Oxistat 1% Lotion 60ml
It is used to treat fungal infections of the skin.
Drug Class
Antifungal
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
C
FDA Approved
Dec 1983
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxistat 1% Lotion is a medicine used on the skin to treat fungal infections like athlete's foot, jock itch, and ringworm. It works by stopping the growth of the fungus that causes these infections.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Before using the medication, shake the container well.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Instructions
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for information on drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
* Do not apply two doses at the same time or extra doses.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Continue using the medication as directed, even if your symptoms improve.
Applying the Medication
Do not take this medication by mouth. It is for use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Before using the medication, shake the container well.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Instructions
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
Check with your pharmacist for information on drug take-back programs in your area.
Missing a Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and continue with your regular schedule.
* Do not apply two doses at the same time or extra doses.
Lifestyle & Tips
- Wash hands before and after applying the lotion.
- Clean and dry the affected skin area thoroughly before application.
- Apply a thin layer of lotion to the affected area and surrounding healthy skin.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Avoid getting the lotion in your eyes, nose, mouth, or vagina. If it gets into your eyes, rinse thoroughly with water.
- Wear loose-fitting clothing and breathable footwear (e.g., cotton socks) to keep the affected area dry.
- Change socks and underwear daily.
- Do not share towels, clothing, or personal items to prevent spreading the infection.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply to affected areas once daily
Condition-Specific Dosing:
tineaPedis:
Apply once daily for 4 weeks
tineaCorporis:
Apply once daily for 2 weeks
tineaCruris:
Apply once daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Safety and efficacy not established in children under 12 years of age for all indications. For tinea pedis, tinea corporis, and tinea cruris, safety and efficacy have been established in pediatric patients 12 years of age and older.
Adolescent:
Apply to affected areas once daily (12 years and older, as per adult dosing for specific indications)
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Oxiconazole is an azole antifungal that inhibits the biosynthesis of ergosterol, a vital component of fungal cell membranes. It does this by inhibiting the cytochrome P450-dependent enzyme 14-alpha-demethylase, which is responsible for the demethylation of lanosterol to ergosterol. This inhibition leads to an accumulation of 14-alpha-methyl sterols and a depletion of ergosterol, resulting in increased fungal cell membrane permeability, leakage of cellular contents, and ultimately, fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<0.3% of applied dose)
Tmax:
Not clinically relevant for topical application
FoodEffect:
Not applicable for topical formulation
Distribution:
Vd:
Not clinically relevant due to minimal systemic absorption
ProteinBinding:
Not clinically relevant due to minimal systemic absorption
CnssPenetration:
Limited (not expected to penetrate CNS significantly due to minimal systemic absorption)
Elimination:
HalfLife:
Not well-defined for systemic relevance due to minimal absorption
Clearance:
Not clinically relevant due to minimal systemic absorption
ExcretionRoute:
Primarily via urine and feces if absorbed, but very little is absorbed.
Unchanged:
Not clinically relevant due to minimal systemic absorption
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 1-2 weeks
PeakEffect:
Full therapeutic effect usually observed after completion of the recommended treatment duration (2-4 weeks)
DurationOfAction:
Effect persists as long as treatment continues; recurrence possible if treatment is stopped prematurely.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Blistering
Swelling
Oozing or bleeding
Burning
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Blistering
Swelling
Oozing or bleeding
Burning
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
Irritation at the site where the medication was applied
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased redness, itching, or irritation at the application site
- Swelling or blistering of the skin
- Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat - seek immediate medical attention)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions. Your doctor needs to be aware of your complete medical history to ensure safe treatment.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other drugs and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions. Your doctor needs to be aware of your complete medical history to ensure safe treatment.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other drugs and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are pregnant, planning to become pregnant, or are breast-feeding, be sure to discuss this with your doctor. You and your doctor will need to carefully weigh the benefits and risks of using this medication during pregnancy or breast-feeding to make an informed decision about its use.
Overdose Information
Overdose Symptoms:
- Systemic overdose is highly unlikely with topical application due to minimal absorption. Local irritation may occur with excessive application.
What to Do:
If accidentally ingested, contact a poison control center (1-800-222-1222) or seek emergency medical attention. For excessive topical application, wash the area with soap and water.
Drug Interactions
Monitoring
Routine Monitoring
Clinical signs and symptoms of fungal infection (e.g., redness, itching, scaling)
Frequency: Daily by patient, weekly by healthcare provider (if follow-up is needed)
Target: Resolution or improvement of symptoms
Action Threshold: Lack of improvement after 2-4 weeks of treatment, or worsening symptoms, warrants re-evaluation.
Local skin reactions (e.g., burning, stinging, itching, irritation)
Frequency: Daily by patient
Target: Absence or mild, tolerable reactions
Action Threshold: Severe or persistent local reactions warrant discontinuation and medical advice.
Symptom Monitoring
- Resolution of itching
- Reduction in redness
- Decrease in scaling
- Improvement in skin appearance
- Monitoring for local irritation or allergic reactions (e.g., burning, stinging, rash, swelling)
Special Patient Groups
Pregnancy
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some adverse effects at high doses, but systemic absorption in humans is minimal.
Trimester-Specific Risks:
First Trimester:
Potential risk, but minimal systemic absorption limits concern.
Second Trimester:
Potential risk, but minimal systemic absorption limits concern.
Third Trimester:
Potential risk, but minimal systemic absorption limits concern.
Lactation
Lactation Risk L3 (Moderately Safe). It is not known whether oxiconazole is excreted in human milk. However, systemic absorption is minimal, making infant exposure unlikely. Use with caution; consider applying after breastfeeding or avoiding application to areas that may come into direct contact with the infant.
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Safety and efficacy have not been established in pediatric patients under 12 years of age for all indications. For tinea pedis, tinea corporis, and tinea cruris, safety and efficacy have been established in pediatric patients 12 years of age and older. Use with caution in younger children and only if clearly indicated and supervised by a healthcare professional.
Geriatric Use
No specific dosage adjustments or precautions are required for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, no differences in safety or effectiveness have been observed between elderly and younger patients.
Clinical Information
Clinical Pearls
- Oxiconazole is a broad-spectrum azole antifungal effective against dermatophytes and yeasts.
- Ensure the affected area is clean and dry before application to maximize efficacy.
- Patients should be advised to complete the full course of therapy, even if symptoms improve, to prevent relapse.
- Topical antifungals like oxiconazole are generally well-tolerated with a low incidence of systemic side effects due to minimal absorption.
- Advise patients on proper hygiene practices (e.g., keeping skin dry, wearing breathable fabrics) to aid in treatment and prevent recurrence.
Alternative Therapies
- Clotrimazole (topical)
- Miconazole (topical)
- Terbinafine (topical)
- Ketoconazole (topical)
- Econazole (topical)
- Sertaconazole (topical)
- Naftifine (topical)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and formulation (e.g., $50-$200+) per 60ml lotion
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.