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Overview

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This medicine contains an important and useful components, as it consists of
Allantoin, Borax, Boric acid, Chlorbutol, Clorbutol, Distilled witch hazelis available in the market in concentration

Name

Clioquinol 1% + Flumetasone Pivalate 0.02% Ear prep

Precaution

Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation is a combination medication used for treating ear infections, specifically those caused by bacterial and fungal pathogens. Before using this medication, patients should be assessed for any known allergies to clioquinol, flumetasone pivalate, or any other ingredients in the ear drop formulation. Clioquinol has antimicrobial properties that may disrupt the normal microbial flora of the ear canal, so it is important to monitor for any secondary fungal infections, particularly in patients with a history of recurrent yeast infections. Patients with a history of perforated tympanic membranes or ear drum perforations should not use this ear preparation, as it may lead to systemic absorption and increase the risk of side effects, especially from flumetasone, a corticosteroid. Since corticosteroids suppress the immune system, they may delay wound healing or exacerbate infections, so this product should be used cautiously in individuals with any form of immunosuppression or those with active, untreated infections. Pregnant or breastfeeding women should consult their healthcare provider before using this medication, as corticosteroids are classified as Category C in pregnancy, meaning potential risks to the fetus cannot be ruled out. If symptoms worsen or do not improve within a week of treatment, the patient should consult their doctor, as this could indicate an incorrect diagnosis or resistance to the medication.

Indication

Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation is primarily indicated for the treatment of otitis externa (outer ear infections) caused by bacterial and fungal organisms. The combination of clioquinol, an antifungal and antibacterial agent, and flumetasone, a corticosteroid, works synergistically to relieve inflammation, reduce itching, and eliminate the pathogens responsible for the infection. Clioquinol helps by targeting both Gram-positive and Gram-negative bacteria as well as certain fungi, while flumetasone helps reduce inflammation and pain associated with the infection. The medication is particularly effective for conditions like swimmer's ear, where inflammation and infection of the outer ear canal are common. Off-label, the medication may be used for other ear conditions as determined by a healthcare provider, though its primary use remains for otitis externa. The corticosteroid component, flumetasone, also helps alleviate symptoms such as ear canal swelling, discomfort, and itching, which are commonly associated with these infections. The combination therapy is often preferred due to its dual action in treating both the infection and its associated symptoms simultaneously.

Contra indication

Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation should not be used in patients with a known hypersensitivity to clioquinol, flumetasone pivalate, or any of the excipients in the formulation. This combination product is contraindicated in patients with a history of a perforated tympanic membrane (eardrum) or tympanic membrane rupture, as the steroid component, flumetasone, can be absorbed systemically when the ear drum is compromised, leading to potential adverse effects. Additionally, the use of this medication should be avoided in patients with fungal or viral ear infections, as clioquinol is an antibacterial and antifungal agent but is not effective against viral pathogens, and the corticosteroid could exacerbate the infection. Patients with pre-existing conditions such as untreated active infections, especially tuberculosis or systemic fungal infections, should not use this product due to the immunosuppressive effects of the corticosteroid, which can worsen these conditions. Pregnant women should use this medication only if the potential benefits justify the risks, as corticosteroids, including flumetasone, are categorized as Category C in pregnancy. The drug should not be used in children under 2 years of age unless specifically prescribed by a doctor. Additionally, the product should not be used for more than 7–10 days to avoid the risk of local skin thinning or systemic absorption of the corticosteroid.

Side Effect

The most common side effects of Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation are localized reactions at the application site, including ear irritation, itching, redness, or a burning sensation. These effects are usually mild and temporary. Overuse or prolonged use may lead to more serious effects such as skin thinning in the ear canal, as well as delayed wound healing due to the corticosteroid component (flumetasone). Rarely, patients may experience a secondary fungal or bacterial infection, particularly if the corticosteroid alters the balance of microbial flora in the ear. In such cases, the infection could worsen and lead to additional symptoms, such as pain or discharge. If signs of an allergic reaction occur, such as swelling, itching, or difficulty breathing, the medication should be discontinued immediately, and emergency medical care should be sought. Systemic absorption of the corticosteroid is unlikely with proper use, but prolonged application, especially in patients with a perforated eardrum, could lead to systemic side effects associated with corticosteroids, such as adrenal suppression or elevated blood pressure. If the ear becomes increasingly painful, swollen, or if there is an increase in discharge, this may indicate that the infection is not improving, and further medical evaluation is needed.

Pregnancy Category ID

0

Mode of Action

Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation works through a dual mechanism of action. Clioquinol, an antimicrobial agent, exhibits both antibacterial and antifungal activity. It works by disrupting the cellular membranes of bacteria and fungi, preventing their replication and survival in the ear canal. This helps to clear infections caused by *Staphylococcus aureus*, *Escherichia coli*, and other common bacterial pathogens, as well as certain fungi that may contribute to ear infections. Flumetasone pivalate, a corticosteroid, reduces inflammation in the ear canal by inhibiting the release of pro-inflammatory mediators such as prostaglandins and leukotrienes. This helps to reduce symptoms such as swelling, pain, and itching, which are common in ear infections. The combination of these two agents provides a comprehensive approach to treating ear infections by targeting the underlying infection and reducing the associated inflammation and discomfort. The corticosteroid also helps relieve the symptoms of irritation and swelling that might otherwise make the condition worse.

Interaction

Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation generally has limited systemic absorption due to its localized application in the ear. As a result, significant drug-drug interactions are uncommon. However, if this product is used concurrently with other topical or systemic corticosteroids, the risk of systemic corticosteroid side effects may increase, particularly with prolonged or frequent use. Patients should avoid using other ear preparations that contain corticosteroids or antifungal medications unless directed by a healthcare provider to prevent redundancy and avoid exacerbating irritation or increasing the risk of systemic side effects. Additionally, caution should be taken when using this product with other immunosuppressive drugs, as the corticosteroid in the formulation could amplify the effects of these medications and impair immune function. Although there is no direct interaction with food or alcohol, patients should avoid alcohol-based products in the ear, as they can cause irritation. In rare cases, systemic absorption of the corticosteroid from prolonged or inappropriate use may lead to interactions with other medications metabolized by the liver, such as certain enzyme inhibitors or inducers, but this is less common with localized use in the ear.

Pregnancy Category Note

Information not available

Adult Dose

The standard dosage of Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation for adults is to instill 3–5 drops into the affected ear(s) once or twice daily, depending on the severity of the infection. The treatment duration typically lasts between 7 to 10 days, but patients should follow the healthcare provider’s instructions and not exceed the recommended duration of use. The ear should be gently pulled to straighten the ear canal before instilling the drops, and the patient should remain lying down for a few minutes after application to allow the medication to reach the inner ear. In cases of more severe infections, the dosage may be adjusted based on the clinical response. It is important to avoid using the ear drops with other topical ear treatments unless approved by a healthcare provider. The ear should not be rinsed or irrigated after treatment unless directed by the physician, as doing so may dilute or remove the medication.

Child Dose

The use of Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation in children is generally limited to those over the age of 2. For children aged 2 years and older, the recommended dose is typically the same as for adults: 3–5 drops in the affected ear(s) once or twice daily. However, the treatment duration should generally not exceed 7–10 days to avoid potential side effects, particularly from the corticosteroid component. Close monitoring for any signs of skin irritation, excessive dryness, or worsening infection is essential. The use of this medication should be avoided in younger children (under 2 years) unless specifically prescribed by a pediatrician. Additionally, parents should ensure that the child does not experience any adverse reactions, such as allergic reactions or symptoms indicating the need for discontinuation of the medication.

Renal Dose

Clioquinol 1% + Flumetasone Pivalate 0.02% ear preparation is a topical ear medication with minimal systemic absorption, so renal dose adjustments are generally not necessary. Since the medication is localized to the ear and is not significantly absorbed into the bloodstream, there is little risk of renal impairment influencing its pharmacokinetics. However, in patients with severe renal dysfunction, it is still important to monitor for any signs of systemic absorption or side effects, particularly if the medication is used incorrectly (e.g., if the ear drum is perforated). No specific renal dose adjustments are required for patients with renal impairment.

Administration

Information not available