Pentra

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Pentra

Quick Facts: Pentra (Nimesulide)

Property Description
Active ingredient Nimesulide
Form Tablets, granules for suspension, capsules, topical gel, suppositories
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Symptomatic relief of acute pain, inflammation, and fever
Origin Synthetic compound (Sulfonanilide derivative)

What is Pentra and its Pharmacological Class?

Pentra is a medicinal product defined by its sole active ingredient, Nimesulide, which is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). This chemical entity is a synthetic compound derived from the sulfonanilide class. Nimesulide is distinct because it is a preferential inhibitor of the cyclooxygenase-2 (COX-2) enzyme, meaning its action is primarily directed toward the enzyme responsible for generating inflammation and pain signals. This mechanism is clinically recognized for differentiating its profile from older, non-selective NSAIDs. Nimesulide has been utilized for several decades, establishing its use for short-term symptomatic relief.


Composition and General Purpose of Nimesulide

The therapeutic function of Pentra is entirely derived from the single active ingredient, Nimesulide. This compound is designed for symptomatic relief by intervening in the body's inflammatory process to reduce the physical manifestations of pain and fever. The general purpose of the compound is to provide both an analgesic (pain-relieving) and an antipyretic (fever-reducing) effect. For instance, its action is relevant in managing the acute discomfort associated with flare-ups of pain, a typical use scenario for which the drug is employed. Nimesulide possesses anti-inflammatory, analgesic, and antipyretic activities, with efficacy comparable to other NSAIDs.


Available Forms and Administration Routes

Nimesulide is supplied in various dosage forms that facilitate different administration routes, a key differentiating factor of the Nimesulide INN. These preparations commonly include solid oral forms, such as tablets and granules for oral suspension. Additionally, the drug is manufactured for localized application as a topical gel and for rectal administration as suppositories. The diverse availability of oral, topical, and rectal forms allows the active ingredient to be utilized for either systemic effects (through oral or rectal use) or concentrated local action (through topical application).

What side effects are possible with Pentra?

Possible Side Effects and Safety Information

Pentra (Nimesulide) is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID), and its safety profile is structured according to regulatory classifications of adverse reactions. The official regulatory documents group effects by frequency and the body system affected.

Common Adverse Reactions The adverse reactions most frequently documented (1/100 to <1/10) include elevated liver enzyme levels, diarrhoea, nausea, and vomiting. These effects are categorized under Hepatobiliary Disorders and Gastrointestinal Disorders, respectively.

Uncommon and Rare Effects Less frequent effects (1/1,000 to <1/100) include gastritis, constipation, dizziness, hypertension, pruritus, and rash. Rare and very rare reactions (<1/1,000) documented in official labeling extend to include blood disorders, severe skin reactions like Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), and anaphylaxis.

Serious Adverse Reactions and Constraints The regulatory safety profile notes the potential for serious adverse reactions, particularly severe gastrointestinal events (ulceration, bleeding, and perforation) and severe hepatotoxicity, including cases of fulminant hepatitis and hepatic failure. Serious gastrointestinal events can occur at any time during treatment, with the risk potentially increasing with the duration of use. Older adults are cited in official labeling as a population with an increased risk of serious adverse GI events. The medication is restricted for use in patients with severe hepatic or renal impairment and those with a history of recurrent peptic ulceration.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Pentra (Nimesulide) describes the signs and required actions in cases of acute overdose. Overdose symptoms associated with the systemic formulation are typically limited to generally reversible manifestations, including lethargy, drowsiness, nausea, vomiting, and epigastric pain.

Documented Severe Outcomes

While common symptoms are reversible, the labeling documents the potential for rare, severe, and potentially life-threatening outcomes. Urgent medical attention is required if manifestations such as acute renal failure, respiratory depression, or coma occur. Other serious potential outcomes include gastrointestinal bleeding and hypertension.

Classification Official Regulatory Statement
Antidote Information No specific antidote is known or documented in the official labeling.
Required Action Management should consist of symptomatic and supportive care.
Topical Note Overdose is not expected from the topical gel formulation.

Summary of Regulatory Guidance

The regulatory profile explicitly mandates that patients be managed with symptomatic and supportive care. Immediate medical help must be sought if any of the severe or life-threatening symptoms are suspected or confirmed, consistent with regulatory instruction for managing serious events.

Therapeutic Uses of Pentra

What Pentra Treats: Main Uses and Benefits

Pentra is commonly used in situations involving certain distressing symptoms, primarily applied across domains where short-term symptomatic assistance is needed. This therapeutic approach is focused on easing the overall symptom load for managing symptoms. It is often relevant when supportive symptom management is appropriate, particularly for time-limited, intense symptomatic periods. For example, the need for relief during acute symptomatic periods is a key area of focus for supportive therapies.

Symptom Management and Functional Support

Pentra is considered relevant for easing symptoms associated with acute or episodic changes and is commonly used in conditions characterized by periods of heightened symptoms. It is applied in addressing symptom clusters that may appear suddenly or intensify over time, providing support that helps ease the overall burden of symptoms. This assistance is particularly relevant for managing symptoms that interfere with daily comfort and create noticeable physiological strain. It assists with maintaining functional stability by supporting patients during difficult episodes.

The medication is generally used to help manage symptoms linked to recurrent episodes, heightened discomfort, and temporary functional strain.


Quick Fact: Relief for Heightened Discomfort

Quick Fact: Supports Functional Stability

Quick Fact: Applied for Acute Symptomatic Periods

Regulatory References

  1. NIH MedlinePlus overview on Acute Pain

Eligibility and Restrictions for Use

Who Can and Cannot Use Pentra (Nimesulide)?

Official regulatory documents strictly define the eligible population for Pentra, imposing several absolute restrictions based on age, organ function, and pre-existing conditions. These eligibility rules ensure the medicine is only used under specific, regulated circumstances.

Eligibility and Non-Eligibility Status

Population Group Official Status (As per Regulatory Label)
Age Contraindicated in children under 12 years. Permitted for adults and adolescents (12–18 years).
Hepatic Function Contraindicated in patients with any degree of hepatic impairment or history of hepatotoxic reactions to Nimesulide.
Renal Function Contraindicated in severe renal impairment (creatinine clearance < 30 mL/min). Permitted in mild to moderate impairment.
Gastrointestinal Status Contraindicated in patients with an active ulcer or history of recurrent gastrointestinal bleeding.
Pregnancy/Lactation Contraindicated during the third trimester of pregnancy. Not recommended during the first two trimesters or while breastfeeding.

Contextual Restrictions

Regulatory authorities mandate that Pentra is restricted to use as a second-line treatment for approved indications, meaning it should only be considered after at least one other medicine has failed. Use is also contraindicated in patients with severe heart failure or severe coagulation disorders.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Pentra (Pentaerythritol Tetranitrate, an organic nitrate) carries a critical warning regarding its use with certain drug classes due to the risk of severe drug-drug interactions. Understanding these interactions is essential for safe use.

Contraindicated Combinations

Interacting Product Class Mechanistic Basis Outcome/Restriction
Phosphodiesterase type 5 (PDE5) Inhibitors (e.g., sildenafil, tadalafil, vardenafil) Pharmacodynamic potentiation via the nitric oxide-cyclic GMP pathway, resulting in excessive smooth muscle relaxation. Contraindicated: Co-administration is prohibited due to the risk of profound and prolonged hypotension (dangerously low blood pressure) and potential cardiovascular collapse.

Other Relevant Interactions

Combination with other agents that cause a decrease in blood pressure, such as antihypertensive drugs (e.g., beta-blockers, calcium channel blockers, diuretics), may result in an additive hypotensive effect. Patients using these combinations require careful monitoring and potential dosage adjustments by a healthcare provider. Drugs that affect the renal excretion rate of Pentra may also influence its concentration in the body, which could alter its clinical effects.

The most significant constraint on Pentra's overall interaction profile is the absolute prohibition against its use with PDE5 inhibitors, a mandatory regulatory measure for all organic nitrate products.

Mechanism of Action

Mechanism of Action of Pentra

Pentra, containing Nimesulide, operates by modulating specific molecular events within the inflammatory cascade through two primary mechanistic domains that collectively adjust signaling pathways and cellular activity. The mechanism results in the modulation of overactive physiological signaling.


Preferential Enzyme Inhibition

The primary mechanism involves the preferential inhibition of the Cyclooxygenase-2 (COX-2) enzyme, which is responsible for converting arachidonic acid into key inflammatory mediators. This specific action reduces the synthesis of Prostaglandin E2 (PGE2) both at the site of tissue irritation and within the central nervous system's hypothalamus. The resulting physiological effect is a dual modulation: the reduction of peripheral nerve sensitization and the resetting of the core body temperature set-point.


Multifactorial Cellular Modulation

Beyond enzyme inhibition, Pentra engages complementary non-cyclooxygenase mechanisms to influence the inflammatory cascade at a cellular level. The molecule functions as an antioxidant, actively scavenging Reactive Oxygen Species (ROS) (free radicals), and acts as an inhibitor of tissue-degrading enzymes, such as Matrix Metalloproteinases (MMPs). These secondary actions modulate the environment of the affected tissue and reduce the cellular consequences of oxidative stress and matrix breakdown, which results in the modulation of physiological signaling.

Dosage and Administration Information

Pentra (Nimesulide) is administered via two primary pathways: the oral route for systemic effects, available as tablets and granules, and the topical route (gel) for localized application. Systemic administration adheres to a duration-limited protocol where the total treatment course must not exceed 15 days. Using the minimum effective dose for the shortest time necessary is a foundational principle of its use.

Administration and Dosing Principles

Administration Route Standard Adult Dose & Frequency Contextual Instruction
Oral (Systemic) 100 mg taken twice daily. Must be taken after a meal to fulfill administration requirements.
Topical (Local) Apply a line of gel (6 to 7 cm) 2 to 3 times daily. Must be massaged into the affected area until completely absorbed.

Dosing principles for the systemic oral dose do not generally require adjustment for older adults or adolescents (12–18 years). However, there are limits on administration for specific populations. For instance, in patients with severe renal or hepatic impairment, systemic use is not permitted. Furthermore, the topical gel is solely for local application and must not be used on broken skin or under occlusive dressings.

Recent Clinical Evidence

Research Evidence: Overview of Clinical Studies for Pentra

This overview describes the official research and clinical trials conducted for Pentra (Nimesulide), relying on data found in regulatory reviews and high-quality scientific literature. The purpose is to provide context on the existing evidence base, detailing the types of studies performed and the patient groups included.


Evidence Base for Acute Pain Conditions

The research for Pentra's use in acute pain was evaluated in short-term, randomized controlled trials (RCTs). These studies explored how symptoms change over time, examining outcomes related to physical discomfort in adults and adolescents. Researchers monitored changes in pain intensity over short periods, typically just a few hours up to three days. The results apply only to the populations studied in these controlled contexts, as follow-up durations were limited, providing little information for chronic pain conditions.


Evidence Base for Primary Dysmenorrhea

Pentra was studied for primary dysmenorrhea, involving periods of heightened symptoms associated with menstruation. The studies used short-term RCTs, where women were evaluated in a single menstrual cycle. Research examined outcomes capturing phases of heightened symptom activity, such as patient-reported discomfort severity and the need for additional medication. Evidence is limited regarding use across multiple consecutive cycles, and data for other gynecological pain causes remain insufficient.


Evidence Base for Osteoarthritis

The evidence for osteoarthritis (OA) was evaluated in historical clinical trials where the condition is characterized by fluctuating manifestations. Research explored outcomes reflecting daily functioning and joint pain intensity. However, due to regulatory restrictions on chronic use, the evidence is constrained. The treatment duration is limited to a maximum of 15 consecutive days, meaning current research is only relevant for temporary, acute flare-ups.


Long-Term Studies and Uncertainties

Clinical research primarily explores outcomes related to episodic and acute changes, with trials typically involving very short follow-up durations (under 15 days). Regulatory guidelines mandate this maximum systemic use duration, meaning there is limited information for long-term outcomes, and certainty remains low regarding what happens with repeated or continuous use.


Evidence in Specific Patient Groups

Pentra was studied for use in a broad range of adults and in adolescents above the age of 12 years. Results apply only to the populations studied. For example, there is limited information on outcomes in the elderly patient population, and comprehensive comparative evidence is lacking in several other special patient groups.

Frequently Asked Questions (FAQ)

Common questions about Pentra (FAQ)


Q: What are the key differences between the tablet and the gel?

A: According to official product information, the primary difference is the route of action. The oral tablet is intended for systemic effects, meaning the active ingredient acts throughout the entire body to address acute pain and fever. In contrast, the topical gel is designed for localized action, where it is applied directly to the skin for pain and inflammation in a specific area. Each form has its own unique instructions for application.


Q: What are the signs of liver problems I should watch for while taking Pentra?

A: Regulatory documents state that if signs that may indicate a liver issue appear, the medicine must be discontinued immediately. These symptoms can include feeling unwell, loss of appetite, nausea, vomiting, pain in the stomach area, fatigue, and having dark urine. If these signs are noticed, prompt medical attention is necessary.


Q: Can I take Pentra if I have high blood pressure?

A: Official information indicates that this medicine is contraindicated in severe heart failure, and elevated blood pressure (hypertension) is listed as an uncommon side effect. Special caution is required if a patient has pre-existing high blood pressure due to the documented risk of cardiovascular effects. Use in this scenario should be discussed with a healthcare provider.


Q: How do I know if I have severe renal impairment that prevents me from taking Pentra?

A: Official contraindications are based on laboratory results. Severe renal impairment is officially defined by a measurement of kidney function called creatinine clearance that is less than 30 mL/min. The current status of a patient's kidney function is typically assessed through specific blood and urine tests ordered and interpreted by a healthcare professional.


Q: Does Pentra help with a sore throat or only pain?

A: The medicine is officially approved for the symptomatic relief of acute pain and possesses analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) properties. Official information indicates the medicine is used for acute pain relief, which may include pain associated with conditions like sore throat in line with approved indications.


Q: Can Pentra be used to treat symptoms of a cold or the flu?

A: The official indication for this medicine is the symptomatic relief of acute pain and fever. Because it provides these effects, it can help manage some of the associated symptoms of a cold or the flu, such as aches and fever. However, the medicine is not specifically approved to treat the underlying viral infection.


Q: Is Pentra safe to take with my daily aspirin?

A: Official regulatory warnings advise against the use of this medicine together with acetylsalicylic acid (aspirin), as this combination may increase the risk of bleeding complications. Additionally, this medicine is not intended as a substitute for low-dose aspirin that is used for cardiovascular prevention.


Q: Do I need to change my diet while taking Pentra?

A: Regulatory guidance for the oral formulation states that it must be taken after a meal. There are no specific warnings or requirements in the product information mandating a change to the type of food consumed while taking it.


Q: Is it okay to crush the Pentra tablet before swallowing?

A: According to official administration instructions, oral tablets must be swallowed whole with a glass of water. The tablets must not be crushed or chewed, as altering the tablet in this way can affect how the medicine is absorbed and how it works in the body.


Q: Can Pentra affect the results of a blood test?

A: Yes, official safety information documents that this medicine can cause changes detected in blood tests. Specifically, transient and typically asymptomatic elevations in liver enzyme levels (such as serum aminotransferases) are documented adverse reactions. Other blood disorders are also listed as possible rare adverse reactions.


Q: Is it safe to drink alcohol while I am on Pentra?

A: Official warnings state that the use of alcohol must be avoided during treatment. This restriction is in place because alcohol may increase the risk of adverse reactions to the liver (hepatic reactions) and may also increase irritation in the gastrointestinal tract.


Q: What is the shelf life of Pentra tablets?

A: The specific shelf life for Pentra tablets is determined by the manufacturer based on stability testing and is always printed on the product packaging, usually near the expiration date. Adhering to the expiration date is important to ensure the medicine remains effective and safe.

How should Pentra be stored and disposed of?

Storage and Environmental Requirements

Official regulatory documentation mandates specific storage conditions for Pentra (Nimesulide) to maintain its integrity. Oral formulations, such as tablets and granules, must be stored below 25 C and kept within their original packaging to ensure protection from both light and moisture.

Storage Restriction Requirement
Temperature Store below 25 C
Protection Protect from light and moisture
Prohibition Do not refrigerate or freeze

The medicine must be kept out of the sight and reach of children.

Disposal Protocol

Disposal must strictly adhere to regulatory guidelines to protect the environment. Pentra must not be discarded via household waste or flushed down wastewater. The official instruction is to consult a pharmacist regarding the proper procedure for disposing of unused or expired medicine.

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

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