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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

West-Ward Pharmaceuticals Corp.

INJECTION

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 West-Ward Pharmaceuticals Corp.. 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
  • 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 intravenous or intramuscular 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
  • u2022u00a0 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 ).
  • CARDIOVASCULAR THROMBOTIC EVENTS
  • u2022u00a0 Non steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see andu00a0).
  • u2022 u00a0Ketorolac tromethamine injection is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see and ).
  • RENAL RISK
  • u2022u00a0 Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see ).
  • RISK OF BLEEDING
  • u2022u00a0 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 u00a0 and ).
  • Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.
  • HYPERSENSITIVITY
  • u2022u00a0 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 and ). Ketorolac tromethamine is CONTRAINDICATED in patients with previously demonstrated hypersensitivity to ketorolac tromethamine or allergic manifestations to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
  • INTRATHECAL OR EPIDURAL ADMINISTRATION
  • u2022u00a0 Ketorolac tromethamine is CONTRAINDICATED for intrathecal or epidural administration due to its alcohol content.
  • RISK DURING LABOR AND DELIVERY
  • u2022u00a0 The use of ketorolac tromethamine in labor and delivery is CONTRAINDICATED because it may adversely affect fetal circulation and inhibit uterine contractions.
  • CONCOMITANT USE WITH NSAIDs
  • u2022u00a0 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
  • u2022u00a0 Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs.) of body weight (see ) and for patients with moderately elevated serum creatinine (see ). Doses of ketorolac tromethamine injection are not to exceed 60 mg (total dose per day) in these patients.u00a0u00a0u00a0u00a0u00a0
  • DOSAGE AND ADMINISTRATION
  • Ketorolac Tromethamine Tablets
  • u2022u00a0 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.
  • u2022u00a0 The recommended total daily dose of ketorolac tromethamine tablets (maximum 40 mg) is significantly lower than for ketorolac tromethamine injection (maximum 120 mg) (see ).u00a0u00a0
  • 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 chemical structure is:
  • Ketorolac tromethamine 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 pKa of 3.5 and an n-octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.41. Its molecular formula is CHNO.
  • Ketorolac tromethamine 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; 60 mg in 2 mL (3%) of ketorolac tromethamine in sterile solution is available for intramuscular administration only. The solutions contain 0.1% citric acid, 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 is adjusted with sodium hydroxide or hydrochloric acid, and the solutions are packaged with nitrogen. The sterile solutions are clear and slightly yellow in color.
  • No data
  • Carefully consider the potential benefits and risks of ketorolac tromethamine 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 ).
  • Acute Pain in Adult Patients
  • Ketorolac tromethamine is indicated for the short-term (u2264 5 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 intravenous or intramuscular dosing of ketorolac tromethamine, and oral ketorolac tromethamine is to be used only as continuation treatment, if necessary.
  • 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 n n n n n and ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
  • Ketorolac tromethamine injection has been used concomitantly with morphine and meperidine and has shown an opioid-sparing 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 ).
  • (See also .)
  • Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.
  • 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.
  • Ketorolac tromethamine 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 n , and ).
  • Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery.
  • Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).
  • Ketorolac tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see u00a0for correction of volume depletion).
  • Ketorolac tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage.
  • 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 ).
  • Ketorolac tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.
  • The concomitant use of ketorolac tromethamine and probenecid is contraindicated.
  • The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.
  • Ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.
  • (See also .)
  • The total combined duration of use of oral ketorolac tromethamine and intravenous or intramuscular dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine is not indicated for use in pediatric patients.
  • The most serious risks associated with ketorolac tromethamine are:
  • 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 GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see n n n n n andu00a0n ). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately.
  • 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
  • *Incidence greater thanu00a0 10%
  • Additional adverse experiences reported occasionally (<1% in patients taking ketorolac tromethamine or other NSAIDs in clinical trials) include:
  • Body as a Whole:
  • Cardiovascular:
  • Dermatologic:
  • Gastrointestinal:
  • Hemic and Lymphatic:
  • Metabolic and Nutritional:
  • Nervous System:
  • Reproductive, female:
  • Respiratory:
  • Special Senses:
  • Urogenital:
  • Other rarely observed reactions (reported from postmarketing experience in patients taking ketorolac tromethamine or other NSAIDs) are:
  • Body as a Whole: n- Array
  • Cardiovascular:
  • Dermatologic:
  • Gastrointestinal:
  • Hemic and Lymphatic: n- Arrayn- Arrayn- Array
  • Metabolic and Nutritional:
  • Nervous System:
  • Respiratory:
  • Special Senses:
  • Urogenital:
  • Postmarketing Surveillance Study
  • 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 Tables 3A and 3B). This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of ketorolac tromethamine (see Table 3A).u00a0
  • No data
  • 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 intravenous or intramuscular 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 intravenous or intramuscular dosing of ketorolac tromethamine. See package insert for ketorolac tromethamine tablets for transition from intravenous or intramuscular dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose oral ketorolac tromethamine.
  • Note: Oral formulation n- not n- as an initial dose.
  • Use minimum effective dose
  • Total duration of treatment in adult patients:
  • Ketorolac Tromethamine Injection
  • Ketorolac tromethamine injection may be used as a single or multiple dose on a regular or u201cprnu201d schedule for the management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see ). Patients should be switched to alternative analgesics as soon as possible, but ketorolac tromethamine therapy is not to exceed 5 days.
  • When administering ketorolac tromethamine injection, the intravenous bolus must be given over no less than 15 seconds. The intramuscular administration should be given slowly and deeply into the muscle. The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing intravenous or intramuscular. Duration of analgesic effect is usually 4 to 6 hours.
  • Single-Dose Treatment: The following regimen should be limited to single administration use only
  • Intramuscular Dosing
  • Intravenous Dosing
  • Multiple-Dose Treatment (Intravenous or Intramuscular)
  • For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine. Consideration should be given to supplementing these regimens with low doses of opioids u201cprnu201d unless otherwise contraindicated.
  • Pharmaceutical Information for Ketorolac Tromethamine Injection
  • Ketorolac tromethamine injection should not be mixed in a small volume (e.g., in a syringe) with morphine sulfate, meperidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution.
  • NOTE:
  • Ketorolac Tromethamine Injection, USP is available as follows:
  • For IV or IM Single Dose use:
  • NDC 0641-6041-25, 2 mL vials containing 1 mL of 15 mg/mL Ketorolac Tromethamine, USP, available in boxes of 25.
  • NDC 0641-6042-25, 2 mL vials containing 1 mL of 30 mg/mL Ketorolac Tromethamine, USP, available in boxes of 25.
  • For IM Single Dose use only:
  • NDC 0641-6043-25, 60 mg/2 mL, 2 mL vials containing 2 mL of 30 mg/mL Ketorolac Tromethamine, USP, (60 mg), available in boxes of 25.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F), excursions permitted to 15u00b0 to 30u00b0C (59u00b0 to 86u00b0F) [See USP Controlled Room Temperature].
  • PROTECT FROM LIGHTn- Array
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or .
  • For Product Inquiry call 1-877-845-0689.
  • Manufactured by:
  • WEST-WARD
  • A HIKMA COMPANY
  • Eatontown, NJ 07724 USA
  • Revised November 2017
  • 462-103-05
  • What is the most important information I should know about medicines called Nonsteroidal 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.
  • NSAIDs should only be used:
  • 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:
  • 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.u00a0u00a0u00a0u00a0u00a0u00a0
  • 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 Nonsteroidal n n- Anti-inflammatory Drugs (NSAIDs)?u201d
  • 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.
  • 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
  • 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.
  • Manufactured by:
  • WEST-WARD
  • A HIKMA COMPANY
  • Eatontown, NJ 07724 USA
  • For Product Inquiry call 1-877-845-0689
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Revised November 2017u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 462-103-05
  • NDC 0641-6041-01n n n 1 mL Single Dose Vialn
  • NDC 0641-6041-25n 25 x 1 mL Single Dose Vialsn n
  • Arrayn- Arrayn- Array
  • NDC 0641-6042-01n n n 1 mL Single Dose Vialn
  • NDC 0641-6042-25n 25 x 1 mL Single Dose Vialsn n
  • Arrayn- Array
  • NDC 0641-6043-01n n 2 mL Single Dose Vialn
  • NDC 0641-6043-25n n 25 x 2 mL Single Dose Vialsn n n n n
  • No data

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