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Ketoral sr

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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.

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Overview of Ketoral sr

Property Description
Active Ingredient Ketoprofen
Form Extended-Release Capsule (Sustained-Release)
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
General Use Relief of Pain, Inflammation, and Fever
Origin Synthetic (Propionic Acid Derivative)

The Definitive Classification of Ketoral sr

Ketoral sr is the specific trade designation for a medicine containing the active ingredient Ketoprofen, a drug officially classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Chemically, Ketoprofen is a synthetic propionic acid derivative and is clinically recognized for its established analgesic, antipyretic, and anti-inflammatory properties. The key characteristic of this product is the “sr” appended to its name, which denotes a sustained-release formulation. This specific type of capsule is engineered to provide consistent drug levels over a prolonged period, distinguishing it from conventional, immediate-release tablets and supporting less frequent oral administration.

Composition, Origin, and Pharmaceutical Form

The pharmaceutical preparation, Ketoral sr, is confirmed to be a single-ingredient product, utilizing only Ketoprofen as its therapeutically effective component. The active substance is manufactured as a synthetic compound. This medication is presented as an extended-release capsule, a specialized solid dosage form engineered for oral administration. The composition includes specialized pharmaceutical excipients built into the capsule’s core; these materials are essential for controlling the release kinetics of the drug, enabling the sustained and consistent delivery profile needed for managing symptoms like acute flare-ups of chronic pain conditions.

General Therapeutic Role and Mechanism Principles

The general purpose of Ketoral sr is to provide comprehensive symptomatic relief by addressing the three core physical manifestations: pain, inflammation, and fever. The foundation of this therapeutic role is its primary physiological action, which involves the crucial inhibition of prostaglandin synthesis. Ketoprofen's primary mechanism is the non-selective inhibition of cyclooxygenase enzymes. This mechanism simply means the drug works by blocking the production of the natural chemical mediators the body uses to generate the signals for pain, fever, and swelling, thereby mitigating these symptoms.

Regulatory References

  1. Ketoprofen: MedlinePlus Drug Information
  2. Ketoprofen - LiverTox - NCBI Bookshelf
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What side effects are possible with Ketoral sr?

Possible Side Effects and Safety Information

This information is strictly based on authoritative government regulatory documents and describes the documented risk profile of the medicine.

Serious Warnings and Life-Threatening Risks

Regulatory documents include Boxed Warnings highlighting the most critical safety concerns:

  • Serious Gastrointestinal (GI) Risk: The medication carries a high risk of developing peptic ulcers, bleeding, and perforation of the stomach or intestines, which can be fatal. This may occur without prior warning symptoms.
  • Serious Cardiovascular (CV) Risk: Use of the medicine is associated with an increased risk of serious cardiovascular thrombotic events, such as myocardial infarction (heart attack) and stroke, which can also be fatal.

Safety-Related Restrictions and Limitations

Due to the dose- and duration-related risk of serious adverse events, regulatory documents impose strict limits on use:

Restriction Category Regulatory Statement
Maximum Duration of Use Strictly limited to short-term treatment, not exceeding 5 days in total for adult patients.
Contraindications Contraindicated in individuals with active GI bleeding, advanced renal impairment, cerebrovascular bleeding, and late in pregnancy (third trimester).

Adverse Reactions by Body System

Regulatory documents classify adverse reactions by affected body system. Common adverse reactions include events in the following System-Organ Classes:

  • Gastrointestinal Disorders: Gastrointestinal pain, nausea, dyspepsia.
  • Nervous System Disorders: Headache, dizziness.
  • Skin and Subcutaneous Tissue Disorders: Rash, itching.

Serious but rare adverse reactions documented in regulatory sources include severe skin reactions (e.g., Stevens-Johnson Syndrome), kidney failure, liver failure, and severe hypersensitivity (anaphylactoid) reactions.

Population-Specific Considerations

Official safety profiles indicate an increased risk of serious adverse reactions, particularly GI and renal problems, in the elderly. The medicine is contraindicated late in pregnancy due to the risk of premature closure of the fetal ductus arteriosus and impaired fetal renal function.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official overdose profile for Ketoral sr (an NSAID) emphasizes that immediate medical help must be sought for any suspected overdose.

Documented Overdose Manifestations

Symptoms following an acute overdose of Ketoral sr or similar nonsteroidal anti-inflammatory drugs (NSAIDs) are typically limited and often resolve upon discontinuation of the medicine. The most commonly reported signs are related to the gastrointestinal and central nervous systems, including:

  • Gastrointestinal: Nausea, vomiting, epigastric (upper stomach) pain, and, in severe cases, gastrointestinal bleeding.
  • CNS: Lethargy and drowsiness. Hyperventilation may also occur.

Serious Outcomes and Emergency Action

Although rare, severe outcomes from NSAID overdose can include acute renal failure, hypertension (high blood pressure), respiratory depression, and coma. Because of these risks, individuals must call emergency services immediately if they suspect an overdose has occurred.

There is no specific antidote for Ketoral sr overdose. Management is limited to providing supportive and symptomatic care to address the clinical manifestations. In rare instances of severe, life-threatening overdose, measures like forced diuresis or hemoperfusion may be considered by medical professionals. Recovery from acute overdose symptoms has been documented following immediate cessation of the drug and supportive treatment.

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Therapeutic Uses of Ketoral sr

The extended-release formulation of Ketoprofen (Ketoral sr) is applied across domains where additional symptomatic support is needed, relevant for managing symptoms that interfere with daily comfort. The medication is commonly used across conditions presenting with acute episodes or periods of heightened symptoms.

It is commonly used across conditions presenting with acute episodes or periods of heightened symptoms, such as Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis (AS), acute inflammatory pain (e.g., bursitis or gout), and Primary Dysmenorrhea (menstrual pain). The medication is relevant for managing symptoms that interfere with daily comfort, particularly chronic pain, swelling, and stiffness. The goal is to provide support that helps ease the overall symptom burden for patients with chronic conditions.

“The goal is to provide support that helps ease the overall symptom burden for patients with chronic conditions.”

It offers symptomatic relief that contributes to easing the overall symptom load and helps patients cope more steadily. It may assist with maintaining a sense of stability when symptoms are more noticeable and supports general well-being during symptomatic phases.


Symptom Focus: Pain, Inflammation, and Stiffness

Ketoral sr is relevant for easing symptoms related to inflammatory or irritative states and contributes to improved day-to-day comfort during symptomatic periods.

Regulatory References

  1. DailyMed listing for Ketoprofen Extended-Release Capsules
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Eligibility and Restrictions for Use

Eligibility Profile: Ketorolac Use Restrictions

This section outlines who can and cannot use ketorolac (as found in Ketoral sr and other formulations) based strictly on authoritative government regulatory documentation, such as FDA and EMA labels.

Ketorolac is typically restricted to adult patients (ge 16 years of age) for the short-term management of moderately severe acute pain. Use for chronic pain is prohibited.


Absolute Contraindications (Must Not Use):

Population/Condition Restriction Reason
GI Disease Active peptic ulcer disease, recent GI bleeding/perforation, or history of these events.
Renal Impairment Advanced kidney failure or high risk of renal failure due to volume depletion.
Hemorrhagic Risk Suspected/confirmed bleeding (e.g., cerebrovascular), hemorrhagic diathesis, or high bleeding risk.
Hypersensitivity Known allergy to ketorolac, aspirin, or other NSAIDs.
Peripartum Use Labor and delivery; third trimester of pregnancy; breastfeeding.
Concomitant Drugs Concurrent use of aspirin, other NSAIDs, probenecid, or pentoxifylline.

Restricted/Special Populations:

  • Elderly (ge 65 years): Use requires caution, a reduced maximum daily dose, and short duration due to increased risk of serious adverse effects.
  • Low Body Weight (<50 kg): Requires dose adjustment.
  • Pediatric Patients (<16 years): Safety and efficacy are generally not established for routine use.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines interactions for Ketoral sr (Ketoprofen) as documented in official government regulatory information, focusing on restrictions and effects on drug exposure.

Official Interaction Restrictions

Substance Category Interaction Pattern Restriction / Classification
Other NSAIDs / Aspirin Increased risk of serious gastrointestinal adverse effects. Not Generally Recommended
Probenecid Reduces the plasma clearance of Ketoprofen, increasing exposure. Not Recommended

Clinically Significant Co-administration

The regulatory profile highlights co-administrations that require specific monitoring due to altered drug exposure or synergistic adverse risks:

  • Anticoagulants (e.g., Warfarin): A synergistic risk for gastrointestinal bleeding is documented, requiring careful observation.
  • Diuretics and ACE Inhibitors/ARBs: Ketoral sr may reduce the antihypertensive effect of these medicines and increase the risk of renal injury. This risk is specifically noted as elevated for elderly patients.
  • Lithium: Co-administration causes an elevation of plasma lithium levels and a reduction in renal clearance, potentially leading to toxicity.
  • Methotrexate: Ketoprofen may cause changes in the elimination of methotrexate, resulting in elevated serum levels and increased toxicity.

Food and Other Substances

Daily consumption of alcohol combined with this medicine may increase the risk for stomach bleeding. Antacids (Aluminum or Magnesium Hydroxide) do not interfere with the absorption of Ketoprofen.

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Mechanism of Action

How Ketoral SR Works

Ketoral SR (ketorolac) acts by intervening in a key chemical cascade that regulates local physiological responses. The drug's mechanism is defined by its targeted action on specific enzyme systems and the subsequent adjustments this causes in chemical signaling.


Inhibiting the COX Enzyme System

The primary action of the drug is its role as a non-selective inhibitor of the Cyclooxygenase (COX-1 and COX-2) enzymes. By blocking the active sites of these enzymes, the drug prevents them from performing their metabolic function within the Arachidonic Acid Cascade. This enzyme targeting is the initial molecular step that modifies the subsequent physiological consequences.


⬇️ Limiting Prostaglandin Chemical Messengers

Consequent to COX inhibition, the synthesis of prostaglandins is stopped. Prostaglandins are mediators that contribute to nerve ending sensitization and local vascular permeability. This interruption of the pathway cascade alters the chemical environment and modifies signaling dynamics within the affected tissues.


Modulating Peripheral Signaling Dynamics

The mechanism primarily involves modulating chemical signaling peripherally, at the site of tissue stress. This action modifies the input of chemical mediators onto peripheral nerve endings, resulting in an adjustment of local physiological responses.

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Dosage and Administration Information

How to Use Ketoral sr — Official Administration Guidelines

Ketoral sr is a systemic pain reliever used according to a strict, short-term protocol. Adherence to these instructions is mandatory for proper use.


Administration Protocol and Duration

Administration Scope Official Instruction
Route of Administration Oral (PO) tablet.
First Dose Must not be the first dose of treatment; oral use is only for continuation therapy following an initial injection (IM or IV).
Total Duration The total combined duration of use for all systemic forms (oral, IM, IV) must not exceed 5 days.

Standard Dosing and Frequency

For most adults, the maintenance dose is 10 mg taken every 4 to 6 hours as needed for pain. The maximum total dose from all forms, including the oral tablets, must not exceed 40 mg per day. The dose and frequency must be carefully followed and should not exceed the prescribed limit.


Special Instructions for Intake

  • Intake Condition: The tablet should be taken with food or an antacid to minimize stomach upset, and with a full glass of water.
  • Physical Form: The tablet must be swallowed whole. It is forbidden to crush, break, or chew the tablet to ensure the controlled-release mechanism is maintained.
  • Position: Do not lie down for 15 to 30 minutes after taking the medicine.

Population Adjustments

Specific dosage adjustments apply to certain patients. Individuals aged 65 years and older or those with impaired kidney function may require a lower daily dose. These adjustments are utilized to reduce potential risk factors.

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Recent Clinical Evidence

Recent Clinical Evidence for Ketorolac Sustained-Release

Clinical research examining formulations of ketorolac, the active substance in Ketoral sr, generally focuses on its use for the short-term management of moderate-to-severe acute pain. This summary reviews recent findings concerning efficacy and the safety profile, particularly as it relates to sustained-release or continuous administration.


Efficacy Findings

Studies across various acute pain settings, including postoperative care, have investigated the analgesic effectiveness of ketorolac. Evidence suggests that the substance is associated with pain reduction, often demonstrating effects comparable to certain opioid analgesics, supporting its role in multimodal pain management strategies.

  • Opioid-Sparing Effect: Research consistently shows that the administration of ketorolac is linked to a significant reduction in the requirement for concurrent opioid medications in post-surgical patients. This finding is considered clinically important in managing pain while reducing opioid exposure.
  • Dosing and Effect: Clinical data have investigated the relationship between the dose administered and the degree of pain relief. Findings from some studies suggest that increasing the dose beyond a certain level may not lead to greater pain relief but could potentially increase the risk of adverse events.

Safety and Administration

Recent studies have sought to clarify the safety profile, particularly with newer continuous or sustained-release administration methods, and in vulnerable patient populations.

Area of Research Key Findings Observed
Sustained-Release (SR) / Continuous Infusion Studies on novel formulations (e.g., continuous intravenous infusion) demonstrated lower variability in plasma concentrations and, in some cases, fewer adverse events compared to standard bolus dosing.
Older Adults Research specifically examined the use of ketorolac in older participants, including those with mild-to-moderate renal impairment. The results indicated that the new administration methods were studied to see if they were associated with a predictable pharmacokinetic profile in this population.

It is important to note that, as an NSAID, ketorolac is associated with known risks, including gastrointestinal and cardiovascular events. Trials confirm that use is typically limited to five days or less to mitigate the potential for these serious adverse events.

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Frequently Asked Questions (FAQ)

Common questions about Ketoral sr (FAQ)


Q: Is Ketoral sr a type of opioid or controlled substance?

A: Official regulatory documents confirm that the active ingredient in Ketoral sr is a Nonsteroidal Anti-inflammatory Drug (NSAID), not a narcotic.

Therefore, the medicine is not classified as an opioid and is not considered to be habit-forming.


Q: Is it true that Ketoral sr can affect your liver function?

A: Yes, official product information lists elevated liver enzymes as an adverse experience that has been reported in clinical studies (in 1% to 10% incidence).

Serious events involving the liver, such as hepatitis and liver failure, have also been reported, though these are considered rare.


Q: What are the signs of a serious allergic reaction to Ketoral sr?

A: Regulatory documents list severe hypersensitivity reactions, also known as anaphylactic or anaphylactoid reactions, as a serious potential complication.

If a severe reaction is suspected, official guidance indicates that immediate medical attention should be sought.


Q: Can Ketoral sr be taken with common blood pressure medications?

A: Co-administration may reduce the effectiveness of certain blood pressure medicines, specifically diuretics (like furosemide and thiazides).

Regulatory documents state that the drug may also make high blood pressure worse. When these combinations are used, close monitoring for potential kidney issues is generally indicated.


Q: Is it better to take Ketoral sr in the morning or at night?

A: Official guidance focuses on the frequency of administration, which is typically every four to six hours as needed for pain.

Product labeling indicates the medicine should be taken with food to minimize stomach upset and advises against lying down for a short period after intake, but does not specify a preferred time of day.


Q: Can older adults safely use Ketoral sr?

A: Official guidance indicates that use in older adults (age 65 and older) warrants caution and may involve a lower maximum daily dose.

This population is generally more sensitive to the drug's effects and is at an increased risk for serious side effects, particularly those affecting the stomach and kidneys.


Q: Are there any studies on the effectiveness of Ketoral sr in different patient demographics?

A: Regulatory documents and clinical studies discuss specific considerations and dosage adjustments for certain populations.

This includes special instructions for the elderly and those with low body weight or impaired kidney function.


Q: Why would a doctor choose Ketoral sr over other similar medications?

A: The medicine is indicated for the short-term management of moderately severe acute pain that requires pain relief at the opioid level.

Evidence from clinical studies suggests the drug can have an opioid-sparing effect, meaning it may reduce the need for concurrent opioid medications.


Q: Is Ketoral sr generally considered stronger than over-the-counter pain relievers?

A: Ketoral sr is indicated for short-term, moderately severe acute pain that requires analgesia at the opioid level.

This classification distinguishes it from medications generally used for mild pain. It is available only by prescription.


Q: What should I watch out for when first starting Ketoral sr?

A: Official warnings advise remaining alert for signs of serious gastrointestinal issues, such as bleeding or ulceration.

These serious events can occur at any time, even early in the course of treatment, and may happen without prior warning symptoms.


Q: Can I take Ketoral sr if I'm also taking an antidepressant medicine?

A: Co-administration with certain types of antidepressant medicines, particularly Selective Serotonin Reuptake Inhibitors (SSRIs), may increase the risk of bleeding.

It is important that healthcare providers are made aware of all current prescription medications.


Q: How many hours does the effect of Ketoral sr usually last?

A: The drug is administered every four to six hours as needed for pain relief.

This dosing frequency, as outlined in the official documentation, is generally aligned with the drug's expected duration of therapeutic effect.


Q: What should I do if I miss a scheduled dose of Ketoral sr?

A: If a dose is missed, official instructions advise skipping that dose if it is almost time for the next one, and continuing with the regular schedule without doubling the amount.

Patients should follow the specific guidance provided by their healthcare professional.


Q: Has Ketoral sr been recalled or withdrawn in any country?

A: Yes, the injection form of Ketorolac has been subject to a voluntary recall in the past, according to FDA safety alerts.

These recalls were often issued for issues related to quality control, such as the presence of particulate matter.


Q: Is Ketoral sr habit-forming?

A: No, the medicine is a Nonsteroidal Anti-inflammatory Drug (NSAID) and official sources confirm it is not classified as a narcotic.

The drug is therefore not considered to be habit-forming.


Q: Is Ketoral sr available in generic form?

A: The active ingredient in the medicine, ketorolac, is the generic name for the substance.

This ingredient is available under various trade names and in different formulations.


Q: Does Ketoral sr affect your ability to drive or operate machinery?

A: Drowsiness and dizziness are listed as potential side effects in the official product labeling.

Due to these potential effects, caution is generally advised when engaging in activities that require concentration, such as driving or operating machinery.


Q: What should a person do if they accidentally take more than the recommended amount of Ketoral sr?

A: Symptoms of an acute overdose may include lethargy, drowsiness, nausea, vomiting, or stomach pain.

If a person suspects they have taken more than the recommended amount, official documentation advises seeking immediate medical assistance.


Q: Is Ketoral sr known to cause weight gain or loss?

A: Weight change is listed as an adverse experience that has been reported occasionally during clinical trials, specifically in less than 1% of patients.


Q: Can Ketoral sr affect sleep patterns or cause insomnia?

A: Yes, difficulty sleeping (insomnia) and abnormal dreams are listed as occasional adverse experiences under Nervous System disorders in the official adverse reactions profile.


Q: What are the typical available dosage strengths of Ketoral sr?

A: The oral tablet is commonly available in a mathbf10 mg strength, as this is the standard dose used for continuation therapy.

Other strengths are available for the injection and nasal spray routes of administration.


Q: Can Ketoral sr make a person more sensitive to sunlight?

A: Photosensitivity, or increased sensitivity to the sun, has been reported as an occasional adverse reaction.

This reaction occurs in less than 1% of patients, according to official documentation.


Q: Is Ketoral sr available only by prescription, or can I buy it over the counter?

A: The medicine is indicated for short-term management of moderately severe acute pain that requires analgesia at the opioid level.

Due to its intended use and risk profile, it is available only by prescription.

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How should Ketoral sr be stored and disposed of?

How to Store and Dispose of Ketoral SR (Ketoprofen Extended-Release Capsules)

Official regulatory labeling dictates specific conditions for storing and discarding Ketoral SR to maintain the stability of the extended-release formulation.

Storage Requirements

Ketoral SR must be stored at Controlled Room Temperature, defined as 20 C to 25 C (68 F to 77 F). Protection from excessive heat, freezing, and moisture is mandatory. The capsules must remain in their original container and be kept tightly closed. As a critical safety measure, the medicine must be stored out of the sight and reach of children.

Disposal Instructions

Expired or unused Ketoral SR should not be flushed down a toilet or poured into a drain. The product must be disposed of according to local pharmaceutical waste regulations, typically utilizing a medicine take-back program.

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

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