Ketorolac Tromethamine (Page 8 of 9)
OVERDOSAGE
Symptoms and Signs
Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Treatment
Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 g to 100 g in adults, 1 g/kg to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large oral overdose (5 to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.
Single overdoses of ketorolac tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac 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 ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
Transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac 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 ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days.
The following table summarizes ketorolac tromethamine tablet dosing instructions in terms of age group:
Patient Population | Ketorolac Tromethamine Tablets (following IV or IM dosing of ketorolac 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 |
HOW SUPPLIED
Ketorolac Tromethamine Tablets USP are available as follows:
10 mg: White, round, convex, unscored, film-coated tablets, debossed “93” on one side and “314” on the other side. They are available in bottles of 15 tablets (NDC 70934-029-15), bottles of 20 tablets (NDC 70934-029-20), and bottles of 30 tablets (NDC 70934-029-30)
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
PROTECT FROM LIGHT AND EXCESSIVE HUMIDITY.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Distributed By:
TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454
Rev. K 7/2015
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) | |
What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? | |
NSAIDs can cause serious side effects, including: | |
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NSAIDs should only be used: | |
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What are NSAIDs? | |
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. | |
Who should not take NSAIDs? | |
Do not take NSAIDs: | |
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Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: | |
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Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. | |
What are the possible side effects of NSAIDs? | |
NSAIDs can cause serious side effects, including: | |
See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?” | |
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Get emergency help right away if you get any of the following symptoms: | |
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Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: | |
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| is black and sticky like tar |
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If you take too much of your NSAID, call your healthcare provider or get medical help right away. | |
These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. | |
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |
Other information about NSAIDs | |
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General information about the safe and effective use of NSAIDs | |
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. | |
If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals. | |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised July 2015 |
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