Small Ear solution Cetraxal Salvat treat acute external otitis (15 tubes)

Dosage form 15 tube box
Specifications Ciprofloxacin
Ingredient Middle otitis, external otitis

Ingredient

Composition information	Content
Ciprofloxacin	0.2%

Uses

Indications

Cetraxal small solution indicated treatment in the following cases:

Treatment of acute external otitis caused by bacteria sensitive to ciprofloxacin.

Mechanism of action

As a fluoroquinolone antibiotic, the bactericidal effect of ciprofloxacin is the result of inhibiting both Topoisomerase Enzyme Type II (DNA Gyrase) and Topoisomerase IV necessary for bacterial copy, code, repair and recombinant DNA of bacteria.

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There is no pharmacological association that is described in the use of drugs on the spot. With the type of drug used on the spot, the concentration achieved is much higher than the plasma concentration.

resistance mechanism

In-Vitro resistance with ciprofloxacin can be obtained through a staircase of using the target position in both DNA Gyrase and Topoisomerase IV. The degree of cross resistance obtained between ciprofloxacin and fluoroquinolone is a variable. Single gene mutations may not lead to clinical resistance but multi -mutations often lead to clinical resistance for many or all active ingredients of this group.

The non -absorbing resistance mechanism or pumping the output may have different effects on sensitivity to fluoroquinolone, which depends on the biochemical properties of different active ingredients in the group and the affinity of the transportation system for each active ingredient. All in-Vitro resistance mechanisms are observed commonly in clinical independent.

Mechanisms to resist the loss of activity of other antibiotics such as obstructing permeability (common in Pseudomonas Aeruginosa) and pumping the output mechanism may affect the sensitivity to Ciprofloxacin.

Indirect drug resistance through chromosomal -carrying structures of bacteria encrypted by the QNR gene has been reported.

antibacterial activity spectrum

The sensitive point is limited to distinguishes of bacterial strains sensitive to average sensitive strains and then resistance strains.

Eucast's recommendation (European Commission evaluates antibiotic sensitivity).

pseudomonas:

Sensitive: S ≤ 0.5 mg/l

Anti -drug: R> 1 mg/l

Sensitive: S ≤ 1 mg/l

resistant to drugs: R> 1 mg/l

The popularity of the obtained resistance may vary by geographic area and over time for a certain species and local information about resistance is very necessary, especially when treating severe infections. If necessary, consult experts when doubting the effect of that antibiotic on at least some local infections.

Based on the current data, the following table presents the sensitivity of ciprofloxacin with leading pathogenic bacteria in the approved indications.

Filial bacteria when gram (+): Staphylococcus aureus. There are still some doubts related to the dynamics of local drug concentration, chemical and physical conditions at the place where the drug can change the effects of antibiotics and the stability of the product used on the spot.

pharmacokinetic pharmacokinetics

Ciprofloxacin plasma concentrations are not evaluated after using 0.25 ml of Cetraxal 0.2% (total dose of 0.5mg of ciprofloxacin). The plasma concentration is considered not to be detected or very low, although there is no significant amount of ciprofloxacin on the circulation when used in normal conditions.

Even if the entire amount of ciprofloxacin is absorbed after use at two at (total dose is 1mg), it is not sure to detect the concentration of drugs in plasma in humans, if it considers the distribution volume of ciprofloxacin as 180L (eucast information) and the detection concentration is pipe/mL.

Before taking Small Ear solution Cetraxal Salvat treat acute external otitis (15 tubes)

How to use

Hold the vial in hand a few minutes before using to warm the drug solution, avoiding the feeling of dizziness may occur when a cold solution into the ear canal.

Patients should lie in the ears in the upper and small infections in the ears, performed several times. Maintain such a position for 5 minutes to facilitate the drug to penetrate into the ear. Repeat for the other if necessary.

Patients should remove single -dose pipe after use, should not be used again.

In case of using the instrument to guide the drug in the ear, the first dose should be used twice (2 tubes instead of 1 tube).

Dosage

Adults and children from one year of age

Small the drug solution in a tube into the ear inflammation twice a day for 7 days.

Children under 1 year of age

Safety and effectiveness of Cetraxal with children under 1 year of age has not been proven.

For patients with liver failure, renal failure

There is no need to adjust the dose for these groups of patients due to non -detection of drug concentration in plasma.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when using overdose?

In an emergency, call the 115 emergency center immediately or go to the nearest local health station.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

In a phase clinical trial III, 319 patients were treated with small solution of Cetraxal 2mg/ml.

The most unwanted effects are reported: itching occurs at 0.9% of patients treated with ciprofloxacin, headache and pain in the place where the drug occurs in about 0.6% of patients.

Unwanted effects related to treatment are not common (≥ 1/1000 and

Disorders of ear and inner ears:

Not common: itchy ears, tinnitus.

Nervous system disorders:

Not common: dizziness, headache.

Skin and subcutaneous disorders.

Not common: Dermatitis.

Common disorders and drug status:

Not common: Pain in the place of use.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Small Cetraxal solution is contraindicated in the following cases:

Hypersensitivity to the active ingredient Ciprofloxacin or any antibiotic belonging to the Quinolone group or sensitive to any ingredient of the drug.

Caution when using

This drug is used to shrink the ears, not used to small eyes, inhalation or injection.

Despite the progression of the disease when taking children for children under 1 year of age similar to that when used for older children, the safety and effectiveness of the drug with children under 1 year of age has not been proven.

Stop the drug immediately if the skin rash appears or any signs of hypersensitivity. Severe hypersensitivity reactions and sometimes life -related, some occurred immediately after the first dose, have been reported in patients using Quinolone Systemic System. Serious acute hypersensitivity reactions may need immediately emergency treatment.

As well as other antibiotics, using this antibiotic can lead to excessive growth of non -sensitive organisms, including strains of bacteria, yeast and fungi. Proper treatment should be conducted if superinfection occurs.

After a week of treatment, if some signs and symptoms remain, it is necessary to examine it to re -evaluate the disease and the treatment.

Some patients using Quinolone Systemic System shows signs of sunlight sensitivity from medium to heavy. Because the sugar is used on the spot, this drug does not cause light allergic reaction.

Used in pregnant and lactating women

Pregnant women

There is no data on the use of small solutions at 0.2% Ciprofloxacin in pregnant women. There is an average number of data on oral ciprofloxacin in pregnant women. No reproductive toxicity occurs when using small sugar at. However, after using systemic sugar, animal studies also not indicated the direct or indirect effects of reproductive toxicity.

Due to the whole body absorption of ciprofloxacin after using small lines is negligible, so no effect is predicted for pregnant women. Cetraxal can be used for pregnant women.

breastfeeding women

ciprofloxacin is excreted in breast milk after using systemic sugar. It is unclear whether ciprofloxacin is excreted in breast milk after using small sugar at or not. Due to the body exposure in breastfeeding women for ciprofloxacin is negligible, there is no effect on infant breastfeeding. Cetraxal can be used for nursing women.

The effect of the drug on the ability to drive and operate machinery

The drug can cause dizziness, headache. Although this is not popular, careful if driving or operating machines while taking the drug.

Drug interaction

specific drug interactive studies have not been conducted with small solution of Cetraxal 2mg/ml.

Due to the low plasma concentration after using the ear, Ciprofloxacin usually does not interact with the body with other drugs.

recommend not to be used simultaneously with other small drugs.

Storage

Store in a cool dry place, avoid sunlight, cover tightly after use.

Other drugs

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