Ofloxacin-Teva tablets 200mg, No. 10

Infectious and inflammatory diseases caused by microorganisms sensitive to ofloxacin, including:

- diseases of the lower respiratory tract, ear, throat, nose, skin, soft tissues, bones, joints,

- infectious and inflammatory diseases of the abdominal cavity (with the exception of bacterial enteritis) and small pelvis, kidney and urinary tract infections, prostatitis, gonorrhea.

Individual.

Inside in a daily dose of 200-800 mg, frequency of application 2 times / day. For patients with impaired renal function (CC 20-50 ml / min), the first dose is 200 mg, then 100 mg every 24 hours. With CC less than 20 ml / min, the first dose is 200 mg, then 100 mg every 48 hours.

Film-coated tablets

1 tab. ofloxacin

• Epilepsy (including history),

• lowering the threshold of convulsive readiness,

• chronic renal failure (CC <50 ml / min).

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.