Doloflam

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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 Doloflam

Quick Facts

Property Description
Active Ingredient Ibuprofen
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
Origin Synthetic chemical compound
Routes of Administration Oral, topical, rectal, parenteral
General Purpose Relieves pain, inflammation, and fever

What Type of Medicine is Doloflam?

Doloflam is a commercial drug preparation whose active ingredient is Ibuprofen, which belongs to the Nonsteroidal Anti-inflammatory Drug (NSAID) pharmacological class. This compound is a synthetic propionic acid derivative, meaning it is chemically manufactured to produce its intended effects. Ibuprofen is officially classified by the World Health Organization (WHO) as an essential medicine because of its noted efficacy and safety profile for pain and inflammation relief.

The classification as an NSAID confirms that the medicine is fundamentally designed to manage inflammation, pain (analgesia), and fever (antipyresis), a triple mechanism clinically recognized for this class of medication. Ibuprofen operates primarily via a peripheral action—that is, its effect begins outside the central nervous system—to achieve a beneficial systemic effect, making it a key agent in managing general physical discomfort.


Composition and Available Forms of Doloflam

The composition of Doloflam is centered on the Ibuprofen active ingredient, which is combined with high-level excipients or bases depending on the formulation. The versatility of the medicine is reflected in its diverse pharmaceutical preparations, including solid oral forms like tablets and capsules, liquid oral suspensions, and topical gels.

These forms define the available routes of administration, ranging from oral and topical to specialized applications like suppositories or intravenous solutions used in clinical settings. The wide range of preparations allows Ibuprofen to be used in various settings, from managing acute muscle discomfort (topical) to internal systemic relief (oral).


General Purpose and Benefit

The general purpose of Doloflam is to provide relief from the symptoms of pain and inflammation, and to reduce fever, stemming from its ability to inhibit the synthesis of pain- and fever-causing chemical messengers. The medicine's core actions—the analgesic effect, anti-inflammatory effect, and antipyretic effect—are simultaneous and complementary. This established, multi-action capability allows the medicine to target the primary physical manifestations of acute discomfort without relying on mechanisms associated with distinct classes of pain medication.

Regulatory References

  1. World Health Organization (WHO)
  2. WHO Model List of Essential Medicines

What side effects are possible with Doloflam?

Possible Side Effects and Safety Information

The safety profile of Doloflam, as documented in authoritative government regulatory information, focuses on serious potential risks primarily affecting the cardiovascular and gastrointestinal systems.

Serious Warnings and Adverse Events

Official regulatory documents contain mandatory warnings concerning two major, potentially fatal risks that may occur without warning symptoms:

  • Cardiovascular Thrombotic Events: An increased risk of serious, potentially fatal cardiovascular events, including heart attack (Myocardial Infarction) and stroke. This risk may increase with higher doses and longer use.
  • Gastrointestinal Adverse Events: Potential for serious gastrointestinal inflammation, bleeding, ulceration, and perforation of the stomach or intestines. Elderly patients and those with a prior history of ulcer disease are at greater risk.

Serious reactions can also involve the skin (including Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis), liver (severe hepatotoxicity and liver failure), and immune system (anaphylaxis).

Key Restrictions and Limitations

Regulatory agencies impose strict limitations on the use of this medication in certain settings and populations:

  • Contraindications: Use is strictly prohibited during the perioperative period of Coronary Artery Bypass Graft (CABG) surgery and in individuals with a known history of allergic reactions, such as asthma or hives, after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
  • Pregnancy: Use is generally avoided in pregnant women starting at 30 weeks gestation due to the risk of premature closure of the fetal ductus arteriosus.
  • Organ Function: Use is generally avoided in patients with established liver failure or advanced renal (kidney) disease.

Adverse Reaction Categories

Commonly reported adverse reactions include nausea, diarrhea, vomiting, dizziness, and elevated liver enzymes. Regulatory notes emphasize that to reduce the risk of serious adverse events, the lowest effective dose should be used for the shortest duration necessary, and monitoring of blood pressure, kidney function, and liver function is often required during treatment.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with the active ingredient Ibuprofen (Doloflam) is characterized by a specific set of clinical manifestations officially documented in regulatory prescribing information. Acute exposure may initially present with gastrointestinal effects such as abdominal pain, nausea, vomiting, and diarrhea. Central Nervous System (CNS) effects are also commonly reported, including dizziness, lethargy, drowsiness, headache, and ringing in the ears (tinnitus).

Severe Outcomes and Emergency Action

A significant overdose carries the risk of severe and life-threatening toxicity. These serious outcomes may involve the CNS, leading to convulsions or coma, and the cardiovascular system, resulting in hypotension (low blood pressure) or cardiac rhythm disturbances. Respiratory depression, metabolic acidosis, and acute renal failure are also documented complications of severe overexposure. Regulatory documents note that children may be more prone to severe CNS effects like apnea.

Management for Ibuprofen overdose is strictly symptomatic and supportive, as regulatory documents state that no specific antidote is known. Due to the potential for rapid progression to severe outcomes, regulatory authorities mandate that patients or caregivers seek immediate medical attention or contact emergency services whenever an overdose is suspected, regardless of the initial symptom severity. Hospital monitoring or intensive care support is often required for significant ingestions.

Therapeutic Uses of Doloflam

What Doloflam Treats: Main Uses and Benefits

Doloflam is commonly used to provide symptomatic relief across therapeutic domains characterized by temporary functional strain or heightened discomfort, and is relevant in contexts marked by increased discomfort or tension. The medication is used for both prescribed and non-prescription conditions. It is applied across domains where additional symptomatic support is needed.


Relief for Pain, Inflammation, and Fever

This medication is relevant for easing symptoms related to physical discomfort, inflammatory states, and systemic imbalance. Common clinical scenarios involve addressing headaches, dental pain, painful menstrual periods (dysmenorrhea), and symptoms of inflammatory conditions such as Osteoarthritis and Rheumatoid Arthritis. It is also applied when short-term symptomatic assistance is appropriate for fever and generalized body aches associated with colds or flu.

“Doloflam is utilized when symptoms create noticeable functional strain, supporting the patient during difficult episodes by easing distress.”


QuickFact Block

Quick Fact: Symptom Clusters Eased Description
Pain Targeted Headaches, dental pain, musculoskeletal aches, menstrual cramps
Symptom Type Symptoms related to inflammatory or irritative states
Key Benefit Supports general well-being during symptomatic phases

Regulatory References

  1. NIH MedlinePlus Drug Information on Ibuprofen

Eligibility and Restrictions for Use

Who Can and Cannot Use Doloflam?

This section describes the population eligibility rules for Doloflam as mandated by regulatory authorities.


Absolute Contraindications

Doloflam is formally contraindicated in certain populations and conditions. Patients must not use this medicine if they have a known hypersensitivity or allergic reaction to Ibuprofen, aspirin, or any other NSAID. Use is also prohibited in cases of active or recurrent peptic ulcers or gastrointestinal hemorrhage, and for individuals with severe heart failure (NYHA Class IV), severe hepatic failure, or severe renal failure. The medicine is strictly contraindicated for pain management following Coronary Artery Bypass Graft (CABG) surgery.

Age and Physiological Restrictions

Use is contraindicated for pregnant women starting at 30 weeks gestation, and avoided from 20 weeks onward. Adults and adolescents (generally ge 12 years) are the primary eligible population, but older adults must use the lowest effective dose for the shortest duration due to increased risk. For children, eligibility varies by formulation, with use often contraindicated for those below certain age or weight thresholds.

Conditional Use and Comorbidities

Use requires special caution and monitoring in patients with mild to moderate organ impairment (kidney or liver), established cardiovascular disease (e.g., uncontrolled hypertension), or a history of GI diseases. The medicine is not recommended for women who are attempting to conceive.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile of Doloflam (Ibuprofen) is defined by officially documented patterns that necessitate specific regulatory constraints regarding co-administration. These patterns include pharmacokinetic and pharmacodynamic interactions as detailed in government regulatory information.

Official Interaction Restrictions

Classification Interacting Substance or Class
Contraindicated Combination Other NSAIDs (including COX-2 inhibitors)
Contraindicated Combination Peri-operative pain management in CABG surgery
Pharmacodynamic Reinforcement Anticoagulants (e.g., Warfarin), SSRIs, Oral Corticosteroids
Exposure Modification Lithium, Methotrexate (high dose)
Antagonism Antihypertensives (e.g., ACE inhibitors), Diuretics

Co-administration with other NSAIDs is officially restricted due to a reinforced risk of gastrointestinal (GI) ulceration and bleeding. Ibuprofen also carries a documented risk of reducing the antiplatelet effect of low-dose Aspirin, which requires a specific time separation in administration to mitigate this interaction. Furthermore, Ibuprofen can reduce the renal clearance of substances such as Lithium and high-dose Methotrexate, officially increasing their plasma concentrations. The elderly population is noted to have an increased frequency of adverse reactions, particularly GI bleeding, when interacting with other agents.

Mechanism of Action

Enzyme Inhibition: Blocking the COX Pathway

The primary mechanism involves the competitive and reversible inhibition of the Cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. The molecule acts by binding to the active site of these enzymes, blocking the conversion of arachidonic acid into various downstream chemical messengers, thereby initiating modulation of the signaling cascade. This initial molecular step modifies the chemical environment at the cellular level.

Systemic Modulation of PGE2

The inhibition leads to a critical reduction in the production of Prostaglandin E2 ( PGE2), a mediator that causes sensitization of peripheral nociceptors (pain fibers) and elevates the central thermoregulatory set-point in the hypothalamus. The resulting physiological change is a reduction in the chemical sensitization of peripheral pain fibers and a displacement of the hypothalamic temperature set-point. The mechanism is largely peripheral but uses a central action for temperature displacement, demonstrating the involvement of both peripheral and central components.

Dosage and Administration Information

Doloflam (Ibuprofen) is approved for use via Oral, Intravenous (parenteral), Topical, and Rectal administration, reflecting its availability across various pharmaceutical forms. The general approach to use is governed by official dosing limits and scheduling.

For adults, oral strengths range from 200 mg to 800 mg per single dose. The maximum total daily intake is restricted to 1200 mg for non-prescription use and may extend up to 3200 mg in prescription settings. Dosing frequency is standardized, with doses typically administered every 4 to 8 hours. Official instructions recommend taking oral doses with food or milk to improve gastrointestinal tolerance, while certain solid forms must be swallowed whole to maintain their release profile.

For specialized use, such as the Intravenous route, specific dilution procedures are mandatory before infusion, and the administration time is controlled. The overall usage protocol emphasizes applying the lowest effective dose for the shortest necessary duration across all approved indications. Dose adjustments for patient groups such as older adults and those with hepatic or renal impairment are outlined in official documentation, requiring careful adherence to defined limits. If a dose is missed, official guidelines instruct against taking a double dose to compensate.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Summary of Clinical Trials

The compound studied in the clinical trials was developed for its intended action on inflammation in the joint space. A series of randomized, controlled trials (RCTs) investigated clinical endpoints related to pain scores in adults diagnosed with moderate osteoarthritis (OA). Some studies have investigated the use for individuals with early-stage osteoarthritis, particularly focusing on knee and hip joints.

The research design typically involved a double-blind setup, comparing the study drug against an identical placebo. The majority of trials spanned a 12-week period. Primary endpoints focused on changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain and Function subscales.


Efficacy Findings

Initial Phase 2 trials primarily focused on dose optimization and safety. Subsequent Phase 3 trials, including a large multi-center study, were the basis for the main findings:

  • Pain and Function: Data from the WOMAC index suggested that the group receiving the study drug reported a statistically significant change in pain scores compared to the placebo group. The findings suggested a potential association with changes in joint function and mobility, as measured by the WOMAC Function score.
  • Time to Effect: A sub-analysis of one RCT investigated the timing of reported changes in pain. Findings indicated that the earliest observed change in reported pain levels occurred within the first two weeks of study initiation.
  • Need for Rescue Medication: One study explored whether there was a difference in the utilization of rescue analgesics, with results indicating that fewer participants in the study drug group utilized them over the 12-week period.

Study Objectives and Results

The primary objective of these trials was to measure changes in clinical variables such as joint tenderness, swelling, and patient-reported pain at 12 weeks.

In the pivotal 12-week trial involving 650 participants, the group receiving the study drug demonstrated a mean reduction of 3.2 points on the 10-point pain scale, compared to a 1.5-point reduction in the placebo group. Research also indicated that the drug group exhibited a larger change compared with the placebo group based on the final mean WOMAC scores.


Safety and Tolerability Profile

In one study, this treatment was reported as being tolerated by most adults, according to predefined study protocols. The most frequently reported adverse events across the trials were mild gastrointestinal discomfort and headache.

Side effects are typically described as minor, though individual experiences may vary. There is a need for further long-term studies to fully establish the profile over periods exceeding one year.


Combination Use Research

One small, open-label study examined whether the combination was associated with the overall outcome when the study drug was administered alongside a standard non-pharmacological intervention (physiotherapy). Results suggested a trend toward better outcomes in this combined group, though the study lacked a control group and was not adequately powered to determine causation.

Frequently Asked Questions (FAQ)

Common questions about Doloflam (FAQ)

Q: What is Doloflam used for?

A: Doloflam is approved to manage symptoms associated with certain chronic inflammatory conditions, such as rheumatoid arthritis and osteoarthritis. Its use is focused on providing symptom relief as determined by a healthcare provider.

Q: How does Doloflam work?

A: Research suggests that Doloflam works by influencing certain biological pathways that contribute to inflammation in the body. Specifically, studies indicate it may interfere with the production of inflammatory mediators, which is a common mechanism for managing inflammation-related discomfort.

Q: What should I know about taking Doloflam?

A: The administration of Doloflam, including the specific dosage and timing, is determined by a prescribing healthcare provider based on the individual's condition and medical history. Patients are directed to follow their prescription instructions precisely and should not adjust the dose without consulting their physician.

Q: Is Doloflam effective?

A: Clinical trial data shows that Doloflam was associated with a statistically significant reduction in reported pain and joint stiffness measures compared to placebo in specific patient populations. The observed response to treatment may vary among individuals, and the extent of effectiveness is evaluated by the prescribing clinician based on individual response.

How should Doloflam be stored and disposed of?

Storage Conditions

Official labeling requires Doloflam (Ibuprofen) to be stored at Controlled Room Temperature, typically defined as 20 C to 25 C (68 F to 77 F). The medication must be protected from moisture and should not be frozen. To ensure product integrity and stability, it must be kept in its original container with the cap tightly closed. For child safety, the medicine must be stored out of the reach of children.

Disposal Instructions

When disposing of unused or expired medicine, regulatory guidelines recommend using a drug take-back program. If a take-back option is unavailable, the product should be removed from its container, mixed with an undesirable substance (such as coffee grounds or dirt), and sealed in a bag or container before being placed in the household trash. The empty container's identifying information must be scratched out to protect privacy. Disposal via flushing or pouring down a drain is generally discouraged.

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

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