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Active Substance: Purified Diphtheria Toxoid, Purified Tetanus Toxoid, Inactivated B. Pertussis, Hib oligosacharide (conjugated to CRM197 protein), Recombinant HBsAg.

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Overview

Welcome to Dwaey, specifically on ARAPENTA page.
This medicine contains an important and useful components, as it consists of
Purified Diphtheria Toxoid, Purified Tetanus Toxoid, Inactivated B. Pertussis, Hib oligosacharide (conjugated to CRM197 protein), Recombinant HBsAgis available in the market in concentration

Name

Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% Eye prep

Precaution

Before using Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% eye preparation, patients must consult their healthcare provider, particularly those with pre-existing medical conditions or those taking other medications. Special caution should be exercised for individuals with glaucoma, as corticosteroids like fluorometholone can increase intraocular pressure. Tetrahydrozoline hydrochloride, being a sympathomimetic agent, may cause systemic effects, especially if overused, leading to cardiovascular symptoms like increased blood pressure or tachycardia. Pregnant or breastfeeding women should only use this drug if the potential benefits outweigh the risks, and it should be used under strict medical supervision. Children should be carefully monitored for potential side effects, as the safety of this combination has not been well established in pediatric populations. Long-term or excessive use can lead to rebound redness or other side effects due to the vasoconstrictor activity of tetrahydrozoline. Patients should be advised to avoid prolonged or frequent use and to follow the prescribed dosage strictly to avoid complications.

Indication

Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% eye preparation is primarily indicated for the treatment of inflammation and redness associated with various eye conditions. Fluorometholone serves as a corticosteroid, reducing inflammation in the eye, while tetrahydrozoline acts as a decongestant, relieving eye redness caused by irritation or congestion. This combination is effective for conditions such as allergic conjunctivitis, eye irritation due to environmental factors, and post-operative inflammation. It is also used to relieve temporary redness or swelling of the eyes from non-infectious causes. Tetrahydrozoline works by constricting the blood vessels in the eyes, thereby reducing redness, while fluorometholone helps control inflammatory responses. Off-label, this medication may be used for other inflammatory eye conditions, but it should only be done under a healthcare provider's guidance. It is important to note that this medication should not be used in cases of bacterial or viral infections without proper antibiotic therapy.

Contra indication

Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% is contraindicated in patients who are allergic to any of its components, including fluorometholone or tetrahydrozoline. It is also contraindicated for individuals with ocular infections (viral, fungal, or bacterial) due to the risk of exacerbating the condition, particularly with the corticosteroid component. It should not be used in patients with a history of glaucoma or ocular hypertension, as corticosteroids can increase intraocular pressure, which may worsen these conditions. The use of this drug in individuals with known cardiovascular issues should be closely monitored, as tetrahydrozoline, being a sympathomimetic, can increase blood pressure and heart rate. It is also not recommended for children under the age of 6 unless prescribed by a healthcare provider, due to the risks of systemic absorption and side effects. Pregnant or breastfeeding women should avoid using this medication unless absolutely necessary and prescribed by a healthcare provider after a risk-benefit assessment.

Side Effect

Common side effects of Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% include mild eye irritation, stinging, and temporary blurred vision upon application. These effects typically resolve shortly after use. However, more serious side effects may occur with prolonged use, particularly the corticosteroid component. These include increased intraocular pressure, cataracts, and delayed wound healing. Tetrahydrozoline can also lead to rebound redness and eye dryness if overused, as well as systemic side effects such as increased blood pressure, tachycardia, or headaches. Allergic reactions such as swelling, redness, or itching around the eyes are rare but possible. Long-term use may result in thinning of the cornea or conjunctiva, which increases the risk of eye injury. If any of these more serious symptoms arise, patients should discontinue use and consult their healthcare provider. To mitigate these side effects, it is important to follow the prescribed dosing schedule and avoid prolonged or excessive use.

Pregnancy Category ID

3

Mode of Action

Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% eye preparation works through a dual mechanism. Fluorometholone, a corticosteroid, reduces inflammation by inhibiting the production of pro-inflammatory mediators like prostaglandins and leukotrienes. This reduces the redness, swelling, and discomfort associated with inflammatory eye conditions. On the other hand, tetrahydrozoline is a sympathomimetic agent that works as a vasoconstrictor. It constricts the blood vessels in the eye, reducing the appearance of redness. The combination of these two components addresses both the inflammatory and vascular components of eye irritation or redness. Fluorometholone’s anti-inflammatory effects help to prevent tissue damage caused by inflammation, while tetrahydrozoline provides rapid relief from redness due to congestion. The medication exerts its action locally in the eye with minimal systemic absorption, which reduces the potential for widespread side effects.

Interaction

Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% can interact with other topical eye medications, particularly those containing other corticosteroids, leading to increased intraocular pressure and potentially causing glaucoma. Combining this drug with other vasoconstrictors or sympathomimetics can amplify systemic cardiovascular effects such as hypertension and tachycardia. Additionally, the use of other eye drops, such as those containing antifungals or antivirals, may interfere with the effectiveness of tetrahydrozoline or fluorometholone. Systemic medications that affect the cardiovascular system, like beta-blockers or antihypertensive agents, may interact with tetrahydrozoline’s vasoconstrictive action. To avoid potential complications, patients should inform their doctor of all medications they are taking. Lifestyle factors like alcohol consumption can enhance the vasoconstrictive effects of tetrahydrozoline, potentially causing increased blood pressure. Patients should also avoid wearing contact lenses while using the eye drops, as the drug may cause discomfort or increased risk of infection when used with contacts.

Pregnancy Category Note

Information not available

Adult Dose

The standard adult dose for Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% eye preparation is 1-2 drops in the affected eye(s) up to 4 times daily, depending on the severity of the condition. For acute inflammation or severe redness, the dosage may be increased temporarily, but it should not exceed the recommended dose without the guidance of a healthcare provider. Once symptoms improve, the frequency of application can be reduced to prevent rebound redness. Patients should avoid using the drops longer than prescribed, as prolonged use of tetrahydrozoline can lead to increased side effects such as rebound congestion or elevated intraocular pressure. The drug should be used strictly as directed to avoid complications.

Child Dose

For pediatric patients, Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% should only be used under the supervision of a healthcare provider. The safety and efficacy of this combination have not been well established in children under the age of 6. For children above 6 years old, the usual adult dosage of 1-2 drops in the affected eye(s) 3-4 times daily may be used, but dosage adjustments should be made based on individual circumstances and the severity of the condition. Caution should be exercised in pediatric patients, especially regarding the risks of systemic absorption from tetrahydrozoline, which could potentially cause adverse cardiovascular effects. Regular follow-up is recommended to monitor for any side effects, particularly increased intraocular pressure or adverse systemic reactions.

Renal Dose

There are no specific renal dose adjustments required for Fluorometholone 0.1% + Tetrahydrozoline Hydrochloride 0.025% eye preparation, as the systemic absorption of this topical medication is minimal. However, for patients with severe renal impairment, it is important to monitor for potential systemic side effects, particularly from tetrahydrozoline, which could affect blood pressure and heart rate. Although the drug is used primarily for its local effects, caution is advised when considering its use in patients with existing renal conditions, as poor renal function can lead to altered drug metabolism or clearance, especially with prolonged or frequent use.

Administration

Information not available

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