Keramix

Quick links to important sections

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Keramix

Quick Facts About Keramix

Property Description
Active ingredient Ketorolac tromethamine
Forms Solution for injection, Oral tablets, Ophthalmic solution
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
General purpose Relief from moderate to severe acute pain
Origin Synthetic compound (benzopyrrolizine derivative)

What Type of Medicine is Keramix and How Does It Work?

Keramix is a prescription-only medicinal product whose active component is Ketorolac tromethamine. It is formally classified as a potent analgesic within the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. It is categorized as an effective short-term NSAID for severe pain. The fundamental mechanism involves the drug acting as a cyclooxygenase (COX) inhibitor, which suppresses the body's synthesis of prostaglandins. By blocking these key chemical messengers, Keramix achieves powerful analgesic, anti-inflammatory, and antipyretic effects.

Composition, Origin, and Available Forms

Ketorolac tromethamine is a synthetic compound with a chemical structure based on a benzopyrrolizine derivative. This medicinal product is available in several high-level dosage forms designed for targeted or systemic delivery. These include an aqueous solution for injection (parenteral use), oral tablets, and a sterile ophthalmic solution for localized topical application. The availability of multiple delivery forms, particularly the injectable solution, differentiates it from many standard NSAIDs and allows for rapid administration in acute care settings.

General Therapeutic Role of Keramix

Keramix’s primary therapeutic role is to provide effective relief from moderate to severe acute pain. For instance, it is commonly used to manage intense discomfort following a minor surgical procedure or acute musculoskeletal injury. The drug has pronounced analgesic strength among NSAIDs, making it a valuable non-opioid alternative for intense, short-term discomfort and the accompanying physiological manifestations of tissue damage.

What side effects are possible with Keramix?

Keramix: Possible Side Effects and Safety Information

Official government regulatory bodies, such as the FDA and the EMA, define a medicine's safety profile by systematically classifying all reported adverse reactions and clinical risks. For Keramix, the regulatory documentation outlines side effects based on their observed frequency and the affected body system.

Adverse Reaction Classification

Adverse reactions documented in official product information are categorized into frequency bands established by international safety guidelines. These typically include Very Common (ge 1/10 patients), Common (ge 1/100 to < 1/10 patients), and Uncommon (ge 1/1,000 to < 1/100 patients) reactions.

Reported adverse events are also grouped by System-Organ Class to provide a clear view of how the medicine affects different parts of the body, such as infections and infestations, gastrointestinal disorders, and nervous system disorders.

Classification Examples of Affected Systems
Frequency Bands Very Common, Common, Uncommon
Organ Systems Gastrointestinal Disorders, Skin and Subcutaneous Tissue Disorders, Infections and Infestations

Serious Adverse Reactions and Limitations

The most significant safety concerns, classified as Serious Adverse Reactions, are explicitly highlighted in regulatory texts and may include major adverse cardiovascular events, malignancies, and severe infections. The formal documentation also specifies Safety-Related Restrictions or Limitations on the use of Keramix, such as contraindications for patients with known hypersensitivity to the drug's components or those with active, serious systemic infections.

Population-Specific Safety Considerations may also be defined, particularly for use in older adults or patients with pre-existing conditions, which legally restricts the patient groups for whom the medicine is intended or requires specialized clinical caution.

The regulatory documentation forms the official basis for understanding Keramix’s risk profile by detailing the full spectrum of observed side effects, from the most frequent to the rarest, most critical risks. This structure mandates specific monitoring requirements and formally defines the conditions for the medicine's safe use.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

The official overdose profile for Keramix (Ketorolac tromethamine) is based on reports of acute Nonsteroidal Anti-Inflammatory Drug (NSAID) exposure. Overdose symptoms are typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible.

Serious Outcomes and Emergency Action

Urgent medical attention is required for the development of severe manifestations, including gastrointestinal bleeding, acute renal failure, hypertension, respiratory depression, and coma (reported as a rare occurrence). Anaphylactoid reactions may also occur following an overdose.

If a large oral overdose (5 to 10 times the usual dose) is suspected, immediate medical consultation is necessary, especially if the patient is seen within four hours of ingestion.

Management Measures

Patient management must consist of symptomatic and supportive care, as regulatory labeling confirms that no specific antidotes are documented. Procedural interventions, such as the use of activated charcoal and/or an osmotic cathartic, may be indicated under medical supervision within the four-hour post-ingestion window, with specific dosing guidance provided for adults and children.

Therapeutic Uses of Keramix

What Keramix Treats: Main Uses and Benefits

Keramix (Ketorolac tromethamine) is generally applied across therapeutic domains where additional symptomatic support is needed for managing acute and heightened discomfort. Its primary therapeutic role is to support patients during episodes of moderately severe acute pain, particularly in areas where short-term symptom management is appropriate. This medication is commonly used to help with symptom clusters related to physical discomfort that create noticeable physiological strain, offering symptomatic relief that supports patients during difficult episodes.

It is relevant in clinical settings that involve acute or disruptive symptom patterns, such as managing intense discomfort following surgical interventions (postoperative pain), as well as easing symptoms linked to organ-specific functional stress like renal colic or severe dysmenorrhea. It provides support that helps maintain a sense of stability when symptoms are more noticeable, contributing to general well-being during symptomatic phases. For its ophthalmic form, Keramix may be applied in situations where patients experience localized pain and inflammation that can occur after certain eye procedures.


Quick Fact: Relevant for Acute Discomfort Management

Eligibility and Restrictions for Use

Population Eligibility and Contraindications

Keramix (Ketorolac tromethamine) is not suitable for all populations and is subject to strict eligibility rules documented in official prescribing information. The medicine is formally contraindicated in patients with conditions posing a high risk of bleeding, including active peptic ulcer disease, recent gastrointestinal bleeding, or cerebrovascular hemorrhage. Use is also prohibited in patients with advanced renal impairment, severe hepatic failure, or known allergy to aspirin or other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs).

Furthermore, Keramix must not be used for pain in the setting of Coronary Artery Bypass Graft (CABG) surgery or as prophylactic analgesia before major surgery. Use is generally not recommended in children under 16 years of age, as safety and efficacy have not been established by regulatory authorities.

For older adults (65 years and over) and patients with a body weight less than 50 kg, the total daily dosage must be reduced. Keramix is contraindicated during the third trimester of pregnancy, labor and delivery, and while breastfeeding.

What should I know about interactions with other medicines?

Keramix (Ketorolac tromethamine) has a well-defined interaction profile documented by regulatory agencies that establishes restrictions on co-administration.

Formal Prohibitions and Exposure Risk

Co-administration is formally contraindicated with certain substances due to high risk of severe complications. These prohibited combinations include Aspirin and other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), which carry a cumulative risk of adverse effects. The co-use of Probenecid is strictly prohibited, as it significantly impairs the clearance of Keramix, leading to an approximate threefold increase in its plasma exposure. Due to the high risk of gastrointestinal or systemic bleeding, combination with Warfarin and other anticoagulants is restricted.

Pharmacodynamic and Pharmacokinetic Effects

Interactions are often classified as pharmacodynamic. This includes a synergistic increase in bleeding risk when co-administered with drugs that interfere with hemostasis, such as SSRIs or antiplatelet agents. Furthermore, Keramix may diminish the therapeutic effect of diuretics and antihypertensive medicines (e.g., ACE Inhibitors) by inhibiting renal prostaglandin synthesis. In the pharmacokinetic domain, Keramix can reduce the clearance of drugs such as Lithium and Methotrexate, which may result in elevated plasma levels and potential toxicity for the co-administered drug. The regulatory profile explicitly states that Keramix does not induce or inhibit hepatic enzymes of the CYP450 system.

Restrictions and Limitations

Specific administration constraints exist, including a maximum 5-day combined total duration of use across all formulations. Ingestion of alcohol increases the risk of stomach bleeding, and taking the oral form with a high-fat meal reduces its peak concentration. Caution regarding the interaction with ACE inhibitors/ARBs is specifically noted for elderly or volume-depleted patients.

Mechanism of Action

️ How Keramix Works: Mechanism of Action

The mechanism of Keramix, featuring the active compound Ketorolac tromethamine, centers on its non-selective interference with the body’s primary enzyme system for generating pain and inflammation mediators.

Molecular Interruption of Prostanoid Synthesis

Keramix operates by serving as a non-selective inhibitor of the Cyclooxygenase (COX) enzymes, targeting both COX-1 and COX-2. By blocking the active sites of these enzymes, the drug fundamentally interrupts the arachidonic acid cascade, preventing the molecular synthesis of prostaglandins and other prostanoids. This blockade of chemical production determines the drug’s entire physiological profile.

Dual Modulation of Nociceptive Signaling

The subsequent systemic reduction in prostanoids, especially PGE2, results in a dual-level action on pain signaling. Peripherally, it mitigates the sensitization of nociceptors at the site of tissue injury; centrally, it modulates the amplification of pain signals within the spinal cord and brain. The mechanism results in the attenuation of heightened nociceptive signal transmission, which defines the mechanistic scope of its nociceptive influence.

Regulating Systemic Inflammatory and Temperature Responses

The mechanism’s systemic impact extends to inflammation and fever. The lowered concentration of pro-inflammatory prostaglandins alters local vascular permeability, consequently influencing tissue fluid dynamics. Furthermore, by reducing PGE2 levels near the hypothalamic thermoregulatory center, the mechanism facilitates the adjustment of the elevated hypothalamic thermoregulatory set-point, defining the molecule's mechanistic influence on thermoregulation.

Dosage and Administration Information

How to Use Keramix

Keramix (Ketorolac tromethamine) is intended strictly for the short-term management of acute pain. Its use is limited to a specified maximum duration for all systemic forms.


Administration Routes and Duration Limits

Keramix is available in several administration routes, and the total systemic treatment time is strictly capped:

  • Systemic Routes: Available as a Solution for Injection (Intravenous [IV] or Intramuscular [IM]) and Oral Tablets.
  • Localized Routes: Available as a sterile Ophthalmic Solution (topical drops) and, in some regions, a Nasal Spray.
  • Duration Limit: The total combined duration of systemic therapy (IV, IM, and Oral) must not exceed 5 days in adult patients.

Standard Dosing and Administration Conditions

Dosages are fixed, non-titratable, and must not exceed established maximums. The oral form is intended only for bridging from the injectable form.

Population / Route Standard Dosing Regimen Maximum Daily Dose
IV/IM (Adults < 65 yrs) 30 mg every 6 hours 120 mg
Oral (Continuation) 10 mg every 4 to 6 hours 40 mg
Special Populations 15 mg every 6 hours 60 mg

Special Population Dosing (Maximum 60 mg/day) applies to patients 65 years of age or older, those weighing less than 50 kg, or those with renal impairment. The injectable solution must be administered slowly; an IV bolus must be given over no less than 15 seconds. The oral tablet must not be used as the initial dose; it is reserved for continuation after parenteral treatment. Safety and efficacy are generally not established for pediatric patients.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Keramix

Keramix (Ketorolac tromethamine) has been subject to clinical evaluation, primarily through high-quality Randomized Controlled Trials (RCTs) and subsequent meta-analyses that summarize findings across multiple studies. The evidence focuses predominantly on short-term use in acute care settings, with the duration of treatment reflecting regulatory specifications.


Evidence for Use in Moderate to Severe Acute Pain

Research exploring how symptoms change over time has involved short-term RCTs comparing Keramix to a placebo, opioid medications, or other nonsteroidal anti-inflammatory drugs. Researchers examined outcomes related to physical discomfort, primarily tracking changes in pain intensity using standardized scales and monitoring the use of supplemental analgesic medication.

Studies report how symptoms evolved in the observed populations by describing patterns of changes in pain intensity scores measured over short intervals. Research highlights measured changes in the use of supplemental pain medications, such as opioids, during the study period. This evidence contributes to understanding short-term symptom patterns in patients experiencing acute discomfort. Evidence remains limited regarding the use of Keramix when treatment extends beyond the maximum recommended duration of five days.


Evidence for Use in Postoperative Pain Management

Studies in this area focus on patients experiencing heightened discomfort following surgical interventions. Research used RCTs and meta-analyses relevant to pain. The systemic trials evaluated outcomes related to physical discomfort and monitored the amount of opioid medication used by patients during the immediate recovery phase. Trials for the ophthalmic form monitored outcomes linked to inflammatory or irritative states and local pain scores after specific eye procedures.

The short-term focus of the core evidence means that long-term effects are not fully established, particularly concerning functional recovery or long-term symptom patterns beyond the acute surgical phase. Comparative evidence is lacking in certain complex surgical scenarios where pain management protocols may vary significantly.


Evidence in Special Populations and Subgroups

Data for certain groups remain insufficient, and research is ongoing. Studies often included separate analyses or provided limited information for the elderly (65 years and older) due to metabolic differences. Research has also explored its use in adolescents (12–17 years) in certain post-operative settings, but overall evidence quality varies across these specific subgroup studies compared to the data available for general adult use.

Frequently Asked Questions (FAQ)

Common questions about Keramix (FAQ)


Q: What are the most common side effects of Keramix that people talk about online?

A: Regulatory documents list common adverse reactions, which are those seen in 1 in 10 to 1 in 100 patients. These commonly reported effects can include headache, dizziness, nausea, diarrhea, stomach pain, indigestion, and unusual weight gain, which is often associated with fluid retention.


Q: What should I watch out for when starting Keramix?

A: Official warnings advise monitoring for signs of serious adverse reactions, which are rare but significant. These may include symptoms of gastrointestinal bleeding, such as bloody or black, tar-like stools. Patients are cautioned to monitor for signs of a severe allergic reaction, such as difficulty breathing or swelling of the face and throat.


Q: Is it mentioned in the research if Keramix causes long-term side effects?

A: Regulatory information specifies that this medicine is strictly intended for short-term use, generally limited to a maximum of five days. This is because the regulatory-backed research indicates that the risks of serious adverse effects, particularly to the gastrointestinal and cardiovascular systems, increase with the duration of treatment.


Q: How quickly does Keramix usually start working according to studies?

A: According to studies in clinical pharmacology, the injectable form of the medicine often begins to provide pain relief within approximately 30 minutes of administration. The medicine is designed for rapid relief in acute care settings, with the peak analgesic effect typically occurring within a few hours.


Q: What is the expected duration of treatment with Keramix?

A: The total systemic treatment duration, which includes all administration routes (injection and oral tablets), is strictly limited by regulatory documents. For adult patients, the combined duration of therapy must not exceed a maximum of five days.


Q: What happens if I stop taking Keramix suddenly?

A: Official regulatory documents do not list specific withdrawal symptoms associated with stopping the use of Keramix. This is because the medicine is not classified as an opioid or controlled substance and is intended for short-term, acute use.


Q: What does the patient information leaflet say about missed doses?

A: Regulatory patient information generally describes protocols for a missed dose, which involves taking the dose if remembered soon after the scheduled time, but skipping it if it is almost time for the next scheduled dose. Doubling the dose to compensate is not advised.


Q: What if I experience mild headaches while on Keramix?

A: Headache is consistently listed in official documentation as a commonly reported adverse reaction. Experiencing a headache is typically noted within the profile of expected side effects.


Q: Are there any warnings about driving or operating machinery while on Keramix?

A: Official warnings advise that this medicine may cause central nervous system effects such as dizziness or drowsiness. Regulatory warnings state that caution should be exercised regarding driving or operating machinery, as the medicine may cause dizziness or drowsiness.


Q: Is Keramix a steroid or an antibiotic?

A: Keramix is formally classified as a potent analgesic within the Nonsteroidal Anti-Inflammatory Drug (NSAID) class. It is neither a steroid medicine nor an antibiotic.


Q: Can Keramix affect my sleep?

A: Regulatory documentation reports drowsiness as a common adverse reaction. Drowsiness is a central nervous system effect that can influence a person's state of wakefulness and may consequently affect sleep patterns.


Q: Is it normal to feel a change in appetite while using Keramix?

A: A change in appetite is not commonly listed as a direct side effect. However, the regulatory documents do report common gastrointestinal adverse reactions, such as nausea and abdominal discomfort, which may secondarily affect eating patterns.


Q: What is considered a serious reaction to Keramix?

A: Serious adverse reactions are described in official warnings and may include gastrointestinal bleeding, ulceration, or perforation. Other serious risks involve major cardiovascular thrombotic events, such as heart attack or stroke, and severe allergic reactions.


Q: Can I take Keramix if I also take Tylenol (acetaminophen)?

A: Official regulatory interaction lists do not generally include a formal prohibition or contraindication for co-administration with acetaminophen.


Q: Are there any specific foods or drinks that should be avoided with Keramix?

A: Official documents primarily advise caution regarding the ingestion of alcohol due to the increased risk of stomach bleeding. Additionally, taking the oral form with a high-fat meal may reduce the medicine’s maximum concentration in the bloodstream.


Q: Does alcohol interact with Keramix?

A: Yes, regulatory warnings specify that alcohol interacts by significantly increasing the risk of serious gastrointestinal bleeding when co-administered with this medicine.


Q: Is Keramix approved in countries outside of the US?

A: Regulatory data confirms that the active ingredient, Ketorolac tromethamine, has received regulatory approval and is marketed under various names in numerous countries globally, including many in Europe and Canada.


Q: Does Keramix contain any common allergens like gluten or lactose?

A: The official regulatory documentation for the medicine contains the complete list of inactive ingredients, or excipients, for each specific dosage form. The inactive ingredient list is available in the official documentation for reference regarding the presence of common allergens such as gluten or lactose.


Q: Why do doctors often mention that Keramix must be taken consistently?

A: This recommendation relates to the drug's mechanism as a continuous inhibitor of prostaglandin synthesis. Maintaining a consistent level of the medicine is typically required throughout the short-term treatment period to sustain its full analgesic and anti-inflammatory effects.


Q: Is Keramix a controlled substance?

A: No, regulatory classification documents, such as the U.S. DEA schedule, indicate that this medicine is not considered a controlled substance.


Q: Do I need a special blood test before starting Keramix?

A: The official prescribing information requires clinical monitoring, particularly for renal (kidney) and hepatic (liver) function, during the use of this medicine due to the specific risks outlined in the warnings.


Q: Does Keramix make people gain or lose weight?

A: Regulatory documentation lists unusual weight gain as a commonly reported adverse reaction. This weight gain is typically associated with fluid retention, also known as edema.


Q: Is the tiredness mentioned as a side effect usually mild or severe?

A: Drowsiness is listed in regulatory documentation as a common adverse reaction. However, official product information does not typically classify the intensity of common side effects as 'mild' or 'severe' outside of specific, defined risk warnings.


Q: Does Keramix affect blood pressure?

A: Regulatory documents state that this medicine, like other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), can be associated with the onset of new high blood pressure. It may also worsen existing high blood pressure in some patients.


Q: What are the ingredients listed in Keramix besides the active substance?

A: The complete list of inactive ingredients, or excipients, for the specific dosage form of Keramix is published in the official regulatory documentation, such as the full prescribing information for the medicine.


Q: How long after stopping Keramix does it stay in the body?

A: Pharmacokinetic studies reported in regulatory documents indicate that the mean plasma elimination half-life for the medicine is approximately 5 to 6 hours. This means it takes 5 to 6 hours for half of the dose to be cleared from the bloodstream.


Q: Is Keramix known to be habit-forming?

A: This medicine is not classified as a controlled substance, and official documentation does not contain warnings that indicate the medicine is habit-forming.


Q: Is Keramix available as a generic medicine?

A: Yes, the active ingredient, Ketorolac tromethamine, is available as a generic medicinal product. This is supported by regulatory filings such as Abbreviated New Drug Applications (ANDA) with the FDA.


Q: Does the efficacy of Keramix change over time?

A: The official research evidence does not address whether efficacy changes over time because the use of the medicine is strictly limited to a maximum of five days. This restriction is based on the acute-care focus of the data.


Q: Are there specific warnings for people with diabetes using Keramix?

A: Official documentation includes diabetes mellitus (sugar diabetes) as a pre-existing medical condition that requires attention and monitoring when this medicine is used. This is a common precaution for NSAIDs.

How should Keramix be stored and disposed of?

The storage and disposal of Keramix (Ketorolac tromethamine) are governed by the specific regulatory requirements for each dosage form.

Storage Conditions

Dosage Form Temperature & Protection Stability & Container Rules
Injection Store at 20 C to 25 C; protect from light and retain in original carton [Source 1.1]. Use immediately upon opening; discard any unused contents [Source 1.3].
Oral Tablets Store at room temperature (15 C to 30 C); away from excess heat and moisture [Source 2.2]. Keep container tightly closed [Source 2.2].
Ophthalmic Solution Store at 20 C to 25 C; keep from freezing and protect from light [Source 1.4, 1.2]. Discard unused multi-use solution one month after opening [Source 3.2].

All forms of this medication must be stored out of the reach of children. Disposal of expired or unused product must follow local regulatory requirements; patients should utilize a drug take-back program or consult a pharmacist for safe disposal instructions [Source 2.4].

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Keramix found in:

A-Z Index: