Ketoracin (Ketoracin) is a nonsteroidal anti-inflammatory drug (NSAID). Ketoracin works by reducing hormones that cause inflammation and pain in the body.
Ketoracin is used short-term (5 days or less) to treat moderate to severe pain.
Ketoracin may also be used for purposes not listed in this medication guide.
Ketoracin indications
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.
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Carefully consider the potential benefits and risks of Ketoracin Tromethamine and other treatment options before deciding to use Ketoracin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
Acute Pain in Adult Patients
Ketoracin Tromethamine 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 Ketoracin Tromethamine, and oral Ketoracin Tromethamine is to be used only as continuation treatment, if necessary.
The total combined duration of use of Ketoracin Tromethamine injection and oral Ketoracin Tromethamine 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 Ketoracin Tromethamine therapy is not to exceed 5 days.
Ketoracin Tromethamine 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 Ketoracin Tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketoracin Tromethamine injection and narcotics should not be administered in the same syringe.
How should I use Ketoracin?
Use Ketoracin spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ketoracin spray comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ketoracin spray refilled.
Do not take Ketoracin 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 Ketoracin spray for more than 5 days. Ketoracin spray is not for the treatment of mild to moderate or chronic pain (eg, headache).
Avoid contact with the eyes. If you get Ketoracin 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 Ketoracin spray. Discard each bottle within 24 hours of opening it, even if it still contains some unused medicine.
If you miss a dose of Ketoracin 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 Ketoracin spray.
Uses of Ketoracin 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.
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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
Migraine
Data from a prospective, randomized, double-blind, double-dummy, placebo and active comparator, crossover, non-inferiority trial suggests that intranasal Ketoracin may be beneficial for acute abortive treatment of migraine in patients with a history of episodic migraines for at least 1 year.
Ketoracin description
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. Ketoracin 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)
Ketoracin dosage
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Carefully consider the potential benefits and risks of Ketoracin tromethamine tablets and other treatment options before deciding to use Ketoracin tromethamine 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 Ketoracin tromethamine and Ketoracin tromethamine tablets is not to exceed 5 days. In adults, the use of Ketoracin tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of Ketoracin tromethamine.
Transition from IV or IM dosing of Ketoracin tromethamine (single- or multiple-dose) to multiple-dose Ketoracin tromethamine 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:
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 Ketoracin tromethamine and Ketoracin tromethamine tablets is not to exceed 5 days.
The following table summarizes Ketoracin tromethamine tablet dosing instructions in terms of age group:
Table 4: Summary of Dosing Instructions
Patient Population
Ketoracin Tromethamine Tablets (following IV or IM dosing of Ketoracin tromethamine)
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 Ketoracin tromethamine 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 Ketoracin does not change.
Heparin: Prolongs average bleeding time (placebo: 5.1 min; heparin: 6 min; heparin + Ketoracin: 6.4 min).
Digoxin: Protein-binding of digoxin and Ketoracin does not change.
Salicylate: Protein-binding of Ketoracin 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 Ketoracin and significant increases in Ketoracin 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 Ketoracin 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 Ketoracin clearance has not been studied.
Nondepolarizing Muscle Relaxants: Concomitant use of Ketoracin 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.
Morphine: No detrimental interactions are observed. Do not mix Ketoracin and morphine in the same syringe.
There are no reports of interactions between Ketoracin and antibacterials, antiemetics, laxatives, sedative, anxiolytics, corticosteroids, bronchodilators or hormones.
No evidence (in animal or human studies) shows that Ketoracin induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs.
Adverse reaction rates increase with higher doses of Ketoracin (Ketoracin tromethamine). Practitioners should be alert for the severe complications of treatment with Ketoracin (Ketoracin tromethamine), 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 Ketoracin (Ketoracin tromethamine) is indicated, especially when the drug is used inappropriately.
In patients taking Ketoracin (Ketoracin tromethamine) or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
Gastrointestinal (GI) experiences including:
abdominal pain*
constipation/diarrhea
dyspepsia*
flatulence
GI fullness
GI ulcers (gastric/duodenal)
gross bleeding/perforation
Heartburn
nausea*
stomatitis
Vomiting
Other experiences:
abnormal renal function
Anemia
dizziness
drowsiness
Edema
elevated liver enzymes
headaches*
Hypertension
increased bleeding time
injection site pain
Pruritus
purpura
rashes
Tinnitus
sweating
*Incidence greater than 10%
Additional adverse experiences reported occasionally ( < 1% in patients taking Ketoracin (Ketoracin tromethamine) or other NSAIDs in clinical trials) include:
Ketoracin Tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to Ketoracin Tromethamine.
Ketoracin Tromethamine 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.
Ketoracin Tromethamine 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.
Ketoracin Tromethamine is contraindicated as prophylactic analgesic before any major surgery.
Ketoracin Tromethamine is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Ketoracin Tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion.
Ketoracin Tromethamine 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.
Ketoracin Tromethamine 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.
Ketoracin Tromethamine 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 Ketoracin Tromethamine and probenecid is contraindicated.
The concomitant use of Ketoracin Tromethamine and pentoxifylline is contraindicated.
Ketoracin Tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.
Ketorolac (Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Kenya, Lithuania, Malta, Netherlands, New Zealand, Peru, Philippines, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Venezuela)
Injectable; Injection; Ketorolac Tromethamine 15 mg / ml
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Information checked by Dr. Sachin Kumar, MD Pharmacology
