Cortane-B Lotion 60ml

Manufacturer MARNEL Active Ingredient Chloroxylenol, Hydrocortisone, and Pramoxine Lotion(klor oh ZYE le nole, HIGH droe CORE tih sone, & pram OX een) Pronunciation klor oh ZYE le nole, HIGH droe CORE tih sone, & pram OX een
It is used to treat skin irritation.
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Drug Class
Topical Anti-inflammatory, Topical Anesthetic, Antiseptic
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Pharmacologic Class
Topical Corticosteroid (Glucocorticoid), Local Anesthetic (Amide Type), Halogenated Phenol Antiseptic
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This lotion contains a mild steroid (hydrocortisone) to reduce redness and swelling, a numbing medicine (pramoxine) to relieve itching and pain, and an antiseptic (chloroxylenol) to help prevent infection. It's used to treat various skin conditions that cause itching, inflammation, and minor irritation.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this medication only as directed.

Apply this medication to your skin only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, ears, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated. In that case, do not wash your hand after application.
Before use, shake the medication well and clean the affected area. Make sure the area is dry before applying the medication.
Apply a thin layer of the medication to the affected area and gently rub it in.

Important Application Instructions

Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.

Storage and Disposal

Store this medication at room temperature, protected from light and moisture. Do not store it in a 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 guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.

Missed Dose Instructions

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 application schedule.
Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Cleanse the affected area gently before application.
  • Apply a thin layer of the lotion to the affected skin area and rub in gently until it disappears.
  • Wash hands thoroughly after applying the lotion, unless hands are the treated area.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not cover the treated area with bandages or other occlusive dressings unless directed by your doctor, as this can increase absorption and side effects.
  • Do not use for longer than prescribed or on large areas of the body without consulting a doctor.
  • Keep out of reach of children.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin layer to the affected skin area 2 to 4 times daily, or as directed by a physician.

Condition-Specific Dosing:

pruritus_inflammation: Apply a thin layer to the affected area 2-4 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to increased systemic absorption risk of hydrocortisone)
Infant: Not established (use with extreme caution due to increased systemic absorption risk of hydrocortisone)
Child: Apply a thin layer to the affected skin area 2 to 4 times daily, or as directed by a physician. Use the lowest effective dose for the shortest duration possible. Avoid prolonged use or use on large body surface areas.
Adolescent: Apply a thin layer to the affected skin area 2 to 4 times daily, or as directed by a physician.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical use due to minimal systemic absorption.
Severe: No specific adjustment needed for topical use due to minimal systemic absorption.
Dialysis: No specific adjustment needed for topical use due to minimal systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate: No specific adjustment needed for topical use due to minimal systemic absorption.
Severe: No specific adjustment needed for topical use due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Hydrocortisone, a topical corticosteroid, exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It induces phospholipase A2 inhibitory proteins (lipocortins), which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Pramoxine is a topical anesthetic that works by stabilizing the neuronal membrane, thereby inhibiting the ionic fluxes required for the initiation and conduction of nerve impulses, leading to local anesthesia and relief of itching and pain. Chloroxylenol is an antiseptic that disrupts bacterial cell walls and inactivates enzymes, providing broad-spectrum antimicrobial activity against bacteria, fungi, and some viruses.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption for all components when applied topically to intact skin. Absorption of hydrocortisone can increase with skin integrity compromise, inflammation, occlusive dressings, and application to large surface areas.
Tmax: Not applicable (topical, minimal systemic absorption)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not applicable (minimal systemic distribution)
ProteinBinding: Hydrocortisone: Approximately 90% (systemic); Pramoxine: Not well-quantified for topical use; Chloroxylenol: Not well-quantified for topical use.
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Hydrocortisone: Approximately 1.5-2 hours (systemic); Pramoxine: Not well-quantified for topical use; Chloroxylenol: Not well-quantified for topical use.
Clearance: Not applicable (minimal systemic clearance for topical use)
ExcretionRoute: Hydrocortisone: Primarily renal excretion of inactive metabolites. Pramoxine: Not well-quantified for topical use. Chloroxylenol: Not well-quantified for topical use.
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Pramoxine: Within minutes for anesthetic effect. Hydrocortisone: Hours to days for anti-inflammatory effect.
PeakEffect: Pramoxine: Within 5-10 minutes. Hydrocortisone: Days to weeks for maximal anti-inflammatory effect.
DurationOfAction: Pramoxine: 2-4 hours. Hydrocortisone: Varies, typically requires multiple daily applications.
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Irritation at the site where the medication was applied
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Skin breakdown at the site where the medication was applied

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Dryness
* Burning

This is not an exhaustive list of possible side effects. If you have questions or concerns 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.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, swelling, or irritation at the application site.
  • Signs of skin infection (e.g., pus, spreading redness, fever).
  • Skin thinning, easy bruising, or stretch marks (striae) with prolonged use.
  • Worsening of the original skin condition.
  • Any signs of systemic side effects (e.g., unusual fatigue, weight gain, swelling in ankles/feet - rare with topical use).
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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 allergic reaction you experienced, including any symptoms that occurred.
If you currently have a viral skin infection, such as chickenpox or herpes.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other treatments and health issues.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before using any other medications or products on your skin, such as soaps, consult with your doctor to ensure safe use.

Do not use this medication for a longer period than prescribed by your doctor. If you accidentally swallow this medication, immediately contact a doctor or a poison control center, as it can cause harm.

In children and teenagers, this medication may potentially affect growth in some cases. Regular growth checks may be necessary, so discuss this with your doctor. When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this age group.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during pregnancy or breastfeeding to ensure the best outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Symptoms of systemic corticosteroid excess (e.g., Cushing's syndrome features: moon face, buffalo hump, central obesity, hypertension, hyperglycemia) - rare with topical use unless applied extensively or for prolonged periods.
  • Severe local irritation or allergic reaction.

What to Do:

Discontinue use and seek medical attention. For accidental ingestion or significant systemic exposure, call a Poison Control Center (1-800-222-1222) or emergency services immediately.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of inflammation, pruritus, and infection.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Daily to weekly, as appropriate for condition.

Target: Improvement in symptoms and skin appearance.

Action Threshold: Lack of improvement or worsening of symptoms after appropriate duration of therapy; signs of local irritation or infection.

Local adverse effects (e.g., skin atrophy, irritation, folliculitis)

Frequency: Regularly during therapy, especially with prolonged use.

Target: Absence of adverse effects.

Action Threshold: Development of skin thinning, striae, telangiectasias, burning, stinging, or signs of secondary infection.

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Symptom Monitoring

  • Reduction in itching
  • Reduction in redness
  • Reduction in swelling
  • Healing of skin lesions
  • Absence of burning or stinging (new onset)
  • Absence of skin thinning or discoloration

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Limited data, but systemic absorption is minimal. Avoid if possible.
Second Trimester: Generally considered low risk with limited topical use.
Third Trimester: Generally considered low risk with limited topical use.
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Lactation

L3 (Moderately Safe). Use with caution. Minimal systemic absorption is expected, but avoid applying to areas that may come into direct contact with the infant's mouth or skin, especially the breast area.

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption, but monitor for potential effects if used on large areas or for prolonged periods.
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Pediatric Use

Children, especially infants and young children, are more susceptible to systemic adverse effects from topical corticosteroids (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration possible. Avoid prolonged use or use on large body surface areas. Not recommended for use in neonates or infants without specific medical advice.

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Geriatric Use

Generally safe for use in the elderly. However, older patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and monitor for local skin reactions.

Clinical Information

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Clinical Pearls

  • This combination lotion provides anti-inflammatory, anesthetic, and antiseptic properties, making it useful for various itchy, inflamed, and potentially irritated skin conditions.
  • Emphasize proper application technique: thin layer, gentle rubbing, and avoiding occlusive dressings unless specifically instructed.
  • Educate patients on the signs of skin atrophy (thinning, bruising, striae) that can occur with prolonged or potent topical corticosteroid use.
  • While chloroxylenol provides antiseptic action, this product is not intended for treating active, spreading bacterial or fungal infections; these require specific antimicrobial therapy.
  • Pramoxine provides rapid relief of itching, while hydrocortisone's anti-inflammatory effects take longer to manifest.
  • Advise patients to discontinue use and consult a healthcare professional if symptoms worsen, persist, or if signs of infection or severe irritation develop.
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Alternative Therapies

  • Topical corticosteroids (e.g., triamcinolone, betamethasone)
  • Topical anesthetics (e.g., lidocaine, benzocaine)
  • Topical antiseptics (e.g., povidone-iodine, chlorhexidine)
  • Oral antihistamines for pruritus
  • Emollients and moisturizers for dry skin conditions
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Cost & Coverage

Average Cost: Variable per 60ml lotion
Generic Available: Yes
Insurance Coverage: Often Tier 1 or 2 for generic versions; brand-specific coverage varies.
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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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.