Medication info

Hanlim Romefloxacin Hydrochloride Tablet 200 mg

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Lomefloxacin Hydrochloride›220.8mg / 1 tablet
Manufacturer / importer
Hanlim Pharmaceutical Co., Ltd.
Appearance
White oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 200004289 · Notified 2000.08.14

This product's status changed to Approval withdrawn on 2025.02.21. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of genitourinary and intestinal infections, respiratory and ear, nose, and throat infections, and skin, eye, and dental infections
Who takes it
Adults
Adult dose
1. Administer 100 ~ 200 mg of lomefloxacin orally 2 ~ 3 times daily. 2. However, for acute exacerbation of chronic obstructive pulmonary disease, including chronic bronchitis, the usual adult dose is 400 mg of this medicine once daily, taken with or without food. The duration of treatment varies depending on the severity of the infection, but is usually up to 14 days; treatment should continue for at least 2 days after the symptoms of infection have resolved. 3. Patients with renal impairment 1) In patients with a creatinine clearance of less than 30 mL per minute, administer 400 mg of this medicine as a single initial dose, followed by 200 mg once daily starting the next day. 2) In patients on hemodialysis, administer 400 mg of this medicine as a single initial dose, followed by 200 mg once daily starting the next day. 3) No dose adjustment is necessary in patients with hepatic impairment; adjust the dose according to renal function.

Ingredients

Manufacturer
Hanlim Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of genitourinary and intestinal infections, respiratory and ear, nose, and throat infections, and skin, eye, and dental infections

  • Folliculitis
  • pustular acne
  • boils
  • large boils
  • superficial cellulitis
  • cellulitis
  • lymphangitis
  • fingertip infection
  • suppurative paronychia
  • subcutaneous abscess
  • suppurative hidradenitis
  • necrotizing acne
View approved original text

This drug is effective against various types of bacteria and is used for a variety of infections in the skin and soft tissues, such as folliculitis, acne, and suppurative paronychia. It is also effective against respiratory infections such as acute exacerbation of chronic obstructive pulmonary disease, community-acquired pneumonia, and lung abscess. It is utilized for genitourinary infections such as pyelonephritis, cystitis, and prostatitis, as well as intestinal infections like bacterial dysentery and enteritis. This drug is widely used for infections of the uterus and around the eyes, otitis media, and sinusitis. However, due to the risk of serious adverse reactions, it should be used with caution when no other treatment options are available for specific conditions. Overall, this drug is effectively used for the treatment of various bacterial infections.

How to take

Adult dose

1. Administer 100 ~ 200 mg of lomefloxacin orally 2 ~ 3 times daily. 2. However, for acute exacerbation of chronic obstructive pulmonary disease, including chronic bronchitis, the usual adult dose is 400 mg of this medicine once daily, taken with or without food. The duration of treatment varies depending on the severity of the infection, but is usually up to 14 days; treatment should continue for at least 2 days after the symptoms of infection have resolved. 3. Patients with renal impairment 1) In patients with a creatinine clearance of less than 30 mL per minute, administer 400 mg of this medicine as a single initial dose, followed by 200 mg once daily starting the next day. 2) In patients on hemodialysis, administer 400 mg of this medicine as a single initial dose, followed by 200 mg once daily starting the next day. 3) No dose adjustment is necessary in patients with hepatic impairment; adjust the dose according to renal function.

Precautions

This drug may cause serious side effects such as tendonitis or tendon rupture, peripheral neuropathy, and central nervous system abnormalities. If these symptoms appear, the use of this drug should be stopped immediately. This drug is not administered to patients with myasthenia gravis as it may worsen symptoms. Furthermore, it is only used for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, uncomplicated urinary tract infections, and acute otitis media when no other treatment options are available. Elderly patients, patients with reduced kidney function, transplant recipients, or those taking corticosteroids may have an increased risk of tendon rupture, so concomitant use should be avoided. If symptoms of tendonitis or tendon rupture occur, rest should be taken and strenuous exercise should be avoided. This drug should not be used by individuals with hypersensitivity to it, growing adolescents under the age of 18, pregnant women, lactating women, or patients with a history of tendonitis or rupture from previous use of this drug. Caution should be exercised when administering to patients with a history of epilepsy or seizures, severe renal impairment, the elderly, or those with aortic aneurysm or heart valve disease. This drug can cause various side effects such as anaphylactic shock, skin rash, photosensitivity, gastrointestinal disturbances, kidney and liver function abnormalities, central nervous system abnormalities, and respiratory problems; therefore, any abnormal symptoms should be reported to a healthcare professional immediately. Additionally, this medication may react sensitively to sunlight or ultraviolet rays, so exposure to strong sunlight should be avoided, and care should be taken when driving or operating machinery due to the risk of dizziness. Diabetic patients whose blood sugar levels need to be controlled should be cautious of blood sugar fluctuations and must disclose any concurrent medications as interactions may occur. Pregnant or breastfeeding women should avoid using this drug, and it is not recommended for children or adolescents as safety has not been proven. Elderly patients may experience an increased drug concentration due to reduced renal function, necessitating dose adjustment and caution. In cases of overdose, emergency measures such as inducing vomiting or gastric lavage should be taken, while hemodialysis is not effective for drug removal. Lastly, prolonged use of this drug may increase the risk of skin cancer due to UV exposure, so caution is advised.

Side effects

  • Tendonitis
  • tendon rupture
  • peripheral neuropathy
  • central nervous system effects
  • exacerbation of myasthenia gravis
  • anaphylactic shock
  • anaphylactoid reactions
  • rash
  • urticaria
  • erythema
Show 119 more
  • pruritus
  • edema
  • angioedema
  • conjunctival injection
  • vesicles
  • erythema
  • photosensitivity reactions
  • exfoliative dermatitis
  • hyperpigmentation
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • hypokalemia
  • increased BUN
  • increased serum creatinine
  • acute kidney failure
  • elevated AST/ALT
  • elevated ALP
  • increased serum bilirubin
  • gastrointestinal inflammation
  • oral candidiasis
  • constipation
  • diarrhea
  • anorexia
  • dyspepsia
  • vomiting
  • nausea
  • abdominal pain
  • stomatitis
  • angular cheilitis
  • oral psoriasis
  • upper abdominal discomfort
  • abdominal distention
  • gastrointestinal disorders
  • dry mouth
  • membrane colitis
  • bloody stools
  • neuropsychiatric symptoms
  • drowsiness
  • agitation
  • appetite changes
  • confusion
  • personality loss
  • depression
  • delirium
  • hallucinations
  • paranoia
  • anxiety
  • disorientation
  • attention deficit
  • memory impairment
  • headache
  • dizziness
  • insomnia
  • tremors
  • nightmares
  • dyspnea
  • respiratory infections
  • nosebleeds
  • influenza
  • other respiratory disorders
  • increased monocytes
  • elevated ESR
  • leukopenia
  • thrombocytopenia
  • eosinophilia
  • anemia
  • decreased hemoglobin
  • decreased hematocrit
  • hemolytic anemia
  • paresthesia
  • seizures
  • sweating
  • flushing
  • edema
  • hypertension
  • lethargy
  • tachycardia
  • arrhythmia
  • ectopic beats
  • phlebitis
  • palpitations
  • angina
  • cerebral thrombosis
  • QT prolongation
  • ventricular tachycardia
  • leg cramps
  • arthralgia
  • Achilles tendon rupture
  • myalgia
  • weakness
  • elevated creatine kinase
  • increased myoglobin
  • rhabdomyolysis
  • tinnitus
  • vaginitis
  • vaginal discharge
  • intermenstrual bleeding
  • vaginal candidiasis
  • orchitis
  • fatigue
  • abdominal pain
  • debility
  • anxiety
  • coldness of the face or hands
  • malaise
  • heat sensation
  • lymphedema
  • loss of taste
  • visual impairment
  • gout
  • thirst
  • palatal edema
  • hypoglycemia
  • polyuria
  • laryngeal and pulmonary edema
  • aortic aneurysm
  • aortic dissection
  • heart valve regurgitation
  • heart valve insufficiency

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

Storage

This drug is sensitive to light and should be stored in a sealed container that blocks light. The storage temperature should be kept between 1 to 30 degrees Celsius, and extreme hot or cold conditions should be avoided.

Appearance and packaging

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 100 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.