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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

Mylan Pharmaceuticals Inc.

TABLET, FILM COATED

Strength 10 mg/1

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 Mylan Pharmaceuticals Inc.. It is available in strength of 10 mg/1 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.

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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 tablets, a nonsteroidal 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
  • CARDIOVASCULAR THROMBOTIC EVENTS
  • RENAL RISK
  • RISK OF BLEEDING
  • Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery.
  • RISK DURING LABOR AND DELIVERY
  • CONCOMITANT USE WITH NSAIDs
  • SPECIAL POPULATIONS
  • 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-1-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol, and the structural formula 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.
  • Each tablet for oral administration contains 10 mg ketorolac tromethamine, USP. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, glyceryl triacetate, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.
  • No data
  • No data
  • Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.
  • Ketorolac tromethamine tablets are 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 ketorolac tromethamine-IV or IM and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary.
  • The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets 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 tablet therapy is not to exceed 5 days.
  • (see also )
  • Ketorolac tromethamine tablets are contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine.
  • Ketorolac tromethamine tablets are 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 tablets 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 ).
  • Ketorolac tromethamine tablets are contraindicated as prophylactic analgesic before any major surgery.
  • Ketorolac tromethamine tablets are 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 for 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 contractions, 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.
  • (see also )
  • The total combined duration of use of ketorolac tromethamine-IV/IM and ketorolac tromethamine tablets is not to exceed 5 days in adults. Ketorolac tromethamine tablets are 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 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.
  • 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:
  • 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 post-marketing experience in patients taking ketorolac tromethamine or other NSAIDs) are:
  • Body as a Whole:
  • Cardiovascular:
  • Dermatologic:
  • Gastrointestinal:
  • Hemic and Lymphatic:
  • Metabolic and Nutritional:
  • Nervous System:
  • Respiratory:
  • Special Senses:
  • Urogenital:
  • Post-Marketing Surveillance Study:
  • 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 ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to IV or IM dosing of ketorolac tromethamine.
  • Ketorolac Tromethamine Tablets, USP are available containing 10 mg of ketorolac tromethamine, USP.
  • The tablets are white, film-coated, round, unscored tablets debossed with over on one side and blank on the other side. They are available as follows:
  • NDC 0378-1134-01 bottles of 100 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.]
  • Protect from light and excessive humidity.
  • Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
  • PHARMACIST:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Mylan Pharmaceuticals Inc.
  • Revised: 9/2019KTLC:R9m
  • NDC 0378-1134-01
  • Ketorolacn- Tromethaminen- Tablets, USPn- 10 mg
  • PHARMACIST: Dispense the accompanyingn- Medication Guide to each patient.
  • Rx onlyu00a0u00a0u00a0u00a0u00a0100 Tablets
  • Each film-coated tabletcontains: Ketorolactromethamine, USP 10 mg
  • Dispense in a tight, light-resistantcontainer as defined in the USPusing a child-resistant closure.
  • Keep container tightly closed.
  • Keep this and all medicationn- out of the reach of children.
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Roomn- Temperature.]
  • Protect from light and excessiven- humidity.
  • Usual Adult Dosage:
  • Mylan Pharmaceuticals Inc.
  • Mylan.com
  • RM1134A6

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