Drolgan

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Drolgan

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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 Drolgan

Quick Facts

Property Description
Active ingredient Aceclofenac, Drotaverine
Form Tablet (Oral formulation)
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID) and Antispasmodic agent
Common use Symptomatic relief of pain and smooth muscle spasm
Origin Synthetic compound

What Type of Medicine is Drolgan and What Does it Contain?

Drolgan is a synthetic medicine classified as an oral Fixed-Dose Combination (FDC) product, meaning it delivers two distinct active ingredients in a single tablet. The core composition includes Aceclofenac and Drotaverine, which is typically utilized as Drotaverine Hydrochloride. This formulation is categorized by its two high-level pharmacological classes: an Antispasmodic agent and a Non-Steroidal Anti-Inflammatory Drug (NSAID). Aceclofenac is categorized as an NSAID, which targets inflammatory processes in the body. This combination is particularly recognized in pharmaceutical practice for its ability to address complex pain states where both inflammation and involuntary muscle contraction are present. The preparation is designated for the oral route of administration.

Drolgan's Dual-Action Classification and Purpose

The primary therapeutic purpose of Drolgan is to provide symptomatic treatment in clinical scenarios where pain is associated with underlying smooth muscle spasm. The dual-action mechanism is key: the Aceclofenac component is responsible for reducing inflammation and dulling pain perception, while the Drotaverine component functions as a potent spasmolytic to relax involuntary muscle contractions. As an antispasmodic, Drotaverine relaxes smooth muscles. This indicates the medicine works by targeting the physical contraction causing discomfort alongside the inflammatory response. This approach leverages a powerful synergistic effect that differentiates the FDC from standard single-agent pain relievers, making it a clinically recognized option for conditions involving simultaneous inflammation and painful spasticity.

What side effects are possible with Drolgan?

Possible side effects and safety information

The safety profile for Drolgan (Aceclofenac/Drotaverine) is defined by officially documented adverse reactions, primarily associated with the Non-Steroidal Anti-Inflammatory Drug (Aceclofenac) component. Regulatory agencies classify side effects based on how frequently they appear.

Adverse Reaction Classifications

Side effects are categorized by the affected System-Organ Class (SOC), with Gastrointestinal Disorders, Nervous System Disorders, and Hepatic Disorders being among those most frequently documented. Common (ge 1/100 to <1/10) reported adverse reactions include dyspepsia, abdominal pain, nausea, and dizziness, along with increases in hepatic enzyme levels. Uncommon reactions (ge 1/1,000 to <1/100) include flatulence, rash, and pruritus.


Serious Adverse Reactions and Risk Patterns

The regulatory profile identifies rare but serious adverse reactions (ge 1/10,000 to <1/1,000) linked to the NSAID component, including Gastrointestinal haemorrhage, ulceration, or perforation, which can be fatal. Other serious documented risks include severe mucocutaneous skin reactions (such as Stevens-Johnson Syndrome) and anaphylactic shock.

The official labeling notes that the risk of gastrointestinal bleeding is explicitly documented as higher with increasing doses and duration of exposure. Serious skin reactions are most common early in the course of therapy.


Safety Constraints for Specific Populations

Safety constraints are defined for specific patient populations. The medicine is formally contraindicated in individuals with severe hepatic impairment or moderate to severe renal impairment. Regulatory documents also state that use of the NSAID component may impair female fertility and is generally not recommended in women attempting to conceive. Furthermore, effects such as dizziness or visual disturbance are documented as potentially impairing the ability to drive or operate machinery.

Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory authorities mandate that an overdose of Drolgan, which combines an NSAID and an antispasmodic, requires immediate medical attention due to the risk of severe systemic complications. Documented clinical manifestations of overdose often include signs such as headache, vomiting, dizziness, confusion, weakness, and epigastric pain, as well as gastrointestinal irritation or bleeding.

Required Emergency Actions

The most serious outcomes documented in regulatory labeling are life-threatening events affecting major organs. These include acute renal failure, liver damage, convulsions, respiratory depression, and severe heart rhythm and conduction disorders, which may lead to cardiac arrest. Due to these potential severe or fatal outcomes, official labeling explicitly requires patients to seek immediate medical attention or contact emergency services if an overdose is suspected or has occurred.

Official Management Profile

The regulatory profile confirms that no specific antidote is known for overdose with this combination. Management relies entirely on symptomatic and supportive treatment. Procedures described in official documents include the consideration of activated charcoal or gastric lavage within one hour of ingesting a potentially toxic amount. Close monitoring of renal function, liver function, and cardiac rhythm is required to manage the documented toxicities.

Therapeutic Uses of Drolgan

The medication is used to provide symptomatic relief in conditions where symptoms are related to inflammatory or irritative states and increased muscular activity. This therapeutic focus is applied across several key domains.

Relief from Acute Colicky Pain and Visceral Spasm

This medicine is commonly used to help with symptoms linked to organ-specific functional stress, often presenting as symptoms related to physical discomfort. It is typically applied in clinical settings that involve acute or unstable symptom patterns, such as the pain associated with renal colic and biliary colic. These conditions are characterized by periods of heightened symptoms, and the medication provides supportive relief when symptoms become more noticeable.

Managing Pain and Cramping in Primary Dysmenorrhea

Drolgan is relevant for managing symptoms that interfere with daily comfort, such as those of primary dysmenorrhea (painful menstruation). This condition involves symptoms that create noticeable physiological strain. Applied when appropriate, it helps improve day-to-day comfort during symptomatic periods, such as during phases of increased distress or discomfort.


Quick Fact: Relief for Pain and Spasm The medication is relevant for easing symptoms that interfere with daily functioning across conditions presenting with localized discomfort. It provides support that helps ease the overall symptom burden.

Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility for Drolgan

The eligibility profile for Drolgan (which contains an antispasmodic and a non-steroidal anti-inflammatory drug or NSAID component) is strictly governed by regulatory documentation, which defines specific populations who must avoid the medicine or use it with caution.

Classification Population or Condition
Absolute Contraindication Hypersensitivity or allergy to any component; Severe Heart Failure; Active or history of gastrointestinal bleeding/ulceration; Severe Hepatic or Renal Impairment; Third trimester of pregnancy.
Use Not Recommended Pediatric patients (safety and efficacy not established, typically under 18 years); Pregnant women (first and second trimesters); Breastfeeding women.

Age-Related Eligibility

The medicine is generally intended for adults who do not possess any contraindications. Use in the pediatric population is not recommended due to a lack of established safety and efficacy data from regulatory authorities. Older adults may use Drolgan, but official prescribing information advises caution, and a lower dose may be recommended due to increased risk of adverse effects, such as kidney or liver dysfunction.

Condition-Specific Restrictions

Use is restricted or requires special medical consideration in patients with pre-existing conditions like mild to moderate hepatic or renal impairment, certain cardiovascular risk factors, or a history of severe asthma. Official documentation mandates caution and monitoring in these situations, although use is not strictly prohibited unless the condition is classified as severe.

What should I know about interactions with other medicines?

The interaction profile of Drolgan, a fixed-dose combination of Aceclofenac (NSAID) and Drotaverine (Antispasmodic), is defined by the unique interaction patterns of each active substance as documented in official regulatory sources.

Aceclofenac (NSAID Component) Interactions

The NSAID component carries specific restrictions regarding co-administration:

  • Drugs affecting Hemostasis: Co-administration with anticoagulants (e.g., Warfarin), anti-platelet agents, SSRIs, or SNRIs increases the risk of serious hemorrhage due to additive effects. Co-administration with other NSAIDs or salicylates is restricted.
  • Renal and Blood Pressure Agents: Concomitant use with ACE Inhibitors, ARBs, or Diuretics may result in a diminished antihypertensive or diuretic effect and carry a risk of deterioration of renal function. This renal risk is noted as heightened in elderly patients and those with existing renal impairment.
  • Exposure Modification: Co-administration may increase plasma concentrations of Lithium and Digoxin due to reduced clearance, requiring regulatory caution.

Drotaverine (Antispasmodic Component) Interactions

The official labeling contains a formal restriction regarding the antiparkinsonian agent Levodopa, as co-administration is advised to be avoided due to a decrease in Levodopa's effect, which may worsen rigidity. Furthermore, the use of other spasmolytics may lead to a pharmacodynamic enhancement of the spasmolytic effect, and combinations with Tricyclic Antidepressants may result in enhanced hypotension.

Mechanism of Action

The drug's activity involves two distinct mechanistic domains: enzyme inhibition that affects inflammation and signaling modulation that affects smooth muscle contraction.

Modulating the Inflammatory Cascade via COX Enzyme Inhibition

This domain covers the Aceclofenac component, which functions as a preferential inhibitor of the Cyclooxygenase-2 ( COX-2) enzyme. By blocking this enzyme, the drug suppresses the synthesis of pro-inflammatory prostaglandins ( PGE2) at sites of tissue irritation. This mechanism reduces the chemical signaling that sensitizes peripheral sensory nerves, resulting in the attenuation of inflammatory processes and a reduction in nociceptor excitability.

Inducing Spasmolysis via Intracellular Signaling Modulation

This domain is driven by the Drotaverine component, which acts by selective inhibition of the Phosphodiesterase Type 4 ( PDE4) enzyme in smooth muscle cells. This inhibition prevents the breakdown of cyclic adenosine monophosphate ( cAMP), thereby interrupting the final molecular steps necessary for the muscle to contract. The cascade results in the cessation of involuntary smooth muscle contraction, functionally categorized as spasmolysis.

Mechanistic Synergy for Comprehensive Physiological Adjustment

The components provide a complementary dual-mechanism by influencing both the pathways of chemical inflammation and the processes of mechanical muscle tension. The engagement of two distinct molecular targets permits simultaneous influence over both the inflammatory cascade and the smooth muscle contraction pathway.

Dosage and Administration Information

Drolgan is an oral fixed-dose combination (FDC) tablet intended for short-term symptomatic use. The medicine is strictly administered via the oral route, defining the exclusive path for its use. The standard administration pattern for adults involves a single dose of one tablet containing Aceclofenac 100 mg and Drotaverine 80 mg. This dose is typically repeated twice daily, maintaining a separation of approximately 12 hours between administrations, and should not exceed the standard maximum daily allowance.

The proper intake of the medicine involves specific conditions for correct use. The tablet must be swallowed whole with water and should not be crushed, chewed, or broken. Furthermore, Drolgan is designated to be taken with or immediately after food, which is a procedural instruction tied to the FDC's composition.

High-level population-specific rules determine the boundaries of use. The medication is not recommended for use in children under the age of 12 years. Additionally, usage for adults with hepatic or renal impairment may require careful consideration or dose modification due to the Aceclofenac component. If an administration is missed, the regular schedule is resumed with the next dose; doubling the dose to compensate is prohibited. The overall duration is limited to the acute symptomatic period.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Drolgan


Evidence for Symptom Relief in Primary Dysmenorrhea

The research evidence for Drolgan (Aceclofenac + Drotaverine FDC) was evaluated in research exploring short-term randomized controlled trials (RCTs) associated with primary dysmenorrhea (painful menstruation). These studies were designed to explore how symptoms change over time when compared to taking only the NSAID component, Aceclofenac, or a placebo. Researchers typically included adult women, who were experiencing an acute episode of symptoms.

Studies conducted during periods of increased symptom activity reported measurements of outcomes related to physical discomfort over the defined periods. Research describes the patterns of measurements for outcomes like the Total Pain Relief (PR) score and Sum of Pain Intensity Differences (SPID) tracked over short time intervals. Additionally, regulatory bodies have required Active Post-Marketing Surveillance to gather real-world usage information.


Evidence for Management of Acute Colicky Pain

Research has evaluated the FDC in contexts relevant to acute colicky pain (such as renal or biliary colic), conditions characterized by acute or disruptive episodes of pain caused by smooth muscle spasm. The research examined very short-term responses, with studies monitoring patient-reported outcomes describing perceived discomfort at defined time intervals. These studies primarily tracked outcomes reflecting episodic or acute changes in pain intensity, such as the Visual Analog Scale (VAS) score.

Findings from some studies showed patterns related to measured changes in pain intensity observed in the study populations. Because this combination is an FDC, comparative evidence is sometimes limited against every possible alternative combination therapy, leading to mandated Active Post-Marketing Surveillance studies to gather real-world data.


Areas of Research Uncertainty and Study Gaps

The research is heavily concentrated on acute symptom changes; long-term effects are not fully established because the primary efficacy studies were not designed as maintenance or durability trials. The limited information for long-term outcomes means there is little published research exploring the outcomes of sustained, repeated use over extended time frames. The results apply only to the populations studied, and data for certain groups, such as children, pregnant women, or older adults, remain insufficient for definitive conclusions.

Key Studies & References

  1. Clinical efficacy and safety of drotaverine plus aceclofenac combination in postoperative pain management after laparoscopic surgery: an open-label, randomized study

Frequently Asked Questions (FAQ)

Common questions about Drolgan (FAQ)


Q: Is Drolgan classified as an opioid or a narcotic?

Official regulatory classifications identify Drolgan as a combination of an NSAID (Non-Steroidal Anti-Inflammatory Drug) and an Antispasmodic agent. These components are used to manage inflammation and muscle spasm, respectively. According to authoritative drug information, neither component is classified as an opioid or narcotic substance.


Q: Is Drolgan a steroid or a hormone treatment?

Drolgan is a Fixed-Dose Combination (FDC) that contains two active ingredients: an NSAID and an Antispasmodic. This medicine is designed to influence pain and smooth muscle contraction. Official drug classifications indicate that Drolgan is not categorized as a steroid or a hormone treatment.


Q: Is Drolgan an antibiotic medication?

No, Drolgan is not an antibiotic medication. Its therapeutic purpose, as described in regulatory summaries, is the symptomatic relief of pain and smooth muscle spasm. It is classified as an NSAID/Antispasmodic agent and is not used to treat bacterial infections.


Q: Is Drolgan a biologic medicine or a small-molecule drug?

Regulatory documents state that Drolgan’s active components, Aceclofenac and Drotaverine, are synthetic compounds. They are categorized as small-molecule drugs, which means they are chemically synthesized substances rather than complex, large molecules derived from biological sources (biologics).


Q: Why might a healthcare provider choose Drolgan as a treatment option over others?

Drolgan is designed to provide a complementary dual-mechanism of action. It influences both the chemical signals that cause inflammation (via the NSAID component) and the involuntary smooth muscle contraction that causes spastic pain (via the Antispasmodic component) simultaneously.


Q: What are the common reasons patients discontinue Drolgan based on clinical trial data?

Clinical trial data indicates that the most common adverse events that may lead patients to discontinue use are related to gastrointestinal disorders. This includes common complaints such as nausea, abdominal pain, and dyspepsia. Dizziness is also listed among the frequently reported adverse events.


Q: Do side effects from Drolgan typically decrease or go away after the first few weeks of use?

Official labeling indicates that the risk for rare, serious mucocutaneous skin reactions is highest during the early stages of therapy. While general information suggests common side effects may be temporary, the official documents do not provide a guaranteed timeframe for all side effects to diminish.


Q: Are there any known side effects that are more likely to affect certain age groups?

Regulatory documents note that older adults (those 65 years and above) have a heightened risk compared to younger adults. This increased risk is associated with potentially serious adverse effects, including gastrointestinal bleeding and deterioration of renal (kidney) function.


Q: Does taking Drolgan cause any noticeable changes in appetite or weight?

Official drug labels have occasionally reported changes such as loss of appetite (anorexia) or other appetite changes as a documented adverse event. However, regulatory summaries do not list weight gain as a frequent or common adverse reaction associated with Drolgan.


Q: Is it common to experience no side effects at all when using Drolgan?

Official drug information provides frequency data for common adverse reactions (such as stomach upset or dizziness) reported in clinical trials. These common effects are generally reported in less than 10% of patients. This means that the reported frequency for these common effects occurred in less than 10% of the studied patient population.


Q: Can Drolgan interact with common over-the-counter pain relievers like ibuprofen or acetaminophen?

Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen, is officially restricted due to the increased risk of hemorrhage. While official labeling may not list every single over-the-counter product, the interaction warnings for the NSAID component apply broadly to this drug class.


Q: What does the official labeling say about the co-use of Drolgan and alcohol?

Official labeling describes a warning that co-use of alcohol can significantly increase the risk of specific side effects, including central nervous system effects like dizziness and gastrointestinal bleeding.


Q: Are there any specific foods that are listed as interacting with Drolgan?

Official instructions require that Drolgan be taken with or immediately after food. This is a procedural instruction tied to the drug’s composition and is intended to mitigate the possibility of gastrointestinal discomfort or irritation that can be caused by the NSAID component. No specific major food interactions are routinely highlighted other than this administration requirement.


Q: Can Drolgan interact with popular herbal supplements like St. John's Wort or ginseng?

The official product information does not list every possible herbal supplement interaction. However, restrictions may be advised for co-administration with supplements that significantly affect the serotonin pathways or the CYP450 enzyme system, as these systems are involved in the metabolism of Drolgan’s components.


Q: What is the reported timeframe for Drolgan to start having its intended effect?

Based on pharmacokinetic data, which measures how the body handles the drug, the antispasmodic component (Drotaverine) typically reaches its peak concentration in the blood within 45 to 60 minutes after taking the tablet. This timeframe generally aligns with the expected timeframe for the peak therapeutic concentration.


Q: How long does Drolgan stay in the body, based on known half-life information?

Pharmacokinetic studies show that the antispasmodic component (Drotaverine) has a biological half-life ranging from 7 to 16 hours. Regulatory information indicates that the drug is considered to be practically eliminated from the body within three days (72 hours).


Q: Is Drolgan known to affect a patient's mood or sleep patterns?

Adverse events documented in the regulatory classification of Nervous System Disorders include reports of insomnia (difficulty sleeping) and occasionally headache.


Q: What is the difference between a drug interaction and a contraindication?

Official terminology clarifies that a contraindication is an absolute condition or situation where using the drug is inappropriate or dangerous (e.g., severe heart failure). An interaction means the effects of the drug are changed when it is taken with another drug or food, requiring caution or dose adjustment.


Q: Where can I find the Patient Information Leaflet (PIL) or package insert for Drolgan?

The Patient Information Leaflet (PIL) or package insert is supplied with the medication when dispensed. Official, full-text versions of these documents are typically published online and are available through government-run sources like the FDA's DailyMed database or the EMA (European Medicines Agency) website.


Q: Does the FDA/EMA label mention Drolgan causing dependency or withdrawal symptoms?

Official regulatory documents and post-marketing surveillance reports have not indicated that Drolgan is a habit-forming drug. Therefore, it is not associated with dependency or severe withdrawal symptoms upon cessation of use.

--UNSAFE PHRASE REPORT

Q: Why do some online discussions suggest that Drolgan is hard to get or highly regulated?

Drolgan is a Fixed-Dose Combination (FDC) that contains an NSAID with certain safety risks; it requires a prescription in most regions. It is approved for acute use only, which contributes to its highly regulated status.


Q: What research has been conducted on Drolgan's use in people who have multiple health issues?

While research focuses on efficacy in specific conditions, regulatory documents emphasize the need for caution and monitoring in patients who have pre-existing conditions. These conditions include cardiovascular risk factors or mild to moderate impairment of the kidney or liver function.


Q: Is there special medical monitoring required for certain patient groups when taking Drolgan?

Yes. Official prescribing information mandates special caution and monitoring for patients with existing kidney or liver impairment. This monitoring, which often includes regular laboratory tests, is required due to the specific risks posed by the NSAID component of the medicine.

How should Drolgan be stored and disposed of?

How to Store and Dispose of Drolgan

Drolgan tablets must be stored according to official regulatory specifications to maintain the product's stability and effectiveness.

Storage Requirements

Condition Specification
Temperature Store below 30 C; some regions require below 25 C.
Environment Protect from light and moisture.
Container Keep in the original container and ensure it is tightly closed.
Child Safety Mandatory to keep out of the sight and reach of children and pets.

Disposal Instructions

Unused or expired Drolgan must be disposed of according to local regulations. The official guidance recommends utilizing an authorized drug take-back program as the preferred method. If a take-back program is unavailable, follow specific steps for safe household trash disposal, such as mixing the medicine with an undesirable substance. Do not flush the medicine down a sink or toilet.

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

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