Floxin 400 mg Tablets

Brand name

The drug is known under the trade name Floxin. This designation is registered in pharmaceutical registries and is used to identify the drug in pharmacies, medical institutions and among specialists. The name has become recognizable due to its effectiveness in the treatment of bacterial infections that require a powerful antibacterial effect. It was chosen by the manufacturers to emphasize the belonging of the drug to a particular group of antibiotics, emphasizing its importance in clinical practice.

International Nonproprietary Name (INN)

The international nonproprietary name of this medicine is ofloxacin. This term is approved by the international community and is used to designate the active substance that provides the therapeutic effect. Ofloxacin belongs to the class of second-generation fluoroquinolones, known for their ability to fight a wide range of bacterial pathogens. The name is standardized by the World Health Organization, which allows to unify the prescription and production of this drug in different countries.

Form of release

The medication is available in several forms, which makes it convenient for use in various clinical situations. The main options include:

• Film-coated tablets with dosages of 200 mg and 400 mg of the active ingredient, intended for oral administration.
• Solution for intravenous infusion (2 mg/mL) in 100 mL or 200 mL vials used in hospital settings.
• Eye drops (0.3% concentration) used for topical treatment of eye infections.

Each form is designed to meet the needs of patients: tablets are suitable for outpatient treatment, infusions for severe cases, and drops for topical exposure. The choice of form is determined by the doctor depending on the nature of the infection and the condition of the patient.

Composition

The main active substance is ofloxacin, an antibiotic from the group of fluoroquinolones. Auxiliary components depend on the form of release. In tablets, the following are used:

• Microcrystalline cellulose - filler for uniform distribution of the active substance.
• Pregelatinized starch - a binder for the formation of the mass.
• Crospovidone - disintegrant, accelerating the disintegration of the tablet.
• Magnesium stearate - lubricating agent to facilitate manufacture.
• Film shell of hypromellose, titanium dioxide and polyethylene glycol - for protection and ease of administration.

The infusion solution contains sodium chloride, lactic acid, and water for injection. Eye drops include benzalkonium chloride as a preservative and saline solution as a base. The formulation is carefully balanced to ensure stability and efficacy.

Pharmacologic Properties

Pharmacodynamics

The drug has bactericidal action by blocking the activity of DNA gyrase and topoisomerase IV enzymes in bacterial cells. These enzymes are necessary for the processes of DNA replication, transcription and repair, and their suppression leads to the death of microorganisms. The drug is effective against a wide range of pathogens, including Gram-negative bacteria (Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae) and Gram-positive microorganisms (Staphylococcus aureus, Streptococcus pneumoniae). It is also active against intracellular pathogens such as Chlamydia trachomatis and Mycoplasma pneumoniae.

The mechanism of action provides rapid destruction of bacteria, which makes the medication valuable in acute infections. Its ability to penetrate into tissues and body fluids enhances the therapeutic effect, especially in systemic infections. The action begins soon after reaching the desired concentration, which allows effective control of the infectious process.

Pharmacokinetics

Absorption

After oral administration, the active substance is absorbed in the small intestine, reaching maximum plasma concentration in 1-2 hours. Bioavailability is about 98%, which provides high efficacy of the oral form. The intake of food, especially rich in calcium or magnesium, slows absorption, so it is recommended to take the drug on an empty stomach.

Distribution

The component is well distributed in the body, penetrating into the lungs, kidneys, liver, skin, bones and urinary tract. Binding to plasma proteins is 20-25%, which contributes to free distribution. The drug reaches high concentrations in urine and bile, making it particularly useful in infections of these systems.

Metabolism is minimal: about 80-90% of the dose remains unchanged. A small portion is metabolized in the liver to form inactive derivatives such as ofloxacin N-oxide.

Excretion

Excretion is mainly through the kidneys (70-80% unchanged) by tubular filtration and tubule secretion. The elimination half-life is 5-7 hours, but may increase in renal failure. The remainder is excreted with bile and feces.

Indications for Use

The drug is prescribed for the treatment of infections caused by sensitive microorganisms:

• Infections of the urinary tract: cystitis, pyelonephritis, prostatitis.
• Infections of the respiratory tract: pneumonia, bronchitis, exacerbation of COPD.
• Infections of the skin and soft tissues: abscesses, wound infections.
• Infections of bones and joints: osteomyelitis.
• Infections of the genital tract: gonorrhea, chlamydia.
• Gastrointestinal infections: salmonellosis, shigellosis.

Eye drops are used for conjunctivitis and keratitis. The drug is also used in systemic infections, such as sepsis, if the pathogen is sensitive.

Contraindications

The use of the drug is prohibited in:

• Hypersensitivity to fluoroquinolones.
• Children under 18 years of age (except in special cases).
• Pregnancy and lactation.
• Epilepsy or seizures in the anamnesis.
• Tendinitis associated with quinolones.

Prescribe with caution in atherosclerosis, psychiatric disorders, and QT prolongation.

Method of Administration and Dosage

How to take

Tablets are taken orally, drinking water (200 ml), 1-2 hours before a meal or 2 hours after, avoiding dairy products and antacids. Solution for infusion is administered intravenously by drip over 60 minutes. Eye drops are used topically, 1-2 drops in the affected eye every 4-6 hours.

Dosages for adults and children

Dosage depends on the infection:

• Adults (tablets): 200-400 mg every 12 hours, course 7-14 days.
• Adults (infusions): 200-400 mg every 12 hours.
• Children (in exceptional cases): 7.5-15 mg/kg/day, divided into 2 doses.
• Eye drops: 1-2 drops 4-6 times a day, course 7 days.

Dose adjustment for certain conditions

In renal failure:

• Clearance 20-50 ml/min: 200 mg every 12 hours.
• Clearance less than 20 mL/min: 200 mg every 24 hours.

Hepatic insufficiency does not require correction.

Side Effects

Unwanted reactions include:

• Gastrointestinal: nausea, diarrhea, abdominal pain
• Nervous: dizziness, insomnia, tremor.
• Motor: tendonitis, joint pain.
• Skin: photosensitivity, rash.
• Cardiac: QT prolongation (rare).

Discontinue if symptoms are serious.

Overdose

Symptoms of overdose

Exceeding the dose causes nausea, vomiting, convulsions, confusion.

First aid measures

In overdose:

• Stop taking.
• Rinse the stomach (within 1-2 hours).
• Provide hydration and symptomatic therapy.
• Refer to a physician.

Drug Interactions

Influence on the effects of other drugs

The drug affects:

• Theophylline: increase in concentration, risk of toxicity.
• Barfarin: increased anticoagulant effect.
• Antacids: decrease in absorption.

Compatibility with alcohol and food

Alcohol increases toxicity, avoided. Dairy products reduce absorption.

Special Precautions

Use in pregnancy and breastfeeding

The drug is contraindicated in pregnancy (category C) and lactation due to the risk to the fetus and child.

Effects on driving and operating machinery

Dizziness or tremor may make driving difficult.

Particulars of Use in the Elderly and Children

The elderly have a higher risk of tendonitis, monitoring is required. In children the drug is used only for vital indications.