Hydrocortisone Val 0.2% Cream 45gm

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
Anti-inflammatory agent
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Pharmacologic Class
Topical Corticosteroid (Medium Potency)
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Pregnancy Category
Category C
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FDA Approved
Aug 1979
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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 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, avoiding freezing. 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 continue with 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 to the affected area and rub it in gently until it disappears.
  • Do not use more than directed or for longer than prescribed.
  • Avoid applying the cream to your eyes, mouth, or inside your nose.
  • 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.
  • Do not use on the face, groin, or armpits unless directed by your 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 film to the affected skin area 2 or 3 times daily.

Condition-Specific Dosing:

general: Apply sparingly and rub in gently. Do not use occlusive dressings unless directed by a physician.
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Pediatric Dosing

Neonatal: Not established (increased risk of systemic absorption and adrenal suppression)
Infant: Not established (increased risk of systemic absorption and adrenal suppression)
Child: Apply a thin film to the affected skin area 2 or 3 times daily. Use the smallest amount for the shortest duration possible. Avoid occlusive dressings. Monitor closely for systemic effects.
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 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)

Pharmacology

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Mechanism of Action

Hydrocortisone valerate is a medium-potency topical corticosteroid. Corticosteroids diffuse across cell membranes and bind to specific cytoplasmic glucocorticoid receptors. These complexes then enter the nucleus, bind to DNA (glucocorticoid response elements), and modulate gene expression. This leads to the synthesis of lipocortins (annexins), which are phospholipase A2 inhibitory proteins. Lipocortins inhibit the release of arachidonic acid from membrane phospholipids, thereby preventing the synthesis of potent mediators of inflammation such as prostaglandins and leukotrienes. Corticosteroids also suppress the immune response by inhibiting the migration of macrophages and leukocytes to the site of inflammation, stabilizing lysosomal membranes, and reducing capillary permeability.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <1%), but can increase with inflammation, skin barrier disruption, occlusion, large surface area application, or prolonged use.
Tmax: Not applicable for systemic Tmax for topical application; local effect onset within hours to days.
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for systemic Vd; primarily distributed within the skin layers.
ProteinBinding: If absorbed systemically, binds to plasma proteins (e.g., transcortin, albumin).
CnssPenetration: Limited/No (minimal systemic absorption)

Elimination:

HalfLife: Not well-defined for topical due to minimal systemic absorption; systemic half-life of hydrocortisone is approximately 80-118 minutes.
Clearance: Not applicable for topical; systemic clearance is primarily hepatic.
ExcretionRoute: Renal (if absorbed systemically)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Hours to days (for noticeable clinical improvement)
PeakEffect: Days to weeks (with consistent application)
DurationOfAction: Varies with application frequency and individual response; effects persist as long as applied.

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 passing out
+ 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 where the medication was applied
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 may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

Burning or stinging
Dryness
* Tingling

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 irritation, burning, itching, or redness at the application site.
  • Development of new skin problems like thinning skin, stretch marks, or acne.
  • Signs of skin infection (pus, increased pain, fever).
  • Any signs of systemic side effects, such as unusual weight gain, swelling in the face, or extreme tiredness (especially with prolonged or extensive 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.
* Any existing health problems, as this medication may interact with other drugs or health conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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 monitor your child's growth.

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

If you are pregnant, planning 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:

  • Acute overdose with topical application is unlikely due to minimal systemic absorption.
  • Chronic overuse or use on large body surface areas, especially under occlusion, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, glucosuria, and adrenal suppression (fatigue, weakness, dizziness).

What to Do:

If chronic systemic toxicity occurs, gradually withdraw the drug under medical supervision. Symptomatic and supportive treatment. For acute ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To determine the type and extent of dermatosis and establish a baseline for treatment efficacy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Therapeutic response

Frequency: Weekly to monthly, or as clinically indicated

Target: Reduction in inflammation, pruritus, erythema, and scaling.

Action Threshold: Lack of improvement or worsening of 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, especially with prolonged use

Target: Absence of or minimal adverse effects.

Action Threshold: Development of significant local adverse effects warrants discontinuation or reduction in frequency/potency.

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

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings, and in pediatric patients.

Target: Normal adrenal function and metabolic parameters.

Action Threshold: Any signs or symptoms of systemic absorption require immediate medical evaluation and potential discontinuation.

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Symptom Monitoring

  • Increased skin irritation (burning, itching, redness)
  • Skin thinning, easy bruising, striae (stretch marks)
  • Acne-like eruptions or folliculitis
  • Signs of skin infection (pus, increased pain, fever)
  • Unusual hair growth
  • Weight gain, moon face, buffalo hump (signs of Cushing's syndrome)
  • Fatigue, weakness, dizziness (signs of adrenal suppression)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with systemically administered corticosteroids. Avoid large areas, prolonged use, or occlusive dressings.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption from topical use is minimal.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Risk of fetal adrenal suppression with prolonged or high-dose use, though unlikely with typical topical application.
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Lactation

L3 (Moderately Safe). Unknown if excreted in human milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use (avoiding breast area, large areas, prolonged use). Monitor infant for signs of systemic corticosteroid effects (e.g., growth suppression).
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Pediatric Use

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., adrenal suppression, Cushing's syndrome, intracranial hypertension). Use the smallest effective dose for the shortest duration possible. Avoid occlusive dressings. Close monitoring for growth retardation and other systemic effects is recommended.

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Geriatric Use

Generally safe. However, geriatric patients may have thinner, more fragile skin, increasing the risk of local adverse effects like skin atrophy and purpura. Monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone valerate is a medium-potency topical corticosteroid, suitable for various inflammatory dermatoses.
  • Educate patients on proper application technique: thin layer, gentle rubbing, and avoiding overuse.
  • Emphasize the importance of not using occlusive dressings unless specifically instructed by a healthcare provider, especially in children, due to increased systemic absorption.
  • Monitor for local side effects such as skin atrophy, striae, and telangiectasias, particularly with prolonged use or on sensitive areas.
  • Be vigilant for signs of systemic absorption (e.g., adrenal suppression, Cushing's syndrome), especially in pediatric patients or with extensive application.
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Alternative Therapies

  • Other topical corticosteroids (e.g., hydrocortisone, triamcinolone, clobetasol, betamethasone) of varying potencies.
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy.
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole).
  • Emollients and moisturizers for barrier repair.
  • Systemic therapies (e.g., oral corticosteroids, immunosuppressants) for severe or widespread conditions.
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Cost & Coverage

Average Cost: $30 - $100 per 45gm tube (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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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 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.