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Anti-Fungal Nail Solution

Anti-Fungal Nail Solution (Terbinafine / Itraconazole / Ibuprofen) (15 mL) is a comprehensive treatment formulated to address fungal infections and associated symptoms. This solution combines three powerful ingredients: Terbinafine and Itraconazole, both of which are antifungal agents, and Ibuprofen, an anti-inflammatory drug. Terbinafine and Itraconazole work synergistically to target and eradicate fungal infections such as onychomycosis, while Ibuprofen provides relief from inflammation and discomfort. This solution is designed to offer effective, multi-faceted treatment for both the infection and its symptoms, making it a versatile choice for managing nail fungus and its associated pain.

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Hydroquinone

Function

Topical depigmenting agent used to lighten hyperpigmented skin conditions like melasma, freckles, and lentigines. It works by inhibiting melanin production.

Considerations

Reversibility: Unlike monobenzone, the depigmentation caused by hydroquinone is reversible. Sun Protection: Sunscreens should be used in conjunction with hydroquinone to prevent further pigmentation. History: Available since before 1938 and used in various applications, including as an antioxidant and in photographic development.

Use

Typically applied to affected areas to reduce pigmentation.

About Anti-Fungal Nail Solution

Terbinafine

Terbinafine is a potent antifungal agent available in both oral and topical forms, specifically designed to treat various fungal infections, including onychomycosis (nail fungus). By inhibiting fungal growth and concentrating within the nail, Terbinafine is highly effective in treating and eradicating this condition, making it a go-to solution for patients suffering from nail fungus.

Features

  • Proven Efficacy: Terbinafine has demonstrated superior efficacy in clinical studies, with cure rates for onychomycosis ranging from 50% to 70%. It outperforms other antifungals like griseofulvin and itraconazole, with a notably lower relapse rate, ensuring long-term relief from nail fungus.

  • Versatile Applications: Beyond its primary use in treating nail fungus, Terbinafine has shown promise in treating refractory bronchopulmonary aspergillosis in small studies. It also holds FDA approval for multiple conditions, including tinea capitis in pediatric patients, showcasing its versatility as an antifungal treatment.

  • FDA-Approved: Terbinafine's safety and efficacy are backed by FDA approval across various formulations.
    1. Topical Terbinafine: Approved in 1993
    2. Oral Tablets: Approved in 1996
    3. Over-the-Counter Cream: Approved in 1999
    4. Oral Granules for Pediatric Use: Approved in 2007
    These approvals reflect its trusted status in the medical community.

Itraconazole

Itraconazole is a powerful oral antifungal agent classified within the azole class. It is widely utilized to treat an extensive array of fungal infections, including pulmonary and extrapulmonary blastomycosis, histoplasmosis, aspergillosis, onychomycosis, and candidiasis. Its broad-spectrum activity makes it a vital medication in combating various severe fungal conditions.

Features

  • Broad-Spectrum Antifungal Action: Itraconazole is effective against a wide range of fungal infections, making it a versatile treatment option for conditions such as blastomycosis, histoplasmosis, and onychomycosis.

  • FDA-Approved Indications: The specific FDA-approved uses for itraconazole vary based on its dosage form, which is not interchangeable. This ensures that patients receive the appropriate formulation tailored to their specific medical needs.

  • Superior Comparative Effectiveness: Compared to ketoconazole, itraconazole offers fewer adverse effects and exhibits greater efficacy against certain fungi, particularly Aspergillus. It also surpasses fluconazole in terms of activity against a broader spectrum of fungi, ensuring better treatment outcomes.

Ibuprofen

Ibuprofen is a widely used nonsteroidal anti-inflammatory drug (NSAID) known for its analgesic, antipyretic, and anti-inflammatory effects. It is commonly prescribed to manage various conditions, including rheumatoid arthritis, osteoarthritis, dysmenorrhea, and mild to moderate pain. Its effectiveness and broad application make it a staple in pain management and inflammation control.

Features

  • Pharmacology: Ibuprofen is a racemic mixture, but only the l-isomer is clinically active. The d-isomer is slowly converted to the l-isomer in the body, contributing to its therapeutic effects.

  • Adverse Effects: As with all NSAIDs, ibuprofen carries risks of serious gastrointestinal side effects, such as bleeding, ulcers, and perforation, as well as cardiovascular risks including myocardial infarction and stroke. The FDA advises using the lowest effective dose for the shortest duration to minimize these risks.

  • Special Populations: Elderly patients are at an increased risk of NSAID-induced adverse events. The American Geriatrics Society recommends avoiding NSAIDs for persistent pain in this population unless absolutely necessary. In such cases, careful monitoring and possibly using concurrent medications like PPIs or misoprostol are advised to protect against gastrointestinal side effects.

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GREAT SKIN ISN'T ABOUT LUCK.
IT'S ABOUT THE RIGHT ROUTINE.

No Quick Fixes. No Hype.
Genuine Treatments. Expert Care. True Transformation.

Dual Antifungal Action

This solution combines Terbinafine and Itraconazole, providing broad-spectrum antifungal activity. Terbinafine inhibits fungal cell membrane synthesis, while Itraconazole disrupts cell membrane integrity, effectively targeting a wide range of fungi including dermatophytes and Candida species.

Comprehensive Treatment

Designed for ease of use, this solution offers a holistic approach to treating nail fungus. It not only combats the fungal infection but also addresses the inflammation and pain, providing a complete solution in a single application.

Chelation Agent for Skin Lightening

Kojic acid is included in Melasma HQ Cream for its ability to inhibit melanin production through chelation. This naturally occurring compound, produced by fungi such as Aspergillus oryzae, helps lighten skin and prevent further discoloration.

Product Overview

5/5

Dosage Strengths

  • Anti-Fungal Nail Solution (Terbinafine / Itraconazole / Ibuprofen) (15 mL) 2 / 1 / 2%
Nourishes deeply
1
Reduces blemishes
2
Enhances glow
3

More Details About Product

Terbinafine

  • Class: Allylamine antifungal.
  • Target: Fungal sterol biosynthesis.
  • Mechanism: Terbinafine inhibits the enzyme squalene epoxidase, a critical enzyme in the fungal sterol biosynthesis pathway. This enzyme is responsible for converting squalene into ergosterol, an essential component of the fungal cell membrane. By inhibiting squalene epoxidase, terbinafine causes a deficiency of ergosterol, leading to increased permeability of the fungal cell membrane and eventually fungal cell death.
  • Spectrum of Activity: Effective against dermatophytes (e.g., Trichophyton species) and shows in vitro activity against other fungi like Candida albicans.

Itraconazole

  • Class: Azole antifungal.
  • Target: Fungal cell membrane integrity.
  • Mechanism: Itraconazole inhibits 14-alpha demethylase, a cytochrome P-450 (CYP450) enzyme. This enzyme is necessary for converting lanosterol into ergosterol, an essential component of the fungal cell membrane. The inhibition of ergosterol synthesis disrupts the fungal cell membrane’s integrity, causing increased cellular permeability and leakage of cellular contents.
  • Additional Mechanisms: Itraconazole may also interfere with other cellular processes, such as respiration, membrane phospholipid interactions, and yeast-to-mycelium transformation.
  • Spectrum of Activity: Broad, including efficacy against Aspergillus, Blastomyces, Histoplasma, and Candida species.

Ibuprofen

  • Class: Nonsteroidal anti-inflammatory drug (NSAID).
  • Target: Cyclooxygenase (COX) enzymes.
  • Mechanism: Ibuprofen competitively inhibits both COX-1 and COX-2 isoenzymes, blocking arachidonic acid from binding to these enzymes. COX enzymes catalyze the conversion of arachidonic acid into prostaglandins and thromboxanes, which are mediators of inflammation, pain, and fever. By inhibiting COX enzymes, ibuprofen reduces the production of prostaglandins, leading to its anti-inflammatory, analgesic, and antipyretic effects.
  • COX Isoenzymes: COX-1: Constitutively expressed in most tissues, responsible for maintaining normal physiological functions such as gastric mucosal protection, renal function, and platelet aggregation. COX-2: Inducible enzyme, primarily involved in inflammation and expressed in response to inflammatory stimuli. Ibuprofen is slightly more selective for COX-1 but inhibits both enzymes, contributing to its effectiveness and side effect profile.
  • Clinical Implications: The anti-inflammatory effects of ibuprofen are mainly attributed to COX-2 inhibition, though COX-1 is also expressed at sites of inflammation, such as in rheumatoid arthritis or osteoarthritis.

Terbinafine

  • Hematological Effects:

    Lymphopenia and Neutropenia: Oral terbinafine may cause transient lymphopenia and neutropenia. For patients with immunodeficiency or immunosuppression, including those with HIV, baseline and periodic complete blood counts are recommended, especially for treatment durations exceeding 6 weeks. If neutrophil counts fall below 1000/mm³, discontinue the medication.

  • Pregnancy and Breastfeeding:

    Pregnancy: Insufficient data exist regarding the risk of major birth defects or adverse outcomes from oral terbinafine in pregnant women. However, animal studies at high doses did not show malformations. Topical terbinafine should be used during pregnancy only if absolutely necessary.

    Breastfeeding: Terbinafine is excreted in breast milk at low concentrations (0.03% to 0.13% of the dose). While there are no data on effects on the infant, breastfeeding mothers should avoid applying terbinafine topically to the breast. Consider the benefits of breastfeeding against potential risks from the drug.

  • Neuropsychiatric Effects:

    Adverse Reactions: Reports include depression, suicidal ideation, anxiety, insomnia, nausea, forgetfulness, and social withdrawal in children aged 13 to 16. Symptoms resolved after discontinuation of the medication.

  • Hepatic Concerns:

    Hepatotoxicity: Oral terbinafine is contraindicated in patients with chronic or active hepatic disease due to the risk of severe hepatotoxicity, including liver failure. Monitor liver function tests before and during therapy, and discontinue if liver enzyme elevations occur. Patients should report symptoms like persistent nausea, abdominal pain, jaundice, or dark urine.

  • Renal Concerns:

    Renal Impairment: Oral terbinafine use is not recommended in patients with renal impairment (creatinine clearance ≤50 mL/min) due to lack of study data.

  • Hypersensitivity and Skin Reactions:

    Hypersensitivity Reactions: Terbinafine is contraindicated in patients with hypersensitivity to the drug. Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred. Discontinue if rash or sensitivity develops.

  • Thrombotic Microangiopathy:

    TMA: Serious cases of thrombotic microangiopathy (TMA), including TTP and hemolytic-uremic syndrome, have been reported. Evaluate patients for thrombocytopenia and anemia; discontinue if TMA symptoms are present.

Itraconazole

  • Hepatic Effects:

    Hepatotoxicity: Itraconazole can cause serious liver damage. Use with caution in patients with liver disease or those with a history of hepatic toxicity from other drugs. Monitor liver function tests regularly, and discontinue if hepatic symptoms develop.

  • Cardiovascular Effects:

    Ventricular Dysfunction: Itraconazole has a negative inotropic effect and should be avoided in patients with evidence of ventricular dysfunction or heart failure. Monitor for signs of CHF and reassess therapy if symptoms develop.

  • Drug Interactions:

    CYP3A4 Interactions: Itraconazole can cause severe interactions with drugs metabolized by CYP3A4. Use with caution and avoid contraindicated combinations to prevent serious adverse effects, including cardiac dysrhythmias.

  • QT Prolongation:

    Cardiac Risks: Itraconazole may prolong the QT interval, increasing the risk of arrhythmias. Use cautiously in patients with cardiac disease or conditions that increase QT prolongation risk.

  • Cystic Fibrosis:

    Pharmacokinetics: Variability in drug absorption and efficacy in cystic fibrosis patients may lead to therapeutic failure. Alternative treatments may be considered if itraconazole is ineffective.

  • Acidic Environment for Absorption:

    Hypochlorhydria: Absorption of itraconazole capsules and tablets may be poor in patients with reduced stomach acidity, such as those with HIV. Taking the medication with an acidic beverage like cola may improve absorption.

  • Pediatric Use:

    Children: Limited data are available for the safety of itraconazole in neonates, infants, and children. Long-term effects in this population are not well-studied.

  • Pregnancy and Breastfeeding:

    Pregnancy: Itraconazole is contraindicated for treating onychomycosis during pregnancy. Use only if the benefit outweighs the risk for serious infections. There are no comprehensive studies on its safety during pregnancy.

    Breastfeeding: Itraconazole is distributed into breast milk. Weigh the benefits of therapy against the potential risks to the infant and consider alternatives if necessary.

Ibuprofen

  • Hypersensitivity Reactions:

    NSAID Sensitivity: Contraindicated in patients with hypersensitivity to aspirin or other NSAIDs due to the risk of severe allergic reactions. Use with caution in individuals with aspirin-sensitive asthma or the aspirin triad.

  • Renal and Cardiovascular Concerns:

    Renal Disease: Monitor kidney function closely in patients with renal disease or those on diuretics. Hydration is important to minimize renal adverse effects.

    Heart Failure: Use ibuprofen cautiously in patients with heart failure or hypertension, as it may exacerbate these conditions. Monitor blood pressure and fluid status.

  • Gastrointestinal and Skin Reactions:

    GI Risks: NSAIDs, including ibuprofen, can cause gastrointestinal issues, including bleeding and ulcers. Patients should be aware of symptoms such as persistent nausea and abdominal pain.

    Skin Reactions: Serious skin reactions can occur. Discontinue use if severe skin symptoms develop.

  • Asthma and Respiratory Effects:

    Asthma: Use with caution in patients with asthma due to potential respiratory effects. Monitor for any decline in lung function.

Terbinafine

  • Topical Terbinafine:
    • Adverse Effects: Generally well tolerated. Common side effects include skin irritation (1%), application site burning (0.8%), pruritus (0.2%), and xerosis (0.2%). Dermal gel may cause pruritus, skin irritation, and burning in 1-2% of patients.
  • Oral Terbinafine:
    • Hematologic Concerns: Can cause transient lymphopenia and neutropenia. Monitoring is recommended for patients with immunodeficiency or immunosuppression. Discontinue if neutrophil count drops below 1000/mm³.
    • Pregnancy: Insufficient data on major birth defects or adverse outcomes. Use topical terbinafine during pregnancy only if clearly indicated.
    • Breastfeeding: Present in breast milk in low amounts. Avoid topical application to the breast. Consider the risk to the infant and the mother’s need for the medication.
    • Neuropsychiatric Reactions: Depression, suicidal ideation, and self-harm have been reported in children (ages 13-16). Symptoms resolved after discontinuation.
    • Hepatic Concerns: Contraindicated in patients with chronic or active hepatic disease. Associated with serious hepatotoxicity. Monitor liver function and discontinue if liver function tests are elevated.
    • Renal Impairment: Not recommended for use in patients with creatinine clearance ≤50 mL/min due to lack of studies.
    • Hypersensitivity: Contraindicated in patients with known hypersensitivity. Serious skin reactions, including DRESS syndrome and toxic epidermal necrolysis, have been reported.
    • Thrombotic Microangiopathy: Associated with serious cases of TMA, including TTP and hemolytic-uremic syndrome. Discontinue if symptoms of TMA occur.

Itraconazole

  • General Adverse Effects:
    • Gastrointestinal: Commonly reported GI effects include nausea (1.7% to 11%), vomiting (5% to 7%), diarrhea (1.7% to 11%), and abdominal pain (1.7% to 6%). Other effects include dyspepsia, flatulence, constipation, and gastritis.
    • Cardiovascular: Can cause edema (4% or less), hypertension (2% to 3%), and chest pain (3%). Rare cases of congestive heart failure and pulmonary edema have been reported. Monitor for signs of heart failure and QT prolongation.
    • Neurologic: Headache (1% to 10%) is common. Other neurologic effects include anxiety, confusion, depression, dizziness, and tremor. Rare cases of neuropathy have been reported.
    • Visual and Auditory: Less than 2% experienced visual impairment. Tinnitus and hypoacusis have been reported, especially in elderly patients.
    • Dermatologic: Rash reported in 3% to 9% of patients, more frequent in immunocompromised patients. Hypersensitivity reactions and serious skin conditions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been noted.
    • General: Includes fever, fatigue, and malaise.
  • Special Considerations:
    • Cardiac Effects: Due to negative inotropic effects, use with caution in patients with ventricular dysfunction. Monitor for signs of heart failure and QT prolongation.
    • Drug Interactions: Potent CYP3A4 inhibitor. Coadministration with other CYP3A4 drugs requires caution to avoid severe interactions.
    • Cystic Fibrosis: Variable pharmacokinetics in cystic fibrosis patients; may lead to therapeutic failure.
    • Acidic Environment: Absorption may be impaired in patients with hypochlorhydria. Taking with cola may help.
    • Pediatric Use: Limited data on long-term use in children.

Ibuprofen

  • Adverse Effects:
    • Dermatologic: Pruritus in 1-10% of patients; rash including maculopapular rash and bullous rash has been reported. Serious skin reactions, including exfoliative dermatitis, are possible.
    • Topical Use: May cause burning, itching, and redness. Serious allergic reactions are rare but include rash, itching/swelling, severe dizziness, and trouble breathing.
  • General Considerations:
    • Renal and Cardiovascular: Monitor patients with renal disease or heart failure. May exacerbate heart failure and hypertension. Increased risk for renal adverse events with dehydration.

Terbinafine

  • Pregnancy:
    • Oral Terbinafine: Data on human pregnancy are insufficient to determine the risk of major birth defects or other adverse outcomes. Animal studies showed no fetal harm at doses up to 23 times the maximum recommended human dose. Use oral terbinafine during pregnancy only if clearly needed.
    • Topical Terbinafine: No well-controlled studies in pregnant women. Use only if the benefits outweigh the risks.
  • Breastfeeding:
    • Oral Terbinafine: Present in breast milk at low levels (0.03% to 0.13% of the dose). The effects on the breast-fed child are unknown. Advise against applying topical terbinafine to the breast. Consider the importance of the medication to the mother versus the potential risk to the infant.
    • Topical Terbinafine: Discontinue breastfeeding or the topical application, considering the importance of the drug to the mother.

Itraconazole

  • Pregnancy:
    • Use in Pregnancy: Contraindicated for treating onychomycosis during pregnancy and in women planning pregnancy. For systemic fungal infections, use only if the benefit justifies the risk. Limited data available, with some epidemiologic studies showing no major birth defect risk with short-term use but inconclusive miscarriage data. Teratogenic effects in animals are noted.
  • Breastfeeding:
    • Distribution in Milk: Itraconazole is present in breast milk. Consider the benefits of treatment for the mother against potential risks to the infant. Alternatives such as fluconazole or ketoconazole may be considered. In HIV-positive patients, avoid breastfeeding to prevent postnatal HIV transmission.

Ibuprofen

  • Pregnancy:
    • Third Trimester: Avoid use starting at 30 weeks of gestation due to the risk of premature closure of the fetal ductus arteriosus. The risks during the first and second trimesters are inconclusive. Animal studies show some developmental effects but no major malformations at lower doses.
    • Labor and Delivery: NSAIDs like ibuprofen can delay labor and increase the risk of stillbirth.
  • Breastfeeding:
    • Safety: Considered safe for breastfeeding as it is present in breast milk at low levels (0.06% to 0.6% of the maternal dose). No adverse effects on milk production or the breast-fed infant reported.
Store this medication in its original container at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

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