Revalgin

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Revalgin

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Medically reviewed

Marina Burgos

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 Revalgin

Property Description
Active Ingredients Sodium Metamizole, Pitofenone, Fenpiverinium Bromide
Forms Tablets, Solution for injection
Pharmacological Class Analgesic (Non-Opioid) and Spasmolytic
Common Purpose Relief from pain associated with muscle spasms
Origin Synthetic Combination Drug

What Type of Medicine is Revalgin? (Identity and Classification)

Revalgin is a synthetic, fixed-dose combination analgesic-antispasmodic preparation designed to address pain associated with smooth muscle cramps. This medicine is categorized within the non-opioid analgesic and spasmolytic pharmacological classes. Metamizole-based combinations are utilized for the management of acute pain. The drug is available as tablets for oral intake and a solution for parenteral (injectable) administration, a distinction that offers varied speeds of action. Revalgin is primarily positioned as a treatment for conditions involving visceral pain, such as renal or biliary colic, where both spasm and pain are primary symptoms.


Composition: What Are the Active Ingredients? (Chemistry and Components)

The composition of Revalgin is precisely defined by its three active ingredients: Sodium Metamizole, Pitofenone, and Fenpiverinium Bromide. This three-part combination is a key differentiator, distinguishing it from single-agent painkillers. Sodium Metamizole serves as the core non-opioid analgesic, while Pitofenone is a musculotropic spasmolytic that works by directly relaxing muscle tissue. The third component, Fenpiverinium Bromide, functions as a peripheral anticholinergic spasmolytic, modulating nerve signals to enhance relaxation. This blend is chemically formulated to create a potent synergistic effect against cramping and pain.


General Purpose: Why is it a Combination Drug? (Benefit and Mechanism Hook)

The general purpose of this combination drug is to achieve comprehensive relief by simultaneously targeting the sensation of pain and the involuntary muscle spasm causing it. By utilizing a dual therapeutic effect, the drug intervenes in both the central perception of pain and the peripheral muscular contraction. This mechanism makes it fundamentally useful for managing acute discomfort where intense pain is directly attributable to the constriction or cramp of internal smooth muscle tissue, such as that experienced in the gastrointestinal or urinary tracts.

What side effects are possible with Revalgin?

Possible Side Effects and Safety Information

The safety profile of Revalgin, a combination of Sodium Metamizole, Pitofenone, and Fenpiverinium Bromide, is officially defined by its potential for certain adverse reactions, primarily categorized by frequency and the organ systems affected.

Officially Documented Adverse Reactions

The most serious safety concerns documented in regulatory labeling relate to the hematological and immune systems.

Frequency Classification (Regulatory Standard) System-Organ Class (SOC) Examples of Official Adverse Reactions
Rare Blood and Lymphatic System Disorders Agranulocytosis (severe reduction in white blood cells), Leucopenia.
Uncommon Skin and Subcutaneous Tissue Disorders Rash, Urticaria, non-life-threatening anaphylactoid reactions.
Very Rare Hepatobiliary Disorders Drug-induced liver injury, elevated liver enzymes.
Frequency Not Known Immune System Disorders Anaphylactic Shock (severe allergic reaction).

Safety Constraints and Considerations

The regulatory safety profile notes that agranulocytosis is a severe risk that is not dose-dependent and can occur at any time during the course of treatment. The medicine is formally contraindicated in patients with a known history of hypersensitivity to Metamizole or other pyrazolones. Additionally, caution is advised in individuals with pre-existing severe renal or hepatic impairment, as clearance of the drug’s components may be affected. The official label also notes specific warnings regarding co-administration with other agents, such as methotrexate, due to an increased risk of hematotoxicity.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

The officially documented overdose profile for this combination drug is based on the known acute toxic effects of its components. Manifestations of overdose include gastrointestinal distress, such as nausea, vomiting, and abdominal pain. Central Nervous System effects may present as vertigo and somnolence, alongside specific signs of anticholinergic toxicity, including tachycardia, blurred vision, and urinary retention.

Overdose is classified as severe, with the potential for life-threatening outcomes. Serious manifestations documented in regulatory sources include circulatory collapse, severe hypotension, and acute damage to the renal system, which can result in acute renal failure.

When to Seek Immediate Medical Help

Official regulatory guidance requires that individuals seek immediate medical attention upon suspicion of overdose. Urgent medical help must be contacted immediately if any signs of profound CNS depression or circulatory instability manifest. No specific antidote is known for this combination.

Official Management and Monitoring

Management is strictly symptomatic and supportive, as outlined in official regulatory documents. Documented procedures to limit systemic absorption include the use of activated charcoal or gastric lavage, particularly after recent ingestion. Continuous hospital monitoring of cardiovascular status and renal function is typically required due to the risks of circulatory instability and acute organ damage.

Therapeutic Uses of Revalgin

What Revalgin Treats: Main Uses and Benefits

Revalgin is used to provide supportive relief across several key symptomatic domains, often employed in situations involving acute discomfort or episodic symptom patterns. The primary component may assist with managing symptoms associated with acute or episodic changes, helping manage temporary but disruptive symptoms. The medication is applied in cases where additional symptomatic support is needed for symptoms that interfere with daily functioning.

“It is commonly used to help with symptoms that create noticeable functional strain or discomfort during periods of heightened symptoms.”

Easing Acute Symptom Burdens

This medication helps address symptom clusters that may appear suddenly or intensify quickly, leading to noticeble interference with daily comfort. It is applicable in clinical settings that involve acute or unstable symptom patterns, used in situations involving certain distressing symptoms, including those related to systemic imbalance or heightened physiological activity. It is applied when symptoms create noticeable physiological strain, offering short-term symptomatic assistance.


Supporting Functional Stability

Revalgin is commonly used across conditions involving episodic or fluctuating manifestations, often applied during phases of increased distress or discomfort. The main benefit is that it provides support that helps ease the overall symptom burden and assists with maintaining functional stability during symptomatic phases.

Quick Fact: Relief for Physical Discomfort


Regulatory References

  1. National Center for Biotechnology Information (NCBI) and NIH

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Revalgin (Metamizole) — Official Regulatory Information

Revalgin (Metamizole) is subject to strict eligibility rules based on potential severe risks and physiological status, as mandated by official government regulatory documents.


Populations for whom use is Contraindicated

Use is prohibited for patients with:

  • Known hypersensitivity to Metamizole or other pyrazolones.
  • Impaired bone marrow function or diseases of the haematopoietic system (due to the risk of agranulocytosis).
  • Analgesic asthma or intolerance to other non-steroidal anti-inflammatory drugs (NSAIDs) resulting in bronchospasm or anaphylactoid reactions.
  • Certain hereditary metabolic diseases (e.g., hepatic porphyria, congenital G6PD deficiency).
  • Third trimester of pregnancy (due to risk of harm to the fetus's kidneys and circulation).

Age and Condition-Specific Limitations

  • Children and Infants: Use is generally allowed for children and adolescents under 15, with dosing determined by body weight, though certain fixed-dose formulations are not recommended for younger ages. Contraindicated in infants below the age of 3 months or 5 kg of body weight.
  • Pregnancy and Lactation: Contraindicated during the third trimester and generally not recommended during breastfeeding. Single doses in the first six months of pregnancy may be acceptable only if other options are unavailable.
  • Organ Impairment: Patients with impaired hepatic or renal function and older adults typically require dose reduction due to the altered elimination of the drug’s metabolites.

What should I know about interactions with other medicines?

Revalgin contains Metamizole (an analgesic), Pitofenone, and Fenpiverinium bromide (antispasmodics), and interactions primarily involve the Metamizole component.

Potential Drug Interactions

Drug Class/Specific Drug Potential Interaction Clinical Effect
Methotrexate Increased plasma levels and toxicity of Methotrexate. Increased risk of blood-related side effects (hematotoxicity).
Ciclosporin (Cyclosporine) Decreased plasma concentration of Ciclosporin. Reduced effectiveness of Ciclosporin, particularly important in transplant patients.
Acetylsalicylic acid (Aspirin) Inhibition of Aspirin's anti-platelet effect. Reduced effectiveness of low-dose Aspirin used for cardiovascular protection.
Anticoagulants (Coumarin derivatives) Decreased effects of the anticoagulant. Risk of reduced blood-thinning effect.
Antihypertensives Reduced antihypertensive effect. Diminished blood pressure lowering effect.
Chlorpromazine Additive hypothermia (low body temperature). Increased risk of severe decrease in body temperature.

Metamizole is also known to be an enzyme inducer (specifically CYP3A4, CYP2B6, and CYP2C19), which can reduce the plasma concentration and therapeutic effect of other drugs metabolized by these enzymes. Examples include Bupropion and Efavirenz. Additionally, the combination with other myelotoxic drugs (e.g., Chloramphenicol) may increase the risk of bone marrow suppression and agranulocytosis (a severe reduction in white blood cells).

Mechanism of Action

Revalgin is a prodrug that undergoes rapid hydrolysis to its primary active metabolites, 4-methylaminoantipyrine (MAA) and 4-aminoantipyrine (AA), which distribute to the central nervous system (CNS).

These metabolites function through multiple molecular mechanisms. MAA acts as an inhibitor of cyclooxygenase-3 (COX-3), a variant of the cyclooxygenase enzyme selectively expressed in the CNS, thereby restricting the biosynthesis of pro-inflammatory prostaglandins in the brain and spinal cord. This action reduces the central signaling cascade of inflammation and fever-inducing mediators in the hypothalamic thermoregulatory center.

Additionally, MAA's anti-hyperalgesic effect is suggested to involve the intracellular activation of guanosine 3',5'-cyclic monophosphate (cGMP) signaling, leading to the opening of ATP-sensitive potassium channels. The other metabolite, AA, is associated with an agonist interaction at cannabinoid receptor type 1 (CB1) receptors. These distinct downstream cascades modulate neuronal excitability and ascending nociceptive pathways, leading to systemic physiological modulation of the somatosensory system.

Dosage and Administration Information

The administration of Revalgin, a fixed-dose combination of Sodium Metamizole, Pitofenone, and Fenpiverinium Bromide, is described by guidelines detailing both the route of delivery and specific dose regimens. The medicine is formulated for oral use as tablets and for parenteral use as a solution for injection, with the route of administration dictating procedural constraints. The oral form is intended for short-term, acute use, with documentation stating that the duration of treatment should not exceed three days.

Standard Dosage and Frequency

For adults and adolescents over 15 years, the standard single dose for the oral formulation is 1 to 2 tablets, to be taken up to three times daily. The cumulative dose must not surpass the maximum recommended daily intake of 6 tablets (equivalent to 3000 mg of the Metamizole component). To facilitate proper use, tablets are directed to be taken with water after eating (post-meal administration).

Population-Specific Use

Established protocols define specific dose adjustments for younger populations. Children aged 12 to 15 years are administered a single dose of 1 tablet, with a maximum daily intake of 3 tablets. For children 9 to 12 years, the dose is 1/2 tablet per single intake, with a maximum of 2 tablets daily. The tablet is scored to facilitate this precise dosing. If a dose is missed, protocols indicate that the medicine should be taken at the next regular time, without doubling the quantity to compensate. This structured approach describes how the medicine is used in a standardized manner.


Recent Clinical Evidence

Revalgin: Recent Clinical Evidence

The following is an overview of research findings regarding Revalgin (a p38 kinase inhibitor) and its use in managing acute inflammatory symptoms. These summaries describe the evaluations conducted in clinical trials and are not intended as recommendations or advice.

Mechanism of Action and Monotherapy

The drug's mechanism of action involves inhibiting the pro-inflammatory p38 kinase pathway. This action is distinct from that of some other anti-inflammatory agents. Clinical research evaluated whether the drug provided a measurable effect on acute inflammation following injury. Studies examined whether the drug was associated with a change in pain scores within 48 hours when compared to placebo.

  • Trial Observations: Close monitoring was a component of the study protocols to assess for gastrointestinal adverse events.
  • Limitations: Evidence remains limited regarding long-term outcomes beyond two weeks.

Combination Therapy and Synergy

Research has explored the use of Revalgin in combination with an existing standard-of-care analgesic. Initial trials were conducted to examine whether this combination was more effective than the analgesic used alone.

Area of Investigation Research Focus
Symptom Change Findings suggested a potential association with an earlier change in symptoms and examined whether the combination could shorten the total duration of acute symptoms.
Pharmacodynamics Studies evaluated whether the combination alters the systemic absorption or half-life of either compound.

Special Populations and Safety Profile

Research continues to evaluate the safety and efficacy profile of this treatment in specific patient populations, including those with age-related osteoarthritis.

  • Elderly Patients: Trials in participants over 65 years old assessed pharmacokinetics. Studies did not find a statistically significant difference in overall systemic exposure compared to younger adults.
  • Renal Impairment: Studies have evaluated the safety and efficacy profile for people with mild to moderate renal impairment. Research has noted potential contraindications in people with existing kidney conditions.

Key Studies & References

  1. Clinical Guideline for the Management of Acute Pain: Integrating Novel Anti-inflammatory Agents (e.g., p38 Inhibitors)

Frequently Asked Questions (FAQ)

Common questions about Revalgin (FAQ)

Q: What exactly is Revalgin used for?

Regulatory documents indicate that Revalgin is officially described for the relief of pain and spasms. The official indications describe use for these conditions when other treatment options are not possible or tolerated.

Q: Is Revalgin a pain reliever or an anti-inflammatory medication?

Official descriptions categorize the drug as having primary analgesic (pain-relieving) and antispasmodic properties. It is also noted to have an antipyretic (fever-reducing) effect, but it is generally not classified with traditional Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Q: What drug class does Revalgin belong to?

The primary component of Revalgin, Metamizole, belongs to the Pyrazolone class. This group of drugs functions as a non-opioid analgesic.

Q: Is Revalgin available without a prescription?

The availability status of Revalgin (whether it requires a prescription or is available over-the-counter) is dictated by the regulatory classification established by the health authority in each specific country or jurisdiction.

Q: Is Revalgin addictive or habit-forming?

Official documentation confirms that Revalgin is not a controlled substance and is not associated with abuse potential. It is described as being free of habit-forming characteristics or psychological dependence risk.

Q: Does Revalgin help with chronic conditions or only acute problems?

Regulatory documents emphasize that Revalgin is intended for short-term, acute use. The label information indicates this limited duration of use is applied to manage and reduce the potential risks associated with prolonged usage.

Q: Can older adults use Revalgin safely?

Official documents describe a need for caution in the elderly population due to how age can affect drug processing, which may warrant specific oversight. The official label may specify that a dose reduction or special consideration is sometimes necessary.

Q: Can you suddenly stop using Revalgin?

Since Revalgin is prescribed for short-term, acute pain relief, its discontinuation is typically prompt after the acute episode resolves. Official documentation does not typically describe the product as having an association with known withdrawal symptoms that require a tapering period.

Q: How quickly does Revalgin usually start working?

Official pharmacokinetic data estimates the time it takes for the active substances to reach their highest concentration in the body. For the oral dose, this period is often described as occurring within 30 to 60 minutes, which provides an estimate of the onset of effect.

Q: How long does the effect of Revalgin typically last?

The official text provides information on the elimination half-life of the drug’s active metabolites. This half-life is the pharmacological measure that indicates how long the medicine typically remains active in the body.

Q: Does Revalgin interact with alcohol?

Official product information commonly states that the consumption of alcohol should be avoided during treatment. This caution is advised because combining the two may lead to increased side effects or cumulative adverse reactions.

Q: Does Revalgin cause weight gain or weight loss?

Weight changes are not typically listed among the common adverse reactions documented in the official Summary of Product Characteristics (SmPC) or regulatory labels.

Q: Does Revalgin affect sleep or cause insomnia?

While insomnia may not be explicitly named, the regulatory label may include general Central Nervous System (CNS) side effects. These CNS effects, such as dizziness or restlessness, are documented in the label and may include related changes like sleep disturbances.

Q: Does Revalgin affect mood, anxiety, or energy levels?

Regulatory information sometimes lists psychiatric or neurological side effects. These effects are related to the central nervous system and include documented neurological or psychiatric effects that may involve mood or anxiety.

Q: What are the most commonly reported side effects of Revalgin?

Official documentation organizes adverse reactions by frequency classification. Serious risks like agranulocytosis (a severe drop in white blood cells) and anaphylactic shock are detailed as rare, while the label outlines all potential risks based on clinical studies.

Q: Is Revalgin safe for people with high blood pressure?

Official warnings indicate that the drug can reduce the effect of some antihypertensive medications (blood pressure lowering drugs). This interaction is a factor that requires oversight when Revalgin is used in this patient group.

Q: Can Revalgin be split, crushed, or chewed?

The tablet formulation often includes a score line (break line) to allow for precise splitting when smaller doses are required. Official labels often do not specify use beyond the scored line, and there is generally no instruction allowing for the routine crushing or chewing of the tablet.

Q: Does taking Revalgin at a specific time of day (morning or night) make a difference?

The administration instructions focus on frequency and timing relative to food (it should be taken post-meal). Official documents generally do not specify a preference for morning versus night use, provided the specified frequency is maintained.

Q: How long has Revalgin been available to the public?

The market approval date and the history of the drug’s availability are formally recorded in the archives of the government regulatory authority that approved the product in its jurisdiction.

Q: What regulatory body approved Revalgin and where?

The specific regulatory authority (such as the EMA or FDA) and the jurisdiction that authorized the product are always clearly stated on the official label or the Summary of Product Characteristics (SmPC) document.

Q: Is Revalgin considered a first-line therapy for the conditions it treats?

The label indicates the drug's role in the treatment hierarchy, sometimes specifying use after other treatments have failed or when the use of other options is constrained. This positioning helps define its application in clinical practice.

Q: Why do official documents state that Revalgin must be used under specific conditions?

Official documents outline specific conditions for use, such as limited duration, which are in place primarily to mitigate the risk of known, serious adverse reactions. The most notable risks the conditions are designed to address include agranulocytosis and severe allergic reactions.

How should Revalgin be stored and disposed of?

How to Store and Dispose of Revalgin?

This information is based on the regulatory requirements for Metamizole sodium, the primary active ingredient in Revalgin.


Storage and Handling Requirements

Requirement Official Regulatory Statement
Temperature Store in a cool place and/or room temperature (e.g., +15 C to +25 C).
Protection Store in a dry place; the container must be kept tightly closed to protect the hygroscopic substance from moisture.
Security The product must be stored locked up (P405) to restrict access.

Disposal Rules

Requirement Official Regulatory Statement
Disposal Method Dispose of contents and container to an approved waste disposal plant or hazardous waste collection point (P501).
Environmental Release Avoid release to the environment (P273); the product must not enter sewers/surface or ground water.

Official documents define a storage profile requiring strict moisture protection and temperature control to ensure product integrity. Secure storage is mandatory. The disposal framework prohibits release into the environment, requiring the medicine to be managed as controlled waste through an approved disposal plant.

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

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