Keralyt 6% Shampoo 160ml

Manufacturer SUMMERS LABS Active Ingredient Salicylic Acid Shampoo(sal i SIL ik AS id) Pronunciation sal i SIL ik AS id
It is used to treat psoriasis.It is used to control seborrheic dermatitis.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Keratolytic; Antiseborrheic
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Pharmacologic Class
Salicylic acid derivative; Keratolytic agent
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Pregnancy 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?

Keralyt 6% Shampoo contains salicylic acid, which helps to loosen and shed dead skin cells from the scalp. It's used to treat conditions like dandruff, seborrheic dermatitis, and psoriasis of the scalp by reducing scaling, flaking, and itching.
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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. It is essential to use this medication only as directed.

Apply this medication to your skin only. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning. If the medication gets in your eyes, rinse them with cool water.
Before applying the medication, clean the affected area and dry it thoroughly.
Do not inhale the vapors of this medication.
* Wash your hands before and after use, unless your hand is the area being treated. In this case, do not wash your hand after applying the medication.

Special Instructions for Hair Application

If you are using this medication on your hair, be sure to follow the specific instructions provided by your doctor or pharmacist. Sometimes, the medication is applied to wet hair, while other times it is applied to dry hair. If you are unsure about how to use the medication, consult with your doctor or pharmacist.

Storage and Disposal

To store this medication, keep it at room temperature and do not freeze it. Protect the medication from heat or open flames, and keep the lid tightly closed.

Missed Dose

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not apply two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Use as directed, typically 2-3 times per week.
  • Wet hair thoroughly before applying the shampoo.
  • Massage into the scalp to create a rich lather.
  • Leave on the scalp for several minutes (e.g., 3-5 minutes) to allow the active ingredient to work.
  • Rinse thoroughly with water.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on broken, inflamed, or irritated skin.
  • Limit sun exposure and use sunscreen, as salicylic acid can increase sun sensitivity.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply to wet hair and scalp, lather, leave on for several minutes, then rinse thoroughly. Use 2-3 times per week or as directed by a physician.

Condition-Specific Dosing:

Seborrheic Dermatitis/Psoriasis: Use 2-3 times per week or as directed by a physician.
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Pediatric Dosing

Neonatal: Not established (Avoid in infants due to potential for systemic absorption)
Infant: Not established (Avoid in infants due to potential for systemic absorption)
Child: Consult a physician for use in children under 12 years. Generally, use with caution and under medical supervision due to potential for increased systemic absorption.
Adolescent: Same as adult dosing for children 12 years and older.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption from topical use.
Moderate: No specific adjustment needed due to minimal systemic absorption from topical use.
Severe: No specific adjustment needed due to minimal systemic absorption from topical use. However, caution is advised with extensive use on compromised skin due to theoretical risk of increased systemic absorption.
Dialysis: No specific considerations for topical use.

Hepatic Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption from topical use.
Moderate: No specific adjustment needed due to minimal systemic absorption from topical use.
Severe: No specific adjustment needed due to minimal systemic absorption from topical use. However, caution is advised with extensive use on compromised skin due to theoretical risk of increased systemic absorption.
Confidence: Medium

Pharmacology

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Mechanism of Action

Salicylic acid is a keratolytic agent that causes shedding of the outer layer of the skin. It works by softening keratin, a protein that forms part of the skin structure, and loosening dry, scaly skin. It also has mild antiseptic and antifungal properties, which can help control the growth of microorganisms associated with dandruff and seborrheic dermatitis.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from intact skin; increased absorption with inflamed or damaged skin, or with occlusive dressings.
Tmax: Not well-defined for topical application; systemic levels, if detectable, are typically very low.
FoodEffect: Not applicable (topical product)

Distribution:

Vd: Not applicable (minimal systemic distribution)
ProteinBinding: Highly protein bound if systemically absorbed (to albumin)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not well-defined for topical application; if systemically absorbed, elimination half-life is typically 2-3 hours, but can be prolonged with higher doses.
Clearance: Not applicable (minimal systemic clearance from topical use)
ExcretionRoute: Renal (as metabolites) if systemically absorbed.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Local effect seen within days to weeks of consistent use.
PeakEffect: Weeks of consistent use for optimal results.
DurationOfAction: Effect persists as long as product is used regularly.
Confidence: Medium

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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Mood changes
- Rapid breathing
- Nausea or vomiting
- Ringing in the ears, hearing loss, or other changes in hearing
- Dizziness
- Feeling extremely tired or weak
- Diarrhea

Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
- Skin irritation
- Dry skin
- Burning or stinging sensations
- Peeling skin

Important Note
This list does not include all possible side effects. If you have questions or concerns about side effects, contact your doctor. For medical advice 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 skin irritation, redness, or burning that worsens after use.
  • Allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
  • Signs of systemic salicylate toxicity (rare): ringing in the ears (tinnitus), dizziness, headache, nausea, vomiting, confusion, rapid breathing. Seek immediate medical attention if these occur.
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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.
* Any health problems you have, as these may interact with this medication.

This medication can interact with other drugs and health conditions, so it is crucial to discuss your individual situation with your doctor. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety. Your doctor and pharmacist need to know about all your medications and health problems to determine if it is safe for you to take 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.

When using certain acne products that contain benzoyl peroxide or salicylic acid, there is a rare risk of severe and potentially life-threatening allergic reactions or irritation. To minimize this risk, you may need to follow specific steps before using the product for the first time. Be sure to use this medication exactly as directed by your doctor or as indicated on the package label, and consult with your doctor if you have any questions.

Avoid applying this medication to open wounds, cuts, or irritated skin. When using it on a large area of skin, exercise caution and discuss this with your doctor. Do not use this medication on birthmarks, moles, or warts with hair growth, or on cervical, genital, or oral warts.

Using this medication too frequently can exacerbate your skin condition. Additionally, using other skin products concurrently may increase the risk of irritation. Before using any other drugs or products on your skin, including soaps, consult with your doctor.

This medication may interfere with certain laboratory tests, so it is crucial to inform your doctor and laboratory personnel that you are using it. Some of these products are flammable, so avoid using them near an open flame or while smoking. If ingested, this medication can cause harm, so if you or someone else swallows it, contact a doctor or poison control center immediately.

This medication is not recommended for children and teenagers who are experiencing or recovering from flu symptoms, chickenpox, or other viral infections, as it may increase the risk of Reye's syndrome, a condition that can cause severe brain and liver damage. If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. Different brands of this medication may be suitable for different age groups, so consult with your doctor before administering it to a child.

If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of using this medication with your doctor. If you are breastfeeding, avoid applying this medication to your chest, and consult with your doctor for guidance.
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Overdose Information

Overdose Symptoms:

  • Ringing in the ears (tinnitus)
  • Dizziness
  • Headache
  • Nausea
  • Vomiting
  • Confusion
  • Rapid breathing (hyperventilation)
  • Lethargy
  • Seizures (severe cases)

What to Do:

Systemic overdose from topical salicylic acid shampoo is rare but can occur with extensive use on compromised skin, especially in children. If ingestion or significant systemic absorption is suspected, seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

Monitoring

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Routine Monitoring

Scalp condition (redness, scaling, itching)

Frequency: Daily/Weekly during treatment

Target: Improvement in symptoms

Action Threshold: Worsening symptoms, severe irritation, or lack of improvement after several weeks of use warrant medical re-evaluation.

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Symptom Monitoring

  • Scalp irritation
  • Redness
  • Itching
  • Dryness
  • Peeling
  • Signs of systemic salicylate toxicity (rare with topical use): tinnitus, dizziness, headache, nausea, vomiting, confusion (especially if used extensively on compromised skin)

Special Patient Groups

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Pregnancy

Salicylic acid is Pregnancy Category C. While systemic absorption from topical use is generally minimal, caution is advised, especially with extensive application or prolonged use. Consult a healthcare provider before use.

Trimester-Specific Risks:

First Trimester: Generally considered low risk for topical use, but large surface area application should be avoided.
Second Trimester: Generally considered low risk for topical use, but large surface area application should be avoided.
Third Trimester: Avoid large surface area application or prolonged use, especially late in pregnancy, due to theoretical risk of premature closure of the ductus arteriosus (similar to NSAIDs).
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Lactation

Lactation Risk L3 (Moderately Safe). Minimal systemic absorption is expected. Use on small areas and avoid application to areas where the infant might ingest the product (e.g., breast). Consult a healthcare provider.

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption. However, avoid direct contact with the infant's skin or mouth.
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Pediatric Use

Use with caution in children, especially those under 12 years, and avoid in infants due to the potential for increased systemic absorption and risk of salicylate toxicity (Reye's syndrome concern, though primarily associated with oral salicylates in viral illness). Always consult a physician for pediatric use.

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Geriatric Use

No specific dose adjustments are typically needed. Use with caution on very thin or fragile skin, as older adults may have increased skin sensitivity.

Clinical Information

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Clinical Pearls

  • For best results, allow the shampoo to remain on the scalp for the recommended duration (e.g., 3-5 minutes) before rinsing.
  • Avoid using on broken, inflamed, or open skin as this can increase systemic absorption and irritation.
  • Patients should be advised to use sunscreen and protective clothing, as salicylic acid can increase sensitivity to sunlight.
  • If irritation occurs, reduce frequency of use or discontinue. If severe, consult a healthcare provider.
  • This product is for external use only. Do not ingest.
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Alternative Therapies

  • Coal tar shampoos (e.g., T/Gel)
  • Selenium sulfide shampoos (e.g., Selsun Blue)
  • Zinc pyrithione shampoos (e.g., Head & Shoulders)
  • Ketoconazole shampoos (e.g., Nizoral)
  • Topical corticosteroids (prescription for severe cases)
  • Calcipotriene (prescription for psoriasis)
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Cost & Coverage

Average Cost: $15 - $30 per 160ml bottle
Generic Available: Yes
Insurance Coverage: Over-the-counter (OTC) product, generally not covered by insurance unless prescribed and deemed medically necessary.
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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 consult with your pharmacist to confirm. 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 support. 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.