Hydrocortisone Val 0.2% Cream 15gm

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
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy 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 psoriasis. It's a type of steroid that works by calming down the body's inflammatory response.
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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 are 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 are treating a skin condition in the diaper area, do not use tight-fitting diapers or plastic pants, as this can cause the medication to be absorbed into the body more easily.

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 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 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, gently rubbing it in until it disappears.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the cream to your eyes, mouth, or inside your nose.
  • Do not use on broken skin or open wounds unless directed by your doctor.
  • Do not use for longer than prescribed or on larger areas than instructed.
  • 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 film to the affected skin area 2 or 3 times daily.

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin area 2 or 3 times daily.
eczema: Apply a thin film to the affected skin area 2 or 3 times daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, if at all, due to high risk of systemic absorption and HPA axis suppression)
Infant: Apply a thin film to the affected skin area 2 or 3 times daily. Use smallest effective amount for shortest duration possible. Avoid use on large surface areas or under occlusive dressings.
Child: Apply a thin film to the affected skin area 2 or 3 times daily. Use smallest effective amount for shortest duration possible. Avoid use on large surface areas or under occlusive dressings.
Adolescent: Apply a thin film to the affected skin area 2 or 3 times daily.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Hydrocortisone valerate is a medium-potency topical corticosteroid. It acts 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. Corticosteroids also possess vasoconstrictive, antipruritic, and anti-inflammatory properties.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, generally low systemic absorption (typically <5%) but can increase significantly with damaged skin, inflammation, occlusion, or application to large surface areas.
Tmax: Not applicable for topical systemic absorption; local effect is rapid.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical systemic absorption; if absorbed, distributes widely.
ProteinBinding: If systemically absorbed, binds extensively to plasma proteins (e.g., transcortin, albumin).
CnssPenetration: Limited, unless significant systemic absorption occurs.

Elimination:

HalfLife: Systemic half-life of hydrocortisone is approximately 8-12 hours, but for topical, it's more about local tissue retention.
Clearance: Not precisely quantified for topical systemic absorption.
ExcretionRoute: Renal (metabolites), small amount in bile.
Unchanged: <1% (systemically)
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Pharmacodynamics

OnsetOfAction: Within hours for anti-inflammatory and antipruritic effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Varies with application frequency and individual response, typically maintained with twice or thrice daily application.

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 signs or symptoms, contact your doctor or seek immediate medical attention:

Allergic reaction symptoms, 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 can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Burning or stinging
Dryness
* Tingling

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:

  • Skin irritation, burning, or itching that gets worse after applying the cream.
  • Signs of skin infection (e.g., pus, spreading redness, fever).
  • Thinning of the skin, easy bruising, or stretch marks in the treated area.
  • Acne-like breakouts or increased hair growth in the treated area.
  • If your skin condition does not improve after 2 weeks of treatment, or if it worsens.
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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.
* 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 current medications and health conditions. Never start, stop, or adjust 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. Before using any other medications or skin products, including soaps, consult with your doctor to ensure safe use.

To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. When using this medication on a large area of skin, exercise caution and discuss this with your doctor.

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; therefore, consult with your doctor to discuss potential risks. Certain 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 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, necessitating regular growth checks; consult with your doctor to monitor growth and development.

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

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, considering both your health and the health of your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or extensive use, especially under occlusion or on large surface areas, can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, fatigue, high blood pressure, and hyperglycemia.
  • Adrenal suppression (HPA axis suppression) can also occur, leading to symptoms like fatigue, weakness, nausea, vomiting, and dizziness upon withdrawal.

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center (1-800-222-1222) or seek immediate medical attention if systemic symptoms are severe or concerning.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., active infection).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Regularly during treatment, typically weekly to bi-weekly initially.

Target: Improvement in symptoms and skin appearance.

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

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

Frequency: At each follow-up visit.

Target: Absence or minimal signs of adverse effects.

Action Threshold: Presence of significant adverse effects warrants reduction in frequency, potency, or discontinuation.

Signs of HPA axis suppression (especially with prolonged use, large areas, or occlusion)

Frequency: Consider periodic assessment (e.g., ACTH stimulation test, plasma cortisol) if risk factors are present.

Target: Normal HPA axis function.

Action Threshold: Evidence of suppression requires gradual withdrawal or alternative therapy.

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Symptom Monitoring

  • Worsening of skin condition
  • Increased redness, swelling, or pain (signs of infection)
  • Severe burning, itching, or irritation at application site
  • Thinning of skin, easy bruising, stretch marks (striae)
  • Acne-like eruptions or folliculitis
  • Unusual fatigue, weight gain, moon face (signs of systemic absorption/Cushing's syndrome, rare with proper topical use)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high systemic exposure, but topical absorption is generally low.
Second Trimester: Risk of fetal growth restriction or adrenal suppression with high systemic exposure.
Third Trimester: Risk of fetal growth restriction or adrenal suppression with high systemic exposure.
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Lactation

Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic absorption is generally low. If used, avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use, but monitor for potential adverse effects if significant systemic absorption occurs in mother.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier. Risk of HPA axis suppression and Cushing's syndrome is higher. Use the smallest effective amount for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

Generally safe for use in the elderly. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and 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.
  • Always apply a thin layer; more cream does not mean better results and increases the risk of side effects.
  • Avoid prolonged use on the face, groin, or axillae, as these areas are more prone to corticosteroid-induced skin atrophy.
  • If an infection is present, it should be treated concurrently with an appropriate antimicrobial agent.
  • Patients should be advised not to use this cream for conditions other than those for which it was prescribed.
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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
  • Systemic therapies (e.g., oral corticosteroids, biologics) for severe, widespread conditions
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Cost & Coverage

Average Cost: $15 - $40 per 15gm 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 evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.