Infacalm

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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 Infacalm

Property Description
Active ingredient Ibuprofen
Form Oral Suspension, Oral Drops
Pharmacological class Non-Steroidal Anti-Inflammatory Drug (NSAID)
Common use Symptomatic relief of pain, fever, and inflammation
Origin Synthetic compound (Propionic acid derivative)

Infacalm is a medicinal product based on the active ingredient Ibuprofen, which is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). This synthetic compound derived from propionic acid functions as a single active ingredient product, distinguished pharmacologically by its ability to act as an analgesic (pain-relieving), an antipyretic (fever-reducing), and an anti-inflammatory agent. Its inclusion in the NSAID class defines its ability to modulate the production of chemical mediators in the body, which are responsible for initiating discomfort and swelling.

What Type of Medicine is Infacalm?

Infacalm is formally categorized as a core NSAID and a Cyclooxygenase (COX) inhibitor. This classification affirms its ability to provide symptomatic relief by interfering with the chemical processes that cause pain and swelling. Ibuprofen is categorized as an essential medicine, highlighting its fundamental importance in providing safe and effective symptomatic relief for common conditions. Infacalm is primarily positioned as an Over-The-Counter (OTC) product, ensuring accessibility for addressing mild to moderate symptomatic fever and pain.

Infacalm’s Core Purpose and Form

The overall purpose of Infacalm is to provide efficient and temporary relief from the symptoms of fever, pain, and inflammation. The medicine is uniquely prepared as an oral suspension or oral drops, which is a liquid formulation administered via the oral route (by mouth). The selection of this specific oral route and liquid form is primarily intended for ease of administration to its main target audience, pediatric patients (infants and children), distinguishing it from solid adult dose forms. This liquid presentation, using an aqueous suspension vehicle, is favored when managing a child's sudden fever or discomfort.

Regulatory References

  1. Ibuprofen Drug Information
  2. WHO Essential Medicines List

What side effects are possible with Infacalm?

Possible side effects and safety information for Infacalm

Infacalm, which contains the active ingredient Simethicone, is documented by government regulatory authorities as having a generally favorable safety profile. The medicine is not absorbed systemically into the bloodstream, which accounts for its low incidence of side effects.

Adverse Reaction Scope

Category Regulatory Documentation Status
Frequency-Classified Reactions Official regulatory documents indicate that there are no common or important systemic side effects reported.
System-Organ Classes Involved Due to minimal systemic absorption, adverse reactions primarily involve the Gastrointestinal system, generally limited to isolated reports of mild diarrhea or nausea.
Serious Adverse Reactions No serious adverse events have been consistently documented or mandated for inclusion on regulatory labels for this active ingredient.
Population-Specific Considerations Use in special populations (e.g., pediatric, geriatric) has not been shown to cause different adverse effects compared to adults, though individual dosage may vary.

Safety-Related Restrictions and Monitoring

Official regulatory sources generally include minimal safety restrictions, focusing primarily on the possibility of allergic reactions.

  • Hypersensitivity: The only safety limitation explicitly stated is caution regarding known allergy or hypersensitivity to the active ingredient or any excipients.
  • Monitoring Notes: No specific laboratory tests or physiological monitoring beyond general patient observation are required for safe use, as the product is not absorbed systemically.
  • Dose- or Exposure-Related Patterns: Risks are generally not documented to increase with duration of treatment, but the maximum daily dose limit is set by regulatory agencies for safety purposes.

Regulatory Safety Summary

The official safety structure for this medicine is characterized by a very narrow risk profile. The majority of regulatory attention is placed on excluding use in cases of known allergy. The lack of documented severe, frequent, or systemic adverse events establishes the regulatory profile as low-risk, requiring minimal clinical monitoring as defined by official drug labels.

Overdose and Emergency Response

Overdose and when to seek help

Overdose of Infacalm (ibuprofen) is associated with a documented spectrum of clinical manifestations. Symptoms typically involve the central nervous system (CNS) and gastrointestinal (GI) systems, often presenting as nausea, vomiting, upper abdominal pain, drowsiness, dizziness, or severe headache. Regulatory descriptions also include tinnitus and, in severe cases, the potential for convulsions or coma.

Overdose may lead to life-threatening outcomes such as acute renal failure, metabolic acidosis, hypotension (shock), and serious gastrointestinal events, including bleeding or perforation. The regulatory labeling notes that elderly patients are at greater risk for serious GI complications. The risk of severe cardiovascular events, including myocardial infarction and stroke, is documented as increasing with higher doses of the medication.

Regulatory authorities explicitly state that immediate medical attention must be sought for any suspected overdose. Emergency services or a Poison Control Center should be contacted right away. This urgency is emphasized because no specific antidote is known for Ibuprofen overdose. Consequently, management is officially defined as symptomatic and supportive treatment, often requiring continuous monitoring of vital signs and renal function in a hospital setting.

Therapeutic Uses of Infacalm

Infacalm may be part of symptomatic management across key domains of discomfort. The therapeutic domains often associated with Infacalm include supporting the management of fever, pain, and inflammation in various clinical situations. The medicine is applied in addressing elevated body temperature, which is a key symptom related to systemic imbalance, and is relevant for easing symptoms related to physical discomfort, such as headache, toothache, earache, and muscular aches. It may also be part of symptomatic management for pain and stiffness tied to conditions like juvenile idiopathic arthritis.

“This symptomatic approach may assist with maintaining a sense of stability when symptoms are more noticeable.”

This medication is considered relevant in clinical settings that involve acute or disruptive symptom patterns. It is applied in addressing symptom clusters that may appear suddenly, like fever during acute infections or sudden-onset localized discomfort. By supporting symptom management, Infacalm supports patients during difficult episodes by easing distress and may help maintain functional stability when symptoms interfere with routine activities.

Quick Fact: Managing Fever Infacalm is applied in addressing high body temperature associated with infections and temporary post-vaccination reactions.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who can and cannot use Infacalm?

Population eligibility for Infacalm (Ibuprofen) is determined by regulatory guidelines, focusing on specific health conditions, age, and physiological states.

Contraindicated Populations

Infacalm is strictly contraindicated for individuals with a known hypersensitivity to Ibuprofen, aspirin, or other NSAIDs, including those with a history of allergic reactions like asthma or urticaria. It must not be used by patients with severe heart, hepatic, or renal failure, active gastrointestinal bleeding, or recurrent peptic ulceration. The medicine is also prohibited for use in the treatment of pain following coronary artery bypass graft (CABG) surgery.


Eligibility and Restrictions

Population Group Regulatory Status
Age (3 months and over, ge 5 kg) Allowed for short-term symptomatic treatment.
Infants under 3 months Not suitable or not recommended due to insufficient data.
Pregnancy (Third Trimester) Contraindicated (absolute prohibition).
Dehydrated Children Caution Required (risk of renal impairment).
Older Adults (Geriatrics) Caution Required (increased risk of adverse effects).

Use is not recommended after 20 weeks of pregnancy. Patients with a history of Crohn's disease or ulcerative colitis should use Infacalm with caution, as the condition may be exacerbated, as documented in official regulatory labeling.

What should I know about interactions with other medicines?

Infacalm Interactions with other medicines and products

Official regulatory documents classify the interaction profile of Infacalm (Ibuprofen) based on its activity as a Non-Steroidal Anti-Inflammatory Drug (NSAID).

Formal Interaction Restrictions

Classification Interacting Product or Class
Contraindicated Other NSAIDs (including COX-2 inhibitors) and other ibuprofen-containing products, due to additive risk.
Contraindicated Treatment of pain around the time of Coronary Artery Bypass Graft (CABG) surgery.

Officially Documented Interactions

  • Anticoagulants (e.g., Warfarin) and SSRIs: Co-administration is formally associated with a significant increase in the risk of serious gastrointestinal bleeding and ulceration.
  • Antihypertensives and Diuretics: Infacalm may reduce the blood pressure-lowering effect of medicines such as ACE inhibitors, ARBs, and diuretics. Co-use may also increase the risk of adverse effects on kidney function.
  • Lithium and Methotrexate: Regulatory information states that Infacalm reduces the renal clearance of these medicines, potentially leading to increased plasma concentrations.
  • Low-Dose Aspirin (for cardioprotection): Ibuprofen may interfere with the anti-platelet effect of aspirin. Occasional use is less likely to interfere, but for routine use, the FDA advises separating the administration time by taking Ibuprofen at least 30 minutes after or 8 hours before an immediate-release low-dose aspirin dose.
  • Alcohol: Consumption of three or more alcoholic drinks every day is documented to increase the risk of gastrointestinal bleeding when using Infacalm.

Population-specific warnings note that the elderly have an increased risk of serious gastrointestinal events, and there is a documented risk of renal impairment in dehydrated children and adolescents.

Mechanism of Action

Infacalm (Ibuprofen) operates through non-selective, reversible competitive inhibition of the Cyclooxygenase ( COX) enzymes—specifically the COX-1 and COX-2 isoforms. This molecular interaction blocks the enzymes' active sites, preventing them from converting arachidonic acid into prostanoids. The resulting suppression of mediator synthesis modifies the initial steps in the signaling pathway, influencing the subsequent physiological response.

This molecular action yields dual physiological consequences across central and peripheral systems. Peripherally, the reduction in PGE2 synthesis decreases the sensitization of nociceptors (pain-sensing nerves) at tissue sites. Centrally, the suppression of PGE2 affects the elevated thermal set-point within the hypothalamus. These dual actions influence the signaling sequence, affecting nociceptor sensitivity and promoting the operation of heat-loss mechanisms, thereby modulating the body's acute systemic responses.

Dosage and Administration Information

Infacalm is an orally administered medicinal product, provided as a liquid oral suspension or oral drops, which defines its method of use. Proper administration requires that the bottle be shaken well before use to ensure the suspension is uniform, and that the dose is measured precisely using only the calibrated dosing device supplied with the product.

Dosing is primarily based on the weight of the child (in kilograms), which determines the amount of ibuprofen necessary, with a typical single dose ranging from 5 mg/kg to 10 mg/kg. Use in infants under 3 months of age or less than 5 kg is restricted and should not occur without prior medical guidance.

The administration frequency is limited to a maximum of four doses in any 24-hour period, with a minimum interval of four to six hours maintained between administrations. This structured schedule is designed for short-term symptomatic management only, and product labeling typically limits continuous over-the-counter use to no more than three days for fever or four days for pain.

The medicine may be administered with food or milk to potentially lessen the chance of stomach upset. If a dose is missed, standard instructions advise administering the next dose at its regularly scheduled time, explicitly stating that a double dose must not be taken to compensate.

Recent Clinical Evidence

Research evidence / Overview of studies for Infacalm

Evidence for Symptomatic Fever Reduction

Research exploring how symptoms change over time has focused heavily on the medicine’s use in contexts involving elevated body temperature in children. The evidence base includes numerous short-term Randomized Controlled Trials (RCTs), many of which were used in research exploring short-term symptom changes, often comparing the active compound against a placebo or against other fever-reducing compounds (active comparators). Researchers examined outcomes related to systemic or functional imbalance, specifically monitoring the patterns in the time required to measure temperature change and the overall duration of that measured change over a set period, such as 4 to 8 hours post-dose.

Findings describe patterns observed in the studies, including measurements of change in body temperature, which were noted during the study period. These studies contribute to the broader evidence landscape for fever research.

Evidence for Acute Mild to Moderate Pain Relief

Research has also extensively examined the compound’s role in contexts involving acute physical discomfort. The research has explored episodic or acute changes by relying on short-term RCTs and systematic reviews. This evidence was applied in studies examining patient-reported experiences related to pain from specific sources, such as headache, dental pain, and earache. Research examined outcomes related to physical discomfort, tracking measures like symptom intensity or variability using standardized patient-reported outcomes describing perceived discomfort.

Studies monitored the proportion of children and adolescents who reported a measured level of pain relief, as well as the time until the onset of that reported change. Findings describe patterns observed in the studies that show short-term changes in pain intensity over the study's observation period.

Areas of Research Uncertainty and Study Gaps

Clinical evidence derived from settings with varying symptom burdens typically addresses the short-term, acute use of the compound. Key areas where research indicates certainty remains low or where study gaps are noted include:

  • Long-Term Outcomes: There is limited information for long-term outcomes and chronic, continuous use, as the majority of research has examined short-term, episodic use.
  • Special Populations: Data are still emerging, and there is limited information for long-term outcomes in children with complex health needs or those with conditions that affect how the compound is processed by the body.
  • Comparative Evidence: Comparative evidence is lacking for certain specific symptom patterns, and some comparative trials against other active compounds report mixed findings.

Key Studies & References

  1. OTC medicine monograph: Ibuprofen for oral use | Therapeutic Goods Administration (TGA) Monograph
  2. Juvenile Idiopathic Arthritis Treatment Guidelines | Arthritis Foundation (on initial symptomatic treatment)

How should Infacalm be stored and disposed of?

How to Store and Dispose of Infacalm?

The storage and disposal of Infacalm (Ibuprofen Oral Suspension/Drops) are governed by specific regulatory requirements to maintain product stability and ensure public safety.


Storage Requirements

Requirement Official Guideline
Temperature Store at Controlled Room Temperature (20 C to 25 C), with acceptable excursions up to 30 C.
Protection Do not freeze. Store in the original container to maintain integrity and light protection.
Child Safety Keep this and all drugs out of the reach of children.
Handling Shake well before using to ensure uniform suspension.

Disposal Instructions

Unused or expired Infacalm must not be disposed of via household waste or wastewater (e.g., sink or toilet). To prevent environmental contamination, the medicine should be returned to a pharmacy or designated pharmaceutical take-back collection point for official regulated disposal.

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

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