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Apental

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Apental

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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 Apental

Quick Facts

Property Description
Active ingredient Aceclofenac
Form Film-coated tablet
Pharmacological class Non-steroidal Anti-inflammatory Drug (NSAID)
Common use Relief of pain and inflammation
Origin Synthetic, Phenylacetic acid derivative

What Type of Medicine is Apental? (Classification and Identity)

Apental is a medicinal product defined by its sole active ingredient, the substance Aceclofenac, which belongs to the therapeutic class of Non-steroidal Anti-inflammatory Drugs (NSAIDs). This classification establishes its function as both an analgesic and an anti-inflammatory agent. The medicine facilitates the relief of pain by reducing the biological sources of inflammation.

The active compound, Aceclofenac, is a synthetic drug chemically identified as a phenylacetic acid derivative. This structure places it within a family of compounds used to mitigate pain and inflammatory processes. As a single-ingredient product, Apental's pharmacological profile is focused entirely on the specific properties of Aceclofenac.

Composition and Pharmaceutical Presentation (Form and Origin)

Apental is most commonly presented as a film-coated tablet designed for the oral route of administration, which ensures the systemic delivery of the therapeutic compound throughout the body. The tablet is composed of the primary active substance, Aceclofenac, integrated within a solid oral matrix of inert excipients, a standard pharmaceutical requirement.

Aceclofenac is characterized by its primary mechanism of inhibiting cyclooxygenase. By inhibiting these key enzymes, Apental reduces inflammation and provides symptomatic relief.

General Purpose: Pain Relief and Inflammation (High-Level Benefit)

The general purpose of Apental is to mitigate inflammatory processes and provide pain relief by functioning as an inhibitor of the Cyclooxygenase (COX) enzymes. By reducing the localized production of prostaglandins, it addresses the chemical signals responsible for pain and driving inflammation. This focused physiological action means the medication is designed to manage discomfort, stiffness, and swelling in adults experiencing pain caused by an underlying inflammatory component.

What side effects are possible with Apental?

Possible Side Effects and Safety Information

The documented safety profile for Apental (Aceclofenac) is consistent with its classification as a Non-steroidal Anti-inflammatory Drug (NSAID). Adverse reactions are officially categorized by frequency and system involvement, based on regulatory standards.

Classification Examples of Documented Adverse Reactions
Common (1/100 to <1/10) Dyspepsia, abdominal pain, nausea, diarrhoea, dizziness, hepatic enzymes increased.
Uncommon (1/1,000 to <1/100) Flatulence, gastritis, vomiting, rash, pruritus, mouth ulceration, blood creatinine increased.

Serious adverse reactions are reported in the rare category (1/10,000 to <1/1,000) and include severe gastrointestinal events such as haemorrhage, ulceration, or perforation. Immune reactions like anaphylactic shock and severe skin conditions such as Stevens-Johnson Syndrome are also documented in the rare or very rare frequency classifications. Serious skin reactions are most often noted early in the course of therapy.

Safety statements in regulatory labels note that risks, particularly those related to the cardiovascular system, may increase with higher doses and longer duration of use. Specific attention is required for certain patient groups:

  • Elderly: Increased risk for serious adverse events, notably fatal gastrointestinal bleeding.
  • Organ Function: Contraindicated in cases of severe hepatic or renal failure. Long-term use requires monitoring of hepatic function, renal function, and blood counts.
  • Pregnancy/Fertility: Not recommended for women attempting to conceive and contraindicated during the last trimester of pregnancy.

Overdose and Emergency Response

The official regulatory profile for Aceclofenac overdose defines both common manifestations and severe, life-threatening risks.

Overdose may present with gastrointestinal effects, including nausea, vomiting, epigastric pain, and gastrointestinal bleeding. Central Nervous System symptoms are also documented, such as headache, dizziness, drowsiness, and the occasional occurrence of convulsions.

In cases of significant poisoning, official documents classify the potential for severe systemic outcomes, including the onset of Acute Renal Failure and Liver Damage. Complications, such as severe gastrointestinal bleeding, are noted to have more serious consequences in the elderly.

Immediate medical attention is required for any severe, regulator-listed systemic signs. This includes the sudden onset of chest pain, trouble breathing, sudden weakness or numbness on one side of the body, or slurred speech. Contacting emergency services is mandated under these conditions.

Treatment is described as symptomatic and supportive. No specific antidote is known. Management procedures listed in official prescribing information may include preventing drug absorption using activated charcoal or administering intravenous diazepam to control prolonged convulsions. Close monitoring of renal and liver function is required following an overdose event.

Therapeutic Uses of Apental

The primary therapeutic purpose of Apental (Aceclofenac) is aligned with its classification as a non-steroidal anti-inflammatory drug (NSAID), and may be part of symptomatic management for pain and inflammation.

The medication is commonly used to help with symptoms related to persistent inflammation, joint pain, and stiffness across several specific conditions. Apental plays a role in managing conditions characterized by periods of heightened symptoms such as Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis. It is relevant for easing symptoms in acute contexts, including localized low back pain, certain forms of gynaecological pain, and dental pain.

“The medication helps address symptom clusters that may become intense or disruptive and contributes to easing the overall symptom load.”

Apental supports patients by assisting with maintaining functional stability, and this may contribute to easing overall distress during symptomatic periods. It is relevant for easing symptoms of physical stiffness and restricted movement, and may assist when short-term symptomatic assistance is needed.

Quick Fact: Relief for Inflammation and Pain
Main Conditions Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis
Key Symptoms Joint pain, swelling, stiffness
Primary Benefit Support for functional stability and comfort

Regulatory References

  1. ACECLOFENAC - FDA Verification Portal

Eligibility and Restrictions for Use

Who Can and Cannot Use Apental?

Eligibility for Apental (Aceclofenac) is determined by specific regulatory criteria concerning age, pre-existing health conditions, and physiological status, as outlined in official government labeling. Use is primarily established for the adult population.

Contraindicated Populations (Must Not Use)

Apental is strictly contraindicated and must not be used by patients who have a known hypersensitivity to Aceclofenac, or demonstrated cross-sensitivity to Aspirin or other NSAIDs.

Use is also prohibited in patients with established severe conditions, including:

  • Severe heart failure (NYHA class II–IV) or established vascular diseases (e.g., ischaemic heart disease).
  • Active or recurrent gastrointestinal bleeding/ulcers.
  • Hepatic failure or moderate to severe renal failure.

Age and Reproductive Restrictions

Population Group Eligibility Status
Pediatric (Under 18) Not recommended (due to insufficient clinical data).
Last Trimester of Pregnancy Contraindicated (absolute prohibition).
Lactation / Fertility Not recommended (due to documented risks or lack of data).

Conditional Use

Patients with mild renal or hepatic impairment may use the medicine but require close medical surveillance and may need dose adjustments. Elderly patients are allowed standard use but are cautioned due to an increased risk of serious adverse reactions, particularly GI bleeding.

What should I know about interactions with other medicines?

Apental Interactions with other medicines and products

This section details interaction patterns for Apental (Aceclofenac) as described in official government regulatory documents.

Contraindicated Combination

Co-administration with other NSAIDs, including Aspirin (Acetylsalicylic acid) and cyclooxygenase-2 selective inhibitors, must be avoided. This restriction is documented due to an increased risk of gastrointestinal adverse effects.

Clinically Significant Interaction Outcomes

Official labeling defines interactions primarily by increased toxicity or altered efficacy of the co-administered substance. The co-administration of Apental with Anticoagulants (e.g., Warfarin) may enhance the anticoagulant effect, increasing the risk of bleeding. This risk is also documented for combinations with Corticosteroids, Antiplatelet agents, and SSRIs.

Apental can cause decreased elimination of both Lithium and Methotrexate, which officially results in increased plasma concentrations and potential toxicity risk for these substances. Similarly, co-administration with Cardiac Glycosides may lead to increased plasma levels.

Efficacy and Renal Risk Interactions

Interactions affecting organ function or drug efficacy are documented for several classes. Use with ACE-Inhibitors or Angiotensin II Receptor Blockers (ARBs) may result in a reduced anti-hypertensive effect. This combination, particularly in elderly or dehydrated patients, carries a documented increased risk of acute renal insufficiency.

Use with Ciclosporin or Tacrolimus is associated with an increased risk of nephrotoxicity. Furthermore, Apental should not be used for 8–12 days following Mifepristone administration, a mandatory timing rule to prevent reduction of the Mifepristone's effect.

Mechanism of Action

Preferential Inhibition of the Cyclooxygenase-2 Enzyme

Apental acts primarily by mathbfp r e f e r e n t i a l l y inhibiting the Cyclooxygenase-2 (mathbfC O X - 2) enzyme, which is responsible for synthesizing pro-inflammatory Prostaglandins (mathbfP G E 2 ) at the site of tissue damage. This molecular blockade mathbfd a m p e n s the nociceptive signaling pathway and results in a mathbfd a m p e n i n g of mathbfn o c i c e p t o r sensitization and mathbfm i t i g a t i o n of mathbfv a s c u l a r permeability changes.

Modulation of Cellular Inflammatory Signals

The drug’s mechanism extends beyond simple enzymatic blockade to mathbfm o d u l a t e mathbfc e l l u l a r mathbfr e s p o n s e s by suppressing the production of mathbfp r o - i n f l a m m a t o r y cytokines (mathbfIL-1beta) and mathbfi n t e r f e r i n g with the mathbfa d h e s i o n of mathbfn e u t r o p h i l s to the vascular lining. This activity mathbff u n c t i o n a l l y mathbfc o n s t r a i n s the mathbfc e l l u l a r recruitment phase of the inflammatory cascade, which mathbfa c h i e v e s mathbff u r t h e r modulation of the overall mathbfi n f l a m m a t o r y mathbfp a t h w a y dynamics.

Action on Cartilage Matrix Homeostasis

A specialized feature of this drug’s mechanism is its direct influence on mathbfc a r t i l a g e mathbft i s s u e via active metabolites, where it mathbfs t i m u l a t e s the synthesis of mathbfG l y c o s a m i n o g l y c a n s (GAGs) and mathbfs u p p r e s s e s mathbfm a t r i x degrading enzymes. This mathbfm o d u l a t i o n of the mathbfc a r t i l a g e mathbfm a t r i x mathbfc o n t r i b u t e s to the mathbfb a l a n c e between mathbfs y n t h e s i s and mathbfd e g r a d a t i o n within the mathbfc a r t i l a g e mathbfm a t r i x, which is a mathbfd i s t i n c t i v e mechanistic outcome.

Dosage and Administration Information

The administration of Apental is governed by specific parameters concerning dosage, frequency, and method of intake, defining its use in clinical practice. The medicine is supplied as a 100 mg film-coated tablet intended for oral administration.

Standard Dosing and Frequency

The standard regimen for adults is 200 mg daily, achieved by taking one 100 mg tablet twice daily, typically once in the morning and once in the evening. A fundamental principle governing use is to employ the lowest effective dose for the shortest duration necessary to control symptoms, with a periodic re-evaluation of the need for symptomatic relief.

Administration Requirements

The tablets must be swallowed whole with a sufficient quantity of liquid and should not be crushed or chewed. Apental is intended to be taken preferably with or after food.

Population-Specific Adjustments

For specific populations, dose modifications are utilized. For patients with hepatic impairment, a reduced initial daily dose of 100 mg is indicated. The medication is not recommended for use in the paediatric population due to a lack of clinical data. While no modification is generally necessary for older adults or those with mild renal impairment, the objective remains the use of the minimum necessary dosage.

Recent Clinical Evidence

Apental: Recent Clinical Evidence

Compound Activity Research

Studies were conducted to assess the compound’s activity. Early in vitro and animal studies investigated the compound. Subsequent trials included the measurement of specific biological indicators in human participants.

Clinical Trial Outcomes

Acute Symptom Assessment

Studies assessed changes in acute pain scores over a short duration. The trials primarily utilized randomized, placebo-controlled designs, with researchers tracking changes in pain intensity (using standard scales) and the time to reported symptom change. The findings collected were variable, with some trials observing changes in pain scores and others noting no statistically significant difference from placebo.

Chronic Condition Research

Research examined the administration of the compound in chronic conditions. Studies assessed whether the long-term use of the compound was associated with changes in patient quality of life measures. Trials also explored the relationship between the compound's administration and the severity and frequency of flare-ups, tracking symptom changes over time.

Combination Therapy

Studies compared the outcomes associated with combination therapy versus monotherapy. Research explored whether the compound's use alongside other standard treatments influenced measured outcomes. Pharmacokinetic trials examined the potential effects of co-administration on the concentration of both compounds in the body.

️ Research Limitations and Risk Assessment

Research examined the administration of the compound in participants with mild liver impairment. Studies assessed the reported outcomes and potential risks of the compound. Clinical trials collected data on the frequency and type of side effects reported by participants, and explored the administration of high doses in participants with pre-existing heart conditions. Studies tracked the tolerability of the compound across the evaluated dose range, though it is not yet clear whether the compound's full long-term risk profile has been established.

Key Studies & References Clinical Practice Guideline: Management of Chronic Pain Conditions (Relevant Section on Novel Analgesics)

Frequently Asked Questions (FAQ)

Common questions about Apental (FAQ)

Q: How quickly does Apental start working after I take it?

Studies on the drug’s profile indicate that the time required to reach the highest concentration of the medicine in the blood is generally between 1.25 and 3.00 hours after an oral dose. This time range represents when the active substance typically reaches peak levels in the body.

Q: Is Apental safe for people with liver conditions?

Official regulatory guidance advises that patients with existing liver conditions, specifically mild to moderate hepatic impairment, require close medical surveillance and may need a reduced starting dose. The medicine is strictly contraindicated, meaning its use is prohibited, if a patient has severe hepatic failure.

Q: What are the common signs of an allergic reaction to Apental?

Official documents note that allergic reactions may occur, including rare severe events like anaphylactic shock. More commonly reported signs of an allergic reaction include skin effects such as a rash, hives (urticaria), and itching (pruritus).

Q: Are there any warnings about using Apental before driving or operating machinery?

Official labeling documents contain warnings regarding the potential for dizziness and drowsiness, which may impair the ability to drive or operate machinery. These warnings are included because the medicine may cause these central nervous system effects.

Q: If I miss a scheduled dose of Apental, what should I generally do?

Regulatory patient information generally states that if a dose is missed, it should be skipped entirely. The next dose should then be taken at the usual scheduled time. It is stated that a double dose should not be taken to make up for a forgotten dose.

Q: Can I use Apental if I have a history of kidney problems?

Official labeling states that no change in dose is usually needed for those with mild renal impairment. However, patients with mild to moderate kidney problems require close medical oversight. The medicine is strictly contraindicated, meaning its use is prohibited, in patients with severe renal failure.

Q: Is there a risk of becoming dependent on Apental?

Apental is classified as a Non-steroidal Anti-inflammatory Drug (NSAID). This class of medicines is not classified as a narcotic or controlled substance and is not associated with a risk of physical or mental dependence.

Q: Does Apental affect blood pressure?

Official warnings note that the use of this medicine is associated with an increase in blood pressure. Additionally, it can reduce the blood pressure-lowering effect of certain anti-hypertensive medicines when taken together.

Q: Is Apental considered a controlled substance?

No. Apental is classified as a Non-steroidal Anti-inflammatory Drug (NSAID). Based on regulatory schedules, it is not listed as a controlled substance that has a potential for abuse.

Q: Why are there warnings about Apental and seizures?

Regulatory documents indicate that the medicine has a potential drug-drug interaction when co-administered with certain other substances. Specifically, combining it with certain medications, such as quinolone antibiotics, may increase the risk of seizures.

Q: What is the purpose of the extended-release formulation of Apental?

The extended-release formulation is a specialized tablet designed to release the active ingredient slowly over time. The purpose of this design is to allow for a once-daily dosing schedule, which is less frequent than the typical twice-daily dosing of the immediate-release tablet.

Q: Does Apental affect sleep patterns?

Official side effect profiles list central nervous system effects such as drowsiness and dizziness. These effects are listed as potential central nervous system effects.

Q: Why do official documents mention Apental should not be used with MAO inhibitors?

The warning concerns a potential drug-drug interaction where combining the medicine with certain reversible MAO inhibitors may lead to an unfavorable outcome. This combination is noted in regulatory information for having the potential to increase the risk of high blood pressure (hypertension).

Q: What type of pain is Apental best known for treating?

The medicine is officially indicated for the relief of pain and inflammation associated with certain chronic conditions. These include osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis.

How should Apental be stored and disposed of?

Storage and Disposal Requirements

Apental (Aceclofenac) must be stored strictly according to the conditions defined in the official regulatory labeling to maintain the product's quality and stability.

Official Storage Conditions

Apental tablets must be stored at Controlled Room Temperature, which is generally specified as below 25 C (77 F). It is essential to protect the medicine from moisture and humidity, requiring that the product be kept in its original package and outer carton. The label strictly advises not to refrigerate or freeze the tablets. For safety, the medicine must always be kept out of the sight and reach of children.

Disposal Instructions

Unused or expired Apental must be disposed of according to local regulations. Regulatory guidelines advise against disposing of the medicine via wastewater (e.g., flushing) or general household trash. The preferred method is to utilize an authorized drug take-back program or collection point in your area.

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

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