Halcinonide 0.1% Cream 30gm

Manufacturer MYLAN Active Ingredient Halcinonide(hal SIN oh nide) Pronunciation hal SIN oh nide
It is used to treat skin rashes and other skin irritation.
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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
Aug 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Halcinonide cream is a strong medicine applied to the skin to reduce redness, swelling, and itching caused by certain skin conditions like eczema or psoriasis. 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. Continue using the medication as directed, even if your symptoms improve.

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, or eyes, 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 make sure it is completely dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.
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 heat sources, and do not freeze.
Keep all medications in a safe place, out of the reach of children and pets.

Missed Dose

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

  • Wash your hands before and after applying the cream.
  • Apply a thin layer of cream only to the affected skin areas, as directed by your doctor.
  • Rub it in gently until it disappears.
  • Do not cover the treated area with bandages or dressings unless specifically told to by your doctor, as this can increase absorption and side effects.
  • Avoid applying the cream to your eyes, mouth, or inside your nose.
  • Do not use this cream for longer than prescribed, especially on the face, groin, or armpits, as it can cause skin thinning.
  • Do not use on children without consulting a doctor, as they are more sensitive to its effects.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas two to three times daily.

Condition-Specific Dosing:

occlusion: Occlusive dressings may be used for severe or resistant conditions, but should be used with caution due to increased systemic absorption.
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Pediatric Dosing

Neonatal: Not established
Infant: Use with caution; not recommended for prolonged use or extensive areas due to increased risk of systemic absorption and adrenal suppression.
Child: Use with caution; not recommended for prolonged use or extensive areas due to increased risk of systemic absorption and adrenal suppression.
Adolescent: Similar to adult dosing, but monitor closely for systemic effects.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical application.
Moderate: No specific adjustment needed for topical application.
Severe: No specific adjustment needed for topical application.
Dialysis: No specific considerations for topical application.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Halcinonide is a potent synthetic corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins, collectively called 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: Systemic absorption varies depending on the vehicle, integrity of the epidermal barrier, and the use of occlusive dressings. Absorption is increased on thin skin areas (e.g., face, groin, axillae) and with inflammation or other diseases of the skin. Generally low systemic absorption.
Tmax: Not precisely quantified for topical application; local effect is rapid.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not precisely quantified for topical application.
ProteinBinding: Systemically absorbed corticosteroids are bound to plasma proteins to varying degrees.
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely quantified for topical application; systemic half-life of absorbed drug is variable.
Clearance: Not precisely quantified for topical application.
ExcretionRoute: Metabolites are excreted primarily in the urine, and to a lesser extent in the bile.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief (e.g., reduction in itching, redness).
PeakEffect: Within days of consistent application.
DurationOfAction: Local effect persists for several hours after application.

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 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 Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
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 high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Irritation where the medication was applied
Change in skin color
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 help if they bother you or do not go away:

Dry skin
Itching
* Burning

This is not a comprehensive list of all 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:

  • Skin irritation, burning, or itching that gets worse after applying the cream.
  • Signs of skin infection (e.g., pus, spreading redness, fever).
  • Thinning of the skin, easy bruising, or stretch marks in the treated area.
  • Unusual weight gain, swelling in the face, or increased fatigue (signs of systemic absorption).
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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.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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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.

When applying this medication, avoid putting it on cuts, scrapes, or damaged skin to prevent potential complications. If you need to use this medication on a large area of skin, exercise caution and discuss this with your doctor to determine the best course of action.

Do not use this medication for a longer period than prescribed by your doctor. If the patient is a child, use this medication with caution, as children may be at a higher risk for certain side effects. In some cases, this medication may affect growth in children and teenagers, so regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during these situations to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic effects similar to those seen with oral corticosteroids, including adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure), Cushing's syndrome (moon face, buffalo hump, central obesity, thin skin, striae), hyperglycemia, and glucosuria.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To determine severity of dermatosis and establish a baseline for treatment efficacy.

Timing: Prior to initiation of therapy.

Area of involvement

Rationale: To assess the extent of disease and potential for systemic absorption.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Weekly or as clinically indicated.

Target: Improvement in symptoms.

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, telangiectasias, folliculitis, burning, itching)

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, glucosuria, adrenal suppression)

Frequency: Periodically, especially with prolonged use, extensive body 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

  • Worsening of skin condition
  • Increased redness, swelling, or pain at application site (signs of infection)
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Easy bruising
  • Increased hair growth at application site
  • Acne-like eruptions
  • Changes in vision (e.g., blurred vision, glaucoma, cataracts)
  • Unusual fatigue or weakness
  • Weight gain, especially in the face and trunk

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 are limited and generally low risk with appropriate use.
Second Trimester: Risk of fetal growth restriction or adrenal suppression with extensive or prolonged use.
Third Trimester: Risk of fetal adrenal suppression with extensive or prolonged 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 limited, short-term use. Potential for adverse effects if significant systemic absorption occurs in the mother and drug is transferred to milk.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Prolonged use should be avoided. Not recommended for infants or young children unless specifically directed by a physician.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local adverse effects like skin atrophy and purpura. Monitor closely.

Clinical Information

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Clinical Pearls

  • Halcinonide 0.1% is a high-potency topical corticosteroid; use should be limited to short-term treatment of severe dermatoses.
  • Avoid use on the face, groin, or axillae unless specifically directed by a dermatologist, due to increased risk of skin atrophy and other local side effects.
  • Patients should be instructed to apply the cream sparingly and only to the affected areas.
  • Discontinuation should be gradual after prolonged use to prevent rebound flares of the dermatosis.
  • Educate patients on signs of local adverse effects (e.g., skin thinning, striae) and systemic absorption (e.g., weight gain, fatigue).
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Alternative Therapies

  • Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Betamethasone dipropionate augmented)
  • Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
  • Low-potency topical corticosteroids (e.g., Hydrocortisone)
  • Calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for certain inflammatory skin conditions, especially on sensitive areas.
  • Systemic therapies (e.g., oral corticosteroids, biologics) for severe, widespread, or recalcitrant dermatoses.
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Cost & Coverage

Average Cost: $50 - $150 per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (preferred or non-preferred brand/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 occurred.