TriOxin Ear Drops

Uses

For the temporary relief of pain due to minor injury or irritation of the mouth and gums like Toothache, Sore gums, Canker sores, Braces, Minor dental procedures, Dentures

Disinfectant for skin and gloved hands; obstetrics, antiseptic lubricant for vaginal examinations and on forceps; for hand antisepsis .

Hydrocortisone Acetate is used for:

• Primary irritant dermatitis
• Contact allergic dermatitis
• Eczema: atopic, infantile, discoid, stasis
• Seborrheic dermatitis
• Lichen simplex and pruritus ani
• Flexural psoriasis
• Skin irritations, itching and rashes, for example those caused by insect bites, minor thermal burns, sunburn, etc

TriOxin Ear Drops is also used to associated treatment for these conditions: Acute Sore Throat Pain, Dental Pain, Gangrene Stomatitis, Gingivitis, Hemorrhoids, Laryngitis, Pharyngitis, Premature Ejaculation, Secondary Bacterial Infection caused by Tonsillectomy, Secondary Bacterial Infection caused by Tooth Extractions, Skin Irritation, Sore Throat, Stomatitis, Sunburn, Teething pain, Tonsillitis, Tooth Pain, Vomiting, Pruritic dermatosis, Ulceration of the mouth, Buccopharyngeal anesthesiaSkin Infections, Oral Hygiene, Skin disinfectionAcute, Inflammatory Superficial Cutaneous Lesions caused by susceptible bacteria, Adrenal cortical hypofunctions, Anal Fissures, Anal inflammation, Androgenital syndrome, Conjunctivitis, Conjunctivitis allergic, Corneal Inflammation, Dermatitis infected, Diaper Dermatitis, Eczema infected, Episcleritis, Hemorrhoids, Iridocyclitis, Iritis, Ocular Inflammation, Ocular Irritation, Postoperative pain, Proctitis, Pruritus, Pruritus Ani, Radiation Induced Proctitis, Rheumatoid Arthritis, Scleritis, Skin Infections, Skin Irritation, Superficial ocular bacterial infections caused by susceptible bacteria, Thyroiditis, Ulcerative Colitis, Anal eczema, Bacterial blepharitis, Corneal clouding, Corticosteroid responsive Dermatosis of the anal region, Corticosteroid-responsive dermatoses, Cryptitis, Localized uninfected hemorrhoids, Mild Anal Fissures, Pruritus associated with bowel movements, Skin and skin-structure infections caused by susceptible bacteria, Postoperative Eye Care

How TriOxin Ear Drops works

Benzocaine diffuses into nerve cells where it binds to sodium channels, preventing the channels from opening, and blocking the influx of sodium ions. Nerve cells unable to allow sodium into cells cannot depolarize and conduct nerve impulses.

As a phenol antiseptic, it is believed that the hydroxyl -OH groups of the chloroxylenol molecule binds to certain proteins on the cell membrane of bacteria, and disrupts the membrane so as to allow the contents of the bacterial cell to leak out . This allows chloroxylenol to enter the bacterial cell to bind further with more proteins and enzymes to disable the cell's functioning . At particularly high concentrations of chloroxylenol, the protein and nucleic acid content of targeted bacterial cells become coagulated and cease to function, leading to rapid cell death .

Hydrocortisone binds to the cytosolic glucocorticoid receptor. After binding the receptor the newly formed receptor-ligand complex translocates itself into the cell nucleus, where it binds to many glucocorticoid response elements (GRE) in the promoter region of the target genes. The DNA bound receptor then interacts with basic transcription factors, causing the increase in expression of specific target genes. The anti-inflammatory actions of corticosteroids are thought to involve lipocortins, phospholipase A2 inhibitory proteins which, through inhibition arachidonic acid, control the biosynthesis of prostaglandins and leukotrienes. Specifically glucocorticoids induce lipocortin-1 (annexin-1) synthesis, which then binds to cell membranes preventing the phospholipase A2 from coming into contact with its substrate arachidonic acid. This leads to diminished eicosanoid production. The cyclooxygenase (both COX-1 and COX-2) expression is also suppressed, potentiating the effect. In other words, the two main products in inflammation Prostaglandins and Leukotrienes are inhibited by the action of Glucocorticoids. Glucocorticoids also stimulate the lipocortin-1 escaping to the extracellular space, where it binds to the leukocyte membrane receptors and inhibits various inflammatory events: epithelial adhesion, emigration, chemotaxis, phagocytosis, respiratory burst and the release of various inflammatory mediators (lysosomal enzymes, cytokines, tissue plasminogen activator, chemokines etc.) from neutrophils, macrophages and mastocytes. Additionally the immune system is suppressed by corticosteroids due to a decrease in the function of the lymphatic system, a reduction in immunoglobulin and complement concentrations, the precipitation of lymphocytopenia, and interference with antigen-antibody binding.

Dosage

TriOxin Ear Drops dosage

Apply to the affected area up to 4 times daily or as directed by a doctor/dentist. Children under 12 years of age should be supervised during the use of this product. Children under 2 years of age should be consulted to a doctor/dentist prior to the use of this product. An easy application might be done by fixing applicator on the tube’s nozzle. After application, supplied cap should be fixed on top of the applicator.

Wash with one table spoonful of Chloroxylenol to a tumbler of water (1 in 13) for urgent application, undiluted Chloroxylenol may be used but not in a sensitive skin.

Hydrocortisone cream should be applied in a thin smear to the affected area one to two times per day or as directed by the physician. The recommended duration of treatment is usually two weeks. For rectal use apply to the irritated anorectal tissue in the morning and at evening and after each bowel movement for two to six days.

Side Effects

Side effects are less common. The side effects include allergies, swelling in the mouth or throatetc.

Skin sensitivity; irritation of conjunctiva, mucosal irritation; reversible brown staining of the teeth; tongue discoloration and burning sensation; transient taste disturbance; parotid gland swelling.

Hydrocortisone Acetate 1% cream is usually well-tolerated, but if signs of hypersensitivity appear, application should be stopped.

Toxicity

Patients experiencing an overdose may present with local anesthetic systemic toxicity syndrome, decreased cardiovascular function, decreased central nervous system function, cardiac arrest, bradycardia, hypotension, cardiac arrhythmias, syncope, and seizures. Patients should be treated with symptomatic and supportive measures which include airway maintenance, controlling seizures, and hemodynamic stabilization.

As chloroxylenol is predominantly employed as an active ingredient in various liquids or creams as cleaners, disinfectants, or antiseptics that are generally designed to be used topically, it is widely accepted that the use of such liquids - when used appropriately - is unlikely to present a sufficient volume that could be ingested to cause any medical problems . In the event of accidental eye contact, was with Luke warm water .

Chloroxylenol is known to have a low systemic toxicity, even at dosage levels many times higher that those likely to be absorbed during normal usage of the agent .

Side effects include inhibition of bone formation, suppression of calcium absorption and delayed wound healing

Precaution

Patient with asthma, bronchitis, emphysema, heart disease; smokers. Children, Pregnancy and lactation.

Condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

In infants and children, long-term continuous topical therapy should be avoided where possible, as adrenal suppression can occur. As with all corticosteroids, prolonged application to the face is undesirable.

Interaction

May antagonise the therapeutic effect of sulfonamides. Anticholinesterases may inhibit the metabolism benzocaine.

There are no known drug interactions and none well documented.

Volume of Distribution

The only data available regarding the volume of distribution of chloroxylenol is the mean Vss of 22.45 L determined after 200 mg intravenous single dose of chloroxylenol was administered to healthy mongrel dog subjects .

Elimination Route

No chloroxylenol was detected in the blood following the dermal administration of 2 g of p-chloroxylenol in an ethanol/olive oil vehicle in human subjects . After a dose of 5 g, only traces were found, after 8 g, 1 mg % (1 mg/dL) was found in the blood after 3 hours, and 4 mg % (4 mg/dL) after 24 hours . After a dose of 20 g, 4 mg % (4 mg/dL) was measured after half an hour, and 1 mg % (1 mg/dL) was present at 72 hours .

For antiseptic purposes, chloroxylenol is considered to be well-absorbed when applied to the skin .

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption.

Half Life

One study estimated the mean terminal half-life and mean residence time after a 200 mg intravenous single dose of chloroxylenol in healthy mongrel dog subjects to be 1.7 and 1.69 hours, respectively . Alternatively, some product monographs liken chloroxylenol to a similar liquid antiseptic, triclosan, whose calculated urinary excretion half-life in man is approximately 10 hours .

6-8 hours

Clearance

The only data available regarding the clearance of chloroxylenol is the mean clearance rate of 13.76 L/hr following a 200 mg intravenous single dose of the substance into healthy mongrel dog subjects .

Moreover, in another study, when 8 g of chloroxylenol was administered dermal on a human subject in an alcohol/glycerin vehicle, 11% was excreted in 48 hours .

Elimination Route

The major route of excretion is likely in urine , although some amounts may be found in bile and traces in exhaled air .

Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Pregnancy & Breastfeeding use

Pregnancy Category C. Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

Pregnancy Category-Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

There is inadequate evidence for safety in human pregnancy. It is recommended that topical corticosteroids should not be used extensively during pregnancy. It is highly unlikely that sufficiently high blood levels of Hydrocortisone are achieved during topical therapy to reach breast milk.

Contraindication

Epiglottis (oral spray), methaemoglobinaemia.

Hypersensitivity

Contraindicated in infections (bacterial; viral; fungal), skin ulcers, hypersensitivity to the preparation

Acute Overdose

Symptom: Methaemoglobinaemia, manifested by cyanotic (greyish) skin discolouration, unusual breathing or breathlessness.

Management: Symptomatic and supportive treatment. IV methylene blue 1% may be administered.

Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation topical steroids should be discontinued

Storage Condition

Store between 15-30° C.

Store in a cool and dry place, away from light. Keep out of reach of children.

Innovators Monograph

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