chloroxylenol/pramoxine/zinc acetate

Action and Spectrum

Actions and Spectrum: 

Actions: 

ZINOTIC, which includes chloroxylenol, pramoxine, and zinc acetate, is formulated to offer a combination of actions for treating superficial infections of the external ear caused by susceptible organisms. The individual actions of its components are outlined below: 

Chloroxylenol: Demonstrates broad-spectrum bactericidal properties, combating bacteria and fungi to control microbial activity in the affected area. 

Pramoxine Hydrochloride: Acts as a topical anesthetic, delivering temporary relief from pain and itching by stabilizing neuronal membranes, resulting in a numbing effect on nerve endings. 

Zinc Acetate: Functions as a topical skin protectant, providing temporary shielding from harmful stimuli for injured or exposed skin surfaces, potentially offering relief to these surfaces. 

Together, these actions collaboratively address both the microbial aspects of the infection and the associated symptoms of pain and itching. This synergy contributes to the overall efficacy of ZINOTIC in managing superficial infections of the external ear. Always use the medication as directed by healthcare professionals or in accordance with product labels for safe and effective application. 

Spectrum: 

Chloroxylenol is a broad-spectrum bactericidal agent that presents as white crystals with a phenolic odor. It exhibits solubility in alcohol, ether, and alkali hydroxides and is chemically identified as 4-chloro-3,5-xylenol. 

Pramoxine Hydrochloride, validated as a safe and effective topical anesthetic through hospital tests, manifests as a white to practically white crystalline powder with a numbing taste and a faint, aromatic odor. It is freely soluble in water and alcohol, soluble in chloroform, and minimally soluble in ether. Its chemical designation is 4-[3-(4-butoxyphenoxy)propyl]-Morpholine hydrochloride. 

Zinc acetate, in its dihydrate form, represents a zinc salt acknowledged as safe and effective for topical skin protection. It appears as white crystals or granules, readily dissolving in water and boiling alcohol and exhibiting slight solubility in alcohol. The chemical structure is denoted as C4H6O4Zn•2H2O. 

Drug Interaction

Adverse Reaction

Frequency not defined 

Dryness or pain, redness, burning, swelling, irritation, stinging at the affected area 

Rash 

Fever 

Black Box Warning

Black Box Warning: 

Oral or ophthalmic usage is not recommended for this product. If irritation or hypersensitivity develops, stop using this preparation right away and take further precautions. 

Contraindication / Caution

Contraindication/Caution: 

Contraindications 

• Hypersensitivity 
• If there is a perforated eardrum or if the drug can enter the middle ear, do not apply it in the external auditory canal. 

Cautions 

• Drug interactions 
• Pregnancy  
• Breastfeeding 

Pregnancy / Lactation

Pregnancy consideration:  

No data is available regarding the administration of the drug during pregnancy. 

Breastfeeding warnings:  

No data is available regarding the excretion of drug in breast milk. 

Pregnancy category: C 

Category A: well-controlled and satisfactory studies show no risk to the fetus in the first or later trimester. 

Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women. 

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.    

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

This product exhibits effectiveness as both an antibacterial and antifungal agent. Chloroxylenol, present in low concentrations, acts as a germicide suitable for treating bacterial and fungal infections. It is a halogenated phenol known for its non-toxic, non-corrosive, and non-staining properties, possessing a high phenol coefficient.

Application directly to wounds is possible, and it demonstrates no chemical reactivity with blood. Pramoxine Hydrochloride, a topical anesthetic chemically distinct from procaine and other “caines,” offers temporary relief from itching and pain by stabilizing neuronal membranes of nerve endings it contacts. Zinc acetate serves to temporarily shield injured or exposed skin surfaces from harmful stimuli, potentially providing relief to such areas.  

Pharmacodynamics: 

The pharmacodynamics of ZINOTIC involves studying how the medication’s components interact with the body to produce their effects. ZINOTIC combines chloroxylenol, known for its broad-spectrum bactericidal properties against bacteria and fungi, and pramoxine hydrochloride, a topical anesthetic providing temporary relief from pain and itching by stabilizing neuronal membranes. 

These components synergistically work together to address superficial infections of the external ear caused by susceptible organisms. Chloroxylenol focuses on controlling microbial activity, while pramoxine hydrochloride delivers analgesic effects, numbing the affected area to alleviate pain and itching. The combined pharmacodynamics aim to manage infections and relieve associated symptoms, enhancing the overall effectiveness of ZINOTIC in treating external ear infections. 

Pharmacokinetics: 

Absorption 

Chloroxylenol is generally absorbed through topical application, particularly in formulations like ear drops, and is anticipated to undergo some level of metabolic transformation. 

Pramoxine Hydrochloride is absorbed topically, delivering a local anesthetic effect. 

Zinc Acetate may be absorbed through the skin, and its distribution is expected to be localized to the application site.  

Distribution 

Limited data is available 

Metabolism 

Metabolic processes for chloroxylenol and pramoxine may vary, with elimination expected to primarily occur through local mechanisms. 

Elimination and Excretion 

Systemic absorption, if any, could contribute to elimination through urine. 

Adminstartion

Administration: 

Proper cleaning and drying of the auditory canal and auricle, components of the external ear, are essential. To administer drops effectively, the patient should lie on their side, gently pulling the outer earlobe upward and backward. This position should be maintained for up to five minutes to ensure your ear canal gets optimal penetration of the drops. If needed, repeat the process for the opposite affected ear. 

An alternative approach involves inserting a wick or gauze ear plug into the ear canal before applying chloroxylenol/pramoxine/zinc acetate drops. If using a wick, enhance its hydration by applying a few drops of sterile water directly onto it after insertion.

Saturate the wick with chloroxylenol/pramoxine/zinc acetate and instruct the patient to add a few drops of the solution to the wick with the 4 hour time interval. Remove the wick after one day, then continue instilling five drops of chloroxylenol/pramoxine/zinc acetate three or four times daily. 

For a gauze earplug, start by treating the ear canal (external) with chloroxylenol/pramoxine/zinc acetate drops. Subsequently, to contain the medication insert the gauze into the ear canal. To remove the expanded wick or gauze ear plug, utilize forceps, fingers, or tweezers. As a preventative measure, this product may be used three times a day in the unaffected. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: chloroxylenol/pramoxine/zinc acetate 

Pronounced: klor-oh-ZY-luh-nol/PRAH-mox-een/zink AS-uh-tayt 

Why do we use chloroxylenol/pramoxine/zinc acetate?  

To address superficial infections of the external ear caused by organisms susceptible to the antimicrobial agent’s action and to manage associated pain and itching.