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Febrectal Lactantes

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Febrectal Lactantes

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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.

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Overview of Febrectal Lactantes

What is Febrectal Lactantes?

Febrectal Lactantes is a pharmaceutical formulation developed for rectal administration in infants and young children. It belongs to the group of medications known as analgesics and antipyretics, which are primarily used to manage symptoms related to pain and elevated body temperature.

Composition and Mechanism

The active ingredient in Febrectal Lactantes is paracetamol, a widely recognized medicinal compound. Paracetamol works by inhibiting the synthesis of prostaglandins in the central nervous system and acting on the hypothalamic heat-regulating center. This dual action helps to reduce fever and alleviate mild to moderate pain.

Therapeutic Use

This specific presentation is designed as a suppository to facilitate treatment in pediatric patients who may have difficulty swallowing oral medications or who are experiencing nausea and vomiting. It is typically utilized for the symptomatic relief of:

  • Febrile states: Reducing high temperatures associated with common viral infections or post-vaccination reactions.
  • Mild to moderate pain: Addressing discomfort such as teething pain, headaches, or general malaise.

As a rectal formulation, the medication is absorbed through the intestinal mucosa, providing an alternative route for systemic relief when oral administration is not feasible.

Regulatory References

  1. WHO Essential Medicines List for Children (eEML) - Paracetamol
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What side effects are possible with Febrectal Lactantes?

Possible Side Effects and Safety Information

Adverse reactions associated with Acetaminophen (Paracetamol) are classified in official regulatory documents based on the body systems affected and the estimated frequency of occurrence. While most systemic effects are considered Rare or Very Rare, the official safety profile documents potential effects across multiple systems, including the blood, immune, hepatic, renal, and skin.

Frequency-Classified Adverse Reactions

Frequency System-Organ Class Specific Adverse Reaction
Common Localized Reaction Redness of the rectal mucous membranes
Rare Skin/Immune System Allergic reactions, skin rash (Urticaria)
Very Rare Blood System Changes in blood count (e.g., Thrombocytopenia, Agranulocytosis)

Serious Adverse Reactions and Safety Constraints

The most serious safety concerns officially documented are Severe Hepatotoxicity (liver damage, which can be fatal) and Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Regulatory safety information notes specific cautions for patient populations. Increased risk of complications is documented for those with pre-existing hepatic impairment (liver disease) or renal impairment (kidney disease). Additionally, the use of Acetaminophen is officially restricted for individuals who have experienced a previous severe skin reaction with the drug.

Safety notes specify that long-term regular daily use is associated with increased risk of liver damage and kidney disease (analgesic nephropathy), and may enhance the effect of oral anticoagulants.

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Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for an overdose of Febrectal Lactantes (Acetaminophen/Paracetamol) highlights the risk of severe, delayed toxicity, necessitating immediate action.

Immediate Medical Attention Required Governmental guidance mandates that immediate medical attention be sought for any suspected overdose, even if the infant appears well or initial symptoms have resolved. The risk of delayed, life-threatening progression requires immediate contact with emergency services, underscoring the time-critical nature of the event.

Documented Overdose Manifestations Initial clinical manifestations are often non-specific and may include nausea, vomiting, anorexia, pallor, and abdominal pain. These early signs do not reliably correlate with the severity of the ultimate damage. The critical danger lies in the delayed progression to acute hepatic necrosis, a documented severe outcome. This can lead to acute liver failure, metabolic acidosis, and hypoglycemia, which are noted severe consequences. Due to the infant target population, susceptibility to acute toxicity is elevated, requiring urgent, weight-based assessment.

Emergency Treatment The primary management involves the timely administration of the specific antidote, N-acetylcysteine (NAC), as formally defined in prescribing information. Supportive measures, such as gastric decontamination, may be initiated depending on the time of ingestion. Hospital monitoring of plasma drug levels and hepatic function tests is required until the risk of toxicity has passed.

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Therapeutic Uses of Febrectal Lactantes

What Febrectal Lactantes Treats: Main Uses and Benefits

The primary therapeutic role of Febrectal Lactantes, which contains the active ingredient Acetaminophen (Paracetamol), is relevant for easing symptomatic relief for the infant patient population. The medication is commonly used when short-term symptomatic assistance is needed to manage discomfort and elevated body temperature.

Antipyresis, Pain Management, and Supportive Care

The medication is commonly used to help with the reduction of elevated body temperature (fever) associated with infectious illnesses or temporary physiological responses, such as post-vaccination fever and discomfort. It is also relevant for managing mild to moderate pain that appears suddenly or fluctuates, including pain associated with teething, minor earaches, and general muscular aches. Acetaminophen is used to help reduce fever and pain in children with colds and other conditions.

This supportive action may assist with managing the systemic distress and irritability that accompany febrile states, supporting the patient during difficult episodes by easing distress. The suppository formulation is also considered relevant when oral medicine intake is difficult, such as when an infant is experiencing vomiting or nausea. This is relevant when supportive symptom management is appropriate, contributing to easing the overall symptom load.

“It is commonly used across conditions presenting with acute episodes that require short-term symptomatic assistance.”


Quick Fact: Relief for Episodic Discomfort The medicine is relevant for easing symptoms related to fever and mild pain during acute, short-term episodes in young pediatric patients.

Regulatory References

  1. MedlinePlus Medical Encyclopedia
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Eligibility and Restrictions for Use

The eligibility for using Febrectal Lactantes, a paracetamol suppository intended for infants, is strictly defined by regulatory body labeling based on patient profile and pre-existing conditions.

Populations and Eligibility Status

Category Regulatory Status
Recommended Population Infants and children weighing mathbf10 kg or more.
Contraindications (Must NOT Use) Known mathbfhypersensitivity to paracetamol or any excipients.
Restricted Use (Use with Caution) Patients with severe mathbfhepatic impairment or severe active liver disease.
Use Not Recommended Concomitant use with other mathbfparacetamol -containing products (due to overdose risk).

Key Eligibility Rules

Official regulatory guidelines mandate that the mathbf150 mg strength is mathbfweight -dependent, typically requiring the infant to be mathbfge 10 kg. Use in patients with mathbfimpaired kidney function or mathbfhepatic impairment requires mathbfspecial caution and often dose adjustment under medical supervision. The most critical restriction is the absolute mathbfprohibition of use if the patient is allergic to the active substance or excipients.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents classify interactions for the active ingredient, Acetaminophen (Paracetamol), across several risk domains, defining specific co-administration restrictions and outcomes.

Formal Contraindications and Restrictions

Co-administration with any other product containing Acetaminophen or Paracetamol is formally contraindicated due to the significantly increased risk of severe liver damage and potential overdose.

Pharmacokinetic and Pharmacodynamic Interactions

Interacting Substance Official Interaction Description
Hepatic Enzyme Inducers (e.g., Phenytoin, Carbamazepine) May accelerate metabolism, increasing the formation of the hepatotoxic metabolite.
Probenecid Reduces Acetaminophen clearance by inhibiting conjugation, resulting in significantly increased plasma exposure.
Vitamin K Antagonists (e.g., Warfarin) Prolonged regular use may enhance the anticoagulant effect, increasing the risk of bleeding.
Flucloxacillin (Antibiotic) Concurrent intake has been associated with High Anion Gap Metabolic Acidosis (HAGMA).

Timing and Population Constraints

Absorption is reduced by Cholestyramine, requiring the Acetaminophen dose to be administered at least one hour before or four hours after Cholestyramine. The hazard of overdose is officially noted as greater in individuals with underlying hepatic impairment or those with chronic alcohol consumption.

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Mechanism of Action

Central Regulation of the Thermoregulatory Set Point

The antipyretic mechanism targets the Cyclooxygenase (COX) enzymes located within the hypothalamus, the brain's thermoregulatory center. Inhibition of this central COX activity reduces the local synthesis of prostaglandin E2 (PGE2), the molecular mediator responsible for establishing an elevated set point. This reduction in PGE2 concentration influences the hypothalamic control, initiating heat-dissipating physiological processes such as peripheral vasodilation and increased sweating.

Complex Spinal Nociceptive Modulation

The modulation of nociceptive signaling involves metabolite action within the spinal cord. The active metabolite, AM404, engages the Endocannabinoid System by inhibiting the enzyme Fatty Acid Amide Hydrolase (FAAH) and also directly activating Transient Receptor Potential Vanilloid 1 (TRPV1) receptors. These molecular events contribute to the attenuation and inhibition of ascending nociceptive signaling pathways.

Mechanistic Confinement to the Central Nervous System

A key feature of the drug is its sensitivity to peroxide levels. Because its mechanism of COX inhibition is functionally constrained by the high peroxide tone typically present at sites of peripheral inflammation, the drug's activity is selectively concentrated on the Central Nervous System (CNS) pathways. This biological specificity confines the physiological modulation to central thermal regulation and nociceptive pathways, without functional engagement of peripheral inflammatory processes.

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Dosage and Administration Information

How to Use Febrectal Lactantes

This section describes the administration principles and dosing regimens for Febrectal Lactantes (150 mg Paracetamol) for this specialized pediatric form.

Administration Principles

Febrectal Lactantes is administered exclusively via the rectal route as a suppository. This specialized administration method is intended for use when the oral route is not possible, such as when an infant is experiencing vomiting or nausea. The medicine is intended for short-term, symptomatic use and should be discontinued once the symptoms have resolved.

Dosing Regimen

The dosage is primarily calculated based on the infant's body weight in kilograms (kg), and the 150 mg strength is generally indicated for children weighing 10 kg or more (approximately 1 year of age). The standard unit dose is 15 mg of Paracetamol per kg of body weight. An alternative unit dose of 10 mg/kg may also be used.

Dosing Parameter Instruction
Standard Interval 6 hours between doses for the 15 mg/kg dose, or 4 hours for the 10 mg/kg dose.
Minimum Interval A strict minimum of 4 hours must be maintained between administrations.
Maximum Daily Dose The total 24-hour dose must not exceed 60 mg Paracetamol per kg of body weight.
Max Suppository Count Administration must not exceed 5 doses every 24 hours for children under 12 years.

In cases of severe renal impairment (creatinine clearance less than 10 ml/min), the interval between doses should be prolonged to 8 hours.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Febrectal Lactantes


Evidence for Symptomatic Reduction of Fever (Antipyresis)

Research exploring the active ingredient in Febrectal Lactantes was studied for outcomes related to systemic or functional imbalance and has largely relied on Randomized Controlled Trials (RCTs) and systematic reviews. Researchers typically monitored outcomes linked to physiological strain or stress, specifically measuring the change in body temperature and the time elapsed until those changes were observed. Findings describe patterns observed in the short-term studies, primarily concerning initial acute changes.

However, a key limitation is the documented variability in drug absorption via the rectal route. Research has explored that the amount of medicine absorbed can be variable and less predictable. This limited information for long-term outcomes means that while immediate, short-term study parameters are established, certainty remains low regarding predictability over extended periods.


Evidence for Symptomatic Relief of Acute, Mild Pain (Analgesia)

The medicine was studied in research settings involving outcomes related to physical discomfort during acute or disruptive episodes. Study designs included RCTs and clinical studies conducted in perioperative settings (after surgery). Researchers monitored measured outcomes related to patient-reported discomfort, primarily using validated pediatric pain assessment scales and observing the requirement for additional pain medication.

Findings were mixed in some trials, which suggests that the measured pain outcomes may be tied to the amount of medicine absorbed. A significant challenge relates to the difficulty in predicting consistent drug levels due to the variability in drug absorption. Furthermore, follow-up durations were limited, meaning the research contributes to understanding short-term changes but not the duration of any observed patterns.


Long-Term Studies and Follow-Up

The research landscape shows a clear focus on acute care and research exploring short-term symptom changes. The vast majority of clinical trials were observed in study populations for very limited periods. Due to this focus, long-term effects are not fully established. Dedicated, multi-year Randomized Controlled Trials designed to monitor long-term outcomes are lacking. Certainty remains low for long-term safety, as existing short-term studies do not provide sufficient data beyond the initial acute symptom episode.

Key Studies & References

  1. Comparison Of The Effects Of Preemptive Intravenous And Rectal Acetaminophen On Pain Management After Inguinal Herniorrhaphy In Children: A Placebo-Controlled Study (Analgesic outcomes and vomiting)
  2. Therapeutic Goods Administration (TGA) Recommended paracetamol doses (Regulatory guidance on pediatric use)
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Frequently Asked Questions (FAQ)

Common questions about Febrectal Lactantes (FAQ)

Q: Is Febrectal Lactantes the same as the adult version of the medicine?

A: Regulatory documents indicate that the product contains the same active ingredient, Paracetamol (Acetaminophen). However, the Lactantes form is a lower strength (150 mg) suppository designed for infants. Adult versions of the suppository typically contain higher strengths per unit, such as 325 mg or 600 mg.


Q: How fast does Febrectal Lactantes start working after it's administered?

A: Studies on rectal administration of the active ingredient suggest that its absorption can be variable and may take longer compared to oral forms. Clinical research indicates that observed changes in the infant’s body temperature often begin to occur within 60 to 180 minutes after administration.


Q: How long do the effects of Febrectal Lactantes typically last?

A: Official regulatory labels provide guidance on the time interval between administrations, specifying a minimum of 4 hours between doses. The standard interval for one dose calculation is 6 hours, which serves as a general guideline for administration frequency.


Q: Why is the dosage measured in milligrams and not just by age?

A: Official dosing guidelines state that the amount of medicine (milligrams) is primarily calculated based on the child's body weight in kilograms. This calculation method is the regulatory standard for this product, using weight as the primary determining factor.


Q: What is the age limit for using Febrectal Lactantes?

A: The 150 mg strength is generally recommended for infants and children weighing 10 kg or more. This weight often corresponds to children approximately 1 year of age or older, according to regulatory guidelines.


Q: Does the official labelling mention use in children who are dehydrated?

A: Official safety notes advise that special caution is necessary when the patient has severe illnesses or underlying renal (kidney) or hepatic (liver) impairment. Regulatory warnings mention special caution for patients with underlying renal or hepatic impairment, which are conditions that can be affected by the patient’s overall health status.


Q: Can I give Febrectal Lactantes if my child has a stomach bug?

A: The suppository is intended for use when oral administration is compromised, such as by vomiting. It is important to know that official studies note the medicine's absorption can be affected by the presence of rectal contents, such as diarrhea, which may make the outcome less predictable.


Q: Is it true that suppositories are gentler on the stomach?

A: Official administration principles indicate that the rectal suppository form is structurally intended for use in situations where the oral route is not possible. This includes times when an infant is experiencing vomiting or nausea, suggesting a way to administer the medicine without using the digestive system.


Q: Can Febrectal Lactantes be used for teething pain?

A: The active ingredient in this medicine, Acetaminophen, is broadly indicated in official documents for the symptomatic relief of mild to moderate pain. This general indication covers many common sources of discomfort.


Q: What are the main differences between Febrectal Lactantes and other medicines for children's fever?

A: Regulatory literature describes the active ingredient (Acetaminophen) as primarily having a central mechanism of action, focused on the brain's temperature and pain centers. Other medicines used for fever, such as Ibuprofen, are described as acting both centrally and peripherally, which includes an anti-inflammatory component not associated with Acetaminophen's primary mechanism.


Q: Do official sources discuss the risk of allergic reactions to Febrectal Lactantes?

A: Official safety warnings describe signs of a severe allergic reaction to the active ingredient, which may include a rash, difficulty swallowing or breathing, and swelling of the lips, face, throat, or tongue. Official documentation advises that if such signs are observed, discontinuation of the product's use is warranted.


Q: What happens if a child spits up or vomits after receiving Febrectal Lactantes (if it were oral)?

A: Febrectal Lactantes is formulated and administered exclusively as a suppository via the rectal route. It is intended to bypass the digestive system when the infant is unable to keep down an oral dose, such as when they are vomiting. The product itself is not an oral liquid.


Q: Does Febrectal Lactantes interact with common antibiotics?

A: Regulatory documents specifically note that concurrent intake of the antibiotic Flucloxacillin has been associated with a serious risk of blood and fluid abnormality called High Anion Gap Metabolic Acidosis (HAGMA). This is one of the specific interactions documented for the active ingredient.


Q: Is Febrectal Lactantes available over the counter or does it require a prescription?

A: The active ingredient, Acetaminophen (Paracetamol), in suppository form, is widely available from pharmacies and shops without the need for a prescription.


Q: Are there studies available about the long-term effects of Febrectal Lactantes use?

A: Regulatory overviews state that dedicated, multi-year clinical trials designed to monitor long-term outcomes of the medicine are lacking. The focus of existing clinical research has historically been on acute, short-term use for symptom management.


Q: Is the absorption rate of Febrectal Lactantes affected by diarrhea?

A: Studies on rectal administration note that the medicine's absorption can be erratic and is dependent on various factors. Regulatory-cited data confirms that the presence of rectal contents, such as diarrhea, may affect the predictability of how much medicine is absorbed.


Q: What is the difference between a high-strength and a low-strength Febrectal Lactantes?

A: Acetaminophen suppositories are manufactured in different strengths for pediatric use, such as 80 mg, 120 mg, and the 150 mg used for the Lactantes product. The appropriate strength is chosen based on the child's body weight to ensure proper dosage.


Q: Is there any research on the use of Febrectal Lactantes for post-vaccination fever?

A: The general therapeutic purpose of the active ingredient, Acetaminophen, is the symptomatic treatment of elevated body temperature. This indication applies regardless of the specific cause of the fever, including fever that may follow a vaccination.


Q: Why do some people prefer suppositories over oral liquids for infants?

A: Official administration principles indicate that the suppository form is specialized for use in circumstances where the oral route is compromised. This primarily includes when an infant is experiencing vomiting, nausea, or a strong refusal to swallow liquid medication.


Q: Do the official documents mention any potential for dependence or tolerance?

A: Official regulatory documents focus on the serious risk of liver damage (hepatotoxicity) associated with exceeding the recommended dose or with long-term regular daily use. The documents do not classify the active ingredient as a drug associated with dependence or tolerance.


Q: Can Febrectal Lactantes be used for headaches in infants?

A: The active ingredient, Acetaminophen, is broadly indicated in official documents for the symptomatic relief of mild to moderate pain. This general indication covers various sources of discomfort, including headaches.


Q: Is Febrectal Lactantes meant for chronic or acute use?

A: Official regulatory documents state the medicine is approved exclusively for short-term, symptomatic use. The medicine should be discontinued once the symptoms have resolved.


Q: Are there different forms of the drug available internationally?

A: Regulatory documents from various agencies confirm that the active ingredient, Acetaminophen, is available in different specialized forms globally. These include oral liquids, tablets, suppositories, and in some healthcare settings, intravenous injections.


Q: How is the safety of Febrectal Lactantes monitored after it's approved?

A: After approval, the medicine is continuously monitored through a regulatory process called pharmacovigilance. This involves regulatory agencies collecting and evaluating reports of adverse reactions to identify and manage any potential safety issues in the broader population.


Q: Are there studies comparing the pain relief effectiveness of Febrectal Lactantes to other delivery methods?

A: Scientific studies have examined the effects of the active ingredient across different routes of administration, including suppositories versus oral liquid forms. Research notes that absorption through the rectal route can be variable, leading to mixed findings in comparative studies.

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How should Febrectal Lactantes be stored and disposed of?

Official Storage and Disposal Requirements

Official regulatory information states that Febrectal Lactantes suppositories do not require special conditions for preservation under normal circumstances. The suppositories must be kept out of the sight and reach of children as a mandatory safety precaution. The product should be stored in its original sealed packaging.

If a suppository is too soft to insert, the official instructions require it to be cooled in the refrigerator for 30 minutes or placed under cold water to harden. The medicine must not be used after the expiration date printed on the carton.

For disposal, unused or expired Febrectal Lactantes must not be thrown into household waste or wastewater. The product must be returned to a designated pharmaceutical waste collection point at a pharmacy for proper handling, following environmental protection guidelines.

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

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