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Treatment of moderate to severe pain
RAAM DE SAHUAYO, S.A. of C.V., LABORATORIES
Pharmaceutical form and formulation:
Each tablet contains:
Ketorolac tromethamine ……. 10 mg
Excipient ……………………. 1 tablet
Non-narcotic analgesic It is indicated in the short-term treatment of pain of moderate to severe intensity and
Different etiology. Postoperative pain, dental, traumatic.
Pharmacokinetics and pharmacodynamics in humans:
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug with analgesic activity.
low anti-inflammatory and anti-operative activity.
Ketorolac tromethamine is a member of the nonsteroidal anti-inflammatory drugs group. The chemical name of
Ketorolac tromethamine is pyroolizine-1-carboxylic acid (±) -5 benzyl-2,3-dihydro-1H,
2-amino-2- (hydro-methyl) -1.3. propane Ketorolac tromethamine is a racemic mixture of enantiomers (-) S
and (+) R, the first of which has analgesic activity.
Its mechanism of action is to inhibit the synthesis of prostaglandins and has no effect on the
In addition, it does not affect the central nervous system in animals and has no sedative or anxiolytic properties.
Ketorolac tromethamine is not an opioid and none of its effects have been described on central
opioids Intrinsic defects are missing during breathing and do not increase sedation or depression
Opioids related to the respiratory tract.
Absorption, distribution and elimination:Ketorolac tromethamine tablets are absorbed
rapid after oral administration to healthy young volunteers. After oral administration of a dose
10 mg fasting ketorolac tromethamine, the maximum plasma concentration (0.7 to 1.0 μg / ml) is
reached after 44 minutes on average. Plasma life is ranged from 5.3 to 6.1 hours
healthy and elderly patients, respectively.
Ketorolac tromethamine binds strongly to serum proteins (99%), liquid and organic tissues are distributed to
ratio of 0.15 to 0.33 kg. The main route of excretion of ketorolac tromethamine and its metabolites (conjugate and
para-hydroxy) is the kidney route, 91% is excreted in the urine and the rest in the stool. Ketorolac tromethamine penetrates
poorly the blood-brain barrier had levels lower than 0.002 of those in the plasma.
Like other NSAIDs, keto is contraindicated in patients with active peptic ulcer disease, haemorrhage
Recent digestion, recent gastrointestinal perforation or history of ulcer.
Gastroduodenal or digestive haemorrhage.
It is contraindicated in patients with moderate to severe renal impairment (serum creatinine> 442 mmol / l).
and in patients at risk of renal failure due to hypovolemia or dehydration.
Keto is contraindicated during childbirth.
Keto is contraindicated in patients with demonstrated hypersensitivity to ketoroloca or other NSAIDs, as well as to
patients with a history of allergy to acetylsalicylic acid or other inhibitors of
postaglandins, severe analphylactoid reactions have been described in these patients.
The combination of ketorolac and pentoxifylline is contraindicated. Do not administer to children after surgery.
Peptic ulcer, gastrointestinal bleeding and gastrointestinal perforation: You can hurt the
Gastrointestinal mucosa In patients treated with NSAIDs (including keto), they may occur at any time.
serious side effects of the digestive type, such as gastrointestinal irritation, gastrointestinal bleeding,
ulceration or perforation, sometimes without any previous symptoms.
Studies conducted to date with different NSAIDs have not allowed us to identify subgroups of patients.
no risk of peptic ulcer or gastrointestinal bleeding. The commercial experience gained with parenteral keto
and other NSAIDs indicate that the risk of ulceration, haemorrhage and perforation is greater
elderly and debilitated patients, who seem to tolerate these more serious side effects than others
Patients Most spontaneous reports of death due to undesirable digestive reactions
They occur in this population.
As with other NSAIDs, the incidence and severity of digestive complications increases as
They make the dose and the duration of the treatment with keto. The risk of serious gastrointestinal bleeding depends on the
dose. This is particularly true in the case of elderly people treated with average doses of keto over 60%.
mg / day The frequency of gastrointestinal complications during keto treatment is higher in patients.
patients with a history of peptic ulcer.
Effects on the kidneys: As with other NSAIDs, keto should be used with caution in patients with
renal insufficiency or a history of nephropathy because it is a potent inhibitor of the synthesis of
Prostagladins A renal toxicity with keto and other NSAIDs has been described in patients with diseases causing
hypovolemia and reduction of renal blood flow, in which the renal prostaglandins exert a function of
support to maintain renal perfusion. In these patients, the administration of keto or other NSAIDs may cause
a dose-dependent reduction in renal prostaglandin formation, sufficient to decompensate
the situation of renal failure. Patients at greatest risk of suffering from this complication are those who
kidney failure, hypovolemia, heart failure or hepatic dysfunction, as well as
patients on diuretic therapy and the elderly (see Contraindications). Renal function usually
return the previous sub-values after stopping keto (or other NSAID) treatment.
Anaphylactoid anaphylactoid reactions: Anaphylactic reactions may occur or
anaphylactoids (eg, anaphylaxis, bronchospasm, facial erythema, rash, hypotension, laryngeal edema, and angioedema),
in patients with a history of and no history of hypersensitivity to keto, acetylsalicylic acid or
other NSAIDs. These side effects may also occur in people with a history of angioedema,
bronchial hyperactivity (eg bronchial asthma) and nasal polyps. Anaphylactoid reactions, such as
anaphylaxis, can be fatal (see Contraindications). Therefore, keto should be used with caution
in patients with a history of bronchial asthma and in patients with partial or complete syndrome
nasal polyps, angioedema and bronchospasm.
Haemological effects: Keto inhibits platelet aggregation, decreases thromboxane concentration and prolongs
Bleeding time Contrary to the prolonged action of acetylsalicylic acid, platelet function comes back
at normal values within 24 to 48 hours after cessation of keto treatment.
Keto should be used with great caution and close monitoring in patients with bleeding disorders.
Although no significant interaction between the keto and warfarin or heparin has been demonstrated, it is possible that
the risk of bleeding increases if the keto is associated with other drugs acting on hemostasis, such as warfarin in
therapeutic doses, low dose prophylactic heparin (2500 to 5000 units every 12 hours) and dextrans.
In these cases, ceto should be used with great caution and close monitoring (see Drug Interactions).
and of another sex).
Post-surgical hematomas and other haemorrhages have been described in the post-marketing experience.
surgical wound related to the perioperative use of parenteral keto. Physicians need to keep this in mind.
risk of bleeding in situations where haemostasis is essential, such as resection of
prostate, tonsillectomy or cosmetic surgery (see Contraindications).
The elders: As with all NSAIDs and all medications in general, the risk of effects
High school is more important in the elderly than in patients under 65 years of age. With regard to characteristics
Pharmacokinetics, the terminal plasma half-life of ketorolac is longer in the elderly and clearance
Plasma, minor. It is recommended to place the dose in the lower part of the dose range.
d & # 39; habit
Water retention and edema: Cases of water retention, arterial hypertension and edema have been reported in patients treated with
should be administered with caution to patients with heart failure, hypertension or
Other cardiovascular diseases.
Ability to drive and use machines: Some patients may experience
drowsiness, dizziness, vertigo, insomnia or depression during keto treatment. In such cases, patients
They must take extreme precautions when performing activities that attract attention.
Caution should be exercised when probenecid is administered concomitantly as this drug may affect
the pharmacokinetics of ketorolac (see Drug Interactions and Other Sex).
Precautions should be taken when administering methotrexate concomitantly with certain inhibitors of
The synthesis of prostaglandins decreases the clarification of mextotrexate and may increase its toxicity (see
Drug Interactions and Other Sex).
Restrictions of use during pregnancy and
The keto administration during pregnancy and breastfeeding is not indicated.
It is not recommended in obstetric anelgesia.
Secondary and undesirable reactions:
Nausea, vomiting, constipation, diarrhea, flatulence, ulcer, peptic, gastrointestinal and renal bleeding, lelena,
edema, myalgia, weight gain, hypertension, purpura, somnolence, vertigo, headache,
dry mouth, kinship, depression, euphoria, insomnia and vertigo.
Drugs and other gender interactions:
Probenecid reduces the clearance of the keto, increases the plasma concentration and its half-life. furosemide
It reduces your diuretic response when administered concomitantly with ketorolac.
Concomitant administration of ketorolac and ACE inhibitors increases the risk of kidney damage.
Alterations in the test results of
Like other NSAIDs that inhibit prostaglandin synthesis, ketorolac increases serum levels.
of urea and creatinine.
Ketorolac may prolong bleeding time by inhibiting platelet aggregation. It can also
produce high liver function tests (GOT).
Precautions for carcinogenic effects
- Do not administer as a preparatory or obstetric analgesic.
- Do not administer more than 10
- Do not administer in children under 16 years.
Administer with caution and dose adjustment in elderly patients or with serum creatinine values between
1.9 to 5.0 mg / dl.
The administration of ketorolac may cause renal failure in patients with decreased circulating volume or
Clinical studies to date do not report carcinogenic, mutagenic or teratogenic potential
Dosage and route of administration:
Oral 1 tablet (10 mg) every 4 to 6 hours, not exceeding 40 mg per day.
MANIFESTATIONS AND MANAGEMENT OF OVERDOSES OR ACCIDENTAL INGESTION:
Consecutive administration of 360 mg for 5 days may cause abdominal pain or peptic ulcer
with cessation of treatment. Metabolic acidosis of intentional overdose of
ketorolac The treatment will be favorable with general measures.
Box with blister of 10 and 20 tablets (VP).
Store it at room temperature not exceeding 30 ° C and in a dry place.
Legends of protection:
His sale requires a prescription. Do not leave within the reach of children. Do not administer for more than 10 days. Literature
exclusively for doctors.
Laboratory and address:
Made in Mexico by: LABORATORIOS RAAM DE SAHUAYO, S.A. of C.V.
Offices: Quetzalcóatl n ° 385
Gardens of the sun
45050 Zapopan, Jalisco
Factory: Lázaro Cárdenas Boulevard No. 794 South
59000 Sahuayo, Michoacán
Register number 035M2007, SSA IV
BEAR-06330060102497 / R2007 / IPPA