Hydrocortisone Val 0.2% Ont 45gm

Manufacturer TARO 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
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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 ointment is a topical steroid medication used to reduce inflammation, redness, and itching caused by various skin conditions like eczema and dermatitis. It works by calming down the skin's immune 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, eyes, or vagina, as it may cause burning.

Application Instructions

1. Wash your hands before and after applying the medication, unless your hand is the treated area.
2. Clean the affected area before applying the medication and dry it thoroughly.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
5. Avoid applying the medication to your face, underarms, or groin area unless your doctor specifically tells you to do so.
6. If you are treating a 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. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.

Missed Dose Instructions

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 dose.
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Lifestyle & Tips

  • Wash hands before and after applying the ointment.
  • Apply a thin layer to the affected area and rub in gently. Do not use more than directed.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on the face, groin, or armpits unless specifically directed by your doctor, as these areas are more susceptible to side effects.
  • Do not cover the treated area with bandages or other occlusive dressings unless instructed by your doctor, as this can increase absorption and side effects.
  • Do not use for longer than prescribed, especially in children, as prolonged use can lead to skin thinning or other side effects.
  • Inform your doctor if your condition does not improve within 2 weeks 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 skin area 2 to 3 times daily.

Condition-Specific Dosing:

eczema: Apply a thin film to the affected area 2-3 times daily.
dermatitis: Apply a thin film to the affected area 2-3 times daily.
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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); use lowest effective dose for shortest duration if necessary.
Child: Apply a thin film to the affected skin area 2 to 3 times daily, but limit duration and area of application due to increased risk of systemic absorption and adrenal suppression. Use lowest effective dose for shortest duration.
Adolescent: Apply a thin film to the affected skin area 2 to 3 times daily.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Hydrocortisone valerate is a medium-potency 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 suppress the immune response, reduce capillary permeability, and inhibit migration of polymorphonuclear leukocytes.
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Pharmacokinetics

Absorption:

Bioavailability: Low (minimal systemic absorption from topical application); absorption increases with occlusive dressings, inflamed skin, and in children.
Tmax: Not applicable for topical use (systemic levels are generally undetectable or very low).
FoodEffect: Not applicable for topical use.

Distribution:

Vd: Not applicable for topical use (minimal systemic distribution).
ProteinBinding: High (for systemically absorbed hydrocortisone, primarily to corticosteroid-binding globulin and albumin).
CnssPenetration: Limited (for systemically absorbed hydrocortisone).

Elimination:

HalfLife: Approximately 8-12 hours (for systemically absorbed hydrocortisone).
Clearance: Not applicable for topical use (minimal systemic clearance).
ExcretionRoute: Renal (for systemically absorbed hydrocortisone).
Unchanged: Minimal (for systemically absorbed hydrocortisone).
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Days to weeks depending on condition and severity.
DurationOfAction: Varies with application frequency and individual response.

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

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 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 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 attention if they bother you or do not go away:

Burning or stinging
Dryness
* Tingling

Reporting Side Effects

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:

  • Signs of skin infection (increased redness, swelling, pus, fever)
  • Severe burning, itching, or irritation at the application site
  • Skin thinning, stretch marks, or easy bruising
  • Acne-like breakouts
  • Unusual hair growth
  • Any signs of systemic side effects (e.g., unusual weight gain, swelling in face, fatigue, muscle weakness - rare but serious with extensive/prolonged 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 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 it is safe to take this medication 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 products on your skin, including soaps, consult with your doctor.

To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. When using it on a large area of skin, exercise caution and discuss this with your doctor.

If this medication is accidentally swallowed, seek immediate medical attention by calling a doctor or poison control center. 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. 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 may affect growth in children and teenagers, necessitating regular growth checks; consult with your doctor to discuss this risk.

If you are breast-feeding and using this medication on your breast or nipple, ensure you wash the area thoroughly before breast-feeding your child. Certain formulations 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, plan to become pregnant, or are breast-feeding, inform your doctor, as they will need to discuss the potential 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:

  • Acute overdose with topical application is unlikely due to minimal systemic absorption.
  • Chronic excessive use, especially over large surface areas or under occlusion, can lead to systemic effects such as Cushing's syndrome, hyperglycemia, and adrenal suppression.

What to Do:

Discontinue use and consult a healthcare professional. For suspected systemic effects, medical evaluation and supportive care are necessary. Call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any signs of infection.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, itching)

Frequency: Regularly during treatment (e.g., weekly or bi-weekly).

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 reactions (e.g., skin atrophy, striae, folliculitis, burning, itching)

Frequency: Regularly during treatment.

Target: Absence of or minimal adverse effects.

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

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

Frequency: Periodically, especially with prolonged use, large surface area application, 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

  • Worsening of skin condition
  • Increased redness, swelling, or pain (signs of infection)
  • Severe burning, itching, or irritation at application site
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like eruptions
  • Increased hair growth at application site
  • Changes in vision (rare, with prolonged high-dose use)

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-dose systemic corticosteroids; topical absorption is minimal but caution advised.
Second Trimester: Minimal risk with appropriate topical use.
Third Trimester: Minimal risk with appropriate topical use; however, prolonged or extensive use near term could theoretically affect fetal adrenal function.
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Lactation

Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic corticosteroids are excreted in human milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use due to minimal systemic absorption, but monitor infant for potential adverse effects if used extensively by mother.
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Pediatric Use

Children are more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) due to a larger skin surface area to body weight ratio. Use the lowest effective dose for the shortest duration. Avoid occlusive dressings. Not recommended for infants unless specifically directed by a physician.

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Geriatric Use

Generally safe for use in the elderly. However, geriatric patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy. Monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone valerate 0.2% ointment is a medium-potency topical corticosteroid, suitable for inflammatory dermatoses that respond to steroids.
  • Ointment formulations are generally more potent and occlusive than creams or lotions, making them suitable for dry, scaly lesions.
  • Educate patients on the 'less is more' principle: a thin film is sufficient. Excessive application does not increase efficacy but increases risk of side effects.
  • Avoid abrupt discontinuation after prolonged use on sensitive areas (e.g., face) to prevent rebound flares.
  • Always consider the potential for skin infection when using corticosteroids, as they can mask or worsen infections.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinonide, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
  • Emollients and moisturizers for barrier repair
  • Antihistamines for symptomatic relief of itching
  • Systemic therapies (e.g., oral corticosteroids, immunosuppressants) for severe, widespread conditions
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Cost & Coverage

Average Cost: $20 - $60 per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred 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 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 ensure you receive the best possible care.