Universal reference book for medicines
Name of the preparation: OFLO ® (OFLO ® )

Active substance: ofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: UNIQUE PHARMACEUTICAL Laboratories (India) JB Chemicals & Pharmaceuticals (India)
Composition, form of production and packaging
The solution for infusions is
transparent, from light yellow to brownish-yellow color.

1 ml of 1 fl.

ofloxacin 2 mg 200 mg

Auxiliary substances: sodium chloride, disodium edetate, water d / and.

100 ml - disposable plastic bottles (1) - cellophane wrappers (1) - cardboard packs.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

A broad-spectrum antimicrobial agent from the group of fluoroquinolones acts on the bacterial DNA-gyrase enzyme, which provides super-convolution and thus the stability of bacterial DNA (the destabilization of DNA chains leads to their death).
Has a bactericidal effect.
The drug is active against microorganisms that produce? -lactamase, and fast-growing atypical mycobacteria.

To the drug are sensitive: Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter spp., Klebsiella spp.
(including Klebsiella pneumonia), 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, Plesiomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acne, Brucella spp.
Different sensitivity to the preparation is possessed by: Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Serratia marcescens, Pseudomonas aeruginosa, Acinetobacter spp., Mycoplasma hominis, Mycoplasma pneumoniae, Mycobacterium tuberculosis, Mycobacterium fortuitum, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.

In most cases, the drug is insensitive: Nocardia asteroides, anaerobic bacteria (eg, Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacter spp., Fusobacterium spp., Clostridium difficile).

Ofloxacin does not affect Treponema pallidum.

PHARMACOKINETICS

After a single 60-minute IV infusion of 200 mg ofloxacin, the mean C max is 2.7 μg / ml;
12 hours after administration, the concentration is 0.3 μg / ml. C ss areachieved after the administration of 4 doses.
Mean C ss max and C ss min are achieved after iv injection of 200 mg ofloxacin every 12 hours for 7 days and are 2.9 and 0.5 μg / ml, respectively.

Ofloxacin widely penetrates into many liquids and tissues of the body, incl.
saliva, bronchial secretion, bile, tear and spinal fluid, pus, into the lungs, the prostate gland, the skin.
Ofloxacin undergoes partial (5%) metabolism in the liver.
Binding to plasma proteins is 20-25%.
T 1/2 of ofloxacin is 6-7 hours. Up to 80% of the ingested drug is excreted by the kidneys unchanged, a small part of the active substance is also excreted with feces.With hemodialysis, 10-30% of the drug is removed.

In patients with impaired renal function (creatinine clearance 50 ml), T 1/2 ofloxacin is increased.

INDICATIONS

- respiratory tract infections (bronchitis, pneumonia);

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

- infections of the skin, soft tissues;

- infection of bones, joints;

- infectious and inflammatory diseases of the abdominal cavity and bile ducts (with the exception of bacterial enteritis);

- kidney infection (pyelonephritis), urinary tract (cystitis, urethritis);

- infections of the pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis);

- infections of the genitals (colpitis, orchitis, epididymitis);

- Gonorrhea;

- Chlamydia;

- septicemia;

- meningitis;

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

DOSING MODE

In / in the drip.
Doses are selected individually depending on the localization 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.
In / drip introduction begins with a single dose of 200 mg, which is injected slowly for 30-60 minutes.
When the patient's condition is improved, they are transferred to oral intake of the drug at the same daily dose.
Urinary tract infections - 100 mg 1-2 times / day, infections of the kidneys and genitals - from 100 mg 2 times / day to 200 mg 2 times / day, respiratory tract infections, as well as ENT organs, skin and soft tissue infections, infection of bones and joints, infection 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.

If necessary, in / in the drip - 200 mg in a 5% solution of glucose.
Duration of infusion - 30 min. Use only freshly prepared solutions.
In patients with impaired renal function (with a creatinine clearance of 50-20 ml / min), a single dose should be 50% of the average dose with a multiplicity of 2 times / day, or a full one dose administered 1 time / day.
At CC less than 20 ml / min single dose - 200 mg, then - at 100 mg / day every other day.
With hemodialysis and peritoneal dialysis - 100 mg every 24 hours.

The maximum daily dose for liver failure is 400 mg / day.

SIDE EFFECT

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

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 musculoskeletal system: tendonitis, myalgia, arthralgia, tendosinovitis, tendon rupture;

On the part of the cardiovascular system: tachycardia, lowering blood pressure (with iv introduction, with a sharp decrease in blood pressure, stopping), vasculitis, collapse.

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

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

On the part of the skin: pinpoint hemorrhage (petechiae), bullous hemorrhagic dermatitis, papular rash with a cortex, indicating the defeat of blood vessels (vasculitis).

Allergic reactions: skin rash, itchy skin.
hives, allergic pneumonitis, allergic nephritis, eosinophilia, fever, Quincke's edema, bronchospasm; (including Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell's syndrome), photosensitivity, anaphylactic shock.
Other: dysbacteriosis, superinfection, vaginitis, hypoglycemia (in patients with diabetes mellitus).

Local reactions: pain, hyperemia at the injection site, thrombophlebitis (with iv introduction).

CONTRAINDICATIONS

- deficiency of glucose-6-phosphate dehydrogenase;

- epilepsy (including in the anamnesis);

- lesions of the central nervous system with a lower convulsive threshold (after traumatic brain injury, stroke, inflammatory diseases of the brain);

- Pregnancy;

- lactation;

- Children and adolescence (up to 18 years), until the skeleton growth is completed;

- High sensitivity or intolerance of ofloxacin and other fluoroquinolone derivatives.

Care should be taken when prescribing the drug to patients with cerebral artery atherosclerosis, cerebral circulation disorder (in the anamnesis), organic CNS lesions, chronic renal insufficiency.

PREGNANCY AND LACTATION

Contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function (with a creatinine clearance of 50-20 ml / min), a single dose should be 50% of the average dose with a multiplicity of 2 times / day, or the total single dose is administered 1 time / day. At a CC less than 20 ml / min single dose - 200 mg, then - 100 mg / day every other day.

With hemodialysis and peritoneal dialysis - 100 mg every 24 hours.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

The maximum daily dose for liver failure is 400 mg / day.

APPLICATION FOR CHILDREN

Children are only used in case of a life threat, taking into account the prospective benefit and the potential risk of side effects when it is impossible to use other, less toxic drugs.
The average daily dose in this case is 7.5 mg / kg, the maximum - 15 mg / kg.
SPECIAL INSTRUCTIONS

It is not a drug of choice for pneumonia caused by pneumococci.
Not indicated in the treatment of acute tonsillitis.
It is not recommended to use more than 2 months, to be exposed to sunlight, to UV rays (mercury quartz lamps, solarium).

In the event of side effects from the central nervous system, allergic reactions, pseudomembranous colitis, drug withdrawal is necessary.
With pseudomembranous colitis, confirmed colonoscopically and / or histologically, oral administration of vancomycin and metronidazole is indicated.
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.
During the treatment, ethanol should not be used.

When using the drug, women are not recommended to use hygiene tampons due to the increased risk of thrush development.

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

Can lead to false-negative results in the bacteriological diagnosis of tuberculosis (prevents the release of Mycobacterium tuberculosis).

In patients with impaired hepatic or renal function, it is necessary to monitor the concentration of ofloxacin in plasma.
In severe renal and hepatic insufficiency, the risk of toxic effects increases (dose adjustment is required).
Children are only used in case of a life threat, taking into account the prospective benefit and the potential risk of side effects when it is impossible to use other, less toxic drugs.
The average daily dose in this case is 7.5 mg / kg, the maximum - 15 mg / kg.
Impact on the ability to drive vehicles and manage mechanisms

During the treatment period it is necessary to refrain from driving motor vehicles and practicing potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions



OVERDOSE

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

Treatment: gastric lavage, symptomatic therapy.

DRUG INTERACTION

Compatible with the following infusion solutions: isotonic sodium chloride solution, Ringer's solution, 5% fructose solution, 5% dextrose solution.
Do not mix with heparin (risk of precipitation).
Reduces the clearance of theophylline by 25% (with simultaneous use should reduce the dose of theophylline).

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

Increases the concentration of glibenclamide in plasma.

At simultaneous admission with antagonists of vitamin K, it is necessary to control the blood coagulation system.

When administered 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.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature of no higher than 25 ° C in a dark place.
Do not freeze. Keep out of the reach of children. Shelf life - 3 years. Do not use after the expiry date printed on the package.
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