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

Active substance: ofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: NIZHFARM (Russia) manufactured by MAKIZ-PHARMA (Russia)
Composition, form of production and packaging
Tablets covered with a coat of
white or almost white, biconvex, with a slight roughness;
Two layers are visible on the transverse section: the inner layer (the core) of a white with a yellowish tint of color.
1 tab.

ofloxacin 200 mg

Excipients: microcrystalline cellulose, croscarmellose sodium, low molecular weight polyvinylpyrrolidone, magnesium stearate, colloidal silicon dioxide, hydroxypropylmethylcellulose, polyethylene glycol, titanium dioxide, talc.

10 pieces.
- packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

The description of the drug was approved by the manufacturer for the 2006 print edition.

PHARMACHOLOGIC EFFECT

The broad-spectrum antibacterial agent from the group of fluoroquinolones acts on the bacterial DNA-gyrase enzyme, which ensures super-spiralization and, thus, the stability of bacterial DNA (the destabilization of DNA chains leads to their death).
Has a bactericidal effect.
It is active against microorganisms producing beta-lactamase and fast-growing atypical mycobacteria.
Sensitive Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter spp., Klebsiella spp. (including Klebsiella pneumonia), Enterobacter spp., Hafhia spp., Proteus spp. (including Proteus mirabilis, Proteus vulgaris, as well as indole-positive and indole-negative), Salmonella spp., Shigella spp. (including Shigella sonnei), Yersinia enterocolitica, Campilobacter jejuni, Aeromonas hydrophila, Plesiomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp., Gerratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Staphylococcus spp., Brucella spp.
The different sensitivity to the preparation is possessed by Enterococcus faecalis, Streptococcus pyogenes, pheumonis and viridans, Serrratio marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis and pneumoniae, Mycobacterium tuberculosis, and Mycobacterium fortuim, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis.

In most cases, Nocardia asteroides, anaerobic bacteria (eg, Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile) are insensitive .
It acts on Treponema pallidum.
PHARMACOKINETICS

Suction

After taking the drug vnutriofloksatsin quickly and almost completely (95%) is absorbed from the digestive tract.
Bioavailability is over 96%, binding to plasma proteins is 25%, C max is achieved 1-2 hours after ingestion and is after taking 100 mg, 300 mg, 600 mg respectively 1, 3, 4 and 6.9 mg / l : after a single dose of 200 mg and 400 mg she. is 2.5 μg / ml and 5 μg / ml, respectively. Admission together with food can slow absorption, but does not have a significant effect on bioavailability.
Distribution

Apparent V d is 100 liters.
Ofloxacin penetrates into leukocytes, alveolar macrophages, into the skin, soft tissues, bones, organs of the abdominal cavity and small pelvis, respiratory system, into urine, saliva, bile, secret prostate. Penetrates through the BBB, the placental barrier, excreted in breast milk. Penetrates into cerebrospinal fluid with inflamed and non-inflamed meninges (14-60%).
Metabolism and distribution

Metabolised in the liver (about 5%) to form N-oxide ofloxacin and dimethylfloxacin.
T 1/2 - 4.5-7 hours (regardless of dose). It is excreted by the kidneys - 75-90% (unchanged), about 4% - with bile. The extrarenal clearance is less than 20%. After a single application at a dose of 200 mg in urine is detected within 20-24 hours.
Pharmacokinetics in special clinical cases

With renal / hepatic failure, excretion can be slowed down.
Do not cumulate. With hemodialysis, 10-30% of the drug is removed.
INDICATIONS

Treatment of infectious-inflammatory diseases caused by drug-susceptible pathogens:

- 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 (only for intravenous administration);

- Meningitis.

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

DOSING MODE

The dosage regimen is set 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 parameters of the liver and kidney function.

The average recommended dose for adults is 200-800 mg / day.
The course of treatment is 7-10 days, the frequency of application is 2 times / day. A dose of up to 400 mg / day can be given in one session, preferably in the morning.
With gonorrhea - 400 mg once.

In patients with impaired renal function (with KK 50-20 ml / min ) single dose should be 50% of the average dose with a multiplicity of appointment 2 times / day or a full single dose administered 1 time / day.
At CC less than 20 ml / min single dose - 200 mg, then - 100 mg every other day.
With hemodialysis and peritoneal dialysis - 100 mg every 24 hours.

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

The duration of the course of treatment is determined by the sensitivity of the pathogen and the clinical picture;
treatment should continue for at least 3 more days after the disappearance of the symptoms of the disease and complete normalization of temperature. In the treatment of salmonellosis treatment course - 7-8 days, withuncomplicated infections of the lower urinary tract treatment course - 3-5 days.
Tablets are taken whole, washed down with water before or during meals.

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 peripheral nervous system: headache, dizziness, uncertainty of movements, tremor, convulsions, numbness and paresthesia of the limbs, intense dreams, nightmares, psychotic reactions, anxiety, state of arousal, phobias, depression, confusion, hallucinations, increased intracranial pressure.

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

From the senses: a violation of color perception, diplopia, a violation of taste, smell, hearing and balance.

From the cardiovascular system: tachycardia, lowering blood pressure, 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: nephritis, impaired renal function, hypercreatininaemia, increased urea levels.

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

Dermatological reactions: pinpoint hemorrhages (petechiae), dermatitis bullous hemorrhagic, papular rash with a cortex, indicative of vascular lesions (vasculitis).

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

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);

- age to 18 years (until the skeleton growth is completed);

- Pregnancy;

- lactation (breastfeeding);

- Hypersensitivity to the components of the drug.

With caution, the drug is used for atherosclerosis of cerebral vessels, cerebral circulation disorder (in anamnesis);
in patients with chronic renal failure, organic lesions of the central nervous system.
PREGNANCY AND LACTATION

The drug is contraindicated for use in pregnancy and lactation (breastfeeding).

APPLICATION FOR FUNCTIONS OF THE LIVER

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

The drug is contraindicated for children and adolescents under 18 years (until the skeleton has been completed).

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 intended for the treatment of acute tonsillitis.

It is not recommended to use more than 2 months.

Against the background of the drug should be avoided exposure to sunlight and UV-irradiation (mercury quartz lamps, solarium).

If there are side effects from the central nervous system, allergic reactions, pseudomembranous colitis, it is necessary to cancel the drug.

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.
When there are signs of tendonitis, it is necessary to immediately stop treatment, make an immobilization of the Achilles tendon and consult an orthopedist.
Women are not recommended to use tampons against the background of the drug in connection with 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).

U. Patients with impaired liver or kidney function, it is necessary to control the concentration of ofloxacin in plasma.
In severe renal and hepatic insufficiency, the risk of toxic effects increases (dose adjustment is required).
Against the background of the drug should not drink alcohol.

Use in Pediatrics

Children are only used in case of a life threat, taking into account the expected 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.
With hemodialysis, 10-30% of the drug is removed.
DRUG INTERACTION

Food products, antacids containing ions of aluminum, calcium, magnesium or iron preparations, reduce the absorption of ofloxacin, forming insoluble complexes (the time interval between administration of these drugs should be at least 2 hours).

With simultaneous use ofloxacin reduces the clearance of theophylline by 25% (when using this combination should reduce the dose of theophylline).

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

With simultaneous use ofloxacin increases the concentration of glibenclamide in plasma.

At simultaneous reception with indirect anticoagulants it is necessary to carry out the control of indicators of blood coagulation.

When combined with NSAIDs, nitroimidazole derivatives 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 combined with drugs alkalinizing urine (inhibitors of carbonic anhydrase, citrates, sodium bicarbonate), the risk of developing crystalluria and nephrotoxic effects increases.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored in a dry, protected from light, out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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