Hydrocortisone Val 0.2% Oint 60gm

Manufacturer COSETTE PHARMACEUTICALS Active Ingredient Hydrocortisone Cream, Gel, Ointment, and Solution(hye droe KOR ti sone) Pronunciation hye droe KOR ti sone
It is used to treat skin irritation.It is used to treat skin rashes.
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Drug Class
Corticosteroid, Topical
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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 psoriasis. 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. It is essential to use this medication only as directed.

Application Instructions

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, eyes, or vagina, as it may cause burning.
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.

Special Precautions

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

  • Apply a thin layer only to the affected skin areas as directed by your doctor.
  • Wash your hands before and after applying the ointment.
  • 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 using on the face, groin, or armpits unless specifically directed by your doctor, as these areas are more prone to side effects.
  • Do not use for longer than prescribed, especially in children, to avoid potential side effects.
  • 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 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.
psoriasis: Apply a thin film to the affected skin areas 2 or 3 times daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Apply a thin film to the affected skin areas 2 or 3 times daily, with caution. Avoid prolonged use or occlusive dressings due to increased systemic absorption risk.
Child: Apply a thin film to the affected skin areas 2 or 3 times daily, with caution. Avoid prolonged use or occlusive dressings due to increased systemic absorption risk.
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 specific adjustment needed for topical use.
Moderate: No specific adjustment needed for topical use.
Severe: No specific adjustment needed for topical use.
Dialysis: No specific adjustment needed for topical use.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Hydrocortisone valerate is a medium-potency topical 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: Variable (depends on vehicle, skin integrity, site of application, duration of exposure, and use of occlusive dressings). Systemic absorption can occur.
Tmax: Not precisely defined for topical application due to variable absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not precisely defined for topical application; systemically absorbed drug distributes throughout the body.
ProteinBinding: High (to plasma proteins, primarily transcortin and albumin) once systemically absorbed.
CnssPenetration: Limited (systemic absorption can lead to CNS effects, but not a primary route of action).

Elimination:

HalfLife: Approximately 8-12 hours (for systemically absorbed hydrocortisone).
Clearance: Not precisely defined for topical application.
ExcretionRoute: Renal (primarily as inactive metabolites).
Unchanged: Minimal (primarily excreted as metabolites).
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief.
PeakEffect: Days to weeks for full therapeutic effect.
DurationOfAction: Depends on frequency of application and severity of condition.

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 experience no 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 symptoms that bother you or do not go away, contact your doctor:

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).
  • Development of new skin infections.
  • Acne-like breakouts or increased hair growth in the treated area.
  • Any signs of systemic effects like unusual weight gain, swelling in the face, or feeling unusually tired (especially in children).
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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 change 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 in 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 if you have any questions or concerns, consult with your doctor.

It is also important to inform your doctor if you are pregnant, plan to become pregnant, or are breast-feeding, as you will need to discuss the potential benefits and risks of using this medication to ensure the best outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Chronic overdose or misuse can lead to signs of hypercorticism (Cushing's syndrome), including: weight gain, moon face, buffalo hump, thinning skin, easy bruising, striae, hyperglycemia, hypertension, 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, erythema)

Frequency: Weekly to bi-weekly during initial treatment, then as needed.

Target: Improvement in symptoms.

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

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

Frequency: At each follow-up visit.

Target: Absence or minimal signs of adverse reactions.

Action Threshold: Presence of significant adverse reactions may require dose reduction, discontinuation, or change in therapy.

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

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

Target: Normal physiological parameters.

Action Threshold: Any signs of systemic effects warrant immediate medical evaluation and discontinuation of therapy.

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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 (especially in children)
  • Moon face (especially in children)
  • Growth retardation (in children)

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, though data for topical corticosteroids is limited and generally low risk.
Second Trimester: Risk of fetal growth restriction or adrenal suppression with high-potency or extensive use.
Third Trimester: Risk of fetal growth restriction or adrenal suppression with high-potency or extensive use.
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Lactation

Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use, but potential for systemic effects in infant if significant absorption occurs in mother and transferred via milk.
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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, especially with occlusive dressings. Monitor for signs of systemic toxicity and growth retardation.

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Geriatric Use

No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could increase susceptibility to local adverse effects like skin atrophy and purpura. Monitor for skin fragility.

Clinical Information

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Clinical Pearls

  • Hydrocortisone valerate 0.2% ointment is a medium-potency topical corticosteroid.
  • Apply sparingly and only to affected areas. A 'thin film' means just enough to cover the lesion.
  • Avoid prolonged use, especially on the face, groin, or axillae, due to increased risk of skin atrophy, telangiectasias, and striae.
  • Occlusive dressings significantly increase systemic absorption and local side effects; use only if specifically directed by a physician.
  • Patients should be advised to report any signs of local adverse reactions or systemic effects.
  • Not for ophthalmic use.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, fluocinolone, betamethasone, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies for severe or widespread dermatoses
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Cost & Coverage

Average Cost: $20 - $60 per 60gm tube
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 taken, the amount, and the time it happened.