Medication info
Opla Tablets (Ofloxacin)

Opla Tablets (Ofloxacin)

Prescription medicationTabletOral
Ingredient · strength
Ofloxacin›100mg / 1 tablet
Manufacturer / importer
Hwa-il Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 201309390 · Approved 2013.09.23 · Insurance code 684500980

Summary

Main use
Treatment of respiratory, ear, nose, and eye infections; genitourinary, intestinal, and skin and soft tissue infections; combination treatment of leprosy
Who takes it
Adults
Adult dose
○ Adults: The usual dose of ofloxacin is 300~600 mg per day, divided into 2~3 doses. ○ For Hansen's disease, the dose is 400~600 mg per day, divided into 2~3 doses. In principle, use in combination with other anti-Hansen's disease drugs. Adjust the dose as appropriate according to age and symptoms.

Ingredients

Manufacturer
Hwa-il Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of respiratory, ear, nose, and eye infections; genitourinary, intestinal, and skin and soft tissue infections; combination treatment of leprosy

  • Complicated skin infections
  • soft tissue infections
  • acute otitis media
  • chronic suppurative otitis media
  • acute bacterial sinusitis
  • chronic bacterial sinusitis
  • community-acquired pneumonia
  • chronic bronchitis
  • acute exacerbations of chronic obstructive pulmonary disease
  • acute pyelonephritis
  • uncomplicated acute cystitis
  • bacterial prostatitis
View approved original text

This medication is used to treat infections caused by various bacteria. It is primarily effective for complicated skin and soft tissue infections, acute and chronic otitis media, acute and chronic sinusitis, community-acquired pneumonia, and acute exacerbations of chronic obstructive pulmonary disease. It is also used for urogenital infections, such as urinary tract infections, pyelonephritis, prostatitis, epididymitis, and gonococcal and non-gonococcal urethritis. Additionally, it is suitable for treating bacterial dysentery and enteritis, pelvic inflammatory disease, intrauterine infections, Bartholin's gland infections, as well as various ophthalmic infections such as blepharitis, styes, dacryocystitis, and corneal ulcers. It is used in combination therapy for Hansen's disease, and may be selected for certain infections when other treatments are unavailable or ineffective. Thus, this medication is widely used for the treatment of various types of bacterial infections.

How to take

Adult dose

○ Adults: The usual dose of ofloxacin is 300~600 mg per day, divided into 2~3 doses. ○ For Hansen's disease, the dose is 400~600 mg per day, divided into 2~3 doses. In principle, use in combination with other anti-Hansen's disease drugs. Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication is a fluoroquinolone antibiotic and is used for the treatment of certain bacterial infections. When taking this medication, serious side effects such as tendonitis or tendon rupture, peripheral neuropathy, central nervous system disorders, and exacerbation of myasthenia gravis may occur, requiring caution. Especially, patients with myasthenia gravis may experience exacerbation of symptoms when taking this medication, and should not use it. This medication is only used when there are no other treatment options for conditions such as acute non-sinusitis, acute bacterial exacerbations of chronic bronchitis, chronic obstructive pulmonary disease, uncomplicated urinary tract infections, or acute otitis media. Elderly patients or those with impaired renal function, and patients who are taking corticosteroids may have an increased risk of tendonitis and tendon rupture. Thus, combination should be avoided, and if symptoms of pain, inflammation, or tendon rupture occur, the medication should be discontinued immediately. This medication has neuromuscular blocking effects and can cause serious side effects in patients with myasthenia gravis, requiring special caution when administering. Additionally, patients who have hypersensitivity to this medication or have experienced tendonitis or tendon rupture from this or similar medications, children under 18 years old, pregnant or breastfeeding women, patients with certain inherited metabolic disorders, and those with a history of seizure disorders should not use this medication. When administering, careful consideration should be given to liver and kidney function, mental health status, and cardiovascular disease. Especially in cases of aortic aneurysms or heart valve abnormalities, it should only be used when no alternative treatment options are available. While taking this medication, various side effects such as allergic reactions, gastrointestinal disturbances, blood disorders, neurological symptoms, skin reactions, musculoskeletal pain, and respiratory problems may occur; thus, if any abnormal symptoms appear, immediate consultation with healthcare professionals is necessary. Also, this medication may interact with other medications, so it is important to inform healthcare professionals if you are taking anticoagulants such as warfarin, antidiabetics, certain antacids, and non-steroidal anti-inflammatory drugs. Adequate hydration is necessary during treatment, and care should be taken to avoid excessive exposure to sunlight or artificial ultraviolet light. Caution is advised when performing tasks requiring concentration, such as driving or operating machinery, as neurological side effects such as dizziness or drowsiness may occur. Pregnant or breastfeeding women should not take this medication, and if taking it, breastfeeding should be discontinued. In case of overdose, seek immediate medical attention for appropriate treatment, as this drug is not completely removed by hemodialysis or peritoneal dialysis. Finally, this medication should be kept out of reach of children, and care should be taken not to transfer it to other containers.

Side effects

  • Tendinitis
  • tendon rupture
  • peripheral neuropathy
  • central nervous system effects
  • exacerbation of myasthenia gravis
  • anaphylactic shock
  • anaphylactoid reactions
  • rash
  • itching
  • redness
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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/ALT
  • elevated ALP
  • elevated γ-GTP
  • elevated total bilirubin
  • obstructive jaundice
  • fulminant hepatitis
  • membranous colitis
  • abdominal pain
  • diarrhea
  • nausea
  • vomiting
  • discomfort in the upper abdomen
  • cirrhosis
  • anorexia
  • upper abdominal pain
  • dyspepsia
  • chest pain
  • thirst
  • taste disturbance
  • stomatitis
  • glossitis
  • abdominal distension
  • constipation
  • dysphagia
  • gastrointestinal bleeding
  • oral mucosal pain
  • bowel perforation
  • anemia
  • leukopenia
  • decreased hemoglobin
  • decreased hematocrit
  • thrombocytopenia
  • eosinophilia
  • agranulocytosis
  • thrombotic thrombocytopenic purpura
  • petechial and ecchymotic bleeding
  • prolonged prothrombin time
  • reversible bone marrow suppression
  • lymphopenia
  • neutropenia
  • increased ESR
  • insomnia
  • dizziness
  • headache
  • seizures
  • tremors
  • numbness
  • peripheral nerve disorders
  • visual disturbances
  • auditory disturbances
  • hallucinations
  • drowsiness
  • nervousness
  • sleep disorders
  • delirium
  • anxiety
  • depression
  • restlessness
  • euphoria
  • confusion
  • seizures
  • nightmares
  • paranoia
  • disorientation
  • attention deficit
  • memory impairment
  • delirium
  • suicidal ideation
  • suicide
  • perceptual disturbances
  • olfactory and vestibular dysfunction
  • ataxia
  • aphasia
  • heaviness of the head
  • skin and mucous membrane syndrome
  • toxic epidermal necrolysis
  • arthralgia
  • myalgia
  • muscle weakness
  • myositis
  • fatigue
  • elevated CPK
  • elevated myoglobin
  • rhabdomyolysis
  • pharyngitis
  • dyspnea
  • bronchospasm
  • allergic pneumonia
  • nosebleeds
  • stridor
  • fever
  • cough
  • abnormal chest X-ray
  • eosinophilia
  • interstitial pneumonia
  • cerebral thrombosis
  • pulmonary edema
  • tachycardia
  • hypertension
  • hypotension
  • palpitations
  • vasodilation
  • circulatory collapse
  • prolonged QT interval
  • ventricular tachycardia
  • dysuria
  • frequency
  • urinary retention
  • anuria
  • polyuria
  • pyuria
  • diabetes
  • proteinuria
  • alkaline urine
  • vaginitis
  • vaginal candidiasis
  • increased vaginal discharge
  • itching of the female external genitalia
  • irregular menstruation
  • uterine cramps
  • rash in the female genital area
  • pain
  • irritation
  • burning sensation
  • symptoms of hypoglycemia
  • limb pain
  • malaise
  • fever
  • drowsiness
  • nausea
  • facial flushing
  • facial edema
  • numbness
  • and inaccurate articulation
  • loss of spatial orientation

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture exposure, and is best kept at room temperature between 1 and 30 degrees Celsius. Proper storage can help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 tablets/bottle

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.

Questions about this medicine

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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.