Medication info

Ephexis Injection (Ofloxacin)

Prescription medicationInjectionsIntramuscular injection · Intravenous injection · Subcutaneous injection
Ingredient · strength
Ofloxacin›2mg / 1mL
Manufacturer / importer
Ildong Pharmaceutical Co., Ltd.
Appearance
A colorless vial injection containing a pale yellow liquid.
Packaging
100 milliliters/vial
Approval status
Active

MFDS item code 199500311 · Approved 1995.10.18 · Insurance code 642901341

Summary

Main use
Treatment of respiratory tract infections, urinary tract infections, and skin and soft tissue infections
Who receives it
Adults
Adult administration
Ofloxacin should be administered by slow intravenous injection over at least 60 minutes. Do not use by intramuscular, subcutaneous, intrapleural, or intrathecal injection. 1. Usual adults with normal renal function (creatinine clearance of 50 mL per minute or more): Administer 200 mg of this medicine per dose twice daily; the dose may be increased to 600mg daily depending on the degree of response. 2. Adjust the dose in patients with renal impairment as follows. 1) Creatinine clearance of 20~50 mL per minute: Administer the usual dose once daily, every 24 hours. 2) Less than 20 mL: Administer 1/2 of the usual dose once daily, every 24 hours.

Ingredients

Manufacturer
Ildong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory tract infections, urinary tract infections, and skin and soft tissue infections

  • Acute exacerbation of chronic bronchitis
  • community-acquired pneumonia
  • complicated skin and soft tissue infections
  • complicated urinary tract infections
  • simple acute cystitis
  • acute bacterial exacerbations
  • simple urinary tract infections
  • urethritis
  • acute otitis media.
View approved original text

This medication is effective against various bacteria, including Staphylococcus, Streptococcus pneumoniae, and Streptococcus pyogenes. It is used to treat acute exacerbations of chronic bronchitis and pneumonia acquired in the community. It is also indicated for complicated skin and soft tissue infections, complicated urinary tract infections, and simple acute cystitis. As a fluoroquinolone antibiotic, it carries a risk of serious adverse effects; therefore, it is used restrictively when other treatment options are unavailable. Patients should strictly adhere to their doctor's instructions and immediately report any adverse reactions. Considering these points, it is used for the acute exacerbation of chronic bronchitis, urinary tract infections, skin infections, and pneumonia.

How it is given

Adult administration

Ofloxacin should be administered by slow intravenous injection over at least 60 minutes. Do not use by intramuscular, subcutaneous, intrapleural, or intrathecal injection. 1. Usual adults with normal renal function (creatinine clearance of 50 mL per minute or more): Administer 200 mg of this medicine per dose twice daily; the dose may be increased to 600mg daily depending on the degree of response. 2. Adjust the dose in patients with renal impairment as follows. 1) Creatinine clearance of 20~50 mL per minute: Administer the usual dose once daily, every 24 hours. 2) Less than 20 mL: Administer 1/2 of the usual dose once daily, every 24 hours.

Precautions

This medication is used to treat bacterial infections as a fluoroquinolone antibiotic. Caution is advised when using this medication as serious side effects such as tendon issues like tendonitis or tendon rupture, peripheral neuropathy, central nervous system abnormalities, and exacerbation of myasthenia gravis may occur. Particularly in patients with myasthenia gravis, this drug may worsen symptoms and should not be used. This medication is to be used only when other treatment methods are unavailable for specific bacterial infections such as acute bacterial rhinosinusitis, acute exacerbations of chronic bronchitis and chronic obstructive pulmonary disease, simple urinary tract infections, and acute otitis media. Also, in elderly patients, those with impaired kidney function, organ transplant recipients, and when used with corticosteroids, the risk of tendon rupture increases, so it should be avoided. If symptoms of pain, inflammation, or tendon rupture occur in the shoulder, hand, or Achilles tendon, the use of this medication should be immediately stopped and a consultation with a physician is necessary. This medication can induce seizures, so it should be used with extreme caution in patients with epilepsy or central nervous system disorders, and use should be immediately discontinued if seizures occur. Hypersensitivity reactions such as skin rash, itching, and fever may occur; if these symptoms arise, administration should be stopped and appropriate treatment should be sought. It can affect kidney and liver function; therefore, regular examinations are necessary, and if abdominal pain or diarrhea symptoms indicating colitis appear, treatment should be stopped immediately. This medication may cause neurological side effects such as dizziness or drowsiness and caution is needed when driving or operating machinery. Patients with diabetes who require blood sugar monitoring should closely observe blood sugar changes during the use of this medication, and if hypoglycemic symptoms occur, they should seek immediate treatment. Pregnant women, women who may become pregnant, nursing mothers, and children and adolescents in the growth stage should not use this medication. This medication has many drug interactions, especially with anticoagulants, antihypertensives, and non-steroidal anti-inflammatory drugs, so it should be taken under a physician's guidance. Adequate hydration during administration is necessary, and exposure to sunlight or artificial UV light should be avoided. In cases of overdose, immediate hospital visit and appropriate treatment is required, as this medication is not removed by dialysis. When storing, keep it out of reach of children and do not transfer it to another container.

Side effects

  • Tendonitis
  • tendon rupture
  • peripheral neuropathy
  • central nervous system effects
  • exacerbation of myasthenia gravis
  • anaphylactic shock
  • anaphylactic reactions
  • rash
  • itching
  • erythema
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  • edema
  • fever
  • warmth
  • blisters
  • erythema
  • photosensitivity reactions
  • hematuria
  • acute renal failure
  • nephrolithiasis
  • interstitial nephritis
  • elevated BUN
  • elevated serum creatinine
  • jaundice
  • liver failure
  • elevated AST
  • elevated ALT
  • elevated ALP
  • elevated γ-GTP
  • elevated total bilirubin
  • cholestatic jaundice
  • fulminant hepatitis
  • membranous colitis
  • hematochezia
  • abdominal pain
  • diarrhea
  • nausea
  • vomiting
  • gastrointestinal discomfort
  • cirrhosis
  • loss of appetite
  • abdominal discomfort
  • dyspepsia
  • chest pain
  • thirst
  • taste disturbances
  • stomatitis
  • glossitis
  • abdominal distension
  • constipation
  • dysphagia
  • gastrointestinal bleeding
  • oral mucosal pain
  • intestinal perforation
  • anemia
  • leukopenia
  • decreased hemoglobin
  • decreased hematocrit
  • thrombocytopenia
  • eosinophilia
  • agranulocytosis
  • thrombotic thrombocytopenic purpura
  • petechiae
  • purpura
  • prolonged prothrombin time
  • reversible bone marrow suppression
  • lymphopenia
  • neutropenia
  • increased ESR
  • insomnia
  • dizziness
  • headache
  • seizures
  • tremors
  • numbness
  • peripheral neuropathy
  • visual disturbances
  • diplopia
  • hallucinations
  • nystagmus
  • auditory disturbances
  • tinnitus
  • hearing loss
  • hallucinations
  • drowsiness
  • nervousness
  • sleep disorders
  • confusion
  • anxiety
  • depression
  • agitation
  • delirium
  • seizures
  • nightmares
  • paranoia
  • disorientation
  • attention deficit
  • memory impairment
  • delirium
  • suicidal ideation
  • suicide
  • perceptual disturbances
  • reversible olfactory dysfunction
  • reversible vestibular dysfunction
  • ataxia
  • aphasia
  • heaviness of the head
  • skin-mucosal syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Lyle's syndrome
  • arthralgia
  • myalgia
  • muscle weakness
  • myositis
  • fatigue
  • elevated CPK
  • elevated myoglobin
  • rhabdomyolysis
  • pharyngitis
  • dyspnea
  • bronchospasm
  • allergic pneumonia
  • nosebleed
  • stridor
  • fever
  • cough
  • interstitial pneumonia
  • brain thrombosis
  • pulmonary edema
  • tachycardia
  • hypertension
  • hypotension
  • palpitations
  • vasodilation
  • circulatory collapse
  • prolonged QT interval
  • ventricular tachycardia
  • dysuria
  • increased urination
  • urinary retention
  • anuria
  • polyuria
  • pyuria
  • diabetes
  • proteinuria
  • alkaline urine
  • vaginitis
  • vaginal candidiasis
  • increased vaginal discharge
  • vulvar itching
  • menstrual irregularities
  • uterine cramps
  • genital rash
  • genital pain
  • genital irritation
  • burning sensation in the genital area
  • symptoms of hypoglycemia
  • limb pain
  • malaise
  • fever

Not everyone experiences these, and they can vary from person to person.

Storage

Medicines should be stored in a sealed container to prevent air or moisture from entering. This will help maintain the efficacy of the medication and prevent degradation.

Appearance and packaging

Appearance

A colorless vial injection containing a pale yellow liquid.

Package unit

100 milliliters/vial

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.