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Cistalgan

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Cistalgan

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Treatment option:

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.

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Overview of Cistalgan

Cistalgan is a synthetic, fixed-dose combination drug designed for oral administration, provided in the form of a tablet. It is characterized by its dual action, which is necessary for managing symptoms involving both muscle spasm and pain.

Property Description
Active Ingredients Flavoxate, Propyphenazone
Form Oral Tablet
Pharmacological Class Antispasmodic, NSAID
Common Use Relief of spasm and associated pain
Origin Synthetic

What Type of Medicine is Cistalgan?

Cistalgan is clinically recognized as a combination of two distinct therapeutic agents: a urological Antispasmodic and a Non-Steroidal Anti-Inflammatory Drug (NSAID). The antispasmodic component, Flavoxate, is specifically categorized as a Cholinergic Muscarinic Antagonist. This class of substance works to relax the smooth muscles, particularly those found in the urinary tract, easing involuntary contractions. The NSAID component, Propyphenazone, is a pyrazolone derivative used for its analgesic and antipyretic properties in pain management.


What are the Active Ingredients in Cistalgan?

The formulation comprises the two active substances, Flavoxate (often administered as the hydrochloride salt) and Propyphenazone. The inclusion of Flavoxate is intended to provide a spasmolytic effect, calming hyperactive or involuntary contractions in the bladder and related structures. Conversely, the Propyphenazone component contributes the necessary analgesic effect, working to lower the perception of pain and discomfort that often accompanies spastic episodes. This pairing ensures that a comprehensive therapeutic approach to acute symptoms is contained within a single oral tablet, which differentiates Cistalgan from single-agent formulations.


What is the General Purpose of This Combination Drug?

The primary general purpose of Cistalgan is to offer combined symptomatic relief from acute conditions characterized by both involuntary muscle contractions and their accompanying pain. By targeting both the muscle spasm with Flavoxate and the associated discomfort with Propyphenazone, the drug aims to manage the complex sensory profile that may arise from irritation or hyperactivity in the urinary tract.

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What side effects are possible with Cistalgan?

Possible Side Effects and Safety Information

The safety profile for Cistalgan is officially documented through the classification of adverse reactions by frequency and physiological system, consistent with regulatory standards. The effects noted derive from both its antispasmodic (Flavoxate) and NSAID (Propyphenazone) components.

Documented Adverse Reactions

The most frequently listed adverse reactions, which are not explicitly categorized by frequency in all regulatory documents, include gastrointestinal effects such as nausea and vomiting, dry mouth, and gastrointestinal disturbances.

Neurological effects commonly documented are slight drowsiness and accommodation disturbances (blurred vision). Effects on the cardiovascular system include tachycardia and palpitations. Difficulty urinating and skin eruptions are also noted.

Seriousness and Classification

Certain reactions are classified by their seriousness or occurrence rate. Agranulocytosis (severe reduction in white blood cells) is classified as Rare in official documentation. Angioedema and Anaphylactic reaction are noted as potential serious adverse events, classified as frequency Not Known.

System-Organ Class Example Adverse Reaction (Unclassified)
Gastrointestinal Disorders Nausea, Dry mouth, Vomiting
Nervous System Disorders Slight drowsiness
Eye Disorders Accommodation disturbances, Increased ocular tension
Blood and Lymphatic Leucopenia, Agranulocytosis (Rare)

Safety Considerations and Constraints

Official labeling limits the use of this product to adult subjects. Specific caution is required for older adults, where a careful determination of dosage is necessary due to the potential for confusion. Safety notes indicate that slight drowsiness may decrease by increasing the time interval between administrations, and nausea/vomiting may decrease when taken with food. Due to the possibility of drowsiness or blurred vision, patients are cautioned about the effect on the capacity to drive or operate machinery. A reddish color in the urine may appear due to a non-pathological metabolite of the pyrazolone component.

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Overdose and Emergency Response

Overdose and when to seek help

Overdose with Cistalgan, a combination product containing the antispasmodic flavoxate and the NSAID propyphenazone, primarily presents with symptoms linked to excessive anticholinergic activity, as documented in regulatory information for flavoxate. The official documentation emphasizes that immediate emergency attention is required for suspected overdose.

Documented Overdose Manifestations and Actions

System Affected Regulator-Listed Manifestations
Central Nervous System Mental confusion, hallucinations, convulsions, severe drowsiness, unsteadiness, or clumsiness
Cardiovascular/Thermal Tachycardia (increased heart rate), increased blood pressure, hyperpyrexia (fever), reduced ability to sweat, flushing or redness of the face

When Immediate Medical Help is Required

The regulatory instructions state that emergency medical attention must be sought immediately if an overdose is suspected. For severe signs such as collapse, seizure, troubled breathing, or unresponsiveness, emergency services must be contacted immediately. Mental confusion is a documented CNS effect that may be especially likely to occur in elderly patients.

Officially Described Management

The regulatory labeling for the flavoxate component notes that it is not known whether the substance is dialyzable. Management of overdose focuses on general supportive and symptomatic measures, consistent with clinical strategies for pyrazolone-class toxicity, which include observation for serious outcomes like arrhythmias and impaired consciousness.

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Therapeutic Uses of Cistalgan

Quick Facts: Uses of Cistalgan

  • Relief of Symptoms: May help manage discomfort associated with bladder and urinary tract issues.
  • Specific Conditions: Used to address symptoms related to cystitis, prostatitis, and urethritis.
  • Post-Procedure Care: May be utilized after medical procedures such as catheterization or cystoscopy.
  • Pain Management: Indicated for reducing pain and spastic conditions in the urinary system.

Cistalgan is a prescription treatment option used to address a range of symptoms associated with disorders of the urinary tract and related conditions. It is indicated for managing painful or spastic conditions, which include common signs like difficulty or discomfort during urination (dysuria), an urgent need to urinate, or increased frequency of urination at night (nocturia).

This medication may also be utilized to help manage pain associated with specific disorders of the bladder and prostate, such as cystitis, urethritis, and prostatitis. Furthermore, Cistalgan is sometimes used as an adjunct treatment for pain linked to ureteral or kidney stones and to relieve discomfort following procedures involving the lower urinary tract, such as cystoscopy or catheterization.

It is also recognized for its use in addressing painful spastic conditions of the female reproductive system, including specific types of pelvic pain and menstrual pain (dysmenorrhea).

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Eligibility and Restrictions for Use

Cistalgan eligibility is strictly defined by regulatory documents, which restrict its use based on the properties of its active ingredients, Flavoxate (antispasmodic) and Propyphenazone (NSAID pyrazolone derivative).

Populations Excluded from Use

Use is mathbfcontraindicated in patients with known hypersensitivity to the active substances, any pyrazolone derivatives, or excipients. The medicine must not be used by women who are pregnant or by breastfeeding women.

Absolute Contraindications (Conditions)

The following conditions render patients ineligible: Obstructive Uropathies leading to urinary retention, Gastrointestinal Obstruction or Hemorrhage, Glaucoma, and Myasthenia Gravis. Furthermore, due to the NSAID component, Cistalgan is contraindicated in patients with Bone Marrow Deficiencies, Acute Hepatic Porphyria, and G6PD Deficiency.

Age and Condition Restrictions

The medicine is generally restricted to adolescents mathbf12 years of age and older. Use is mathbfnot recommended for children under mathbf12 years as safety and efficacy have not been established. Special mathbfcaution is required for use in elderly patients and those with documented Renal or Hepatic Impairment, where use may be conditional.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Cistalgan, a combination drug, presents an official interaction profile based on the actions of its components, Flavoxate (anticholinergic) and Propyphenazone (NSAID). Official regulatory documentation defines specific constraints and prohibited combinations.

Contraindicated Combination

Co-administration with Pramlintide is formally contraindicated. This prohibition stems from a pharmacodynamic synergism between the anticholinergic effect of Flavoxate and Pramlintide, which results in the severe inhibition of gastrointestinal motility.


Documented Interaction Constraints

Interacting Product Category Interaction Outcome Described in Label
Other Anticholinergic Agents Risk of additive anticholinergic adverse effects (e.g., mental confusion), especially heightened in the elderly population.
Anticoagulants/Other NSAIDs Increased risk of bleeding and gastrointestinal adverse effects due to the Propyphenazone component.
Oral Solid Potassium Forms Increased risk of ulceration due to Flavoxate-mediated reduction of gastrointestinal motility.
Alcohol Documented to increase the risk of gastrointestinal bleeding.

Timing-Based Regulatory Requirement

For diagnostic purposes, Cistalgan requires mandatory discontinuation for a period of at least 5 half-lives before the administration of the agent Secretin to prevent a procedural hyporesponse.

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Mechanism of Action

Modulation of Smooth Muscle Contraction

This domain describes how the Flavoxate component acts as a functional inhibitor of calcium ion ( Ca^2+) channels in the smooth muscles of the genitourinary tract. This blockade prevents the Ca^2+ influx required to activate the contractile machinery, thereby reducing intracellular Ca^2+ concentration. This molecular action leads to a direct and targeted relaxation of smooth muscle tone.


Inhibition of Local Mediator Pathways

This section covers the mechanism involving the inhibition of Prostaglandin synthesis by the Propyphenazone component, which targets and inhibits the Cyclooxygenase (COX) enzymes. By suppressing the COX pathway, the production of inflammatory and sensitizing Prostaglandin mediators is reduced, which serves to attenuate chemical signals mediated by Prostaglandins.


Combined Peripheral Mechanistic Profile

These two distinct actions occur concurrently within peripheral tissues. The synergistic effect of muscle relaxation and decreased inflammatory signaling results in a comprehensive reduction in muscle contractility and local mediator activity within the affected organ systems.

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Dosage and Administration Information

Official Administration Guidelines

Cistalgan is a fixed-dose combination drug administered through the oral route as a film-coated tablet containing Flavoxate 200 mg and Propyphenazone 250 mg. Parameters for administration are defined for adult subjects.

Administration Scope

The standard adult regimen involves taking one tablet per dose. The frequency of administration is generally between two and three times daily, and the final number of doses within this range is determined by the intensity of the symptoms being managed. The maximum daily dose limit is three tablets, and all doses should be administered at regular intervals throughout the day.

Administration Rule Labeled Instruction
Route of Administration Oral
Timing in Relation to Meals Must be taken on a full stomach (a stomaco pieno)
Swallowing Procedure The tablet should be swallowed whole with water
Maximum Daily Dose Three tablets

Age-Group Specific Rules

Use is limited to adult subjects, as the product is not recommended for children and adolescents. For older adults, a dosage reduction may be considered by the prescribing physician.

Protocol for Missed Doses

If a dose is missed, patients should not double the subsequent dose to compensate. Instead, the patient is directed to resume their regular schedule and take the next dose at the usual time. Treatment duration is typically intended for acute symptomatic episodes and should not exceed the prescribed length of therapy.

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Recent Clinical Evidence

Research evidence / Overview of studies

The research examined a non-steroidal anti-inflammatory compound combined with a muscle relaxant. The combination was developed for conditions associated with painful spasms of the urinary tract.

Overview of Efficacy Research

Studies assessed the relationship between the compound and changes in patient-reported pain scores in individuals with chronic osteoarthritis. Research has explored the compound's potential association with inflammatory markers and its relationship to changes in joint movement.

  • Studies examined whether combining the compound with specific physical therapies had an impact on the perceived rate of pain reduction and mobility restoration. Research also examined the compound's potential role in certain pain management protocols.

Dosage and Administration Studies

Research on the compound often evaluated a starting dosage at the lowest available concentration to explore the individual response to that concentration.

  • The half-life of the non-steroidal component was recorded as approximately 12 hours in studies. Research explored whether different administration schedules impacted the reported efficacy or side-effect profile.

Safety and Tolerability Profile

Adverse effects were recorded in studies, and researchers noted instances of potential gastrointestinal distress, which is a consideration common to this class of compounds.

Cardiovascular Considerations

Studies often excluded or flagged individuals with a history of heart conditions, citing research that explored cardiovascular events associated with similar drug classes. This exclusion was based on the need to maintain trial safety and did not necessarily reflect the compound's individual profile.

  • Research evaluated the relationship between the combination and blood pressure parameters, and tracked changes in edema. The most commonly reported side effects in trials were headache and nausea.

Key Studies & References Pharmacokinetic Profile of the Combined NSAID and Muscle Relaxant Component: Half-Life and Plasma Concentration Studies

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Frequently Asked Questions (FAQ)

Common questions about Cistalgan (FAQ)


Q: What is the main difference between Cistalgan and over-the-counter pain relievers?

A: The primary difference is the dual action. According to official information, Cistalgan is a combination of a non-steroidal anti-inflammatory drug (NSAID) for pain and an antispasmodic component. The antispasmodic component works to relax the smooth muscles, which is a different function than a single-ingredient, over-the-counter pain reliever.


Q: Does Cistalgan treat the cause of the problem or just the symptoms?

A: Cistalgan is indicated for symptomatic relief. This means the drug helps manage discomfort, pain, and other symptoms associated with a condition. Regulatory documents state that it is not intended as a definitive cure or treatment for the underlying cause of a condition, but it can be used alongside drugs that do treat infections.


Q: How quickly should I expect Cistalgan to start working?

A: Studies suggest an onset of action can occur within one hour. Research on the Flavoxate component, which addresses muscle spasm, indicates that the time to the first noticeable effect was approximately 55 minutes. The peak therapeutic effect was observed at just under two hours.


Q: How long does the effect of one dose of Cistalgan typically last?

A: Official dosing guidance suggests the effect is intended to last several hours. The regulatory intent suggests the effect is designed to cover the intended regular dosing period for the acute treatment.


Q: Is there a reason Cistalgan is available only by prescription?

A: The medication is classified as a human prescription drug. Official regulatory product information indicates that the Flavoxate component requires a prescription. This classification means professional oversight is required to determine appropriate use and monitoring.


Q: What is the general safety classification of Cistalgan?

A: Cistalgan is a fixed-dose combination of two classes of medicine. In terms of pregnancy risk, the Flavoxate component is assigned a Pregnancy Category B classification by the FDA. This classification means that animal studies have not demonstrated a risk to the fetus, but there are no adequate studies in pregnant women.


Q: Can Cistalgan be taken with common vitamins or supplements?

A: Official documents do not list interactions with common vitamins. Regulatory information examined for the Flavoxate component does not include documented interactions with common vitamins such as Vitamin B12, Vitamin C, or Vitamin D.


Q: Are there different versions or strengths of Cistalgan available?

A: The official approved version is a single fixed-dose tablet. Regulatory documents specify that the dosage form is a combination tablet. This tablet contains two active ingredients: Flavoxate and Propyphenazone.


Q: Can women who are planning to become pregnant use Cistalgan?

A: Caution is generally noted regarding the planning stage of pregnancy. While the Flavoxate component is listed as Pregnancy Category B, the drug also contains an NSAID component. Regulatory sources often advise caution with NSAIDs around conception, which is a factor to consider.


Q: Is Cistalgan chemically similar to any other drugs on the market?

A: Yes, its components belong to recognized drug classes. The antispasmodic component, Flavoxate, is a muscarinic antagonist, and the analgesic component, Propyphenazone, is classified as a pyrazolone derivative. These classifications define the drug's properties and how it relates to other medications within the same pharmacological groups.


Q: How does Cistalgan compare to other treatments mentioned in research papers?

A: Research evidence includes comparative analysis. Studies have examined the compound's use in combination with specific physical therapies to assess the impact on pain reduction and mobility. Furthermore, research often flags or references information concerning similar drug classes when discussing the safety profile.


Q: Can Cistalgan affect the results of any lab tests?

A: Yes, it is noted to interact with at least one diagnostic agent. Official regulatory documents state the drug must be stopped before the administration of the agent Secretin. This is done to prevent a procedural hyporesponse, meaning a potentially incorrect test result.


Q: What is the risk of a serious side effect from Cistalgan?

A: Official safety information documents several serious adverse events. Rare serious effects, such as agranulocytosis (a severe drop in white blood cells), are listed. Other serious reactions like angioedema (swelling) and anaphylactic reaction are noted as potential events, though their frequency is classified as Not Known.


Q: Are there any long-term health consequences described for people taking Cistalgan?

A: The medication is indicated for short-term, acute use. The official use guidelines state that treatment is typically intended for acute symptomatic episodes. Official warnings highlight the potential for additive adverse effects, like mental confusion, which is a specific consideration for use in the elderly population.


Q: Can Cistalgan be taken at the same time as cold or flu medicines?

A: Interactions with other NSAIDs are documented. Official product information notes that using Cistalgan with other non-steroidal anti-inflammatory drugs (NSAIDs) carries an increased risk of bleeding and gastrointestinal side effects. Many over-the-counter cold and flu medications contain NSAIDs.


Q: Are there any specific lifestyle changes mentioned in studies that enhance Cistalgan's effect?

A: Studies have looked at the combination with physical therapies. Research has examined whether the compound, when combined with specific physical therapies, had an impact on the rate of pain reduction and mobility restoration. No official claims are made regarding enhancement of effect by other common lifestyle changes.


Q: Is Cistalgan safe for patients who have high blood pressure?

A: The safety profile includes cardiovascular considerations. Studies related to the drug have tracked changes in blood pressure parameters in participants. Due to risks associated with similar drug classes, individuals with a history of heart conditions were often flagged or excluded from trials.


Q: Can Cistalgan cause changes in sleep patterns?

A: Slight drowsiness is a documented neurological effect. Official safety information includes slight drowsiness as a commonly documented adverse reaction. Other central nervous system effects noted are headache and nervousness, which could potentially impact a person's sleep or wakefulness.


Q: Are there any known interactions between Cistalgan and mental health medications?

A: Yes, additive anticholinergic effects are a documented concern. Official warnings note a risk of additive anticholinergic adverse effects, which may include mental confusion, when Cistalgan is combined with other anticholinergic agents. This is a class that includes several types of older mental health medications.


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How should Cistalgan be stored and disposed of?

Storage Requirements

Cistalgan tablets must be stored at Controlled Room Temperature, which is defined as 20°C to 25°C (68°F to 77°F). It is mandatory to keep the medicine from freezing and to store it away from excessive heat and moisture to ensure product stability. The container must be light-resistant and tightly closed.

Child Safety

The medication must always be kept out of the reach of children.

Disposal Instructions

Unused or expired Cistalgan should be discarded safely. The preferred method is to utilize an authorized drug take-back program. If this is not possible, the medicine may be mixed with an unappealing substance (like dirt or coffee grounds) and sealed in a plastic bag before being placed in household trash; pills must not be crushed.

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

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