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Ketotop 100 mg / 2 ml 10s solution for injection in ampoules




The instruction for medical use

of Ketotop® medicine

the Trade name
of Ketotop®

the International unlicensed

name Ketoprofen Dosage Form Solution for injections of 100 mg / 2 ml

One ampoule contains
active agent – ketoprofen (in terms of 100% substance) 100.0 mg,
excipients: propylene glycol, ethanol, benzyl alcohol, sodium metabisulphite, sodium hydroxide, sodium hydroxide of 1 M solution, water for injections.

Transparent, colourless or slightly yellowish liquid

Pharmacotherapeutic group
Anti-inflammatory and antirheumatic drugs. Derivatives of propionic acid. Ketoprofen.
ATX M01AE03 code

the Pharmacological

Pharmacokinetics Maximum Concentration properties in blood plasma at intravenous administration is reached in 5 min., at intramuscular – in 15-30 min. Elimination half-life of ketoprofen from blood plasma later in/in introductions – 2 h.
Linking with proteins of blood plasma makes 99%. Equilibrium concentration in blood plasma and cerebrospinal fluid remains from 2 to 18 h.
Ketoprofen well gets into synovial fluid and connective tissues. Significant levels of concentration in synovial fluid are reached in 15 minutes after single intramuscular introduction of 100 mg of ketoprofen. Though concentration of ketoprofen in synovial fluid are slightly lower, than in blood plasma, they are more stable (remain till 30 o’clock) therefore the therapeutic effect of drug for longer time remains. It is removed mainly by kidneys and in much smaller degree through intestines.
A pharmacodynamics
of Ketotop® – the non-steroidal anti-inflammatory drug (NPVS) derivative of propionic acid. Кетотоп® has soothing, anti-inflammatory and febrifugal effect.
Influencing a cyclooxygenase and lipooksigenazny link of metabolism of arachidonic acid, drug inhibits synthesis of prostaglandins, leukotrienes and thromboxanes. Also stabilizes membranes of lysosomes, slows down release of lizosomalny enzymes, has antibradikininovy effect, interferes with aggregation of thrombocytes, causes considerable braking of activity of neutrophils in patients with a pseudorheumatism, reduces vascular permeability.
Possesses the significant analgeziruyushchy action. At an articulate syndrome weakens a joint pain at rest and at the movement, reduces morning constraint and a swelling of joints, promotes increase in volume of movements.

– inflammatory diseases of the musculoskeletal device (rheumatoid, psoriasis, gouty, juvenile chronic arthritises, an ankylosing spondylitis)
– degenerative diseases of the musculoskeletal system (the deforming osteoarthrosis, osteochondrosis)
– a lumbago, a sciatica, neuralgia, myalgia, a tendovaginitis, a bursitis
– the posttraumatic pain syndrome which is followed by inflammation
– postoperative pain, migraine, renal colic
– primary algodismenoreya, an adnexitis, a proctitis

the Route of administration and doses
the Recommended dose – on 100 mg (1 ampoule) of Ketotopa® intramusculary 1-2 times a day.
If necessary treatment can be complemented with use of oral or external dosage forms of Ketotopa®.
Intravenous infusion is appointed only in the conditions of a hospital.
100-200 mg of ketoprofen get divorced in 100 ml of 0.9% of solution of sodium of chloride. It is entered within not less than 30-60 minutes.
The maximum daily dose (including all dosage forms) should not exceed 200 mg of ketoprofen.
Duration of treatment is defined by the doctor, it is not recommended to continue treatment by the injection Ketotopa® form more than 3 days.
At patients with a 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.
At elderly patients the treatment of Ketotopom® should be begun with a low dose of ketoprofen and to carry out the supporting treatment by a drug minimal effective dose.

It is impossible to mix prevention tramadol and ketoprofen rolled into one as the deposit is formed. Bottles for infusion have to be wrapped in black paper or aluminum foil as ketoprofen is sensitive to light.

Side effects
At assessment of frequency of emergence of different side reactions were used such gradation:
‘very often’ – ³ 10%
are ‘frequent’ – from ³ 1% to & lt, 10%
‘infrequently’ – from ³ 0.1% to & lt, 1%
is ‘rare’ – from ³ 0.01% to & lt, 0.1%
is ‘very rare’ – & lt, 0.01%.
– dispeptic phenomena, loss of appetite, nausea, vomiting, meteorism, abdominal pains, constipation
– diarrhea, gastritis
– a headache, dizziness, drowsiness
– skin rash
– puffiness, pain and burning sensation in the place of an injection
It is rare:
– hemorrhagic anemia, a leukopenia
– a depression, insomnia, nervousness, paresthesia
– deterioration in sight
– sonitus
– stomatitis, ulcer of stomach and duodenum
– hepatitis, increase in level of transaminases and bilirubin
– increase in body weight
– an acute anaphylaxis
– a bronchospasm, an attack of bronchial asthma
Very seldom:
– exacerbation of colitis and Crohn’s disease, gastrointestinal bleedings
– an abnormal liver function
– an acute renal failure, tubulointerstitsialny nephrite
– a hypernatremia, a hyperpotassemia
– an agranulocytosis, thrombocytopenia
– spasms
– heart failure
– arterial hypertension
– rhinitis
– a photosensitization, a Quincke’s edema, bullous rash, including Stephens-Johnson’s syndrome, a toxic epidermal necrolysis

of the Contraindication
– individual hypersensitivity to ketoprofen, aspirin or other non-steroidal anti-inflammatory drug (instructions in the anamnesis on asthma, a bronchospasm, urticaria or rhinitis connected with intake of acetylsalicylic acid)
– heavy heart failure
– digestive tract diseases in an aggravation phase (gastritis, a peptic ulcer of a stomach, the instruction in the anamnesis on gastrointestinal bleedings, education or a perforation of ulcers)
– bleedings (gastrointestinal, cerebrovascular or other active bleedings)
– tendency to bleedings
– the significant disturbances of functions of a liver or kidneys
– disturbances from blood (leukopenia, thrombocytopenia, disturbances of hemocoagulation)
– bronchial asthma, rhinitis
– pregnancy and the period of a lactation
– children’s age up to 15 years.

Medicinal interactions
Forces out medicines from communication with proteins of blood plasma. Weakens effect of diuretics. At co-administration of Ketotopa® and loopback diuretics the nephrotoxic effect of both
drugs amplifies.
Exponentiates effect of anticoagulants. At simultaneous use of Ketotop® and warfarin or salts of lithium the patients have to be under strict observation of the doctor (increase in concentration of lithium in blood plasma before its renal excretion, toxic at the expense of decrease).
Increases concentration in methotrexate blood (strengthening of its side effect). In order to avoid a deposit it is not necessary to mix rolled into one Ketotop® and tramadol.
Кетотоп® can reduce effect of antihypertensive drugs (beta blockers, APF inhibitors, diuretics) and to strengthen effect of oral gipoglikemiziruyushchy drugs – sulphonylurea derivatives.

Special instructions
It is necessary to avoid simultaneous use of Ketotopa® of solution for injections with other non-steroidal anti-inflammatory drugs, including selection TsOG-2 inhibitors.
With extra care patients should appoint drug with digestive tract diseases in the anamnesis (bleeding and perforation can suddenly develop without the previous symptoms).
It is necessary to be careful also at the patients taking medicine which can increase risk of formation of ulcers or bleeding, such as corticosteroids of oral introduction, anticoagulants (for example warfarin), selective serotonin reuptake inhibitors or antiagregantny means (including acetylsalicylic acid). The risk of developing of gastrointestinal bleeding, formation or perforation of ulcers increases with increase in doses of non-steroidal anti-inflammatory drugs. In such cases it is necessary to consider combination therapy with the drugs having protective effect on digestive tract (for example, mizoprostol or inhibitors of a protonew pomp).
Patients with digestive tract diseases (especially to elderly people) should report to the attending physician about any abdominal manifestations.
In case of developing of gastrointestinal bleeding or ulceration of digestive tract, it is necessary to stop treatment immediately.
Careful observation of patients with arterial hypertension and/or stagnant heart failure as there are messages about development or strengthening of a delay of liquid in an organism during therapy by ketoprofen is necessary.
During treatment, ketoprofen recommends monitoring of arterial blood pressure, especially at patients with cardiovascular diseases.
Patients with uncontrollable arterial hypertension, acute and heavy chronic heart failure, coronary heart disease, diseases peripheral arteries and/or cerebrovascular diseases should carry out treatment by ketoprofen with care. Use of some non-steroidal anti-inflammatory drugs can be connected with risk of developing arterial thromboses (myocardial infarction, a stroke). Data for an exception of such risk for ketoprofen are not enough.
At patients with asthma, with chronic rhinitis, chronic sinusitis and/or a nasal polipoz, emergence of allergic reactions is possible more often than at other patients.
It is also necessary to be careful at patients with disturbances of a hemostasis, hemophilia, an angiohemophilia – Jürgens, heavy thrombocytopenia, a renal or liver failure and at those patients who accept anticoagulants (coumarin and derivatives of heparin, first of all heparins of low molecular weight).
In an initiation of treatment it is necessary to carry out careful monitoring of renal function at patients with heart failure, cirrhosis and a nephrosis, at the patients accepting diuretics at patients with chronic kidney disease, especially if the patient at advanced age. Intake of ketoprofen can cause decrease in a renal blood-groove as a result of inhibition of prostaglandin in such patients and lead to a renal decompensation.
If during treatment visual disturbances are observed, treatment should be stopped.
Treatment by ketoprofen should be stopped before performing radical surgical interventions.
Кетотоп® it is possible to apply in combination with morphine derivatives if pain is serious.
Intake of ketoprofen can worsen female fertility and is not recommended for women who want to become pregnant.
This medicine contains ethanol of 12.3% (in / c). Each dose of 2 ml contains 0.2 g of ethanol.
With care people of advanced age should appoint drug.
Long courses of therapy by non-steroidal anti-inflammatory drugs, including ketoprofen, demand monitoring of hematologic indicators, indicators of function of a liver and kidneys, in particular from elderly patients and if the clearance of creatinine at the patient below 0:33 ml / with (20 ml/min.), is required ketoprofen dose adjustment.
The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
in case of developing of dizziness, a spatial disorientation, drowsiness, out-of-focus sight or spasms should not conduct transport or to operate potentially dangerous mechanisms.

Symptoms: strengthening of side effects.
Treatment: symptomatic. Specific antidote does not exist.

The form of release and packing
On 2.0 ml spill in ampoules of spray filling of light-protective glass with a point or a ring of a break.
On each ampoule paste the label from paper label or writing.
On 5 ampoules pack into blister strip packaging from a film of polyvinylchloride and aluminum foil.
Blister strip packagings together with the approved iinstruktion on medical use in the state and Russian languages place in boxes of cardboard for a retail container or corrugated.
On 2 blister strip packagings together with the approved instruction for medical use in the state and Russian languages place in a pack from cardboard.
It is allowed information from the approved instruction for medical use in the state and Russian languages to apply on a pack.
Packs with medicine place in boxes of cardboard for a retail container or corrugated.
It is allowed blister strip packagings (without investment in a pack) together with the approved iinstruktion on medical use in the state and Russian languages to place in boxes of cardboard for a retail container or corrugated.

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!

3 years
not to use a period of storage after an expiration date.

Prescription status
According to the prescription

the Name and the country
of the JSC Khimfarm manufacturing organization,
Republic of Kazakhstan, Shymkent, Rashidov St., 81

the Name and the country of 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, Republic of Kazakhstan, Shymkent, Rashidov St., 81 Phone number 7252 (561342) Fax number 7252 (561342)

to Develop the E-mail address of

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