Ileffexime Otic Solution 5ml Ilongpharm Treatment

Dosage form Bottle x 5ml
Specifications Ofloxacin

Ingredient

Thành phần cho 1ml

Composition information	Content
Ofloxacin	3mg

Uses

Indications

Ileffexime Otic Solution is indicated in the following cases:

Treatment

External ear infections in adults and children over 6 months old due to Escherichia Coli, Pseudomonas Aeruginosa and Staphylococcus aureus.

Acute otitis media in children over 1 year of age with an ear catheter is caused by Haemophilus influenzae, Moraxella Catatrhalis, Pseudomonas Aeruginosa Staphylococcus aureus and Streptococcus Pneumoniae.

Ofloxacin has a broad antibacterial activity on in vitro against both gram -negative and gram -positive bacteria. Ofloxacin's main mechanism is to inhibit DNA gyrase, a bacterial topoisomerase. DNA Gyrase is an Ezym that is essential for humanity, copies, repair and re -combination of DNA. This enzyme inhibition leads to bacterial DNA instability and thus killing bacteria cells.

recorded the cross -resistance between ofloxacin and other fluoroquinolones. In general, there is no cross-resistance between ofloxacin and other antibiotic groups such as beta-lactam or aminoglycosides.

Ofloxacin is indicated as antibiotic activity for the following species on in vitro and clinically when treating infections in the ear:

Gram -positive bacteria: Staphylococcus aureus, Streptococcus pneumoniae

Gram bacteria - Aerobic sound: Escherichia Coli, Haemophilus Influenzae, Moraxella Catatrhalis, Proteus Mirabilis, Pseudomonas Aeruginosa.

pharmacokinetic pharmacokinetics

Serum concentration (for patients to open the eardrum and perforation of the eardrum), in the ear fluid and in the mucosa of the middle ear (for patients with perforation of the eardrum), it is determined after the use of small ear ear solution.

In two studies at the usual dose, the low serum ofloxacin concentration in adult patients opened the eardrum with or without ear fluid, after using the small solution of Ofloxacin, 0.3% (4.1ng/ml (n = 3) and 5.4ng/ml (n = 5) respectively). In adults perforation of the eardrum, the maximum serum concentration is 10ng/ml after the small solution of Ofloxacin East solution is 0.3%, ofloxacin is detected in the middle ear mucosa in some adult patients perforation of ear ear membrane (11 of 16 people).

ofloxacin concentration in the mucosa between the oscillation in a large area. The concentration is measured from 1.2 to 602µg/g after small solution ofloxacin solution 0.3%. Ofloxacin concentration is high in the pus epidemic (389-2850µg/g, n = 13) 30 minutes after using the 0.3% small tai tai tai solution for patients who are adults with chronic ear infections with chronic pus and perforation of the eardrum. However, the measurement of ofloxacin concentration in pus discharge does not necessarily reflect the contact of the middle ear with ofloxacin.

Before taking Ileffexime Otic Solution 5ml Ilongpharm Treatment

How to use

by each specified specification.

Dosage

Outitis external inflammation

Children from 6 months to 13 years: 5 drops/day (0.25ml equivalent to 0.75mg ofloxacin) into the ear infected with 7 days.

Patients aged 13 years and older: Put 10 drops/day (0.5ml equivalent to 1.5mg ofloxacin) into the ear infected with 7 days.

Keep the vial in hand for 1 to 2 minutes to warm before the drug is used to avoid the effect of dizziness when the drug is cold. The patient needs to lie on his side, the ears are infected upward and small. Should keep the position for 5 minutes to infuse the drug. Repeat if necessary in the other ear.

Chronic chronic otitis media

recommended dose for patients 12 years and older is 10 drops/time (0.5ml equivalent to 1.5mg ofloxacin) x 2 times/day for 14 days.

Keep the vial in hand for 1 to 2 minutes to warm before the drug is used to avoid the effect of dizziness when the drug is cold. The patient needs to lie on his side, the ears are infected upward and small. Press the jar about 4 times for the drug to soak into the middle ear. Should keep the position within 5 minutes. Repeat if necessary in the other ear.

Acute otitis media

Dosage recommended for children from 1 to 12 years old is 5 drops/time (0.25ml equivalent to 0.75mg ofloxacin) x 2 times/day in the ear infected for 10 days.

Keep the vial in hand for 1 to 2 minutes to warm before the drug is used to avoid the effect of dizziness when the drug is cold. The patient needs to lie on his side, the ears are infected upward and small. Press the jar about 4 times for the drug to soak into the middle ear. Should keep the position within 5 minutes. Repeat if necessary in the other ear.

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 overdose? Following the ECG should be conducted because of the risk of extension of QT.

What to do when forgetting a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Do not drink twice as prescribed.

Side Effects

When using Ileffexime Otic Solution, you may experience unwanted effects (ADR).

Uncommon, 1/1000

Infection system: Fungal infection, drug resistance.

Mental: agitation, sleep disorders, insomnia.

Central nerve: fatigue, headache, dizziness.

Eye: eye irritation.

Respiratory: cough, rhinitis - throat.

digestive: pain, diarrhea, nausea, vomiting.

Skin and subcutaneous tissue: itching, rash.

Rare, 1/10000

The immune system: anaphylactic reaction, angioedema.

Metabolism: Anorexia. Mental: Mental disorders (illusion), anxiety, nightmares, depression.

Central nerve: drowsiness, paresthesia, taste disorders. eyes: vision disorders. Cardiovascular: tachycardia, hypertension.

Respiratory: Difficulty breathing, bronchial spasm.

digestive: bowelitis, sometimes bleeding.

Liver metabolism disorders: Hyper enzyme, hyperburin blood bilirubin.

Skin and subcutaneous tissue: urticaria.

musculoskeletal and connective tissue: tendonitis.

Urinary system: increased serum creatinine.

Very rare, ARD

Blood and lymphatic system: Anemia, hemolytic anemia, leukopenia, platelets.

Central nerve: peripheral neurological disorders, motor disorders, convulsions.

Tinnitus, hearing loss.

Digestive: fake colitis, jaundice.

Skin and subcutaneous tissue: Diverse roses, epidermal necrosis due to poisoning, sensitive to light, pink balls, chromosomes, hemorrhage, vasculitis.

Bone muscle and connective tissue: muscle pain, joint pain, tendon rupture (such as Achilles) can occur within 48 hours from the beginning of the drug and may be on both sides.

Urinary system: Acute renal failure.

Not determined frequency

Blood and lymphatic system: leukemia, bone marrow failure.

Metabolic: Hypoglycemia in diabetes patients treated with hypoglycemic drugs, hyperglycemia, coma due to hypoglycemia.

Mental: Mental disorders and depression with self -dangerous behavior for themselves, agitated.

Central nervous system: Run, dysfunction, loss of taste, unconsciousness.

Eye: Peach grave inflammation.

ears: loss of hearing ability. Cardiovascular: ventricular arrhythmia, torsion (recorded in patients at risk of extending the QT). Respiratory: Pneumonia caused by allergies, shortness of breath. digestive: indigestion, flatulence, constipation, pancreatitis.

Hepatitis metabolism: Hepatitis, liver damage, including acute liver failure, can be life -threatening that has been recorded in patients with Ofloxacin, mainly in people with liver disorders.

Skin and subcutaneous tissue: Stevens-Johnson syndrome, acute ulcerative ulcer, skeletal peeling dermatitis and connective tissue, muscle pattern or muscle disease, muscle weakness, muscle rupture, interlocking tendon, arthritis.

Urinary system: Acute nephritis.

Systemic: weakness, fever, pain (including back, chest, and limbs).

Instructions on how to handle ADR

Notify the doctor with unwanted effects when using the drug.

Warnings

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

Contraindicated

Ileffexime Otic Solution is contraindicated in the following cases:

Ileffexime small solution is not used for patients with a history of hypersensitivity to ofloxacin and with other quinolones or for people who are sensitive to the ingredients of the drug.

Caution when using

ileffexime small ears only used to treat at the ear, not injected.

Serious and hypersensitivity reactions are sometimes dead (anaphylactic/anaphylactic) right after the first dose, which has been reported in patients with systemic quinolon, including ofloxacin. Some reactions accompanied by shock, loss of consciousness, angioedema (including larynx, throat or facial edema), obstruction of airway, shortness of breath, urticaria and itching. If an allergic reaction occurs, stop taking the drug. Severe anaphylactic reactions may require immediate treatment (oxygen supply, airway management, including internal intubation).

As well as antibacterial drugs, taking drugs for a long time can develop uncertainty bacteria, including fungi. If the superinfection occurs, the drug should be stopped and replaced. If the infection does not improve after a week, the next treatment should be available. If there is still pus in the ear after the treatment of the procedure or if there are two or more pus appears in the ear for 6 months, it is necessary to evaluate the condition to eliminate cases such as tumor and foreign objects.

Be careful when taking the drug in patients with signs of sensitivity to other antibacterial quinolones.

The ability to drive and operate machinery

Because the drug can cause unwanted effects such as dizziness, headache, vision reduction ... should be cautious when using drugs in drivers and operating machinery.

Pregnancy

of high doses of Ofloxacin can cause fetal disabilities and other animal problems. There is no research on human being conducted. It is necessary to consult a doctor if you are pregnant or plan to get pregnant. Ileffexime should only be used for pregnant women when the benefits of treatment beyond the risk may occur with the fetus.

Breastfeeding period

Do not know if ofloxacin is excreted through breast milk when used in the form of medications on the spot or not. Due to the potential to cause serious side effects in breastfeeding children, it is necessary to decide to stop breastfeeding or stop the drug when needed for women who are breastfeeding.

Drug interaction

studies on drug interactions have not been done.

Using a few body quinean quinumons has been shown to inhibit the metabolic clearance of caffeine and theophylllin. Interactive studies with drugs with ofloxacin using systemic sugar have proven that the clearance of caffeine and theophyllin is not significantly affected by ofloxacin.

Despite the report on the increase in the central nervous toxicity ratio for the use of systemic fluoquinolon when used along with nonsteroidal anti -inflammatory drugs (NSAIDs), it has not been reported with the common use of NSAIDs and ofloxacin.

Like other fluoroquinolones, careful use of drugs in patients taking drugs that extend the QT (such as anti -arrhythmia IA and III, three -round antidepressants, macrolid, anti -psychotic drugs).

Storage

Store in closed boxes at temperatures not exceeding 30 ° C. To be out of reach of children.

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