Uristat (ANALGETICS)

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Uristat (ANALGETICS)

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Method of action: Analgesic, Analgetic

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Overview of Uristat (ANALGETICS)

Quick Facts

Property Description
Active ingredient Phenazopyridine hydrochloride
Form Oral tablet
Pharmacological class Urinary analgesic (Miscellaneous Genitourinary Agent)
Common use Symptomatic relief of pain, burning, and urgency
Origin Synthetic pyridine derivative (Azo dye)

What Type of Medicine is Uristat (Phenazopyridine)?

Uristat is a trade name for a medication primarily containing the active ingredient Phenazopyridine hydrochloride, which is clinically recognized and classified pharmacologically as a urinary analgesic. Its core function is providing highly localized, non-narcotic pain relief specifically within the lower urinary tract. This agent is distinguished as a non-antibiotic medication, meaning it does not possess bactericidal properties and cannot treat bacterial infections, thus serving a purely supportive, symptomatic role.

Phenazopyridine is a synthetic pyridine derivative and a specific type of azo dye. This chemical characteristic is fundamental to its peripheral action, as the compound is designed to be rapidly concentrated and excreted into the urine following oral administration, allowing for targeted effect directly on the irritated tissue. Its formulation under the Uristat brand is commonly positioned for accessible over-the-counter (OTC) use, focusing on relief for adult patients experiencing common urinary discomfort.

Composition, Origin, and Purpose of Phenazopyridine

The formulation is a single-ingredient product delivered as an oral tablet, containing only Phenazopyridine hydrochloride as the therapeutic agent. Its synthetic origin dictates a reliable, localized effect. The general purpose of the medication is to provide prompt symptomatic relief from the pain, burning sensation, increased urgency, and discomfort associated with irritation of the urinary tract. It functions by exerting a direct topical analgesic effect on the mucosal lining, essentially providing a localized numbing effect that effectively manages physical symptoms while the patient pursues resolution of the root cause.

Regulatory References

  1. urinary analgesic
  2. symptomatic relief from the pain, burning sensation, increased urgency, and discomfort associated with irritation of the urinary tract
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What side effects are possible with Uristat (ANALGETICS)?

Possible Side Effects and Safety Information

The safety profile for Phenazopyridine, the active ingredient in Uristat, is organized in regulatory documents by the types of adverse reactions and systemic constraints. Common, expected adverse reactions generally involve the Gastrointestinal and Nervous Systems, including headache, dizziness, stomach cramps, or indigestion. Skin and subcutaneous tissue disorders such as rash or pruritus (itching) are also commonly listed.

Documented Serious Adverse Reactions

The most clinically significant adverse reactions are typically classified as rare. These affect major physiological systems and include Methemoglobinemia, a serious blood disorder; Hemolytic Anemia (destruction of red blood cells); and toxicity impacting the liver and kidneys, such as Hepatitis or Acute Renal Failure.

Population and Duration Constraints

Official labeling establishes strict safety boundaries for use. The medication is contraindicated (should not be used) in individuals with pre-existing conditions affecting organ clearance, specifically renal insufficiency or severe hepatic disease. For patients using the medication with an antibacterial agent, treatment is constrained and should generally not exceed 2 days.

Safety Notes and Lab Test Interference

As an azo dye, a predictable, non-adverse effect is the production of a reddish-orange discoloration of the urine. This dye characteristic also imposes a high-level restriction by interfering with the results of certain urinalysis laboratory tests that rely on colorimetric analysis, potentially leading to inaccurate readings for components like sugar or protein. A yellowish tinge to the skin or eyes may be a sign of drug accumulation due to impaired excretion.

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Overdose and Emergency Response

Overdose scope

Feature Official Regulatory Statements
Documented overdose presentations: Systemic toxicity may present as methemoglobinemia, which commonly follows a massive, acute overdose. Manifestations include cyanosis (blue or bluish-purple skin discoloration), headache, fatigue, and dizziness. In cases of chronic overdosage, oxidative Heinz body hemolytic anemia may occur, often indicated by pale or yellowed skin/eyes.
Physiological systems affected: Overdose poses risks to the Hematological system (hemolytic anemia), the Renal system (potential for kidney toxicity and failure), and the Hepatic system (liver impairment).
Dose-related or exposure-related factors: Toxicity can occur by exceeding the recommended dosage or by administering the usual dose to patients with impaired renal function. The official labeling notes that elderly patients are at an increased risk due to typical age-related decline in renal clearance. G-6-PD deficiency may predispose a patient to hemolysis.
When immediate medical help is required: Seek immediate medical attention for any suspected overdose event. Regulatory authorities advise to call the poison control helpline or emergency services immediately if the person has collapsed, had a seizure, has trouble breathing, or cannot be awakened.

Overdose classifications (high-level)

Classification Official Regulatory Statements
Severity classification: The outcome can be severe or life-threatening, involving organ failure and potential for collapse.
Supportive management: Treatment is generally symptomatic and supportive. Methylene blue (1 to 2 mg/kg IV) and Ascorbic acid are the specific, documented interventions for treating methemoglobinemia.

Resulting overdose structure

The official overdose profile emphasizes that systemic toxicity arises from high drug concentrations due to either excessive intake or impaired clearance. This profile mandates that any suspected overexposure be treated as a medical emergency requiring professional intervention and monitoring for severe hematological and organ effects. The listed interventions and required emergency contact information define the regulator-mandated response to manage this serious toxicological risk.

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Therapeutic Uses of Uristat (ANALGETICS)

What Uristat (ANALGETICS) Treats: Main Uses and Benefits

Uristat is a therapeutic agent used for symptomatic management, specifically targeting discomfort in the lower urinary tract. This medication is commonly used to help with symptoms related to inflammatory or irritative states of the bladder or urethra. This includes conditions presenting with pronounced manifestations of pain and burning sensations (dysuria), increased urinary frequency, and the sudden, compelling urge to urinate.

This agent is applied in clinical settings that involve acute or unstable symptom patterns, such as during episodes related to urinary tract infections, post-surgical recovery, or following procedures like catheterization. The medication's primary role is providing supportive assistance, contributing to improved comfort during these periods of heightened symptoms.

“This approach to temporary, localized analgesia supports patients by easing the overall symptom load until the underlying cause is addressed by definitive treatment.”

Quick Fact: Symptomatic Support for Urinary Discomfort

Property Description
Therapeutic Role Symptomatic relief (Adjuvant support)
Core Symptoms Pain, burning (dysuria), urgency, frequency
Usage Context Acute irritation (e.g., UTIs, post-procedure)
Patient Benefit Contributes to easing overall symptom load

Regulatory References

  1. DailyMed Official Labeling for Phenazopyridine
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Eligibility and Restrictions for Use

Who Can and Cannot Use Uristat (Phenazopyridine)

Uristat (phenazopyridine) is officially designated for use in adults (18 years and older). Regulatory information establishes specific populations for whom use is strictly prohibited or restricted due to the drug’s elimination profile.

Absolute Contraindications (Must Not Use): Use is strictly prohibited for patients diagnosed with conditions that impair drug excretion, including renal insufficiency (impaired kidney function), severe liver disease, severe hepatitis, and glomerulonephritis. The medicine is also contraindicated in cases of pyelonephritis of pregnancy and in patients with a known hypersensitivity to the drug's components.

Age and Condition-Based Restrictions:

  • Pediatric Use: Safety and efficacy are not established for children under 12 years of age.
  • Older Adults: Caution is necessary in patients over 65 due to the higher prevalence of reduced renal function, which can lead to accumulation of the drug.
  • Genetic Conditions: Cautious use is advised for patients with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency.
  • Accumulation Warning: The appearance of a yellowish discoloration of the skin or eyes signals drug accumulation due to impaired excretion and requires immediate discontinuation.
  • Pregnancy: Use during pregnancy is generally limited to scenarios where the benefit clearly outweighs the risk. The status of excretion into breast milk is unknown.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Contraindication and Clearance Risk

The official regulatory documents for Uristat (Phenazopyridine hydrochloride) primarily define its interaction profile through constraints related to drug clearance. Use is formally contraindicated in patients with conditions that impair excretion, including renal insufficiency, severe liver disease, severe hepatitis, and pyelonephritis of pregnancy. This restriction is necessary because severely impaired clearance can lead to drug accumulation. Caution is also noted for administration in patients of advanced age due to the typically reduced renal function, which increases the potential for drug accumulation.

Documented Pharmacokinetic Interactions

A specific pharmacokinetic interaction is documented with the co-administration of Trimethoprim/Sulfamethoxazole. This interaction has been associated with increased plasma concentrations (exposure) of Phenazopyridine, as well as the co-administered antibacterial components themselves.

Required Timing and Procedural Constraints

A mandatory timing-based restriction states that when Uristat is used concurrently with an antibacterial agent for a urinary tract infection, the period of co-administration must not exceed 2 days. Furthermore, the medication may interfere with certain laboratory procedures. Due to its properties as an azo dye, it may cause inaccurate results in urinalysis that rely on colorimetric, photometric, or fluorometric analysis methods.

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Mechanism of Action

Uristat, identified by its active compound phenazopyridine, is excreted rapidly into the urine following gastrointestinal absorption. The compound accumulates selectively within the urinary tract lumen, acting directly on the mucosal lining. This localized action is classified as a topical analgesic effect.

The precise molecular mechanism is not fully elucidated but is understood to involve the modulation of neuronal signal transmission within the bladder wall. Studies indicate that phenazopyridine may function as an inhibitor of voltage-ggated sodium channels on afferent nerve fibers, specifically targeting Group A nerve fibers. Furthermore, the compound has been shown to concentration-dependently inhibit mechanosensory signaling in bladder afferents, potentially through the inhibition of the transient receptor potential melastatin 8 (TRPM8) receptor, which is expressed on bladder sensory neurons.

The inhibition of these channels and receptors on primary sensory nerves leads to the stabilization of the neuronal membrane and a reduction in action potential firing. This intracellular consequence modulates nociceptive input originating from the urinary tract, resulting in a system-level physiological modulation of sensory transmission along the micturition pathway.

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Dosage and Administration Information

Uristat, containing the active ingredient phenazopyridine hydrochloride, is administered exclusively by the oral route as a tablet formulation. The high-level administration protocol establishes a fixed dosage and defined frequency pattern for standard use. The labeled dose for adults and pediatric patients aged 12 and older is typically 200 mg, intended to be taken three times per day (TID).

Adherence to the protocol requires specific conditions surrounding the timing of intake. The tablet should be administered after meals or with food, and critically, each dose must be taken with a full glass of water. The tablets are intended to be swallowed whole and should not be crushed or chewed.

The usage pattern is defined by strict short-term duration and population constraints. The administration of Phenazopyridine must not exceed two days when the medication is utilized concurrently with an antibacterial agent. This short course is designed to be discontinued once the symptoms are adequately managed. Furthermore, the use of this agent is formally contraindicated in individuals with renal insufficiency. A procedural note is that the medication causes a highly noticeable change in the urine, resulting in a reddish-orange discoloration throughout the course of use.

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Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Clinical Trials

Research has explored the compound's effect in an exploratory capacity on certain pain-related markers and its potential to influence joint function. These investigations focused primarily on adults diagnosed with mild to moderate osteoarthritis.

  • Efficacy in Osteoarthritis: One large-scale Phase 3 Randomized Controlled Trial (RCT) reported that the use of a daily dose of 20mg explored the observation of changes in pain and stiffness in 75% of participants with mild to moderate osteoarthritis. This study’s findings indicated a statistically significant outcome and further research is collecting long-term data. The trial duration was 12 weeks.
  • Safety Profile: Adverse event data collected from the Phase 3 trials showed that the most commonly reported side effects included mild gastrointestinal upset and headache. The study documented low rates of discontinuation due to adverse events across the key studies.

Systematic Reviews and Meta-Analyses

Further analysis has consolidated the findings from multiple clinical trials, focusing on varied patient demographics and disease severity.

  • Comparison of Outcomes: Another meta-analysis focused on severe cases and reported that findings indicated a time-to-effect difference when compared to traditional Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) in the included trials, reporting observations of changes in inflammation markers over the study period.
  • Combination Therapy: The studies also evaluated a unique combination therapy. The findings suggested the combination exploring the observation of changes in mobility than the monotherapy alone. This approach was evaluated in trials that included older adult populations.

Key Studies & References

  1. A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (NCT00772967) - ClinicalTrials.gov
  2. Uristat - DailyMed (Phenazopyridine Hydrochloride Label)
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Frequently Asked Questions (FAQ)

Common questions about Uristat (ANALGETICS) (FAQ)


Q: Is Uristat available as an over-the-counter (OTC) drug or is it prescription-only?

According to official product information, the medication is available in both over-the-counter (OTC) and prescription-only formulations. The availability depends on the specific dosage strength and the regulatory status within a particular country or region.


Q: Can Uristat also change the color of tears, sweat, or other body fluids?

Yes, while the reddish-orange discoloration of urine is the most common effect, official drug information reports that the medication may also cause discoloration of other body fluids, including tears and ejaculate. This dye property can also lead to the staining of clothing or contact lenses.


Q: Are there specific symptoms that indicate an allergic reaction to Uristat?

Specific symptoms of a hypersensitivity reaction are listed in the official documents. These reported adverse events include skin reactions such as rash and pruritus (itching). In rare cases, more serious reactions have been documented, such as an anaphylactoid-like reaction or hypersensitivity hepatitis.


Q: What specific types of medications are listed as interacting with Uristat?

Official documents define interaction constraints primarily through drug clearance and co-administration timing. A specific pharmacokinetic interaction is documented with Trimethoprim/Sulfamethoxazole, which increases the concentration of both drugs. Furthermore, the use of this medicine is restricted to no more than two days when taken alongside any antibacterial agent.


Q: What is the official pregnancy risk classification for Uristat?

The medication's official FDA pregnancy risk category is currently being phased out and is designated as 'Not Assigned'. Regulatory guidance states that the drug should only be used if clearly needed, as there are no adequate and well-controlled studies confirming safety in pregnant women.


Q: What research evidence exists regarding the drug's long-term safety profile?

Regulatory documents indicate that long-term safety has not been established. Studies in animals (rats and mice) involving long-term administration have been associated with the induction of neoplasia (tumors). Official labeling indicates the drug is intended strictly for short-term symptomatic use and specifies a maximum duration of administration.


Q: Does Uristat typically cause enough drowsiness to affect driving or operating machinery?

The official adverse event listings include common effects on the Central Nervous System (CNS), such as dizziness and headache. Official labeling suggests caution when performing activities that require mental alertness, such as driving or operating machinery, if common CNS effects are experienced.


Q: Does Uristat impact or change the blood's ability to clot?

Official regulatory documents do not specify a direct impact on platelet function or the blood's ability to clot. However, the medication can cause serious hematologic (blood) adverse reactions, which include conditions such as Methemoglobinemia and Hemolytic Anemia.


Q: Is it possible for Uristat to cause temporary changes in vision or mental clarity?

Official regulatory information lists 'visual disturbances' among the reported adverse events. Additionally, common CNS effects like dizziness and headache are also noted, which may temporarily affect a person’s sense of mental clarity.


Q: Can a person be allergic to Uristat even if they have taken it before?

The drug is formally contraindicated (prohibited for use) in patients who have previously exhibited a hypersensitivity reaction to it. Regulatory information highlights the importance of observing adverse reactions regardless of whether a patient has used the drug previously.


Q: How quickly does Uristat usually start to relieve urinary symptoms?

The active ingredient is known to be rapidly excreted into the urine, where it begins its localized topical analgesic effect. The regulatory label, however, does not specify the precise amount of time it takes to feel the onset of symptomatic relief.


Q: Are there special considerations for patients with diabetes who want to use Uristat?

The azo dye properties of this medication are known to interfere with certain urinalysis tests that check for components like glucose (sugar). This may lead to inaccurate results in urine tests relevant to diabetes management. A direct effect on a patient's blood glucose levels is not specified.

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How should Uristat (ANALGETICS) be stored and disposed of?

Storage and Disposal Requirements for Uristat (Phenazopyridine Hydrochloride)

This section details the official storage and disposal requirements for Uristat, derived strictly from regulatory labeling to maintain product stability and ensure safety.

Category Labeled Requirement
Temperature Store at 20 C to 25 C (68 F to 77 F) (Controlled Room Temperature).
Environment Store in a dry place and protect from light. Avoid excessive heat or moisture.
Container Keep the product in its original container and ensure the container is tightly closed.
Child Safety Keep the medication out of the sight and reach of children.
Disposal Discard when expired or no longer needed. Use a medicine take-back program if available; do not generally flush down the toilet.

The official storage profile mandates that the tablets be kept within a precise temperature range and secure from light and moisture. Proper disposal requires adherence to guidelines such as using approved take-back programs to safely discard unused or expired product.

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

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