Ketorol 30 mg / ml 10s solution for injection in ampoules

The instruction for medical use


of Ketorol® medicine

the Trade name
of Ketorol®

the International unlicensed


name Ketorolak Lekarstvennaya a form
Solution for intramuscular introduction of 30 mg/ml 1 ml

Structure
of 1 ml of solution contains
active agent - ketorolak a trometamina of 30 mg
excipients: ethanol of 0.121 ml (it is equivalent to ethanol of anhydrous 0.115 ml), sodium chloride, dinatrium edetat, oktoksinol-9, sodium a hydrochloride, propylene glycol, water for injections.

Description
Transparent, colourless or light yellow liquid

Pharmacotherapeutic group
Non-steroidal anti-inflammatory drugs. Derivatives of acetic acid.
ATC M01AB15 code

Pharmacological

Pharmacokinetics At properties parenteral administration pharmacokinetics of a ketorolak of a trometamin linear. After intramuscular introduction of 30 mg of drug its maximum concentration in blood plasma is reached in 50 minutes. The bioavailability of a ketorol after intramuscular introduction is about 80 - 100%.
Кеторол® almost completely contacts proteins of plasma (& gt, 99%) at the expense of the small volume of distribution (& lt, 0.3 l/kg). Almost all substance circulating in blood plasma represents ketorolak (96%) or it pharmacological an inactive metabolite r-hydroksiketorolak. Drug passes through a placental barrier for 10%. In small concentration it is found in breast milk of women. Passes through a blood-brain barrier badly.
Drug is metabolized mainly in a liver, contacting glucuronic acid, and is removed by kidneys. In urine about 92% of the entered drug dose, and 40% - in the form of metabolites, 60% - in the form of not changed substance are found. About 6% of the entered dose are removed with a stake. Metabolites have no essential analgesic activity.
At patients of senile age (65 years are more senior) the elimination half-life of a terminal phase, in comparison with those at persons of young age, increases till 7 o'clock (from 4.3 to 8.6 hours). The general plasma clearance in comparison with persons of young age can be reduced on average to 0.019 l/hour/kg.
At defeat of function of kidneys the removal of a ketorolak slows down what lengthening of elimination half-life and decrease in the general plasma clearance in comparison with young healthy volunteers testifies to. Speed of elimination decreases approximately in proportion to degree of a renal failure, except for patients with a heavy renal failure. At such patients the plasma clearance of a ketorolak becomes slightly higher than the damage of kidneys expected for this degree.
A pharmacodynamics
of Ketorol® – the non-steroidal anti-inflammatory drug (NPVS) possessing soothing, anti-inflammatory action and febrifugal action. The main mechanism of action of a ketorol is shown in its pharmacological effect - inhibition of synthesis of prostaglandins. NPVS are most active on the periphery.
Кеторол® has no sedative or anxiolytic effect, does not influence opioid receptors. Кеторол® does not possess the oppressing action on a respiratory center and does not strengthen the respiratory depression and sedation caused by opioid analgetika. Кеторол® does not cause medicinal dependence. After sharp drug withdrawal the symptoms of cancellation do not arise.

Indications
- stopping of pains in the postoperative period (including in stomatology)
- stopping of pains in muscles and joints
- a posttraumatic pain syndrome
- renal colic



the Route of administration and doses
At patients are younger than 65 years a single dose makes 60 mg. The maximum single dose – 60 mg. The maximum daily dose should not exceed 120 mg. Therapy should not exceed 5 days.
At patients at the age of 65 years is also more senior and also at patients with impaired renal function and/or with body weight less than 50 kg the single recommended dose makes 30 mg. The maximum daily dose for these patients should not exceed 60 mg.
The soothing effect begins approximately in 30 minutes, the maximum effect reaches in 1 - 2 hour after intramuscular introduction. Duration of soothing effect is usually 4 - 6 hours. Intramuscular injections need to be entered slowly and deeply into a muscle.
It is necessary to carry out correction of a hypovolemia prior to treatment ketoroly.
Ketorol apply to treatment of the profound acute pain in which anesthesia at the level of opioid drugs, usually in the postoperative period is necessary.

Side effects
Often (more than 3%)
- a headache, dizziness, drowsiness
- edemas of face, shins, anklebones, fingers, a foot
- increase in body weight
- pains and discomfort in a stomach, anorexia, a constipation, diarrhea, dyspepsia, an eructation, a meteorism, nausea, vomiting, stomatitis, an esophagitis, exacerbation of a peptic ulcer of a stomach and duodenum
Less often (1 – 3%)
- skin rash, a purpura
- burning or pain in the injection site
- the increased perspiration
Seldom (less than 1%)
- an acute renal failure, a back pain with or without hamaturia and/or azotemias, a hemolytic uraemic syndrome (hemolytic anemia, a renal failure, thrombocytopenia, a purpura), frequent urination, increase or decrease in volume of urine, nephrite, swell renal genesis
- decrease in hearing, a ring in ears, a disorder of vision
- a bronchospasm or dispnoe, rhinitis, a laryngeal edema
- anemia, an eosinophilia, a leukopenia
- bleeding from a postoperative wound, nasal bleeding, rectal bleeding, gastrointestinal bleedings
- an anaphylaxis or anaphylactoid reactions (discoloration of face skin, skin rash, a small tortoiseshell, an itching of skin, a tachypnea, swell a century, periorbital swelled, an asthma, the complicated breath, weight in a thorax, goose breathing)
- aseptic meningitis (fever, a severe headache, spasms, muscle tension of a neck and/or back), hallucinations, a depression, psychosis
- exfoliative dermatitis (fever with a fever or without it, reddening, consolidation or peeling of skin, swelling and/or morbidity of palatine tonsils), a small tortoiseshell, Stephens-Johnson's syndrome, a Lyell's disease
- a paraglossa, fever.

Contraindications
- hypersensitivity to a ketorol, aspirin or to other NPVS
- aspirinovy asthma, a Quincke's disease
- a hypovolemia
- dehydration
- digestive tract erosive cankers
- round ulcers
- hypocoagulation, including hemophilia
- a liver, renal failure
- a hemorrhagic stroke
- bleedings, including after operation
- hemopoiesis disturbance
- before - and the operational period, because of high risk of bleeding
- chronic pains
- pregnancy and the period of a lactation
- children's and teenage age up to 16 years


the Simultaneous use of a ketorol with acetylsalicylic acid or other NPVS, calcium drugs, glucocorticoids, ethanol, corticotropin can lead Medicinal interactions to formation of ulcers of digestive tract and development of gastrointestinal bleedings.
Combined use with paracetamol increases nephrotoxicity, with a methotrexate – gepato- and nephrotoxicity. Co-administration of a ketorol and methotrexate is possible only when using low doses of the last.
Probenetsid reduces plasma clearance and volume of distribution of a ketorol, increases its concentration in blood plasma and extends elimination half-life twice. The concomitant use of a ketorol and a probenetsid is contraindicated.
At combination with opioid analgetics, doses of the last can be significantly reduced.
Hypoglycemic effect of insulin and oral hypoglycemic drugs increases.
Joint appointment with Valproatum of sodium causes disturbance of aggregation of thrombocytes.
Кеторол® increases concentration in blood plasma of verapamil and nifedipine.
When assigning with other nefrotoksichny medicines, including with gold drugs, risk of development of nephrotoxicity increases.
The medicines blocking canalicular secretion reduce clearance of a ketorol and increase its concentration in blood plasma.
Кеторол® slightly reduces linking of warfarin with proteins. At a concomitant use with furosemide ketorol reduces diuretic effect of furosemide approximately by 20%.
At a concomitant use of a ketorol with drugs of lithium the concentration of lithium in plasma at the expense of inhibition of clearance of lithium kidneys some NPVS increases.
At a concomitant use of a ketorol and not depolarizing muscular relaxants the patients have a short wind.
At reception with antiepileptic drugs (Phenytoinum, carbamazepine) the frequency of attacks amplifies. At a concomitant use with psychotropic drugs (fluoxetine, tiotiksin, to alprazola) patients have hallucinations.
Solution for injections should not be mixed in one syringe from morphine sulfate, promethazine and Hydroxyzinum because of loss of a deposit.
Co-administration of a ketorol and pentoksifillin can increase risk of developing bleedings.
At simultaneous use with furosemide ketorol reduces diuretic effect of furosemide approximately by 20% therefore patients with heart failure need to appoint drug with care.
At simultaneous use with APF inhibitors ketorol increases risk of a renal failure.

The special
instructions Ketorol® cannot be entered epiduralno and in covers of a spinal cord.
As NPVS reduce aggregation of thrombocytes, it is necessary to appoint ketorol with care the patient with disturbance of a coagulant system of blood.
Use for patients from the liver broken by function
At reception of a ketorol is possible increase in level of hepatic transaminases. Кеторол® it is necessary to appoint a short course of treatment the patient with liver diseases.
Use for patients with impaired renal function
of Ketorol® is appointed by the patient with impaired renal function with care under control of analyses of urine.
Use for patients of advanced age
At reception of a ketorol the side reactions at patients of advanced age meet more often, purpose of low doses of drug is necessary. The maximum doses should not exceed 60 mg for patients 65 years are more senior.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
As at patients when assigning a ketorol develop by-effects from the central nervous system (dizziness, drowsiness) and from sense bodys (decrease in hearing, a ring in ears, a disorder of vision), it is recommended to avoid performance of work, the requiring special attention and fast reaction.

Overdose
Symptoms: abdominal pains, nausea, vomiting, round ulcer of a stomach and duodenum, erosive gastritis, renal failure, metabolic acidosis.
Treatment: gastric lavage, administration of adsorbents (the coal activated), symptomatic treatment.

The form of release and packing
On 1 ml of drug spill in ampoules from glass of amber color. On an ampoule paste the label from paper self-adhesive.
On 10 ampoules place in blister strip packaging from a film of the polyvinylchloride and printing aluminum foil varnished.
On 10 blister strip packagings together with the instruction for medical use in the state and Russian languages place in a pack from cardboard bandbox.


To Store storage conditions in the place protected from light at a temperature not over 25 of 0C. To store in the places inaccessible for children!

Period of storage
3 years.
After an expiration date not to apply, specified on packing.

Prescription status
According to the prescription


Dr. of Reddi's Laboratoris Limited Producer
7-1-27 Amerpert, Hayderabad-500,016, India

the Name of the owner of the Registration certificate:
The Dr. of Reddi's Laboratoris Limited, India

the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
Representative office Dr. of Reddi's Laboratoris Limited in the Republic of Kazakhstan:
050057 Almaty, st. 22 lines, the 45th
post office box 7,
ph. 8 (727) 3941688
fax: 8 (727) 3941294

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