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

Active substance: ofloxacin

Type: Antibacterial drug of the group of fluoroquinolones

Manufacturer: MACLEODS PHARMACEUTICALS (India)
Composition, form of production and packaging
The tablets covered with a film membrane of
yellow color, oval, biconcave.

1 tab.

ofloxacin 200 mg

Excipients: microcrystalline cellulose, lactose, sodium lauryl sulfate, povidone, sodium carboxymethyl starch, crospovidone, colloidal silicon dioxide, talc purified, magnesium stearate.

The composition of the shell: hypromellose, talc purified, titanium dioxide, magnesium stearate, dye quinoline yellow, macrogol 6000, diethyl phthalate.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (6) - packs of cardboard.
10 pieces.
- blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Antimicrobial drug from the group of fluoroquinolones of broad spectrum of action.
It is bactericidal. The mechanism of the action of ofloxacin is associated with the blockade of the DNA-gyrase enzyme in bacterial cells.
Highly active against most Gram-negative and some Gram-positive microorganisms: Aeromonas hydrophila, Branhamella catarrhalis, Brucella spp., Clostridium perfringens, Esherichia coli, Salmonella spp., Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus ducreyi, Plesiomonas, Legionella, Shigella spp., Proteus spp., Including Proteus mirabilis, Proteus vulgaris (indole poselitelny and indole negative), Moraxella'morganii, Klebsiella spp., Including Klebsiella pneumoniae, Helicobacter pylori, Mycoplasma spp., Vibrio spp., Gardnerella vaginalis, Neisseria gonorrhoeae, Neisseria meningitidis, Chlamydia trachomatis, Staphylococcus aureus methi-S, Staphylococcus coagulase negative.

Moderately sensitive to ofloxacin, Acinetobacter spp., Ureaplasma urealyticum, Bacteroides fragilis, Mycobacterium tuberculosis, Mycobacterium leprae, Chlamidia psittaci, Anaerobic Gram positive cocci, Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp., Streptococcus spp (especially p-hemolytic).

To ofloxacin are insensitive: Acinetobacter braumanmii, Clostridium difficile, Enterococci, Listeria monocytogenes, Staphylococci methi-R, Nocardia spp., Ofloxacin is inactive against Treponema pallidum.

PHARMACOKINETICS

After oral intake ofloxacin quickly and almost completely (95%) is absorbed from the digestive tract.
Bioavailability is almost 100%. C max ofloxacin in blood plasma after taking a single dose of 200 mg is 2.5-3 mg / ml and is achieved after 1 hour, food can slow absorption.
Binding to plasma proteins is 25%.

Metabolised in the liver (about 5%) to form the N-oxide ofloxacin and dimethylfloxacin.

T 1/2 is 6-7 hours. Up to 90% ofloxacin is excreted by the kidneys unchanged.

In patients with impaired renal function (TC 50 ml / min or less), T 1/2 ofloxacin is increased.

INDICATIONS

Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin:

- Lower respiratory tract infections (except for cases of pneumococcal infection);

- infections of the ENT organs (except for cases of acute tonsillitis);

- infection of the abdominal cavity and bile ducts;

- kidney infection (pyelonephritis) and urinary tract (cystitis, urethritis (including gonococcal nature));

- infections of the pelvic organs and genital organs (including gonococcal and chlamydial etiology);

- infections of bones and joints;

- infections of the skin and soft tissues.

Prevention of infections in patients with immunodeficiency of various etiologies (including neutropenia).

DOSING MODE

The dose of ofloxacin and the duration of treatment depend on the severity and type of infection, the general condition of the patient and the function of the kidneys.Tablets are taken internally as a whole, washed down with water, before or during meals.

The average daily intake for adults is from 200 mg to 600 mg.
A dose of up to 400 mg / day can be given in 1 reception, preferably in the morning. Doses over 400 mg / day should be divided into two doses at equal intervals.
The duration of treatment is 7-10 days.
Treatment should continue for at least 3 more days after the disappearance of the symptoms of the disease and complete normalization of body temperature. In the treatment of salmonellosis, the course of treatment is 7-8 days.
In severe infections or in the treatment of patients with overweight, the daily dose can be increased to 800 mg.

In uncomplicated infections of the lower urinary tract, the drug is prescribed at a dose of 200 mg / day for 3-5 days.
With gonorrhea prescribed 400 mg once.
In patients with impaired renal function, the dose of ofloxacin is determined depending on the creatinine clearance:

- in patients with CK over 50 ml / min dose adjustment is not required;

- in patients with KK 50-20 ml / min single dose is 200 mg with an interval between doses of 24 hours.

In patients with hepatic insufficiency it is not recommended to exceed the maximum daily dose of 400 mg.

SIDE EFFECT

Allergic reactions: skin rash, itching, urticaria, angioedema, allergic nephritis, allergic pneumonitis, eosinophilia, bronchospasm, anaphylactic shock, erythema multiforme exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), purpura, fever.

From the skin: spot hemorrhages (petechiae), dermatitis bullous hemorrhagic, papular rash with cortex, vasculitis.

On the part of the digestive system: gastralgia, abdominal pain, anorexia, nausea, vomiting, diarrhea, flatulence;
rarely - hyperbilirubinemia and increased activity of liver transaminases in blood plasma; in isolated cases of hepatitis, cholestatic jaundice. There is a risk of developing pseudomembranous colitis.
From the side of the central nervous system: decreased reaction speed, headache, dizziness, sleep disturbance, general weakness;
in some cases, extrapyramidal disorders or other disorders of muscle coordination, tremor, muscle cramps, numbness and paresthesia in the limbs, intense dreams, nightmarish dreams, psychotic reactions in the form of anxiety, excitement, feelings of fear, depressions, confusion, visual and auditory hallucinations, increased intracranial pressure.
On the part of the sense organs: diplopia, violations of color perception, violation of taste, smell, hearing and balance.

On the part of the hematopoiesis system: leukopenia, agranulocytosis, thrombocytopenia, eosinophilia;
in isolated cases - hemolytic anemia, pancytopenia, aplastic anemia.
From the side of the urinary system: in some cases - acute interstitial nephritis, hypercriticinemia, increased urea concentration, impaired renal function.

From the cardiovascular system: tachycardia, lowering blood pressure.

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

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

CONTRAINDICATIONS

- epilepsy (including in the anamnesis);

- lesions of the central nervous system with a decrease in convulsive threshold (after craniocerebral trauma, stroke, inflammatory processes of the central nervous system);

- deficiency of glucose-6-phosphate dehydrogenase;

- creatinine clearance less than 20 ml / min;

- Pregnancy;

- lactation period;

- age up to 18 years;

- hypersensitivity to ofloxacin and other quinolone preparations.

With caution: atherosclerosis of cerebral vessels, cerebral circulatory disorders (in the anamnesis), chronic renal failure, organic lesions of the central nervous system, in patients with prolonged QT interval.

PREGNANCY AND LACTATION

Contraindicated during pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

With caution in chronic renal failure.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with hepatic insufficiency it is not recommended to exceed the maximum daily dose of 400 mg


SPECIAL INSTRUCTIONS

When using ofloxacin should not be exposed to natural and artificial ultraviolet radiation.

It is not recommended to use more than 2 months.

In case of side effects, especially from the nervous system or allergic reactions, which may appear after the first application, the drug must be immediately canceled.

In case of signs of tendonitis (especially in elderly patients) it is recommended to immediately stop treatment, to immobilize the Achilles tendon and provide orthopedic consultation

In the first weeks of treatment, severe, prolonged diarrhea caused by Clostridium difficile (pseudomembranous colitis) can occur, in this case, immediately stop taking ofloxacin and prescribe adequate therapy involving oral administration of vancomycin or metronidazole.

When using the drug, women are not recommended to use hygienic tampons due to the increased risk of thrush development, Ofloxacin can lead to a worsening of myasthenia flow.
Perhaps more frequent attacks of porphyria in predisposed patients.
Ofloxacin prevents the release of Mycobacterium tuberculosis, leading to false-negative results in the bacteriological diagnosis of tuberculosis.
During the treatment, ethanol should not be used.
Impact on the ability to drive vehicles and manage mechanisms

The drug may interfere with the patient's ability to engage in potentially hazardous activities requiring increased attention and rapid psychomotor reactions.

OVERDOSE

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

Treatment: gastric lavage;
if necessary, symptomatic therapy. There is no specific antidote. When hemodialysis is removed 10-30% ofloxacin.
DRUG INTERACTION

With simultaneous administration with aitacids containing aluminum, calcium and magnesium or iron-containing preparations, the effectiveness of ofloxacin.decreases (the time interval between the appointment of these drugs should be at least 2 hours).
With simultaneous use ofloxacin, a slight increase in the concentration of glibenclamide in the blood plasma is possible.
With simultaneous use ofloxacin with probenicide, cimetidine, furosemide or methotrexate, it is possible to increase the concentration of ofloxacin in the blood plasma.
Reduces the clearance of theophylline by 25% (with simultaneous use should reduce the dose of theophylline).
When administered with non-steroidal anti-inflammatory drugs, derivatives of nitroimidazole and methylxanthines, the risk of neurotoxic effects increases.
At simultaneous appointment with glucocorticosteroids, 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.
With the simultaneous use of ofloxacin with vitamin K antagonists, control over the blood coagulation system is necessary.
In patients with impaired liver or kidney function.
it is necessary to monitor the concentration of ofloxacin in plasma, tk; with severe hepatic or renal insufficiency, the risk of toxic effects increases.
When co-prescribing with QT prolonging drugs (IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides), the risk of QT interval prolongation increases.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store in a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children. Shelf life - 3 years.
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