Anti-Inflammatory (internal use and injection) / Musculoskeletal System / Painkillers / Painkillers and Antispasmodics

Ketotop® forte 20s 100 mg coated tablets

Brands: KhimPharm (Kazakhstan)

$10.20

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Ketotop® forte 20s 100 mg coated tablets quantity

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f80e3e676080

Brands:: KhimPharm (Kazakhstan)

Description

The instruction for medical use

of Ketotop® medicine forte

the Trade name
of Ketotop® forte

the International unlicensed

name Ketoprofen Dosage Form
of the Tablet, coated, 100 mg

Structure
One tablet contains
active agent – ketoprofen of 100.0 mg,
excipients: microcrystalline cellulose, potato starch, talc, povidone, sodium starch glikolit, silicon dioxide colloidal (aerosil), calcium stearate,
structure of a cover: gipromelloz (hydroksipropilmetiltsellyuloz), titan dioxide, triacetin.

Description
of the Tablet, coated, white or almost white color, biconvex.

Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs.
Propionic acid derivatives.
The code of automatic telephone exchange M01AE03

the Pharmacological

Pharmacokinetics At properties intake ketoprofen is quickly and rather fully soaked up from the digestive tract (DT), 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 — 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 bólshego time (6–8 h). It is metabolized in a liver by a glyukuronidation. It is removed mainly by kidneys — 80% during 24 h, mainly in the form of glucuronic derivative. Less than 10% are removed in not changed view with a stake. T1/2 — 2–4 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 forte 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 (TsOG-1 and TsOG-2) and blockade of E2 prostaglandin, and also slowing down of synthesis of bradykinin and stabilization of lizosomalny membranes. As a result the Ketotop forte reduces manifestations of inflammatory and degenerative diseases of the musculoskeletal system, in particular 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
by the Adult and to teenagers are more senior than 15 years
In an initiation of treatment drug is used in a shock dose of 300 mg a day. As the supporting treatment appoint 100 mg a day (on 1 tablet 2-3 times a day). The maximum single dose – 2 tablets.
The maximum daily dose – 3 tablets a day.
Duration of a course of treatment is determined by the attending physician.
The tablets Ketotop forte need to be taken after a meal, washing down with enough liquid.

Side effects
Often
– 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, fatigue
– a ring in ears, illegibility of sight
– increase in arterial blood pressure
– an edematous syndrome
– skin rash (including. erythematic), a small tortoiseshell, an itching of skin
– 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
– rhinitis, pharyngitis, dispnoe, a pneumorrhagia, a bronchospasm, probability
of an asthmatic attack
– exfoliative dermatitis, a Quincke’s disease, an acute anaphylaxis
– myalgias, muscular twitchings
– an asthma
– a photosensitization, an alopecia, eczema, purpuropodobny rash
– thrombosis, including 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
– a hallucination, a disorientation, disturbances of the speech
– a menometrorrhagia
– is described

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 at operation of aortocoronary shunting
– disturbances from the system of blood (leukopenia,
thrombocytopenia, disturbances of hemocoagulation)
– bronchial asthma (in the anamnesis)
– the profound abnormal liver functions and kidneys
– pregnancy, the lactation period
– children’s and teenage age up to 15 years

Medicinal interactions
At simultaneous use with diuretics and means for a lowering of arterial pressure, decrease in hypotensive effect is possible. The ketotop forte can increase efficiency of hypoglycemic means and antikonvulsant. The concomitant use forte with diuretics and inhibitors of angiotensin-converting enzyme leads the Ketotop to strengthening of nephrotoxic effect. The ketotop forte can increase toxicity of cardiac glycosides, drugs of lithium, a methotrexate and other tsitostatik, cyclosporine. Reception the Ketotop forte together with other NPVS is not recommended.
Ketoprofen can reduce efficiency of mifepristone. Reception nonsteroid anti-inflammatory 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 forte along with anticoagulants or corticosteroids need continuous monitoring.
The antiacid means or other medicines reducing acidity of gastric juice do not influence the speed and volume of absorption the Ketotop forte.

Special instructions
With care to appoint the Ketotop forte sick which in the anamnesis had gastrointestinal 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. When assigning the Ketotop forte it is necessary to control strictly a condition of patients with impaired renal function and a liver as deterioration in their state is possible. Reception forte can lead the Ketotop 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. When assigning the Ketotop is forte recommended monitoring of the general blood test, because of risk of developing thrombocytopenia, anemia and an agranulocytosis. 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 reception the Ketotop forte 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 forte 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 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On the 2nd blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.

To store storage conditions in the dry, protected from light place, at
a temperature not above 25 °C.
To store out of children’s reach!

The period of storage

not to use 4 years Drug after an expiration date.

Prescription status
According to the prescription

JSC Khimfarm Producer,
REPUBLIC OF KAZAKHSTAN, Shymkent, Rashidov St.,/N, ph.: 561342

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.,/N, ph.: 560882
Phone number 7252 (561342)
Fax number 7252 (561342)

to Develop the E-mail address of standart@santo.kz

Additional information