Hydrocortisone 1%/iodoquinol 1% Crm

Manufacturer KMM PHARMACEUTICALS Active Ingredient Iodoquinol and Hydrocortisone(eye oh doe KWIN ole & hye droe KOR ti sone) Pronunciation eye oh doe KWIN ole & hye droe KOR ti sone
It is used to treat skin irritation.It is used to treat skin infections.
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Drug Class
Topical Corticosteroid and Antifungal/Antiprotozoal Combination
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Pharmacologic Class
Glucocorticoid; Hydroxyquinoline Derivative
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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 cream contains two medicines: hydrocortisone, which helps reduce redness, itching, and swelling, and iodoquinol, which helps fight certain skin infections caused by fungi or bacteria. It's used to treat skin conditions that have both inflammation and infection.
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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. Continue using the medication as directed, even if your symptoms improve.

Application Instructions

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
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 dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.

Special Instructions

When applying the medication to the groin area, use a small amount and avoid wearing tight clothing.

Storage and Disposal

Store the medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep the lid tightly closed to maintain the medication's effectiveness.

Missed 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 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

  • Wash your hands before and after applying the cream.
  • Apply a thin layer of cream to the affected skin area and rub it in gently until it disappears.
  • Do not cover the treated area with bandages or dressings unless your doctor tells you to, as this can increase absorption and side effects.
  • Avoid getting the cream in your eyes, nose, mouth, or other mucous membranes. If it gets into your eyes, rinse thoroughly with water.
  • Do not use this cream for longer than prescribed, especially on the face, groin, or armpits, or in children, as this can increase the risk of side effects.
  • Inform your doctor if your condition does not improve after 1-2 weeks of treatment or if it worsens.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected area 2-3 times daily

Condition-Specific Dosing:

generalUse: Apply to affected skin areas. Rub in gently and completely. Do not use with occlusive dressings unless directed by a physician.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to increased systemic absorption and HPA axis suppression risk)
Infant: Not established (use with extreme caution due to increased systemic absorption and HPA axis suppression risk)
Child: Apply a thin film to the affected area 2-3 times daily. Use with caution; pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids.
Adolescent: Apply a thin film to the affected area 2-3 times daily.
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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)
Confidence: Medium

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that 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. Iodoquinol is an antimicrobial agent with antifungal and antiprotozoal properties. Its exact mechanism of action is not fully understood but is thought to involve chelation of trace metals essential for microbial growth and/or inhibition of microbial enzyme systems.
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Pharmacokinetics

Absorption:

Bioavailability: Not applicable for topical; systemic absorption is minimal but can occur, especially with prolonged use, large surface areas, or occlusive dressings. Hydrocortisone absorption varies from 1-5%. Iodoquinol absorption is also minimal.
Tmax: Not applicable for topical; systemic Tmax not well-defined for topical application.
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable for topical; if systemically absorbed, hydrocortisone distributes widely. Iodoquinol distribution is not well-characterized for topical use.
ProteinBinding: Hydrocortisone: Approximately 90% (to albumin and corticosteroid-binding globulin). Iodoquinol: Not well-defined for topical.
CnssPenetration: Limited (for systemically absorbed components)

Elimination:

HalfLife: Hydrocortisone (systemic): Approximately 1.5-2 hours (biological half-life is longer). Iodoquinol: Not well-defined for topical.
Clearance: Not applicable for topical; systemic clearance for hydrocortisone is rapid.
ExcretionRoute: Hydrocortisone: Primarily renal (as inactive metabolites). Iodoquinol: Primarily renal (if systemically absorbed).
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory and antimicrobial effects.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Varies; effects persist as long as applied regularly.

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: 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.
Signs of a weak adrenal gland: severe stomach upset or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Skin changes: acne, stretch marks, slow healing, or excessive hair growth.
Irritation at the site of application.
Changes in skin color.
Thinning of the skin.

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 persist, contact your doctor:

Burning sensation.
Dry skin.
* Itching.

This is not an exhaustive list of 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.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, itching, burning, or irritation at the application site
  • Development of new skin problems like thinning skin, stretch marks, or acne
  • Signs of a new infection (e.g., pus, fever)
  • Unusual tiredness, weight gain, or swelling in the face (rare, but can indicate too much medicine absorbed into the body)
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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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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. This is crucial because it may interfere with certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are using this drug.

This medication can cause discoloration of fingernails, hair, and skin. To prevent staining, take precautions to protect your clothing and fabrics. Before using any other skincare products, including soaps, consult with your doctor to avoid potential interactions.

When applying this medication, avoid putting it on cuts, scrapes, or damaged skin. If you need to use it on a large area of skin, discuss this with your doctor to ensure safe usage. Do not use this medication for an extended period beyond the recommended duration, as this may increase the risk of a secondary infection.

Avoid using this medication under tight-fitting clothing, and if the treated area is in the diaper region, do not use tight-fitting diapers or plastic pants. This can cause excessive absorption of the medication into the body.

When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss the potential risks and benefits. This medication should not be given to infants.

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

Overdose Symptoms:

  • With topical use, overdose is unlikely but prolonged or extensive use can lead to systemic corticosteroid effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (fatigue, weakness, nausea, vomiting).

What to Do:

Discontinue use and contact your doctor immediately. For severe systemic symptoms, seek emergency medical attention. Call 1-800-222-1222 for Poison Control.

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, signs of infection)

Frequency: Regularly during treatment, typically weekly or bi-weekly depending on severity

Target: Improvement in symptoms and skin appearance

Action Threshold: Lack of improvement or worsening of symptoms after 1-2 weeks may indicate need for re-evaluation or alternative therapy.

Local adverse effects (e.g., skin atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, hypopigmentation)

Frequency: At each follow-up visit

Target: Absence of or minimal adverse effects

Action Threshold: Presence of significant or worsening local adverse effects may require discontinuation or change in therapy.

Signs of systemic corticosteroid absorption (e.g., Cushing's syndrome, hyperglycemia, glucosuria, HPA axis suppression)

Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings

Target: Absence of systemic effects

Action Threshold: Any signs of systemic absorption warrant immediate discontinuation and medical evaluation.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pain at application site
  • Development of new skin lesions or signs of secondary infection
  • Unusual fatigue or weakness (potential HPA axis suppression)
  • Increased thirst or urination (potential hyperglycemia)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy 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: Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is minimal but caution is advised.
Second Trimester: Similar considerations as first trimester; minimal systemic absorption expected.
Third Trimester: Similar considerations as first trimester; minimal systemic absorption expected. Risk of HPA axis suppression in the neonate with extensive maternal use.
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Lactation

L3. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited topical use; potential for adverse effects if significant systemic absorption occurs in mother and drug is excreted in milk.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • This combination cream is useful for inflammatory dermatoses where a fungal or bacterial infection is suspected or confirmed.
  • Advise patients not to use this cream for prolonged periods, especially on sensitive areas like the face, groin, or armpits, due to the risk of skin atrophy and other corticosteroid side effects.
  • Educate patients on proper application technique: thin layer, gentle rubbing, and avoiding occlusive dressings unless specifically instructed.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan, as the infection might be resistant or the condition might not be infectious.
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Alternative Therapies

  • Topical corticosteroids alone (if infection is ruled out)
  • Topical antifungals alone (e.g., clotrimazole, miconazole, terbinafine)
  • Topical antibiotics alone (e.g., mupirocin, fusidic acid)
  • Oral antifungals or antibiotics for more severe or widespread infections
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Cost & Coverage

Average Cost: Varies widely, typically $50 - $200+ per 30g tube
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (varies by insurance plan)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.