Hydrocortisone Val 0.2% Oint 15gm

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 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 Ointment is a medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema or dermatitis. It 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 as directed and follow all instructions carefully.

Application Instructions

Do not take this medication by mouth. It is for skin use only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Continue using the medication as directed, even if your symptoms improve.
Wash your hands before and after applying the medication, unless your hand is the treated area.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.

Important Usage Precautions

Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
Avoid applying the medication to the face, underarms, or groin area unless your doctor advises you to do so.
If the treated area is in the diaper region, do not use tight-fitting diapers or plastic pants, as this may increase the amount of medication absorbed into the body.

Storage and Disposal

Store the medication at room temperature and do not freeze it.
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 a drug take-back program in your area.

Missed Dose Instructions

If you miss a dose, apply it as soon as you remember.
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.
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Lifestyle & Tips

  • Apply a thin layer of ointment to the affected skin area as directed by your doctor. Do not use more than prescribed.
  • Wash your hands before and after applying the ointment, unless your hands are the treated area.
  • Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • 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 directed by your doctor.
  • Do not use for longer than prescribed, especially in children, as prolonged use can lead to skin thinning or other side effects.
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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 or 3 times daily, or as directed by a physician.

Condition-Specific Dosing:

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

Neonatal: Not established (use with extreme caution due to increased systemic absorption risk)
Infant: Apply a thin film to the affected skin areas 2 or 3 times daily. Use with caution, avoid prolonged use or occlusion.
Child: Apply a thin film to the affected skin areas 2 or 3 times daily. Use with caution, avoid prolonged use or occlusion.
Adolescent: Apply a thin film to the affected skin areas 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 adjustment needed (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 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: Varies (minimal systemic absorption; depends on skin integrity, vehicle, site, inflammation, and occlusion)
Tmax: Not well-quantified for topical application (local effect)
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not well-quantified for topical application (primarily local)
ProteinBinding: Not well-quantified for topical application (minimal systemic absorption)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not well-quantified for topical application (minimal systemic absorption)
Clearance: Not well-quantified for topical application (minimal systemic absorption)
ExcretionRoute: Renal (for systemically absorbed portion)
Unchanged: Not well-quantified for topical application
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Pharmacodynamics

OnsetOfAction: Within hours (for symptomatic relief)
PeakEffect: Days to weeks (for full therapeutic effect)
DurationOfAction: Varies (requires repeated 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 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 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 minor ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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:

  • Increased redness, itching, or irritation at the application site
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or increased hair growth in the treated area
  • Signs of infection (pus, fever, worsening pain)
  • Unusual weight gain, swelling in the face (moon face), or fatigue (signs of systemic absorption, rare but serious)
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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 or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that it is safe to take this medication in conjunction with 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, including 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, seek medical attention immediately by calling a doctor or poison control center. Do not use this medication for an extended period beyond the duration prescribed by your doctor.

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 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. Discuss this with your doctor to determine the best course of action.

If you are breast-feeding and apply this medication to 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 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:

  • Chronic overdose or misuse can lead to systemic effects of hypercorticism (Cushing's syndrome), including: weight gain, moon face, central obesity, thinning skin, easy bruising, muscle weakness, high blood pressure, high blood sugar, and adrenal suppression.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify areas for treatment.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

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

Target: Improvement in symptoms

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

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

Frequency: Regularly during treatment

Target: Absence of new or worsening adverse effects

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

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

Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients

Target: Normal physiological parameters

Action Threshold: Any signs or symptoms warrant immediate medical evaluation and potential discontinuation.

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
  • Weight gain (rare, systemic)
  • Moon face (rare, systemic)
  • Fatigue (rare, systemic)

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of teratogenicity with high systemic exposure.
Second Trimester: Limited data, theoretical risk of teratogenicity with high systemic exposure.
Third Trimester: Limited data, theoretical risk of teratogenicity with high systemic exposure; potential for adrenal suppression in neonate with extensive maternal use.
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Lactation

Caution is advised when administered to a nursing woman. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. L3 (Moderately Safe).

Infant Risk: Low risk with proper application (avoiding nipple/areola area, minimal use). Monitor infant for adverse effects.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Avoid prolonged use, large amounts, and occlusive dressings. Not recommended for infants without strict medical supervision.

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Geriatric Use

No specific dosage adjustments are typically needed. However, geriatric patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy or purpura. Monitor for skin fragility.

Clinical Information

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Clinical Pearls

  • Hydrocortisone valerate 0.2% ointment is a medium-potency topical corticosteroid, generally more potent than creams or lotions of the same active ingredient due to the occlusive nature of the ointment base.
  • Always apply a thin layer; 'less is more' with topical steroids to minimize side effects.
  • Avoid using on the face, groin, or axillae unless specifically instructed by a dermatologist, as these areas are more prone to steroid-induced side effects (e.g., skin thinning, perioral dermatitis).
  • Prolonged use, especially under occlusion or on large body surface areas, can lead to systemic absorption and adverse effects like HPA axis suppression.
  • Educate patients on the signs of skin atrophy (thinning, bruising, stretch marks) and to report them to their healthcare provider.
  • Do not abruptly stop treatment for chronic conditions; gradual tapering may be necessary to prevent rebound flares.
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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
  • Topical PDE4 inhibitors (e.g., crisaborole)
  • Emollients and moisturizers (for barrier repair)
  • Antihistamines (for pruritus)
  • Systemic therapies (for severe cases, e.g., oral corticosteroids, biologics)
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Cost & Coverage

Average Cost: $20 - $80 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 details. 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.