Ketotop 20s 50 mg capsules
- $10.10
The instruction for medical use
of medicine
the Ketotop
A trade name
the Ketotop
the International unlicensed
name Ketoprofen Dosage Form
of the Capsule, 50 mg
Structure
One capsule contains
active agent ketoprofen
(in terms of 100% substance) 50.000 mg,
excipients: lactoses monohydrate, sodium laurisulfat, kopovidon (kollidon VA-64), silicon dioxide colloidal anhydrous, calcium stearate,
structure gelatin capsules: gelatin, titan dioxide (E 171).
Description
Solid gelatin capsules No. 2 of white color. Contents of capsules powder of white or almost white color.
Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs. Propionic acid derivatives. Ketoprofen.
The ATX M01AE03 code
The pharmacological
Pharmacokinetics At properties intake ketoprofen is soaked up quickly and rather fully, bioavailability about 90%. Cmax in blood is reached in 2-6 hours after intake. At a concomitant use with food the general bioavailability (AUC) does not change, but the speed of absorption slows down. Absorption is followed by effect of the first passing through a liver. Linking with proteins of blood plasma, mainly with albumine of 99%. Equilibrium concentration in plasma is reached in 24 h after the beginning of regular reception. Easily passes through gistogematichesky barriers and it is distributed in fabrics and bodies. Ketoprofen level in synovial fluid is lower, than in blood, but within therapeutic remains on an extent бó, lshy time (68 h). It is metabolized in a liver by a glyukuronidation. It is removed mainly by kidneys of 80% during 24 h, mainly in the form of glucuronic derivative. T1/2 24 h after intake. In a renal failure the removal slows down.
At elderly patients plasma and renal clearance are reduced, the size Cmax, AUC and untied fraction raise with increase in age (at women more, than at men).
The pharmacodynamics
the Ketotop belongs to group of non-steroidal anti-inflammatory drugs (NPVS) and has analgeziruyushchy, anti-inflammatory and febrifugal effect. The mechanism of action is connected with suppression of activity of cyclooxygenase (COG) and blockade of E2 prostaglandin, slowing down of synthesis of bradykinin and stabilization of lizosomalny membranes. As a result drug causes easing of a joint pain at the movement and at rest, reduction of morning constraint and a swelling of joints, promotes increase in volume of the movement.
Indications
- arthritises, including rheumatoid, psoriasis, reactive
(as a part of complex therapy)
- a spondylarthritis
- a tendinitis, a bursitis
- the neuralgia, myalgia and other diseases of the musculoskeletal system
which are followed by inflammation and a pain syndrome
the Route of administration and doses
accept the Ketotop of the capsule without chewing, washing down with enough water or milk (not less than 100 ml), at meal time or right after meal.
Capsules of 50 mg: appoint the adult on 1 capsule in the morning, during the lunchtime and in the evening.
The recommended dose at treatment of a pseudorheumatism 1 capsule each 6 hours. The maximum daily dose makes 200 mg.
In order to avoid undesirable side effects the patient can accept antiacid means along with Ketotop.
At patients with not heavy renal failure with clearance of creatinine is lower 20ml/mines and with a chronic disease of a liver (with the reduced level of albumine in blood serum) it is necessary to reduce a ketoprofen dose.
Duration of a course of treatment is determined by the attending physician.
Side effects
- nausea, vomiting, an abdominal pain, dyspepsia, formation of round ulcers
which can be complicated by development of bleedings up to fatal
- an abnormal liver function (with possible increase in level of transaminases), including jaundice, hepatitis
- a headache, dizziness
- insomnia, drowsiness, excitement, nervousness, a depression, an asthenia
- a ring in ears, illegibility of sight
- increase in arterial blood pressure
- an edematous syndrome
- skin rash (including erythematic), urticaria, an itching of skin, rhinitis, a Quincke's disease
- strengthening of sweating
Is rare
- change of taste, thirst
- confusion or a loss of consciousness, memory disturbance, migraine, peripheral neuropathy, paresthesias
- conjunctivitis, dryness of a mucous membrane of eyes, eye pain,
conjunctiva hyperaemia
- decrease in hearing
- stomatitis, a meteorism, an abdominal cavity pains, a constipation, diarrhea
- tachycardia, heart failure
- a leukopenia, an agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, a purpura
- a hamaturia, cystitis, an urethritis, a renal failure, interstitial
nephrite, a nephrotic syndrome
- a bronchospasm, pharyngitis, dispnoe, a pneumorrhagia, probability of an asthmatic attack
- exfoliative dermatitis, an acute anaphylaxis
- myalgias, muscular twitchings
- an asthma
- a photosensitization, an alopecia, eczema, purpuropodobny rash
- development of a myocardial infarction and stroke
- colitis, perforation of intestines, exacerbation of ulcer colitis or
Crohn's disease, an enteropathy with perforation, an ulceration or followed
by bleeding
- hallucinations, a disorientation, disturbances of the speech
- a menometrorrhagia
-
the Contraindication brain pseudoneoplasm case
- hypersensitivity to ketoprofen or other components
of drug, acetylsalicylic acid and other
non-steroidal anti-inflammatory drugs
- ulcer colitis, exacerbation of a peptic ulcer, gastritis, dyspepsia in
the anamnesis
- bleedings (in the anamnesis), including cerebrovascular
- heart failure in a decompensation stage
- perioperatsionny pain is described at operation of aortocoronary shunting
- disturbances from the system of a hemopoiesis (leukopenia, thrombocytopenia, disturbances of hemocoagulation)
- bronchial asthma (in the anamnesis)
- the profound abnormal liver functions and kidneys
- a hereditary lactose intolerance, deficiency of Lapp-lactases enzyme,
glucose galactose malabsorption
- pregnancy, the lactation period
- children's and teenage age up to 18 years
Medicinal interactions
At simultaneous use with diuretics and means for pressure decrease, decrease in hypotensive effect is possible. The ketotop can increase efficiency of hypoglycemic means and antikonvulsant.
The concomitant use of Ketotop with diuretics and inhibitors of angiotensin-converting enzyme leads to strengthening of nephrotoxic effect.
The ketotop can increase toxicity of cardiac glycosides, drugs of lithium, a methotrexate and other tsitostatik, cyclosporine.
Ketotop's reception together with other NPVS is not recommended.
The ketotop can reduce efficiency of mifepristone.
Intake of non-steroidal anti-inflammatory drugs needs to be begun not earlier than in 8-12 days after mifepristone cancellation.
Due to the increased risk of bleedings, the patients accepting the Ketotop along with anticoagulants or corticosteroids need continuous monitoring.
The antiacid means and other medicines reducing acidity of gastric juice do not influence the speed and volume of absorption of Ketotop.
Special instructions
With care to appoint the Ketotop sick which in the anamnesis had gastric bleedings or cankers of a GIT. It must be kept in mind that gastrointestinal bleedings can develop without the previous clinic and to be asymptomatic. At Ketotop's appointment it is necessary to control strictly a condition of patients with impaired renal function and a liver as deterioration in their state is possible.
Ketotop's reception can lead to aggravation of symptoms at patients with arterial hypertension, heart diseases and to cause development of peripheral hypostases.
Special observation is required for patients of advanced age as at these patients the development of side effects is possible.
At Ketotop's appointment the monitoring of the general blood test, because of risk of developing thrombocytopenia, anemia and an agranulocytosis is recommended.
For the period of therapy it is desirable to refuse smoking and alcohol intake.
Drug should not be used before surgical intervention. Use of ketoprofen can reduce fertility therefore Ketotop's reception is not recommended to the women planning pregnancy.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
In most cases, the Ketotop does not affect ability to run motor transport or difficult mechanisms, but there can sometimes be dizziness or drowsiness, in such cases it is better to refuse actions of the mental reactions demanding high speed.
Overdose
Symptoms: nausea, vomiting, pains in the field of epigastrium, extremely seldom, as a result of overdose, can develop gastrointestinal bleeding, confusion of consciousness.
Treatment: gastric lavage, reception of sorbents and symptomatic therapy.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On the 2nd blister strip packagings together with the approved instruction for medical use in the state and Russian languages place in a pack from cardboard.
Packs place in boxes of cardboard.
It is allowed planimetric packings (without investment in a pack from cardboard) to place in boxes of cardboard for a retail container. Put the approved instructions for medical use in each box in the state and Russian languages. The number of instructions put in group packing on number of packs.
To Store storage conditions in the dry, protected from light place, at
a temperature not higher than 25 S. Hranit out of children's reach!
4 years
not to use a period of storage after an expiration date.
Prescription status
According to the prescription
JSC Khimfarm Producer,
Republic of Kazakhstan, Shymkent, Rashidov St., 81, ph.: 560882
The owner of the registration certificate
of JSC Khimfarm, the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of JSC Khimfarm,
Shymkent, Republic of Kazakhstan, Rashidov St., 81, ph.: 560882
Phone number 7252 (561342)
Fax number 7252 (561342)
to Develop the E-mail address of standart@santo.kz
of medicine
the Ketotop
A trade name
the Ketotop
the International unlicensed
name Ketoprofen Dosage Form
of the Capsule, 50 mg
Structure
One capsule contains
active agent ketoprofen
(in terms of 100% substance) 50.000 mg,
excipients: lactoses monohydrate, sodium laurisulfat, kopovidon (kollidon VA-64), silicon dioxide colloidal anhydrous, calcium stearate,
structure gelatin capsules: gelatin, titan dioxide (E 171).
Description
Solid gelatin capsules No. 2 of white color. Contents of capsules powder of white or almost white color.
Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs. Propionic acid derivatives. Ketoprofen.
The ATX M01AE03 code
The pharmacological
Pharmacokinetics At properties intake ketoprofen is soaked up quickly and rather fully, bioavailability about 90%. Cmax in blood is reached in 2-6 hours after intake. At a concomitant use with food the general bioavailability (AUC) does not change, but the speed of absorption slows down. Absorption is followed by effect of the first passing through a liver. Linking with proteins of blood plasma, mainly with albumine of 99%. Equilibrium concentration in plasma is reached in 24 h after the beginning of regular reception. Easily passes through gistogematichesky barriers and it is distributed in fabrics and bodies. Ketoprofen level in synovial fluid is lower, than in blood, but within therapeutic remains on an extent бó, lshy time (68 h). It is metabolized in a liver by a glyukuronidation. It is removed mainly by kidneys of 80% during 24 h, mainly in the form of glucuronic derivative. T1/2 24 h after intake. In a renal failure the removal slows down.
At elderly patients plasma and renal clearance are reduced, the size Cmax, AUC and untied fraction raise with increase in age (at women more, than at men).
The pharmacodynamics
the Ketotop belongs to group of non-steroidal anti-inflammatory drugs (NPVS) and has analgeziruyushchy, anti-inflammatory and febrifugal effect. The mechanism of action is connected with suppression of activity of cyclooxygenase (COG) and blockade of E2 prostaglandin, slowing down of synthesis of bradykinin and stabilization of lizosomalny membranes. As a result drug causes easing of a joint pain at the movement and at rest, reduction of morning constraint and a swelling of joints, promotes increase in volume of the movement.
Indications
- arthritises, including rheumatoid, psoriasis, reactive
(as a part of complex therapy)
- a spondylarthritis
- a tendinitis, a bursitis
- the neuralgia, myalgia and other diseases of the musculoskeletal system
which are followed by inflammation and a pain syndrome
the Route of administration and doses
accept the Ketotop of the capsule without chewing, washing down with enough water or milk (not less than 100 ml), at meal time or right after meal.
Capsules of 50 mg: appoint the adult on 1 capsule in the morning, during the lunchtime and in the evening.
The recommended dose at treatment of a pseudorheumatism 1 capsule each 6 hours. The maximum daily dose makes 200 mg.
In order to avoid undesirable side effects the patient can accept antiacid means along with Ketotop.
At patients with not heavy renal failure with clearance of creatinine is lower 20ml/mines and with a chronic disease of a liver (with the reduced level of albumine in blood serum) it is necessary to reduce a ketoprofen dose.
Duration of a course of treatment is determined by the attending physician.
Side effects
- nausea, vomiting, an abdominal pain, dyspepsia, formation of round ulcers
which can be complicated by development of bleedings up to fatal
- an abnormal liver function (with possible increase in level of transaminases), including jaundice, hepatitis
- a headache, dizziness
- insomnia, drowsiness, excitement, nervousness, a depression, an asthenia
- a ring in ears, illegibility of sight
- increase in arterial blood pressure
- an edematous syndrome
- skin rash (including erythematic), urticaria, an itching of skin, rhinitis, a Quincke's disease
- strengthening of sweating
Is rare
- change of taste, thirst
- confusion or a loss of consciousness, memory disturbance, migraine, peripheral neuropathy, paresthesias
- conjunctivitis, dryness of a mucous membrane of eyes, eye pain,
conjunctiva hyperaemia
- decrease in hearing
- stomatitis, a meteorism, an abdominal cavity pains, a constipation, diarrhea
- tachycardia, heart failure
- a leukopenia, an agranulocytosis, anemia, hemolytic anemia, thrombocytopenia, a purpura
- a hamaturia, cystitis, an urethritis, a renal failure, interstitial
nephrite, a nephrotic syndrome
- a bronchospasm, pharyngitis, dispnoe, a pneumorrhagia, probability of an asthmatic attack
- exfoliative dermatitis, an acute anaphylaxis
- myalgias, muscular twitchings
- an asthma
- a photosensitization, an alopecia, eczema, purpuropodobny rash
- development of a myocardial infarction and stroke
- colitis, perforation of intestines, exacerbation of ulcer colitis or
Crohn's disease, an enteropathy with perforation, an ulceration or followed
by bleeding
- hallucinations, a disorientation, disturbances of the speech
- a menometrorrhagia
-
the Contraindication brain pseudoneoplasm case
- hypersensitivity to ketoprofen or other components
of drug, acetylsalicylic acid and other
non-steroidal anti-inflammatory drugs
- ulcer colitis, exacerbation of a peptic ulcer, gastritis, dyspepsia in
the anamnesis
- bleedings (in the anamnesis), including cerebrovascular
- heart failure in a decompensation stage
- perioperatsionny pain is described at operation of aortocoronary shunting
- disturbances from the system of a hemopoiesis (leukopenia, thrombocytopenia, disturbances of hemocoagulation)
- bronchial asthma (in the anamnesis)
- the profound abnormal liver functions and kidneys
- a hereditary lactose intolerance, deficiency of Lapp-lactases enzyme,
glucose galactose malabsorption
- pregnancy, the lactation period
- children's and teenage age up to 18 years
Medicinal interactions
At simultaneous use with diuretics and means for pressure decrease, decrease in hypotensive effect is possible. The ketotop can increase efficiency of hypoglycemic means and antikonvulsant.
The concomitant use of Ketotop with diuretics and inhibitors of angiotensin-converting enzyme leads to strengthening of nephrotoxic effect.
The ketotop can increase toxicity of cardiac glycosides, drugs of lithium, a methotrexate and other tsitostatik, cyclosporine.
Ketotop's reception together with other NPVS is not recommended.
The ketotop can reduce efficiency of mifepristone.
Intake of non-steroidal anti-inflammatory drugs needs to be begun not earlier than in 8-12 days after mifepristone cancellation.
Due to the increased risk of bleedings, the patients accepting the Ketotop along with anticoagulants or corticosteroids need continuous monitoring.
The antiacid means and other medicines reducing acidity of gastric juice do not influence the speed and volume of absorption of Ketotop.
Special instructions
With care to appoint the Ketotop sick which in the anamnesis had gastric bleedings or cankers of a GIT. It must be kept in mind that gastrointestinal bleedings can develop without the previous clinic and to be asymptomatic. At Ketotop's appointment it is necessary to control strictly a condition of patients with impaired renal function and a liver as deterioration in their state is possible.
Ketotop's reception can lead to aggravation of symptoms at patients with arterial hypertension, heart diseases and to cause development of peripheral hypostases.
Special observation is required for patients of advanced age as at these patients the development of side effects is possible.
At Ketotop's appointment the monitoring of the general blood test, because of risk of developing thrombocytopenia, anemia and an agranulocytosis is recommended.
For the period of therapy it is desirable to refuse smoking and alcohol intake.
Drug should not be used before surgical intervention. Use of ketoprofen can reduce fertility therefore Ketotop's reception is not recommended to the women planning pregnancy.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
In most cases, the Ketotop does not affect ability to run motor transport or difficult mechanisms, but there can sometimes be dizziness or drowsiness, in such cases it is better to refuse actions of the mental reactions demanding high speed.
Overdose
Symptoms: nausea, vomiting, pains in the field of epigastrium, extremely seldom, as a result of overdose, can develop gastrointestinal bleeding, confusion of consciousness.
Treatment: gastric lavage, reception of sorbents and symptomatic therapy.
A form of release and packing
On 10 capsules in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On the 2nd blister strip packagings together with the approved instruction for medical use in the state and Russian languages place in a pack from cardboard.
Packs place in boxes of cardboard.
It is allowed planimetric packings (without investment in a pack from cardboard) to place in boxes of cardboard for a retail container. Put the approved instructions for medical use in each box in the state and Russian languages. The number of instructions put in group packing on number of packs.
To Store storage conditions in the dry, protected from light place, at
a temperature not higher than 25 S. Hranit out of children's reach!
4 years
not to use a period of storage after an expiration date.
Prescription status
According to the prescription
JSC Khimfarm Producer,
Republic of Kazakhstan, Shymkent, Rashidov St., 81, ph.: 560882
The owner of the registration certificate
of JSC Khimfarm, the Republic of Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of JSC Khimfarm,
Shymkent, Republic of Kazakhstan, Rashidov St., 81, ph.: 560882
Phone number 7252 (561342)
Fax number 7252 (561342)
to Develop the E-mail address of standart@santo.kz
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