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Product Line:

Anti-inflammatory and Pain Line

Patient Product Information

Formulation:
Coated Tablets 10 mg. Each coated tablet contains: ketorolac tromethamine 10 mg; Excipients  q.s; Coated Tablets 20 mg. Each coated tablet contains: ketorolac tromethamine 20 mg; Excipients  q.s

Therapeutical Action:
Analgesic – Non-steroidal anti-inflammatory drug.

Indications:
Oral Tablets: Short-term treatment of moderate to severe acute pain.
Sublingual and Parenteral Tablets: Short-term treatment of moderate to severe acute post-surgical pain.
Ketorolac is not indicated for the treatment of chronic pain.

Dosage and Administration:
Daily dosage should be adapted to the intensity of pain, with a maximum daily dose of 90 mg in adults y 60 mg in the geriatric population.
Tablets – Sublingual Tablets
The initial dose is 10 mg and the maintenance doses are from 10 to 20 mg every 6 hours, up to a maximum of 5 days of treatment.
Therapy for longer periods of time has been associated with an increase in the incidence of adverse effects. In all cases, the maximum indicated dose should be respected.
Sublingual tablets should not be chewed or swallowed. The tablets should be placed under the tongue and kept there for 5 minutes.
Injection
For intramuscular or endovenous use. In venoclysis, dilute 60 mg in 50 mL of physiological solution or 5% dextrose. The daily dose should be adapted to the intensity of pain, with a maximum daily dose of 90 mg in adults y 60 mg in the geriatric population.
The initial dose is 10 mg and subsequent doses are from 10 to 30 mg every 4 to 6 hours, up to a maximum of 2 days of treatment.
In the case of patients who have received ketorolac for injection and who are switched to tablets of 10 to 20 mg, the combined daily dose should not exceed 90 mg in adults and 60 mg in the geriatric population.

Contraindications
-    Hypersensibility to the active ingredient.
-    Pregnancy and lactation.
-    Patients under 16 years of age.
-    Due to the lack of enough clinical experience with ketorolac in patients older than 65 years, its use is contraindicated in this age group until more information about its safety is collected.
-    Severe hepatic or renal insufficiency.
-    Patients affected by hypovolemia or acute dehydration.
-    History of allergy to other nonsteroidal anti-inflammatory drugs, especially those in which aspirin or other prostaglandin synthesis inhibitors induce allergic reactions.
-    History of asthma, or partial or total syndrome of nasal polyps, angioedema, and bronchospasm.
-    Patients with hemorrhagic diathesis, bleeding risk, and suspected or confirmed gastrointestinal or cerebrovascular bleeding.
-    Gastroduodenal ulcerous disease or a history of stomach ulcer or digestive hemorrhage.
-    Concomitant treatment with lithium salts.

How-Supplied:
Coated Tablets 10 mg: Packages containing 20 coated tablets. Coated Tablets 20 mg: Packages containing 10 and 20 coated tablets.  Sublingual Tablets: Packages containing 10 sublingual tablets.  Injection 30 and 60 mg: Packages containing 3 ampoules.