Halog 0.1% Cream

Manufacturer RANBAXY 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
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
Aug 1975
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Halog 0.1% 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 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. 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.
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, 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 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 hands before and after applying the cream.
  • Apply a thin layer only to the affected skin areas as directed by your doctor.
  • Do not use more than prescribed or for longer than recommended.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor.
  • Do not use with occlusive dressings (e.g., bandages, plastic wrap) unless directed by your doctor, as this can increase absorption and side effects.
  • Keep out of reach of children.
  • Avoid contact with eyes.

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:

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

Neonatal: Not established
Infant: Not established, use with caution and under strict medical supervision due to increased risk of systemic absorption.
Child: Apply a thin film to the affected skin areas two to three times daily. Use the least amount for the shortest duration possible. Avoid use on large surface areas or under occlusive dressings.
Adolescent: Apply a thin film to the affected skin areas two to three 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

Halcinonide is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its primary mechanism of action involves binding to glucocorticoid receptors in the cytoplasm of target cells. This complex then translocates to the nucleus, where it modulates gene expression by activating or repressing the transcription of specific genes. This leads to the synthesis of lipocortins (annexins), which are proteins that inhibit phospholipase A2, thereby preventing the release of arachidonic acid from membrane phospholipids. This, in turn, inhibits the synthesis of inflammatory mediators such as prostaglandins and leukotrienes. Corticosteroids also suppress the migration of neutrophils and macrophages to the site of inflammation, reverse capillary permeability, and inhibit the release of lysosomal enzymes.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (systemic absorption varies)
Tmax: Not available (systemic absorption is minimal but can occur)
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not available
ProteinBinding: Not available (systemic binding would occur if absorbed)
CnssPenetration: Limited (systemic absorption is minimal)

Elimination:

HalfLife: Not available (systemic half-life not well-defined for topical use)
Clearance: Not available
ExcretionRoute: Primarily renal excretion of metabolites.
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Hours to days (for anti-inflammatory and antipruritic effects)
PeakEffect: Days to weeks (with consistent use)
DurationOfAction: Varies with application frequency

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 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 where the medication was applied
Change in skin color
Thinning of the skin

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Dry skin
Itching
* Burning

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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
  • Burning or stinging sensation
  • Skin thinning, easy bruising, or stretch marks (striae)
  • Acne-like breakouts or folliculitis
  • Changes in skin color (lightening)
  • Signs of skin infection (pus, warmth, fever)
  • Unusual fatigue, weakness, dizziness, nausea, or vomiting (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, any of 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 taking
Any natural products or vitamins you are using
* Existing health problems or conditions

Carefully review your medications and health conditions with your doctor to confirm that it is safe to take this medication. 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 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 you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

What to Do:

Discontinue use and contact your doctor immediately. For severe systemic symptoms, seek emergency medical attention. Call 1-800-222-1222 for poison control.

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 atrophy or infection.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Skin condition (e.g., redness, swelling, itching, lesions)

Frequency: Regularly during treatment, typically at follow-up visits (e.g., weekly to bi-weekly initially, then as needed).

Target: Improvement in symptoms without adverse effects.

Action Threshold: Worsening of condition, lack of improvement, or development of adverse skin reactions (e.g., atrophy, striae, infection).

Signs of HPA axis suppression (e.g., fatigue, weakness, weight loss, hypotension)

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

Target: Absence of symptoms.

Action Threshold: Presence of symptoms suggestive of systemic absorption; consider ACTH stimulation test if suspected.

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Symptom Monitoring

  • Improvement in itching
  • Reduction in redness
  • Decrease in swelling
  • Healing of skin lesions
  • Signs of skin atrophy (thinning, bruising, telangiectasias)
  • Signs of infection (pus, increased pain, fever)
  • Signs of HPA axis suppression (unusual fatigue, weakness, dizziness, nausea, vomiting)

Special Patient Groups

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Pregnancy

Halcinonide is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown corticosteroids to be teratogenic. Systemic absorption can occur with topical use.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester: Risk of systemic effects on the fetus, including growth retardation, if significant absorption occurs.
Third Trimester: Risk of systemic effects on the fetus, including growth retardation and HPA axis suppression, if significant absorption occurs. Neonates born to mothers who received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.
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Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when Halcinonide is administered to a nursing woman. 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 transfers 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 due to a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings. Monitor for signs of systemic effects and growth retardation.

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Geriatric Use

No specific dosage adjustments are typically required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption or local adverse effects. Use with caution and monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Halcinonide is a high-potency topical corticosteroid; use it judiciously and for short durations to minimize side effects.
  • Avoid prolonged use on the face, groin, or axillae due to increased risk of skin atrophy, telangiectasias, and striae in these sensitive areas.
  • Do not use on infected skin without concomitant antimicrobial therapy.
  • Patients should be instructed on proper application technique: apply a thin film, rub in gently, and wash hands after application.
  • Tapering may be necessary after prolonged use to prevent rebound flares of the dermatosis.
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Alternative Therapies

  • Clobetasol propionate (Temovate)
  • Betamethasone dipropionate (Diprolene)
  • Fluocinonide (Lidex)
  • Triamcinolone acetonide (Kenalog)
  • Mometasone furoate (Elocon)
  • Desonide (DesOwen) - lower potency
  • Pimecrolimus (Elidel) - calcineurin inhibitor
  • Tacrolimus (Protopic) - calcineurin inhibitor
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Cost & Coverage

Average Cost: $50 - $150 per 60g tube
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often covered by most plans, especially 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 this 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 overdose, including the medication taken, the amount, and the time it occurred.