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Hydrocortisone Val 0.2% Oint 45gm

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
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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 topical medication that belongs to a class of drugs called corticosteroids. It is used to reduce inflammation, redness, and itching caused by various skin conditions such as eczema, dermatitis, and psoriasis. It works by calming the immune response in the skin.
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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. If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.

Missed Dose

If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular application 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

  • Apply a thin layer of the ointment to the affected skin area exactly as directed by your doctor, usually 2 to 3 times a day.
  • Wash your hands thoroughly before and after applying the ointment.
  • Do not cover the treated area with bandages, plastic wrap, or tight dressings unless specifically instructed by your doctor, as this can increase the amount of medication absorbed into your body.
  • Avoid applying the ointment to the face, groin, or armpits unless your doctor has specifically told you to do so.
  • Do not use the ointment for longer than prescribed, especially on children, as this can increase the risk of side effects.
  • Avoid contact with your eyes. If contact occurs, rinse thoroughly with water.
  • Keep the medication out of reach of children and pets.
  • Inform your doctor if your condition does not improve after 2-4 weeks of treatment, 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 area 2 to 3 times daily.

Condition-Specific Dosing:

corticosteroidResponsiveDermatoses: Apply a thin film to the affected area 2 to 3 times daily. Rub in gently and completely.
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Pediatric Dosing

Neonatal: Not established. Use with extreme caution; increased risk of systemic absorption and adverse effects.
Infant: Not established. Use with extreme caution; increased risk of systemic absorption and adverse effects, especially under occlusive dressings or on large surface areas.
Child: Apply a thin film to the affected area 2 to 3 times daily. Use the lowest effective dose for the shortest duration possible. Avoid prolonged use or application to large body surface areas. Avoid occlusive dressings.
Adolescent: Same as adult dosing. Apply a thin film to the affected area 2 to 3 times daily.
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Dose Adjustments

Renal Impairment:

Mild: Not typically required for topical application due to minimal systemic absorption.
Moderate: Not typically required for topical application due to minimal systemic absorption.
Severe: Not typically required for topical application due to minimal systemic absorption.
Dialysis: Considerations: Not typically required for topical application due to minimal systemic absorption, unless extensive use or impaired skin barrier leads to significant systemic absorption.

Hepatic Impairment:

Mild: Not typically required for topical application due to minimal systemic absorption.
Moderate: Not typically required for topical application due to minimal systemic absorption.
Severe: Not typically required for topical application due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Hydrocortisone valerate is a corticosteroid. Corticosteroids diffuse across cell membranes and bind to specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA (chromatin), and stimulate the transcription of mRNA and subsequent protein synthesis of various enzymes thought to be responsible for the anti-inflammatory effects. They inhibit the release of hydrolytic enzymes from leukocytes, prevent macrophage accumulation in inflamed areas, reduce adhesion of leukocytes to capillary walls, reduce dilation and permeability of capillaries, and decrease edema formation. They also suppress the immune system by inhibiting lymphocyte proliferation and function.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (0.2% to 5% or more depending on skin integrity, vehicle, site, and occlusion). Absorption is increased by occlusion, inflammation, and in areas with thin skin (e.g., face, groin, axillae).
Tmax: Not well-defined for systemic effects; local anti-inflammatory effect onset is within hours.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not applicable for topical administration; minimal systemic distribution.
ProteinBinding: High (to transcortin and albumin) once absorbed systemically.
CnssPenetration: Limited (systemic absorption is minimal, thus CNS penetration is negligible for topical use).

Elimination:

HalfLife: Systemic half-life of hydrocortisone is approximately 8-12 hours, but topical absorption is slow and variable.
Clearance: Renal excretion of inactive metabolites.
ExcretionRoute: Urine (primarily metabolites).
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours for anti-inflammatory and antipruritic effects.
PeakEffect: Days to weeks for full therapeutic effect, depending on the condition.
DurationOfAction: Varies; typically requires 2-3 times daily application for sustained effect.
Confidence: High

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:

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 may only have 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

This is not an exhaustive list of all 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:

  • Worsening of your skin condition or no improvement after the prescribed treatment period.
  • Signs of a new skin infection (e.g., increased pain, redness, swelling, pus, fever).
  • Severe burning, itching, irritation, or dryness at the application site.
  • Signs of skin thinning, such as easy bruising, stretch marks (striae), or shiny skin.
  • Acne-like eruptions or increased hair growth in the treated area.
  • Changes in skin color (lightening or darkening).
  • Rarely, signs of systemic absorption like unusual weight gain, swelling in the face or neck, increased thirst or urination, or fatigue (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 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 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 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.

In case of accidental ingestion, this medication can be harmful. If swallowed, immediately contact a doctor or a poison control center.

Adhere to your doctor's prescribed duration of use and do not exceed it. Prolonged use may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor.

Certain products may not be suitable for use in the diaper area, so consult with your doctor before application. When using this medication on children, exercise caution, as they may be at a higher risk of experiencing 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 course of action.

If you are breast-feeding and apply this medication to your breast or nipple, make sure to wash the area thoroughly before feeding your child.

Some 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, planning to become pregnant, or are breast-feeding, inform your doctor. It is essential 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:

What to Do:

Discontinue use gradually under medical supervision. Symptomatic and supportive treatment for systemic effects. For accidental ingestion or significant systemic exposure, contact a poison control center immediately. Call 1-800-222-1222 for poison control advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (type, severity, extent of dermatosis)

Rationale: To establish baseline for treatment efficacy, identify potential contraindications (e.g., fungal infections), and guide appropriate use.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, lesion size)

Frequency: Regularly, as per physician's instructions (e.g., weekly to bi-weekly initially, then as needed).

Target: Resolution or significant improvement of symptoms.

Action Threshold: Lack of improvement, worsening of condition, or development of adverse effects.

Adverse skin reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis, secondary infection, acneiform eruptions)

Frequency: At each follow-up visit and with patient self-monitoring.

Target: Absence of adverse reactions.

Action Threshold: Presence of any adverse reaction, especially those indicating prolonged use or high potency effects.

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

Frequency: Periodically, especially with extensive use, prolonged use, or in pediatric patients. Consider laboratory tests (e.g., morning cortisol, ACTH stimulation test) if systemic absorption is suspected.

Target: Normal HPA axis function.

Action Threshold: Symptoms or lab values suggestive of systemic corticosteroid effects.

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Symptom Monitoring

  • Improvement in redness, swelling, and itching of the treated area.
  • Signs of skin thinning or damage (e.g., easy bruising, stretch marks, shiny skin).
  • Signs of secondary skin infection (e.g., increased pain, pus, fever, spreading redness).
  • Unusual hair growth or changes in skin color.
  • Symptoms of systemic absorption (rare): unusual weight gain, swelling in face/neck (moon face), increased thirst/urination (hyperglycemia), fatigue, weakness.

Special Patient Groups

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Pregnancy

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

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high systemic exposure, but topical absorption is minimal and risk is generally considered low with appropriate use.
Second Trimester: Similar to first trimester; minimal risk with appropriate topical use.
Third Trimester: Potential for low birth weight or adrenal suppression in the neonate with extensive maternal use, though rare with topical application.
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Lactation

L3 (Moderately safe). Use with caution. It is not known whether topical hydrocortisone is excreted in human milk. However, systemic absorption is minimal. Avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk with appropriate use; monitor the infant for any signs of adverse effects if the mother uses the medication extensively.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation). Use the lowest effective dose for the shortest duration possible. Avoid occlusive dressings. Monitor closely for signs of systemic effects.

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Geriatric Use

No specific dosage adjustments are needed. Elderly patients may have thinner skin, which could potentially increase susceptibility to local adverse effects like atrophy, purpura, and telangiectasias. Use with caution and monitor skin integrity.

Clinical Information

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Clinical Pearls

  • Hydrocortisone valerate 0.2% is considered a medium-potency topical corticosteroid.
  • Educate patients on the 'less is more' principle: a thin layer is sufficient. Over-application does not increase efficacy but increases the risk of side effects.
  • Warn patients about the potential for skin atrophy, especially on sensitive areas like the face, intertriginous areas (skin folds), and in children.
  • If no improvement is seen after 2-4 weeks of treatment, re-evaluate the diagnosis and consider alternative therapies or referral to a dermatologist.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to a rebound flare of the dermatosis.
  • Topical corticosteroids should not be used for skin infections (bacterial, fungal, viral) without concomitant appropriate antimicrobial therapy, as they can worsen infections.
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Alternative Therapies

  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
  • Emollients and moisturizers (as primary therapy for dry skin conditions or adjunct to corticosteroids).
  • Antihistamines (oral or topical) for symptomatic relief of pruritus.
  • Phototherapy (UVB, PUVA) for extensive or severe dermatoses.
  • Systemic immunosuppressants (e.g., methotrexate, cyclosporine) for severe, refractory cases.
  • Crisaborole (Eucrisa) for mild to moderate atopic dermatitis.
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Cost & Coverage

Average Cost: Typically low cost for generic; varies by pharmacy and insurance plan. per 45gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.