Borraza-G

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Borraza-G

Medically reviewed

Laura Arias

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 Borraza-G

Quick Facts

Property Description
Active Ingredients Lidocaine Hydrochloride, Tribenoside
Forms Suppositories, Ointment
Pharmacological Class Local Anesthetic + Vasoprotective Agent
General Purpose Symptom relief and vascular support
Origin Synthetic Compound Combination

What Type of Medicine is Borraza-G? (Identity and Classification)

Borraza-G is a specialized, dual-action combination medicinal product designed for local treatment. It is classified pharmacologically as a fixed-dose association that merges a Local Anesthetic with a Vasoprotective Agent. This integrated approach targets acute anorectal symptoms, providing more comprehensive efficacy than single-agent topical preparations. The medicine is manufactured as an external preparation provided in forms suitable for direct application via the topical or rectal route of administration.

Composition and Available Forms (Ingredients and Pharmaceutical Preparation)

Borraza-G's effectiveness depends on its two distinct active ingredients: Lidocaine Hydrochloride and Tribenoside. Lidocaine is a prototypical amide-type anesthetic and an entirely synthetic compound. The second entity, Tribenoside, is also a synthetic compound, categorized as a Capillary Stabilizing Agent. This formulation is provided in two core drug forms: suppositories and an ointment, allowing for flexibility in external and rectal administration.

General Purpose and Benefit of the Combination (High-Level Function)

The general purpose of the Borraza-G combination is to achieve immediate symptomatic relief and local tissue support through its synergistic mechanism of effect. The Lidocaine component provides a rapid surface anesthetic effect, immediately addressing intense localized pain, itching, and discomfort. Concurrently, the Tribenoside component contributes an anti-inflammatory effect and vasoprotective agent properties by influencing local microcirculation and reducing capillary permeability, which supports the structural integrity of the affected tissue. This dual strategy targets both the sensation and the physical pathology of the localized area.

What side effects are possible with Borraza-G?

Possible Side Effects and Safety Information

The safety characteristics of Borraza-G are formally documented according to regulatory standards, classifying potential effects based on frequency and affected physiological systems.

Adverse Reactions: Classification and Systems

Adverse reactions listed in official regulatory documents are predominantly classified as Rare or Very Rare.

Classification Examples of Documented Reactions
Rare (1 in 1,000 to 1 in 10,000) Local Pruritus (itching), Eruption (rash), or Pain at the administration site.
Very Rare (Fewer than 1 in 10,000) Serious systemic reactions including Anaphylactic reaction, Angioedema, Bronchospasm, and systemic Cardiovascular Disorders.

These effects are grouped into System-Organ Classes (SOCs), most commonly involving General Disorders and Administration Site Conditions and, for the serious reactions, the Immune System Disorders and Skin and Subcutaneous Tissue Disorders.

Specific Safety Considerations

The regulatory safety profile includes explicit constraints for specific patient populations, based on official prescribing information:

  • Pregnancy: Use is advised to be avoided during the first three months of pregnancy unless considered essential, based on regulatory review of available data.
  • Hepatic Impairment: The medication requires caution in patients with severely impaired liver function due to how the active ingredient Lidocaine is processed by the body.
  • Children: Safety and efficacy have not been established in pediatric populations, meaning there is no clinical experience available for use in this group.
  • Drug-Related Safety Note: A safety restriction is documented regarding the concomitant use of Borraza-G with other preparations containing local anesthetics, which may result in additive systemic toxic effects.

This structure ensures that potential risks, particularly the serious but very rare systemic reactions and the population-specific constraints, are communicated strictly according to official regulatory classification.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Borraza-G overdose is primarily defined by the potential for excessive systemic absorption of its local anesthetic component, Lidocaine Hydrochloride. Documented overdose presentations often begin with initial Central Nervous System (CNS) effects, which include sensory disturbances such as dizziness, tinnitus (ringing in the ears), blurred vision, and perioral paresthesia (numbness around the mouth). Gastrointestinal effects like nausea and vomiting are also officially noted.

Overdose is classified as potentially life-threatening due to the risk of severe outcomes. These include escalation of CNS signs to convulsions and respiratory arrest, as well as profound effects on the Cardiovascular System leading to severe hypotension, bradycardia, and cardiac arrest.

Immediate medical attention is required at the first sign of systemic toxicity or suspected overdose. Regulatory guidance mandates that the medicine be immediately discontinued and that emergency medical care be initiated. No specific antidote is known for acute toxicity. Management relies on symptomatic and supportive treatment, including maintaining a patent airway and controlling convulsions. Patients with severe hepatic impairment or those who are elderly carry an officially recognized increased risk of developing toxic concentrations.

Therapeutic Uses of Borraza-G

What Borraza-G Treats: Main Uses and Benefits

Borraza-G is commonly used for the local, conservative management of hemorrhoidal disease and related symptomatic anorectal discomfort. The combination therapy is commonly considered relevant when supportive symptom management is appropriate for low-grade hemorrhoids.

This medication is applied across domains where additional symptomatic support is needed, addressing symptoms that create noticeable physiological strain. It is commonly used to help with symptom clusters that may become intense or disruptive, such as localized pain, itching, and burning sensation. Borraza-G is relevant in conditions characterized by periods of heightened symptoms that involve inflammatory or irritative states, and is applied in addressing objective manifestations like swelling, edema, and intermittent bleeding.

The use is relevant for the symptomatic, local management of conditions such as hemorrhoidal disease and anal fissures. This provides support that helps ease the overall symptom burden and supports patients during episodes of heightened discomfort. It is commonly used to help with maintaining functional stability and supports general well-being during symptomatic periods. The medicine is relevant in contexts involving heightened systemic burden, including those associated with symptoms in postpartum women and women during pregnancy.


Quick Fact: Relief for Acute Local Discomfort

Property Therapeutic Focus
Primary Indication Symptomatic Hemorrhoidal Disease
Symptom Eased Localized Pain and Burning Sensation
Key Benefit Supports symptom management during acute flare-ups
Contextual Use Conservative local treatment protocols

Eligibility and Restrictions for Use

Who Can and Cannot Use Borraza-G?

This section details the official population eligibility rules for Borraza-G (Tribenoside/Lidocaine) as stated in government-approved regulatory documents.


Official Eligibility Constraints

Classification Status and Population Restriction Details (As Labeled)
Contraindicated Allergy/Hypersensitivity Individuals with known hypersensitivity to lidocaine, tribenoside, any excipients, or other amide-type local anesthetics must not use this medicine.
Contraindicated Local Integrity Must not be applied to areas with active infections, open wounds, or ulcerations.
Not Established Pediatric Patients The medicine is intended for adult use only. Safety and efficacy have not been established in children or infants.
Restricted Use Pregnancy Should not be used during the first three months of pregnancy. May be used from the fourth month onward.
Use with Caution Lactation Requires caution during breastfeeding, as lidocaine may pass into breast milk.
Use with Caution Comorbidities Patients with severe hepatic (liver) impairment, severe shock, or heart block require special consideration due to increased systemic risk.

The regulatory profile strictly defines who can use Borraza-G by establishing absolute non-eligibility for those with specific allergies and pediatric patients. Conditional use is documented for specific stages of pregnancy and for individuals with severe hepatic or cardiac issues.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

Borraza-G has the potential to interact with other medicinal products, which may alter the intended effects of Borraza-G or the co-administered substance. These interactions are generally classified as affecting drug activity, leading to either an enhancement or diminution of medicinal effects.

While specific, high-risk combinations are not universally documented in initial general regulatory statements, a cautious and comprehensive approach to concurrent substance use is necessary. The potential for interaction extends beyond prescription drugs to include over-the-counter medicines and dietary supplements.


Interaction Scope Details
Interacting Categories Prescription medicines, over-the-counter medicines, and dietary supplements.
Mechanistic Basis Potential to alter medicinal effects (pharmacodynamic or pharmacokinetic changes).
Regulatory Requirement Patients are formally advised to inform their doctor and pharmacist of all other products they are taking.

Concomitant use with other substances must be discussed with a healthcare professional to determine if a clinically significant interaction may occur. This procedural step helps manage the risk of effects being either too strong or too weak due to altered absorption, metabolism, or elimination pathways.

Mechanism of Action

How Borraza-G Works

Borraza-G is a small molecule that acts as a reversible, competitive inhibitor of the cysteine protease Cathepsin K (CTSK). This enzyme is highly expressed in osteoclasts and is essential for the degradation of the organic bone matrix. By selectively binding to the active site of CTSK, Borraza-G blocks the enzymatic hydrolysis of collagen, gelatin, and other non-collagenous proteins within the bone resorption lacuna.

The inhibition of Cathepsin K directly impairs the osteoclast's resorptive activity. This targeted inhibition leads to a reduction in ruffled border formation and decreased lysosomal secretion of protons and hydrolytic enzymes necessary for dissolving bone tissue. The final system-level physiological consequence of this action is a reduction in overall bone resorption rate, modulating the bone remodeling pathway solely through the disruption of CTSK-mediated degradation.

Dosage and Administration Information

The administration of Borraza-G, a combination of Lidocaine and Tribenoside, involves specific application routes and time-bound regimens. The medicine is intended for rectal insertion of the suppository form or topical application of the ointment to the perianal area.

Usage follows a structured schedule defined by the phase of the condition. For the acute phase, the standard adult regimen is one unit dose (either one suppository or one application of ointment) administered twice daily, typically in the morning and evening. This frequency is then reduced to once daily for subsequent or maintenance use after acute symptoms have diminished.

Administration and Preparation

Proper use requires the affected area to be cleaned and dried thoroughly prior to application, and hands must be washed before and after handling. For internal use, the ointment applicator must be inserted carefully and not too deeply. The treatment is designated for short-term use, which is typically limited to seven days if no improvement is observed.

Population-Specific Rules

Usage is subject to specific population constraints. The product is not suitable for children. Furthermore, use is generally restricted during the first three months of pregnancy and is only permitted from the fourth month onward, provided the maximum recommended dosage is not exceeded.

Recent Clinical Evidence

Research evidence / Overview of studies for Borraza-G

Evidence for use in Symptomatic Hemorrhoidal Disease

The evidence base for this two-component medicine primarily consists of Randomized Controlled Trials (RCTs) and systematic reviews. These studies were applied in trials assessing short-term or episodic symptom patterns for hemorrhoidal disease, which is a condition characterized by fluctuating or episodic manifestations. Research examined patients of either gender presenting with symptoms of hemorrhoids. The studies explored outcomes related to physical discomfort, such as localized pain, burning sensation, and itching. They also monitored objective outcomes, including changes in localized swelling, edema, and the manifestation of bleeding or prolapse.

Studies conducted during periods of increased symptom activity described the patterns of symptom change in the observed populations. Research describes changes measured during the study period for both the subjective symptoms and the physical signs that accompany acute episodes. Findings describe patterns observed in the studies related to the initial time interval until observed changes, and the time over which symptomatic changes were recorded. Evidence describes symptom patterns during these acute episodes.


Comparative Studies and Outcomes Examined

This medicine was evaluated in comparative clinical studies against preparations containing only one of its active components, as well as against some steroid-containing topical preparations. Research examined outcomes reflecting daily functioning and the reported experience of the combination when evaluated against its components or other standard treatments. Findings describe the focus of the comparisons on outcomes related to symptom intensity or variability. Data describe patterns related to the initial time interval until changes were observed across the different treatment groups.


Evidence in Special Populations

Specific research explored the use of this medicine in certain patient groups, particularly women with hemorrhoids associated with pregnancy and the postpartum period. These studies examined patient-reported outcomes describing perceived discomfort in these specific populations. Research reports the short-term changes observed when the medicine was evaluated in these defined groups. However, results apply only to the populations studied and do not determine whether an individual will respond similarly.


Long-Term Evidence and Follow-Up Duration

Studies exploring short-term symptom changes have primarily focused on defining the initial response and time over which symptomatic effects were recorded during acute episodes. Follow-up durations were limited, reflecting the focus on acute treatment protocols. Therefore, long-term effects are not fully established. There is limited information for long-term outcomes, and research provides context but not individual predictions regarding the recurrence of the condition or any influence on the natural progression of hemorrhoidal disease.


Research Gaps and Areas of Uncertainty

The evidence base, as it relates to acute symptom patterns, has certain research limitations. Data are still emerging for some questions, and the evidence is limited regarding outcomes over extended periods. The research has focused primarily on conservative local treatment, and data for certain groups remain insufficient regarding more severe presentations of the condition. While studies describe what has been observed so far, there is limited information for long-term outcomes, and the certainty remains low regarding whether long-term studies will examine future flare-ups.

Key Studies & References Anatomical Therapeutic Chemical (ATC) Classification: C05CX01 (Capillary Stabilizing Agents)

Frequently Asked Questions (FAQ)

Common questions about Borraza-G (FAQ)


Q: What is the specific dosage strength (e.g., mg or %) of Lidocaine and Tribenoside in each form?

A: According to official product information, each Borraza-G suppository contains 400 mg of Tribenoside and 40 mg of Lidocaine. For the cream, the strength is 50 mg of Tribenoside and 21.2 mg of Lidocaine Hydrochloride per 1 gram of cream. These specific strengths are stated in the official product information.


Q: Is it safe to use Borraza-G while breastfeeding?

A: Official regulatory documents indicate that the lidocaine component in Borraza-G has the potential to pass into breast milk. For this reason, official safety information advises caution during breastfeeding. Consultation with a healthcare professional is recommended to weigh the benefits of treatment for the mother against any potential risks to the child.


Q: Is Borraza-G available without a prescription (over-the-counter) or does it require a doctor's prescription?

A: Official drug labeling often classifies Borraza-G as available without a medical prescription for short-term use. It is generally recognized as over-the-counter (OTC) in many regions. However, the exact availability status may vary based on the local regulations in different countries.


Q: How long does it usually take for the Borraza-G to start providing relief from pain?

A: Clinical data cited in regulatory reviews suggests a fast onset of symptom relief for pain, primarily due to the Lidocaine component. Symptom reduction is sometimes reported as early as 10 minutes after the application of the medicine.


Q: If I miss a dose of the medicine, what should I do?

A: Official instructions indicate that if a dose is missed, it can be applied when remembered. However, the product label strongly advises against applying two doses at once to compensate for a missed dose, as this could lead to using more medicine than intended.


Q: What kind of hemorrhoids (internal, external, degree) is this medicine meant to treat?

A: Regulatory documents state that Borraza-G is indicated for the local relief of symptomatic hemorrhoids. The suppository form is generally indicated for internal hemorrhoids, while the cream is indicated for both internal and external hemorrhoids.


Q: What are the signs of a severe allergic reaction (anaphylaxis) I should look out for?

A: While serious reactions like anaphylaxis are considered very rare, official safety information lists signs that warrant immediate attention. The official safety information advises seeking immediate medical attention if signs such as difficulty breathing, severe localized swelling of the face or throat, or a generalized, severe skin reaction are observed.

How should Borraza-G be stored and disposed of?

The storage and disposal of Borraza-G (Ointment and Suppositories) must follow specific rules documented in regulatory labeling to maintain product stability and ensure household safety.

Storage Requirements

Storage Factor Official Requirement
Temperature (Suppositories) Store at room temperature (1 C to 30 C only).
Environmental Protection Store away from direct sunlight, heat, and moisture (both forms).
Stability Constraint Do not store suppositories over 30 C, as this may cause the product to crack or be deformed.
Child Safety Keep out of the reach of children (both forms).

Disposal Instructions

Official instructions require that any remaining or unused product be handled carefully. The label explicitly states to discard the remainder and do not store them (referring to the leftover medicine).

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

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