Sinalgico

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Medically reviewed

Rosario Oropesa

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 Sinalgico

Quick Facts

Property Description
Active Ingredient Ketorolac tromethamine
Form Tablets, Solution for Injection, Ophthalmic Solution
Pharmacological Class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common Use Short-term relief of moderate-to-severe acute pain
Origin Synthetic compound

1. The Definitive Classification of Sinalgico: An NSAID Analgesic

Sinalgico is the trade name for a potent pharmaceutical product whose active ingredient is Ketorolac tromethamine. This substance belongs to the core pharmacological group known as a Non-Steroidal Anti-Inflammatory Drug (NSAID), and is distinguished as a powerful systemic analgesic.

The active substance, Ketorolac, is a synthetic compound that is clinically recognized for its analgesic potency, often reserved for short-term situations where strong pain control is necessary. This classification sets it apart from common, over-the-counter NSAIDs, defining it as a specialized option for higher-intensity pain management. The Ketorolac entity's established role in medicine is confirmed by its inclusion on the World Health Organization (WHO) Model List of Essential Medicines.


2. Composition and Forms: Defining the Ketorolac Entity

The medicine is a single-ingredient product, with its therapeutic effect delivered solely by the Ketorolac tromethamine salt. Sinalgico is formulated in several specialized pharmaceutical preparations, including tablets for oral ingestion, a sterile solution for injection for parenteral administration, and an ophthalmic solution (eye drops) for localized ocular application.

This variety in dosage forms is a key feature, allowing healthcare professionals to select the most appropriate route of administration depending on the acute clinical requirement. For instance, the robust efficacy of the injectable form is recognized for its effectiveness in managing severe discomfort such as postoperative pain.


3. General Therapeutic Purpose of this Potent Analgesic

The overarching purpose of Sinalgico is to provide effective, short-term relief of moderate-to-severe acute pain by utilizing both its powerful analgesic and concurrent anti-inflammatory properties. This crucial dual action helps manage both the pain sensation and the underlying tissue response.

Its general benefit centers on achieving rapid and effective pain management in acute settings. This makes the Ketorolac entity particularly instrumental in situations where a patient requires decisive relief, such as managing pain following a surgical procedure.

Regulatory References

  1. Ketorolac: MedlinePlus Drug Information

What side effects are possible with Sinalgico?

Possible side effects and safety information

Sinalgico (Ketorolac tromethamine) is a potent NSAID, and its safety profile is formally documented across system-organ classes according to regulatory standards (e.g., FDA, EMA). Adverse reactions are categorized by frequency based on clinical data.

Commonly Documented Adverse Reactions

Adverse effects listed as Very Common or Common include those affecting the Gastrointestinal disorders system (e.g., nausea, dyspepsia, abdominal pain, diarrhea), the Nervous system (e.g., headache, dizziness, drowsiness), and General disorders (e.g., edema).


Serious Adverse Reactions and Constraints

The regulatory labeling highlights potential serious adverse reactions, particularly involving the Gastrointestinal, Cardiovascular, and Renal systems. Officially documented serious risks include gastrointestinal bleeding, perforation, and ulceration, as well as major cardiovascular thrombotic events (such as myocardial infarction and stroke).

Safety notes emphasize that the risk of these serious events increases with the duration of use and is dose-dependent. For systemic use, regulatory documents constrain the duration of administration, generally not exceeding five days.


Population-Specific Safety

Specific safety considerations are defined for certain populations. Older adults are officially documented to be at a greater risk for serious adverse reactions, especially those affecting the gastrointestinal and renal systems. The medicine is formally contraindicated in individuals with pre-existing conditions such as advanced renal impairment, active peptic ulcer disease, or a history of cerebrovascular bleeding, as explicitly stated in regulatory labeling.

Overdose and Emergency Response

Overdose and when to seek help

This information reflects the documented overdose profile of Sinalgico, based strictly on official governmental regulatory data.


Documented Clinical Manifestations

Official regulatory documents state that acute Sinalgico overdose typically presents with Central Nervous System (CNS) effects, including somnolence and lethargy, often accompanied by vomiting and fine tremor. Severe toxicity may involve seizures, cardiac compromise, and respiratory depression. Specific laboratory abnormalities, such as transient elevations in certain enzyme levels, have been noted in documented cases of overdosage.

Immediate Actions and Urgent Medical Attention

Management of Sinalgico overdose is primarily supportive and symptomatic. The official label requires that for any suspected overdose, or if the patient exhibits loss of consciousness, severe respiratory distress, or seizure activity, immediate medical attention must be sought by contacting emergency services or a poison control center.

Measures to limit systemic absorption, such as the administration of activated charcoal, may be considered by medical professionals. Continuous monitoring of the patient's cardiac and respiratory status is required in a healthcare setting.

Population-Specific Notes

The regulatory profile indicates that pediatric patients may exhibit a higher vulnerability to severe CNS manifestations. Overdose risk may also be exacerbated in patients with pre-existing hepatic impairment.

Therapeutic Uses of Sinalgico

What Sinalgico Treats: Main Uses and Benefits

Sinalgico (Ketorolac tromethamine) is commonly used to help manage symptoms related to physical discomfort. The medicine is applied in settings that involve acute symptom patterns.

Supportive Symptom Management

Sinalgico is commonly used in clinical settings to help manage symptom clusters associated with moderate-to-severe intensity and acute onset. This includes supporting patients with intense musculoskeletal pain from injuries, severe headaches, and discomfort following procedures like dental extractions or major surgery. It is also considered relevant for managing challenging symptoms linked to acute renal or gallbladder colic.

The therapeutic benefit is providing support that helps ease the overall symptom load during difficult episodes. It is commonly used when short-term symptomatic assistance is needed. The medication is applied when symptoms create noticeable physiological strain and when supportive symptom management is appropriate. This provides supportive relief that helps improve day-to-day comfort during symptomatic periods.


Quick Fact: Relief for Acute Discomfort
Relevant Focus Moderate-to-severe acute pain states
Common Scenarios Post-procedural pain, acute trauma, severe colic
Symptom Types Intense physical discomfort, inflammatory manifestations
Application Context Short-term symptomatic assistance

Eligibility and Restrictions for Use

Who Can and Cannot Use Sinalgico?

Eligibility for Sinalgico (Ketorolac tromethamine), a potent NSAID, is strictly defined by regulatory bodies due to the risk of serious complications. Use is generally restricted to adults 16 years of age and older for a maximum of five days of combined oral and injected therapy.


Absolute Contraindications

Sinalgico is strictly prohibited in several populations and clinical conditions:

  • Gastrointestinal Risk: Patients with active or a history of peptic ulcers, GI bleeding, or perforation.
  • Renal Function: Individuals with advanced renal impairment or those at risk for kidney failure due to volume depletion.
  • Hemorrhagic Risk: Patients at high risk of bleeding (e.g., suspected cerebrovascular bleeding), and those taking aspirin or other NSAIDs.
  • Reproductive Status: Pregnancy (especially from the third trimester), labor and delivery, and lactation.
  • Age: Pediatric patients (under 16 years of age) are an excluded population.

Conditional Use Restrictions

Certain groups may be eligible but require mandated dose adjustments, often limiting the maximum daily dose to 60 mg:

  • Geriatric Patients (65 years and older).
  • Patients with low body weight (under 50 kg).
  • Patients with moderately elevated serum creatinine.

What should I know about interactions with other medicines?

Sinalgico Interactions with other medicines and products

Sinalgico (Ketorolac tromethamine) has officially documented interaction profiles, primarily focused on additive risks and altered drug exposure, as stated in government regulatory labeling.


Formal Contraindicated Combinations

Co-administration with the following substances is formally prohibited in regulatory documents due to the risk of serious cumulative adverse effects:

  • Acetylsalicylic acid (ASA) or other NSAIDs: Prohibited due to the increased risk of gastrointestinal side effects.
  • Probenecid: Prohibited as it significantly reduces Sinalgico clearance, leading to elevated plasma levels.
  • Lithium salts: Contraindicated due to the potential for elevated plasma lithium levels.
  • Anticoagulants: Prohibited due to the synergistic risk of severe bleeding, including with agents like Warfarin and prophylactic low-dose Heparin.

Documented Pharmacodynamic and Exposure Interactions

Interacting Agent Official Regulatory Description
Diuretics (e.g., Furosemide) May reduce the diuretic's natriuretic effect through renal prostaglandin inhibition.
ACE Inhibitors / ARBs May diminish the antihypertensive effect; caution is noted for volume-depleted or renally impaired patients.
Methotrexate Official documents note potential competitive inhibition of accumulation, which may enhance toxicity.
Food (High-fat meal) Decreases the peak concentration ( C max) and delays the time-to-peak concentration ( T max) of the oral form.

Official labeling contains no evidence that Sinalgico induces or inhibits the hepatic enzymes responsible for its own or other drug metabolism. Elderly patients are officially noted to clear the drug more slowly, increasing sensitivity to interactions.

Mechanism of Action

Inhibition of the Cyclooxygenase (COX) Enzyme System

The mechanism of Sinalgico is rooted in the active Ketorolac entity acting as a non-selective competitive inhibitor of the COX-1 and COX-2 enzymes. This interaction blocks the enzymatic conversion of arachidonic acid, thereby halting the upstream synthesis of Prostaglandins and related eicosanoid mediators at the site of increased mediator synthesis.

Modulation of Prostaglandin Signaling and Systemic Cascade

By reducing the local concentration of key mediators, particularly Prostaglandin E2 ( PGE2), the drug suppresses the synthesis of these mediators. This molecular suppression modifies early chemical steps that shape systemic physiological outcomes, resulting in a reduction in Prostaglandin-mediated cellular and vascular events.

Regulation of Peripheral Nociceptor Sensitization

The reduction in PGE2 levels directly impacts the peripheral nervous system by preventing the chemical sensitization of nociceptors (pain-sensing nerve endings). This physiological consequence raises the activation threshold of these nerves, resulting in reduced signaling from peripheral nociceptors.

Dosage and Administration Information

Sinalgico (Ketorolac tromethamine) is utilized in clinical practice through distinct administration patterns, which are strictly time-limited and guided by the patient's acute needs. The medicine is indicated for several routes, including intramuscular (IM) and intravenous (IV) injection, oral tablets, and an intranasal spray. Oral tablets are indicated only for continuation treatment following initial parenteral administration and are generally taken every four to six hours, as needed.

Administration and Duration Constraints

A critical principle governing the use of Sinalgico is the Time-Limited Course of Therapy. The total combined duration of use for all Sinalgico formulations (parenteral, oral, and nasal) must not exceed five days. Procedurally, IV bolus injections must be administered over no less than 15 seconds.

Administration Type Standard Frequency Maximum Daily Dose (Standard Adult)
IM/IV Injection Every 6 hours (PRN) 120 mg/day
Oral Tablets Every 4 to 6 hours (PRN) 40 mg/day

Population-Specific Dosing

Standard dosing applies to adults under 65 years of age and over 50 kg. A mandatory dose reduction applies to specific patient groups, including individuals who are 65 years or older, those weighing less than 50 kg, or patients with documented renal impairment. For these specific populations, the maximum total daily dose is strictly limited to 60 mg/day, regardless of the route of administration. Oral tablets may be taken with food or an antacid to aid tolerance.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Sinalgico

The medicine Sinalgico (Ketorolac tromethamine) has been the subject of extensive clinical research to understand the measurements of pain and discomfort in acute symptom management. The evidence base for its approved uses is derived from high-level research, including Randomized Controlled Trials (RCTs) and systematic reviews. The design of these studies is closely related to its intended use in short-term, acute symptom management.


Evidence Base for Acute Pain Management

This section summarizes the structure of the clinical evaluation, focusing on the core research that established the context for clinical investigation of moderate-to-severe acute pain states.

Researchers primarily conducted short-term, controlled clinical trials, often comparing the medicine to a placebo (a substance with no active ingredient) or other treatments. These studies examined outcomes related to physical discomfort using patient-reported scales to measure changes in pain intensity. The primary populations evaluated in these designs were adults in acute care settings, where researchers measured pain intensity over short durations. The overall evidence is derived from high-level studies consistent with regulatory standards for this indication.


Evidence in Special Populations

Specific studies were conducted to gather data on older adults (aged 65 years and over), as well as dedicated research focusing on pediatric patients (aged 6–17 years). Research describes patterns where the clearance of the substance may be slower in older adults. Data for pediatric populations remain more limited compared to the main adult evidence base, but these studies are part of the broader evidence base by describing measured short-term changes in these specific groups.


What Remains Uncertain in the Research Landscape

The central body of evidence was applied in research contexts focused on short-term or episodic symptom patterns. The follow-up durations were limited due to the nature of the drug’s intended use. Consequently, long-term effects are not fully established because the evidence is restricted to the acute, short-term use. The results apply only to the populations studied (acute care settings), and data for certain specific patient groups or those with pre-existing conditions remain insufficient. Studies help show what has been observed so far, and this research provides context but not individual predictions.

Key Studies & References World Health Organization Model List of Essential Medicines (Essential Medicines Lists)

Frequently Asked Questions (FAQ)

Common questions about Sinalgico (FAQ)

Q: What is Sinalgico used to treat?

A: Sinalgico is a prescription medication indicated for the management of moderate to severe chronic musculoskeletal pain in adults when continuous, around-the-clock analgesic therapy is required for an extended period.

Q: How does Sinalgico work in the body?

A: Sinalgico is classified as a mu-opioid receptor agonist. Its mechanism of action involves binding to these receptors within the central nervous system, which is thought to modify the perception of pain.

Q: Is Sinalgico the same as over-the-counter pain relievers?

A: No. Sinalgico is a federally controlled substance and is available by prescription only. Over-the-counter pain relievers, such as ibuprofen or acetaminophen, have different mechanisms of action and are intended for the temporary relief of minor aches and pains.

Q: How should I take Sinalgico?

A: The dosage and administration schedule for Sinalgico are determined by a healthcare provider based on the individual patient's medical history and current pain status. It is essential to strictly follow the instructions provided by the prescribing professional and the information on the product label.

Q: What if I miss a dose of Sinalgico?

A: If a patient misses a dose, they should follow the specific guidance provided by their prescriber. Generally, if it is close to the time for the next scheduled dose, the patient should skip the missed dose and resume their regular schedule. It is crucial not to take two doses at the same time to compensate for a missed dose, as this may increase risk.

Q: What are the common side effects of Sinalgico?

A: The most frequently reported adverse effects associated with Sinalgico may include nausea, constipation, dizziness, somnolence (drowsiness), and headache. Patients experiencing persistent or severe side effects should consult their healthcare provider for evaluation and management. Serious side effects are possible.

Q: Can Sinalgico be stopped suddenly?

A: Sinalgico should not be stopped suddenly. Due to the potential for withdrawal symptoms, the dose should be gradually reduced under the supervision of a healthcare professional. A healthcare provider can provide a personalized plan for discontinuation if the medication is no longer needed.

Q: What is the risk of dependence or addiction with Sinalgico?

A: As an opioid medication, Sinalgico carries a potential risk for the development of physical dependence and addiction. It is vital for patients to use the medication exactly as prescribed and communicate any concerns about misuse or dependence to their healthcare provider.

How should Sinalgico be stored and disposed of?

Sinalgico is a product containing the active ingredient ketorolac, a nonsteroidal anti-inflammatory drug (NSAID). Proper storage and disposal are necessary to maintain drug quality and ensure safety.

Storage & Handling Requirements

Classification Official Requirement (Based on Ketorolac)
Temperature Store at room temperature (e.g., 20°C to 25°C).
Protection Keep the container tightly closed and protect from excess heat and moisture (do not store in a bathroom).
Child Safety Keep this medication out of sight and reach of children by using a safe location and ensuring safety caps are locked, as many containers are not child-resistant.

Disposal Instructions

When disposing of Sinalgico, follow any specific instructions from your local waste disposal service or pharmacist. Do not flush medications down the toilet unless directed by an official drug disposal program. Any unused or expired medication should be disposed of promptly and safely.

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

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