Hydrocortisone Val 0.2% Cream 60gm

Manufacturer PERRIGO /PADAGIS Active Ingredient Hydrocortisone Cream, Gel, Ointment, and Solution(hye droe KOR ti sone) Pronunciation hye droe KOR ti sone VAL er ate
It is used to treat skin irritation.It is used to treat skin rashes.
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Drug Class
Topical Corticosteroid, Anti-inflammatory
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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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?

Hydrocortisone valerate cream is a medicine applied to the skin to reduce redness, itching, and swelling caused by various skin conditions like eczema or dermatitis. It belongs to a group of medicines called corticosteroids.
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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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning. Do not apply it to the vagina.

Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you're treating a skin condition on your hand, do not wash your hand after applying the medication.

Before applying the medication, clean the affected area and dry it well. Then, gently rub a thin layer of the medication onto the affected skin. Unless your doctor advises otherwise, do not cover the treated area with bandages or dressings. Also, avoid applying the medication to your face, underarms, or groin area unless your doctor specifically instructs you to do so.

If you're treating a skin condition in the diaper area, do not use tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.

Storage and Disposal

Store this medication at room temperature, away from freezing temperatures. 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. You can also check with your pharmacist about drug take-back programs in your area.

Missed Dose

If you miss a dose, apply it as soon as you remember. However, if it's 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 one.
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Lifestyle & Tips

  • Wash your hands before and after applying the cream.
  • Apply a thin layer of cream only to the affected skin area.
  • Do not cover the treated area with bandages or tight dressings unless directed by your doctor, as this can increase absorption.
  • Avoid applying the cream to the face, groin, or armpits unless specifically instructed by your doctor.
  • Do not use for longer than prescribed, especially on children.
  • Avoid contact with eyes, nose, and mouth.
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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 skin areas 2 to 3 times daily.
Dose Range: 2 - 3 mg

Condition-Specific Dosing:

eczema: Apply a thin film to the affected skin areas 2 to 3 times daily.
dermatitis: Apply a thin film to the affected skin areas 2 to 3 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to increased systemic absorption risk)
Infant: Apply a thin film to the affected skin areas 2 to 3 times daily. Use with caution; avoid prolonged use, large surface areas, or occlusive dressings due to increased systemic absorption risk.
Child: Apply a thin film to the affected skin areas 2 to 3 times daily. Use with caution; avoid prolonged use, large surface areas, or occlusive dressings due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected skin areas 2 to 3 times daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use, as systemic absorption is minimal.

Hepatic Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.

Pharmacology

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Mechanism of Action

Hydrocortisone valerate is a medium-potency corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <5%), but can be increased with damaged skin, inflammation, occlusion, or application to large surface areas (up to 60% in some cases).
Tmax: Not typically measured for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not precisely quantified for topical use due to minimal systemic absorption.
ProteinBinding: If absorbed systemically, binds to plasma proteins (primarily corticosteroid-binding globulin and albumin).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: If absorbed systemically, similar to endogenous hydrocortisone (approx. 8-12 hours).
Clearance: Not precisely quantified for topical use.
ExcretionRoute: Renal (primarily as inactive metabolites) if absorbed systemically.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours of application (local effect).
PeakEffect: Within days of consistent application.
DurationOfAction: Varies depending on formulation and individual response, generally lasts until next application.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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 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
Changes in eyesight
Severe headache
Irritation at the site of application
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. While many individuals 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 or stinging
Dryness
* Tingling

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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:

  • Worsening of skin condition
  • Signs of skin infection (e.g., pus, increased pain, fever)
  • Severe burning, itching, or irritation at the application site
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Changes in skin color
  • Unusual hair growth
  • Signs of systemic absorption (rare): unexplained weight gain, moon face, swelling in ankles/feet, muscle weakness, fatigue, vision problems (report immediately)
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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 existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dosage 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. Before using any other medications or skin products, such as soaps, consult with your doctor to ensure safe use.

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 minimize potential risks.

In case of accidental ingestion, immediately contact a doctor or poison control center, as this medication can be harmful if swallowed. Adhere to your doctor's prescribed treatment duration and do not use this medication for an extended period.

Prolonged use of this medication may increase the risk of developing cataracts or glaucoma. Consult with your doctor to discuss this potential risk. Additionally, some products may not be suitable for use in the diaper area, so it is crucial to consult with your doctor before application.

When using this medication on children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor to ensure proper monitoring.

If you are breast-feeding and apply this medication to your breast or nipple, make sure to wash the area thoroughly before breast-feeding your child. Certain forms of this medication may not be suitable for all age groups of children, so consult with your doctor if you have any questions or concerns.

If you are pregnant, plan to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the benefits and risks of using this medication with you to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, striae, hypertension, hyperglycemia, muscle weakness, and adrenal suppression.

What to Do:

Discontinue use gradually under medical supervision. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis, identify signs of infection, and determine appropriate treatment duration.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Daily to weekly, depending on severity.

Target: Improvement in symptoms.

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, folliculitis, hypertrichosis)

Frequency: Weekly to monthly, or as clinically indicated.

Target: Absence of adverse effects.

Action Threshold: Presence of adverse effects, especially skin atrophy, requires discontinuation or reduction in potency/frequency.

Signs of systemic absorption (rare, e.g., Cushing's syndrome, hyperglycemia, 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 require immediate medical evaluation and discontinuation.

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Symptom Monitoring

  • Reduction in redness
  • Decrease in itching
  • Decrease in swelling
  • Healing of skin lesions
  • Absence of new skin irritation
  • 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: Potential for fetal harm, though systemic absorption is minimal. Use with caution.
Second Trimester: Potential for fetal harm, though systemic absorption is minimal. Use with caution.
Third Trimester: Potential for fetal harm, though systemic absorption is minimal. Use with caution.
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Lactation

Use with caution. It is not known whether topical corticosteroids 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 application, but monitor infant for any unusual effects.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension). Use the least potent effective dose for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption, though this is generally not clinically significant with appropriate use. Monitor for skin atrophy.

Clinical Information

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Clinical Pearls

  • Hydrocortisone valerate 0.2% is a medium-potency topical corticosteroid, suitable for moderate dermatoses.
  • Advise patients to apply sparingly and rub in gently until absorbed.
  • Emphasize that topical corticosteroids are for external use only and should not be used on open wounds or infected skin without specific medical advice.
  • Warn against prolonged use, especially on the face, groin, or in children, due to increased risk of local and systemic side effects.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinolone, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
  • Emollients and moisturizers for dry skin conditions
  • Antihistamines for pruritus (oral or topical, if appropriate)
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Cost & Coverage

Average Cost: $30 - $80 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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. 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.