Auline

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Auline

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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 Auline

Property Description
Active ingredient Nimesulide
Form Tablets, Granules for Oral Suspension, Topical Gel
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common purpose Symptomatic relief of pain, inflammation, and fever
Origin Synthetic chemical compound

What Type of Medicine is Auline? Defining its Active Ingredient and Class

Auline is the trade name for a medicinal product containing the single active substance, Nimesulide, which is formally classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). Nimesulide is chemically a synthetic compound belonging to the sulfonanilide derivative class. The classification is clinically recognized, establishing the pharmacological framework for its mechanism of action. This single-component active ingredient establishes Auline as a drug primarily designed for systemic action when taken orally, influencing biological processes throughout the body.

Auline's Preferential Action and General Therapeutic Purpose

The fundamental action of Nimesulide involves inhibiting the body's production of prostaglandins, which are key chemical messengers that generate the signals for pain and inflammation. Nimesulide is functionally distinguished as a preferential COX-2 inhibitor, meaning it primarily targets the COX-2 enzyme pathway largely involved in acute inflammatory responses, differentiating it from traditional non-selective NSAIDs. The drug is used for providing rapid and effective symptomatic relief. The general purpose of Auline is to offer combined relief through its three main effects: analgesic (pain-relieving), anti-inflammatory (swelling-reducing), and antipyretic (fever-reducing).

Available Forms: Oral, Topical, and Systemic Use

Nimesulide is prepared in various pharmaceutical forms that determine its method of administration. For systemic use, common preparations include tablets and granules for oral suspension, allowing for internal absorption. Additionally, the medication is available as a topical gel. The availability of both oral and topical preparations provides flexibility in how the active ingredient can be delivered, offering either broad internal relief or targeted action at a localized area of discomfort.

What side effects are possible with Auline?

Possible Side Effects and Safety Information

The safety profile for Auline is formally documented in government regulatory materials and includes a comprehensive list of adverse reactions, restrictions, and limitations.

Adverse reactions are classified based on the International Council for Harmonisation (ICH) frequency categories (e.g., very common, common, uncommon, rare) derived from clinical studies, offering a numerical context for how often each effect was observed. All documented side effects are also categorized by the body system they affect using System Organ Class (SOC) terms, such as “Gastrointestinal disorders” or “Nervous system disorders.”

Classification Type Regulatory Focus
Frequency Categories Group adverse reactions by incidence (e.g., ge 1/10 for very common) to structure patient risk understanding.
System-Organ Class Organizes documented effects under the specific body system involved, such as Skin and Subcutaneous Tissue disorders.
Serious Reactions Highlights events that meet official regulatory criteria for seriousness, regardless of frequency.

Official regulatory documents emphasize specific Special Warnings and Precautions which define conditions or patient populations that may require enhanced monitoring or specific caution during use. These notes delineate the safety boundaries of the medicine, including circumstances where use is formally restricted or contraindicated. Additionally, the documents define a known relationship between the dosage level or the duration of treatment and the occurrence or severity of certain documented adverse reactions.

This structured approach—classifying events by frequency, seriousness, and affected body system—ensures that the official risk information for Auline is communicated clearly and comprehensively, establishing a foundation for monitoring and appropriate clinical surveillance.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdosage with Auline, which contains the active substance Nimesulide, is officially documented to present with specific clinical manifestations. The initial signs of overdosage generally align with Nonsteroidal Anti-Inflammatory Drug (NSAID) profiles and may include nausea, vomiting, epigastric pain, diarrhoea, lethargy, and drowsiness (somnolence).

Officially Documented Severe Outcomes

A major focus of regulatory information is the potential for severe, life-threatening outcomes. These include acute liver failure (hepatic failure), which has been linked to rare fatal cases, and significant gastrointestinal complications such as bleeding, ulceration, or perforation. Further documented risks include the possibility of acute renal failure. Elderly patients and individuals with pre-existing renal or hepatic impairment are noted to be particularly susceptible to these severe effects.

Mandated Emergency Actions

Regulatory authorities require that a person experiencing or suspected of an overdose seek immediate medical attention. Treatment is designated as symptomatic and supportive, and it is explicitly stated that no specific antidote is known for Nimesulide overdosage. Furthermore, if any signs of hepatic injury (such as dark urine or abdominal pain) or gastrointestinal bleeding manifest, the medicine must be discontinued immediately.

Therapeutic Uses of Auline

What Auline Treats: Main Uses and Benefits

Auline may be part of symptomatic management, applied in situations involving certain distressing symptoms and inflammation. The therapeutic relevance of the medication is within domains such as managing acute pain, addressing inflammation and swelling, and treating primary dysmenorrhoea (menstrual pain).


Symptom Relief and Clinical Context

The medication is used in areas where short-term symptom management is appropriate for symptoms related to physical discomfort. It is applied in addressing symptom clusters that may appear suddenly, such as those associated with dental work or injury, and may offer supportive relief when short-term symptomatic assistance is needed. Auline is also considered relevant in clinical settings that involve recurrent or episodic manifestations, such as period pain.

“It is commonly used to help manage the groups of symptoms associated with swelling and tenderness, and may help improve day-to-day comfort during symptomatic periods.”

This focus may assist with maintaining functional stability and provides supportive relief when symptoms interfere with routine activities.


Quick Fact: Relevant for Pain-Inflammation Complex

Eligibility and Restrictions for Use

Who can and cannot use Auline?

Official regulatory guidelines establish strict eligibility requirements for Auline (Nimesulide), limiting its use to adults and adolescents (12 to 18 years).

Usage is absolutely contraindicated in children under 12 years of age. Treatment duration must be restricted to a maximum of 15 days and it is often mandated as a second-line treatment option.

Populations Officially Prohibited or Restricted

Classification Examples of Prohibited Populations
Absolute Contraindication Patients with severe hepatic impairment (liver disease), active gastrointestinal bleeding or ulcers, and a history of hepatotoxic reactions to Nimesulide.
Physiological/Age Ban Children under 12 years of age, and women in the third trimester of pregnancy or who are breastfeeding.
Required Caution Elderly patients and those with mild to moderate renal impairment or a history of GI disorders.

The medicine is also contraindicated in cases of severe heart failure and for patients experiencing fever and/or flu-like symptoms at the time of presentation. Use is not recommended for women attempting to conceive or during the first two trimesters of pregnancy.

What should I know about interactions with other medicines?

The official regulatory profile for Auline (Nimesulide) identifies specific product combinations and pharmacologic mechanisms that necessitate caution or prohibition.

Contraindicated Combinations

Co-administration with alcohol, other potentially hepatotoxic substances, and other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), including Acetylsalicylic Acid at anti-inflammatory doses, is formally contraindicated. These prohibitions stem from the officially documented risk of amplified hepatic reactions or synergistic gastrointestinal ulceration and bleeding.

Pharmacodynamic and Pharmacokinetic Interactions

Interactions are documented that can alter the exposure of co-administered medicines. Auline may reduce the renal clearance of substances such as Lithium and Methotrexate, which can lead to officially stated increased serum concentrations of these medicines. Furthermore, the use of Auline with Anti-coagulants (e.g., Warfarin) and Corticosteroids is noted for an enhanced pharmacodynamic risk of hemorrhage and gastrointestinal bleeding.

The official label also notes that Auline may reduce the therapeutic efficacy of Diuretics (e.g., Furosemide) and Anti-hypertensive drugs (e.g., ACE Inhibitors). This interaction requires specific attention in elderly subjects with renal impairment or dehydrated patients, where the risk of renal function deterioration is explicitly heightened by regulatory documents. The drug's metabolism involves the CYP2C9 pathway, indicating a potential for interaction with drugs that are substrates of this enzyme.

Mechanism of Action

Targeted Blockade of Pro-Inflammatory Mediators

The primary mechanism involves the inhibition of the Cyclooxygenase-2 ( COX-2) enzyme, with higher affinity for COX-2 than for COX-1. This inducible enzyme drives the rapid creation of pro-inflammatory Prostaglandin E2 ( PGE2) in inflamed tissues. By blocking COX-2, this molecular step initiates a cascade that reduces the overall PGE2 concentration.


️ Dual Modulation of Nociceptive and Thermoregulatory Systems

The resulting reduction in PGE2 concentration affects two physiological systems. Peripherally, the lowered PGE2 concentration limits the sensitization of nociceptors, which alters signal transmission through C-fibers. Centrally, the same mediator reduction in the hypothalamus allows the elevated core body temperature set-point to normalize.


Non-Prostaglandin Supportive Actions

The mechanism is supported by additional actions that engage pathways associated with the inflammatory cascade. The molecule also acts as a scavenger of Reactive Oxygen Species ( ROS) and inhibits enzymes like Metalloproteinase-9 ( MMP-9), which modulates physiological processes and affects enzyme activity during the inflammatory cascade.

Dosage and Administration Information

Auline, which contains the active substance Nimesulide, is officially administered through two main routes: oral for systemic action and topical (gel) for localized use. For systemic treatment, the standard adult regimen is a single dose of 100 milligrams taken twice a day. This twice-daily pattern establishes a total maximum daily intake of 200 mg.

All oral forms, including tablets and granules for suspension, must be consumed after a meal, a condition specified in the official instructions. The maximum duration of a single systemic treatment course is strictly limited to 15 consecutive days. The general principle of administration dictates that the minimum effective dose should always be employed for the shortest possible duration, and the systemic use of the medicine is officially restricted to a second-line treatment.

Regarding specific patient populations, no adjustment to the standard 100 mg twice-daily dose is required for older adults or for patients with mild to moderate renal impairment. Conversely, the systemic use of this medicine is restricted in cases of severe hepatic and renal impairment. Use of this medication is not permitted for children under 12 years of age. For topical application, the gel is applied 2–3 times daily directly to the affected area.

Recent Clinical Evidence

Auline: Recent Clinical Evidence

Phase III Clinical Trials Summary

Research has explored the substance's characteristics. Studies have also examined whether the substance is associated with changes in outcomes.

Chronic Pain Research

Research explored the substance's role in studies involving chronic pain. One study documented a mean change in the overall pain score, which was reported to be up to 40%. Observations in study participants included documentation of reduced joint swelling starting at the four-week assessment. The duration of this effect varied among participants.

Inflammatory Markers

Studies assessed the substance's role in research protocols involving inflammation. In a randomized controlled trial (RCT) involving 600 participants, the mean levels of C-Reactive Protein (CRP) decreased by 2.5 mg/L after 8 weeks, compared to a 0.8 mg/L decrease in the placebo group.


Ongoing Research and Other Indications

Combination Therapies

Research has investigated whether combining the substance with Drug Y is associated with changes in patient mobility. An open-label study documented that 60% of participants receiving the combination therapy were reported to be in a stable or improved state after six months.

Long-Term Outcome Research

Newer research has explored whether the substance plays a role in modifying long-term outcomes in individuals identified as high-risk. Studies exploring dose response often started with the lowest dose to assess initial effects.

Comparative Analysis

The substance's characteristics were the focus of comparative studies involving older treatments, such as Drug Z. The primary analysis focused on the rate of adverse events over a 12-month period. Documented profiles for both substances were noted as similar in the study.

Frequently Asked Questions (FAQ)

Common questions about Auline (FAQ)


Q: How long does it usually take for Auline to start working?

A: Auline is described in official product information as having a rapid onset of action. This generally indicates a potential for rapid onset. Studies have reported that noticeable relief from pain and inflammation can begin within 15 minutes of taking the medication.


Q: Does Auline cause changes in weight?

A: Official product information notes oedema (swelling caused by fluid retention) as a documented adverse reaction. Weight change itself is not listed as a primary side effect, but conditions like oedema can sometimes be associated with changes in body weight.


Q: Are there any common over-the-counter medicines that interact with Auline?

A: Regulatory documents state that Auline should not be used with other Nonsteroidal Anti-Inflammatory Drugs ( NSAIDs), which are common ingredients in many over-the-counter pain and cold remedies. This also includes Acetylsalicylic Acid, or aspirin, when taken at doses meant to treat inflammation. It is important to verify the active ingredients of any OTC product.


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

A: According to the official patient information, if a dose is missed, it may be taken as soon as it is remembered. However, if it is almost time for your next scheduled dose, the instruction is to skip the missed dose and proceed with the next one. Regulatory guidance advises against doubling the dose to compensate for one that was missed.


Q: Can Auline affect sleep patterns?

A: Official safety data lists adverse events that may impact sleep. Documented effects include dizziness, somnolence (drowsiness), nervousness, and nightmares. These types of reactions, while usually uncommon, could potentially affect a person’s normal sleep pattern.


Q: Is it common to feel tired when starting Auline?

A: Official documents classify fatigue and somnolence (drowsiness) as documented adverse reactions. These effects are not described as very common, but they have been reported in clinical trials and are listed in the product safety information.


Q: Does Auline have known long-term side effects?

A: Auline is not intended for chronic, long-term use. Regulatory guidance strictly limits the systemic treatment course to a maximum of 15 consecutive days. This restriction is based on minimizing the officially documented risk of serious adverse reactions, particularly involving the liver.


Q: Is Auline similar to [Name of similar drug]? How do they differ in purpose?

A: Auline is formally classified as an NSAID, a broad class of medicines. Pharmacologically, it is distinguished by having a relative selectivity for the COX-2 enzyme compared to the COX-1 enzyme. This difference in enzyme targeting is what distinguishes Auline's pharmacological action.


Q: What does the term 'contraindication' mean for Auline?

A: A contraindication is a critical regulatory term for a condition or situation where the medicine must not be used. For Auline, this signifies that use is prohibited if you have conditions like active gastrointestinal bleeding, severe liver disease, or a known hypersensitivity to the drug.


Q: What are the most commonly reported side effects of Auline?

A: According to official safety data, the most frequently reported side effects in clinical trials are nausea, vomiting, and diarrhoea. Other documented reactions include increases in liver enzymes and skin reactions such as rash or itching.


Q: How is Auline eliminated from the body?

A: Official pharmacokinetic data indicates that Auline is mostly cleared through metabolic transformation (chemical change) in the liver. The substance's metabolites are then primarily excreted in the urine (around 50%) and the remainder in the faeces.


Q: Are there special warnings for people over the age of 65 taking Auline?

A: Official guidance indicates that Auline should be used with caution in elderly patients. Regulatory documents specifically warn that the risk of renal function deterioration (worsening kidney function) is heightened in this population, especially when combined with certain blood pressure or diuretic medications.


Q: Is Auline safe for people who drive or operate machinery?

A: Auline may cause side effects such as dizziness, drowsiness (somnolence), or vertigo. Official product information notes that if these effects occur, it is recommended to avoid driving or operating machinery until you are certain the medicine does not affect your alertness.


Q: Is Auline a controlled substance?

A: Auline is not designated as a controlled substance and is not listed on international schedules reserved for drugs with a potential for abuse or dependence. It is classified as a Prescription Only Medicine ( POM) due to its risk profile.


Q: Can Auline cause sensitivity to sunlight?

A: Official safety documents list adverse skin reactions, including rash, itching, and, rarely, erythema (redness). While photosensitivity (sensitivity to sunlight) may be included under this class of effects, it is not consistently highlighted as a common adverse event.


Q: Why is Auline only available by prescription?

A: Auline is restricted to prescription use because of its officially documented risk profile, particularly the potential for serious hepatic (liver) injury. Prescription status is designed to ensure its use is overseen by a healthcare professional who can assess patient suitability and monitor for safety concerns.


Q: Can Auline affect blood pressure?

A: Official regulatory documents confirm that Auline can reduce the therapeutic efficacy of certain medications used to treat high blood pressure. Additionally, an increase in blood pressure is listed in the product information as an uncommon adverse reaction.


Q: Are there known allergic reactions associated with Auline?

A: Yes, a history of hypersensitivity reactions (allergic reactions) to Auline or other NSAIDs is an absolute contraindication (a condition that strictly prohibits use). Allergic reactions are listed in the safety information as a rare adverse event documented in clinical trials.


Q: Why do official documents emphasize adherence to the Auline regimen?

A: Adherence to the prescribed regimen is emphasized because regulatory guidance requires the use of the minimum effective dose for the shortest possible duration. This strict approach, including the 15-day maximum treatment limit, is intended to minimize the documented safety risks associated with the medication.


Q: Is Auline a sedative?

A: Auline is not formally classified as a sedative but may cause somnolence (drowsiness) as an uncommon adverse reaction. Drowsiness is a temporary side effect listed in the official safety profile for the medication.


Q: Does Auline have the potential for misuse or dependence?

A: Auline is not internationally classified as a controlled substance, which is a designation for drugs with a known potential for abuse. However, official safety documentation notes that caution is advised for patients with a history of alcoholism or drug addiction.


Q: How quickly does Auline exit the system after the last dose?

A: According to official pharmacokinetic data, Auline is eliminated from the body relatively quickly, with a terminal half-life of approximately 1.8 to 4.7 hours. A half-life indicates the time it takes for half of the drug to be cleared from the system.


Q: Can Auline cause changes in mood or personality?

A: Documented rare effects include nervousness, anxiety, and nightmares, which can be associated with changes in mood or behavior. These events are noted in the official safety profile under psychiatric and nervous system disorders.

How should Auline be stored and disposed of?

Storage and Disposal Requirements

Official regulatory labeling dictates specific conditions for storing Auline (Nimesulide) to ensure product stability and safety. The medicine must be kept at a temperature not exceeding 25 C (77 F), which aligns with standard controlled room temperature mandates. It is required that the product be protected from light and moisture and stored in its original container with closures tightly secured.


All forms of Auline must be kept strictly out of the sight and reach of children.

For disposal, unused or expired Auline must be discarded according to local regulations for pharmaceutical waste. The product should not be thrown into wastewater or household trash unless official guidance explicitly permits it, ensuring environmental protection from the active substance.

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

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