Opizole

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Medically reviewed

Laura Arias

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 Opizole

Quick Facts

Property Description
Active Ingredient Clotrimazole
Pharmacological Class Azole Antifungal
Primary Forms Topical Cream, Solution, Vaginal Tablet
General Purpose Combats Fungal and Yeast Infections
Origin Synthetic (Imidazole Derivative)

What Type of Medicine is Opizole and What is it Made Of?

Opizole is a recognized pharmaceutical preparation whose active component is clotrimazole, a compound definitively classified as an azole antifungal agent. This substance is a synthetic imidazole derivative and is commercially defined as a broad-spectrum antimycotic. The availability of Opizole typically focuses on forms suitable for dermal or mucosal application, with the topical cream being a distinguishing feature for ease of localized spread. The core composition of Opizole features clotrimazole, which may be present as the sole active entity or occasionally utilized within a fixed-dose combination alongside other agents, such as certain corticosteroids. The diverse forms dictate the administration route, which is strictly topical, vaginal, or oropharyngeal application, ensuring the active ingredient reaches the intended site of infection directly.

What is the General Purpose of this Broad-Spectrum Antimycotic?

The general purpose of Opizole is to combat and eliminate localized infections caused by various types of fungi and yeasts that affect the body's surface areas. Its clinical utility stems from its action against many problematic organisms. For instance, this medication is typically used in scenarios involving common skin or mucosal yeast overgrowth. The medication is fundamentally designed to reduce the presence and proliferation of these problematic microorganisms, offering a targeted pharmacological intervention against their growth. Its effectiveness is rooted in its primary antimycotic action, which operates by damaging the vital structural integrity of the fungal cell. By impairing the organism's ability to maintain its outer protective layer, Opizole helps to clear the infection at its source, which is the essential benefit derived from its use as an antifungal agent.

Regulatory References

  1. DailyMed/NIH
  2. WHO Essential Medicines List

What side effects are possible with Opizole?

Possible Side Effects and Safety Information

The safety profile for Opizole, a combination product containing an antifungal (Clotrimazole) and a high-potency topical corticosteroid (Betamethasone), is structured around local skin reactions and the systemic risks associated with corticosteroid absorption.

Common Adverse Reactions

Reactions reported at the application site include tingling, burning, itching, dryness, rash, and secondary infections. The most frequent adverse reaction observed in clinical trials is paraesthesia (a tingling or pricking sensation).

Serious and Clinically Significant Risks

Systemic absorption of the corticosteroid component may lead to Hypothalamic-Pituitary-Adrenal (HPA) axis suppression, which is a potentially reversible condition. Manifestations of Cushing’s syndrome, hyperglycemia (high blood sugar), and glucosuria have also been produced in some patients by systemic absorption.

Long-term use of topical corticosteroids has been associated with local adverse effects that may be irreversible, including skin atrophy (thinning), striae (stretch marks), and telangiectasia (visible small blood vessels).

Ophthalmologic Adverse Reactions

Topical corticosteroids may increase the risk of developing cataracts and glaucoma. Patients are advised to report any visual symptoms to a healthcare provider for potential referral to an ophthalmologist.

Safety Restrictions and Population Considerations

  • Pediatric Use: The use of this combination product is generally not recommended in patients under 17 years of age due to a greater risk of HPA axis suppression and other systemic toxicities, such as linear growth retardation. The use of the cream in the treatment of diaper dermatitis is not recommended.
  • Duration/Exposure: Risks of HPA axis suppression and local adverse reactions are augmented by prolonged use and application over large surface areas or under occlusive dressings (e.g., tight bandages).
  • Contraindications: The medicine is contraindicated in patients with known sensitivity to clotrimazole, betamethasone, other corticosteroids, or any other ingredient in the formulation.

Overdose and Emergency Response

Overdose and when to seek help

Opizole, which contains clotrimazole, exhibits minimal systemic absorption following its intended topical or vaginal use. Regulatory documents confirm that due to this pharmacokinetic profile, acute overdosage is considered unlikely and a life-threatening scenario would not be expected from routine application. The official overdose profile is focused entirely on cases of accidental oral ingestion of the formulation.

Should accidental swallowing occur, the documented clinical manifestations of overdose are specific, primarily including dizziness, nausea, and vomiting. Systemic exposure following topical administration is so low that serum concentrations are generally reported as below the limit of detection, reinforcing the low risk of systemic toxicity from typical use.

In the event of suspected overdose or accidental ingestion, government regulatory authorities mandate that immediate emergency medical assistance must be sought. Individuals are required to seek emergency medical attention or call the Poison Help line immediately.

Regarding medical management, regulatory information explicitly states that no specific antidote is known for clotrimazole overdose. Treatment is restricted to symptomatic and supportive measures. For accidental oral ingestion, procedural intervention such as gastric lavage may be considered, but only if clinical symptoms are clearly apparent and the airway can be adequately protected. The regulatory labels do not document specific enhanced overdose severity risks for special populations.

Therapeutic Uses of Opizole

What Opizole Treats: Main Uses and Benefits

Opizole is used across therapeutic domains where additional symptomatic support is needed for dermatological conditions and localized yeast overgrowth. This medication is applied in addressing various conditions presenting with symptomatic discomfort.

The medication is relevant for easing inflammatory and irritative states in common fungal infections, including Athlete's foot (Tinea Pedis), Ringworm (Tinea Corporis), and Jock itch (Tinea Cruris). For conditions involving Candida yeast, such as Vulvovaginal Candidiasis and Oropharyngeal Candidiasis, Opizole helps manage symptom clusters that may become intense or disruptive. It is relevant for easing redness, burning, soreness, and pronounced itching (pruritus).

Quick Fact: Relief for Itching and Burning

Use Case Symptom Focus General Benefit
Dermatomycoses Redness, scaling, irritation Supports functional stability during symptomatic periods
Candidiasis Pruritus, soreness, burning Contributes to improved comfort during periods of heightened symptoms

The application of Opizole contributes to supportive management. The medication offers symptomatic relief that helps patients cope more steadily with difficult episodes and supports improved day-to-day comfort. Opizole provides supportive relief when symptoms interfere with routine activities.

Regulatory References

  1. NIH DailyMed overview of Clotrimazole Cream

Eligibility and Restrictions for Use

Who Can and Cannot Use Opizole?

This section defines the official population eligibility for using Opizole (clotrimazole), based strictly on regulatory prescribing information.


Populations Prohibited from Use

Opizole is contraindicated and must not be used by individuals with a known hypersensitivity or allergy to the active ingredient, clotrimazole, or to any of the product's inactive components (excipients). This represents an absolute exclusion criterion noted in official labeling.


Age-Based and Conditional Restrictions

Use is generally established for adults and adolescents. However, eligibility is restricted in the following groups:

  • Pediatric Patients: Topical use is often not established or restricted for infants and children under 2 years of age. Vaginal formulations are generally not recommended for self-treatment in those under 16 years.
  • Systemic Symptoms: Regulatory labeling excludes self-treatment for patients presenting with signs of systemic illness, such as fever, abdominal pain, or abnormal bleeding, who require professional medical consultation.

Pregnancy and Lactation

Due to minimal systemic absorption, Opizole is generally permitted during pregnancy and lactation. However, use, especially during the first trimester of pregnancy, should only occur under the advice and supervision of a healthcare professional, moving the status from general use to conditional use.

What should I know about interactions with other medicines?

The official regulatory profile for Opizole interactions is highly specific due to the primarily non-systemic use of the drug. The documented interactions fall into two main categories: those that modify the exposure of certain systemic medicines and those that involve physical constraints with medical products.

Interaction Scope

Category Official Regulatory Documentation Summary
Medicinal product categories with documented interactions Systemic immunosuppressants; Topical antifungal agents; Products containing spermicides.
Specific interacting medicines (if explicitly listed) Oral Tacrolimus (FK506); Oral Sirolimus; Polyene Antibiotics.
Mechanistic basis of interactions (only if stated in label) Pharmacokinetic inhibition ( CYP3A4 inhibition); Pharmacodynamic antagonism; Physical material damage.

Resulting Interaction Structure

Official Interaction Statements:

  • Vaginal treatment is formally associated with an increase in the plasma concentration of co-administered oral Tacrolimus and oral Sirolimus. This is a pharmacokinetic interaction that is relevant to the vaginal dosage form.
  • Regulatory documents state that clotrimazole vaginal products cause physical damage to latex-based barrier contraceptives (condoms, diaphragms, cervical caps), which reduces their effectiveness.
  • Alternative, non-latex contraception must be used for at least five days after the completion of vaginal treatment, as specified in regulatory guidance.
  • Co-administration with certain topical Polyene Antibiotics (such as Nystatin) may result in a reduction of the antimycotic effect, an example of a pharmacodynamic interaction.
  • The use of tampons, intravaginal douches, or spermicides is restricted during the use of clotrimazole vaginal preparations.

Connection to the overall interaction profile:

The official drug label defines the interaction structure through specific exposure alterations for immunosuppressants and mandatory procedural constraints regarding physical devices. These statements, derived from governmental documents, establish the essential restrictions for co-administration of Opizole with other medicines or products.

Mechanism of Action

How Opizole Works

Opizole's mechanism centers on a direct and highly specific targeted intervention in the fungal cell's viability through two interconnected mechanistic domains.

️ Blocking the Fungal Sterol Production Line

The core action is the inhibition of the critical enzyme Lanosterol 14-alpha-demethylase (CYP51), an enzyme unique to the fungal organism. This block immediately stops the synthesis of ergosterol, the essential lipid needed to build the fungal cell membrane. This cascade results in the inhibition of the organism's continued growth and proliferation.


Compromising Cell Membrane Integrity and Function

By depleting ergosterol and causing the accumulation of toxic precursor molecules within the membrane structure, the drug fatally compromises the membrane's structural integrity. This physiological effect causes the cell wall to become leaky and rigid, leading to the efflux of vital intracellular components (such as potassium), which results in the inhibition of growth (fungistatic effect) and subsequent cell death (fungicidal effect). In certain fixed combinations, this action is complemented by a distinct mechanism which modulates inflammatory signaling pathways within host tissue.

Dosage and Administration Information

Opizole administration is strictly localized and depends on the infection site, utilizing three primary routes: Topical (Dermal), Intravaginal, and Oropharyngeal (Transmucosal) application. This approach ensures delivery aligns with the available dosage forms, which include creams, solutions, vaginal tablets/suppositories (e.g., 100 mg, 500 mg), and 10 mg lozenges.

Dosage is fixed and not subject to titration. The topical cream or solution is officially directed for use twice daily (morning and evening), and the course is typically maintained for two to four consecutive weeks for skin infections, depending on the specific condition. Intravaginal regimens involve once-daily dosing, preferably at bedtime, with treatment courses lasting one, three, or seven consecutive days, depending on the tablet or cream strength selected.

For oropharyngeal use, the 10 mg lozenge is administered up to five times daily for treatment. A critical procedural condition is that the lozenge must be slowly dissolved in the mouth without chewing or swallowing whole to ensure therapeutic levels are maintained at the mucosal site. Use in pediatric patients is governed by specific age restrictions; for instance, the topical product is authorized for children aged three years and older, typically following the same adult regimen. In all instances, official instructions mandate that the full, prescribed duration of therapy be completed regardless of symptom improvement, and avoidance of other vaginal products is required during intravaginal use.

Recent Clinical Evidence

Research evidence / Overview of Studies for Opizole

Research Context for Skin Fungal Infections (Dermatomycoses) Studies

The research structure for conditions like Athlete's foot (Tinea Pedis) and Ringworm (Tinea Corporis) was largely examined through short-term Randomized Controlled Trials (RCTs) and systematic reviews. These studies monitored outcomes linked to inflammatory or irritative states such as redness, scaling, and blistering, alongside laboratory measurements of fungal clearance, known as Mycological Cure. These studies focused primarily on adult and adolescent populations.

Findings describe patterns observed in the studies where the active ingredient's use was associated with higher measurements of fungal clearance and change in observed symptoms compared to the non-medicated cream used as a comparison. The evidence contributes to understanding symptom patterns related to common fungal organisms.

Research Context for Localized Yeast Infections (Candidiasis) Studies

The active ingredient was studied for its application in conditions associated with acute or disruptive episodes, such as localized yeast infections. Research primarily examined short-term RCTs, where various formulations was evaluated in women experiencing symptoms. Studies monitored patient-reported outcomes describing perceived discomfort, like burning and itching, alongside fungal clearance measurements.

Research reports that topical application was observed in some studies to have measured rates of fungal clearance. For conditions involving periods of heightened symptoms (severe or recurrent cases), trials explored the use of extended treatment course options.

Research on Durability and Long-Term Outcomes

Research explored how the active ingredient influences outcomes related to systemic or functional imbalance over time. This section summarizes what is documented regarding follow-up durations. Currently, follow-up durations were limited in the primary research base. This means that long-term effects are not fully established, particularly when looking at recurrence and relapse rates extending significantly beyond the typical six-month assessment period reported in the original studies.

Documented Research Gaps and Uncertainties

Research provides context but not individual predictions, and findings describe group patterns, not personal outcomes. This part synthesizes areas where the evidence base remains limited. For infections where symptoms may vary in intensity, data for certain groups remain insufficient, especially for patients who are immunocompromised. Additionally, for yeast infections, comparative evidence is lacking for the less common, non-albicans Candida strains.

Key Studies & References

  1. Label: CLOTRIMAZOLE cream (External and Vaginal Use) - DailyMed (FDA-Cited Regulatory Document)
  2. Clotrimazole - StatPearls (NCBI/NIH Clinical Review on Pharmacology and Use in Specific Populations)

Frequently Asked Questions (FAQ)

Common questions about Opizole (FAQ)

Q: What is Opizole and how does it work?

Opizole (omeprazole) belongs to a class of medicines called Proton Pump Inhibitors (PPIs). It works by reducing the amount of acid your stomach produces. This helps to relieve symptoms of acid reflux and allows the healing of ulcers in the stomach and food pipe (esophagus).


Q: What conditions is Opizole used to treat?

Opizole is used to treat several conditions related to excess stomach acid, including:

  • Gastroesophageal Reflux Disease (GERD): For treating symptoms like heartburn and acid regurgitation.
  • Erosive Esophagitis: Healing of damage to the esophagus caused by stomach acid.
  • Zollinger-Ellison Syndrome: A rare condition where the stomach produces too much acid.
  • Stomach and Duodenal Ulcers: Including those caused by H. pylori bacteria (usually given with antibiotics).
  • Prevention of Ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs).

Q: How should I take Opizole?

  • Take Opizole exactly as prescribed by your doctor.
  • It is generally recommended to take the capsule or tablet before a meal, usually in the morning.
  • Swallow the capsules or tablets whole with a glass of water. Do not chew or crush them, as this can affect how the medicine works.
  • If you are taking delayed-release capsules and have trouble swallowing, you may be able to open the capsule and mix the contents (granules) with a small amount of acidic liquid (like apple juice) and swallow immediately. Check with your doctor or pharmacist first.

Q: How long does it take for Opizole to start working?

You may start to feel relief from symptoms like heartburn within 2 to 3 days of starting Opizole. However, it may take up to 4 weeks for the full benefit and complete healing of conditions like ulcers to occur. It is important to continue taking the medication for the full course prescribed by your doctor, even if your symptoms improve quickly.


Q: What are the common side effects of Opizole?

The most common side effects are generally mild and may include:

  • Headache
  • Diarrhea or constipation
  • Stomach pain
  • Gas (flatulence)
  • Nausea or vomiting

These side effects often improve as your body adjusts to the medicine. If they persist or worsen, contact your healthcare provider.


Q: Can I stop taking Opizole when I feel better?

Do not stop taking Opizole without first talking to your doctor. Stopping the medication too soon, especially for conditions like ulcers or erosive esophagitis, may prevent complete healing or cause your symptoms to return.

Your doctor will decide when it is appropriate to stop treatment or change your dose. In some cases, prolonged use of PPIs like Opizole is necessary, but your doctor will regularly review your need for the medication.


Q: Does Opizole interact with other medications?

Yes, Opizole can interact with several other medications, which may change how they work or increase the risk of side effects. It is very important to tell your doctor and pharmacist about all prescription, non-prescription, and herbal supplements you are taking.

Examples of medications that may interact with Opizole include:

  • Clopidogrel (a blood thinner)
  • Certain antifungals (like ketoconazole)
  • HIV medications (like atazanavir, nelfinavir)
  • Methotrexate
  • Digoxin

Your doctor may need to adjust the dose of other medicines or monitor you closely.


Q: Is it safe to take Opizole during pregnancy or while breastfeeding?

If you are pregnant, planning to become pregnant, or breastfeeding, you should consult your doctor before taking Opizole. Your doctor will weigh the potential benefits against any possible risks to you or the baby. Opizole is generally used during pregnancy only if the potential benefit justifies the potential risk. Only use it as prescribed by a healthcare professional.


Q: Is there a risk of nutritional deficiencies with long-term use of Opizole?

Long-term use (typically over a year) of medications like Opizole may be associated with a slight increase in the risk of certain nutritional deficiencies, including:

  • Vitamin B12 deficiency
  • Magnesium deficiency

Your doctor may recommend periodic monitoring or supplements if you are on long-term treatment. Do not start taking supplements without talking to your doctor first.

How should Opizole be stored and disposed of?

How to Store and Dispose of Opizole (Clotrimazole)

Official regulatory documents define strict conditions for the storage and disposal of Opizole.

Storage Requirements

Temperature: Store this medicine at controlled room temperature, generally between 20 C and 25 C. It is mandatory to not freeze the product and to avoid excessive heat.

Protection: Keep the product in its original container and ensure the cap is tightly closed to protect it from moisture and direct light. The medicine must always be kept out of the reach of children.

Disposal Instructions

Dispose of unused or expired Opizole using an authorized drug take-back program. If a take-back program is unavailable, follow the official guidance for disposal in the household trash, which involves mixing the medicine with an undesirable substance, sealing it in a bag, and throwing it away. The medicine must not be flushed down a toilet or sink.

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

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