WARNING
Ketorolac tromethamine tablets, a non-steroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine should not exceed 5 days.
Ketorolac tromethamine tablets are not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events.
GASTROINTESTINAL RISK
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Ketorolac tromethamine can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac 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. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
CARDIOVASCULAR RISK
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS and CLINICAL TRIALS).
- Ketorolac tromethamine is CONTRAINDICATED for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
RENAL RISK
- Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS).
RISK OF BLEEDING
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Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS).
Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.
RISK DURING LABOR AND DELIVERY
- The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions. The use of ketorolac tromethamine is contraindicated in nursing mothers because of the potential adverse effects of prostaglandin-inhibiting drugs on neonates.
CONCOMITANT USE WITH NSAIDS
- Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects.
SPECIAL POPULATIONS
- Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION) and for patients with moderately elevated serum creatinine (see WARNINGS).
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KETOROLAC SUMMARY
Patients age 17 to 64:
Premarin®(conjugated estrogens tablets, USP) for oral administration contains a mixture of conjugated estrogens obtained exclusively from natural sources, occurring as the sodium salts of water-soluble estrogen sulfates blended to represent the average composition of material derived from pregnant mares' urine. It is a mixture of sodium estrone sulfate and sodium equilin sulfate. It contains as concomitant components, as sodium sulfate conjugates, 17(alpha)-dihydroequilin, 17(alpha)-estradiol, and 17(beta)-dihydroequilin.
Premarin therapy is indicated in the:
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Treatment of moderate to severe vasomotor symptoms associated with the menopause.
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Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
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Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
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Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
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Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
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Prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and for whom non-estrogen medications are not considered to be appropriate. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
The mainstays for decreasing the risk of postmenopausal osteoporosis are weight-bearing exercise, adequate calcium and vitamin D intake, and when indicated, pharmacologic therapy. Postmenopausal women require an average of 1500 mg/day of elemental calcium. Therefore, when not contraindicated, calcium supplementation may be helpful for women with suboptimal dietary intake. Vitamin D supplementation of 400-800 IU/day may also be required to ensure adequate daily intake in postmenopausal women.
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NEWS HIGHLIGHTSMedia Articles Related to Ketorolac (Ketorolac Tromethamine)
62-Year-Old Man Becomes First Patient In China Implanted With Rechargeable Neurostimulator For Chronic Pain
Source: Health News from Medical News Today [2009.11.19]
St. Jude Medical, Inc. (NYSE:STJ) announced that a 62-year-old man from Shenzhen, Guangdong province has become the first patient in China to be implanted with the Eon™ neurostimulator, a rechargeable device used to help manage chronic pain. Despite prior back surgeries, the patient suffered from chronic back pain for more than a decade.
Common Pain Relief Medication May Encourage Cancer Growth
Source: Cancer / Oncology News From Medical News Today [2009.11.19]
Although morphine has been the gold-standard treatment for postoperative and chronic cancer pain for two centuries, a growing body of evidence is showing that opiate-based painkillers can stimulate the growth and spread of cancer cells. Two new studies advance that argument and demonstrate how shielding lung cancer cells from opiates reduces cell proliferation, invasion and migration in both cell-culture and mouse models.
CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.
Transplanting People's Own Stem Cells Into Heart Lessens Pain, Improves Ability To Walk
Source: Clinical Trials / Drug Trials News From Medical News Today [2009.11.19]
The largest national stem cell study for heart disease showed the first evidence that transplanting a potent form of adult stem cells into the heart muscle of subjects with severe angina results in less pain and an improved ability to walk. The transplant subjects also experienced fewer deaths than those who didn't receive stem cells.
FDA Approves New Drug For Pain That Persists After Shingles
Source: Dermatology News From Medical News Today [2009.11.18]
The US Food and Drug Administration (FDA) announced yesterday that it has approved Qutenza (capsaicin) 8% patch for the treatment of post-herpetic neuralgia (PHN), an often excruciating pain that can persist for weeks, months and even years in 10 to 15 per cent of people who get shingles. The medicated skin patch, which is made by Lohmann Therapie-Systems AD of Andernach, Germany and distributed in the US by NeurogesX Inc.
Published Studies Related to Ketorolac (Ketorolac Tromethamine)
Opioid-sparing effects of ketorolac and its correlation with the recovery of postoperative bowel function in colorectal surgery patients: a prospective randomized double-blinded study. [2009.07]
OBJECTIVES: Postoperative ileus (PI) is one of many common complications in major abdominal surgery... We suggest that adding ketorolac to morphine IVPCA be included in the multimodal postoperative rehabilitation program for the early restoration of normal bowel function.
Topical bromfenac 0.09% vs. ketorolac 0.4% for the control of pain, photophobia, and discomfort following PRK. [2009.02]
PURPOSE: To compare the efficacy of two topical nonsteroidal anti-inflammatory drugs with regards to the control of pain, burning, photophobia, foreign body sensation, and epithelial healing rates in patients who underwent photorefractive keratectomy (PRK)... CONCLUSIONS: No significant differences were observed between the use of bromfenac (twice daily) and ketorolac (four times daily) with regard to postoperative PRK discomfort and safety when combined with postoperative measures such as cold BSS and a bandage contact lens.
Efficacy of pocket irrigation with bupivacaine and ketorolac in breast augmentation: a randomized controlled trial. [2009.01]
Breast augmentation is the most common cosmetic surgery procedure performed in the United States. The optimal approach to postoperative pain management in these patients, however, has yet to be determined... These findings suggest that intraoperative administration of analgesics into the implant pocket may thus facilitate an early postoperative recovery; yet, patients should be advised that they might require more pain medication at home for the first few days.
The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. [2008.12]
BACKGROUND: We evaluated the safety and efficacy of multiple doses of intranasal ketorolac tromethamine (ketorolac) for postoperative pain... CONCLUSION: Thirty milligrams of intranasal ketorolac demonstrated significant analgesic efficacy compared to 10 mg of intranasal ketorolac and placebo.
Postoperative intravenous patient-controlled analgesia in thyroid surgery: comparison of fentanyl and ondansetron regimens with and without the nonsteriodal anti-inflammatory drug ketorolac. [2008.12]
BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs), through synergistic action with opioids, can reduce postoperative nausea and vomiting via intravenous patient-controlled analgesia (PCA). We compared the efficacy of three PCA regimens... CONCLUSIONS: The NSAID ketorolac when combined with lower doses of the opioid fentanyl and the same dose of ondansetron is associated with the same analgesic efficacy but less nausea and vomiting after thyroid surgery. A higher ratio of NSAID to opioid, when used as reported here, is associated with less postoperative dizziness.
Clinical Trials Related to Ketorolac (Ketorolac Tromethamine)
Use of Ketorolac in Management of Post-Operative Pain After Heart Surgery [Completed]
This study evaluates the safety and efficacy of ketorolac for post-operative pain management
after heart surgery. Ketorolac appears to provide enhanced pain relief while also decreasing
the requirements for morphine during the (immediate) 24-hour post-operative period.
Topical 0.4% Ketorolac and Vitreoretinal Surgery [Completed]
To determine whether use of topical 0. 4% ketorolac has any effect on pupil size during
vitreoretinal surgery.
Intrathecal Ketorolac in Patients With Intrathecal Morphine Dose Escalation [Withdrawn]
The purpose of this study is to determine how the drug ketorolac, when given with the spinal
morphine, affects pain.
Assess Platelet Function and Safety After Administration of Injectable Diclofenac Compared to Ketorolac and Aspirin in Adult Male Volunteers [Completed]
This study will assess platelet function and safety in healthy male volunteers following
doses of intravenous diclofenac compared to cataflam, intravenous ketorolac and aspirin.
Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity [Enrolling by invitation]
The purpose of this study is to test whether ACULAR, a nonsteroidal anti-inflammatory eye
drop medication, can prevent the development of retinopathy of prematurity (ROP) and/ or
decrease its severity. In this study ACULAR will be compared to a placebo (artificial tear).
The hypothesis would be that ACULAR treatment will decrease the incidence of moderate to
severe ROP (grade II and above)by 50%.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 1 ratings/reviews, Ketorolac has an overall score of 7. The effectiveness score is 8 and the side effect score is 10. The scores are on ten point scale: 10 - best, 1 - worst.
| | Ketorolac review by 45 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Considerably Effective |
| Side effects: | | No Side Effects | | |
Treatment Info |
| Condition / reason: | | pain, muscle strain |
| Dosage & duration: | | 1 tablet taken as needed, maybe once per week or month for the period of several years |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | This works very well for mild to moderate pain, usually caused by over-exertion, and charaterized by muscle soreness, spasms, cramps, tightness |
| Side effects: | | I did not personally have any problems with this medication, though like with any NSAID, stomach upset and liver damage certainly have to be considered. |
| Comments: | | I just use this off and on for anytime i have pain and spasms most generally associated with over - exertion |
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Page last updated: 2009-11-19
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