Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

Cardinal Health

INJECTION, SOLUTION

Strength 30 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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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 Cardinal Health. It is available in strength of 30 mg/mL per ml. Read more

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Rx only

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.u00a0 Oral ketorolac tromethamine is indicated only as continuation treatment following intravenous or intramuscular dosing of ketorolac tromethamine, if necessary.u00a0 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.u00a0 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 Deliveryu00a0
Concomitant Use with NSAIDs
Special Populations
DOSAGE AND ADMINISTRATION
Ketorolac Tromethamine Tablets

Ketorolac Tromethamine Injection, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs).u00a0 The chemical name for ketorolac tromethamine is (u00b1)-5-benzoyl-2,3-dihydro-1pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the chemical structure is:
CHNOM.W. 376.41
Ketorolac tromethamine is a racemic mixture of [-]S and [+]R ketorolac tromethamine.u00a0 Ketorolac tromethamine may exist in three crystal forms.u00a0 All forms are equally soluble in water.u00a0 Ketorolac tromethamine has a pKa of 3.5 and an n-octanol/water partition coefficient of 0.26.
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 intramuscular administration only.u00a0 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.u00a0 The pH is adjusted with sodium hydroxide and/or hydrochloric acid.u00a0 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 (u22645 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting.u00a0 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.u00a0
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 the severity of adverse reactions associated with the recommended doses (see and ).u00a0 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.u00a0 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.u00a0 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 and ).
Ketorolac tromethamine is contraindicated as prophylactic analgesic before any major surgery.
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 (seeu00a0for 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 u00a0and ).
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.

()
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.u00a0 Ketorolac tromethamine is not indicated for use in pediatric patients.u00a0
The most serious risks associated with ketorolac tromethamine are:
Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. u00a0Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy.
The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with ketorolac tromethamine. u00a0Do not use ketorolac tromethamine for more than five days.
However, even short-term therapy is not without risk. u00a0In 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. u00a0Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.
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, Crohnu2019s disease) as their condition may be exacerbated.
Arrayn- Hemorrhage
In postmarketing experience, postoperative hematomas and other signs of wound bleeding have been reported in association with the peri-operative use of intravenous or intramuscular dosing of ketorolac tromethamine.u00a0 Therefore, peri-operative use of ketorolac tromethamine should be avoided and postoperative use be undertaken with caution when hemostasis is critical (see ).
Arrayn- Renal Effects
Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.u00a0 Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. u00a0In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. u00a0Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Ketorolac tromethamine and its metabolites are eliminated primarily by the kidneys, which, in patients with reduced creatinine clearance, will result in diminished clearance of the drug (see ).u00a0 Therefore, ketorolac tromethamine should be used with caution in patients with impaired renal function (see ) and such patients should be followed closely.u00a0 With the use of ketorolac tromethamine, there have been reports of acute renal failure, interstitial nephritis and nephrotic syndrome.
Arrayn- Arrayn- Array
Arrayn- Arrayn- Array
Cardiovascular Effects
Arrayn- Cardiovascular Thrombotic Events
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events,
including myocardial infarction (MI) and stroke, which can be fatal. u00a0Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. u00a0The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.u00a0 However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate.u00a0 Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.u00a0 The increase in CV thrombotic risk has been observed most consistently at higher doses. u00a0
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. u00a0Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. u00a0Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. u00a0The concurrent use of aspirin and an NSAID, such as ketorolac tromethamine, increases the risk of serious gastrointestinal (GI) events (see ).
Arrayn- Status Post Coronary Artery Bypass Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.u00a0 NSAIDs are contraindicated in the setting of CABG (see ).
Arrayn- Post-MI Patients
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. u00a0In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. u00a0Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of Ketorolac Tromethamine Injection, USP, in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. u00a0If Ketorolac Tromethamine Injection, USP is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Arrayn- Hypertension
NSAIDs, including ketorolac tromethamine, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events.u00a0 Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ketorolac tromethamine, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.
Arrayn- Heart Failure and Edema
The Coxib and traditional NSAID Trialistsu2019 Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. u00a0Use of ketorolac tromethamine may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)] ().
Avoid the use of Ketorolac Tromethamine Injection, USP, in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. u00a0If Ketorolac Tromethamine Injection, USP, is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
Arrayn- Skin Reactions
NSAIDs, including ketorolac tromethamine, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. u00a0These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.
Arrayn- Pregnancy

No data

Adverse reaction rates increase with higher doses of ketorolac tromethamine.u00a0 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 and ).u00a0 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:u00a0
u00a0*Incidence greater than 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:
euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise
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:
Cardiovascular:
Dermatologic:
including Stevens-Johnson syndrome and toxic epidermal necrolysis
Gastrointestinal:
inflammatory bowel disease (ulcerative colitis, Crohnu2019s disease)
Hemic and Lymphatic:
pancytopenia, postoperative wound hemorrhage (rarely requiring blood transfusion u2014 see and )
Metabolic and Nutritional:
Nervous System:
Respiratory:
Special Senses:
Urogenital:
Arrayn- 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

Arrayn- Symptoms and Signs
Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care.u00a0 Gastrointestinal bleeding can occur.u00a0 Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare.u00a0 Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose.
Arrayn- Treatment
Patients should be managed by symptomatic and supportive care following a NSAIDs overdose.u00a0 There are no specific antidotes.u00a0 Emesis and/or activated charcoal (60 g to 100 g in adults, 1 g/kg to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large oral overdose (5 to 10 times the usual dose).u00a0 Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.
Single overdoses of ketorolac tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers, and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.u00a0u00a0

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. u00a0In adults, the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and oral ketorolac tromethamine is not to exceed 5 days. u00a0In adults, the use of oral ketorolac tromethamine is only indicated as continuation therapy to intravenous or intramuscular dosing of ketorolac tromethamine. u00a0See 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:
Arrayn- 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.u00a0 Hypovolemia should be corrected prior to the administration of ketorolac tromethamine (see ).u00a0 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.u00a0 The intramuscular administration should be given slowly and deeply into the muscle.u00a0 The analgesic effect begins in ~30 minutes with maximum effect in 1 to 2 hours after dosing intravenous or intramuscular.u00a0 Duration of analgesic effect is usually 4 to 6 hours.
Arrayn- Single-Dose Treatment: The Following Regimen Should Be Limited To Single Administration
Arrayn- Use Only
Intramuscular Dosing:
Intravenous Dosing:
Arrayn- Multiple-Dose Treatment (Intravenous or Intramuscular):
u00a0For breakthrough pain, do not increase the dose or the frequency of ketorolac tromethamine.u00a0 Consideration should be given to supplementing these regimens with low doses of opioids u201cprnu201d unless otherwise contraindicated.n n n
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 supplied as follows:
FOR INTRAMUSCULAR OR INTRAVENOUS USE.
The container closure is not made with natural rubber latex.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
Protect from light.
Retain in carton until time of use.NOVAPLUS is a registered trademark of Vizient, Inc.n n n

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
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.u00a0 You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
The risk of getting an ulcer or bleeding increases with:
NSAIDs should only be used:
What are NSAIDs?
Who should not take NSAIDs?n- 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 Nonsteroidal 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.u00a0 For more information, ask your healthcare provider or pharmacist about NSAIDs.
Call your doctor for medical advice about side effects.u00a0 You may report side effects to FDA at 1-800-FDA-1088.
Other information about NSAIDsu00a0
General information about the safe and effective use of NSAIDs
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.u00a0 Do not use NSAIDs for a condition for which it was not prescribed.u00a0 Do not give NSAIDs to other people, even if they have the same symptoms that you have.u00a0 It may harm them.
If you would like more information about NSAIDs, talk with your healthcare provider.u00a0 You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:n n Lake Zurich, IL 60047
Distributed By:
Cardinal Health
Dublin, OH 43017
L51227831118
www.fresenius-kabi.us
451430B
Revised:u00a0u00a0January 2017n n n n

Ketorolac Tromethamine Injection, USP 30 mg per mL
5 x 1 mL Single Dose Vials

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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

INJECTION, SOLUTION

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Ketorolac Tromethamine (Ketorolac Tromethamine)

Trade Name : Ketorolac Tromethamine

INJECTION, SOLUTION

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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