COMPOSITIONS :
Trolac® Film coated tablet 10 mg, each film coated tablet contains : Ketorolac trometamol 10 mg.
DESCRIPTIONS :
Trolac® contains Ketorolac trometamol as active ingredient available in 10 mg film coated tablet and 30 mg/ml injection.
INDICATIONS :
Short-term treatment of moderate post-operative pain.
DOSAGE AND ADMINISTRATIONS :
The recommended oral dose is 10 mg every 4 – 6 hours for pain as required. Doses exceeding 40 mg per day are not recommended. A longer dosing interval (6 – 8 hours) is advisable in the elderly. The lower end of the dosage range is recommended for patients over 65 years of age.
CONTRAINDICATIONS :
- Patients who have previously established allergy to Ketorolac trometamol.
- Because of the possibility of cross-sensitivity, Ketorolac trometamol is also contraindicated in patients who have an allergy to Acetosal or other NSAIDs that can trigger allergic reactions.
- Patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.
- Patients with advanced renal disorder or in patients have a risk for renal failure.
- Ketorolac trometamol is not recommended for pregnant women, during labour and birth.
- Ketorolac trometamol is not recommended for lactating woman.
- Patients with nasal polyps syndrome, angioedema or bronchospasm.
- Hypovolaemia caused by various causes, or patients who suffer dehydration.
- Patients who undergo a surgery with a high risk of haemorrhage and incomplete homeostasis.
- Patients with a prior history of Steven-Johnson syndrome.
- Ketorolac trometamol is contraindicated in epidural and intrathecal administration.
- Ketorolac trometamol is contraindicated in prophylactic administration before surgery when homeostasis is critical because of the increased risk of bleeding.
- Ketorolac trometamol is contraindicated for given children under 16 years.
- In newborns and birth, through the effects of prostaglandin synthesis inhibition. Ketorolac trometamol cause fetal circulation effects and inhibit the of uterine contractions, then increase the risk of uterine haemorrhage.
- Administration with ASA or NSAIDs, caused by cumulative risk of NSAID’s serious adverse effect induction.
- Suspected or confirmed cerebrovascular disease. Haemorrhagic diatheses including coagulant disease.
WARNINGS :
CARDIOVASCULAR EFFECTS
- Cardiovascular thrombotic events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increase risk of serious cardiovascular (CV) thrombotic events, myocardial infarction and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have similar risk. Patients with known CV disease or risk factor for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the sign and/or symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of Acetosal mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of Acetosal and NSAID does increase the risk of serious GI events (see WARNINGS, gastrointestinal (GI) effect – risk of GI ulceration, bleeding and perforation).
Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain the first 10 – 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS).
- Hypertension
NSAIDs, including Ketorolac trometamol can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking Thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including Ketorolac trometamol, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment with Ketorolac trometamol and throughout the course of therapy.
- Congestive heart failure and edema
Fluid retention and edema have been observed in some patients taking NSAIDs. Ketorolac trometamol should be used with caution in patients with fluid retention or hearts failure.
GASTROINTESTINAL (GI) EFFECTS
- Risk of GI ulceration, bleeding and perforation
NSAIDs, including Ketorolac trometamol, can cause serious gastrointestinal events, including inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop serious upper GI adverse events of NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3 – 6 months and in about 2 – 4% of patients treated for one year. These trends with longer duration of use, increasing the likelihood of developing a serious GI event at some time, during the course of therapy. However, even short-term therapy is not without risk.
NSAIDs should prescribed with extreme caution in patients with prior history of ulcer disease or gastrointestinal bleeding. Patients with prior history of ulcer disease and/or gastrointestinal bleeding and who use NSAIDs, have a greater than 10-fold higher risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral Corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age and poor general health status. Most spontaneous reports of fatal GI events are in the elderly or debilitated patients and therefore, special care should be taken in treating this population.
To minimize the potential risk for an adverse GI event, in patients treated with NSAIDs, the lowest effective dose should be used for the shortest possible duration. Physicians and patients should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.
PRECAUTIONS :
- As NSAID analgesic agent, Ketorolac trometamol can cause gastrointestinal irritation, ulcers, perforation or bleeding with or without previous symptoms. Ketorolac trometamol should be given under close supervision to patients with a history of gastrointestinal tract disease.
- Respiratory effects : Bronchospasm may be precipitated in patients with a history of asthma.
- Ketorolac trometamol should be administered with caution in patients with impaired renal function. Perform monitoring and dose reduction in patients with mild renal disorder.
- Ketorolac trometamol should be administered with caution in patients with blood coagulation disorder or were receiving drug therapy that affect homeostasis.
- Ketorolac trometamol should be administered with caution in patients with liver function disorder or patients with a history of liver disease.
- Ketorolac trometamol should be given with special attention to patients with cardiac disorder, hypertension and similar conditions.
- Patients over 65 years may have a greater risk of adverse effects than younger patients.
PRESENTATIONS :
Trolac® Film coated tablet 10 mg Box, 1 blisters @ 10 film coated tablets
Reg. No. DKL0802340817A1
STORAGE :
STORE BELOW 25°C AND DRY PLACE, PROTECT FROM LIGHT.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
PT. BERNOFARM
Sidoarjo – Indonesia
