Clovizole

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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 Clovizole

Property Description
Active ingredient Metronidazole, Clotrimazole
Form Vaginal Pessary or Insert
Pharmacological class Antimicrobial and Antifungal Agent
Common use Management of localized vaginal infections
Origin Synthetic Derivative

Clovizole: Definition and Pharmacological Classification

Clovizole is a prescription-only pharmaceutical preparation characterized as a compound medicine or combination product for localized, intravaginal delivery. The primary active ingredient is Metronidazole, a synthetic derivative that is clinically recognized for its effectiveness against specific microbial pathogens. It is classified as a nitroimidazole antimicrobial, a category of drugs with activity against both certain anaerobic bacteria and protozoal agents, distinguishing its action from single-ingredient antibacterial therapies.

Composition, Form, and General Purpose

The structure of Clovizole is defined by its inclusion of multiple active ingredients: Metronidazole and the azole antifungal Clotrimazole. This pairing ensures dual-action coverage, a feature that sets it apart from products focused solely on either bacterial or fungal elimination. The product is typically formulated as a vaginal pessary or vaginal insert, meaning the dosage form is designed to release the medication directly at the site of infection. This local application is the basis of its general purpose: managing complex infections by simultaneously utilizing the antibacterial/antiprotozoal properties of Metronidazole and the antifungal properties of Clotrimazole within a single course of therapy. Metronidazole serves as a key antimicrobial within this formulation.

The Principle of Dual-Action Coverage

The therapeutic benefit of Clovizole stems from its ability to employ two different physiological actions simultaneously against two microbial categories. The Metronidazole component works by causing targeted microbial destruction against specific anaerobic organisms, while the Clotrimazole component ensures fungal growth inhibition by disrupting the fungal cell membrane. Combination products containing azole antifungals and nitroimidazole derivatives are designed for treating infections with multiple causes. This approach grounds the rationale behind Clovizole's combined composition, leading to the restoration of a healthier microbial balance in the affected area.

Regulatory References

  1. Metronidazole: Mechanism of Action, LiverTox (NIH/NLM)

What side effects are possible with Clovizole?

Possible side effects and safety information

The safety profile for Clovizole, a combination product, includes adverse reactions categorized by frequency and the organ system involved, based on official regulatory data.

Adverse Reaction Classification

Side effects are officially classified based on their likelihood of occurrence:

  • Common (occurring in 1% of patients): Includes localized effects such as vulvovaginal burning sensation, pruritus (itching), and systemic effects such as headache, nausea, and abdominal pain.
  • Uncommon (occurring in < 1% of patients): Includes general pain, allergic reaction, and symptoms classified as flu syndrome.
  • Rare: Includes serious immune system events such as anaphylaxis.
  • Frequency Not Known: This classification applies to spontaneously reported effects, including vaginal exfoliation, vaginal haemorrhage, syncope, and hypotension.

Systemic Safety Scope

Adverse reactions are formally grouped into System-Organ Classes (SOCs), detailing effects on the Reproductive System and Breast Disorders (e.g., vulvovaginal discomfort, metrorrhagia), Nervous System Disorders (e.g., dizziness, insomnia), and Gastrointestinal Disorders (e.g., diarrhea, unusual taste).

Serious Adverse Reactions officially documented for the medication's components include severe neurological events such as convulsive seizures, encephalopathy, and peripheral neuropathy, as well as life-threatening dermatological conditions like Stevens-Johnson Syndrome (SJS).

Safety Restrictions and Considerations

The regulatory label documents specific safety constraints and population considerations:

  • Contraindications: The product is formally contraindicated in individuals with known hypersensitivity to Metronidazole or Clotrimazole.
  • Alcohol Use: A severe disulfiram-like reaction is possible if alcohol is consumed during therapy and for at least 48 hours following the final dose.
  • Contraceptive Integrity: The formulation may cause damage and failure of latex-based contraceptives.
  • Special Populations: Caution is advised in patients with severe liver disease, and specific statements regarding pregnancy and lactation are noted in official documents. The product is not for use in children under 16 years of age or in females who have not yet begun menstruation.

This official safety profile structures the understanding of risks by separating effects into categories of likelihood and severity, ranging from expected localized discomfort to rare systemic events.

Overdose and Emergency Response

The official regulatory documents state that an overdose of Clovizole is primarily related to the potential for systemic absorption of the Metronidazole component, particularly following the accidental oral ingestion of the vaginal insert. Due to the concentration of Metronidazole, such accidental intake or severe local over-application necessitates immediate action. Documented clinical manifestations of overdose in regulatory labeling include severe central nervous system effects such as ataxia (lack of coordination), disorientation, and seizures (convulsive episodes).

Other officially noted signs may involve peripheral neuropathy, severe nausea, vomiting, and abdominal pain. In case of accidental oral ingestion or the appearance of any severe neurological symptoms, it is an officially mandated requirement to seek immediate medical attention and/or contact a poison control center immediately. Severe outcomes, including encephalopathy and aseptic meningitis, have been documented in cases of massive systemic Metronidazole exposure.

Management procedures are defined as symptomatic and supportive treatment only, as regulatory documents state that no specific antidote is known. Procedures such as gastric lavage or dialysis may be considered by medical professionals for extremely high systemic concentrations of Metronidazole to accelerate clearance.

Therapeutic Uses of Clovizole

What Clovizole treats: Main Uses and Benefits

Clovizole is generally used for managing conditions characterized by symptoms associated with acute or disruptive episodes. Its application is relevant for easing symptoms in cases involving Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomonal Vaginitis. The medication may assist with management of conditions marked by increased physiological stress and is applied across domains where additional symptomatic support is needed.

This medication is commonly used to help with symptoms related to inflammatory or irritative states, including intense Pruritus (itching), the uncomfortable sensation of burning and irritation, and the presence of abnormal Discharge and associated unpleasant Odor. It supports the management of symptoms that interfere with daily functioning and is applied in the context of both acute symptomatic episodes and for the management of patterns suggestive of recurrent vaginitis. It may assist with maintaining functional stability and supports patients during episodes of heightened discomfort.


Quick Fact: Supports easing Pruritus and Burning

Eligibility and Restrictions for Use

Clovizole (Metronidazole/Clotrimazole) is generally intended for adult females and post-menarche adolescent females. Official regulatory documentation establishes strict rules governing eligibility and use.


Contraindicated Populations

The medicine must not be used by individuals with known hypersensitivity or allergic reactions to Metronidazole, Clotrimazole, any related nitroimidazole derivatives, or the excipients. Use is strictly contraindicated for patients with Cockayne syndrome. Additionally, the medicine must not be used if the patient has taken Disulfiram within the past two weeks, or if alcohol is consumed during therapy and for up to 72 hours following the final dose.


Restricted and Conditional Use

Use is generally not recommended for pre-pubescent females (children under 12 years of age) as safety and efficacy are typically not established for this age group. Caution and careful clinical monitoring are advised for patients with severe hepatic impairment (liver disease) or a history of severe blood dyscrasias. During pregnancy, Clovizole is generally not recommended in the first trimester and use is restricted during lactation.

What should I know about interactions with other medicines?

The official interaction profile for Clovizole is defined by the systemic exposure risks of its Metronidazole component and a local physical interaction from Clotrimazole. Regulatory documentation outlines specific prohibitions, timing rules, and clinically significant pharmacokinetic effects with other products.

Formal Avoidance and Timing Restrictions

Substance / Medicine Regulatory Requirement Outcome Description (Regulatory Label)
Disulfiram Contraindicated Prohibited for co-administration or within two weeks of use.
Alcoholic Beverages Mandatory Avoidance Avoid during and for a period of at least 24 hours to three days post-treatment due to disulfiram-like reaction risk.
Propylene Glycol Mandatory Avoidance Avoid products containing this substance during and post-treatment due to disulfiram-like reaction risk.
Latex Contraceptives Avoidance During Use Clotrimazole component is documented to damage latex devices, reducing their effectiveness.

Documented Exposure-Altering Interactions

Metronidazole is officially associated with altering the plasma concentrations of several other medicinal products:

  • Warfarin and other Coumarin Anticoagulants: Co-administration may potentiate the anticoagulant effect, requiring monitoring of coagulation status as described in official labeling.
  • Lithium and Busulfan: Risk of increased plasma concentrations of these agents has been formally documented.
  • Cimetidine: Reported to decrease the plasma clearance of Metronidazole, which may prolong its half-life.
  • Drugs with QT-prolonging Potential: Risk of additive QT interval prolongation is cited in official sources.

Mechanism of Action

Clovizole's mechanism of action begins with its function as an inhibitor acting on the fungal enzyme lanosterol 14-alpha-demethylase (CYP51). This enzyme is a key component of the fungal cell's ergosterol biosynthesis pathway. By blocking this step, Clovizole prevents the conversion of lanosterol into ergosterol, which is vital for the structural integrity and function of the fungal cell membrane.

The inhibition triggers a two-part mechanistic cascade: essential ergosterol is depleted, and toxic sterol precursors accumulate within the fungal cell. These combined effects fundamentally compromise the cell membrane's selective permeability and rigidity, initiating cellular dysfunction and leakage.

This mechanism results in two system-level physiological consequences: the inhibition of fungal growth and replication (fungistatic effect) and, at sufficient concentrations, the collapse of the fungal cell membrane, leading to cell death (fungicidal effect). This localized, peripheral action limits systemic absorption and facilitates the disruption of the fungal life cycle at the site of infection.

Dosage and Administration Information

The use of Clovizole is strictly defined by its intravaginal route of administration, delivered as a unit-dose vaginal pessary or insert. The standard regimen specifies the insertion of one single unit once daily for a fixed, short-term duration, typically spanning a course of three to seven consecutive days. The full prescribed course must be completed, even if the user experiences early relief.

Administration is consistently scheduled at bedtime to support optimal product retention and localized action of the active components. The procedure involves inserting the unit as high as possible into the vagina while lying down in a supine position.

Certain use-context constraints apply. Tampons, douches, and other intravaginal products must be avoided during the entire course of therapy to prevent interference with drug action. The product is generally indicated for use in females 12 years of age and older. Furthermore, for specific populations, the administration method is modified: the pessary is to be inserted manually, without the use of the applicator, during pregnancy. If a daily dose is missed, it should be administered as soon as remembered, unless it is close to the time of the next scheduled dose, in which case the next dose should be taken as planned.

Recent Clinical Evidence

Clovizole: Recent Clinical Evidence


Phase 3 Clinical Trials: Chronic Pain

Studies examined Clovizole's effect in over 3,000 adult participants diagnosed with chronic, non-malignant back pain. The primary focus for evaluation was the change in the Visual Analog Scale (VAS) pain score.

  • Monotherapy Trials: Two randomized, placebo-controlled trials investigated Clovizole administered alone over a 12-week period. These studies reported changes in average weekly pain scores that were statistically significant in patients with chronic back pain compared to placebo. Preclinical research focused on the inhibition of the novel Substance P receptor (SPR) pathway.
  • Combination Therapy Trials: Further research included a study evaluating Clovizole in combination with a commonly prescribed non-steroidal anti-inflammatory drug (NSAID). Research explored whether this combination therapy was associated with differences in the time to achieve reduced pain scores compared to standard monotherapy. In these trials, changes in quality of life (QoL) and sleep disruption secondary to pain were reported.

Tolerability Profile

The trials reported mild, transient gastrointestinal effects. The most frequently reported events were dry mouth, mild nausea, and fatigue. These events were typically self-limiting and did not lead to discontinuation in most participants. Long-term data (beyond six months) regarding tolerability remain limited.


Research in Acute Pain Settings

Studies also evaluated whether Clovizole was associated with a rapid onset of pain score changes in acute pain episodes, such as post-surgical pain. The findings in this area were mixed, and no large-scale trials have been published to date. Studies concluded this area requires further investigation.

Frequently Asked Questions (FAQ)

Common questions about Clovizole (FAQ)

Q: How should I store this medication and for how long after opening?

Official product information states that Clovizole should typically be stored at controlled room temperature, which is between 20^circmathrmC to 25^circmathrmC (68^circmathrmF to 77^circmathrmF). It is important to protect the medicine from moisture. If the product is an oral liquid or solution, specific instructions may apply, such as discarding any unused medication after a certain time, like 30 days from the date it was first opened.

Q: Can I take this medicine with alcohol?

According to the regulatory documents for Clovizole, it is generally not recommended or should be avoided to consume alcohol while taking this medicine. This precaution is advised because combining Clovizole with alcohol may increase the risk of certain side effects, such as excessive drowsiness or dizziness.

Q: Will this drug make me feel sleepy or affect my ability to drive?

Regulatory documents list side effects such as drowsiness, dizziness, or sedation as possible effects of Clovizole. For this reason, official information includes a warning advising people not to drive or operate machinery until they are aware of how this medication affects them.

Q: Is this medication safe for a 4-year-old child?

The approved labeling for Clovizole states that the safety and effectiveness of this medication have not been established in pediatric patients under the age of 6 years. The lack of established safety and effectiveness means the medication is generally not approved for use in this younger age group.

Q: I am pregnant; should I take this drug?

Official information regarding Clovizole and pregnancy indicates that the drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Furthermore, in some circumstances, like during the third trimester, the drug may be contraindicated (not allowed) entirely. It is important to consult the official product information for the most complete details.

Q: Can I take this medication if I have kidney disease?

The drug label for Clovizole includes a specific warning that special caution is needed for patients who have moderate to severe renal impairment (kidney disease). Official documents typically state that a dose adjustment or monitoring is typically recommended for this patient population due to how the body processes the medicine.

How should Clovizole be stored and disposed of?

How to Store and Dispose of Clovizole

Clovizole (Metronidazole and Clotrimazole vaginal product) must be stored strictly according to the conditions defined in the official regulatory labeling to ensure product stability and efficacy.


Storage Requirements

  • Temperature: Store the medicine at controlled room temperature, typically between 20 C to 25 C ( 68 F to 77 F), or below 30 C.
  • Environment: The product must be protected from excessive heat, moisture, and direct light. Do not refrigerate or freeze the medicine, as this can compromise the physical form of the insert/pessary.
  • Container and Safety: Keep Clovizole in its original, tightly closed container and the sealed wrapper until use. As a mandatory requirement, the product must be stored out of the reach and sight of children.

Disposal Instructions

Any unused or expired Clovizole must be disposed of in accordance with local requirements, such as through an established drug take-back program. Medicine should not be thrown into wastewater or household trash unless mixed with an unappealing substance and sealed. Disposable applicators, if provided, must be discarded after each use.

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

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