Ubistesin

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Ubistesin

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 Ubistesin

Property Description
Active Ingredients Articaine and Adrenaline (Epinephrine)
Form Solution for Injection (Dental Cartridge)
Pharmacological Class Local Anesthetic (Anesthetic-Vasoconstrictor Combination)
General Purpose Locoregional Anesthesia / Pain Management
Origin Synthetic

Ubistesin is a prescription-only medicine scientifically categorized as an anesthetic-vasoconstrictor combination product. It is supplied as a sterile aqueous solution for locoregional anesthesia, most commonly used in dental procedures to provide immediate and localized pain management. The formulation is characterized by its rapid onset of action compared to older local anesthetics.


Ubistesin: Definition and Pharmacological Classification

Ubistesin is classified as a Local Anesthetic that combines a pain-blocking agent with a vasoconstrictor to manage both sensation and localized blood flow. The primary agent, Articaine, is a well-established amide-type local anesthetic. The medication is a synthetic compound, delivered via injection, and its unique chemical structure, including a thiophene ring, contributes to its high lipid solubility and efficient nerve impulse conduction blockade.


What is the Composition of Ubistesin?

The preparation contains two active ingredients [INN]: the amide-type local anesthetic Articaine, and Adrenaline (Epinephrine), which functions as a sympathomimetic vasoconstrictor. This combination is a standard tool in dental practice. The inclusion of Adrenaline is a key differentiating factor, as it slows the absorption of Articaine away from the injection site, which both prolongs the anesthetic effect and aids in managing localized bleeding.


What is the General Purpose of This Anesthetic Combination?

The general purpose of this combination product is to provide rapid and effective pain management through a profound, localized, and reliable block of sensation. A typical scenario involves its use during complex tooth extractions or deep restorative procedures. By combining the numbing power of Articaine with the duration-extending effect of Adrenaline, Ubistesin is designed to deliver reliable locoregional anesthesia. This ensures the patient experiences temporary, complete relief from pain in the treatment area, which is essential for successfully carrying out various minor surgical procedures.

What side effects are possible with Ubistesin?

Possible Side Effects and Safety Information

Adverse reactions to this anesthetic combination are classified according to frequency, based on reports from clinical trials and post-marketing surveillance, as documented in official regulatory sources such as the FDA and EMA. The safety profile is characterized by the potential for systemic effects on the nervous system and cardiovascular system following absorption of Articaine and Epinephrine.

Official Classification of Adverse Reactions

Side effects are grouped by their reported frequency:

  • Common Reactions (ge 1/100 to < 1/10): Typically involve the injection site and nervous system, including headache, dizziness, paresthesia (numbness/tingling), hypoesthesia (reduced sense of touch), and oral pain or swelling.
  • Uncommon Reactions (ge 1/1,000 to < 1/100): May include tachycardia (rapid heart rate), palpitations, hypertension, anxiety, nervousness, and gastrointestinal effects like nausea.
  • Rare Reactions (ge 1/10,000 to < 1/1,000): These include respiratory depression, convulsions or seizures (due to systemic toxicity), and trismus (lockjaw).

Serious Adverse Reactions and Population-Specific Notes

Serious adverse reactions, though rare, are highlighted in regulatory documents. These include Anaphylaxis (a severe hypersensitivity reaction) and Methemoglobinemia, a documented blood disorder associated with Articaine use. The potential for cardiorespiratory depression also warrants attention.

Safety constraints exist for specific patient populations. Older adults may require dosage adjustment due to the greater frequency of reduced hepatic, renal, or cardiac function. Specific caution is also noted for pediatric patients and those with severe renal or hepatic impairment.

Overdose and Emergency Response

Overdose and when to seek help

The officially documented overdose profile for this Articaine and Epinephrine combination is defined by the risk of excessive systemic absorption, leading to toxicity in the central nervous and cardiovascular systems.

Overdose or accidental intravascular injection is associated with a progression of serious effects, and regulatory documents explicitly mandate the requirement to seek immediate medical attention should symptoms occur.

Property Documented Regulatory Information
Documented Manifestations Initial signs of toxicity include restlessness, anxiety, tremors, dizziness, tinnitus, and confusion. This may progress to seizures (convulsions), coma, and respiratory depression [Source 1.3, 1.8].
Cardiovascular Effects Manifestations include changes in heart rate, such as bradycardia (slow heart rate) or tachycardia, and irregular heart rhythms (arrhythmias) [Source 1.3, 1.8].
Severe Complication Methemoglobinemia is a documented risk, identifiable by signs like a pale, gray, or blue-colored skin/lips/nails, requiring specific supportive care [Source 1.8, 3.2].
Population-Specific Note Patients with severe hepatic or renal impairment have an increased risk of developing toxic plasma levels due to slower drug clearance [Source 3.1, 3.2].

Upon the first appearance of adverse reactions, administration must be immediately interrupted. The official labeling specifies that resuscitative equipment, oxygen, and other resuscitative drugs should be available and that the patient must be observed constantly due to the potential for life-threatening outcomes like cardiac or respiratory arrest [Source 1.3, 2.3].

Therapeutic Uses of Ubistesin

Ubistesin (Articaine HCl with Epinephrine) is a commonly used injectable local anesthetic, applied to provide symptomatic relief from pain during procedures.

Relief from Acute Dental Pain and Discomfort

This medication is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. It is applied in addressing the symptoms related to physical discomfort and heightened physiological activity that may be associated with a range of treatments, including extractions, drilling for fillings, root canals, and minor gum surgery. This application is commonly used when short-term symptomatic assistance is needed to help with patient comfort.

Management of Symptoms in Complex Dental Procedures

Applied across domains where additional symptomatic support is appropriate, this local anesthetic assists in managing symptom clusters that may become intense or disruptive during lengthy or complex dental work. By providing sustained numbness, it supports the patient during difficult episodes by easing distress and contributing to improved functional stability. As a patient benefit, it helps patients cope more steadily with symptomatic periods and receive the necessary treatment. This supportive role is critical, as:

“Local anesthesia in dentistry is generally intended to help procedures be carried out with reduced pain and lessened discomfort.

Quick Fact: Relief for Acute Procedural Pain

The use of Ubistesin is considered relevant for easing distress and supporting the completion of the procedure across conditions characterized by periods of heightened symptoms.

Eligibility and Restrictions for Use

Eligibility for Ubistesin (Articaine HCl with Epinephrine)

Ubistesin is a local anesthetic with specific, officially documented restrictions regarding patient eligibility, determined by the presence of its active ingredients and excipients. These rules define who is eligible to use the medicine, who must be given conditional use, and who is absolutely contraindicated.

Contraindications and Restrictions

The medicine is contraindicated in patients with a known hypersensitivity to articaine, amide-type local anesthetics, or the excipient sodium metabisulfite. Use is prohibited for individuals with uncontrolled severe hypertension, unstable angina pectoris, or a recent myocardial infarction, due to the Epinephrine component. Patients with congenital methemoglobinemia or severe bronchial asthma (linked to sulfite) must also avoid this medicine.

Age Group Eligibility Status
Children under 4 years Contraindicated (Safety not established)
Children 4 years and older Eligible (Under standard conditions)
Older Adults (Geriatric) Conditional Use (Caution required)

Conditional Use also applies to patients with severe hepatic or renal impairment, as well as pregnant or breastfeeding individuals. Use during pregnancy is restricted to cases where the potential benefit justifies the potential risk, as documented in regulatory labeling.

What should I know about interactions with other medicines?

Ubistesin (containing articaine and epinephrine) can interact with a variety of other medications. Inform your healthcare professional about all medicines you are taking, including prescription, over-the-counter drugs, and herbal supplements.

Major Interactions (Risk of Severe Adverse Effects)

  • Tricyclic Antidepressants (e.g., imipramine, desipramine) and Monoamine Oxidase Inhibitors (MAOIs): Concurrent use with the epinephrine component can lead to a significant, prolonged increase in blood pressure (severe hypertension).
  • Non-selective Beta-Blockers (e.g., propranolol, nadolol): These can increase blood pressure due to the vasoconstrictive effect of epinephrine, potentially leading to a hypertensive crisis and bradycardia.
  • Volatile Inhalation Anesthetics (e.g., halothane, enflurane): These agents can sensitize the heart to catecholamines like epinephrine, increasing the risk of cardiac arrhythmias.

Moderate Interactions (Requires Caution and Monitoring)

  • Other Local Anesthetics and Sedatives (e.g., benzodiazepines, opioids): Concurrent use can increase the risk of systemic toxicity and Central Nervous System (CNS) depression.
  • Phenothiazines (antipsychotics): May reduce or reverse the pressor effect of epinephrine, potentially causing a drop in blood pressure.
  • Digitalis and Quinidine (for heart conditions): Used with epinephrine, these may increase the risk of developing cardiac arrhythmias.
  • Blood Thinners (e.g., anticoagulants, antiplatelet drugs): While not a direct drug-drug effect on the active ingredients, the risk of bleeding or hematoma formation at the injection site is increased.
  • Thyroid Hormones and COMT Inhibitors (for Parkinson's disease): Can intensify the effects of epinephrine, requiring cautious administration.

It is crucial to tell your dentist if you have taken sympathomimetic vasopressors (like cocaine, amphetamines, or decongestants) within the last 24 hours, as this may contraindicate the use of epinephrine-containing Ubistesin.

Mechanism of Action

Ubistesin is a fixed-dose combination product containing the amino-amide local anesthetic articaine and the sympathomimetic amine adrenaline (epinephrine).

Articaine functions as a sodium channel inhibitor. After local infiltration, the lipophilic, uncharged form of articaine diffuses across the neuronal membrane. Within the axoplasm, the molecule becomes protonated and binds reversibly to the alpha-subunit of voltage-gated sodium channels (Nav) from the intracellular aspect. This interaction stabilizes the channel in its inactivated state, which blocks the influx of Na^+ ions essential for generating and propagating an action potential. This blockade prevents the depolarization cascade along the nerve fiber.

Adrenaline acts as a non-selective agonist at alpha1- and alpha2-adrenergic receptors located on local vasculature. Agonism at these receptors triggers smooth muscle contraction, inducing vasoconstriction at the injection site. This vascular modulation reduces local blood flow, thereby limiting the rate of systemic absorption of articaine, which maintains a high concentration of the anesthetic at the targeted neural tissue and prolongs the localized sodium channel blockade.

Dosage and Administration Information

How to Use Ubistesin: Administration Guidelines

Ubistesin is a local anesthetic solution delivered exclusively via intraoral submucosal injection for locoregional anesthesia in the oral cavity, which encompasses both infiltration and nerve block techniques. The product is supplied as a sterile solution in single-dose dental cartridges containing 40 mg/mL Articaine with either 1:200,000 or 1:100,000 Epinephrine.

The dosing principle requires the use of the smallest volume necessary to achieve effective anesthesia for the specific acute procedure. The maximum dose for adults and children aged four years and older is restricted to 7 mg/kg of Articaine HCl per procedure. A lower dose range is recommended for older adults, acutely ill, or debilitated patients.

Procedural Administration

Use of the medication is confined to a single treatment session and does not involve long-term or cyclic regimens. The selection between the two available strengths is based on procedural needs: the 1:100,000 concentration is utilized when pronounced hemostasis (localized bleeding control) is required.

Specific technical instructions govern proper administration:

  • Aspiration: Aspiration control must be performed before and during the injection process to help avoid accidental intravascular delivery.
  • Injection Rate: The solution must be administered slowly, ensuring the injection rate does not exceed 0.5 mL every 15 seconds, which is approximately one cartridge per minute.

Standardized protocols define the limits for drug exposure and the rate of delivery, standardizing the application of the local anesthetic.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Ubistesin

Evidence for Use in Routine Dental Procedures

Research exploring the use of articaine with epinephrine combinations, such as Ubistesin, often takes the form of short-term randomized controlled trials (RCTs) and systematic reviews. These studies examined how perceived discomfort changes during common dental procedures like fillings and simple extractions. Researchers measured the time until the onset of anesthesia and the duration of the anesthetic effect. Findings were mixed across studies when evaluating the duration of the anesthetic effect. Regarding the scope of the evidence, there is limited information for long-term outcomes, as follow-up durations were primarily restricted to the time spent in the dental office.

Evidence for Use in Complex/Challenging Dental Procedures

The medicine was evaluated in studies concerning complex dental procedures, such as treating a tooth with irreversible inflammation of the pulp (pulpitis). These trials monitored outcomes related to episodic changes in sensation and measured the success rate of various nerve-blocking techniques in challenging situations. Studies describe patterns in the success rates for achieving pulpal anesthesia in inflamed tissue. The results from trials comparing this medicine to standard therapies in these particularly difficult conditions remain uncertain, and results apply only to the specific populations studied.

Evidence in Special Populations

Research has explored the use of this anesthetic combination in specific patient subgroups, including children (typically aged four and older). These pediatric studies monitored physiological strain and patient-reported outcomes describing discomfort. Furthermore, the combination was studied for use in patients with certain controlled systemic diseases to monitor physiological parameters, such as heart rate and blood pressure, during the procedure. Data for pregnant or breastfeeding populations remain limited.

What Is Still Uncertain About Ubistesin

Studies conducted typically focus on research exploring short-term symptom changes during and immediately after the procedure, resulting in limited information for long-term outcomes. Additionally, comparative evidence is lacking in some areas, and sample sizes were modest in some of the subgroup analyses. Subgroup findings are uncertain for certain medically compromised patients, such as frail older adults, as the results apply only to the populations studied.

Frequently Asked Questions (FAQ)

Common questions about Ubistesin (FAQ)

Q: How quickly does Ubistesin start working after injection?

A: Studies and official information indicate that the numbing effect can begin very rapidly. While the medication typically reaches its peak concentration in the blood around 25 minutes after injection, anesthesia onset is reported in some trials as fast as 1 to 3 minutes after administration.

Q: How long does the numbing effect of Ubistesin usually last?

A: The duration of the numbing effect can vary based on the injection technique and concentration used. According to the official product information, the duration of soft tissue anesthesia is generally longer, but the time an operation can be performed is typically up to 75 minutes when using the stronger concentration (1:100,000 epinephrine).

Q: Is Ubistesin the same as lidocaine or Novocaine?

A: No, Ubistesin is not the same as lidocaine or Novocaine. Ubistesin contains the local anesthetic articaine, which is a different chemical compound from lidocaine and procaine (Novocaine is a brand name for procaine). Articaine is classified as an amide-type anesthetic.

Q: Can I drink alcohol shortly after a dental procedure involving Ubistesin?

A: Regulatory documents flag a moderate interaction between alcohol and articaine/epinephrine. Combining them may increase the risk of central nervous system (CNS) effects. Patients should discuss alcohol use after a procedure with their dental professional, as official warnings advise caution.

Q: Are there any common over-the-counter medicines that interact with Ubistesin?

A: Official labeling warns against combining the epinephrine component in Ubistesin with certain drugs that raise blood pressure or heart rate. Common over-the-counter decongestants or large amounts of caffeine are examples of sympathomimetic agents that are noted as agents that may potentially intensify the effects of epinephrine, requiring patient caution.

Q: Is Ubistesin safe during pregnancy or while breastfeeding?

A: Pregnancy: Official labeling advises that Ubistesin should only be used when the potential benefit to the mother justifies the potential risk to the fetus, as human data are limited. Breastfeeding: Official data indicates the amount excreted into breastmilk is predicted to be low, suggesting adverse effects on the infant following a single dose are not expected.

Q: What's the difference between Ubistesin and articaine-based anesthetics?

A: Ubistesin is a combination product containing articaine and epinephrine, and it is available in two concentrations. The stronger concentration (1:100,000 epinephrine) is used when the dentist needs pronounced hemostasis, which means better localized bleeding control at the site of injection.

Q: Is a metallic taste in the mouth normal right after getting Ubistesin?

A: While not a common side effect, official adverse event reports list an unusual or unpleasant taste as a rare side effect associated with the drug. Any unusual sensation experienced should be reported to the dental professional.

Q: Can I drive right after a dental appointment where I got Ubistesin?

A: Official product information notes that certain side effects, such as dizziness, headache, or drowsiness (sleepiness), have been reported. Official product information notes these effects may temporarily affect the ability to drive or operate machinery, requiring caution.

Q: Does Ubistesin wear off faster in some people than others?

A: Yes, official labeling indicates that the maximum dosage must be individualized based on patient factors such as their physical status and size. This suggests that the response to the drug, including how quickly it wears off, can vary from person to person.

Q: Is Ubistesin used for procedures other than dentistry?

A: According to the official product information, Ubistesin is primarily indicated for local, infiltrative, or conductive anesthesia in dental procedures in the oral cavity. Its intended scope of use is restricted to this setting in regulatory documents.

Q: Why is my jaw or cheek sore the day after receiving Ubistesin?

A: Post-procedure soreness in the jaw or cheek can be related to several documented side effects. Oral pain and swelling are listed as common reactions, while trismus (a condition causing difficulty opening the mouth) is a rare reaction, all of which may cause tenderness the day following the injection.

Q: How common are allergic reactions to Ubistesin?

A: While anaphylaxis (a severe, life-threatening allergic reaction) is listed as a rare, serious adverse event, studies indicate that true allergies to the articaine component itself are exceedingly rare. Many suspected reactions are often attributed to effects from the epinephrine component or the preservatives.

Q: Will Ubistesin make me feel sleepy or tired?

A: Official adverse reaction reports indicate that sleepiness (unusual drowsiness) is reported as a less common side effect. This is related to the potential for the local anesthetic to cause Central Nervous System (CNS) effects.

Q: Is it normal for my injection site to bruise after using Ubistesin?

A: Although not listed as a common effect, bruising is reported as a rare side effect in regulatory documents. Bruising or hematoma (a localized collection of blood) can occur due to the injection process itself.

Q: Does Ubistesin have any long-term side effects?

A: Ubistesin is used for acute procedures, and follow-up in most studies is short-term. However, persistent adverse reactions, such as prolonged paresthesia (numbness or tingling) of the lips or tongue, have been reported in regulatory documents, with slow or incomplete recovery in rare cases.

Q: Is Ubistesin used in minor surgery or stitches outside the mouth?

A: Official regulatory documents indicate that the product is intended for local anesthesia in dental procedures. Therefore, its specified scope of use is limited to the oral cavity, and it is not typically indicated for use in other minor surgeries or stitches outside of this area.

Q: Are there any documented cases of Ubistesin affecting mood?

A: Yes, regulatory documents list adverse reactions that can affect mood. Anxiety and nervousness are reported as uncommon adverse reactions due to the potential systemic effects of the epinephrine component.

Q: Does Ubistesin have an age limit for use?

A: Official labeling states that Ubistesin is contraindicated and should not be used in children under 4 years of age. There is no upper age limit, but a lower dosage may be required for older or debilitated patients.

Q: Can I have coffee or caffeine before getting Ubistesin?

A: Regulatory warnings advise caution when combining the epinephrine component of Ubistesin with agents that increase sympathetic effects, such as caffeine. Since caffeine can also increase blood pressure and heart rate, using them together may enhance these effects.

Q: How is Ubistesin stored by the dental office?

A: Official storage guidelines require Ubistesin to be kept below 25 C (room temperature), protected from light, and not frozen. Dental offices are instructed to keep the cartridges in the outer carton to maintain stability until they are used.

How should Ubistesin be stored and disposed of?

Storage and Disposal Requirements for Ubistesin

Ubistesin (articaine hydrochloride with adrenaline/epinephrine injection) must be stored under specific regulatory conditions to maintain its sterility and stability.

Storage Conditions

The product must be stored below 25°C and protected from light. It is essential not to freeze the solution. The cartridges should be kept in the outer carton to protect them from environmental degradation. For safety, the medicine must be kept in a secure location out of the sight and reach of children.

Handling and Disposal

Ubistesin is a single-use product. Any unused portion of the solution must be discarded immediately, and the cartridge must not be used in other patients. Do not use the solution if it appears discolored or cloudy. Disposal of the unused product and the container must be carried out in accordance with local, provincial, or federal regulations for pharmaceutical waste.

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

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