Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

Alvogen Inc.

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 Alvogen Inc.. 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
  • FOR INTRAVENOUS (IV)/ INTRAMUSCULAR (IM) USE (15 mg and 30 mg)
  • FOR INTRAMUSCULAR (IM) USE ONLY (60 mg)
  • 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.
  • 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
  • Ketorolac Tromethamine Injection, USP 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-1-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the structural formula is presented in .n
  • 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 376.40.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; 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 to slightly yellow in color.n
  • No data
  • In a postoperative study, where all patients received morphine by a PCA device, patients treated with ketorolac tromethamine IV as fixed intermittent boluses (e.g., 30 mg initial dose followed by 15 mg q3h), required significantly less morphine (26%) than the placebo group. Analgesia was significantly superior, at various postdosing pain assessment times, in the patients receiving ketorolac tromethamine IV plus PCA morphine as compared to patients receiving PCA-administered morphine alone.n
  • 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 ).n
  • Ketorolac tromethamine 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, 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 (see .n
  • (see also )n
  • Ketorolac tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.n
  • 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.n
  • 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 , and ).n
  • Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery.n
  • Ketorolac tromethamine is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see ).n
  • Ketorolac tromethamine 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 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.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 is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.n
  • The concomitant use of ketorolac tromethamine and probenecid is contraindicated.n
  • The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.n
  • Ketorolac tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.n
  • (see also )n
  • 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 is not indicated for use in pediatric patients.n
  • The most serious risks associated with ketorolac tromethamine are:n
  • Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy.n
  • The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with ketorolac tromethamine. Do not use ketorolac tromethamine for more than five days.n
  • However, even short-term therapy is not without risk. In addition to past history of ulcer disease, other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids, or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.n
  • To minimize the potential risk for an adverse GI event, the lowest effective dose should be used for the shortest possible duration.
  • NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated.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 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
  • Additional adverse experiences reported occasionally (<1% in patients taking ketorolac tromethamine or other NSAIDs in clinical trials) include:n
  • 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:n
  • 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:
  • 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 and ). This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of ketorolac tromethamine (see ).
  • 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 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 formulationn- notn- as an initial dose.
  • Use minimum effective dose
  • Total duration of treatment in adult patients:
  • Ketorolac Tromethamine Injection, USP is supplied as follows:
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from light.
  • Product of India
  • Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post, Hyderabad-500 043, INDIAn Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USAn
  • July 2017 PI583-00n
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Product of India
  • Manufactured by: Gland Pharma Limited D.P.Pally, Dundigal Post, Hyderabad - 500 043, INDIA
  • Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA
  • July 2017 PL583-00
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Label
  • NDCn- 583
  • Ketorolac Tromethamine Injection, USP
  • 15 mg/mL
  • FOR INTRAMUSCULAR OR INTRAVENOUS USE ONLY
  • 1 mL single-dose vial
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Carton
  • NDCn- 583
  • Ketorolac Tromethamine Injection, USP
  • 15 mg/mL
  • FOR INTRAMUSCULAR OR INTRAVENOUS USE ONLY
  • 25 x 1 mL Single-dose Vials
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Label
  • NDCn- 584
  • Ketorolac Tromethamine Injection, USP
  • 30 mg/mL
  • FOR INTRAMUSCULAR OR INTRAVENOUS USE ONLY
  • 1 mL single-dose vial
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Carton
  • NDCn- 584
  • Ketorolac Tromethamine Injection, USP
  • 30 mg/mL
  • FOR INTRAMUSCULAR OR INTRAVENOUS USE ONLY
  • 25 x 1 mL Single-dose Vials
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Vial Label
  • NDCn- 585
  • Ketorolac Tromethamine Injection, USP
  • 60 mg/2 mL
  • FOR INTRAMUSCULAR USE ONLY
  • 2 mL single-dose vial
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 Carton
  • NDCn- 585
  • Ketorolac Tromethamine Injection, USP
  • 60 mg/2 mL
  • FOR INTRAMUSCULAR USE ONLY
  • 25 x 2 mL Single-dose Vials

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