Halcinonide 0.1% Cream 60gm

Manufacturer SUN PHARMACEUTICALS 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
Corticosteroid
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Pregnancy Category
Category C
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FDA Approved
Mar 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Halcinonide 0.1% Cream is a strong medicine applied to the skin to reduce swelling, redness, and itching caused by certain skin conditions like eczema or psoriasis. It works by calming down the body's inflammatory 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. 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 dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed by your doctor, do not cover the treated area with bandages or dressings.
If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this may 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 area and rub it in gently until it disappears.
  • Do not use more cream than prescribed or apply it more often than directed.
  • Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the cream to your face, groin, or armpits unless specifically directed by your doctor, as these areas are more sensitive to side effects.
  • Avoid getting the cream in your eyes, mouth, or other mucous membranes. If it gets into your eyes, rinse thoroughly with water.
  • Do not use this cream for longer than prescribed, especially on children, as prolonged use can lead to serious side 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 area two to three times daily.

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin area two to three times daily.
eczema: Apply a thin film to the affected skin area two to three times daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (increased risk of systemic absorption)
Child: Not established (increased risk of systemic absorption); use with caution, limit duration and area of application if prescribed.
Adolescent: Similar to adult dosing, but monitor closely for systemic effects, especially with prolonged use or on large surface areas.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use, as systemic absorption is minimal.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Halcinonide is a synthetic corticosteroid. Corticosteroids diffuse across cell membranes and complex with specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA (chromatin), and stimulate the transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be responsible for the anti-inflammatory effects. They induce phospholipase A2 inhibitory proteins, collectively called 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. Halcinonide also exhibits vasoconstrictive and antiproliferative actions.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; minimal systemic absorption through intact skin, but can increase significantly with inflammation, skin barrier disruption, occlusive dressings, or application to large surface areas. Percutaneous absorption ranges from less than 1% to 10% depending on the site and condition of the skin.
Tmax: Not well-defined for topical application due to variable absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not well-defined for topical application.
ProteinBinding: Systemically absorbed corticosteroids are extensively bound to plasma proteins, primarily corticosteroid-binding globulin and albumin.
CnssPenetration: Limited (primarily local action, systemic penetration is minimal but can occur).

Elimination:

HalfLife: Not well-defined for topical application; systemically absorbed corticosteroids have variable half-lives.
Clearance: Not well-defined for topical application.
ExcretionRoute: Metabolites are primarily excreted by the kidneys.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours for initial anti-inflammatory and vasoconstrictive effects.
PeakEffect: Days to weeks for maximal therapeutic effect in chronic conditions.
DurationOfAction: Varies depending on application frequency and individual response.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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 at the site of application
Change in skin color
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 or seek medical help:

Dry skin
Itching
* Burning

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:

  • Severe burning, itching, or irritation that worsens after applying the cream.
  • New or worsening skin thinning, stretch marks, or spider veins in the treated area.
  • Development of acne-like bumps or hair growth in the treated area.
  • Signs of infection (e.g., pus, spreading redness, fever) in the treated area.
  • Unusual tiredness, weakness, nausea, vomiting, or dizziness (signs of adrenal suppression).
  • Increased thirst, frequent urination, or unexplained weight gain (signs of high blood sugar or Cushing's syndrome).
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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.
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.
* Any existing health problems, as this medication may interact with other medical conditions.

To ensure your safety, it is crucial to verify that this medication can be taken 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 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, exercise caution and discuss this with your doctor. 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 have a higher risk of experiencing 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 you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption, potentially causing symptoms of hypercorticism (Cushing's syndrome), including moon face, buffalo hump, central obesity, thinning skin, easy bruising, and muscle weakness.
  • Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure).

What to Do:

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

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin barrier issues that might increase systemic absorption.

Timing: Prior to initiation of therapy.

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Routine Monitoring

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

Frequency: At each follow-up visit, or as symptoms arise.

Target: Absence of new or worsening reactions.

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

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

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

Target: Normal adrenal function, blood glucose levels.

Action Threshold: If suspected, perform appropriate laboratory tests (e.g., ACTH stimulation test, fasting blood glucose) and consider gradual withdrawal or alternative therapy.

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Symptom Monitoring

  • Increased redness or irritation at application site
  • Thinning of skin (atrophy)
  • Stretch marks (striae)
  • Spider veins (telangiectasias)
  • Acne-like eruptions (folliculitis)
  • Perioral dermatitis
  • Unusual hair growth
  • Changes in skin color
  • Slow wound healing
  • Increased thirst or urination (signs of hyperglycemia)
  • Unexplained weight gain or changes in body fat distribution (signs of Cushing's syndrome)

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. Systemic absorption of topical corticosteroids can occur. Higher potency corticosteroids, prolonged use, or application to large surface areas should be avoided.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, though data for topical corticosteroids is limited. Use with caution.
Second Trimester: Use with caution; monitor for signs of systemic absorption.
Third Trimester: Use with caution; monitor for signs of systemic absorption.
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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 direct infant exposure.

Infant Risk: Low risk with appropriate use, but potential for systemic effects in infant if significant maternal absorption occurs or if applied directly to breast.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids (e.g., adrenal suppression, Cushing's syndrome) due to a larger skin surface area to body weight ratio and immature skin barrier. Prolonged use should be avoided. Not recommended for children under 12 without specific medical advice and close monitoring.

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Geriatric Use

No specific dosage adjustments are generally needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for local and systemic side effects.

Clinical Information

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Clinical Pearls

  • Halcinonide 0.1% Cream is a high-potency topical corticosteroid. It should be used for short durations (typically 2-4 weeks) to avoid local and systemic side effects.
  • Avoid abrupt discontinuation after prolonged use, especially on the face, as this can lead to rebound dermatitis.
  • Educate patients on proper application technique: thin layer, gentle rubbing, and avoiding occlusive dressings unless specifically instructed.
  • Not for use on infected skin without concomitant antimicrobial therapy.
  • Patients should be advised to report any signs of skin irritation, thinning, or systemic effects to their healthcare provider.
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Alternative Therapies

  • Other high-potency topical corticosteroids (e.g., Clobetasol propionate, Betamethasone dipropionate)
  • Medium-potency topical corticosteroids (e.g., Triamcinolone acetonide, Mometasone furoate)
  • Low-potency topical corticosteroids (e.g., Hydrocortisone)
  • Topical calcineurin inhibitors (e.g., Tacrolimus, Pimecrolimus) for steroid-sparing therapy, especially on sensitive areas.
  • Emollients and moisturizers for barrier repair and symptom relief.
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread, or refractory dermatoses.
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Cost & Coverage

Average Cost: $30 - $100 per 60gm 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 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.