Sirolac

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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 Sirolac

Property Description
Active ingredient Ketorolac tromethamine
Form Oral tablet, injectable solution, topical solution
Pharmacological class Non-steroidal Anti-inflammatory Drug (NSAID)
Common use Acute, moderately severe pain relief
Origin Synthetic, pyrrolo-pyrrole group

What is Sirolac and What Type of Medicine is It?

Sirolac is a medicinal preparation whose active agent is Ketorolac, formally recognized and classified as a Non-steroidal Anti-inflammatory Drug (NSAID). This medication is a synthetic, prescription-only analgesic agent. Its distinctive pharmacological efficacy places it within the First-generation NSAID category.

Sirolac is intended for the short-term management of acute, moderately severe pain, often administered in the initial phases of recovery. The potency of the Ketorolac compound is clinically recognized for providing analgesia comparable to certain narcotic agents. This means the medication can provide substantial relief for serious discomfort without being a narcotic.

Composition and Available Forms of Ketorolac

Sirolac’s core therapeutic component is Ketorolac tromethamine, the single-active ingredient supplied as a racemic mixture. The compound is derived from the distinct pyrrolo-pyrrole chemical group, differentiating its structure from other NSAIDs.

Sirolac is uniquely defined by the wide range of its dosage forms and routes of administration, which facilitates its use in various clinical settings. These forms include oral tablets, sterile solutions for injection (intramuscular or intravenous), and specialized topical solutions, such as ophthalmic preparations. This versatility is a key feature, enabling rapid delivery where immediate relief is necessary.

General Purpose: Non-narcotic Analgesia

The general purpose of Sirolac is to provide powerful pain relief (analgesia) and reduce associated inflammation. It achieves this primary function by acting as a Cyclooxygenase (COX) inhibitor, thereby blocking the synthesis of chemical mediators (prostaglandins) that transmit pain signals. This pharmacological function establishes its therapeutic utility as a strong, non-narcotic agent for the rapid mitigation of moderately severe acute pain.

Regulatory References

  1. NIH DailyMed label for Ketorolac

What side effects are possible with Sirolac?

Possible Side Effects and Safety Information

The safety profile of Sirolac (sirolimus) is strictly defined by government regulatory agencies and centers on specific categories of risks, side effects, and required monitoring. This information is based exclusively on official regulatory documents and is not a substitute for speaking with a healthcare professional.

Serious and Significant Risks

Sirolac carries an official Boxed Warning regarding two major, life-threatening risks:

  • Serious Infections: The medication increases the risk of developing serious, potentially fatal infections, including bacterial, viral, fungal, and protozoal infections.
  • Malignancy: It increases the risk of developing lymphoma and other malignancies, particularly skin cancer.

Specific Safety Restrictions

Official regulatory documents state that use is not recommended in certain patient populations due to observed excessive risk:

  • Liver Transplant Patients: Use has been associated with excess mortality and hepatic artery thrombosis.
  • Lung Transplant Patients: Use has been associated with bronchial anastomotic dehiscence (separation) and a higher risk of death.

Common Adverse Reactions

Regulatory sources classify the following as Very Common (occurring in 1 in 10 or more people) or Common side effects, organized by the body system affected:

System Very Common Reactions Common Reactions
Blood & Lymphatic Anemia (low red blood cells) Thrombocytopenia (low platelets), Leukopenia (low white blood cells)
Metabolic Hypercholesterolemia (high cholesterol), Hypertriglyceridemia (high triglycerides) Hypokalemia (low potassium), Diabetes Mellitus (high blood sugar)
General Peripheral edema (swelling in limbs), Pain, Hypertension Stomatitis (mouth inflammation), Fever

Safety Monitoring

Due to the drug's narrow therapeutic range, mandatory Therapeutic Drug Monitoring (TDM) is required to measure Sirolac levels in the blood. This monitoring is essential to maintain concentrations within a safe and effective target range to minimize dose-related adverse effects such as high cholesterol and low blood cell counts, which are known to be dose-dependent.

Overdose and Emergency Response

Sirolac (Ketorolac tromethamine) overdose is defined by regulator-documented clinical manifestations, which range from generally reversible symptoms to potential life-threatening events. Common presentations listed in official labeling include signs typical of Non-Steroidal Anti-inflammatory Drug (NSAID) toxicity, such as lethargy, drowsiness, vomiting, and epigastric pain. More specific documented findings involve the gastrointestinal system, including abdominal pain, erosive gastritis, and peptic ulcers, as well as renal dysfunction.

Severe Outcomes and Required Action

Severe outcomes, though rare, are officially documented and include acute renal failure, respiratory depression, and coma. Gastrointestinal bleeding and anaphylactoid reactions are also listed as possible serious events. Due to the potential for these severe manifestations, urgent medical assessment is required when an overdose is suspected.

Treatment is mandated to consist of symptomatic and supportive care, as regulatory information states that no specific antidote is known for Sirolac. Supportive measures, such as the use of activated charcoal and an osmotic cathartic, may be indicated by medical personnel if a large oral ingestion (5 to 10 times the usual dose) is reported within four hours. Procedures like hemodialysis are officially stated as not useful because of the drug's high protein binding.

Therapeutic Uses of Sirolac

What Sirolac Treats: Main Uses and Benefits

Sirolac is commonly used for the short-term management of acute, moderately severe pain, and plays a role in managing intense discomfort. This medication is used to relieve moderately severe pain, commonly used across conditions presenting with acute episodes. Its use is relevant for easing discomfort and symptoms related to inflammatory or irritative states in acute clinical settings.

The medication is generally applied in addressing conditions associated with acute or disruptive episodes, including post-procedural discomfort, acute musculoskeletal pain, and conditions involving inflammatory or irritative processes.

“Sirolac supports the patient during difficult episodes by easing distress and managing the symptom load.”

Therapeutic Focus and Symptom Relief

Sirolac is applied in clinical settings that involve acute or unstable symptom patterns where a patient experiences pronounced symptomatic pain, such as following surgery or acute trauma. This supports general well-being during symptomatic phases. It is relevant when short-term symptomatic assistance is needed in contexts marked by significant discomfort, and plays a role in managing symptoms that interfere with daily comfort. This approach contributes to improved comfort during periods of heightened symptoms, which may assist with managing acute discomfort.


Quick Fact: Managing Acute, Moderately Severe Pain

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Sirolac (Ketorolac) is an NSAID with strict regulatory guidelines defining who can and cannot use the medicine. It is authorized only for short-term management of moderately severe acute pain in adult patients.

The medicine is contraindicated and must not be used by patients with a history of peptic ulcer disease or recent gastrointestinal bleeding. Absolute prohibitions also apply to individuals with advanced renal impairment, severe uncontrolled heart or liver failure, a high risk of bleeding (including suspected cerebrovascular bleeding), or known hypersensitivity to Sirolac, aspirin, or any other NSAID. Sirolac is also contraindicated for pain management during Coronary Artery Bypass Graft (CABG) surgery and must not be used concurrently with other NSAIDs or aspirin.

Use is highly restricted or prohibited in several special populations. Sirolac is not indicated for pediatric patients because safety and efficacy have not been established. It is also contraindicated during breastfeeding, labor and delivery, and from 30 weeks gestation onward. For patients 65 years of age or older and those under 50 kg, regulatory labels require a reduced maximum daily dose.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Sirolac (Sirolimus) is primarily metabolized by the Cytochrome P450 3A4 (CYP3A4) enzyme system and is a substrate for the P-glycoprotein (P-gp) efflux pump. Due to this metabolic pathway, Sirolac's interaction profile is significantly affected by co-administered substances that inhibit or induce these systems, which can alter the concentration of Sirolac in the body.

Clinically Significant Interacting Substances

Official regulatory documents require specific management instructions for the following interaction domains:

Interaction Domain Example Substances/Classes Practical Implication
Strong CYP3A4 Inhibitors Ketoconazole, Voriconazole, Clarithromycin Co-administration is generally not recommended. Requires high vigilance and potential dose modification.
Strong CYP3A4 Inducers Rifampicin, Phenytoin, Rifabutin Co-administration is generally not recommended as it can significantly reduce Sirolac concentration.
Specific Medications Diltiazem, Verapamil, Erythromycin Requires therapeutic drug monitoring of Sirolac blood levels and dose adjustment.
Other Immunosuppressants Ciclosporin Administration requires a 4-hour separation between the two medicinal products to manage absorption effects.

Food and Product Restrictions

Consumption of Grapefruit and Grapefruit Juice is explicitly restricted and must be avoided. These products are known to inhibit the CYP3A4 enzyme, leading to potentially increased Sirolac concentrations. No other specific food or beverage restrictions are uniformly documented in regulatory interaction statements.

Mechanism of Action

Non-Selective Inhibition of COX Enzymes

Ketorolac acts by exerting an inhibitory influence on the body's chemical signaling pathways that are activated in response to tissue injury. The mechanism is highly targeted at the enzyme level, leading to systemic physiological consequences.

Sirolac functions as a non-selective inhibitor that blocks the activity of both the Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) enzymes. This interaction is competitive, where the active S-enantiomer prevents the binding of arachidonic acid to the enzyme, immediately halting the initial molecular step of the prostanoid cascade.

By inhibiting the COX enzymes, the drug prevents the conversion of arachidonic acid into chemical messengers like prostaglandins and thromboxane. The resulting absence of prostaglandins reduces the sensitization of nociceptors and limits local inflammatory processes, which are the resulting physiological consequences of the mechanism.

This non-selective mechanism, specifically its action on COX-1, affects physiological systems in addition to those governing inflammation. By blocking the synthesis of Thromboxane A2 ( TXA2) in platelets, the mechanism suppresses platelet aggregation. Similarly, the mechanism modulates prostaglandin-dependent processes essential for maintaining renal blood flow under certain physiological conditions.

Dosage and Administration Information

Instruction Map: How to use Sirolac — Administration Guidelines


Administration Scope

Property Detail
Route of administration: Intravenous (IV) injection, Intramuscular (IM) injection, Oral (tablets), and Intranasal (spray) for systemic use.
Dosing schedule: Parenteral: 30 mg every 6 hours, up to 120 mg maximum daily dose for standard adults. Oral: 10 mg every 4 to 6 hours.
Timing in relation to meals (if applicable): Instructions do not strictly mandate timing relative to food; oral forms may be taken with food.
Preparation requirements (if applicable): IV Bolus: Must be administered over no less than 15 seconds. Nasal Spray: Requires priming prior to initial use.
Age-group administration rules: Patients 65 years of age or older, low-weight patients, and those with renal impairment require a reduced dose (e.g., maximum 60 mg/day).
Special procedural conditions: Oral therapy is intended solely as a continuation after IV or IM administration; the injection is prohibited for epidural or intrathecal use.

Instruction Classifications (High-Level)

Classification Detail
Administration method type: Parenteral (IV/IM), Oral, and Intranasal.
Frequency pattern: Multiple times per day (e.g., every 6 hours); Duration is time-limited.
Use-context constraints: The total combined duration of use for all systemic forms must not exceed 5 days.

Connection to the overall use protocol (2–4 sentences): Established clinical guidelines outline a controlled, sequential protocol for Sirolac that begins with injection before transitioning to oral or nasal forms for treatment completion. This protocol mandates a maximum total duration of five days for all systemic use, defining the strictly short-term nature of the treatment. Furthermore, standardized dosing protocols set clear maximum daily dose thresholds and require mandatory dose reductions for specific patient populations.

Recent Clinical Evidence

Research evidence / Overview of studies for Sirolac

Evidence Base for Acute, Moderately Severe Pain

Research into Sirolac (Ketorolac), a prescription medication, has focused heavily on its use as an analgesic compound for temporary pain episodes. Studies conducted during periods of increased symptom activity include Randomized Controlled Trials (RCTs), where the compound was evaluated alongside a placebo or standard compounds. These studies monitored outcomes related to physical discomfort over very short, defined time intervals.

The trials were primarily designed to track patient-reported outcomes describing perceived discomfort, such as changes measured using standard pain rating scales. Research highlights changes measured during the study period, which were assessed across short observation durations. Findings describe patterns observed in the studies related to the administration of rescue medication. The studies conducted in these settings evaluated how symptoms evolved in the observed populations during a strictly limited treatment course.

Evidence Base in the Post-Procedural Setting

A significant portion of the evidence base comes from studies where Sirolac was evaluated in patients experiencing discomfort immediately following surgical procedures. These controlled research scenarios examined outcomes related to systemic or functional imbalance often seen after surgery. Studies monitored the use of supplementary pain relievers alongside Sirolac to assess the frequency of their administration during the recovery period.

The short-term symptom patterns in these studies were monitored for a maximum of five days, consistent with the short observation periods of the research. Findings often described patterns related to the measurement of supplementary analgesic consumption.

Research on Follow-up Duration and Long-Term Outcomes

The available research provides context but not individual predictions regarding the duration of effect. The evidence consistently demonstrates that follow-up durations were limited, reflecting the compound's intended use solely for acute pain management. The evidence used for review focused almost exclusively on the short-term observation period, typically le5 days.

Research exploring extended treatment courses beyond the limited le5 day period is minimal. This means that long-term effects are not well characterized in the official evidence base. Study results reflect the specific conditions under which they were conducted.

Evidence in Specific Patient Populations

Studies have monitored the use of Sirolac, often at adjusted amounts, in certain subgroups of older adults (ge65 years old). Conversely, few data are available for the systematic study of Sirolac in the pediatric population (children). Additionally, trial populations often excluded patients with pre-existing conditions such as moderate to severe kidney or heart disease, meaning data for these complex, comorbid groups are still emerging.

Key Studies & References

  1. Ketorolac Tromethamine: Package Insert / Prescribing Information (Oral and Injection)
  2. Ketorolac: Adverse Effects and Clinical Considerations in the Elderly
  3. Ketorolac Injection: MedlinePlus Drug Information (National Library of Medicine)

Frequently Asked Questions (FAQ)

Common questions about Sirolac (FAQ)


Q: How quickly does Sirolac typically start working?

According to the official product information, the pain-relieving effect of Sirolac begins relatively quickly, often starting in approximately 30 minutes after administration. The medication reaches its maximum effect for pain relief typically within one to three hours following a dose.


Q: Does Sirolac cause weight changes, like gain or loss?

Regulatory safety documents indicate that 'unusual weight gain' has been reported as a possible adverse effect. This change is often associated with the common side effect of fluid retention, or edema, which is swelling in the body's tissues.


Q: Is it common to feel tired after starting Sirolac?

Drowsiness and dizziness are listed as common side effects of Sirolac in official prescribing information. Unusual tiredness or weakness has also been reported, which indicates that patients may experience these effects while taking the medication.


Q: What happens if I miss a dose of Sirolac?

The official patient instructions typically describe a course of action for a missed dose, generally advising against taking a double dose to maintain the scheduled regimen. This guidance is derived from regulatory standards.


Q: Does Sirolac affect fertility or trying to get pregnant?

Official safety data for the NSAID drug class, which includes Sirolac, suggests that this type of medication may temporarily interfere with female fertility. Prescribing information notes that use is generally discouraged for women who are actively trying to conceive.


Q: Are headaches a common side effect of Sirolac?

Regulatory sources indicate that headache is listed as a common side effect of this medication, meaning it has been reported to occur in 1% to 10% of people.


Q: How is Sirolac eliminated from the body?

Sirolac is primarily metabolized, or processed, by the liver. The resulting breakdown products, along with some unchanged medication, are then mostly eliminated from the body through the urine, accounting for about 91% of a dose.


Q: How long does the effect of Sirolac last after I stop taking it?

Official information reports that the active components of the drug have a half-life of approximately five to six hours in healthy adults. This half-life is a measure of how long it takes for the concentration of the medication in the body to drop by half.


Q: Can emotional changes or mood swings be linked to Sirolac?

Rare adverse effects reported in official documents include emotional changes or psychiatric effects such as anxiety, depression, and confusion. Regulatory documents note that unusual behavior or mood swings have been reported in the post-marketing setting.


Q: Does Sirolac affect driving or operating machinery?

Official prescribing information notes that side effects such as drowsiness, dizziness, or blurred vision may occur. Since these effects can potentially impair alertness, caution regarding activities like driving or operating machinery is described in regulatory warnings.


Q: Why do some patients stop taking Sirolac?

The primary reason for stopping treatment is mandated by regulatory guidelines: the maximum total duration of systemic use is strictly limited to five days (5 days or less). This short-term limit is in place to minimize the risk of serious adverse events, particularly those affecting the stomach, intestines, and kidneys.


Q: Is Sirolac available as a generic medicine?

The active ingredient in Sirolac, ketorolac tromethamine, has been approved for use as a generic medication by regulatory bodies.


Q: Are there different strengths of Sirolac tablets or capsules?

Official prescribing documents indicate that the oral tablet form and the injectable solutions are available in different concentrations and strengths to facilitate use across various administration routes.


Q: Does alcohol interfere with Sirolac?

Official patient information indicates that combining Sirolac with alcohol can significantly increase the risk of serious side effects, such as gastrointestinal bleeding and ulcer formation. The drug's NSAID classification is linked to this increased risk.


Q: How long has Sirolac been available on the market?

The active ingredient in Sirolac, ketorolac, has been approved and available for medical use for a long time. It was first approved by regulatory authorities in 1989.


Q: What is the full list of inactive ingredients in Sirolac?

The complete list of inactive ingredients (non-medicinal components) for Sirolac is provided in the official prescribing documents. This information can be found in the 'Description' or 'Composition' section of the drug label.


Q: What does the patient leaflet say about overdose?

Official patient information lists symptoms that may occur in case of an overdose. These symptoms can include signs of gastrointestinal distress, such as nausea, vomiting, or stomach pain, as well as neurological symptoms like lethargy and drowsiness.


Q: Can Sirolac be taken with common pain relievers like Tylenol or Advil?

Regulatory documents state that the use of Sirolac concurrently with Advil (ibuprofen) or any other NSAID is contraindicated, meaning it should not be used. There is no official interaction warning listed against the non-NSAID pain reliever Tylenol (acetaminophen).


Q: What is the difference between Sirolac and other drugs that treat the same condition?

Sirolac is classified as a potent, non-selective Cyclooxygenase (COX) inhibitor. Its official regulatory labeling notes that its analgesic potency is considered comparable to certain narcotic agents, but it achieves this effect through a non-narcotic mechanism.


Q: Do you need to stop taking Sirolac before surgery?

Regulatory guidelines strictly contraindicate the use of Sirolac as a prophylactic (preventive) pain reliever before any major surgical procedure. Its use is also prohibited for pain management in the setting of coronary artery bypass graft (CABG) surgery.


Q: Can Sirolac be used by people with diabetes?

Official safety documents list elevated blood sugar (hyperglycemia) and Diabetes Mellitus as a common adverse effect of Sirolac. Regulatory guidance indicates that patients with pre-existing diabetes may require specific considerations related to potential metabolic changes while using this medication.


Q: Can I use Sirolac if I have a history of allergies?

Sirolac is strictly contraindicated if a patient has a known history of known hypersensitivity to the medication itself, or allergic reactions to aspirin or any other NSAID. This is a crucial safety restriction noted in official documents.


Q: Can I use Sirolac if I have high blood pressure?

Hypertension (high blood pressure) is listed as a common adverse effect in official documents. Because the medication has the potential to cause or worsen high blood pressure, official guidance suggests specific considerations for patients with pre-existing or uncontrolled high blood pressure.


How should Sirolac be stored and disposed of?

Storage and Disposal Requirements for Sirolac

Sirolac (Ketorolac tromethamine) must be stored strictly according to official regulatory mandates to maintain its stability and effectiveness.


Mandatory Storage and Handling

Requirement Official Condition
Temperature Store at Controlled Room Temperature (20 C to 25 C), away from excess heat.
Protection Medication must be protected from light and moisture.
Prohibitions The liquid forms (injection, ophthalmic solution) must not be frozen; the injection should not be refrigerated.
Container Rule Keep the medication in its original package and ensure containers are tightly closed.

Stability and Disposal

The injectable solution is single-use only and any unused contents must be immediately discarded after opening. All forms of Sirolac must be kept out of the sight and reach of children.

Dispose of unused or expired medicine through a drug take-back program or by following a secure household trash disposal method, as Ketorolac is not on the FDA's flush list.

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

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