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Ketorolac (Ketorolac Tromethamine) - Summary

 
 



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

  • 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

  • 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).
 

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:

  1. Treatment of moderate to severe vasomotor symptoms associated with the menopause.
  2. 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.
  3. Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure.
  4. Treatment of breast cancer (for palliation only) in appropriately selected women and men with metastatic disease.
  5. Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only).
  6. 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.


See all Ketorolac indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ketorolac (Ketorolac Tromethamine)

Tackling inflammatory pain
Source: Immune System / Vaccines News From Medical News Today [2014.08.29]
Pain from inflammation sidelines thousands of Americans each year. Many face a tough choice: deal with the pain, take a potentially addictive opioid or use a nonsteroidal anti-inflammatory drug that...

'Doctor-Shopping' for Painkillers Common After Broken-Bone Surgery, Study Finds
Source: MedicineNet Chronic Pain Specialty [2014.08.29]
Title: 'Doctor-Shopping' for Painkillers Common After Broken-Bone Surgery, Study Finds
Category: Health News
Created: 8/29/2014 9:35:00 AM
Last Editorial Review: 8/29/2014 12:00:00 AM

Iroko Pharmaceuticals gains FDA approval of ZORVOLEX® for management of osteoarthritis pain
Source: Arthritis / Rheumatology News From Medical News Today [2014.08.28]
Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, has announced the United States Food and Drug Administration (FDA) has...

States that legalize medical marijuana 'have fewer deaths from opioid painkillers'
Source: Alcohol / Addiction / Illegal Drugs News From Medical News Today [2014.08.26]
Annual deaths from prescription painkillers are, on average, 25% lower in states that legalize medical marijuana, according to a new study from Johns Hopkins researchers.

The effect of serotonin on sensitivity to pain
Source: Depression News From Medical News Today [2014.08.26]
In a study published in the scientific journal PLoS One, researchers at the Champalimaud Neuroscience Programme establish the effect of serotonin on sensitivity to pain using a combination of...

more news >>

Published Studies Related to Ketorolac (Ketorolac Tromethamine)

Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification. [2012]
randomized clinical trial... CONCLUSIONS: One month after uneventful phacoemulsification, there was no

The effect of perioperative ketorolac on pain control in pregnancy termination. [2011.11.29]
BACKGROUND: The study was conducted to evaluate the effect of perioperative ketorolac on pain associated with first-trimester aspiration abortion... CONCLUSION: Perioperative ketorolac has the same effect on postoperative pain as determined by VAS as placebo. The use of ketorolac at the 30-mg dose cannot be recommended for better pain control for patients undergoing first-trimester pregnancy termination by suction curettage. The only positive effect of the use of ketorolac compared to placebo was a reduction in the use of acetaminophen. Ketorolac use does not appear to change blood loss in the operating room or through postoperative day 1 compared to placebo. Copyright (c) 2011 Elsevier Inc. All rights reserved.

A randomized, controlled trial validates a peripheral supra-additive antihyperalgesic effect of a paracetamol-ketorolac combination. [2011.11]
The combination of paracetamol with non-steroidal anti-inflammatory drugs (NSAIDs) is widely used; however, the nature and mechanism of their interaction are still debated. A double-blind, pharmacokinetic/pharmacodynamic, randomized, cross-over, placebo-controlled study was carried out in human healthy volunteers...

Preemptive analgesic effectiveness of oral ketorolac plus local tramadol after impacted mandibular third molar surgery. [2011.09.01]
OBJECTIVE: The aim of this study was to compare preemptive analgesia of oral ketorolac plus submucous local placebo with oral ketorolac plus submucous local tramadol after impacted mandibular third molar surgery... CONCLUSIONS: Preemptive use of oral ketorolac plus submucous local tramadol is an alternative treatment for acute pain after surgical removal of an impacted mandibular third molar.

A double-blind placebo-controlled comparison of a novel formulation of intravenous diclofenac and ketorolac for postoperative third molar extraction pain. [2011.06]
Dyloject is a novel formulation of diclofenac intended for intravenous (IV) administration...

more studies >>

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.

Intravenous Ketorolac for Postoperative Pain in Percutaneous Nephrolithotomy [Recruiting]
The purpose of this study is to determine whether continuous intravenous ketorolac infusion reduces pain in patients who are having percutaneous nephrolithotomy for kidney stone disease.

Disposition of Intravenous Ketorolac [Not yet recruiting]
The purpose of this study is:

- to document ketorolac disposition (concentration/time profile, protein binding,

metabolism) and its covariates following intravenous (iv) administration of ketorolac right after caesarean section and to compare those observations (n=32) with non-pregnant state (n=8) (intra-subject PK comparison)

- to document biochemical tolerance of ketorolac

- to evaluate if optimalisation of ketorolac dose regimen during pregnancy and labor are

appropriated and needed

- to quantify the neonatal exposure to ketorolac through excretion in the breast milk

more trials >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based 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

See all Ketorolac reviews / ratings >>

Page last updated: 2014-08-29

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