Ketolac (Ketolac) is a nonsteroidal anti-inflammatory drug (NSAID). Ketolac works by reducing hormones that cause inflammation and pain in the body.
Ketolac is used short-term (5 days or less) to treat moderate to severe pain.
Ketolac may also be used for purposes not listed in this medication guide.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Carefully consider the potential benefits and risks of Ketolac and other treatment options before deciding to use Ketolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketolac is indicated for the short-term (≤5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of Ketolac, and oral Ketolac is to be used only as continuation treatment, if necessary.
The total combined duration of use of Ketolac injection and oral Ketolac is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses. Patients should be switched to alternative analgesics as soon as possible, but Ketolac therapy is not to exceed 5 days.
Ketolac injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing effect. For breakthrough pain, it is recommended to supplement the lower end of the Ketolac injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketolac injection and narcotics should not be administered in the same syringe.
How should I use Ketolac?
Use Ketolac spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ketolac spray comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ketolac spray refilled.
Do not take Ketolac spray by mouth. Use in your nose only.
Before you use each bottle for the first time, you must prime it. Remove the clear plastic cover and the blue plastic safety clip. Hold the bottle at arm's length away from you. Using your index and middle fingers on the top of the bottle and your thumb on the bottom of the bottle, press down evenly and release the pump 5 times. The bottle is now ready to use.
To use this nose spray, gently blow your nose. Sit up straight or stand and tilt your head forward slightly. Place the tip of the spray container into the nose. Be sure to point the container away from the center of your nose. Breathe gently through the nostril and squeeze the spray container. If your dose requires 2 sprays, repeat the process for your other nostril. Replace the clear plastic cover after each use.
Do NOT use Ketolac spray for more than 5 days. Ketolac spray is not for the treatment of mild to moderate or chronic pain (eg, headache).
Avoid contact with the eyes. If you get Ketolac spray in your eyes, rinse it out with water. If eye irritation persists for more than 1 hour, contact your doctor.
Each bottle contains 1 day's supply of Ketolac spray. Discard each bottle within 24 hours of opening it, even if it still contains some unused medicine.
If you miss a dose of Ketolac spray and you are taking it regularly, take it as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Ketolac spray.
Uses of Ketolac in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Pain, moderate to moderately severe: Short-term (up to 5 days) management of moderate to moderately severe pain in adults that requires analgesia at the opioid level.
Off Label Uses
Data from a prospective, randomized, double-blind, double-dummy, placebo and active comparator, crossover, non-inferiority trial suggests that intranasal Ketolac may be beneficial for acute abortive treatment of migraine in patients with a history of episodic migraines for at least 1 year.
A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Ketolac is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
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
Oral formulation should not be given as an initial dose.
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:
Table 4: Summary of Dosing Instructions
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
Should be used with caution in patients undergoing anticoagulant therapy and use must be strictly monitored. Combination of Ketolac and other NSAIDs is not recommended because it would increase the risk of side effects.
Warfarin: Protein-binding of warfarin may be decreased slightly from 99.5-99.3%. It does not significantly change the pharmacokinetics or pharmacodynamics profile. Protein-binding of Ketolac does not change.
Heparin: Prolongs average bleeding time (placebo: 5.1 min; heparin: 6 min; heparin + Ketolac: 6.4 min).
Digoxin: Protein-binding of digoxin and Ketolac does not change.
Salicylate: Protein-binding of Ketolac was decreased from 99.2-97.5% which would represent a potential 2-fold increase in plasma concentrations of unbound drug.
Ibuprofen, Naproxen, Piroxicam, Acetaminophen, Phenytoin and Tolbutamide: Protein-binding does not change.
Probenecid: Results in decreased clearance of Ketolac and significant increases in Ketolac plasma levels (Total AUC increased ±3-folds from 5.4-17.8 mcg/hr/mL, terminal t½ increase of ±2-fold from 6.6-15.1 hrs. Concomitant use of Ketolac and probenecid is contraindicated.)
Lithium: Inhibition of renal lithium clearance leading to an increase in plasma lithium concentration.
Methotrexate: Methotrexate clearance is decreased, enhancing the toxicity of methotrexate. The effect of methotrexate on Ketolac clearance has not been studied.
Nondepolarizing Muscle Relaxants: Concomitant use of Ketolac and muscle relaxants has not been studied so it must be used with caution.
ACE Inhibitors: Renal impairment will be increased especially in volume-depleted patients.
Adverse reaction rates increase with higher doses of Ketolac (Ketolac). Practitioners should be alert for the severe complications of treatment with Ketolac (Ketolac), such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure. These NSAID-related complications can be serious in certain patients for whom Ketolac (Ketolac) is indicated, especially when the drug is used inappropriately.
In patients taking Ketolac (Ketolac) or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
Gastrointestinal (GI) experiences including:
GI ulcers (gastric/duodenal)
abnormal renal function
elevated liver enzymes
increased bleeding time
injection site pain
*Incidence greater than 10%
Additional adverse experiences reported occasionally ( < 1% in patients taking Ketolac (Ketolac) or other NSAIDs in clinical trials) include:
Ketolac is contraindicated in patients with previously demonstrated hypersensitivity to Ketolac.
Ketolac is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.
Ketolac should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.
Ketolac is contraindicated as prophylactic analgesic before any major surgery.
Ketolac is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Ketolac is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion.
Ketolac is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage.
Ketolac inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding.
Ketolac is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.
The concomitant use of Ketolac and probenecid is contraindicated.
The concomitant use of Ketolac and pentoxifylline is contraindicated.
Ketolac injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.
The results of a survey conducted on ndrugs.com for Ketolac are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ketolac. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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Information checked by Dr. Sachin Kumar, MD Pharmacology