KETOROLAC TROMETHAMINE description, usages, side effects, indications, overdosage, supplying and lots more!

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KETOROLAC TROMETHAMINE

Wockhardt Limited

KETOROLAC TROMETHAMINE INJECTION USP


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Rx ONLY

WARNING

Ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID), is indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level. Oral ketorolac tromethamine is indicated only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of oral ketorolac tromethamine and ketorolac tromethamine injection should not exceed 5 days.

Ketorolac tromethamine is not indicated for use in pediatric patients and it is NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine beyond the label recommendations 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 peri-operative 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.

HYPERSENSITIVITY

  • Hypersensitivity reactions, ranging from bronchospasm to anaphylactic shock, have occurred and appropriate counteractive measures must be available when administering the first dose of ketorolac tromethamine injection (see CONTRAINDICATIONS and WARNINGS). Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs).

INTRATHECAL OR EPIDURAL ADMINISTRATION
  • Ketorolac tromethamine is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.

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). Doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients.

DOSAGE AND ADMINISTRATION

Ketorolac Tromethamine Tablets
  • Ketorolac tromethamine tablets are indicated only as continuation therapy to ketorolac tromethamine injection, and the combined duration of use of ketorolac tromethamine injection and ketorolac tromethamine tablets is not to exceed 5 (five) days, because of the increased risk of serious adverse events.
  • The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine injection (maximum 120 mg) (see DOSAGE AND ADMINISTRATION).

KETOROLAC TROMETHAMINE DESCRIPTION


KETOROLAC TROMETHAMINE



CLINICAL PHARMACOLOGY


Pharmacodynamics



Pharmacokinetics



Comparison of IV, IM and Oral Pharmacokinetics:

Table 1 Table of Approximate Average Pharmacokinetic Parameters (Mean± SD) Following Oral, Intramuscular and Intravenous Doses of Ketorolac Tromethamine
Pharmacokinetic Parameters (units) Oral* Intramuscular† Intravenous Bolus‡
10 mg 15 mg 30 mg 60 mg 15 mg 30 mg
Bioavailability (extent) 100%
Tmax 1 (min) 44 ± 34 33 ± 21§ 44 ± 29 33 ± 21§ 1.1 ± 0.7§ 2.9 ± 1.8
Cmax 2 (mcg/mL)
[single-dose]
0.87 ± 0.22 1.14 ± 0.32§ 2.42 ± 0.68 4.55 ± 1.27§ 2.47 ± 0.51§ 4.65 ± 0.96
Cmax (mcg/mL)
[steady state qid]
1.05 ± 0.26§ 1.56 ± 0.44§ 3.11 ± 0.87§ N/A|| 3.09 ± 1.17§ 6.85 ± 2.61
Cmin 3 (mcg/mL)
[steady state qid]
0.29 ± 0.07§ 0.47 ± 0.13§ 0.93 ± 0.26§ N/A 0.61 ± 0.21§ 1.04 ± 0.35
Cavg 4 (mcg/mL)
[steady state qid]
0.59 ± 0.20§ 0.94 ± 0.29§ 1.88 ± 0.59§ N/A 1.09 ± 0.30§ 2.17 ± 0.59
5 (L/kg) 0.175 ± 0.039 0.210 ± 0.044
1
2
3
4
5
maxmax


Linear Kinetics:

Distribution:
β

PRECAUTIONS: Nursing mothers

Metabolism:

Excretion:
CLINICAL PHARMACOLOGY: Kinetics in Special Populations



Accumulation:
max



Kinetics in Special Populations: Geriatric Patients:
max PRECAUTIONS - Geriatric Use

Pediatric Patients:
β

Renally Insufficiency:



WARNINGS- Renal Effects

Hepatic Insufficiency:
max PRECAUTIONS: Hepatic EffectsTable 2

Race:
Table 2 The Influence of Age, Liver, and Kidney Function on the Clearance and Terminal Half-life of Ketorolac Tromethamine (IM1 and ORAL2) in Adult Populations
Total Clearance [in L/h/kg]3 Terminal Half-life [in hours]
Type of Subjects IM ORAL IM ORAL
Mean (range) Mean (range) Mean (range) Mean (range)
Normal Subjects
IM (n=54)
mean age=32, range=18–60
Oral (n=77)
mean age=32, range=20–60
0.023
(0.010–0.046)
0.025
(0.013–0.050)
5.3
(3.5–9.2)
5.3
(2.4–9.0)
Healthy Elderly Subjects
IM (n=13), Oral (n=12)
mean age=72, range=65–78
0.019
(0.013–0.034)
0.024
(0.018–0.034)
7.0
(4.7–8.6)
6.1
(4.3–7.6)
Patients with Hepatic Dysfunction
IM and Oral (n=7)
mean age=51, range=43–64
0.029
(0.013–0.066)
0.033
(0.019–0.051)
5.4
(2.2–6.9)
4.5
(1.6–7.6)
Patients with Renal Impairment
IM (n=25), Oral (n=9)
serum creatinine=1.9–5.0 mg/dL,
mean age (IM)=54, range=35–71
mean age (Oral)=57, range=39–70
0.015
(0.005–0.043)
0.016
(0.007–0.052)
10.3
(5.9–19.2)
10.8
(3.4–18.9)
Renal Dialysis Patients
IM and Oral (n=9)
mean age=40, range=27–63
0.016
(0.003–0.036)
13.6
(8.0–39.1)
1
2
3

IV Administration:Kinetics in Special Populations

Clinical Studies

Adult Patients:

KETOROLAC TROMETHAMINE INDICATIONS AND USAGE

WARNINGS

Acute Pain in Adult Patients



WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION,ADVERSE REACTIONS

DOSAGE AND ADMINISTRATION -Pharmaceutical Information for Ketorolac Tromethamine Injection

KETOROLAC TROMETHAMINE CONTRAINDICATIONS





WARNINGS Anaphylactoid  Reactions,PRECAUTIONS Preexisting Asthma



WARNINGS

WARNINGS for correction of volume depletion





WARNINGS PRECAUTIONS








WARNINGS





Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation




o minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration.


Hemorrhage

PRECAUTIONS

Renal Effects


CLINICAL PHARMACOLOGYDOSAGE ADMINISTRATION

Impaired Renal Function

CONTRAINDICATIONS

Anaphylactoid Reactions
CONTRAINDICATIONS and PRECAUTIONS- Preexisting Asthma

Cardiovascular Effects
Cardiovascular Thrombotic Events:

Gastrointestinal Effects- Risk of Ulceration, Bleeding, and PerforationCONTRAINDICATIONS

Hypertension



Congestive Heart Failure and Edema


Skin Reactions


Pregnancy

PRECAUTIONS


General



Hepatic Effects



Hematological Effects

Preexisting Asthma

Information for patients



Boxed WARNING, WARNINGS, PRECAUTIONS, ADVERSE REACTIONSadvise patients not to give oral ketorolac tromethamine to other family members and to discard any unused drug.




  • Ketorolac tromethamine, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS: Cardiovascular Effects).
  • Ketorolac tromethamine, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS: Gastrointestinal Effects- Risk of Ulceration, Bleeding, and Perforation).
  • Ketorolac tromethamine, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
  • Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
  • Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
  • Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS).
  • In late pregnancy, as with other NSAIDs, ketorolac tromethamine should be avoided because it will cause premature closure of the ductus arteriosus.

Laboratory tests

Drug interactions



Warfarin, Digoxin, Salicylate, and Heparin: in vitro warfarin digoxin In vitro salicylate digoxin, warfarin, ibuprofen, naproxen, piroxicam, acetaminophen, phenytoin tolbutamide

warfarin heparin WARNINGSPRECAUTIONS: Hematological Effects



Aspirin:

Diuretics:
WARNINGS: Renal Effects

Probenecid:
probenecid

Lithium:


Methotrexate:

ACE Inhibitors/Angiotensin II Receptor Antagonists: ACE inhibitors and/or angiotensin II receptor antagonists

Antiepileptic Drugs: antiepileptic drugs

Psychoactive Drugs:
psychoactive drugs

Pentoxifylline: pentoxifylline

Nondepolarizing Muscle Relaxants: nondepolarizing muscle relaxants

Selective Serotonin Reuptake Inhibitors (SSRIs): selective serotonin reuptake inhibitors

Carcinogenesis, mutagenesis, impairment of fertility





Pregnancy

Teratogenic effects: Pregnancy Category C


Nonteratogenic effects




Labor and delivery
CONTRAINDICATIONS

Effects on Fertility

Nursing mothers

Pediatric use



Geriatric use (≥65 years of age)
CLINICAL PHARMACOLOGYWARNINGS: Gastrointestinal Effects- Risk of Ulceration, Bleeding, and PerforationDOSAGE AND ADMINISTRATION

KETOROLAC TROMETHAMINE ADVERSE REACTIONS

Boxed WARNING, WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION


































Body as a Whole:

Cardiovascular:

Dermatologic:

Gastrointestinal:

Hemic and Lymphatic:

Metabolic and Nutritional:

Nervous System:

Reproductive, female:

Respiratory:

Special Senses:

Urogenital:



Body as a Whole:WARNINGS

Cardiovascular:

Dermatologic:

Gastrointestinal:

Hemic and Lymphatic: Boxed WARNING, WARNINGS, PRECAUTIONS

Metabolic and Nutritional:

Nervous System:

Respiratory:

Special Senses:

Urogenital:

Postmarketing Surveillance Study



Table 3 Incidence of Clinically Serious G.I. Bleeding as Related to Age, Total Daily Dose, and History of G.I. Perforation, Ulcer, Bleeding (PUB) after up to 5 Days of Treatment with Ketorolac Tromethamine Injection

A. Patients without History of PUB

Age of Patients

Total Daily Dose of Ketorolac Tromethamine Injection

≤60 mg

>60 to 90 mg

>90 to 120 mg

>120 mg

<65 years of age

0.4%

0.4%

0.9%

4.6%

≥65 years of age

1.2%

2.8%

2.2%

7.7%

B. Patients with History of PUB

Age of Patients

Total Daily Dose of Ketorolac Tromethamine Injection

≤60 mg

>60 to 90 mg

>90 to 120 mg

>120 mg

<65 years of age

2.1%

4.6%

7.8%

15.4%

≥65 years of age

4.7%

3.7%

2.8%

25.0%

OVERDOSAGE

Symptoms and Signs


Treatment



KETOROLAC TROMETHAMINE DOSAGE AND ADMINISTRATION

Carefully consider the potential benefits and risks of ketorolac tromethamine and other treatment options before deciding to use ketorolac tromethamine. 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 oral ketorolac tromethamine is not to exceed 5 days. In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from IV or IM dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.

Note:

Oral formulationnotas an initial dose

Use minimum effective dose

Total duration of treatment in adult patients:

Ketorolac Tromethamine Injection

WARNINGS -


Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration Use Only IM Dosing:
  • Patients < 65 years of age: One dose of 60 mg.
  • Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 30 mg.
IV Dosing:
  • Patients < 65 years of age: One dose of 30 mg.
  • Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: One dose of 15 mg.
Multiple-Dose Treatment (IV or IM)
  • Patients < 65 years of age: The recommended dose is 30 mg ketorolac tromethamine injection every 6 hours. The maximum daily dose for these populations should not exceed 120 mg.
  • For patients ≥ 65 years of age, renally impaired patients (see WARNINGS), and patients less than 50 kg (110 lbs):




Pharmaceutical Information for Ketorolac Tromethamine Injection:



HOW SUPPLIED

Ketorolac Tromethamine Injection USP











*FOR IM USE ONLY
Protect from light.

Manufactured by:




Distributed by:





Medication Guide for
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.

  • with longer use of NSAID medicines
  • in people who have heart disease
NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:


  • can happen without warning symptoms
  • may cause death
The chance of a person getting an ulcer or bleeding increases with:

  • taking medicines called "corticosteroids" and “anticoagulants"
  • longer use
  • smoking
  • drinking alcohol
  • older age
  • having poor health
NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?



  • different types of arthritis
  • menstrual cramps and other types of short-term pain
Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:


  • if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • for pain right before or after heart bypass surgery
Tell your healthcare provider:

  • about all of your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
  • if you are breastfeeding. Talk to your doctor.
What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
Serious side effects include:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
Other side effects include:
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness
Get emergency help right away if you have any of the following symptoms:

  •  shortness of breath or trouble breathing
  •  chest pain
  •  weakness in one part or side of your body
  •  slurred speech
  •  swelling of the face or throat 
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • nausea
  • more tired or weaker than usual
  • itching
  • your skin or eyes look yellow
  • stomach pain
  • flu-like symptoms
  • vomit blood
  • there is blood in your bowel movement or it is black and sticky like tar
  • unusual weight gain
  • skin rash or blisters with fever
  • swelling of the arms and legs, hands and feet


Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over -the -counter). Talk to your healthcare provider before using over -the -counter NSAIDs for more than 10 days.
NSAID medicines that need a prescription
Generic Name Tradename
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbirofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600


KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE
KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE INJECTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55648-757
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE KETOROLAC 15 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 VIAL, SINGLE-DOSE
2 1 in 1 VIAL, SINGLE-DOSE
3 1 in 1 VIAL, SINGLE-DOSE
4 NDC:55648-757-03 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077942 2007-03-27


KETOROLAC TROMETHAMINE

KETOROLAC TROMETHAMINE INJECTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55648-758
Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE KETOROLAC 30 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 VIAL, SINGLE-DOSE
2 1 in 1 VIAL, SINGLE-DOSE
3 2 in 1 VIAL, SINGLE-DOSE
4 2 in 1 VIAL, SINGLE-DOSE
5 2 in 1 VIAL, SINGLE-DOSE
6 10 in 1 VIAL, MULTI-DOSE
7 NDC:55648-758-03 15 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077942 2007-03-27


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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