Hydrocort/iodoq 1-1.9% Cream 60gm

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 Antifungal; Topical Corticosteroid
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Pharmacologic Class
Hydroxyquinoline derivative; Glucocorticoid
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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: Iodoquinol, which helps fight certain skin infections caused by fungi or bacteria, and Hydrocortisone, which is a mild steroid that reduces redness, itching, and swelling. It's used to treat skin conditions that involve both inflammation and infection.
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How to Use This Medicine

Using Your Medication Correctly

To get the most benefit from your medication, use it exactly as directed by your doctor. Carefully read all the information provided with your medication and follow the instructions closely. Continue using the medication as instructed, even if your symptoms improve.

Applying the Medication

This medication is for topical use only, meaning it should be applied directly to the affected area of skin. Do not take it by mouth. Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.

Before applying the medication, wash your hands thoroughly. If the affected area is on your hand, you do not need to wash that hand after application. Clean the affected area before applying the medication and make sure it is completely dry.

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

Storing and Disposing of Your Medication

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

Missing a Dose

If you forget to apply a dose, do so as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and continue with 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, gently rubbing it in until it disappears.
  • Do not cover the treated area with bandages or tight dressings unless directed by your doctor, 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, due to the risk of side effects from the steroid.
  • 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

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to affected area 2-4 times daily, or as directed by physician.
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

duration: Treatment duration should be limited to 2 weeks for hydrocortisone, or as directed by physician for specific conditions.
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Pediatric Dosing

Neonatal: Not established (Increased risk of systemic absorption due to higher surface area to body weight ratio and immature skin barrier)
Infant: Not established (Increased risk of systemic absorption due to higher surface area to body weight ratio and immature skin barrier)
Child: Apply a thin film to affected area 2-4 times daily, or as directed by physician. Use with caution and for the shortest duration possible due to increased risk of systemic absorption and adrenal suppression.
Adolescent: Apply a thin film to affected area 2-4 times daily, or as directed by physician.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No adjustment typically required for topical use due to minimal systemic absorption.
Moderate: No adjustment typically required for topical use due to minimal systemic absorption.
Severe: No adjustment typically required for topical use due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Iodoquinol is an antifungal and antiprotozoal agent. Its exact mechanism of action is not fully elucidated but is thought to involve chelation of trace metals (e.g., iron) essential for microbial growth and enzyme function. Hydrocortisone is a low-potency corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It acts by inducing 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.
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Pharmacokinetics

Absorption:

Bioavailability: Not well characterized for topical application due to low systemic absorption. Absorption of hydrocortisone can increase with inflammation, occlusive dressings, or large surface areas. Iodoquinol absorption is also minimal.
Tmax: Not available for topical application.
FoodEffect: Not applicable for topical application.

Distribution:

Vd: Not well characterized for topical application.
ProteinBinding: Not well characterized for topical application.
CnssPenetration: Limited (systemic levels are typically too low to achieve significant CNS penetration from topical application).

Elimination:

HalfLife: Not well characterized for topical application.
Clearance: Not well characterized for topical application.
ExcretionRoute: Primarily renal for systemically absorbed components.
Unchanged: Not well characterized for topical application.
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory/antipruritic effects; antifungal/antiprotozoal effects may take several days to weeks.
PeakEffect: Variable, depending on the severity of the condition and duration of use.
DurationOfAction: Several hours per application for symptomatic relief.

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 medical attention immediately:

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 a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
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
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation at the site of application
Change 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, contact your doctor for advice:

Burning
Dry skin
* Itching

This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to 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 irritation, redness, burning, or stinging at the application site.
  • Development of new skin problems like thinning skin, stretch marks, or acne.
  • Signs of the infection worsening or spreading.
  • Any signs of systemic steroid effects, such as unusual weight gain, swelling in the face, increased thirst, or unusual tiredness (rare with proper 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 symptoms you experienced.
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 they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your current 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 staining of fingernails, hair, and skin. To prevent staining of clothing and fabrics, take necessary precautions. Before using any other medications or products on your skin, including soaps, consult with your doctor.

Avoid applying this medication to cuts, scrapes, or damaged skin. When using it on a large area of skin, exercise caution and discuss it with your doctor. Do not use this medication for an extended period beyond the recommended duration, as this may lead to a secondary infection.

Avoid wearing tight-fitting clothing, and if the treated area is in the diaper region, do not use tight-fitting diapers or plastic pants, as 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 this further. This medication should not be administered to infants.

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

Overdose Symptoms:

  • Acute overdose with topical application is unlikely due to minimal systemic absorption.
  • Chronic overuse or application to large surface areas, especially in children or with occlusive dressings, can lead to systemic effects of hydrocortisone, including Cushing's syndrome, hyperglycemia, and adrenal suppression.

What to Do:

Discontinue use and consult a healthcare professional. For suspected systemic effects, symptomatic and supportive treatment may be necessary. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To determine the extent and nature of the dermatosis and presence of infection.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, signs of infection)

Frequency: Daily/weekly during treatment

Target: Improvement in symptoms and appearance of skin lesions.

Action Threshold: Lack of improvement after 1-2 weeks, or worsening of symptoms, indicates need for re-evaluation.

Local adverse reactions (e.g., irritation, burning, stinging, atrophy)

Frequency: Daily

Target: Absence of new or worsening local reactions.

Action Threshold: Presence of significant irritation, burning, or signs of skin atrophy requires discontinuation or re-evaluation.

Signs of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression)

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

Target: Absence of systemic effects.

Action Threshold: Any signs of systemic effects (e.g., weight gain, moon face, striae, fatigue) require immediate medical attention and discontinuation.

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Symptom Monitoring

  • Worsening of skin redness, itching, burning, or pain
  • Development of new skin lesions or spread of existing ones
  • Signs of secondary infection (e.g., pus, fever)
  • Unusual fatigue or weakness (potential adrenal suppression with extensive use)
  • Increased thirst or urination (potential hyperglycemia with extensive use)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical hydrocortisone is Pregnancy Category C. Data for topical iodoquinol are limited, but systemic absorption is low.

Trimester-Specific Risks:

First Trimester: Avoid use if possible, or use with caution and for the shortest duration.
Second Trimester: Use with caution; avoid prolonged use or application to large surface areas.
Third Trimester: Use with caution; avoid prolonged use or application to large surface areas.
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Lactation

Use with caution. It is not known whether topical iodoquinol or hydrocortisone are excreted in human milk. Systemic absorption is minimal, but caution is advised. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use due to minimal systemic absorption, but potential for exposure if applied to breast. Monitor infant for any unusual symptoms.
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Pediatric Use

Children are more susceptible to systemic adverse effects from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Use the smallest amount for the shortest duration possible. Adrenal suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids.

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Geriatric Use

No specific dosage adjustments are typically required. Elderly patients may have thinner skin, which could potentially increase absorption, but generally, the risk of adverse effects is similar to adults. Monitor for skin atrophy.

Clinical Information

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Clinical Pearls

  • This combination cream is particularly useful for inflammatory dermatoses where a fungal or bacterial infection is suspected or confirmed.
  • Emphasize the importance of applying a thin layer and avoiding occlusive dressings to minimize systemic absorption of hydrocortisone.
  • Advise patients that improvement in symptoms may be seen quickly due to the corticosteroid, but the full antifungal/antibacterial effect may take longer.
  • Counsel patients on the signs of worsening infection or local irritation, and when to contact their healthcare provider.
  • Not for ophthalmic, oral, or intravaginal use.
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Alternative Therapies

  • Separate topical antifungal (e.g., miconazole, clotrimazole) and topical corticosteroid (e.g., hydrocortisone, triamcinolone) applied sequentially or as monotherapy if only one component is needed.
  • Oral antifungal agents for widespread or severe infections.
  • Topical antibiotics for bacterial infections without significant inflammation.
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Cost & Coverage

Average Cost: $100 - $500+ per 60gm tube
Generic Available: Yes
Insurance Coverage: Often covered as a Tier 1 or Tier 2 generic by most insurance plans, but may require prior authorization for some brand-name versions.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. 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 details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.