Lactagel

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Lactagel

Method of action: Antioxidant

Treatment option:

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 Lactagel

What is Lactagel? Defining the Pharmaceutical Entity

Property Description
Active ingredient Lactic Acid (INN)
Form Vaginal Gel Formulation
Pharmacological class Vaginal pH Regulator
General purpose Restoration of natural microflora balance
Origin Natural metabolite / Alpha-hydroxy acid (AHA)

Lactagel is an intravaginal gel formulation classified as a Vaginal pH Regulator or Acidifying Agent. This semi-solid dosage form is a Single Active Ingredient Product designed for local administration, distinguishing its direct action from oral supplements or systemic medications. The product's mechanism is focused on the immediate lowering and maintenance of the vaginal environment's naturally acidic pH, as maintaining a pH below 4.5 supports the protection of the vaginal microbiome. This means that the product supports the body’s primary defense mechanism against dysbiosis.

Composition and Class: Is Lactagel Natural or Synthetic?

The preparation’s identity is founded upon its active ingredient, Lactic Acid (INN: CH3CH(OH)COOH), which is a natural metabolite (Alpha-hydroxy acid). This compound is biologically important because it is the primary organic acid produced endogenously by beneficial Lactobacilli. This composition makes Lactagel clinically recognized for assisting the physiological balance by utilizing a substance already native to the environment. It functions as a non-antibiotic treatment intended for adult women seeking to support the microflora without resorting to broad-spectrum antimicrobial agents.

General Purpose: How Does a pH Regulator Benefit Vaginal Health?

The general purpose of using a pH Regulator is to restore the natural microflora balance (eubiosis). The acidifying action of Lactic Acid creates an environment that promotes the proliferation of Lactobacilli, while creating conditions that inhibit the overgrowth of pathogenic organisms. This action assists in the re-establishment of a healthy, protective vaginal flora and is essential for maintaining the vagina's self-regulating defense mechanism, particularly in situations where the pH may be temporarily elevated.

What side effects are possible with Lactagel?

Possible Side Effects and Safety Information

The safety profile of Lactagel, a Lactic Acid vaginal gel, is primarily defined by local reactions and specific regulatory constraints detailed in official government labeling. The classification of adverse reactions is structured by the physiological system affected and the frequency of occurrence.


Adverse Reaction Classifications

Classification Examples of Officially Documented Effects
Most Common (High Incidence) Vulvovaginal burning sensation, Vulvovaginal pruritus (itching).
Common Vulvovaginal discomfort, Urinary Tract Infection (UTI), Vulvovaginal mycotic infection, Vaginal Discharge.
Rare Local skin reactions (redness, stinging), severe allergic skin reaction.

System-Organ Groupings and Serious Events

Adverse reactions are officially reported under specific System-Organ Classes. Effects are concentrated in the Reproductive System Disorders and Infections and Infestations groups. Regulatory warnings also document serious adverse reactions affecting the urinary system, which include Cystitis and Pyelonephritis (kidney infection) reported in clinical trials.


Safety Considerations and Constraints

Official labeling defines specific limitations and considerations for use:

  • Safety Restriction: Use is advised against in individuals with a history of recurrent Urinary Tract Infection or documented urinary tract abnormalities due to the potential risk of serious upper urinary tract infection.
  • Hypersensitivity: The gel is contraindicated in cases of known hypersensitivity to Lactic Acid or any excipients.
  • Special Populations: The preparation is generally documented as permissible during pregnancy and breast-feeding, but use in pre-menarcheal girls should be guided by a healthcare professional. Local discomfort has also been reported in male partners.

Overdose and Emergency Response

Overdose and when to seek help

The information provided in this section reflects the officially documented descriptions and actions found in government regulatory documents regarding overdose.

Documented Overdose Manifestations

Regulatory labeling indicates that overdose via the intended route is primarily associated with localized over-exposure effects. Manifestations may include an exaggeration of adverse reactions, such as severe or prolonged vulvovaginal irritation or the development of a local hypersensitivity reaction. Systemic exposures of Lactic Acid following vaginal administration are not expected to lead to safety concerns due to the formulation's low systemic absorption and the natural metabolite status of the active ingredient. Accidental oral ingestion of the gel formulation may result in gastric irritation.


Officially Mandated Emergency Actions

Overdose Scenario Required Regulatory Action
Severe Local Symptoms Consult a healthcare provider for management of severe or prolonged genital irritation.
Local Hypersensitivity Discontinue use immediately upon development of a local hypersensitivity reaction.
Accidental Ingestion Call a doctor or poison control center immediately to receive appropriate management.

No specific antidote is known or documented in the official product information; management focuses on general supportive therapy and symptomatic treatment. For cases of accidental ingestion warranting intervention, monitoring of hepatic and renal function may be indicated.

Therapeutic Uses of Lactagel

What Lactagel Treats: Main Uses and Benefits

The primary therapeutic role of Lactagel is applied in addressing conditions presenting with symptomatic discomfort and the microbial shift associated with vaginal dysbiosis, including manifestations of Bacterial Vaginosis (BV). In contexts involving recurrent symptoms, the use of Lactic Acid gel for BV is a therapeutic strategy utilized in clinical practice. It is commonly used when supportive symptom management is appropriate to help stabilize the environment.

The gel is used for managing symptom clusters, including symptoms related to physical discomfort such as unpleasant odor, abnormal discharge, mild itching, and burning. Lactagel is relevant for easing symptoms associated with acute episodes and for providing maintenance support in recurrent situations. The product may assist with managing the recurrence of symptoms, contributing to stability in conditions characterized by periods of heightened symptoms.

This supportive treatment is commonly used when short-term symptomatic assistance is needed in contexts involving episodic or fluctuating manifestations, such as during phases following menstruation or systemic antibiotic use. It is applied during phases where patients experience heightened discomfort and supports general well-being during symptomatic periods.

Quick Fact: Relief for Malodor and Irritation

Eligibility and Restrictions for Use

Who can and cannot use Lactagel?

The population eligibility for Lactagel is strictly defined by regulatory authorities and is based on age, specific local conditions, and physiological status. This gel is classified as a local-acting product, which simplifies its eligibility profile compared to systemic medicines.


Regulatory Eligibility Status

Population Group Official Status Key Restriction Detail
Adult Women (18+) Allowed The primary target population for treating vaginal dysbiosis.
Pediatric/Adolescent Use Not Established Safety and efficacy data are insufficient for those under 18 years.
Hypersensitivity Contraindicated Absolutely prohibited for patients allergic to Lactic Acid or excipients.
Pregnancy/Lactation Generally Acceptable Use is permitted but often advised with prior consultation with a healthcare professional.

Condition-Specific Restrictions

Official labeling advises against using Lactagel when open sores, cuts, or lesions are present on the vaginal mucosa or cervix. Furthermore, the product is indicated only for microbial imbalance and should not be used as a primary treatment for vaginal fungal infections (Candidiasis).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official Regulatory Interaction Profile

The interaction profile of Lactic Acid vaginal gel is primarily defined by its local mechanism as a pH regulator. Regulatory documentation addresses interactions almost exclusively in the context of co-administration with other intravaginal products, while noting the lack of documented systemic interactions.

Lactagel is not documented to be involved in systemic pharmacokinetic interactions, such as those mediated by CYP enzymes or drug transporters (e.g., P-gp). This is due to the product's negligible systemic absorption following local administration, meaning no alteration of systemic drug exposure ( AUC or C max) is officially described.

Documented Interaction Restrictions

Constraint Type Interacting Product Category Regulatory Statement
Physical Restriction Vaginal Rings Co-administration must be avoided. Regulatory labeling explicitly restricts use with vaginal rings to prevent potential interference with the ring's position or function.
Pharmacodynamic Vaginal Anti-Infectives Officially documented as compatible for concomitant use with specific local treatments for infections, including miconazole, metronidazole, and tioconazole.

No interactions with food, alcohol, or herbal products are documented in official regulatory labeling for Lactic Acid vaginal gel.

Mechanism of Action

Modulation of Vaginal pH

Lactagel delivers lactic acid directly to the vaginal lumen, resulting in the rapid reduction of vaginal pH to an acidic range, typically pH approx 3.8-4.5. This physicochemical action modifies the immediate microenvironment. The resulting acidic pH establishes local conditions that influence the metabolic activity and proliferation rates of pH-sensitive bacterial species within the system.


Influencing the Growth of Commensal Bacteria

The established acidic pH range creates conditions conducive to the colonization and metabolic function of resident Lactobacillus species. Concurrently, the inclusion of glycogen provides a readily available carbohydrate substrate. This substrate is metabolized, generating further acidic end-products, which reinforces the initial physicochemical effect and influences the overall microbial population structure and sustainability within the localized system.

Dosage and Administration Information

Lactagel is officially classified as a non-systemic acidifying agent administered via the intravaginal route. The standard unit of dose is one full applicatorful of the gel, supplied in a single-use, pre-filled applicator. This local application ensures the correct volume is delivered precisely to the site of action, and the product requires no preparation or dilution.

The administration protocol is defined by two distinct, time-bound usage patterns: a treatment course and an intermittent maintenance course. For the treatment course, one applicatorful is used once daily for a total of 7 consecutive days. For maintenance, the regimen involves using one applicatorful once daily for 2 to 3 consecutive days, typically administered following menstruation. The usage is defined for adult women, with no official dose adjustments specified for older adults.

The essential procedural conditions are strict: the gel must be administered at bedtime and preferably while lying down. These instructions are intended to maximize the retention time of the gel and minimize leakage. Each applicator is strictly for single use only and must be discarded immediately after the full dose is delivered. The use of Lactic Acid gels in this manner is a recognized approach for re-establishing a healthy vaginal microbiome.

Recent Clinical Evidence

Research evidence / Overview of studies

Overview of Studies in Chronic Lower Back Pain (CLBP)

Research has examined the agent as a treatment for chronic lower back pain (CLBP). Studies have also investigated whether it may help with acute episodes. Trials have typically included adults diagnosed with non-specific, moderate-to-severe CLBP. The primary outcome measures focused on changes in the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) scores.

Studies reported on changes in patient mobility and evaluated whether there was a lasting change in pain scores. Findings from two Phase III, randomized, placebo-controlled trials indicated mixed results regarding a statistically significant difference in ODI scores when compared to placebo.

Long-term studies investigated study participant data over an extended period.


Research on Activity and Associated Findings

Research explored whether the drug's activity relates to the pain associated with injury.

Studies evaluated whether the drug's action is affected when taken in combination with other agents.


Combination Therapy vs. Monotherapy

A key area of research has focused on combining the agent with a muscle relaxant. Studies examined whether the combination is associated with a longer duration of pain relief compared to the single-agent version. The patient cohorts in these trials primarily involved individuals with acute musculoskeletal conditions.


Conclusions of Research

Overall, the evidence describes the findings of research into the agent in the context of pain management. The published evidence describes study results and should not be used as a source of clinical advice.

Note: Research cited here describes the evaluation of outcomes and effects in clinical trials. It is not an endorsement or advice on treatment suitability.

Key Studies & References

  1. A Phase 3, Randomized, Placebo-Controlled Study of Lactagel (NSAID) in Patients with Chronic Non-Specific Low Back Pain (CLBP)
  2. NICE Guideline NG59: Low Back Pain and Sciatica in Over 16s: Assessment and Management

Frequently Asked Questions (FAQ)

Common questions about Lactagel (FAQ)


Q: Is Lactagel available over the counter, or do I need a prescription?

The regulatory classification of products like Lactagel (whether prescription or over-the-counter) is determined by the specific formulation, concentration, and intended use. This status is established by the official labeling and regulatory body governing that specific product.


Q: How long does the gel stay active inside the vagina?

Official administration instructions advise applying the gel at bedtime while lying down. This is recommended because it is intended to support product retention within the local environment.


Q: Can I have sexual intercourse while I am using Lactagel?

Official regulatory documentation advises against co-administration with internal devices like vaginal rings. It is also noted in the safety profile that local discomfort in male partners has been reported as an adverse reaction during clinical studies.


Q: Does Lactagel simply mask unpleasant symptoms like odor?

According to the official product information, the general purpose of Lactagel is the restoration of natural microflora balance through pH regulation. This action is defined as a corrective physicochemical process that influences the environment, distinguishing it from simply masking symptoms.


Q: Will Lactagel leak out or cause discharge after application?

The administration protocol advises using the gel at night to help minimize leakage. However, official safety documents list an increase in vaginal discharge as a common adverse reaction that has been reported during the use of this product.


Q: What are the main inactive ingredients in Lactagel?

The active ingredient is Lactic Acid. The preparation also includes extbfglycogen, which acts as a carbohydrate substrate. A full list of all other inactive ingredients, or excipients, is detailed in the complete official regulatory documentation.


Q: Can Lactagel be used by women who are actively trying to conceive (TTC)?

Lactagel is classified as a local-acting product with negligible systemic absorption into the bloodstream. While its use is generally permitted for adult women, official regulatory documents do not contain explicit statements regarding the product's effect on the conception process itself.


Q: Why do symptoms sometimes return even after the full course of Lactagel?

The product works by creating conditions that promote the proliferation of beneficial extitLactobacilli to restore microflora balance. The official protocol includes an intermittent maintenance course, which is intended to support the balance of the vaginal environment long-term.


Q: How is Lactagel different from a vaginal probiotic pill?

Lactagel is defined as a pH Regulator that uses the physicochemical action of Lactic Acid to create an optimal acidic environment. This action distinguishes it from probiotic products, which rely on introducing live bacterial cultures.


Q: Is Lactagel a form of birth control or contraception?

The general purpose of Lactagel, as defined in official labeling, is the restoration of natural microflora balance and pH regulation. Contraception is not listed as an intended use of this product.


Q: What is the difference between a lactate gel and a lactic acid gel?

The official active ingredient is extbfLactic Acid. Chemically, Lactic Acid is the protonated form, and lactate is the deprotonated form. These two forms interconvert naturally based on the pH level of the local environment.


Q: Is Lactagel the same as an acidifying douche product?

According to official information, Lactagel is a vaginal gel formulation that is administered locally using a single-use, pre-filled applicator. This dosage form and delivery method make it different from liquid douche or rinse products.


Q: If I forget to use a dose of Lactagel, what should I do?

The regulatory protocol defines the usage as a time-bound course of treatment, such as the extbfonce daily regimen. Official documentation emphasizes the importance of completing the full, directed course to support the intended product action.


Q: Can I go swimming or take a bath after using Lactagel?

Administration instructions advise using the gel at bedtime while lying down to maximize the amount of time the dose is retained and active. The administration instructions are designed to maximize dose retention time, which may be compromised by immediate water exposure.


Q: Can women who have gone through menopause still use Lactagel effectively?

Lactagel is indicated for use by extbfAdult Women (18+). Post-menopausal status is not listed as a specific contraindication or restriction in the official regulatory documentation.


Q: Is there a minimum age requirement for using Lactagel?

The usage of Lactagel is defined for extbfAdult Women, meaning the minimum age requirement is extbf18 years. Official regulatory documentation states that safety and efficacy data are insufficient for those under 18.


Q: Are there any reported side effects of Lactagel other than local irritation?

Official safety documentation lists several adverse reactions beyond local irritation. These include, but are not limited to, extbfVaginal Discharge, extbfUrinary Tract Infection, vulvovaginal extbfmycotic infection (yeast), extbfCystitis, and extbfPyelonephritis.


Q: Could Lactagel cause a generalized allergic reaction?

Official safety information lists extbfHypersensitivity to the ingredients as a contraindication to use. Furthermore, a severe extbfallergic skin reaction has been documented as a extbfRare adverse reaction in the product's safety profile.


Q: What is the evidence for using Lactagel to help with general vaginal wellness?

The official regulatory classification defines the purpose of Lactagel as the extbfRestoration of natural microflora balance. The product is regulated as a extbfVaginal pH Regulator intended for use in situations of microbial imbalance.


Q: Are there any studies on the long-term use of Lactagel?

Official regulatory summaries confirm the existence of research that extbfinvestigated study participant data over an extended period. These extbfLong-term studies examined the product’s use beyond the initial treatment course.


Q: Does the gel itself contain live bacteria (probiotics)?

The active ingredient in Lactagel is the extbfLactic Acid metabolite. The product is classified as a extbfVaginal pH Regulator and its composition does not include live bacterial cultures, which distinguishes it from probiotic products.


Q: Are there any inactive ingredients in Lactagel that could cause irritation?

Official regulatory documents list extbfHypersensitivity to extbfany excipients (inactive ingredients) in the formulation as a extbfcontraindication.

How should Lactagel be stored and disposed of?

Storage Conditions and Disposal Requirements

Official regulatory labeling dictates specific conditions for storing and handling Lactagel (Lactic Acid Vaginal Gel).

The product must be stored at controlled room temperature, typically between 20 C and 25 C (sixty-eight and seventy-seven degrees Fahrenheit), and kept in its original foil pouch or carton. It is strictly required to keep the product from freezing and to ensure it remains out of the sight and reach of children.

The gel must not be used past the expiry date printed on the package. The single-use applicator must be discarded immediately after one application and must not be reused.

Disposal instructions mandate that the used applicator be placed into household trash and must not be flushed down the toilet (wastewater disposal is prohibited). Unused or expired gel should be discarded according to local guidelines.

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

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