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Ketolac Dosage |
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Carefully consider the potential benefits and risks of Ketolac tablets and other treatment options before deciding to use Ketolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of IV or IM dosing of Ketolac and Ketolac tablets is not to exceed 5 days. In adults, the use of Ketolac tablets is only indicated as continuation therapy to IV or IM dosing of Ketolac.
Transition from IV or IM dosing of Ketolac (single- or multiple-dose) to multiple-dose Ketolac tablets:
Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Patients age ≥ 65, renally impaired, and/or weight < 50 kg (110 lbs): 10 mg PO once followed by 10 mg q4 to 6 hours prn not > 40 mg/day
Note:
Use minimum effective dose for the individual patient.
Do not shorten dosing interval of 4 to 6 hours.
Total duration of treatment in adult patients: the combined duration of use of IV or IM dosing of Ketolac and Ketolac tablets is not to exceed 5 days.
The following table summarizes Ketolac tablet dosing instructions in terms of age group:
Patient Population | Ketolac Tablets (following IV or IM dosing of Ketolac) |
Age < 17 years | Oral not approved |
Adult Age 17 to 64 years | 20 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day |
Adult Age ≥ 65 years, renally impaired, and/or weight < 50 kg | 10 mg once, then 10 mg q4 to 6 hours prn not > 40 mg/day |
Ask your doctor before using Ketolac if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.
Tell your doctor about all your current medicines and any you start or stop using, especially:
lithium;
methotrexate;
heparin or warfarin (Coumadin, Jantoven);
antipsychotic medicine;
heart or blood pressure medication, including a diuretic or "water pill";
seizure medicine (carbamazepine, phenytoin); or
steroid medicine (such as prednisone).
This list is not complete. Other drugs may interact with Ketolac, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Ketolac is highly bound to human plasma protein (mean 99.2%).
Warfarin, Digoxin, Salicylate, and Heparin
The in vitro binding of warfarin to plasma proteins is only slightly reduced by Ketolac (99.5% control vs 99.3%) when Ketolac plasma concentrations reach 5 to10 m g/mL. Ketolac does not alter digoxin protein binding. In vitro studies indicate that, at therapeutic concentrations of salicylate (300 m g/mL), the binding of Ketolac was reduced from approximately 99.2% to 97.5%, representing a potential twofold increase in unbound Ketolac plasma levels. Therapeutic concentrations of digoxin, warfarin, ibuprofen, naproxen, piroxicam, acetaminophen, phenytoin andtolbutamide did not alter Ketolac protein binding.
In a study involving 12 adult volunteers, TORADOLORAL was coadministered with a single dose of 25 mg warfarin, causing no significant changes in pharmacokinetics or pharmacodynamics of warfarin. In another study, TORADOLIV/IM was given with two doses of 5000 U of heparin to 11 healthy volunteers, resulting in a mean template bleeding time of 6.4 minutes (3.2 to 11.4 min) compared to a mean of 6.0 minutes (3.4 to 7.5 min) for heparin alone and 5.1 minutes (3.5 to 8.5 min) for placebo. Although these results do not indicate a significant interaction between TORADOL and warfarin or heparin, the administration of TORADOL to patients taking anticoagulants should be done extremely cautiously, and patients should be closely monitored.
Furosemide
TORADOLIV/IM reduced the diuretic response to furosemide in normovolemic healthy subjects by approximately 20% (mean sodium and urinary output decreased 17%).
Probenecid
Concomitant administration of TORADOLORAL and probenecid resulted in decreased clearance of Ketolac and significant increases in Ketolac plasma levels (total AUC increased approximately threefold from 5.4 to 17.8 m g/h/mL) and terminal half-life increased approximately twofold from 6.6 to 15.1 hours. Therefore, concomitant use of TORADOL and probenecid is contraindicated.
Lithium
Inhibition of renal lithium clearance, leading to an increase in plasma lithium concentration, has been reported with some prostaglandin synthesis-inhibiting drugs. The effect of TORADOL on plasma lithium has not been studied, but cases of increased lithium plasma levels during TORADOL therapy have been reported.
Methotrexate
Concomitant administration of methotrexate and some NSAIDs has been reported to reduce the clearance of methotrexate, enhancing the toxicity of methotrexate. The effect of TORADOL on methotrexate clearance has not been studied.
Nondepolarizing Muscle Relaxants
In postmarketing experience there have been reports of a possible interaction between TORADOLIV/IM and nondepolarizing muscle relaxants that resulted in apnea. The concurrent use of TORADOL with muscle relaxants has not been formally studied.
ACE Inhibitors
Concomitant use of ACE inhibitors may increase the risk of renal impairment, particularly in volume-depleted patients.
Antiepileptic Drugs
Sporadic cases of seizures have been reported during concomitant use of TORADOL and antiepileptic drugs (phenytoin, carbamazepine).
Psychoactive Drugs
Hallucinations have been reported when TORADOL was used in patients taking psychoactive drugs (fluoxetine, thiothixene, alprazolam).
Morphine
TORADOLIV/IM has been administered concurrently with morphine in several clinical trials of postoperative pain without evidence of adverse interactions. Do not mix TORADOL and morphine in the same syringe.
There is no evidence in animal or human studies that TORADOL induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs.
Users | % | ||
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3 times in a day | 1 | 50.0% | |
Once in a day | 1 | 50.0% |
Users | % | ||
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6-10mg | 1 | 33.3% | |
1-5mg | 1 | 33.3% | |
11-50mg | 1 | 33.3% |
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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