Ofloxacin pills 400mg, 10pcs

Composition

Active ingredient:

ofloxacin 400 mg;

Auxiliary substances:

corn or potato starch;

MCC;

talc;

low molecular weight polyvinylpyrrolidone;

magnesium or calcium stearate;

aerosil

Shell composition:

 oxypropylmethylcellulose; talc; titanium dioxide; propylene glycol; polyethylene oxide 4000 or opadray iiofloxacin – 400 mg;

Pharmacological action

Ofloxacin – bactericidal, antibacterial.

It acts on the bacterial enzyme DNA gyrase, which provides supercoiling and, thus, stability of bacterial DNA (destabilization of DNA chains leads to their death). It has a wide spectrum of action, has a bactericidal effect.

Pharmacodynamics

It is active against beta-lactamase-producing microorganisms and fast-growing atypical mycobacteria. Sensitive: Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter, Klebsiella spp., (including Klebsiella pneumoniae), Enterobacter spp. (including Enterobacter cloacae), Hafnia, Proteus spp. (including Proteus mirabilis, Proteus vulgaris  — indole-positive and indoctrinated), Salmonella spp., Shigella spp. (including Shigella sonnei), Yersinia enterocolitica, Campylobacter jejuni, Aeromonas hydrophila, Plesiomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp. (including Chlamydia trachomatis), Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Staphylococcus spp., Brucella spp.

The following have different sensitivities to the drug: Enterococcus faecalis, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuitum, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.

In most cases, they are insensitive: Nocardia asteroides, anaerobic bacteria (for example, Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile). It has no effect on Treponema pallidum.

Pharmacokinetics

After oral use, it is rapidly and completely absorbed. Bioavailability-over 96%, binding to plasma proteins-25%. Tmax is 1-2 hours, Cmax after use at a dose of 100,300,600 mg is 1,3.4 and 6.9 mg/l. After a single dose of 200 or 400 mg, it is 2.5 mcg / ml and 5 mcg/ml, respectively.

The apparent volume of distribution is 100 liters. Penetrates into tissues, organs and environments of the body: cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal and pelvic organs, respiratory system, urine, saliva, bile, prostate secretions, passes well through the BBB, placental barrier, is released with mother’s milk. Penetrates the cerebrospinal fluid in inflamed and non-inflamed meninges (14-60%).

It is metabolized in the liver (about 5%) to form N-oxide ofloxacin and dimethylofloxacin. T1 / 2 does not depend on the dose and is 4.5–7 hours. It is excreted by the kidneys 75-90% (unchanged), about 4% – with bile. Extrarenal clearance is less than 20%.

After a single dose of 200 mg, it is detected in the urine for 20-24 hours. With renal/hepatic insufficiency, excretion may slow down. It doesn’t accumulate.

Indications

Infections of the respiratory tract (bronchitis, pneumonia), ENT organs (sinusitis, pharyngitis, otitis media, laryngitis), skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal cavity and biliary tract (except for bacterial enteritis), kidneys (pyelonephritis), urinary tract (cystitis, urethritis), pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis), genitals (colpitis, orchitis, epididymitis), gonorrhea, chlamydia; septicemia (only for intravenous use), meningitis; prevention of infections in patients with impaired immune status (including neutropenia).

Contraindications

Hypersensitivity, glucose-6-phosphate dehydrogenase deficiency, epilepsy (including in the anamnesis), reduced seizure threshold (including after a traumatic brain injury, stroke, or inflammatory processes in the central nervous system); age up to 18 years (until skeletal growth is completed), pregnancy, lactation.

With caution-atherosclerosis of the cerebral vessels, cerebral circulatory disorders (in the anamnesis), chronic renal failure, organic lesions of the central nervous system.

Side effects

From the digestive tract:  gastralgia, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, increased activity of hepatic transaminases, hyperbilirubinemia, cholestatic jaundice, pseudomembranous enterocolitis.

Nervous system and sensory disorders:  headache, dizziness, movement uncertainty, tremor, convulsions, numbness and paresthesia of the extremities, intense dreams, “nightmare” dreams, psychotic reactions, anxiety, agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure; impaired color perception, diplopia, impaired taste, smell, hearing and balance. When applying the ointment — a burning sensation and discomfort in the eyes, hyperemia, itching and dryness of the conjunctiva, photophobia, lacrimation.

From the musculoskeletal system:  tendinitis, myalgia, arthralgia, tendosynovitis, tendon rupture.

Cardiovascular and blood disorders (hematopoiesis, hemostasis):  tachycardia, decreased AP (with intravenous use; with a sharp decrease in Blood pressure is stopped), vasculitis, collapse; leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.

Allergic reactions:  skin rash, pruritus, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, angioedema, bronchospasm, Stevens-Johnson and Lyell syndrome, photosensitization, erythema multiforme, rarely-anaphylactic shock.

From the side of the skin:  spot hemorrhages (petechiae), bullous hemorrhagic dermatitis, papular rash with a crust, indicating vascular damage (vasculitis).

From the genitourinary system:  acute interstitial nephritis, impaired renal function, hypercreatininemia, increased urea content.

Other services:  dysbiosis, superinfection, hypoglycemia (in patients with diabetes mellitus), vaginitis.

Interaction

Compatible with the following infusion solutions: isotonic sodium chloride solution, Ringer’s solution,5% fructose solution,5% dextrose (glucose) solution.

Do not mix with heparin (risk of precipitation).

Food products, antacids containing Al3+, Ca2+, Mg2+ or iron salts reduce the absorption of ofloxacin, forming insoluble complexes (the interval between doses of these drugs should be at least 2 hours).

Reduces the clearance of theophylline by 25% (with simultaneous use, the dose of theophylline should be reduced).

Cimetidine, furosemide, methotrexate and drugs that block tubular secretion increase the concentration of ofloxacin in plasma.

Increases the concentration of glibenclamide in plasma.

When taken concomitantly with vitamin K antagonists, it is necessary to monitor the blood coagulation system.

When prescribed with NSAIDs, nitroimidazole and methylxanthine derivatives, the risk of neurotoxic effects increases.

Concomitant use with glucocorticoids increases the risk of tendon rupture, especially in the elderly.

When prescribed with drugs that alkalize the urine (carbonic anhydrase inhibitors, sodium bicarbonate), the risk of crystalluria and nephrotic effects increases.

How to take, course of use and dosage

Inside, before or during meals, whole, washed down with water. Doses are selected individually depending on the location and severity of the infection, as well as the sensitivity of microorganisms, the general condition of the patient, and liver and kidney function.

Adults — 200-800 mg per day, the course of treatment is 7-10 days, the frequency of use is 2 times a day. A dose of up to 400 mg — in 1 dose, preferably in the morning. For gonorrhea — 400 mg once.

In patients with impaired renal function (with creatinine clearance 50-20 ml / min), a single dose should be taken once a day or 50% of the average dose 2 times a day. When creatinine clearance is less than 20 ml / min, a single dose is 200 mg, then 100 mg per day every other day.

For hemodialysis and peritoneal dialysis-100 mg every 24 hours. The maximum daily dose for hepatic insufficiency is 400 mg.

The duration of the course of treatment is determined by the sensitivity of the pathogen and the clinical picture; treatment should be continued for at least 3 days after the disappearance of symptoms of the disease and full normalization of temperature. In the treatment of salmonellosis, the course of treatment is 7-8 days, with uncomplicated lower urinary tract infections — 3-5 days.

Children — only for vital signs, if it is impossible to replace with other drugs. The average daily dose is 7.5 mg / kg, the maximum is 15 mg / kg.

Overdose

Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting.

Treatment: gastric lavage, symptomatic therapy.

Special instructions

It is not the drug of choice for the treatment of pneumococcal pneumonia and is not indicated for the treatment of acute tonsillitis.

During the treatment period, it is necessary to refrain from driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions. Do not drink alcohol.

During treatment with the drug, do not use sanitary tampons such as Tampax, due to the increased risk of developing thrush.

Against the background of treatment, the course of myasthenia gravis may worsen, and porphyria attacks may become more frequent in predisposed patients.

False-negative results are possible in the bacteriological diagnosis of tuberculosis (prevents the release of Mycobacterium tuberculosis).

Form of production

Tablets

Storage conditions

In a dark place, at a temperature of 15-25 °C. Freezing is not allowed.

Shelf life

2 years

Active ingredient

Ofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Bronchitis, Female genital inflammation, Laryngitis, Pharyngitis, Otitis Media, Urinary Tract Infections, Biliary Dyskinesia, Osteomyelitis, Sinusitis, Sinusitis, Pneumonia, Skin Infections