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Antalgina

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Antalgina

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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 Antalgina

Property Description
Active Ingredient Metamizole sodium (Dipyrone)
Form Oral tablets, solution for injection, suppositories, and oral drops
Pharmacological Class Non-opioid analgesic, Antipyretic, Spasmolytic
Common Purpose Relief of severe pain, high fever, and smooth muscle spasms
Origin Synthetic compound (Pyrazolone derivative)

Defining Antalgina: Active Ingredient and Pharmacological Classification

Antalgina is the trade name for a medicinal preparation whose core component is Metamizole sodium, an active ingredient often known internationally as Dipyrone or Sulpyrin. The drug is fundamentally classified by its primary functions as a non-opioid analgesic, a potent antipyretic (fever reducer), and a distinct spasmolytic agent, making it a unique compound in symptomatic management. Metamizole is a synthetic compound chemically derived from the pyrazolone class of medicines, distinguishing it structurally from common over-the-counter pain relievers. Metamizole is recognized for its rapid onset of pain-relieving effects.

Available Forms and General Symptomatic Purpose

Antalgina is provided in multiple dosage forms to ensure flexibility across various clinical needs and administration routes. These forms commonly include oral tablets, oral drops, suppositories, and solution for injection for parenteral administration. This diverse presentation is a differentiating factor, offering options for patients who cannot swallow or require a rapid onset of action. The general purpose of the drug is to offer acute and effective symptomatic relief through its distinct triple action. This makes it valuable for alleviating severe pain and addressing high fever, with the added benefit of relieving discomfort specifically associated with smooth muscle spasms, such as those encountered during episodes of colic or visceral cramping. The medication is used in managing acute painful conditions.

What side effects are possible with Antalgina?

Possible Side Effects and Safety Information

The safety profile of Antalgina (Metamizole) is primarily defined by the risk of specific serious, rare adverse reactions and restrictions for certain populations, as documented in regulatory labeling.

Serious Adverse Reactions (Rare)

The most clinically significant risk is Agranulocytosis (a severe reduction in white blood cells), which can be fatal. Regulatory information classifies this event as Rare or Very Rare. It is emphasized that this serious side effect is not related to the dose used and can occur at any time during treatment or shortly after cessation. Other rare, severe reactions include Anaphylactic Shock, Severe Cutaneous Adverse Reactions (such as Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis), and Drug-Induced Liver Injury.

Adverse Reaction Scope

Category Examples Frequency
Blood/Lymphatic Agranulocytosis, Neutropenia Rare / Very Rare
Immune System Anaphylaxis, Hypersensitivity Reactions Uncommon to Rare
Hepatobiliary Acute Hepatitis, Liver Enzyme Increase Not Known

Population-Specific Restrictions

  • Pregnancy: Contraindicated during the last 3 months due to evidence of potential effects on the fetus’s kidneys and circulation. Use in the first two trimesters is generally restricted.
  • Lactation: Recommended to avoid repeated use. Following a single dose, breastmilk should be discarded for a 48-hour period before resuming.
  • Pre-existing Conditions: Contraindicated in patients with pre-existing impaired bone marrow function or a history of metamizole-induced agranulocytosis.

Safety-Related Limitations

Treatment must be stopped immediately if symptoms suggestive of Agranulocytosis (e.g., unexplained fever, chills, sore throat, or mucosal lesions) or liver injury (e.g., jaundice, dark urine) appear. The medicine must not be re-initiated if the patient has a history of Metamizole-induced agranulocytosis.

Overdose and Emergency Response

Overdose and When to Seek Help

This section details the officially documented signs and required emergency actions for an overdose of Metamizole sodium (Antalgina), as stated in authoritative government regulatory documents.

Documented Overdose Manifestations

Overdose presentations are documented to primarily affect the central nervous system (CNS), renal, and cardiovascular systems. Manifestations include CNS effects ranging from dizziness, somnolence, and stupor to severe presentations like tonic-clonic seizures and coma. Gastrointestinal symptoms such as nausea, vomiting, and epigastric pain may also occur.

Severe Outcomes and Emergency Action

Severe and potentially life-threatening outcomes documented in regulatory sources include acute renal failure, metabolic acidosis, severe hypotension, and cardiac arrhythmias.

Immediate medical attention is required for any suspected overdose. Individuals must contact emergency services or a poison control center immediately.

Management and Monitoring

Official labeling states that no specific antidote is known for Metamizole overdose. Therefore, treatment is described as strictly symptomatic and supportive. Regulatory documents indicate that procedures such as gastric lavage, activated charcoal, and forced diuresis may be considered to reduce absorption and enhance elimination. Due to the dialyzable nature of its metabolites, hemodialysis may be necessary in severe, life-threatening cases. Hospital monitoring is required to manage potential cardiorenal compromise.

Therapeutic Uses of Antalgina

What Antalgina Treats: Main Uses and Benefits

The therapeutic utility of Antalgina (Metamizole sodium) is applicable in therapeutic areas involving the management of pain, fever, and muscle spasm, which are symptoms related to physical discomfort. Metamizole is used for treating moderate to severe pain and fever.

Relief of Severe, Acute Pain and Visceral Cramping

Antalgina is commonly applied in conditions characterized by periods of heightened symptoms where patients experience severe, acute pain. Its use is relevant for managing symptoms related to physical discomfort after surgery or traumatic injury, and for symptoms of increased muscular activity, such as the intense, cramping pain of renal or biliary colic. The medication addresses conditions such as postoperative pain, post-traumatic pain, and pain associated with visceral spasms. Applying the medication in these instances may help ease the overall symptom load and contributes to improved comfort during periods of heightened symptoms.

“The medication is often utilized in emergency settings to address pronounced pain that includes a significant cramping component.”

Targeting High and Refractory Febrile States

A primary therapeutic domain is its use as an antipyretic for managing high fever (hyperpyrexia). Antalgina is generally considered when the symptoms related to systemic imbalance are significant, persistent, or remain challenging to moderate. Used in these acute symptomatic episodes, the medication may assist in reducing high temperatures, thereby supporting patients during difficult episodes by easing distress.

Quick Fact: Supportive relief for Visceral Pain and Febrile States

Regulatory References

  1. European Medicines Agency

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Antalgina — Official Regulatory Information

The eligibility for Antalgina (Metamizole sodium) is strictly governed by regulatory documents, which define specific populations who are permitted, restricted, or prohibited from using the medicine.

Eligibility Scope

Classification Population Rule (Official Labeling)
Populations Contraindicated Individuals with known hypersensitivity to Metamizole or other pyrazolone derivatives. Patients with a history of agranulocytosis or impaired bone marrow function. Patients with acute intermittent hepatic porphyria or G6PD deficiency.
Age-Related Rules Contraindicated in infants below 3 months of age or under 5 kg body weight. The medicine is also contraindicated during the third trimester of pregnancy.
Condition Restrictions Use in severe renal or hepatic impairment is restricted or requires avoidance. Patients with pre-existing hypotension or circulatory instability require conditional use.
Pregnancy/Lactation Status Contraindicated in the third trimester of pregnancy and during breastfeeding. Following a single administration, breast milk must be discarded for a 48-hour period.

Eligibility Classifications (High-Level)

Classification Description
Eligibility Severity Classified as Contraindicated (absolute prohibition) for blood disorders and late pregnancy.
Regulatory Basis Information harmonized based on the European Medicines Agency (EMA) reviews.
Conditional Use Older adults may require monitoring, and dosage may be reduced due to the potential for prolonged metabolite elimination.

Connection to the overall eligibility profile: Regulatory documents define eligibility through absolute contraindications centered on blood-related risks, known hypersensitivity, and specific metabolic/physiological conditions. Further restrictions are established based on age, gestation stage, and the severity of pre-existing renal and hepatic impairment, explicitly outlining who must not use the medicine.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation requires clear statements on interactions with specific medicinal products and product classes. This section outlines the documented interaction profile for Antalgina (Metamizole), strictly based on governmental and authoritative sources.

Product Category / Specific Medicine Documented Interaction Constraint
Aspirin (for anti-platelet effect) Clinically Severe Interaction noted for vascular disease patients; Antalgina prevents the inhibition of COX-1, reducing aspirin's anti-platelet aggregation (PAI) effect. A delay (spacing requirement) between doses is required for management.
Ciclosporin (Immunosuppressant) Concomitant use can lead to decreased serum levels of Ciclosporin. Therapeutic drug monitoring of Ciclosporin is a required constraint.
Methotrexate (Cytotoxic/Immunosuppressant) Co-administration carries an additive risk for haematologic toxicity, specifically bone marrow aplasia, a risk noted to be greater in the elderly population.
Chlorpromazine (Phenothiazine) Co-administration may lead to an additive risk of hypothermia (low body temperature).
Hydroxyethyl Starch (Plasma Volume Expander) Simultaneous administration is discouraged due to the potential for acute renal insufficiency.

The interaction profile structures the required clinical response into three main domains: avoidance or caution (Hydroxyethyl Starch, Chlorpromazine), procedural timing constraints (Aspirin), and mandatory therapeutic drug monitoring (Ciclosporin). These constraints, as defined in official regulatory labeling, dictate the specific steps necessary to manage the coadministration risk.

Mechanism of Action

Antalgina, a prodrug, is rapidly metabolized into the active moieties, primarily 4-methyl-amino-antipyrine (MAA) and 4-amino-antipyrine (AA). The primary biological targets are believed to be located within the central nervous system (CNS).

MAA and AA function as non-selective cyclooxygenase inhibitors, exhibiting inhibitory action on Prostaglandin G/H synthase isoforms, including the central enzyme COX-3. This inhibition reduces the enzymatic synthesis of pro-inflammatory prostaglandins. Furthermore, MAA and AA interact with and induce the activation of the endogenous opioidergic and cannabinoid systems in a concentration-dependent manner. Additionally, a spasmolytic effect is mediated through the intracellular reduction of inositol phosphate synthesis, which consequentially attenuates the intracellular release of Ca^2+ ions in smooth muscle tissue. These convergent molecular actions modulate central signal transduction and systemic smooth muscle contractility.

Dosage and Administration Information

How to Use Antalgina: Official Administration Guidelines

Administration of Antalgina (Metamizole sodium) follows defined protocols which detail the approved route, dose, and frequency of use. The medication is available for administration via four methods: Oral (tablets, drops, solution), Rectal (suppositories), and Parenteral methods (Intramuscular or Intravenous injection).

Labeled Dosing Regimens

The fundamental principle of use requires treatment to start at the lowest effective recommended dose and be increased only when clinically necessary. The minimum time interval between consecutive oral doses is defined as 6 to 8 hours to adhere to the established daily schedule.

Use Principle Adult Standard (ge 15 yrs) Pediatric Rule (le 14 yrs)
Dose Limit Single oral dose up to 1,000 mg. Single dose is strictly body weight-based (8 to 16 mg/kg).
Daily Max Maximum daily dose up to 4,000 mg (oral) or 5,000 mg (injectable). Specific strength tablets may be unsuitable for younger children.

Procedural Administration Constraints

For injectable administration, the solution must be delivered slowly when administered intravenously, generally not to exceed a rate of 1 mL (500 mg) per minute. If a dose is missed, it is indicated to take it only if the next scheduled dose is more than 6 to 8 hours away, and doubling the dose is prohibited.

Connection to the Overall Use Protocol

The usage protocol is defined by quantitative rules that govern the route, dose, and time intervals for administration. This structure dictates that use must begin at the lowest necessary dose and adhere to defined maximum single and daily limits to standardize the level of exposure.

Recent Clinical Evidence

Research evidence / Overview of studies for Antalgina

Evidence for Use in Managing Severe, Acute Pain

The intervention was studied in patients experiencing outcomes related to physical discomfort (e.g., following surgery, dental procedures, or injury) through short-term Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies primarily examined how symptom intensity or variability changed following a single dose, often monitoring outcomes like the change in pain scores. The studied populations mostly included adults, although some trials have included children in the acute pain setting.

What remains uncertain is the full picture of long-term outcomes or the patterns of effect when used repeatedly over multiple days, as limited information is available for long-term outcomes in the established trial data.

Evidence for Use in Acute Cramping Pain (Visceral Spasms)

Antalgina was studied for conditions associated with acute or disruptive episodes, such as the severe cramping pain experienced during renal or biliary colic. The research design for this indication often involves comparative clinical studies and RCTs conducted during periods of increased symptom activity. The studies explored outcomes related to systemic or functional imbalance by monitoring immediate changes in pain scores over a very short time interval.

What is still uncertain is that the available evidence is restricted to the acute phase of the episodes, and long-term effects are not fully established regarding recurrent symptoms. The comparative evidence is lacking in large, unified reports.

Evidence for Antipyretic Use in High Fever

Outcomes related to systemic or functional imbalance, such as fever, which was evaluated in studies, with the research base including both RCTs and Real-World Evidence (RWE). Studies monitored physiological strain or stress, measured as the change in body temperature over defined time intervals. Populations in these studies have included both febrile children and adolescents and adults.

However, data for certain groups remain insufficient—particularly large, dedicated interventional studies focusing only on fever in the adult population. The reliance on RWE means some data show patterns of use rather than strictly controlled symptom changes.

What is Still Uncertain in the Research Landscape

The evidence highlights what is known—and what is still uncertain—about Antalgina. Key gaps include the limited information for long-term outcomes and the absence of high-quality data tracking the effects of the medicine beyond the acute treatment episode. Furthermore, evidence quality varies across studies, and findings were mixed in some reports where research examined comparisons against other active pain relievers.

Frequently Asked Questions (FAQ)

Common questions about Antalgina (FAQ)

Q: What should I do if I forget to take a dose?

If a dose is missed, official instructions state that it should only be taken if the next scheduled dose is more than 6 to 8 hours away. It is strictly prohibited to double the dose or take two doses close together to make up for the missed one. The primary requirement is to avoid exceeding the established daily dose limits.

Q: What are the main symptoms of Agranulocytosis to watch out for?

Agranulocytosis is a rare but very serious potential side effect. Official safety information requires patients to be aware of symptoms such as unexplained fever, chills, a severe sore throat, or painful mucosal lesions. These lesions may appear in the mouth, nose, throat, or genital regions. If symptoms suggestive of Agranulocytosis appear, the medication must be discontinued immediately as required by the regulatory label.

Q: What is the necessary delay required when taking Antalgina with Aspirin?

If an individual is taking low-dose Aspirin specifically for its anti-platelet effect, regulatory documents require a timing constraint between the two medications. The regulatory constraint is that Aspirin should generally be taken at least 30 minutes before a dose of Antalgina to help preserve Aspirin’s anti-platelet effect.

Q: Is it safe to use Antalgina while I am breastfeeding?

Official regulatory documents state that repeated use of this medicine should be avoided during breastfeeding. Following a single administration, the active ingredients pass into the breastmilk. Because of this, breastmilk must be discarded for a 48-hour period before resuming breastfeeding.

Q: How quickly does Antalgina start to work after I take a tablet?

Data from pharmacokinetic studies indicate that the onset of a pain-relieving effect typically occurs within 30 to 60 minutes after taking an oral tablet. The actual time to effect may vary based on an individual's physiology and other factors.

Q: Does the use of Antalgina require a doctor's prescription?

The required prescription status of this medicine varies significantly depending on the country or region where it is sold. In some areas, it is classified as strictly prescription-only due to its potential side effects, while in other regions, Antalgina may be available over-the-counter.

Q: How should I dispose of an expired bottle of Antalgina drops?

When disposing of expired or unused medicine, including liquid drops, regulatory guidance requires that the medicine not be disposed of with ordinary household trash or flushed down the toilet. The official recommended method for disposal is to use a specific drug take-back program or an authorized pharmaceutical collection point in your local area.

Q: What is the difference between Metamizole and Dipyrone?

Metamizole and Dipyrone are two names for the same core active ingredient, Metamizole sodium, a common analgesic. Dipyrone is a name frequently used in several countries outside of Europe, while Metamizole is the primary name used in many other official regulatory documents.

How should Antalgina be stored and disposed of?

How to Store and Dispose of Antalgina

The storage and disposal of Antalgina (Metamizole sodium) must adhere strictly to regulatory documentation to ensure product stability and safety.

Storage Requirements

Antalgina must be stored at a temperature not exceeding 30°C and should not be frozen. It is mandatory to keep the medicine in its original package with the container tightly closed to protect it from light and moisture. Consistent with regulatory requirements, the product must be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Antalgina must be disposed of according to local pharmaceutical waste regulations. The medicine must not be thrown away with ordinary household trash or disposed of via wastewater (flushed down toilets or poured down sinks). Appropriate disposal is typically achieved through official drug take-back programs or authorized collection points.

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

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