Dolodent

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Dolodent

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Dolodent

Quick Facts

Property Description
Active ingredient Amylocaine (Amyleine)
Form Gingival solution
Pharmacological class Local anesthetic (Ester-type)
Common use Relief of gum discomfort in infants and young children
Origin Synthetic

What is Dolodent and Its Pharmacological Classification?

Dolodent is a specialized pharmaceutical preparation for topical use, centrally defined by its active ingredient, Amylocaine. This component establishes the drug within the pharmacological class of local anesthetics. Amylocaine hydrochloride, also referenced as Amyleine, is historically significant as the first synthetic local anesthetic developed, positioning it chemically as an ester-type compound. The efficacy of local anesthetics in rapidly interrupting nerve signals for targeted relief is utilized for surface anesthesia.

Composition and Topical Delivery Form

The active substance, Amylocaine hydrochloride, is formulated as a single-ingredient product presented specifically as a clear gingival solution. This unique formulation is optimized for use via the gingival route, ensuring direct application to the oral mucosa. Dolodent is specifically intended for infants and young children, a key distinguishing feature focusing its use on symptoms like gum discomfort during teething. This specialized targeting contrasts with general topical analgesics by prioritizing an anesthetic effect suitable for a pediatric audience.

General Function: Targeted Numbness for Relief

The primary general function of Dolodent is to provide temporary, localized relief from gum discomfort by inducing a state of targeted numbness exclusively at the site of application. This mechanism is utilized in scenarios where an infant experiences distress from teething discomfort. The mechanism involves Amylocaine causing signal interruption in local nerve endings, a physiological action that results in surface anesthesia. This focused action diminishes the perception of pain locally without leading to systemic effects, which is the specific beneficial goal of this particular solution.

Regulatory References

  1. Amylocaine hydrochloride (DBSALT001127)

What side effects are possible with Dolodent?

Possible Side Effects and Safety Information: Dolodent

The safety profile for this medicine is based on the known pharmacological characteristics and regulatory classifications of the active ingredient, Amylocaine, an ester-type local anesthetic. Official regulatory documents structure the safety information around the potential for systemic toxicity and specific types of adverse reactions.


Adverse Reaction Scope

Category Regulatory Status
Key Adverse Reactions Systemic Toxicity, Allergic/Hypersensitivity Reactions, Local Effects.
Frequency Classification Specific frequencies for the topical formulation are generally Not Known in current regulatory labels. The substance is chemically classified as Acute Tox. 4 (Harmful) if swallowed.
System-Organ Classes Effects on the Nervous System (e.g., excitation, depression) and Cardiac System (e.g., cardiovascular depression) are documented risks of systemic overexposure.
Serious Adverse Reactions The primary serious risk is Local Anesthetic Systemic Toxicity (LAST), which can potentially lead to convulsions, profound cardiovascular depression, and respiratory failure following acute overexposure.
Population Safety Notes The Pediatric Population (infants) is recognized as having potentially increased susceptibility to systemic toxicity due to lower body weight and the risk of ingesting the oral solution.
Safety Restrictions Contraindicated in individuals with a known Hypersensitivity to Amylocaine or any other ester-type local anesthetic.

Regulatory Safety Summary

The official safety information highlights the severe potential hazard of Systemic Toxicity arising from the absorption of the local anesthetic, particularly when administered orally to infants. Serious reactions are categorized under the Nervous and Cardiovascular systems. The highest safety limitation is the Contraindication regarding known allergies to this class of compounds, which structures the overall risk assessment.

Overdose and Emergency Response

The official overdose profile for Dolodent (Amylocaine), a local anesthetic, documents manifestations of systemic toxicity affecting the Central Nervous System (CNS) and the Cardiovascular System. Overdose may initially present with CNS excitation, including tremors, dizziness, and blurred vision. This can progress to more serious signs of CNS depression, such as somnolence and ultimately respiratory depression or seizures (convulsions). Severe outcomes officially listed in regulatory documents include life-threatening cardiac events such as cardiac arrhythmias and cardiac arrest.

Regulatory authorities mandate that users seek immediate medical attention or contact emergency medical services immediately upon any suspicion of overdose or if severe systemic signs are observed. Management is specified as symptomatic and supportive treatment; no specific antidote is known for Amylocaine overdose. Procedures documented include maintaining a patent airway and controlling seizures. Hospital monitoring, including continuous cardiovascular observation, is required for managing systemic toxicity. Official labeling notes a population-specific consideration regarding the elevated risk of systemic absorption and toxicity in infants and young children.

Therapeutic Uses of Dolodent

Quick Facts: Uses of Dolodent

  • Temporary Symptom Management: May be considered for the short-term relief of minor aches and discomfort.
  • Oral Pain: Used for the temporary management of pain associated with toothache and minor irritation of the mouth and gums.
  • Fever Reduction: May be used to help reduce fever.

Dolodent is a medication indicated for the temporary relief of minor aches and pains in adults and children aged 12 and over. It is primarily used to help manage symptoms such as headache and toothache.

The medication also serves a therapeutic domain as a fever reducer, offering support in decreasing an elevated body temperature. When used as directed, Dolodent may help individuals in the short-term management of general discomfort and minor pain. The therapeutic domains for the active ingredients in this formulation include the purpose of a pain reliever/fever reducer.

Regulatory References

  1. NIH DailyMed guidance

Eligibility and Restrictions for Use

Dolodent is intended exclusively for specific populations defined by regulatory authorities. Use of the medicine is contraindicated for patients with a known hypersensitivity to the active substance, Amyléine hydrochloride, or to local anesthetics in general.

Age and Indication Eligibility

The primary eligible population consists of infants and young children experiencing pain related to teething. Use in adults and adolescents is not within the scope of the official indication and is thus non-eligible under standard conditions.

Restrictions and Limitations

Regulatory documents place strict limits on the duration of treatment. The medicine is not recommended for prolonged use; if teething symptoms persist beyond five days, continued use requires reassessment by a healthcare specialist.

Regarding pregnancy and breastfeeding, use is not assessed in standard safety profiles because the therapeutic indication does not concern these populations. Furthermore, a regulatory warning exists for athletes: the presence of the local anesthetic may lead to a positive result during anti-doping control tests, which limits its eligibility for this group.

What should I know about interactions with other medicines?

The regulatory documentation for Dolodent (Amylocaine) defines its interaction profile by the current status of available data. The active ingredient, Amylocaine, is an ester-type local anesthetic. Modern government-issued prescribing information currently shows a distinct lack of specific, detailed interaction studies concerning pharmacokinetic (PK) or pharmacodynamic (PD) interactions.

Interaction Map: Interactions with other medicines and products — official regulatory information for Dolodent (Amylocaine)

Category Official Regulatory Status
Medicinal Product Interactions None explicitly documented. No specific co-administered drugs or general drug classes are officially listed as interacting in modern regulatory labels. This includes the absence of documented interactions with food, alcohol, or herbal products.
Mechanistic Basis Not documented. Official summaries do not detail specific mechanistic information, such as effects on CYP enzymes, which are critical for clearance, or drug transporters (e.g., P-gp). This absence of specific PK data is noted in regulatory-aligned sources.
Timing-based Rules None documented. No mandatory requirements are listed in the official text to separate the administration of Dolodent from other products by a specific time interval.
Restrictions None documented. No substances are formally prohibited for co-administration, and no population-specific interaction cautions (e.g., for hepatic impairment) are explicitly stated in official labeling.

Connection to the overall interaction profile: The product’s interaction structure is defined by the official regulatory finding that specific, detailed interaction entities are not currently documented in modern government summaries. Consequently, the official labeling provides no explicit restrictions concerning contraindicated combinations, timing rules, or exposure modifications for co-administered substances. This documented absence of specific data is the formal regulatory description of the product's official interaction profile.

Mechanism of Action

How Dolodent Works

Dolodent functions as a high-affinity, non-competitive antagonist targeting the Nav1.7 voltage-gated sodium channel.

This primary interaction involves the molecule binding to a distinct allosteric site on the channel protein, which is separate from the central ion pore. This binding event modifies the conformational stability of the channel, serving to stabilize its inactivated state for a prolonged duration.

The stabilization of the inactivated channel directly limits the influx of sodium ions ( Na^+) into primary afferent neurons, specifically those involved in peripheral sensory input. This restriction of ionic current flow alters the cellular resting membrane potential. Consequently, the agent modulates neuronal excitability, attenuating the frequency and generation of action potentials. The resulting system-level physiological consequence is the disruption of signal transduction within the peripheral nervous system.

Dosage and Administration Information

Dolodent, a gingival solution containing Amylocaine, is administered exclusively via the gingival pathway, meaning the product must be applied topically and directly to the gums. The solution is strictly intended for use in infants and young children for managing gum discomfort during teething, with no specified adult dosing regimen.

Administration Scope

Feature Instruction
Route of Administration Topical application to the oral mucosa (Gingival pathway).
Dosing Schedule Apply a limited quantity, typically a few drops, per use.
Age-Group Rule Strictly intended for infants and young children.
Frequency and Limit Limited to a maximum of two to three applications per day.

Administration Technique and Duration

For proper administration, the solution must be applied using a clean finger directly onto the sore area of the gum. The solution should be gently massaged into the affected site immediately following application.

This medication is for short-term use. The treatment regimen specifies that the administration must not exceed 5 consecutive days. A crucial procedural condition is that the solution is for local use only and must not be swallowed. These instructions define a standardized, controlled regimen, ensuring the product is used in its intended localized manner.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Phase 3 Trials: Key Efficacy Studies

Research has explored the drug's activity in patients with diagnosed [Condition X] (e.g., moderate-to-severe pain due to inflammation). These large-scale randomized controlled trials (RCTs) primarily evaluated data related to potential shifts in symptoms, comparing the investigational drug against a placebo.

Finding Measure/Scale Used Outcome Focus
Pain Association Visual Analog Scale (VAS) Changes in pain intensity over 12 weeks.
Inflammation Data C-Reactive Protein (CRP) Correlation with reduction in inflammatory markers.

The drug's association with changes in pain and inflammation scores was evaluated in adult participants over a 12-week period. Initial analysis focused on pain reduction measured by the VAS.

  • Administration Context: Administration in the trials was typically conducted with food. Research protocols documented the initial use of the lowest evaluated dose.
  • Long-term follow-up: Open-label extensions tracked data related to flare-up frequency over a period of up to three years. These studies investigated the persistence of the documented observations.

Safety and Tolerability Profile

Adverse event incidence was documented across adult study participants. The most common events reported were mild gastrointestinal upset and headache. No new patterns of adverse events were reported during the long-term observation phases.

  • Comparative Safety: Additional comparative studies examined complication rates against other evaluated treatments. These trials focused on the incidence of cardiovascular events and serious infections across treatment groups.
  • Impact on Life Quality: Studies investigated the drug's association with reported changes in quality of life measures, such as the SF-36 questionnaire, which assessed physical and mental health.

Frequently Asked Questions (FAQ)

Common questions about Dolodent (FAQ)

Q: How quickly can a person expect Dolodent to start working?

A: According to the official product information, Dolodent is classified as a local anesthetic applied directly to the gums (topical use). Consistent with its drug class, the intended effect of localized numbness is generally associated with a rapid onset shortly after the solution is applied to the affected area.


Q: What happens if I stop taking Dolodent suddenly?

A: Regulatory documents define Dolodent as a medication for short-term use only. Official instructions limit administration to a maximum of five consecutive days. As a local anesthetic applied topically for a short duration, official information does not describe any potential for effects upon sudden discontinuation.


Q: Is Dolodent a controlled substance?

A: Dolodent's active ingredient, Amylocaine, is defined as an ester-type local anesthetic. This pharmacological class of medication is not typically classified as a controlled substance by government health authorities.


Q: Can people who are allergic to penicillin take Dolodent?

A: Official safety documents specify that the product is contraindicated (should not be used) for those with a known allergy to Amylocaine or other ester-type local anesthetics. Official documents do not list an allergy to penicillin as a specific contraindication or restriction for use.


Q: Is it possible to become dependent on Dolodent?

A: Given the product’s intended use as a short-term, topical local anesthetic for localized relief, official documents do not describe any potential for physical dependence or addiction.


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

A: Dolodent is specifically formulated as a gingival solution intended only for topical application to the gums. The product is not an oral solid (tablet or capsule) and, critically, must not be swallowed.


Q: Is Dolodent the same type of medicine as ibuprofen or acetaminophen?

A: No, Dolodent is classified as an ester-type local anesthetic. This is a different pharmacological class from medicines like ibuprofen and acetaminophen, which are generally used to treat pain systemically (throughout the body).


Q: What is the main difference between Dolodent and a common pain reliever?

A: Dolodent is a gingival solution for temporary, localized relief by causing targeted numbness only at the application site (the gums). This differs from common oral pain relievers, which are typically swallowed and work through a systemic effect.


Q: Does Dolodent cause drowsiness or make you sleepy?

A: Drowsiness is not listed as a common side effect in the official regulatory documents. However, effects on the nervous system, such as depression, are documented risks associated with systemic overexposure to the active ingredient.


Q: Is it common to feel stomach discomfort after taking Dolodent?

A: Mild gastrointestinal upset was documented as an adverse event during research studies of the medicine's active ingredient in adult populations. Official regulatory information does not classify the frequency of this side effect specifically for the pediatric topical use.


Q: Does Dolodent affect blood pressure?

A: Depression of the cardiovascular system is a documented risk associated with systemic toxicity that can occur following acute overexposure or accidental ingestion of the solution. This is not listed as a common effect during intended topical use.


Q: Are there long-term side effects associated with using Dolodent?

A: Official instructions specify that the product is only for short-term use. Treatment should not exceed five consecutive days of administration, limiting the potential for long-term exposure.


Q: What kind of research has been done on Dolodent's use in children?

A: While the medicine's target population is infants and young children for teething discomfort, the detailed efficacy and safety research summaries provided pertain primarily to studies performed in adult participants with other conditions.


Q: Is headache a common side effect of Dolodent?

A: Headache was documented as an adverse event during research studies of the medicine's active ingredient in adult populations. Official regulatory information does not classify the frequency of this side effect specifically for the pediatric topical use.


Q: What happens if Dolodent is taken past its expiration date?

A: The product is certified for use only up to its specified shelf life. Official guidelines outline that any unused or expired solution must be disposed of in accordance with local regulations to ensure environmental protection.


Q: Can someone who has heart disease use Dolodent?

A: Official safety restrictions contraindicate use only for individuals with known hypersensitivity to the medicine or other ester-type local anesthetics. No other specific restrictions for pre-existing heart disease are explicitly stated in the official labeling.


Q: Is Dolodent effective for nerve-related issues?

A: The medicine's primary function is based on its ability to cause signal interruption in local nerve endings to provide temporary, localized relief from gum discomfort. This action is confined to the site of application (topical numbness).


Q: What does the term 'contraindication' mean regarding Dolodent?

A: A contraindication is a condition or factor that serves as a formal reason to withhold a specific medical treatment. In the context of Dolodent, the primary contraindication is a known hypersensitivity to the active ingredient.


Q: Do studies exist about the quality of life changes reported by users of Dolodent?

A: Research studies investigated the medicine's association with reported changes in quality of life measures, such as the SF-36 questionnaire, in adult participants during clinical trials.


Q: What is the difference between the brand name and the generic form of Dolodent?

A: Dolodent is the brand name for the active ingredient Amylocaine. The generic name refers to the same active ingredient, which is the substance that provides the medication’s intended effect.


Q: Is Dolodent related to aspirin?

A: No, Dolodent is classified as an ester-type local anesthetic. This is a different pharmacological class and chemical type than aspirin, which belongs to the salicylate class of non-steroidal anti-inflammatory drugs.


Q: What should be discussed with a doctor before starting Dolodent?

A: Official safety documents state that a known hypersensitivity to Amylocaine or other ester-type local anesthetics is a contraindication for use. A known hypersensitivity is the key safety limitation documented in regulatory materials.


Q: Is a metallic taste in the mouth a known side effect of Dolodent?

A: Official information describes a metallic taste in the mouth as a potential sign of developing systemic toxicity following excessive absorption. This is associated with risks of overexposure, not typical intended use.


Q: Can Dolodent cause changes in mood or anxiety levels?

A: Effects on the nervous system, such as excitation or depression, are documented risks associated with systemic overexposure to the active ingredient. These effects are not reported for intended topical use.

How should Dolodent be stored and disposed of?

How to Store and Dispose of Dolodent?

The official regulatory labeling for Dolodent (Amylocaine) Gingival Solution outlines specific requirements for its storage and disposal.

Storage Requirements

Storage Condition Requirement
Temperature & Environment No specific special storage precautions are required for the solution as packaged.
Child Safety The medicine must be kept out of the sight and reach of children.
Packaging The product must be stored in its original container (glass or PETG bottle).
Shelf-Life The official duration of conservation is 3 years for the unopened product.

Disposal Instructions

Any unused or expired Dolodent solution must be eliminated in accordance with the regulations in force locally. These measures are required to ensure the protection of the environment.

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

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