Halog 0.1% Solution 120ml

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
Topical Corticosteroid
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Pharmacologic Class
Corticosteroid
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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% Solution is a strong medicine applied to the skin to reduce redness, itching, and swelling caused by certain skin conditions like eczema or psoriasis. It belongs to a group of medicines called corticosteroids.
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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 it.
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

  • Apply a thin layer of the solution to the affected skin area(s) as directed by your doctor, usually two to three times a day.
  • Gently rub it in completely.
  • Wash your hands before and after applying the medication, unless your hands are the treated area.
  • Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use this medication for longer than prescribed or on large areas of the body, especially in children, as it can lead to serious side effects.
  • Inform your doctor if your condition does not improve within 2 weeks or if it worsens.

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 due to increased systemic absorption risk.
Child: Apply a thin film to the affected skin areas once daily. Use with caution and for the shortest duration possible due to increased systemic absorption risk.
Adolescent: Apply a thin film to the affected skin areas two to three times daily. Use with caution for prolonged periods.
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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 anti-inflammatory effects are thought to involve the induction of phospholipase A2 inhibitory proteins, 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: Varies; systemic absorption can occur, especially with prolonged use, large surface areas, or occlusive dressings. Intact skin absorbs approximately 1-3%.
Tmax: Not precisely quantifiable for topical application; systemic effects may be observed over days to weeks with chronic use.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not available
ProteinBinding: Extensive plasma protein binding (e.g., transcortin, albumin) once absorbed systemically.
CnssPenetration: Limited

Elimination:

HalfLife: Not precisely quantifiable for topical application; systemic half-life of absorbed drug is variable.
Clearance: Not available
ExcretionRoute: Metabolites are primarily excreted by the kidneys, with some biliary excretion.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Varies depending on application frequency and severity of condition.

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 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 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

Most people do not experience severe side effects, and some may have only minor side effects. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:

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 of the treated skin.
  • New skin infection (e.g., pus, worsening redness, fever).
  • Thinning of the skin, easy bruising, or stretch marks.
  • Changes in skin color.
  • Acne-like rash.
  • Increased hair growth on the treated area.
  • Signs of systemic absorption (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, fatigue, muscle weakness, mood changes).
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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 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 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 this medication 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 the risk of certain side effects may be higher in children. In some cases, this medication may affect growth in children and teenagers, and 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 pregnancy or breastfeeding 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 corticosteroid effects, including adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure), Cushing's syndrome (moon face, buffalo hump, central obesity, thin skin, striae, hyperglycemia), and growth retardation in children.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify areas for treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

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

Frequency: At each follow-up visit (e.g., weekly to monthly depending on duration of use).

Target: Absence of or minimal adverse reactions.

Action Threshold: Discontinue or reduce frequency/potency if severe reactions occur.

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

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

Target: Absence of systemic effects.

Action Threshold: Perform HPA axis suppression tests (e.g., ACTH stimulation test, plasma cortisol, urinary free cortisol) if suspected; discontinue or taper therapy.

Signs of infection (e.g., worsening erythema, pus)

Frequency: At each follow-up visit.

Target: Absence of infection.

Action Threshold: Initiate appropriate antimicrobial therapy; discontinue corticosteroid if infection worsens.

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Skin atrophy
  • Striae
  • Miliaria
  • Weight gain
  • Moon face
  • Fatigue
  • Muscle weakness

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low doses. There are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though systemic absorption from topical use is generally low.
Second Trimester: Potential for fetal growth restriction or other systemic effects with high doses or prolonged use.
Third Trimester: Potential for fetal growth restriction or other systemic effects with high doses or prolonged use.
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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 if significant absorption occurs in mother.
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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 because of a larger skin surface area to body weight ratio. Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are recommended. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Halcinonide is a high-potency topical corticosteroid (Class II).
  • Due to its potency, it should generally be used for short durations (e.g., 2-4 weeks) to minimize the risk of local and systemic side effects.
  • Avoid use on the face, groin, or axillae unless specifically directed by a physician, as these areas are more prone to atrophy and other side effects.
  • Occlusive dressings significantly increase systemic absorption and should be avoided unless specifically prescribed.
  • Patients should be educated on the proper application technique (thin film, gentle rubbing) and the importance of not exceeding the prescribed duration or frequency.
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Alternative Therapies

  • Clobetasol propionate (Class I)
  • Betamethasone dipropionate (Class I/II)
  • Fluocinonide (Class II)
  • Desoximetasone (Class II)
  • Triamcinolone acetonide (Class IV/V)
  • Mometasone furoate (Class IV)
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Cost & Coverage

Average Cost: Not available Not available
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 name of the medication taken, the amount, and the time it occurred.