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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

Sagent Pharmaceuticals

INJECTION, SOLUTION

Strength 15 mg/mL

KETOROLAC TROMETHAMINE Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Cyclooxygenase Inhibitor [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ketorolac Tromethamine (Ketorolac Tromethamine) which is also known as Ketorolac Tromethamine and Manufactured by Sagent Pharmaceuticals. It is available in strength of 15 mg/mL per ml. Read more

Ketorolac Tromethamine (Ketorolac Tromethamine) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • SAGENTu2122Rx onlyn
  • 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.n
  • 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.n
  • GASTROINTESTINAL RISK
  • CARDIOVASCULAR THROMBOTIC EVENTS
  • RENAL RISK
  • RISK OF BLEEDING
  • Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.
  • HYPERSENSITIVITY
  • INTRATHECAL OR EPIDURAL ADMINISTRATION
  • RISK DURING LABOR AND DELIVERY
  • CONCOMITANT USE WITH NSAIDS
  • SPECIAL POPULATIONS
  • DOSAGE AND ADMINISTRATION
  • Ketorolac Tromethamine Tablets
  • Ketorolac tromethamine is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine is (u00b1)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is below:n
  • Ketorolac tromethamine, USP is a white to off-white, crystalline powder and is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. Ketorolac tromethamine has a pK of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40.n
  • Ketorolac Tromethamine Injection, USP is available for intravenous (IV) or intramuscular (IM) administration as: 15 mg in 1 mL (1.5%) and 30 mg in 1 mL (3%) in sterile solution and 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for IM administration only. The solutions contain 10% (w/v) alcohol, USP, and 6.68 mg, 4.35 mg and 8.70 mg respectively, of sodium chloride in sterile water. The pH range is 6.9 to 7.9 and is adjusted with sodium hydroxide and/or hydrochloric acid. The sterile solutions are clear and slightly yellow in color.n
  • No data
  • Carefully consider the potential benefits and risks ketorolac tromethamine injection and other treatment options before deciding to use ketorolac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).n
  • Ketorolac tromethamine injection is indicated for the short-term (u22645 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 ketorolac tromethamine injection, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.n
  • The total combined duration of use of ketorolac tromethamine injection and oral ketorolac 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 (see , , , and ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.n
  • Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioidsparing effect. For breakthrough pain, it is recommended to supplement the lower end of the ketorolac tromethamine injection dosage range with low doses of narcotics prn, unless otherwise contraindicated. Ketorolac tromethamine injection and narcotics should not be administered in the same syringe (see ).n
  • (See also )
  • Ketorolac tromethamine injection is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.n
  • Ketorolac tromethamine injection 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.n
  • Ketorolac tromethamine injection 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 (see and ).n
  • Ketorolac tromethamine injection is contraindicated as prophylactic analgesic before any major surgery.n
  • Ketorolac tromethamine injection is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).n
  • Ketorolac tromethamine injection is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see for correction of volume depletion).n
  • Ketorolac tromethamine injection is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.n
  • Ketorolac 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 (see and ).n
  • Ketorolac tromethamine injection is contraindicated in patients currently receiving asprin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.n
  • The concomitant use of ketorolac tromethamine injection and probenecid is contraindicated.n
  • The concomitant use of ketorolac tromethamine injection and pentoxifylline is contraindicated.n
  • Ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.n
  • (See also )
  • The total combined duration of use of oral ketorolac tromethamine and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine injection is not indicated for use in pediatric patients.n
  • The most serious risks associated with ketorolac tromethamine are:n
  • No data
  • Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see n n n n and ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.n
  • In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:n
  • Gastrointestinal (GI) experiences including:n
  • Other experiences:n
  • Additional adverse experiences reported occasionally (<1% in patients taking ketorolac tromethamine or other NSAIDs in clinical trials) include:n
  • Body as a Whole
  • fever, infections, sepsisn
  • Cardiovascular
  • congestive heart failure, palpitation, pallor, tachycardia, syncopen
  • Dermatologic
  • alopecia, photosensitivity, urticarian
  • Gastrointestinal
  • anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleedingn
  • Hemic and Lymphatic
  • ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenian
  • Metabolic and Nutritional
  • weight changen
  • Nervous System
  • abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaisen
  • Reproductive, female
  • infertilityn
  • Respiratory
  • asthma, cough, dyspnea, pulmonary edema, rhinitisn
  • Special Senses
  • abnormal taste, abnormal vision, blurred vision, hearing lossn
  • Urogenital
  • cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retentionn
  • Other rarely observed reactions (reported from postmarketing experience in patients taking ketorolac tromethamine or other NSAIDs) are:n
  • Body as a Whole
  • angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema (see ), myalgian
  • Cardiovascular
  • arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitisn
  • Dermatologic
  • exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysisn
  • Gastrointestinal
  • acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease)n
  • Hemic and Lymphatic
  • agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, post operative wound hemorrhage (rarely requiring blood transfusion u2014 see )n
  • Metabolic and Nutritional
  • hyperglycemia, hyperkalemia, hyponatremian
  • Nervous System
  • aseptic meningitis, convulsions, coma, psychosisn
  • Respiratory
  • bronchospasm, respiratory depression, pneumonian
  • Special Senses
  • conjunctivitisn
  • Urogenital
  • flank pain with or without hematuria and/or azotemia, hemolytic uremic syndromen
  • A large postmarketing observational, nonrandomized study, involving approximately 10,000 patients receiving ketorolac tromethamine, demonstrated that the risk of clinically serious gastrointestinal (GI) bleeding was dose-dependent (see ). This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of ketorolac tromethamine (see ).n
  • To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or
  • www.fda.gov/medwatch
  • .
  • No data
  • Carefully consider the potential benefits and risks of ketorolac tromethamine injection 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 injection 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 injection. 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 formulationn- notn- as an initial dose
  • Use minimum effective dose
  • Ketorolac Tromethamine Injection, USP is supplied as follows:n
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]n
  • Protect from light.
  • Discard unused portion.
  • Sterile, Nonpyrogenic, Preservative-free.
  • The container closure is not made with natural rubber latex.
  • SAGENTu2122n
  • Mfd. for SAGENT PharmaceuticalsSchaumburg, IL 60195 (USA)Made in Indiau00a92015 Sagent Pharmaceuticals, Inc.n
  • Revised: July 2015n
  • Medication Guide
  • for
  • Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
  • Ketorolac Tromethamine Injection, USP
  • What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
  • NSAIDs can cause serious side effects, including:
  • Do not take NSAIDs right before or after a heart surgery called a u201ccoronary artery bypass graft (CABG).u201d
  • Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
  • 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.n
  • Who should not take NSAIDs?
  • Do not take NSAIDs:
  • Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:
  • Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements.n- 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 u201cWhat is the most important information I should know about medicines called Non-steroidal Anti-Inflammatory Drugs (NSAIDs)?
  • Get emergency help right away if you get any of the following symptoms:
  • Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:
  • 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.n
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.n
  • Other information about NSAIDs
  • 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.n
  • 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.n
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.n
  • SAGENTu2122Mfd. for SAGENT PharmaceuticalsSchaumburg, IL 60195 (USA)Made in Indiau00a92015 Sagent Pharmaceuticals, Inc.n
  • Revised: July 2015n
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Labeln
  • NDC 25021-700-01n
  • Rx onlyn
  • Ketorolac Tromethamine Injection, USPn
  • 15 mg per mLn
  • 1 mL Single-Dose Vialn
  • For Intravenous or Intramuscular Use Onlyn
  • Protect from light.n
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Labeln
  • NDC 25021-701-01n
  • Rx onlyn
  • Ketorolac Tromethamine Injection, USPn
  • 30 mg per mLn
  • 1 mL Single-Dose Vialn
  • For Intravenous or Intramuscular Use Onlyn
  • Protect from light.n
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Labeln
  • NDC 25021-701-02n
  • Rx onlyn
  • Ketorolac Tromethamine Injection, USPn
  • 60 mg per 2 mL (30 mg per mL)n
  • 2 mL Single-Dose Vialn
  • FOR INTRAMUSCULAR USE ONLYn
  • Protect from light.n

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