Doloflam(Ibuprofen)

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Overview of Doloflam(Ibuprofen)

Property Description
Active ingredient Ibuprofen (isobutylphenyl propionic acid)
Pharmacological class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common purpose Analgesic, Antipyretic, Anti-inflammatory
Origin Synthetic drug (propionic acid derivative)
Typical Forms Tablet, Capsule, Liquid Suspension, Gel

The pharmaceutical preparation sold under the trade name Doloflam contains the active ingredient Ibuprofen, which is formally classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). Ibuprofen is an INN for isobutylphenyl propionic acid, a synthetic drug developed as a propionic acid derivative. This classification places it among medications widely recognized for their anti-inflammatory capabilities and is generally recognized as an essential medicine by the World Health Organization (WHO).

Composition and Available Forms

The high-level composition of this drug is typically a single-component product, consisting of the active Ibuprofen substance, which is a racemic mixture of its two enantiomers, combined with pharmaceutical excipients. This allows the drug to be formulated into multiple common dosage forms suitable for the general population, including the widely used tablet, capsule, and liquid suspension for oral intake, as well as gel or cream forms for topical application. These forms determine the effective route of administration, whether systemic or local.

General Purpose: Analgesic, Antipyretic, and Anti-Inflammatory

The core general therapeutic purpose of Ibuprofen is defined by its ability to act simultaneously as an analgesic (to relieve pain), an antipyretic (to reduce fever), and an anti-inflammatory agent (to reduce swelling). This capability is rooted in its mechanism of effect—the cyclooxygenase (COX) enzyme inhibition—which limits the synthesis of prostaglandin precursors. This reliable action makes it clinically recognized for managing general discomfort associated with pain and fever.

Regulatory References

  1. View WHO Essential Medicines List
  2. View MedlinePlus Drug Information
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What side effects are possible with Doloflam(Ibuprofen)?

Possible Side Effects and Safety Information

The safety profile of Ibuprofen (Doloflam) is classified according to the frequency and body system affected, based on authoritative regulatory documentation.

Adverse Reaction Scope

Common Adverse Reactions (may affect up to 1 in 10 people):

  • Gastrointestinal Disturbances: Indigestion (dyspepsia), nausea, vomiting, abdominal pain.
  • Nervous System: Headache, dizziness.

System-Organ Classes Involved include Gastrointestinal Disorders, Nervous System Disorders, Skin and Subcutaneous Tissue Disorders, and Blood and Lymphatic System Disorders.

Serious Adverse Reactions

Regulatory documents list certain rare but serious reactions, which may be fatal. These include:

  • Cardiovascular Events: Increased risk of serious thrombotic events, such as myocardial infarction (heart attack) and stroke. This risk may increase with higher doses (ge 2400 mg/day) and longer treatment duration.
  • Gastrointestinal Events: Serious events like bleeding, ulceration, or perforation of the stomach or intestines.
  • Severe Skin Reactions: Including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Safety Restrictions and Special Populations

Restrictions: Ibuprofen is formally contraindicated for use immediately before or after Coronary Artery Bypass Graft (CABG) surgery, and in patients with active gastrointestinal bleeding or severe heart failure.

Special Populations:

  • Pregnancy: Avoided from 30 weeks gestation (third trimester) due to documented risk of harm to the fetus (premature closure of the ductus arteriosus).
  • Elderly: This population faces an increased risk of severe gastrointestinal side effects.
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Overdose and Emergency Response

Overdose and When to Seek Help

The following information details the officially documented signs and required actions concerning an overdose of Doloflam (Ibuprofen), strictly based on governmental regulatory sources.

Documented Overdose Manifestations

Symptoms of Ibuprofen overdose span several systems, ranging from common gastrointestinal effects (nausea, vomiting, abdominal pain) to CNS effects (dizziness, drowsiness, headache, tinnitus). More severe manifestations explicitly documented in regulatory labeling include seizures, coma, hypotension, and metabolic acidosis, particularly in cases of massive ingestion. Overdose can also result in serious outcomes such as acute renal failure or severe gastrointestinal bleeding.

Required Emergency Action

Immediate medical attention is required if an overdose is suspected or confirmed. Patients should immediately contact a poison control center or emergency services. The official regulatory guidance confirms that no specific antidote is available for Ibuprofen overdose; therefore, management is strictly symptomatic and supportive.

Special Considerations

The official labeling notes a heightened risk of apnoea (cessation of breathing) in young children and specifies that the risk of renal impairment is increased in dehydrated children and adolescents following an overdose.

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Therapeutic Uses of Doloflam(Ibuprofen)

Doloflam may provide symptomatic relief by addressing the core cluster of pain, fever, and inflammation across several clinical contexts. Its primary role is to ease symptom burden, contributing to supportive symptom management during periods of heightened physical discomfort. The medication is commonly used across domains where additional symptomatic support is needed, addressing conditions presenting with systemic or localized discomfort.


Key Symptomatic Domains

The therapeutic scope is relevant for three main areas: easing discomfort related to musculoskeletal conditions like osteoarthritis and symptoms of sprains; managing sudden, localized pain such as tension headaches and dental pain; and addressing systemic symptoms of illness, including fever and generalized body aches from the common cold or flu.

Quick Fact: Symptomatic Relief The medication may assist with managing localized swelling and tenderness and plays a role in managing symptom clusters that may become intense or disruptive, such as the pain of primary dysmenorrhea.


Patient Benefit Summary

This supportive relief helps improve day-to-day comfort during symptomatic periods and may assist with maintaining a sense of stability. This use is commonly applied in scenarios where short-term symptomatic assistance is needed to help patients cope more steadily with difficult episodes.

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Eligibility and Restrictions for Use

Official Population Eligibility for Doloflam (Ibuprofen)

Official regulatory documents define specific populations for whom Ibuprofen use is contraindicated (prohibited) and others for whom use is restricted.

Eligibility Status Patient Population Regulatory Basis
Contraindicated History of allergic reaction to aspirin or other NSAIDs Absolute Ban
History of recurrent peptic ulcer or GI bleeding Severe Comorbidity
Severe heart, hepatic, or renal failure Severe Organ Impairment
Third trimester of pregnancy (after 30 weeks) Time-Based Exclusion
Peri-operative pain for CABG surgery Procedural Exclusion
Restricted Use Older adults (geriatric population) Increased Risk/Caution
Patients with mild organ impairment Conditional Use
Pregnant individuals (20 to 30 weeks) Avoid/Limit Use

Eligibility is generally established for adults, adolescents, and children 6 months of age and older. Use in infants under 6 months is not established for most standard oral preparations. Regarding lactation, Ibuprofen is generally considered an acceptable analgesic during breastfeeding due to very low levels in breast milk. Caution is also required for patients with uncontrolled hypertension or cardiovascular disease, with high doses (ge 2,400 mg/day) specifically noted to be avoided in these groups.

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What should I know about interactions with other medicines?

The official regulatory interaction profile for Doloflam (Ibuprofen) is structured around pharmacodynamic risk and pharmacokinetic interference. Co-administration with other NSAIDs, including COX-2 selective inhibitors, is formally contraindicated due to a documented, substantially increased risk of serious gastrointestinal bleeding and ulceration.

Official Interaction Statements

  • Exposure-Modifying Substances: Ibuprofen may lead to increased plasma concentrations and the risk of toxicity for agents such as Lithium and Methotrexate, through the official mechanism of inhibiting renal clearance.
  • Pharmacodynamic Risk Reinforcement: Concomitant use with Anticoagulants (like Warfarin), Oral Corticosteroids, SSRIs, and Alcohol carries an additive risk of gastrointestinal bleeding.
  • Reduced Efficacy: Ibuprofen may reduce the antihypertensive and diuretic effects of ACE Inhibitors, ARBs, and Diuretics.
  • Timing Constraint: To avoid competitive inhibition that could reduce the antiplatelet effect of low-dose Acetylsalicylic Acid (Aspirin), regulatory documents recommend a time separation. For immediate-release Aspirin, Ibuprofen should be administered at least 30 minutes after or 8 hours before the Aspirin dose.
  • Population Note: Regulatory documents note that elderly patients and those with impaired renal or cardiac function are at the greatest risk for interaction-related adverse reactions when co-administered with diuretics or ACE inhibitors.

This structure reflects the mandated classifications and documented interaction patterns found in government labeling.

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Mechanism of Action

How Doloflam (Ibuprofen) Works: Mechanism of Action

Inhibiting Prostanoid Synthesis

The core mechanism involves Doloflam's action as a non-selective competitive inhibitor of the Cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2 isoforms. This targeted enzyme inhibition blocks the crucial first step in the Arachidonic Acid Cascade, preventing the conversion of Arachidonic Acid into prostanoid chemical mediators like prostaglandins.

Modulating Inflammatory Signaling

By suppressing the production of prostaglandins, which are key sensitizers of peripheral pain nerves and mediators of blood vessel dilation, the drug modulates the entire inflammatory signaling pathway. This leads directly to the physiological consequence of decreased nociceptive nerve sensitivity and reduced localized swelling and redness, which results in the modulation of overactive signaling patterns.

Regulating Thermoregulation

The mechanism extends to the brain, where the reduction of prostaglandin E2 (PGE2) synthesis in the hypothalamus allows the body's temperature set point, which is elevated in certain states, to return toward normal. This effect results in the distinct physiological adjustment of thermoregulation, which represents a key component of the drug's mechanistic profile.

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Dosage and Administration Information

How to Use Doloflam (Ibuprofen) — Official Administration Guidelines

This section outlines the standardized official instructions for the use of Ibuprofen, based on regulatory documents, detailing the procedural structure for correct administration.

Administration Scope

Instruction Category Official Guideline
Route Oral (by mouth)
Dosing Principle Use the lowest effective dose for the shortest duration necessary
Adult Dosing (OTC) 200 mg to 400 mg every 4 to 6 hours as needed; do not exceed 1200 mg in 24 hours (OTC strength)
Timing with Meals May be taken with food or milk to reduce the chance of stomach upset
Liquid Preparation Oral suspension must be shaken well before each use

Procedural Structure

  1. Selection and Interval: Select the lowest effective dose strength and ensure at least 4 hours have passed since the previous dose.
  2. Liquid Measurement: If using a liquid, shake the bottle thoroughly and use the measuring device provided for accurate dosing.
  3. Administration: Swallow the dose. Tablets should be swallowed whole without crushing or chewing.
  4. Duration Limit: Do not use this medication for longer than 10 consecutive days unless specifically directed by a healthcare professional.
  5. Missed Dose: If a dose is missed, take it as soon as it is remembered. If it is close to the time for the next scheduled dose, skip the missed dose and resume the regular schedule. Do not take a double dose to make up for a missed one.

Contextual Note

These instructions define the standardized approach to using the medicine as outlined in regulatory documents and are separate from therapeutic uses or safety information.

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Recent Clinical Evidence

Research evidence / Overview of studies for Doloflam (Ibuprofen)

Evidence for Relief of Acute Pain

Research exploring how symptoms change over time has focused on the use of this medicine for outcomes related to physical discomfort that is acute, or short-term, such as headache or dental pain. These investigations primarily used short-term Randomized Controlled Trials (RCTs) and Meta-analyses. The studies monitored outcomes related to pain intensity, using standardized scales, and assessed the use of rescue analgesia requirements.

Studies reported measurements of pain scores in populations of adults, adolescents, and those with specific localized pain conditions. However, the available evidence is limited regarding the effects for specific types of severe or chronic pain. The follow-up durations were limited, as the majority of high-quality data focuses on the immediate, short-term response.


Evidence for Fever Reduction (Antipyretic Action)

Studies related to the study of outcomes linked to systemic or functional imbalance—often involving elevated body temperature—were evaluated using short-term Randomized Controlled Trials and Systematic Reviews. Researchers specifically measured outcomes such as the absolute change in body temperature and the time it took to observe a change following administration.

Studies reported measurements showing how temperature evolved in observed populations, including both febrile adults and specific cohorts of pediatric patients (children). Research exploring short-term symptom changes is available, but the data are still emerging regarding patterns of long-term monitoring or outcomes over repeated, extended use periods.


Evidence for Symptomatic Management of Inflammation

Research has also examined the use of this medicine for outcomes linked to inflammatory or irritative states, such as osteoarthritis. The study types available include short-term Randomized Controlled Trials and long-running Observational Studies. Outcomes monitored included patient-reported changes in stiffness and functional measures reflecting daily functioning. Certainty remains low regarding the sustained, long-term impact on inflammatory disease progression; the follow-up durations were limited in the controlled trials.


What is Still Uncertain About Doloflam (Ibuprofen) Research

The core body of research exploring short-term or episodic symptom patterns involves studies using short-term follow-up periods. Because of this design, long-term effects are not fully established for sustained usage, and evidence is limited regarding the durability of the observed findings over extended periods. Research describes knowledge gaps related to functional endpoints and outcomes for rare or severe conditions, emphasizing that the findings describe group patterns, not personal outcomes. Data for certain groups, such as pregnant populations or individuals with complex pre-existing health conditions, remain insufficient.

Key Studies & References Label: IBUPROFEN tablet, film coated - DailyMed (Regulatory Monograph)

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Frequently Asked Questions (FAQ)

Common questions about Doloflam(Ibuprofen) (FAQ)

Q: Why do doctors prescribe Doloflam for fever?

Official documents describe Ibuprofen as an antipyretic agent that is associated with reducing fever. Its action involves reducing the synthesis of specific chemical mediators in the brain’s temperature-regulating center, which allows an elevated body temperature to be adjusted toward a normal set point.

Q: Is Doloflam an opioid or a steroid?

According to official regulatory classifications, Ibuprofen is defined as a Nonsteroidal Anti-Inflammatory Drug (NSAID) and a propionic acid derivative. It is not classified as an opioid, which is a different class of pain medication, nor is it a corticosteroid.

Q: Does Doloflam make you sleepy or affect your energy levels?

Official product information lists certain effects on the central nervous system, such as dizziness and headache, as common adverse reactions. These effects are central nervous system changes that could potentially affect mental clarity or energy perception.

Q: Is it okay to take Doloflam every day for a long time?

Regulatory documents state that Ibuprofen should be used for the shortest duration necessary to address symptoms. Regulatory labels emphasize using it for the shortest duration necessary, as prolonged daily use is associated with an increased potential risk of serious adverse events.

Q: Are there any foods or drinks that interact with Doloflam?

Regulatory warnings indicate that there is an additive risk of gastrointestinal bleeding when the drug is used with alcohol. Specific interactions with common foods or non-alcoholic drinks are typically not included in the official drug interaction profiles.

Q: What kind of pain is Doloflam typically used for?

Ibuprofen is officially used as an analgesic for the relief of mild to moderate pain. This commonly includes pain associated with headache, dental pain, and menstrual pain. It is also indicated for the symptomatic management of inflammatory conditions like osteoarthritis.

Q: Is Doloflam known by other names in different countries?

The active ingredient, Ibuprofen, is the globally recognized non-proprietary name (INN) for the substance. However, it is marketed and sold under many different trade names worldwide, such as Doloflam.

Q: Is Doloflam used for migraine headaches?

The official labeling for Ibuprofen commonly lists the relief of general headache. Furthermore, specific formulations of Ibuprofen have received authorization in certain regions for the symptomatic relief of migraine headache.

Q: Are allergic reactions to Doloflam common?

Official product information classifies the frequency of adverse reactions. Common effects include indigestion and headache. Allergic-type reactions, while documented, are listed among the rare but serious adverse events that can occur with the medication.

Q: Can you take Doloflam if you have asthma?

Regulatory documents describe a specific contraindication for Ibuprofen in individuals who have had asthma, urticaria (hives), or allergic-type reactions after taking aspirin or other NSAIDs.

Q: What is the risk of heart problems associated with Doloflam?

Official warnings, including Boxed Warnings in some regions, state that NSAIDs like Ibuprofen may increase the risk of serious cardiovascular thrombotic events, such as myocardial infarction (heart attack) and stroke. This risk tends to be higher with longer duration of use and in individuals with pre-existing heart disease.

Q: Will taking Doloflam affect my ability to drive or operate machinery?

Because Ibuprofen may cause adverse effects like dizziness or headache, official documents advise caution regarding driving or operating machinery until the effects of the medicine are known.

Q: Why does the label warn about taking Doloflam before surgery?

Regulatory documents specifically contraindicate the use of Ibuprofen for pain relief immediately before or after Coronary Artery Bypass Graft (CABG) surgery due to the documented risk of serious cardiovascular events in this setting. The warning specifically addresses the procedural exclusion for CABG surgery.

Q: Does taking Doloflam affect the results of any common medical tests?

The medication is known to be associated with possible effects on the kidneys and liver, especially with prolonged use or high doses. This can lead to temporary changes in blood test results related to the function of these organs. It is important for patients to inform their healthcare providers about the use of Ibuprofen when undergoing common laboratory tests.

Q: What research evidence supports the use of Doloflam for menstrual pain?

Ibuprofen is formally indicated for the relief of menstrual pain in official documents. Clinical study summaries indicate support for this use by examining outcomes related to changes in pain intensity and a reduced need for additional pain medication during menstruation.

Q: Why is it important to check if other medicines I take also contain Ibuprofen?

Official warnings emphasize that exceeding the total daily dose increases the potential risk of serious adverse reactions, which can occur when combining multiple products containing the same active ingredient.

Q: Does Doloflam interact with common cold or flu medications?

Regulatory documents specifically caution against combining Ibuprofen with other NSAIDs, a class of drug often included in multi-symptom cold and flu products. This co-administration can increase the risk of serious gastrointestinal events. Specific combination products containing Ibuprofen are also addressed in official labels.

Q: Do studies show that Doloflam helps with inflammation?

Yes, official documents classify Ibuprofen as an Anti-Inflammatory Agent. Research evidence supports its symptomatic management of inflammatory conditions like osteoarthritis, with studies tracking changes in patient-reported stiffness and functional measures over time.

Q: Is Doloflam available over the counter?

Official regulatory documents define certain dosage strengths, most commonly 200 mg, of Ibuprofen as being approved for Over-The-Counter (OTC) use, meaning they can be purchased without a prescription. Higher dosage strengths generally require a prescription.

Q: Can I take two different pain relievers at the same time as Doloflam?

Regulatory documents address the co-administration of Ibuprofen with other Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) by listing it as a contraindication due to an increased risk of gastrointestinal side effects.

Q: What research exists regarding Doloflam and joint pain?

Research evidence is described supporting the symptomatic management of inflammatory joint conditions like osteoarthritis. These studies assess the drug's effect on key outcomes such as joint stiffness and overall daily functional measures reported by the patient.

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How should Doloflam(Ibuprofen) be stored and disposed of?

Official Storage and Disposal Requirements

Ibuprofen must be stored according to regulatory specifications to ensure stability and safety. The product must be kept strictly out of the sight and reach of children.

Storage Condition Requirement
Temperature Store at Controlled Room Temperature (20 C to 25 C / 68 F to 77 F), away from excessive heat.
Protection Store in the original container and protect from moisture.

Disposal

Expired or unused Ibuprofen should be taken to an authorized drug take-back program. If this is unavailable, the medicine must be mixed with an undesirable substance (like dirt or coffee grounds) in a sealed bag and placed in household trash. It must not be disposed of by flushing down the toilet or sink. All personal information must be removed from container labels prior to disposal.

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

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