Medication info
Samik Ofloxacin Tablet

Samik Ofloxacin Tablet

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

MFDS item code 199502582 · Notified 1995.09.25 · Insurance code 644000850

Summary

Main use
Bacterial infections (e.g., urinary tract, respiratory tract, and skin infections); combination treatment for Hansen's disease
Who takes it
Adults
Adult dose
○ The usual adult dosage is 300~600 mg of ofloxacin per day, divided into 2~3 doses. ○ For Hansen's disease, the dosage is 400~600 mg of this medicine per day, divided into 2~3 doses. In principle, it should be used in combination with other antileprosy drugs. The dosage may be adjusted appropriately according to age and symptoms.

Ingredients

Manufacturer
Samik Pharmaceutical Co., Ltd.

Efficacy & effects

Bacterial infections (e.g., urinary tract, respiratory tract, and skin infections); combination treatment for Hansen's disease

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

This medication is effective against various bacteria and is used for complicated skin and soft tissue infections, otitis media, sinusitis, community-acquired pneumonia, acute exacerbation of chronic obstructive pulmonary disease, urinary tract infections, and inflammatory diseases. It can also be used in combination therapy for intrauterine infections, eye diseases, and leprosy. It is primarily used selectively when other treatment methods are challenging, allowing for safe and expected therapeutic effects. This medication is effectively used in the treatment of several infectious diseases.

How to take

Adult dose

○ The usual adult dosage is 300~600 mg of ofloxacin per day, divided into 2~3 doses. ○ For Hansen's disease, the dosage is 400~600 mg of this medicine per day, divided into 2~3 doses. In principle, it should be used in combination with other antileprosy drugs. The dosage may be adjusted appropriately according to age and symptoms.

Precautions

As a fluoroquinolone antibiotic, this medication is used to treat certain bacterial infections. However, caution is required as serious side effects may occur with its use, such as tendonitis, tendon rupture, peripheral neuropathy, central nervous system abnormalities, and worsening of myasthenia gravis. If these symptoms occur, discontinue the medication immediately and consult a healthcare provider. Patients with myasthenia gravis may experience worsening symptoms, so it is best not to administer this medication. Furthermore, this medication should only be used in limited indications such as acute bacterial non-sinusitis, acute bacterial exacerbations of chronic bronchitis or chronic obstructive pulmonary disease, uncomplicated urinary tract infections, and acute otitis media, and should only be administered when no other treatment methods are available. Elderly patients, those with reduced kidney function, patients with solid organ transplants, and those who are using corticosteroids should avoid co-administration due to increased risk of tendon rupture. This medication may also increase the risk of seizures, so it should be used cautiously in patients with a history of epilepsy or seizure disorders. It is not to be administered to pregnant or nursing women, adolescents under 18 years of age, or patients who have had hypersensitivity reactions to this medication or similar drugs. Regular monitoring of liver function, kidney function, and blood tests is required during administration, along with adequate fluid intake. Additionally, this medication can cause neurological adverse reactions such as dizziness or drowsiness, so caution is advised when driving or operating dangerous machinery. It can cause photosensitivity reactions; therefore, strong sunlight or ultraviolet exposure should be avoided, and administration should be discontinued if skin rash or photosensitivity symptoms appear. Diabetes patients should monitor their blood sugar carefully as disturbances may occur. This medication can interact with other drugs, so it is essential to inform the healthcare provider when used with anticoagulants, antidiabetic agents, certain anti-inflammatory drugs, antacids, etc. In the case of overdose, symptoms such as drowsiness, nausea, and dizziness may occur, and prompt medical attention is necessary. For safe use of this medication, adherence to the prescribed dosages and administration guidelines is crucial, and any unusual symptoms should be reported to a healthcare provider immediately.

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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  • swelling
  • fever
  • heat sensation
  • vesicles
  • erythema
  • photosensitivity reactions
  • hematuria
  • acute renal failure
  • renal calculi
  • interstitial nephritis
  • elevated BUN
  • elevated serum creatinine
  • jaundice
  • liver failure
  • elevated AST/ALT
  • elevated ALP
  • elevated γ-GTP
  • elevated total bilirubin
  • cholestatic jaundice
  • fulminant hepatitis
  • membranous colitis
  • abdominal pain
  • diarrhea
  • nausea
  • vomiting
  • gastrointestinal discomfort
  • cirrhosis
  • loss of appetite
  • abdominal discomfort
  • dyspepsia
  • chest pain
  • thirst
  • taste disturbance
  • 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
  • petechial and ecchymotic hemorrhages
  • prolonged prothrombin time
  • reversible bone marrow suppression
  • lymphopenia
  • neutropenia
  • elevated ESR
  • insomnia
  • dizziness
  • headache
  • seizures
  • tremors
  • numbness
  • peripheral neuropathy
  • visual disturbances
  • auditory disturbances
  • hallucinations
  • drowsiness
  • neuroexcitability
  • sleep disorders
  • confusion
  • anxiety
  • depression
  • agitation
  • euphoria
  • delirium
  • seizures
  • nightmares
  • paranoia
  • disorientation
  • attention deficit
  • memory impairment
  • suicidal ideation
  • suicide
  • perceptual disturbances
  • olfactory and balance disorders
  • ataxia
  • aphasia
  • heaviness in the head
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • arthralgia
  • myalgia
  • muscle weakness
  • myositis
  • rhabdomyolysis
  • pharyngitis
  • shortness of breath
  • bronchospasm
  • allergic pneumonia
  • nosebleed
  • stridor
  • fever
  • cough
  • abnormal chest X-ray
  • eosinophilia
  • interstitial pneumonia
  • cerebral thrombosis
  • pulmonary edema
  • tachycardia
  • hypertension
  • hypotension
  • palpitations
  • vasodilation
  • circulatory collapse
  • QT prolongation
  • ventricular tachycardia
  • dysuria
  • frequency
  • urinary retention
  • anuria
  • polyuria
  • hematuria
  • storage urine
  • pyuria
  • diabetes
  • proteinuria
  • alkaline urine
  • vaginitis
  • vaginal candidiasis
  • increased vaginal discharge
  • itching of the female external genitalia
  • irregular menstruation
  • uterine cramps
  • female genital rash
  • pain
  • irritation
  • burning sensation
  • hypoglycemic symptoms
  • limb pain
  • malaise
  • fever

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

Storage

Store the medication in a tightly closed container to prevent air and moisture from entering. This will help maintain the medication's efficacy and prevent it from degrading.

Appearance and packaging

Appearance

White, oblong 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.