Ofloxacin tablets 200mg, No. 10

Infectious and inflammatory diseases caused by microorganisms sensitive to ofloxacin:

• lower respiratory tract (bronchitis, pneumonia);

• ENT organs (sinusitis, pharyngitis, otitis media, laryngitis, tracheitis);

• skin and soft tissues;

• bones (osteitis, osteomyelitis) and joints;

• infections of the abdominal organs and biliary tract;

• kidney and lower urinary tract;

• genitals and pelvic organs (pelvioperitonitis, endometritis, salpingitis, oophoritis, tubo-ovarian abscesses, prostatitis);

• gonorrhea;

• prevention of infections in patients with impaired immune status (including neutropenia).

Inside. The tablets are taken whole with water, before or during meals. Doses are selected individually, depending on the location and severity of the infection, as well as the sensitivity of microorganisms and the general condition of the patient and the function of the liver and kidneys. In patients with normal renal function, the drug is prescribed at a dose of 400-800 mg / day, the frequency of administration is 2 times a day. The dose of 400 mg per day is administered in one dose, preferably in the morning. With gonorrhea - 400 mg once. In patients with impaired renal function (with creatinine clearance (CC) less than 50 ml / min), it is not recommended to take the drug at a dose of 400 mg. If necessary, use a different dosage form in the form of 200 mg tablets. In case of liver failure, it is not recommended to exceed the dose of ofloxacin 400 mg / day. The duration of treatment depends on the location and severity of the disease;treatment should be continued for at least 48-72 hours after the disappearance of symptoms of the disease and normalization of body temperature. In the treatment of uncomplicated and complicated infections of the lower urinary tract, the course of treatment is 7 and 10 days, respectively; with prostatitis up to 6 weeks; with infections of the pelvic organs -10-14 days; with infections of the respiratory system and skin - 10 days.

Film-coated tablets

1 tab. ofloxacin

• Hypersensitivity to ofloxacin, drug components and other fluoroquinolones;

• epilepsy (including a history), a decrease in the seizure threshold (including after traumatic brain injury, stroke, or inflammatory processes in the central nervous system);

• chronic renal failure (with creatinine clearance (CC) less than 50 ml / min),

• children under 18 years of age,

• pregnancy, lactation period,

• damage to the tendons with previous treatment with fluoroquinolones.

pharmachologic effect

Antimicrobial agent of the broad-spectrum fluoroquinolone group. The bactericidal effect of ofloxacin is associated with the blockade of the enzyme DNA gyrase in bacterial cells. Highly active against most gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumetoophila as well as Chlamydia spp. It is active against some gram-positive microorganisms (including Staphylococcus spp., Streptococcus spp., Especially beta-hemolytic streptococci). Moderately susceptible to ofloxacin are Enterococcus faecalis, Streptococcus pneumoniae,Pseudomonas spp. Anaerobic bacteria (except for Bacteroides ureolyticus) are not sensitive to ofloxacin. It is resistant to the action of ?-lactamases.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. Food intake has little effect on absorption, but may slow down absorption. Cmax in blood plasma is achieved after 2 hours. Protein binding is 25%. Ofloxacin is widely distributed in tissues and body fluids (organs of the urinary system, genitals, prostate gland, lungs, ENT organs, gallbladder, bones, skin). It is excreted in the urine unchanged (about 80% in 24 hours). Concentrations of ofloxacin in urine significantly exceeded the MIC90 for most microorganisms after taking the last dose (300 mg 2 times / day for 14 days). A small part of the active substance (about 4%) is excreted in the feces. T1 / 2 is 6 hours. In elderly patients with CC on average 50 ml / min, an increase in T1 / 2 to 13.3 hours is possible.

Side effect

From the digestive system: nausea, vomiting, diarrhea, abdominal pain and cramps, loss of appetite, dry mouth, flatulence, gastrointestinal dysfunction, constipation; rarely - liver dysfunction, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, bleeding from the gastrointestinal tract, disorders of the oral mucosa, heartburn, increased activity of liver enzymes, including GGT and LDH, increased serum bilirubin levels.

From the nervous system: insomnia, dizziness, fatigue, drowsiness, nervousness; rarely - seizures, anxiety, cognitive changes, depression, pathological dreams, euphoria, hallucinations, paresthesia, syncope, tremors, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggressiveness, emotional lability peripheral neuropathy, ataxia, coordination disorders, exacerbation of extrapyramidal disorders, speech impairment.

Allergic reactions: skin rash, itching; rarely - angioedema, urticaria, vasculitis, allergic pneumonitis, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, conjunctivitis.

From the reproductive system: itching in the external genital area in women, vaginitis, vaginal discharge; rarely - burning, irritation, pain and rash in the genital area in women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis.

From the side of the cardiovascular system: rarely - cardiac arrest, edema, arterial hypertension, arterial hypotension, palpitation, vasodilation, cerebral thrombosis, pulmonary edema, tachycardia.

From the urinary system: rarely - dysuria, increased urination, urinary retention, anuria, polyuria, kidney stones, renal failure, nephritis, hematuria, albuminuria, candiduria.

From the musculoskeletal system: rarely - arthralgia, myalgia, tendonitis, muscle weakness, exacerbation of myasthenia gravis.

From the side of metabolism: rarely - thirst, weight loss, hyper- or hypoglycemia (especially in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents), acidosis, an increase in serum TG, cholesterol, potassium.

From the respiratory system: rarely - cough, nasal discharge, respiratory arrest, dyspnea, bronchospasm, stridor.

From the senses: rarely - hearing impairment, tinnitus, diplopia, nystagmus, impaired clarity of visual perception, impaired taste, smell, photophobia.

Dermatological reactions: rarely - photosensitization, hyperpigmentation, vesicular-bullous rash.

From the hematopoietic system: rarely - anemia, bleeding, pancytopenia, agranulocytosis, leukopenia, reversible suppression of bone marrow hematopoiesis, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymosis, increased prothrombin time.

Others: chest pain, pharyngitis, fever, body pain; rarely - asthenia, chills, general malaise, nosebleeds, increased sweating.

Application during pregnancy and lactation

Use during pregnancy and breastfeeding is contraindicated.

Application for violations of liver function

Use with caution in patients with impaired liver function. Do not exceed 400 mg daily dose.

Application for impaired renal function

Use with caution in patients with impaired renal function.

Application in children

Contraindicated for use in children and adolescents under the age of 18 years.

Use in elderly patients

In elderly patients, use according to the state of renal function.

special instructions

Use with caution in patients with impaired renal and hepatic function. During the period of treatment, it is required to monitor the level of glucose in the blood. With long-term therapy, it is necessary to periodically monitor the functions of the kidneys, liver, and the picture of peripheral blood. When using ofloxacin, sufficient hydration of the body should be ensured, the patient should not be exposed to ultraviolet radiation. In experimental studies, mutagenic potential has not been identified. Long-term studies to determine the carcinogenicity of ofloxacin have not been conducted. In studies on young animals of several species, ofloxacin caused arthropathy and osteochondrosis. Safety and efficacy in children and adolescents under the age of 18 has not been established.

Influence on the ability to drive vehicles and mechanisms

Use with caution in patients whose activities are associated with the need for a high concentration of attention and speed of psychomotor reactions.

Drug interactions

With simultaneous use with antacids containing calcium, magnesium or aluminum, with sucralfate, with preparations containing bivalent and trivalent cations, such as iron, or with multivitamins containing zinc, the absorption of quinolones may be impaired, leading to a decrease in their concentration in the body. These drugs should not be used within 2 hours before or within 2 hours after taking ofloxacin. With the simultaneous use of ofloxacin and NSAIDs, the risk of developing a stimulating effect on the central nervous system and seizures increases. With simultaneous use with theophylline, an increase in its concentration in blood plasma (including in an equilibrium state), an increase in T1 / 2 is possible. This increases the risk of theophylline-related adverse reactions. With the simultaneous use of ofloxacin with beta-lactam antibiotics,aminoglycosides and metronidazole noted an additive interaction.