Omastin

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Medically reviewed

Rosario Oropesa

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 Omastin

Quick Facts

Property Description
Active ingredient Fluconazole (C₁₃H₁₂F₂N₆O)
Form Capsule, Tablet, Oral Suspension, Sterile Solution
Pharmacological class Systemic Antifungal Agent, Triazole Antifungal
Common use Combating fungal infections (Mycoses)
Origin Synthetic

What Type of Medicine is Omastin?

Omastin is a proprietary synthetic triazole antifungal agent, a type of medicine belonging to the broader systemic antifungal agent pharmacological class. Its identity is based solely on the active ingredient, Fluconazole, a compound recognized for its high oral absorption, which is key to treating infections throughout the body. This designation sets it apart from topical preparations, marking it as a required treatment for generalized or deep-seated mycoses. The manufacturer has specifically focused on offering forms, such as the powder for oral suspension, to accommodate diverse patient groups, including pediatric patients.

Composition and Physical Forms

The composition is defined by the single-ingredient product Fluconazole, and it is presented in several pharmaceutical preparations to ensure flexibility in the route of administration. Omastin is supplied as a capsule and tablet for oral intake, and as a sterile solution suitable for intravenous infusion. The simultaneous availability of both Oral and Intravenous forms provides healthcare professionals with necessary options for delivering the active compound consistently, especially when treating immunocompromised patients who require reliable systemic exposure.

Omastin's General Therapeutic Purpose

The fundamental therapeutic purpose of Omastin is to combat fungal organisms by exerting a targeted fungistatic activity. This effect is achieved because the drug acts as a selective inhibitor against a critical fungal enzyme, thereby disrupting the synthesis of ergosterol, an essential component of the fungal cell membrane. This action blocks the structural formation and growth of the pathogen. Omastin's systemic capability offers a generalized benefit for managing both superficial and more challenging systemic fungal infections.

What side effects are possible with Omastin?

Possible Side Effects and Safety Information

The safety profile of Omastin (Fluconazole) is characterized by classifying adverse reactions according to the body system affected and their reported frequency, as established in regulatory documents.

Frequency-Classified Adverse Reactions

Adverse effects are broadly categorized based on incidence rates observed in clinical trials and post-marketing reports:

Classification Examples of Documented Effects
Common (occurring in 1 in 10 to 1 in 100 people) Headache, nausea, vomiting, abdominal pain, diarrhea, and rash.
Uncommon to Rare Dizziness, insomnia, pruritus (itching), and specific changes in laboratory values, including some elevations in liver function tests.

System-Organ-Class and Serious Reactions

Regulatory information documents serious but rare adverse reactions, primarily involving four major systems:

  • Hepatobiliary Disorders: Serious hepatic toxicity, which may include hepatitis, jaundice, and rare cases of hepatic failure. This toxicity has generally been reported as reversible upon stopping the medicine.
  • Skin and Subcutaneous Tissue Disorders: Severe cutaneous reactions are documented, such as Stevens-Johnson syndrome, Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). These are more common in immunocompromised individuals.
  • Immune System Disorders: Severe allergic reactions, including Anaphylaxis.
  • Cardiac Disorders: The medicine is associated with QT interval prolongation, which can potentially lead to a rare, severe arrhythmia known as Torsade de Pointes.

Population-Specific Safety Constraints

Official labeling includes specific constraints for certain populations. The use of high-dose, long-term Fluconazole during pregnancy, particularly in the first trimester, has been associated with reports of congenital anomalies. Caution is also noted for use in patients with pre-existing liver dysfunction or cardiac disease, as well as in those with specific hereditary problems like lactose intolerance, due to excipients present in some oral forms.

Overdose and Emergency Response

Overdose and When to Seek Help

This section summarizes information concerning overdosage strictly as described in authoritative government regulatory documents for the active substance (fluconazole).

Documented Overdose Manifestations

Official reports of overdosage, as documented by regulatory agencies, indicate that an excessive dose of the active substance may be associated with manifestations affecting the central nervous system. These include hallucinations and paranoid behavior.

When to Seek Immediate Medical Help

Any suspected overdosage requires immediate medical attention. Contact a Poison Control Center or emergency medical services without delay. Treatment of an overdose should be initiated in a healthcare setting.

Emergency Management Procedures

Treatment procedures described in official regulatory documents are primarily symptomatic and involve supportive measures as clinically necessary to maintain vital functions. The active substance is largely excreted unchanged by the kidneys, which informs specific management strategies.

Drug Elimination

Due to the way the active substance is processed by the body, an effective method for removing the substance from the plasma is through haemodialysis. Official data indicates that a three-hour session of haemodialysis is effective at decreasing the plasma concentration of the active substance by approximately 50%. In cases of very recent ingestion, gastric lavage may also be considered a necessary measure to limit absorption.

Therapeutic Uses of Omastin

Omastin (Fluconazole) is a systemic antifungal agent generally used for managing conditions presenting with systemic or localized discomfort caused by fungal infections (mycoses). It is used in three main therapeutic areas, contributing to easing the overall symptom load. The focus is on conditions marked by increased physiological stress, including Candidemia, Cryptococcal Meningitis, and localized issues such as Oropharyngeal and Vulvovaginal Candidiasis. It is also applied as preventative therapy in immunocompromised individuals. This approach supports the patient during difficult episodes by easing distress associated with these manifestations.

Quick Fact: Focus on Systemic and Mucosal Symptom Management

Domain of Use Primary Symptom Axis Contextual Benefit
Invasive Fungal Disease Symptoms related to systemic imbalance Assisting with managing severe manifestations
Mucosal Candidiasis Symptoms related to inflammatory or irritative states Contributes to improved day-to-day comfort

Eligibility and Restrictions for Use

Eligibility Profile: Who Can and Cannot Use Omastin

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults and Pediatric patients (including term newborns) are generally eligible for labeled indications. Geriatric patients are also eligible, but their renal function must be assessed.
Populations for whom use is not recommended Use is not recommended for single-dose treatment of certain superficial infections in patients under 16 or over 60 years of age.
Populations for whom use is contraindicated Patients with a known hypersensitivity to fluconazole, related azole agents, or excipients must not use the medicine. Co-administration with specific medications known to prolong the QT interval (e.g., pimozide, cisapride) is contraindicated by regulators.
Condition-specific eligibility rules Patients with impaired renal function are eligible only if a formal dosage reduction is applied. Use requires caution in patients with liver dysfunction or conditions predisposing to heart rhythm abnormalities.
Pregnancy and lactation eligibility status Use during pregnancy is generally avoided and is conditionally permitted only for severe or life-threatening fungal infections. Lactation is generally acceptable, but caution is advised.

What should I know about interactions with other medicines?

Omastin Interactions with Other Medicines and Products

Omastin (Fluconazole) is classified by regulatory authorities as a potent inhibitor of certain liver enzymes, which defines its potential for interactions with numerous co-administered medicines. The official interaction profile primarily mandates Absolute Contraindications and describes significant changes in drug exposure.


Official Contraindicated Combinations

Co-administration with several medicines is formally prohibited due to the documented risk of severe cardiac effects, including QTc prolongation. These include Cisapride, Astemizole, Pimozide, Quinidine, and Erythromycin.

Notably, the use of Terfenadine is also strictly contraindicated when Omastin is taken at doses of mathbf400 mg per day or higher.


Documented Exposure Alterations

Omastin is a strong inhibitor of the CYP2C19 enzyme and a moderate inhibitor of CYP2C9 and CYP3A4. This action increases the plasma levels of co-administered drugs like Abrocitinib, certain anticoagulants (e.g., Warfarin), and the components of Oral Contraceptives.

Conversely, other medicines can affect Omastin levels: Rifampicin is documented to decrease Omastin exposure ( AUC by 25%), while the diuretic Hydrochlorothiazide is documented to increase Omastin exposure ( AUC by approx 45%) by reducing its renal clearance.


Administration Context

Official regulatory information states that Omastin can be taken without regard to meals as food does not affect the drug's systemic exposure.

Mechanism of Action

️ Selective Blockade of the Fungal Life Cycle

Omastin's mechanism of action is the highly specific inhibition of the fungal enzyme lanosterol 14-α-demethylase (CYP51). This interaction halts a crucial step in the ergosterol biosynthesis pathway, which is necessary for the pathogen to build its structure.


Destabilizing Fungal Cell Membrane Integrity

The central mechanistic cascade involves creating a defective fungal cell membrane. By preventing the formation of ergosterol and causing the accumulation of toxic intermediate sterols, the drug compromises the membrane’s rigidity and fluidity. This physiological consequence results in the leakage of vital cellular components; this process underlies the drug's fungistatic activity and results in the inhibition of fungal growth and replication.


️ Mechanism Limitations: Reduced Target Sensitivity

The effectiveness of this mechanism can be physiologically constrained by the fungal organism itself. Limitations arise when the pathogen develops defense mechanisms, such as mutations in the ERG11 gene (which lowers the drug's affinity for the target enzyme) or the overexpression of efflux pumps, which actively expel the drug from the cell, resulting in reduced mechanistic effect.

Dosage and Administration Information

How Omastin is Used: Official Administration Guidelines

Omastin (Fluconazole) is approved for use via two primary, systemically bioavailable routes, ensuring consistent delivery of the active ingredient.


Approved Routes and Forms

Omastin is available for Oral Administration (capsules, tablets, and oral suspension) and as a Sterile Solution for Intravenous (IV) Infusion. The daily dose is the same for both the oral and intravenous routes, allowing for a switch between administration methods as appropriate. Oral forms may be taken with or without food, as absorption is not significantly affected.

Standard Dosing and Frequency

Treatment often begins with a higher loading dose on the first day, typically twice the maintenance dose, to rapidly achieve effective concentration levels. Subsequent dosing is usually administered once daily.

Indication Administration Detail Frequency/Duration Pattern
Acute Vaginal Candidiasis 150 mg oral dose Single-dose therapy
Systemic Infections (Maintenance) 200 mg to 400 mg daily Duration is disease-specific (e.g., weeks to months)

Special Administration Instructions

IV Infusion Rate: The intravenous solution must be administered slowly, with the rate not exceeding 10 mL/minute for adults.

Dose Adjustments: Dosing must be modified for patients with impaired kidney function. For adults with a creatinine clearance of less than or equal to 50 mL/min, the dose is generally reduced by 50% after the initial loading dose. Pediatric dosing is determined based on the patient's body weight.

Recent Clinical Evidence

Research evidence / Overview of Studies for Omastin

Evidence for Systemic and Invasive Fungal Infections

This section summarizes the published evidence, mainly from Randomized Controlled Trials (RCTs) and meta-analyses, that examined research exploring the use of Omastin in systemic infections like candidemia and its use for prophylaxis (prevention) in certain high-risk, immunocompromised patient groups.

Research explored the use of Omastin in the context of other available antifungal treatments in managing severe fungal conditions. Researchers monitored outcomes related to mycological clearance (documented fungal negativity in the blood) and patient survival over the defined study period. Findings describe patterns observed in the studies related to clinical endpoints and mycological clearance measurements. Ongoing research continues to track long-term patient outcomes and address the challenge of Candida species that exhibit reduced susceptibility.


Evidence for Central Nervous System (CNS) Infections

This part of the overview focuses on the evidence base, including comparative trials and long-term cohort studies, that evaluated research exploring the use of Omastin in the treatment and long-term prevention of relapse of Cryptococcal meningitis, particularly in immunocompromised adults.

Outcomes monitored included the sterilization of the cerebrospinal fluid (CSF) and the time to disease relapse. Studies describe group patterns related to the frequency of infection returning during the suppressive therapy period. The evidence base is primarily focused on patients with HIV-associated disease, meaning data for other immunocompromised states remain limited.


Evidence for Localized Mucosal Infections

This heading outlines the nature of the research, typically short-term RCTs and systematic reviews, used to assess research exploring the use of Omastin for localized conditions such as oropharyngeal and vulvovaginal candidiasis.

Studies focused on outcomes related to clinical cure, which means changes in patient-reported outcomes describing perceived discomfort, and mycological negativity. For women with recurrent VVC, studies also explored the use of Omastin for prophylaxis (prevention). Research provides context but not individual predictions, and study results reflect the specific conditions under which they were conducted.


What Remains Uncertain in the Research Landscape

Research limitations exist, as results apply only to the populations studied. Data for certain subgroups remain insufficient, and follow-up durations were limited in some acute infection trials. Research into alternative strategies and resistance patterns remains an area of continued study.

Key Studies & References

  1. IDSA Clinical Practice Guideline for the Management of Candidiasis
  2. Management of Candidemia and Invasive Candidiasis in Adults: Systematic Review and Meta-analysis

Frequently Asked Questions (FAQ)

Common questions about Omastin (FAQ)

Q: How long does it usually take to feel the effects of Omastin?

A: Official information regarding the medicine's behavior in the body (pharmacokinetics) indicates that the highest concentration of Omastin in the bloodstream is reached about 1 to 2 hours after it is taken by mouth. Healthcare providers often administer an initial higher loading dose so that effective concentrations are rapidly achieved, often by the second day of use.

Q: What happens if I accidentally miss a use of Omastin?

A: Regulatory patient information describes a general recommendation for a missed dose. This often involves taking the dose when remembered, unless it is close to the next scheduled time. In such cases, the missed dose is typically skipped to avoid duplication. Taking only the amount designated for the regular schedule is described as important.

Q: Is it true that Omastin requires regular monitoring by a doctor?

A: Official labeling notes that Omastin may be associated with rare but serious effects on the liver, kidneys, or blood. Regulatory documents indicate that regular monitoring, often through laboratory blood tests, is a common practice, particularly for patients using the medicine for a prolonged period or those with pre-existing conditions.

Q: Can Omastin affect the results of standard lab tests?

A: Yes, regulatory safety documents note that Omastin is associated with documented changes in certain laboratory values, which include possible elevations in liver function tests. The potential effect of Omastin on lab values is a factor healthcare professionals take into account when interpreting a patient's laboratory results.

Q: Do the side effects of Omastin usually lessen over time?

A: Common side effects, such as headache, nausea, or stomach upset, are generally described in reports as mild to moderate. These effects often lessen or go away completely within the first few days of use. More serious or persistent effects are documented as requiring notification to a healthcare professional.

Q: Does Omastin interact with commonly used supplements like vitamins or herbal remedies?

A: Omastin is known to affect the metabolism of many medicines due to its influence on certain liver enzymes. Official product information emphasizes the need for patients to provide healthcare professionals with a complete list of all products they are using, including supplements and herbal products, due to the general potential for interactions.

Q: Is Omastin considered a new drug or has it been around for a while?

A: The active ingredient in Omastin, fluconazole, is a well-established medication that has been used globally for many years. It was initially approved by the U.S. FDA in 1990 and is included on the World Health Organization’s List of Essential Medicines.

Q: Can Omastin make you feel tired or sleepy?

A: Official regulatory documents list dizziness and somnolence (sleepiness) as potential uncommon effects of Omastin. Unusual tiredness or weakness has also been reported. If these effects are experienced, regulatory guidelines describe that they should be noted by a healthcare provider.

Q: Can using Omastin affect a person's ability to drive or operate machinery?

A: Regulatory patient leaflets include caution regarding driving or operating machinery until an individual is aware of how the medicine affects them. This is because dizziness or, rarely, seizures are listed as potential effects of Omastin.

Q: Can Omastin cause mood changes or unusual dreams?

A: While not listed as common side effects, mood and mental status changes, such as suspiciousness or fearfulness, have been rarely reported, sometimes in association with cases of overdose. The occurrence of unusual dreams is not generally listed in official adverse event categories.

Q: Are there any long-term effects of using Omastin that people should know about?

A: The most specific long-term safety information relates to the use of high-dose, long-term Omastin during the first trimester of pregnancy, which has been associated with reports of congenital anomalies. For prolonged use in non-pregnant individuals, monitoring of organ function, particularly liver and kidney function, is a documented consideration by regulatory authorities.

Q: Has Omastin been approved in countries outside the US?

A: Yes, Omastin, under its active ingredient fluconazole, is a medicine approved and available in many countries internationally. This includes approvals from major regulatory bodies across Europe, Canada, and Australia.

Q: What is the difference between the 'on-label' use of Omastin and other uses?

A: The 'on-label' use refers exclusively to the specific fungal infections for which Omastin has received official regulatory approval from agencies like the FDA or EMA. This approval is based on research that demonstrated the drug's use in those specific conditions.

Q: Are there any known issues with using Omastin before surgery?

A: Due to its complex drug interaction profile and its potential to cause heart rhythm changes (QT prolongation), regulatory documents require caution regarding its use. These factors are documented in official information as necessary considerations for healthcare professionals when managing a patient's care around surgical procedures and anesthesia.

Q: Is Omastin related to any narcotic or controlled substance categories?

A: Omastin (fluconazole) is officially classified as an azole antifungal agent. Regulatory bodies and international drug enforcement authorities do not list it as a narcotic or a controlled substance.

Q: Does Omastin cause dryness in the mouth or eyes?

A: While not officially classified as a common or uncommon side effect in regulatory documents, reports of dry mouth and increased thirst have been noted. The frequency of these effects is not officially known.

Q: Are there any specific warnings about sun exposure while using Omastin?

A: Official safety data lists a general rash as a common side effect and severe skin reactions as rare events. Regulatory documents indicate that patients should be aware that skin conditions, including severe ones, must be closely monitored, although explicit official warnings on photosensitivity (sun sensitivity) are not widely published across major labels.

Q: Does Omastin have a bitter taste?

A: Official safety documents report a change in the ability to taste food (taste perversion) as a potential uncommon side effect. However, the specific taste quality of the medicine itself is not officially classified in regulatory information.

How should Omastin be stored and disposed of?

How to Store and Dispose of Omastin: Official Regulatory Information

Official regulatory documents define strict conditions for the storage and disposal of this medicine, ensuring product integrity and environmental safety.

Requirement Area Official Instructions
Storage Environment Store at room temperature, typically below 30 C (77 F to 86 F). Protect from light, moisture, and excessive heat.
Handling & Packaging Keep the medicine in its original, tightly closed container. Keep the product strictly out of the reach of children.
Product Integrity Do not use the medicine past the expiration date listed on the packaging.
Disposal Rules Do not dispose of unused or expired medicine by flushing it down the toilet or pouring it into a drain. Return it to a pharmacy or designated collection site according to local regulations to prevent environmental contamination.

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

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