Hydrocortisone Val 0.2% Ont 60gm

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; Anti-inflammatory agent
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Pharmacologic Class
Glucocorticoid
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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 ointment is a type of medicine called a corticosteroid. It is used on the skin to reduce inflammation, redness, itching, and swelling caused by various skin conditions like eczema or dermatitis.
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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're treating a skin condition on your hand, do not wash your hand after application.

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're treating a skin condition in the diaper area, avoid using 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. You can also check with your pharmacist about drug take-back programs in your area.

Missing a Dose

If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not apply two doses at once or use extra doses to make up for a missed one.
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Lifestyle & Tips

  • Apply a thin layer only to the affected skin area as directed by your doctor. Do not use more often or for longer than prescribed.
  • Wash your hands thoroughly before and after applying the ointment.
  • Avoid contact with your eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on the face, groin, or underarms unless specifically directed by your doctor.
  • Do not bandage, wrap, or cover the treated area with an occlusive dressing unless instructed by your doctor, as this can increase absorption and side effects.
  • Do not use for diaper rash unless specifically recommended by a doctor, as diapers can act as occlusive dressings.
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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. Rub in gently and completely.

Condition-Specific Dosing:

eczema: Apply a thin film to the affected skin area 2 or 3 times daily.
dermatitis: 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 due to high risk of systemic absorption)
Infant: Apply a thin film to the affected skin area 2 or 3 times daily. Use with caution, avoid prolonged use or occlusive dressings. Consult pediatrician.
Child: Apply a thin film to the affected skin area 2 or 3 times daily. Use with caution, avoid prolonged use or occlusive dressings. Consult pediatrician.
Adolescent: Apply a thin film to the affected skin area 2 or 3 times daily. Use with caution, avoid prolonged use or occlusive dressings.
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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 corticosteroid. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Corticosteroids also suppress the migration of polymorphonuclear leukocytes and reverse increased capillary permeability, thereby exerting anti-inflammatory, antipruritic, and vasoconstrictive actions.
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Pharmacokinetics

Absorption:

Bioavailability: Low (minimal systemic absorption through intact skin; can increase with inflammation, skin barrier disruption, prolonged use, large surface areas, or occlusive dressings)
Tmax: Not typically measured for topical application (local effect)
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not applicable (minimal systemic distribution)
ProteinBinding: If absorbed systemically, binds to plasma proteins (e.g., transcortin, albumin)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not typically measured for topical application (local effect; systemic half-life of hydrocortisone is ~80-118 minutes)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Renal (if absorbed systemically)
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Within hours to days (local anti-inflammatory and antipruritic effects)
PeakEffect: Varies, sustained with continued application
DurationOfAction: Effects persist as long as applied, and for some time after discontinuation depending on the condition

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 symptoms, contact your doctor or seek immediate medical attention:

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 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. While many people may not experience any 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 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, don't hesitate to reach out to 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:

  • Worsening of your skin condition or no improvement after the prescribed duration.
  • Signs of a skin infection (e.g., pus, increased pain, redness, warmth, fever).
  • Severe burning, stinging, or irritation at the application site.
  • Changes in your skin such as thinning, easy bruising, stretch marks, or unusual hair growth.
  • Any signs of systemic side effects, which are rare but possible with extensive or prolonged use (e.g., unusual weight gain, swelling in ankles/feet, increased thirst or urination, fatigue, muscle weakness).
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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. Do not initiate, discontinue, or modify 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.

To minimize potential risks, avoid applying this medication to cuts, scrapes, or damaged skin. If you need to use it on a large area of skin, discuss this with your doctor to determine the best course of action.

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 determine the best approach.

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 if you have any questions or concerns, consult with your doctor.

It is vital to inform your doctor if you are pregnant, planning to become pregnant, or are breast-feeding. Your doctor will help you weigh the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

  • Systemic overdose is rare with topical use but can occur with prolonged, extensive use, especially in children.
  • Symptoms may include signs of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, striae), hyperglycemia (high blood sugar), glucosuria (sugar in urine), and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (fatigue, weakness, low blood pressure).

What to Do:

If you suspect an overdose or experience severe side effects, contact your doctor or a poison control center immediately (e.g., 1-800-222-1222). Management is supportive; gradual withdrawal of the drug may be necessary if HPA axis suppression occurs.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity and extent of dermatosis.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, miliaria)

Frequency: Regularly during therapy, especially with prolonged use.

Target: Absence of new or worsening local effects.

Action Threshold: If severe or persistent, discontinue use and reassess treatment.

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

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

Target: Normal adrenal function, normal blood glucose.

Action Threshold: If suspected, perform appropriate tests (e.g., ACTH stimulation test, plasma cortisol, urinary free cortisol, blood glucose). Discontinue or gradually withdraw medication.

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Symptom Monitoring

  • Worsening skin condition
  • Signs of skin infection (e.g., pus, increased redness, warmth, pain, fever)
  • Severe burning or stinging at application site
  • Skin thinning, easy bruising, or stretch marks
  • Unusual hair growth
  • Increased thirst or urination (possible hyperglycemia)
  • Fatigue, weakness, weight gain, moon face, buffalo hump (possible Cushing's syndrome)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid large areas or prolonged use.

Trimester-Specific Risks:

First Trimester: Potential risk, use only if clearly needed.
Second Trimester: Potential risk, use only if clearly needed.
Third Trimester: Potential risk, use only if clearly needed.
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Lactation

Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic absorption is minimal. 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.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension, growth retardation). Use the least potent effective corticosteroid for the shortest duration possible. Avoid occlusive dressings. Close monitoring for systemic effects is crucial.

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Geriatric Use

No specific dosage adjustments needed. However, elderly patients may have thinner skin, which could increase the risk of local side effects like atrophy, purpura, and skin tears. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone valerate 0.2% is a medium-potency topical corticosteroid.
  • Ointments are generally more potent than creams for the same concentration and are preferred for dry, scaly, or lichenified lesions.
  • Educate patients on proper application technique: apply a very thin film and rub in gently until it disappears.
  • Warn patients about the potential for skin atrophy, striae, and telangiectasias, especially with prolonged use on sensitive areas (e.g., face, intertriginous areas, skin folds).
  • For chronic conditions, consider step-down therapy to a lower potency steroid or intermittent use (e.g., 2-3 days a week) to minimize side effects and prevent tachyphylaxis.
  • If no improvement is seen after 2 weeks, re-evaluate the diagnosis and treatment plan.
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Alternative Therapies

  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
  • Emollients and moisturizers for dry skin conditions
  • Antihistamines for pruritus (oral or topical, if appropriate)
  • Phototherapy for certain chronic inflammatory skin conditions (e.g., psoriasis)
  • Systemic immunomodulators (for severe, widespread conditions not responsive to topical therapy)
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Cost & Coverage

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 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.