Universal reference book for medicines
Name of the drug: OFLOXACIN (OFLOXACIN)

Active substance: ofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: SYNTHESIS (Russia)
Composition, form of production and packaging
The solution for infusions is
transparent, greenish-yellow in color.

1 ml of 1 fl.

ofloxacin 2 mg 200 mg

Excipients: sodium chloride, water d / and.

100 ml - vials of colorless glass (1) - packs cardboard.

100 ml - bottles of dark glass (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2005.

PHARMACHOLOGIC EFFECT

Antimicrobial preparation of a broad spectrum of bactericidal action from the group of fluoroquinolones.
Effects on the enzyme DNA-gyrase, which provides super-convolution and, thus, the stability of bacterial DNA (destabilization of DNA chains leads to the death of microorganisms).
Active against microorganisms that produce? -lactamase, and fast-growing atypical mycobacteria., Incl.
Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter spp., Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Hafnia spp., Proteus spp.(including Proteus mirabilis, Proteus vulgaris - indole-positive and indole-negative), Salmonella spp., Shigella spp. (including Shigella sonnei), Yersinia enterocolitica, Campylobacter jejuni, Aeromonas hydrophila, Pseudomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Staphylococcus spp., Brucella spp.
Various susceptibility to the preparation is possessed by Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae and viridans, Serratia marcescenes, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis and pneumoniae, Mycobacterium tuberculosis, and Mycobacterium fortuitum, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.

Most cases are insensitive: Nocardia asteroides, anaerobic bacteria (Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile).

Inactive with Treponema pallidum.

PHARMACOKINETICS

Distribution

After a single infusion of 200 mg of ofloxacin for 60 min, C max is 2.7 μg / ml, after 12 hours after administration, the concentration of ofloxacin is 0.3 μg / ml.

Equilibrium concentrations are achieved after 4 infusions.
With IV injection of ofloxacin at a dose of 200 mg every 12 hours for 7 days, the mean maximum and minimum equilibrium concentrations are 2.9 and 0.5 μg / ml, respectively. Ofloxacin widely penetrates into many tissues and body fluids, incl. in saliva, bronchial secretion, bile, tear and spinal fluid, pus, into the lungs, the prostate gland and the skin.
Binding to plasma proteins is 20-25%.

Metabolism and excretion

Ofloxacin partially (5%) is biotransformed in the liver.
T 1/2 - 6-7 hours. Up to 80% of the dose is excreted by the kidneys unchanged, a small part - with feces.
With hemodialysis, 10-30% of the drug is removed.
In patients with impaired renal function (TC 50 ml / min or less), T 1/2 ofloxacin is increased.
INDICATIONS

-infection of the respiratory tract (bronchitis, pneumonia);

-infections of ENT organs (sinusitis, pharyngitis, otitis media, laryngitis);

-infection of skin and soft tissues;

- infection of bones and joints;

- Infectious-inflammatory diseases of the abdominal cavity (including infections of the gastrointestinal tract and bile ducts);

-infection of kidneys (pyelonephritis) and urinary tract (cystitis, urethritis);

-infection of the pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis) and genital organs (colpitis, orchitis, epididymitis);

-gonorrhea;

- Chlamydia;

-septicemia;

-meningitis;

-prophylaxis of infections in patients with impaired immune status (including neutropenia).

DOSING MODE

The drug is injected / drip.
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 the function of the liver and kidneys.
Therapy is started with iv in the drip (for 30-60 minutes) of the drug at a dose of 200 mg.
When the patient's condition is improved, they are transferred to oral intake of the drug at the same daily dose.
With infections of the urinary tract drug prescribed 100 mg 1-2 times / day, with infections of the kidneys and genitals - from 100 to 200 mg 2 times / day;
withinfections of the respiratory tract, as well as ENT organs, infections of the skin and soft tissues, bones and joints, infections of the abdominal cavity, septic infections - 200 mg 2 times / day. If necessary, increase the dose to 400 mg 2 times / day.
For the prevention of infections in patients with a marked decrease in immunity - 400-600 mg / day.

In patients with impaired renal function (with KK from 50 to 20 ml / min), a single dose should be 50% of the average recommended for a multiplicity of appointment 2 times / day.
You can enter a full single dose 1 time / day. At CC less than 20 ml / min, the single initial dose is 200 mg, then the drug is administered at 100 mg / day every other day.
With peritoneal dialysis and hemodialysis, the drug is administered at a dose of 100 mg every 24 hours.

In liver failure, the maximum daily dose is 400 mg.

SIDE EFFECT

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

From the side of the central nervous system and the peripheral nervous system: headache, dizziness, motion uncertainty, tremor, convulsions, numbness and paresthesia of the limbs, intense dreams, nightmares, psychotic reactions, anxiety, psychomotor agitation, phobias, depression, confusion, hallucinations, increased intracranial pressure, violation of color perception, diplopia, a violation of taste, smell and balance.

From the musculoskeletal system: tendonitis, myalgia, arthralgia, tendosinovitis, tendon rupture.

From the cardiovascular system: tachycardia, lowering blood pressure (with a sharp decrease in blood pressure, stopping), vasculitis, collapse.

On the part of the hematopoiesis system: leukopenia, agranulocytosis, anemia, thrombocytopenia, pancytopenia, hemolytic and aplastic anemia.

On the part of the urinary system: acute interstitial nephritis, impaired renal function, hypercreatininemia, increased urea levels.

Dermatological reactions: pinpoint hemorrhages, dermatitis bullous hemorrhagic, papular rash, indicating the defeat of blood vessels (vasculitis).

Allergic reactions: skin rash, skin itch, urticaria, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke's edema, bronchospasm, Stevens-Johnson syndrome and Lyell's syndrome, photosensitivity, erythema multiforme exudative, anaphylactic shock.

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

Local reactions: pain, redness at the injection site, thrombophlebitis.

CONTRAINDICATIONS

- deficiency of glucose-6-phosphate dehydrogenase;

-epilepsy (including in the anamnesis);

- lowering the threshold of convulsive readiness (including after traumatic brain injury, stroke or inflammatory processes in the central nervous system);

-About 18 years of age (until bone skeleton growth is complete);

-pregnancy;

-lactation;

-increased sensitivity to the drug.

PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function (with KK from 50 to 20 ml / min), a single dose should be 50% of the average recommended for a multiplicity of appointment 2 times / day.
You can enter a full single dose 1 time / day. At CC less than 20 ml / min, the single initial dose is 200 mg, then the drug is administered at 100 mg / day every other day.
With peritoneal dialysis and hemodialysis, the drug is administered at a dose of 100 mg every 24 hours.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In liver failure, the maximum daily dose is 400 mg.

APPLICATION FOR CHILDREN

The drug is contraindicated in children and adolescents under the age of 18, because
not completed growth of the skeleton.
In children, the drug is used only with life-threatening infections, taking into account the expected clinical efficacy and the potential risk of side effects when it is impossible to use less toxic drugs.
The average daily dose in this case is 7.5 mg / kg of body weight, the maximum - 15 mg / kg.
SPECIAL INSTRUCTIONS

Ofloxacin is not a drug of choice for pneumonia caused by pneumococci, not shown in the treatment of acute tonsillitis.

Not recommended for more than 2 months.
Against the background of the use of the drug can not be exposed to sunlight, UV radiation.
If there are side effects from the central nervous system, allergic reactions, pseudomembranous colitis, it is necessary to cancel the drug.

Rarely developing tendonitis can lead to rupture of tendons (mainly Achilles tendon), especially in elderly patients.
In case of signs of tendonitis, it is necessary immediately to stop treatment, to immobilize the Achilles tendon and consult an orthopedist.
When using the drug, women are not recommended to use tampon type tampons due to the increased risk of developing candidiasis.

Against the backdrop of treatment, myasthenia flow may worsen, and porphyria attacks may be more frequent in predisposed patients.

There may be false-negative results in the bacteriological diagnosis of tuberculosis (prevents the release of Mycobacterium tuberculosis).

If there is a violation of the liver or kidney function, it is necessary to control the concentration of ofloxacin in the blood plasma.
In severe renal and hepatic insufficiency, the risk of toxic effects increases (reduction dose correction is required).
Against the background of the drug can not use ethanol.

Use in Pediatrics

In children, the drug is used only with life-threatening infections, taking into account the expected clinical efficacy and the potential risk of side effects when it is impossible to use less toxic drugs.
The average daily dose in this case is 7.5 mg / kg of body weight, the maximum - 15 mg / kg.
Impact on the ability to drive vehicles and manage mechanisms

When using the drug should refrain from engaging in potentially dangerous activities that require increased attention and high speed of psychomotor reactions.

OVERDOSE

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

Treatment: gastric lavage, symptomatic therapy.

DRUG INTERACTION

With simultaneous use ofloxacin reduces the clearance of theophylline by 25% (with simultaneous use should reduce the dose of theophylline).

With simultaneous use of cimetidine, furosemide, methotrexate and drugs that block tubular secretion, increase the concentration of ofloxacin in plasma.

Ofloxacin increases the concentration of glibenclamide in plasma.

At simultaneous reception with indirect anticoagulants-antagonists of vitamin K it is necessary to carry out the control of a condition of coagulating system of blood.

When combined with NSAIDs, derivatives of nitroimidazole and methylxanthines, the risk of developing neurotoxic effects increases.

With a simultaneous appointment with the GCS, the risk of rupture of tendons increases, especially in the elderly.

When administered with drugs that alkalinize urine (inhibitors of carbonic anhydrase, citrates, sodium bicarbonate), the risk of crystalluria and nephrotoxic effects increases.

Pharmaceutical interaction

The solution of ofloxacin is compatible with the following infusion solutions: isotonic sodium chloride solution, Ringer's solution, 5% fructose solution, 5% dextrose solution (glucose).

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a place protected from light, inaccessible to children at a temperature of 15 to 25 ° C;
Do not freeze. Shelf life - 2 years.
Conditions of leave from pharmacies

The drug is released by prescription.

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