Microsoft word - ketocam tabs_pil_eng trans_rus.doc
For medical application of the preparation
KETOCAM® Registration number: Commercial name of the preparation: Ketocam® Medicinal form: film coated tablets Composition: Each film coated tablet contains:
Active substance: Ketorolac tromethamine 10.00 mg. Auxiliary substances: Microcrystallic cellulose 150.50mg, Maize starch (dry) 56.00mg, Magnesium stearate 1.00mg, Silicon colloidal dioxide 2.00mg. Coating composition: Universal coating* 8.00mg. *- composition of universal coating: Hypromel ose,Titanium Dioxide, Polyethylene Glycol, Talc. Description: Almost white, round, biconvex film coated tablets. Pharmacotherapeutic group: Non steroidal anti-inflammatory drug (NSAID). Code ATX: [M01 AB15] Pharmacological effect: Pharmacodynamics
Ketorolac includes expressed analgetic effect, possesses also
anti-inflammatory and moderate antipyretic effect.
Mechanism of effect is related to nonselective inhibition of
activity of enzyme of cyclooxygenase 1 and 2, principally in peripheral
tissues, as a result there appears biosynthesis of prostaglandins – modulators of pain sensitivity, thermoregulation and inflammation. Ketorolac represents itself a racemic mixture of [–]S and [+]R of enantiomers, in this regard anesthesia effect had caused [–]S form.
Preparation does not have effect on opioid receptors, does not
oppress breathing, does not cause drug dependency,does not possess sedative and anaxiolytic effect.
Put together analgesic effect with morphine, it significantly
After taking orally at the beginning of anesthesia effect it is
marked accordingly, after 1 hour, the maximum effect is achieved in 2-3 hours. Pharmacokinetics
When administered Ketorolac, it is wel absorved in the
gastrointestinal tract – maximum concentration (Cmax) in blood plasma (0.7-1.1 µg / ml) is achieved in 40 minutes after taking 10 mg of dose on an empty stomach. A fat rich –diet reduces the maximum concentration of drug in blood and prevents its movement for 1 hour.
99 % medicine is related to the blood plasm proteins and an
amount of free substance increases in blood with hypoalbuminemia.
Bioavailability 80 – 100%. Achievement period of equilibrium
concentration (Css) is 24 hours at oral administration, when it is prescribed 4 times in a day (above subtherapeutic) and it is 10 mg – 0.39 – 0.79 µg / ml after an oral intake.
The divided volume is 0.15 – 0.33 l / kg. The divided volume of
the medicine can be increased 2 twice in the patients with kidney failure, and its divided volume R-enantiomer – on 20 %.
It penetrates in breast milk: intake of 10 mg of ketorolac Cmax
in milk by mother is achieved in 2 hours after the first dose and keeps 7.3 mg/ml, in 2 hours after intake of the second dose of ketorolac (using the medicine 4 times in a day) is 7.9 ng / ml.
More than 50 % administered dose is metabolized in the liver
with the formation of pharmacologically inactive metabolites. Glucuronides are the principal metabolites, which are excreted by kidneys and r-hydroxyketrolac. There is excreted on 91 % by kidneys, 6 % - through intestine.
A period of halfexcretion (T 1/2) with normal functions of kidneys
in patients keeps in average 5.3 hours. T ½ increases in elderly
patients and shortens in the young. The function of liver does not bring effect on T ½. It keeps 10.3 – 10.8 hours, with more sever
kidney insufficiency – more than 13.6 hours in the patients with disorder of kidneys function at the concentration of creatinine in the plasm of 19-50 mg/l (168-442 mkmole/l) T ½.
Indication to application Pain syndrome of average and severe intensity of various origin: trauma, toothache, pain in the postpartum and post operative period, oncological diseases, myalgia, arthralgia, neuralgia, radiculitis, sprains, strains, rheumatic diseases. Prescribed for symptomatic therapy, reducing pain and inflammation at the time of use, it does not affect on the progress of the diseases. Contraindications
The increased sensitivity towards ketorolac or other non-
steroidal anti-inflammatory drugs,“aspirin”asthma, bronchospasm, angioedema, hypovolemia (regardless of its reasons), dihydration.
Erosive-ulcerous affected of gastrointestinal tract at the acute
stage, peptuic ulcer, hypocoagulation (including hymophilia).
Hepatic and/or kidney failure (creatinine plasms above 50 mg
Hemorrhagic stroke (approved or suspicious), hemorrhagic
diathesis, simultaneous intake with other NSAID, high risk of
development or recurrence of hemorrhage (including after operations), disorder of bleeding.
Pregnancy, childbirth and period of lactation. Child age upto 16 years(not established efficiency and safety). Medicine is not taken for anesthesia before and during surgery
because of high risk of bleeding, and also for the treatment of chronic pains.
With caution Bronchial asthma, availability of factore increasing gastro-
intestinal toxicity: alcoholism and tobacco smoking; cholecystitis, post-operation period, chronic cardiac failure, inflammatory syndrome, arterial hypertension; disorder of kidney’s function, (creatinine of plasma below 50 mg/l); cholestasis, active hepatitis, sepsis; systemic lupus red, simultaneous intake with other non steroidal anti-inflammatory drugs, coronary heart disease, cerebrovascular disease, dislipidemia / hyperlipidemia, diabetes, peripheral artery diseases, chronic renal insufficiency (creatanine clearance is 30-60 ml/min), ulcerative defects of gastro-intestinal tract in history, the availability of infection H.pylori, long term use of non-steroidal anti-inflammatory drugs, severe somatic diseases, simultaneous intake of oral glucocorticosteroids (including citalopram, fluoksetin, paroksetine, sertraline), old age (above 65 years), pregnancy.
Method of application and dose Ketorolac is taken once inside or repeatedly depending upon
The recommended dose is 20 mg to the paitents from 16 years
to 64, having body weight, exceeding 50 kg, at the first time, then 10 mg 4 times in a day, but not more than 40 mg / daily.
There is recommended dose of 10 mg at the first time and then
10 mg 4 times in a day to the adult paitents, having body weight less than 50 kg or with kidney failure.
Maximum daily dose is 40 mg. During intake the course of medicine should not be increased
Side effects Frequently – more than 3 %,not frequently – 1 – 3 %, rarely – Digestive system: frequently (especially in adult patients, older
than 65 years, having erosive-ulcerous affectated of gastrointestinal tract) – gastralgia, diarrhoea; less frequently - stomatitis, flatulence,constipation,vomiting, feeling of repletion; rarely – nausea, erosive-ulcerous affectd of gastrointestinal tract(including with perforation and / or bleeding – abdominal pain, spasm or burning senstation in the epigastric refion, melena, vomiting the type of “Coffee ground”, nausea, heartburn and others.), cholestatic jaundice, hepatitis, hepatomegaly, acute pancreatitis.
Urine system: rarely – acute kidney failure, pain in back with or
without hematuria and / or azotemia, hemolytic uremic syndrome (hemolytic anemia, kidney failure, thrombocytopenia, purpura), frequently urination, increase or decrease of urine in volume, nephritis, edema of renal original.
Organ feelings: rarely: hearing loss, tinnitus, (including blurring
Breathing syste: rarely: bronchospasm or dysponia. rhinitis,
larygenal edema(breathlessness, difficulty in breathing).
CNS: frequently – headache, dizziness, sleeplessness, rarely –
aseptic meningitis (fever, sever headache, spasm, stiffness in the muscles of neck and/or back), heperactivity (mood of changes, anxiety), hallucination, depression, psychosis.
Cardiac-vascular syste: less frequently – increase of AD, rarely
Organs hematopoiesis: rarely – anemia, eosinophilia,
Haemostasis system: rarely – bleeding from postoperative
Skin integuments: less frequently – skin rash (including makulo
popular rash), purpura, rarely - expholiative dermitet (fever with or without chil s, redness, tightening or exfoliation of skin, swel ing and/or sore tonsils), urticaria, Stevens-Johnson syndrome, lyell syndrome.
Local reactions: less frequently – burning or pain in local
Allergic reactions: rarely – hypersusceptibility or anaphylactoid
reactions(the change of face colour skin, skin rash, urticaria, skin itching, tachypnea or dyspenia, eyelid edema, periorbital edema, breathlessness, trouble in breathing, severity in the brest cell, wheezing).
Others: frequently – edemas (faces, shins, ankles, fingers,
steps, increasing body weight); less frequently – increased sweating, rarely – tongue edema, fever. `
Overdosage Symptoms: stomach pain, nausea, vomiting, erosive-ulcerous
affected of GIT, disorder of kidney’s function, metabolic acidosis.
Treatment: conducting symptomatic therapy (maintain vital
body functions). Dialysis – ineffective.
Interaction with other medicinal preparations Simultaneous administration of ketorolac with acetylsalicylic
acid or other nonsteroidal anti-inflammatory drugs, calcium drugs, glucocortiosteroidal, ethanol, corticotropine may bring to the formation of gastrointenstinal tract ulcers and development of gastro-intestinal bleedings.
Combined administraction with paracetamol increases
nephrotoxicity, with methotrexate – hepato – and nephrotoxicity. Combined administration of ketorolac and methotrexate are possible
only during use of the low doses of the latter (to control methotrexate concentration in the blood plasma).
Probenitsid reduces plasma clearance and the divided volume
of ketorolac, increases its concentration in the blood plasm and increases period of its semiejection.
On the background of ketorolac administration there may be
lowering of methotrexate clearance and lithium and strengthening toxicity of these substances.
Simultaneous administration increases the risk of the origin of
bleeding with indirect anticoagulatents, heparin, thrombolytic, antiagreganty, cefoperazone, cefotetan and pentoxyfylline.
It reduces effect of hypotensive and diuretic medicines
(prostaglandins synthesis is reduced in the kidneys).
In combination with opioid analgesics dose of the latter can be
Antacids do not bring effect on the completeness of drug
There is increased hypoglycaemic effect of insuline and oral
hypoglycaemic agents (required the recalculation of dose).
Combined administration with sodium valproate casues
aggregation disorder of blood platelet. It increases concentration of verapamil and nifedipine in the blood plasm.
During administration with other nephrotoxicin drugs (including
with gold drugs) there is increased the risk of development of nephrotoxicity. Drugs, blocking tubular secretion, reduce ketorolac clearance, and increase its concentration in the blood plasm.
Specific indications Before using drug it is necessary to clarify the question of
previous allergy to the drug or NSAID. The first dose regimen is given under the supervision of a physician because of the risk of development of allergic reactions.
Hypovolaemia increases the risk of development of nephrotoxic
If necessary it may be prescribed in combination with narcotic
Not recommended to administer as DRUGS for premedication,
In combination with other NSAID there may be observed
prevention of liquid, decompensation of cardiac activity, increase of
AD. The effect of aggregation of blood platelet is prevented after 24 – 48 hours. Not to be used simultaneously with paracetamol more than 5 days.
Prescribe patients with clotting disorder only under constant
control of blood platelet, especially it is important for the post operated patients, requiring careful control of hemostasis.
The risk of development of drug complications grows with the
lengthening of treatment (in the patients with chronic pains) and increase of oral dose of the drug more than 40 mg/daily.
There are prescribed antacids DRUGS, mysoprostol,
omeprazol for lowering the risk of NSAID development – gastropathy.
During treatment period it is necessary to follow precaution
when driving vehicles and other hazardous works activity potential y, requiring high concentration and quickness of psychomotor reactions.
For lowering the risk of development of nondesirable
phenomena from the GIT side it should be used the lowest effective dose of the lowest possible short-term course.
Presentation form 10 tablets in a blister. 1, 2 or 10 blisters along with the leaflet are kept in a carton pack for medical application. 10 carton packs are kept in a carton box. Storage conditions:
In a dry place,protected from light, at a temperature not more than 25º C. Keep in an inaccessible place for children. Shelf-life: 3 years. Do not use after expiry date indicated on the pack. Dispensing conditions: By prescription. RC Holder/Manufacturer: “Simpex Pharma Pvt. Ltd.”
B-4/160, Safdarjung Encl., New Delhi – 11 00 29, India Address of the manufacturing plant: Plant: Sec.-35, Begampur Khatola Ind. Area, Gurgaon – 122 001, India. Supplier: ZAO “CORAL-MED” 119571, Moscow, st. 26th Bakinskikh komissarov, h.9, off 62, tel.: (495) 935 -76 -65, Fax: (495) 434-44-31, Consumer’s complaints to be sent to ZAO “CORAL-MED”
SOGC TECHNICAL UPDATE SOGC TECHNICAL UPDATE The Use of Progesterone for Prevention of Preterm Birth represents an abstraction of the evidence rather than aThis technical update has been reviewed by the Maternal Fetalmethodological review. The level of evidence and quality ofMedicine Committee and approved by the Executive of the Societyrecommendations are described using the criteria
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