cefoperazonom, cefamandol and cefotetan increases the risk of bleeding.

With simultaneous use increases the hypoglycemic effect of insulin and oral hypoglycemic drugs (dose recalculation is necessary).

With simultaneous application increases the production of hydroxylated active metabolites by inducers of microsomal oxidation in the liver (phenytoin, ethanol, barbiturates, rifampicin, phenylbutazone, tricyclic antidepressants).

With simultaneous use with sodium valproate, it disrupts the aggregation of platelets.

Antacids and colestyramine reduce the absorption of ketoprofen.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry, protected from light, out of reach of children at a temperature of 15 ° to 25 ° C.
Shelf life - 3 years.
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