Valeris

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Valeris

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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 Valeris

Valeris is a prescription-only fixed-dose combination (FDC) preparation containing two distinct synthetic active pharmaceutical ingredients: Clindamycin Phosphate and Clotrimazole. The core purpose of this dual-action agent is to deliver comprehensive microbial control by addressing both susceptible bacteria and fungi simultaneously via localized administration.

Property Description
Active Ingredients Clindamycin Phosphate, Clotrimazole
Form Topical Vaginal Preparation (e.g., Softgel Capsule, Cream)
Pharmacological Class Combination Antibiotic-Antifungal Agent
Common Use Management of local infectious conditions involving bacteria and fungi
Origin Synthetic

What Type of Medicine is Valeris?

Valeris is classified as a dual-action anti-infective within the pharmacological class of combination antibiotic-antifungal agents. The antibiotic component, Clindamycin, is a lincosamide derivative with activity against certain anaerobic bacteria. The antifungal component, Clotrimazole, belongs to the imidazole class of medications, which acts to suppress the growth of fungi such as yeasts. This fixed combination is a strategically differentiated product designed to provide a comprehensive treatment approach in local infectious conditions where both bacterial and fungal microbial overgrowth are contributing factors.

Composition and Pharmaceutical Form

The medicine's composition features the two active ingredients, Clindamycin Phosphate and Clotrimazole, suspended in a specialized base for local delivery. Its distinctive feature is its formulation as a topical/local preparation, commonly available as a vaginal softgel capsule or cream. The design prioritizes direct application to the area of concern, which ensures high local concentrations of both active components are achieved. This targeted, local route of administration minimizes the systemic absorption of the drugs, concentrating the product’s therapeutic effect precisely at the intended site.

What side effects are possible with Valeris?

Possible side effects and safety information

The safety profile for this medicine is based on adverse reactions and safety statements documented in official regulatory labeling for the combination of Clindamycin Phosphate and Clotrimazole.

Adverse reactions are classified by their frequency and the physiological system affected.

Documented Adverse Reactions

The most frequently reported adverse reactions observed in clinical data are generally related to local effects and the antibiotic component. Reactions officially documented as Common (typically ge 2%) in regulatory documents include fungal vaginosis (e.g., vaginal candidiasis), headache, back pain, constipation, and urinary tract infection.

Less common reactions documented in the official labeling involve gastrointestinal effects, such as diarrhea and vomiting, and nervous system effects, such as dizziness.

System-Organ Class Documented Reactions (Examples)
Infections and Infestations Fungal vaginosis, urinary tract infection
Nervous System Disorders Headache, dizziness
Gastrointestinal Disorders Constipation, diarrhea, vomiting
Reproductive System Disorders Vulvovaginal irritation, pelvic pain

Serious Safety Considerations

The official safety information includes high-level warnings concerning the potential for systemic absorption of the clindamycin component. The most serious risk documented is the possibility of Clostridioides difficile-Associated Diarrhea (CDAD), which can lead to Pseudomembranous Colitis. This risk is specified to have a potential delayed onset, occurring even after treatment is finished.

Formal restrictions apply to individuals with a known history of hypersensitivity to lincosamides or those with a history of certain bowel diseases, such as regional enteritis or antibiotic-associated colitis. Additionally, components of the formulation may weaken latex or rubber contraceptive devices.

Overdose and Emergency Response

Overdose and When to Seek Help

The information below outlines the officially documented manifestations and required emergency actions for Valeris (Clindamycin Phosphate and Clotrimazole), based strictly on government regulatory sources.

Overdose Scope

Category Official Regulatory Statement
Documented overdose presentations Gastrointestinal symptoms including nausea, vomiting, diarrhea, and severe abdominal pain following systemic exposure or oral ingestion.
Physiological systems affected (as stated in label) Primarily the Gastrointestinal tract and the neuromuscular system ( Clindamycin); potential for transient effects on the hepatic system ( Clotrimazole).
Dose-related or exposure-related factors (if applicable) Systemic overdose is considered unlikely with the intended topical application due to minimal absorption; the primary documented risk is associated with accidental oral ingestion.
Emergency-response statements Overdose management is officially defined as symptomatic and supportive treatment; no specific antidote is known for the active ingredients.

When Immediate Medical Help is Required

Regulatory documents mandate specific actions related to overdose:

  • Seek Immediate Medical Attention: This is required for any known or suspected accidental oral ingestion of the topical product.
  • Severe Manifestations: Urgent consultation is required if severe symptoms develop, such as signs of systemic toxicity, profuse diarrhea, or evidence of reversible neuromuscular blockade, which is a documented potential outcome of Clindamycin overdose.

Overdose procedures for oral ingestion may include supportive measures such as gastric lavage or administration of activated charcoal, as directed by medical personnel. Hospital monitoring may be required for patients presenting with severe clinical manifestations or following the ingestion of a large dose.


Therapeutic Uses of Valeris

What Valeris Treats: Main Uses and Benefits

Comprehensive Management of Mixed Vaginosis

Valeris is relevant for managing infective vaginosis when the clinical assessment suggests the presence of both susceptible bacteria and fungi, such as Candida species. This combination therapy is applied across therapeutic domains involving conditions where multiple symptoms occur together. The medicine is applied in contexts marked by increased discomfort. This dual-action approach may be part of symptomatic management that contributes to easing the overall symptom load associated with conditions like Bacterial Vaginosis and Vulvovaginal Candidiasis.

“This medication is applied in scenarios where additional management of discomfort is required due to the combined presence of bacteria and fungi.”

Symptom Relief for Acute Episodes

The medication may assist with managing symptoms that interfere with daily functioning, particularly those related to inflammatory or irritative states. It helps address symptom clusters that may become intense or disruptive, including abnormal vaginal discharge, persistent foul odor, intense itching, and a burning sensation. Valeris supports the patient during difficult episodes by helping to ease distress and contributes to improved day-to-day comfort. This makes it relevant in clinical settings that involve acute or unstable symptom patterns, such as periods of heightened symptoms that lead to noticeable physiological strain.


Quick Fact: Relief for Vulvovaginal Discomfort The combination helps to ease the multiple, distressing manifestations of polymicrobial infection, and may assist with maintaining functional stability during the symptomatic period.

Eligibility and Restrictions for Use

Who Can and Cannot Use Valeris?

Official regulatory documentation establishes specific patient eligibility criteria for using Valeris (Clindamycin Phosphate / Clotrimazole). This medicine is generally intended for use in adult females (age 18 and older).

Absolute Contraindications (Must Not Use) The medicine is absolutely contraindicated and must not be used in the following populations, as stated in regulatory labeling:

  • Individuals with a known hypersensitivity or allergy to Clindamycin, Clotrimazole, Lincomycin, or any component of the formulation.
  • Patients with a history of specific gastrointestinal disorders, including regional enteritis, ulcerative colitis, or antibiotic-associated colitis.

Restricted or Not Established Use

Official documents define use restrictions for other groups:

  • Pediatric and Adolescent Females: The safety and efficacy of this fixed-dose combination have not been established in females under 18 years of age.
  • Pregnancy and Lactation: Use during the first trimester of pregnancy is generally not recommended. For the remainder of pregnancy or while breastfeeding, use is restricted to situations where it is clearly necessary.
  • Treatment Timing: Regulatory labeling indicates that treatment should be avoided or delayed until the menstrual period is completed.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Valeris documents several interactions, spanning pharmacodynamic, pharmacokinetic, and physical substance restrictions.

Contraindicated and Antagonistic Combinations

The fixed-dose combination is contraindicated for co-administration with two specific antibiotics: Erythromycin, due to a documented antagonist effect, and Lincomycin, due to the risk of cross-sensitization. The Clotrimazole component, when applied intravaginally, has been shown to depress the activity of Polyene Antifungal Agents, such as Amphotericin B, and its own effectiveness may be suppressed by Nystatin.

Pharmacokinetic and Exposure Modifiers

The Clindamycin component is primarily metabolized by CYP3A4 and CYP3A5 enzymes. Therefore, co-administration with strong CYP3A4 inhibitors may increase its systemic exposure, while CYP3A4 inducers may decrease it. Although systemic absorption is low from topical use, this interaction mechanism is formally documented. Furthermore, the official labeling notes that the Clindamycin component possesses neuromuscular blocking properties, which may enhance the action of other Neuromuscular Blocking Agents.

Mandatory Physical and Product Restrictions

Certain excipients in the formulation can deteriorate the reliability of products made from latex or rubber, including condoms and contraceptive diaphragms. Regulatory guidance restricts co-use of these barrier contraceptives. Additionally, the concurrent use of other vaginal products (such as tampons or douches) is not recommended, as it may interfere with the concentration or effective retention of the medicine at the application site. Regulatory documents also note that caution is required in patients with severe hepatic impairment.

Mechanism of Action

How Valeris Works

The mechanism of action for Valeris involves the simultaneous engagement of two distinct molecular pathways within susceptible bacteria and fungi. This action delivers two independent molecular interferences against both bacterial and fungal proliferation.


Inhibition of Bacterial Protein Synthesis

The antibiotic component, Clindamycin, binds directly to the bacterial 50S ribosomal subunit . This interaction prevents the function of the peptidyl transferase center, disrupting polypeptide chain elongation. By arresting the ability to produce essential proteins, the physiological effect is the cessation of proliferation within the localized bacterial population.


Structural Disruption of the Fungal Cell Membrane

The antifungal component, Clotrimazole, works by inhibiting the fungal enzyme Cytochrome P450 14alpha-demethylase. This blocks the conversion of lanosterol into ergosterol, the key structural sterol of fungal cell membranes. The resulting ergosterol deficiency and accumulation of toxic sterol intermediates compromises membrane integrity and permeability, leading to the inhibition of growth and functional failure in the local fungal population.


Mechanistic Dual Coverage

The combination targets two essential, independent microbial life processes, achieving simultaneous molecular interference across both bacterial ribosomes and fungal sterol pathways, providing dual-pathway modulation of the local microbial population.

Dosage and Administration Information

How to Use Valeris: Official Administration Guidelines

The administration of Valeris (Clindamycin 100 mg / Clotrimazole 200 mg FDC) is governed by specific procedural instructions, focusing strictly on local application and short-course duration. This fixed-dose combination is utilized for a limited time to deliver both active ingredients directly to the site of concern.


Official Usage Protocol

Category Administration Rule
Route of Administration The medicine is administered via the intravaginal route only.
Dosing Schedule The standard regimen is one vaginal unit (softgel capsule or suppository) containing Clindamycin 100 mg and Clotrimazole 200 mg.
Frequency and Timing The unit is inserted once daily, typically at bedtime, to promote local retention and minimize displacement.
Course Duration The standard duration of treatment is a short course, often three consecutive days, as specified in the product label.

Administration and Procedural Conditions

To ensure proper use, the unit must be inserted deeply into the vagina while the patient is in a lying position. An applicator is commonly provided and used to facilitate correct placement. If a dose is missed, it should be administered as soon as possible, and the once-daily schedule should then be resumed.

Certain administration constraints are noted: use is generally restricted to adults and post-menarche adolescents, and administration is not recommended during menstruation. Additionally, the formulation's excipients may affect the integrity of latex or rubber contraceptive products, and official instructions advise consideration of this constraint during the course of use.

Recent Clinical Evidence

Research evidence / Overview of Studies for Valeris

Valeris for Mixed Infective Vaginosis

Research examined the Valeris fixed-dose combination (Clindamycin and Clotrimazole) in the context of infective conditions involving both susceptible bacteria and fungi. The published research includes short-term clinical trials and observational studies that examined symptom patterns and microbiological status over defined time intervals. These studies were applied in research contexts focusing on outcomes related to physical discomfort and patient-reported measures of symptom change.

The data show patterns related to both clinical cure (absence of signs/symptoms) and microbiological clearance (absence of targeted organisms) were observed in these trials. Research reports measurements of changes observed during the study period, including shifts in the perceived intensity of symptoms. These findings contribute to understanding symptom patterns and how outcomes evolved in the observed populations.

Research Gaps and Limitations

Follow-up durations were limited across the majority of the existing research, meaning long-term effects and recurrence patterns are not fully established. The body of research identifies specific limitations, including that sample sizes were modest in many initial trials, and evidence quality varies across studies. The currently available evidence is derived from settings with varying symptom burdens, and the results apply only to the specific populations studied.

Comparative evidence regarding the combination product versus the single active ingredients used separately is not fully consistent across all available reports. Research provides context but not individual predictions, as findings describe group patterns, not personal outcomes. The evidence highlights what is known—and what is still uncertain.

Key Studies & References

  1. A Clinical Experience to Assess Safety and Efficacy of Fixed Dose Combination of Clindamycin and Clotrimazole in the Treatment of Patients With Mixed Bacterial and Fungal Vaginosis

Frequently Asked Questions (FAQ)

Common questions about Valeris (FAQ)

Q: What is Valeris used for?

Valeris is a prescription medication used to treat high blood pressure (hypertension) in adults. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

Q: How does Valeris work?

Valeris is an angiotensin II receptor blocker (ARB). It works by blocking the action of a natural substance that narrows blood vessels. This allows the blood vessels to relax and widen, which lowers blood pressure and improves blood flow.

Q: How should I take Valeris?

Valeris is taken by mouth, usually once daily, with or without food. You should follow the exact dosing instructions provided by your healthcare provider. It is important to continue taking this medication even if you feel well. Do not stop taking Valeris without talking to your doctor first.

Q: What should I do if I miss a dose of Valeris?

If you miss a dose, take it as soon as you remember. If it is close to the time of your next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses at the same time to make up for a missed dose.

Q: What are the common side effects of Valeris?

Common side effects may include:

  • Dizziness
  • Lightheadedness
  • Headache
  • Fatigue

If these effects persist or worsen, you should talk to your healthcare provider.

Q: Can Valeris be taken with other blood pressure medications?

Valeris may be taken with other blood pressure medications, as determined by your healthcare provider. However, Valeris should not be taken with medications that contain aliskiren if you have diabetes or moderate to severe kidney problems, as this combination can increase the risk of serious side effects.

Q: What are the symptoms of low blood pressure (hypotension) with Valeris?

Symptoms of low blood pressure (hypotension) can include:

  • Severe dizziness or lightheadedness
  • Fainting
  • Unusual weakness

Contact your healthcare provider if you experience symptoms of low blood pressure.

How should Valeris be stored and disposed of?

Official Storage and Handling

Valeris (Clindamycin Phosphate/Clotrimazole) must be stored at controlled room temperature, specifically 25 C (77 F), with excursions permitted between 15 C and 30 C (59 F and 86 F). The medicine must be protected from light, excess heat, and high humidity and kept in the original container, tightly closed. Official labeling mandates that the product must be kept out of the reach of children and explicitly states, “Do not freeze.” Expired or unused product must be discarded after its expiration date.

Disposal Requirements

If disposal instructions are not provided on the immediate packaging, the medicine should be disposed of via a medication take-back program. As an alternative, the product can be prepared for household trash by removing it from the original packaging, mixing it with an undesirable substance like coffee grounds or dirt, sealing the mixture in a bag, and discarding it. The product must not be flushed down the toilet unless directed otherwise by official regulatory guidance.

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

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