Oxistat 1% Lotion 30ml
It is used to treat fungal infections of the skin.
Drug Class
Antifungal, Topical
Pharmacologic Class
Imidazole Antifungal
Pregnancy Category
Category B
FDA Approved
Mar 1988
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oxiconazole is a medicine applied to the skin to treat fungal infections like athlete's foot, jock itch, and ringworm. It works by stopping the growth of the fungus.
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.
Application Instructions
Do not take this medication by mouth. It is for topical 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.
Shake the container well before each use.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Guidelines
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 location, 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 guidance on the best way to dispose of medications, and consider participating in a drug take-back program 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 resume your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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.
Application Instructions
Do not take this medication by mouth. It is for topical 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.
Shake the container well before each use.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Important Usage Guidelines
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 location, 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 guidance on the best way to dispose of medications, and consider participating in a drug take-back program 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 resume your regular schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the lotion.
- Clean and dry the affected area completely before application.
- Apply a thin layer of lotion to the affected skin and surrounding area.
- Do not cover the treated area with bandages or dressings unless directed by your doctor.
- Wear loose-fitting clothing and well-ventilated shoes (for foot infections).
- Change socks and underwear daily.
- Avoid sharing towels, clothing, or personal items.
- 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
tineaVersicolor:
Apply once daily for 2 weeks
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Apply to affected areas once daily (safety and efficacy not fully established for all ages, consult physician)
Adolescent:
Apply to affected areas once daily
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 adjustment needed (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 imidazole antifungal agent that inhibits the biosynthesis of ergosterol, an essential component of the fungal cell membrane. It does this by inhibiting fungal cytochrome P450 14Îą-demethylase. This inhibition leads to structural and functional changes in the fungal cell membrane, resulting in increased permeability, leakage of cellular contents, and ultimately, fungal cell death or inhibition of growth.
Pharmacokinetics
Absorption:
Bioavailability:
<0.3% (systemic after topical application)
Tmax:
Not clinically relevant for topical application
FoodEffect:
Not applicable for topical application
Distribution:
Vd:
Not clinically relevant for topical application
ProteinBinding:
Not clinically relevant for topical application
CnssPenetration:
No
Elimination:
HalfLife:
Not clinically relevant for topical application
Clearance:
Not clinically relevant for topical application
ExcretionRoute:
Primarily via urine and feces if systemically absorbed (minimal)
Unchanged:
Not clinically relevant for topical application
Pharmacodynamics
OnsetOfAction:
Days to weeks (clinical improvement)
PeakEffect:
Weeks (full therapeutic effect)
DurationOfAction:
Maintained with continued application; residual effect after cessation depends on fungal burden and skin turnover
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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, or 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 effects that bother you or do not go away, contact your doctor for advice:
- Irritation at the site where the medication was applied
Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 attention 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, or 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 effects that bother you or do not go away, contact your doctor for advice:
- Irritation at the site where the medication was applied
Note: This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact 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 or irritation at the application site
- Severe burning or stinging
- Blistering or oozing of the skin
- Signs of allergic reaction (e.g., rash, hives, swelling, difficulty breathing - rare)
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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To minimize risks and ensure safe use, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To minimize risks and ensure safe use, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication in combination with your other medications and health conditions.
Precautions & Cautions
It is essential to inform all 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 this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Ingestion may cause gastrointestinal upset.
What to Do:
If ingested, seek medical attention. For topical overdose, wipe off excess medication. Call 1-800-222-1222 (Poison Control) for advice if concerns arise.
Drug Interactions
Monitoring
Baseline Monitoring
Clinical assessment of fungal infection
Rationale: To confirm diagnosis and establish baseline severity
Timing: Prior to initiation of therapy
Routine Monitoring
Resolution of signs and symptoms (e.g., itching, redness, scaling)
Frequency: Weekly or as clinically indicated
Target: Progressive improvement leading to complete resolution
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks of therapy may indicate treatment failure, incorrect diagnosis, or adverse reaction.
Local skin reactions (e.g., burning, stinging, irritation, erythema)
Frequency: Daily, patient self-monitoring
Target: Minimal to no reaction
Action Threshold: Severe or persistent irritation may require discontinuation.
Symptom Monitoring
- Itching
- Redness
- Scaling
- Burning sensation
- Stinging sensation
- Irritation
- Blistering
- Swelling
Special Patient Groups
Pregnancy
Oxiconazole is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Due to minimal systemic absorption, risk is considered low, but use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but caution advised.
Second Trimester:
Low risk due to minimal systemic absorption.
Third Trimester:
Low risk due to minimal systemic absorption.
Lactation
Oxiconazole is classified as Lactation Risk L3 (Moderately Safe). It is not known whether oxiconazole is excreted in human milk. However, systemic absorption is minimal following topical application, making infant exposure unlikely. Use with caution; consider applying after feeding or avoiding application to areas that may come into direct contact with the infant.
Infant Risk:
Low risk due to minimal systemic absorption.
Pediatric Use
Safety and effectiveness in pediatric patients below 12 years of age have not been fully established. Use in children should be under medical supervision, and the potential benefits should outweigh the risks. Generally well-tolerated in older children.
Geriatric Use
No specific dosage adjustments are necessary 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 age-related differences in safety or efficacy have been identified.
Clinical Information
Clinical Pearls
- Ensure the affected area is clean and dry before applying the lotion for optimal efficacy.
- Advise patients to continue treatment for the full prescribed duration, even if symptoms improve, to prevent relapse.
- Oxiconazole lotion is for external use only; avoid contact with eyes, mouth, and other mucous membranes.
- If irritation or sensitivity develops, discontinue use and consult a healthcare professional.
- For intertriginous areas (e.g., groin, between toes), ensure the skin folds are thoroughly dried before application.
Alternative Therapies
- Clotrimazole topical
- Miconazole topical
- Terbinafine topical
- Ketoconazole topical
- Econazole topical
- Sertaconazole topical
- Naftifine topical
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 30ml 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 for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 details about the medication taken, the amount, and the time it happened.