ACTILYSE TREATMENT SET Price

Overview

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This medicine contains an important and useful components, as it consists of
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Name

Chloramphenicol 5% + Lidocaine Hydrochloride 1% Ear drops

Precaution

Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops are a combination medication used for bacterial ear infections with associated pain. Both components serve specific purposes, but there are several precautions to consider: - **Hypersensitivity**: Patients with allergies to Chloramphenicol, Lidocaine, or any other ingredients in the ear drops should avoid using this medication. An allergic reaction could result in irritation, swelling, or rash. - **Ear infections with perforated eardrum**: Care must be taken when using these drops in patients with a perforated eardrum or any type of ear injury. Lidocaine, a local anesthetic, may cause systemic absorption if the eardrum is perforated, potentially leading to toxicity, especially in large doses. - **Prolonged use**: Extended use of Chloramphenicol could increase the risk of bacterial resistance, while the prolonged use of Lidocaine may lead to toxicity. Both drugs should not be used for more than 7-10 days unless directed by a healthcare provider. - **Pregnancy and breastfeeding**: Chloramphenicol can be used during pregnancy when absolutely necessary, as it may cross the placenta. Lidocaine is also categorized as pregnancy category B, indicating that it is generally considered safe in pregnancy but should be used cautiously. Both drugs are excreted in breast milk, but the amount transferred is minimal, suggesting it may be safe to use during breastfeeding with careful monitoring. - **Children**: In young children, especially those under 2 years, the use of ear drops should be carefully considered, as children may have an increased sensitivity to medications. The dose may need to be adjusted, and the risks of potential side effects should be carefully monitored.

Indication

Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops are indicated primarily for the treatment of ear infections, particularly **otitis externa** (outer ear infection) and **otitis media** (middle ear infection) with significant pain and inflammation. This combination of an antibiotic and a local anesthetic provides both antimicrobial treatment and pain relief. - **Otitis externa**: Chloramphenicol effectively targets bacterial pathogens that often cause infections of the outer ear canal, while Lidocaine provides immediate relief from the discomfort associated with this condition. - **Otitis media**: For bacterial infections of the middle ear, these drops may also be used, particularly if the patient presents with pain. Additionally, off-label use may include ear pain relief following ear surgery, or for the management of ear pain due to other causes, as long as bacterial infection is not suspected or ruled out.

Contra indication

The use of Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops is contraindicated in specific situations: - **Known hypersensitivity**: Patients with a known allergy to any of the components, particularly Chloramphenicol or Lidocaine, should not use these drops. Symptoms of an allergic reaction could range from localized irritation to more severe reactions like anaphylaxis. - **Perforated eardrum**: If the patient has a perforated or ruptured eardrum, the use of Lidocaine could result in systemic absorption and increase the risk of Lidocaine toxicity, which can lead to symptoms like dizziness, confusion, seizures, and cardiovascular issues. Chloramphenicol may also be absorbed into the middle ear if the tympanic membrane is damaged, although systemic absorption is minimal with topical use. - **Severe liver or kidney dysfunction**: Lidocaine is metabolized in the liver and excreted through the kidneys, so patients with significant liver or kidney dysfunction should avoid these drops, as they may not properly clear the drug from the body, leading to toxicity.

Side Effect

Side effects of Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops are typically rare but may include: - **Ear-related side effects**: These may include mild irritation, itching, redness, or a burning sensation in the ear after administration. Most symptoms are transient and resolve shortly after application. - **Local numbness**: Lidocaine can cause a temporary numbing effect in the ear canal, which may result in difficulty hearing temporarily or a feeling of fullness in the ear. This is typically short-lived. - **Systemic effects of Lidocaine**: Although rare with topical application, Lidocaine toxicity may occur, especially in patients with a perforated eardrum or high systemic absorption. Symptoms of toxicity include dizziness, confusion, tinnitus, or a slow heart rate. - **Allergic reactions**: Hypersensitivity to Chloramphenicol or Lidocaine can lead to rashes, swelling, or more severe reactions such as difficulty breathing (anaphylaxis), requiring immediate medical attention. - **Infection recurrence**: Prolonged use of Chloramphenicol without addressing underlying causes may contribute to bacterial resistance, leading to recurrent infections or treatment failure. If any of these symptoms persist or worsen, medical attention should be sought immediately.

Pregnancy Category ID

16

Mode of Action

Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops work through the combined action of an antibiotic and a local anesthetic: - **Chloramphenicol**: As an antibiotic, Chloramphenicol acts by binding to the bacterial ribosome, inhibiting protein synthesis, and thereby preventing bacterial replication. It is effective against a broad spectrum of bacteria, including Gram-positive and Gram-negative organisms, commonly responsible for ear infections. - **Lidocaine Hydrochloride**: Lidocaine is a local anesthetic that works by blocking sodium channels in nerve cells, preventing the conduction of nerve impulses. This action numbs the affected area, providing immediate relief from pain or discomfort in the ear, which is particularly beneficial in acute infections. This combination allows for effective treatment of bacterial infections with pain relief, addressing both the infection itself and the associated symptoms such as pain and inflammation.

Interaction

The systemic interactions of Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops are minimal, given the localized nature of the medication. However, there are still some important interactions to be aware of: - **Lidocaine and antiarrhythmic drugs**: Lidocaine is a local anesthetic with potential systemic effects if absorbed. Caution should be exercised when used in conjunction with other antiarrhythmic medications (e.g., quinidine, procainamide) or other medications that alter cardiac conduction, as Lidocaine can enhance the effects and increase the risk of arrhythmias. - **Liver enzyme inhibitors**: Drugs that inhibit liver enzymes (e.g., cimetidine, ketoconazole) may increase the plasma levels of Lidocaine, potentially leading to toxicity. Therefore, if a patient is taking such medications, monitoring for Lidocaine side effects is recommended. - **Chloramphenicol and other antibiotics**: There is no significant interaction between Chloramphenicol and other antibiotics when used topically in the ear. However, combining Chloramphenicol with drugs that also affect bacterial cell wall synthesis may increase the risk of bacterial resistance or result in additive antibacterial effects. - **Alcohol**: Though unlikely to have direct interactions, patients should be cautious about alcohol consumption as it can increase the likelihood of side effects such as dizziness or confusion, particularly in combination with Lidocaine.

Pregnancy Category Note

Information not available

Adult Dose

The typical adult dosage for Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops is: - **Otitis externa (outer ear infection)**: Place 2-3 drops in the affected ear 2-3 times a day. The duration of treatment is generally up to 7-10 days, depending on the severity of the infection and the patient’s response. - **Otitis media (middle ear infection)**: For ear infections with associated pain, the same dosing schedule may be followed. It is important to follow the prescribed dosing instructions and complete the full course of treatment to avoid relapse or bacterial resistance.

Child Dose

For children, the dose of Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops is generally similar to the adult dosage but should be carefully monitored: - **Otitis externa**: 1-2 drops in the affected ear, 2-3 times a day. The duration of treatment is typically 7-10 days. - **Otitis media**: In the case of ear pain due to a bacterial infection, the same dosage schedule is generally followed. The use of these ear drops in children under 2 years should be approached with caution. Pediatric patients are generally more sensitive to medications, and the drops should only be used under healthcare provider guidance to ensure both safety and effectiveness.

Renal Dose

Since Chloramphenicol 5% + Lidocaine Hydrochloride 1% ear drops are applied topically, systemic absorption is minimal. Therefore, no significant renal dosage adjustments are typically required. However, caution should be taken in patients with severe renal dysfunction, as Lidocaine may be more likely to accumulate in the body in these patients. Monitoring renal function and Lidocaine levels is recommended if prolonged or high-dose use is required.

Administration

Information not available