Roflo - instructions for use, dose, side effects, contraindications

Ofloxacin is a synthetic antibacterial agent of a broad spectrum of action from a group of fluoroquinolones having a bactericidal action. The main mechanism of action of quinolones is specific inhibition of bacterial DNA gyrase.DNA-gyrase is necessary for replication, transcription, repair and recombination of bacterial DNA. Its inhibition led to to untwisting and destabilization of bacterial DNA and, as a result, to the death of the microbial cell. Highly active against most Gram-negative and Gram-positive microorganisms. Fluoroquinolones have bactericidal activity, dependent on concentration, and moderate post-antibacterial action. Ratio AUC and the minimum inhibitory concentration (MIC) or the ratio of maximum concentration and MIC are a predictive factor for successful clinical treatment.

Sensitive microorganisms

Unreliable sensitive microorganisms (possibly due to acquired resistance): Citrobacter freundii, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia spp., Staphylococcus spp. (coagulase-negative strains), Staphylococcus aureus (methicillin-sensitive strains), Staphylococcus epidermidis, Campylobacter jejuni, Enterococcus faecalis, Streptococcus pneumoniae.

Resistant microorganisms

Acinetobacter baumannii, Bacteroides spp., Clostridium difficile, Enterococci (including Enterococcus faecium), Listeria monocytogenes, Staphylococcus aureus (methicillin-resistant strains), Nocardia spp.

Resistance

The resistance to ofloxacin develops as a result of a phased mutation process of genes encoding both topoisomerases of type II: DNA gyrase and topoisomerase IV.Other mechanisms of resistance, such as the mechanism of influence on permeability of external structures of a microbial cell (the mechanism characteristic for Pseudomonas aeruginosa) and the mechanism of efflux (active excretion of the antimicrobial from the microbial cell), can also affect the sensitivity of microorganisms to ofloxacin.

Marginal values of the IPC

The boundary values of MPC (mg / l) of ofloxacin approved by the European Committee for the Determination of Antibiotic Sensitivity (EUCAST).

Microorganisms	Sensitive (mg / L)	Resistant (mg / L)
Enterobacteriaceae	≤0,5	>1
Staphylococcus spp.	≤1	>1
Streptococcus pneumoniae	≤0,12	>4
Haemophilus influenzae	≤0,5	>0,5
Moraxella catarrhalis	≤0,5	>0,5
Neisseria gonorrhoeae	≤0,12	>0,25
Boundary values of BMD that are not associated with a particular type of microorganism	≤0,5	>1

Pharmacokinetics:

The maximum serum concentration with a 30-minute intravenous infusion of ofloxacin is achieved at the end of the infusion. Concentrations of ofloxacin in serum after a 30-minute intravenous infusion of the drug:

Dose	Serum concentration of ofloxacin after infusion	Serum concentration of ofloxacin 4 hours after infusion	Serum concentration of ofloxacin 12 hours after infusion
100 mg	2.9 mg / L	0.5 mg / l	0,2 mg / l
200 mg	5.2 mg / l	1.1 mg / l	0.3 mg / l

At the off-line use of ofloxacin, serum concentration does not increase significantly (the accumulation factor when administered twice a day is 1.5).

Ofloxacin penetrates many organs and tissues, including, pulmonary tissue, ear tissue, throat, nose, skin, soft tissue, bone tissue, joints, abdominal organs, bile, small pelvis organs, kidneys, prostate gland, urethra. The concentrations of ofloxacin in the urine and in the infected urinary tracts exceed the concentrations of ofloxacin in the serum 5-100 times.

The volume of distribution is 120 liters. The connection with plasma proteins is approximately 25%. Half-life with intravenous infusion introduction is 5 hours, a decrease in serum concentration of ofloxacin after infusion occurs linearly. Less than 5% ofloxacin undergoes biotransformation in the liver. In the urine two major metabolites are detected: dimethylfloxacin and N-oxide ofloxacin. Excretion by the kidneys (80-90% of the dose) in unchanged form. AT small amounts are excreted through the intestine. In the bile ofloxacin is found in a glucuronated form.

In elderly patients, the half-life increases, but the maximum serum concentration does not change.

With renal failure, the elimination half-life increases; total and renal clearance decrease in proportion to the decrease in creatinine clearance.

Indications:

Treatment of infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin:

- pyelonephritis;

- prostatitis, epididymitis, orchitis;

- infections of organs of small gas;

- sepsis (which is caused by the above infections of the genitourinary system);

- cystitis, urinary tract infections (as an alternative to other antimicrobial drugs).

As an alternative to other antimicrobials ofloxacin can be used to treat the following infectious-inflammatory diseases:

- infections of the skin and soft tissues;

- infection of bones and joints;

- acute sinusitis;

- exacerbation of chronic bronchitis, community-acquired pneumonia;

- prevention of infections caused by ofloxacin-sensitive microorganisms, in patients with a significant decrease in immune status (eg, neutropenia).

When using the drug should take into account the official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country.

Contraindications:

Hypersensitivity to ofloxacin, the components of the drug and other quinolones; epilepsy; children's age till 18 years; pregnancy, lactation; the defeat of tendons in the previously conducted treatment with fluoroquinolones; pseudo-normalized myasthenia gravis (myasthenia gravis).

Carefully:

- Patients who are predisposed to developing seizures (in patients with previous central nervous system (CNS) lesions, such as severe cerebral arteriosclerosis, history of cerebral circulation, organic CNS lesions, a history of brain trauma, and patients receiving concomitant medications , lowering the threshold of seizure activity of the brain, such as fenbufen or other non-steroidal anti-inflammatory drugs, theophylline).

- In patients with latent or manifested deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions in the treatment of quinolones).

- In patients with impaired renal function (mandatory mandatory control of kidney function, as well as correction of the dosing regimen, see section "Method of administration and dose").

- In patients with hepatic insufficiency (control of liver function tests).

- In patients with porphyria (risk of exacerbation of porphyria).

- In patients with known risk factors for lengthening the interval QT: in elderly patients; with uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia); with the syndrome of congenital lengthening of the interval QT; with heart diseases (heart failure, myocardial infarction, bradycardia); while concomitantly taking medications that can lengthen the interval QT (antiarrhythmic drugs IA and III classes, tricyclic antidepressants, macrolides, neuroleptics). In patients with diabetes mellitus, receiving oral hypoglycemic agents (for example, glibenclamide) or insulin (the risk of developing hypoglycemia increases).

In patients with severe adverse reactions to other quinolones, such as severe neurologic reactions (increased risk of similar undesirable reactions with ofloxacin).

- In patients with psychoses and other psychiatric disorders in the anamnesis.

- With the simultaneous use of drugs that can reduce blood pressure, medicines for non-general general anesthesia from the barbiturate (increased risk of arterial hypotension).

Pregnancy and lactation:

Ofloxacin is contraindicated for use in pregnancy.

As ofloxacin excreted into breast milk, then due to the risk to the child, breast-feeding women, women should not use the drug. In case of urgent need for the drug, breastfeeding at this time should be discontinued.

Dosing and Administration:

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.

Adult patients with normal renal function (creatinine clearance greater than 50 mL / min)

In the treatment of infections caused by microorganisms that are sensitive to ofloxacin, the recommended dose is 200 mg twice a day or 400 mg once a day. Usually the daily dose is 400 mg. In case of treatment of severe infections or in patients with overweight, the daily dose can be increased to 600 mg.

Special patient groups

Elderly patients

The age of patients does not require dose adjustment of ofloxacin. However, when using the drug in elderly patients, special attention should be given to kidney function, since in case of its reduction, a corresponding correction of the dosing regimen may be required.

Patients with hepatic impairment

When violations of liver function is not recommended to exceed the daily dose of ofloxacin 400 mg.

Patients with impaired renal function

For violations of kidney function, the following dosing regimen is recommended, depending on the creatinine clearance:

Creatinine clearance

Single dose (mg) *

Multiplicity of the introduction

50-20 ml / min

100-200

1 time per day (every 24 hours)

<20 ml / min ** or hemodialysis and peritoneal dialysis

100 or

200

1 time per day (every 24 hours)

Once every 2 days (every 48 hours)

* According to the testimony.

** It is recommended to monitor serum concentrations of ofloxacin in patients with severe renal dysfunction or in patients on dialysis.

In cases where it is not possible to determine the clearance of creatinine (CC), it can be calculated from the serum creatinine concentration using the Cockcroft formula for adults: for men:

CK (ml / min) = Body weight (kg) x (140-years in years) / 72 blood serum scutin (mg / dL)

CK (ml / min) = Body weight (kg) x (140-years in years) / 0.814crequentinine serum (μmol / L)

for women:

CK (ml / min) = 0.85 x for men

Administration of the drug

The solution of ofloxacin is only for slow infusion introduction. Intravenous infusion is performed once or twice a day. The duration of the infusion should be at least 30 minutes for each dose of ofloxacin 200 mg. This is especially important if ofloxacin is administered concomitantly with other drugs that can reduce blood pressure or means for non-general general anesthesia from the barbiturate group.

The daily dose to 400 mg ofloxacin can be administered once a day. In this case, it is preferable to administer the drug in the morning.

A daily dose of more than 400 mg should be divided into two parts and administered with 12-hour intervals.

The drug should be administered immediately after opening the vial.

A few days after the improvement of the patient's condition, the onloxacin started in the form of intravenous infusions can be continued by taking the drug inside at the same doses.

Duration of treatment

The duration of treatment depends on the severity of the disease. Like any treatment antimicrobial drugs, ofloxacin should be continued for at least 48-72 hours after the normalization of body temperature or if there is evidence of eradication of the pathogen.

Side effects:

The information presented below is based on data obtained from clinical studies and data from a broad post-marketing experience of the drug. The following side effects are presented in accordance with the following gradations of their incidence: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000), (including individual messages); unknown frequency (according to available data, it is not possible to establish frequency of occurrence).

Heart Disease

Rarely: tachycardia.

Infrequently: a feeling of palpitations.

Frequency unknown: interval lengthening QT, ventricular arrhythmia of the "pirouette" type (especially in patients with risk factors for lengthening the interval QT).

Vascular disorders

Often: phlebitis.

Rarely: increased blood pressure, lower blood pressure.

During the infusion of ofloxacin, it is possible to lower arterial pressure, accompanied by the development of tachycardia, and which in very rare cases is strongly pronounced up to the development of collapse. In the case of a significant reduction in blood pressure should immediately stop the infusion of the drug.

Violations of the blood and lymphatic system

Rarely: anemia, hemolytic anemia. leukopenia, eosinophilia, thrombocytopenia.

Frequency unknown: agranulocytosis, pancytopenia, oppression of bone marrow hematopoiesis.

Disturbances from the nervous system

Infrequently: dizziness, headache.

Rarely: drowsiness, paresthesia, dysgeusia (a disorder of perception of taste), parosmia (a disorder of perception of a smell).

Rarely: peripheral sensory neuropathy, peripheral sensory-motor neuropathy, seizures, extrapyramidal symptoms, including tremor, and other disorders of muscle coordination.

Frequency unknown: agesia, increased intracranial pressure.

Disorders of the psyche

Infrequently: agitation, sleep disturbance, insomnia.

Rarely: psychotic reactions (for example, hallucinations), anxiety, nervousness, confusion, nightmares, depression.

Frequency unknown: psychotic reactions and depression with self-harm, in rare cases, up to suicidal thoughts or attempts.

Disturbances on the part of the organ of sight

Infrequently: irritation of the mucous membrane of the eye, conjunctivitis.

Rarely: visual impairment (diplopia, violation of color perception).

Frequency unknown: uveitis.

Hearing disorders and labyrinthine disorders

Infrequently: Vertigo.

Rarely: hearing impairment (ringing in the ears), hearing loss.

Disturbances from the respiratory system, chest and mediastinal organs

Infrequently: cough, nasopharyngitis.

Rarely: shortness of breath, bronchospasm.

Frequency unknown: allergic pneumonitis, pronounced dyspnea.

Disorders from the digestive system

Infrequently: abdominal pain, diarrhea, nausea, vomiting, decreased appetite.

Rarely: enterocolitis (sometimes hemorrhagic).

Rarely: pseudomembranous colitis.

Frequency unknown: dyspepsia, constipation, flatulence, pancreatitis, stomatitis.

Disturbances from the liver and bile ducts

Rarely: an increase in the activity of "hepatic" enzymes, such as alanine aminotransferase (ALT), aspartate aminotransferase (ASAT), lactate dehydrogenase (LDH), gamma-glutamylgranferase (GGT), and / or alkaline phosphatase (APF) and / or bilirubin concentrations in the blood.

Rarely: cholestatic jaundice.

Frequency unknown: hepatitis, which can be severe; when using ofloxacin (mainly in patients with impaired hepatic function), cases of severe hepatic insufficiency, including acute hepatic insufficiency, sometimes fatal, have been reported.

Disorders from the nochek and urinary tract

Rarely: increased serum creatinine concentration.

Rarely: acute renal failure.

Frequency unknown: acute interstitial nephritis, increased urea concentration in the blood.

Disturbances from the skin and subcutaneous tissues

Infrequently: itching, rash.

Rarely: urticaria, hyperhidrosis, pustular rash, "tides" of blood to the skin.

Rarely: exudative erythema multiforme, toxic epidermal necrolysis, photosensitivity reactions, drug rash, vascular purpura, vasculitis, which in exceptional cases can lead to skin necrosis.

Frequency unknown: Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis.

Disturbances from musculoskeletal and connective tissue

Rarely: tendonitis.

Rarely: arthralgia, myalgia, tendon rupture (eg, Achilles tendon) (as with other fluoroquinolones, this side effect can develop within 48 hours after initiation of treatment and can be bilateral).

Frequency unknown: rhabdomyolysis and / or myopathy. muscle weakness, which is especially important for patients with pseudo-paralytic myasthenia, muscle tear, muscle rupture, ligament rupture, arthritis.

Disorders from the metabolism and nutrition

Rarely: anorexia.

Frequency unknown: hyperglycemia, hypoglycemia; hypoglycemic coma (in patients with diabetes mellitus receiving treatment with hypoglycemic agents).

Infectious and parasitic diseases

Infrequently: fungal infections, resistance of pathogenic microorganisms.

Immune system disorders

Rarely: anaphylactic reactions, anaphylactoid reactions, angioedema.

Rarely: anaphylactic shock, anaphylactoid shock.

Congenital, hereditary and genetic disorders

Frequency unknown: exacerbation of porphyria in patients with porphyria.

General disorders and disorders at the site of administration

Often: pain and redness at the site of infusion.

Frequency unknown: asthenia, fever, pain in the back, chest, limbs.

Overdose:

Overdose Symptoms

The most important symptoms of overdose are from the side of the central nervous system (such as dizziness, confusion, impaired consciousness, convulsions), lengthening of the interval QT, as well as reactions from the gastrointestinal tract (such as nausea and erosion of the mucous membranes of the gastrointestinal tract).

Treatment for overdose

It is necessary to monitor the ECG, since it is possible to extend the interval QT. Fractions of ofloxacin can be removed from the body by hemodialysis. There is no specific antidote.

Interaction:

With theophylline, fenbufen or other non-steroidal anti-inflammatory drugs that can reduce the threshold of seizure activity of the brain

In clinical studies, no pharmacokinetic interactions of ofloxacin with theophylline have been established.However, it is possible to significantly reduce the threshold of seizure activity of the brain with the simultaneous use of quinolones with drugs that lower the threshold of seizure activity in the brain (theophylline, fenbufen [and other similar non-steroidal anti-inflammatory drugs]).

FROM drugs capable of lengthening the interval QT

Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that can lengthen the interval QT (antiarrhythmic drugs IA and III classes, tricyclic antidepressants, macrolides, neuroleptics).

With antagonists of vitamin K

Increased prothrombin time / international normalized and / or the development of bleeding (including severe bleeding) has been reported in patients with simultaneous use of ofloxacin and vitamin K antagonists (eg, warfarin). With the simultaneous use of vitamin K antagonists, control of the blood coagulation system is necessary.

With glibenclamide

Ofloxacin may slightly increase the serum concentrations of glibenclamide when used concomitantly.When bothloxacin and glibenclamide are used concomitantly, it is recommended to carefully monitor the patients' condition and the concentration of glucose in the blood.

With other hypoglycemic agents for oral administration and insulin

Ofloxacin increases the risk of developing hypoglycemia, requires a more careful monitoring of the concentration of glucose in the blood.

With probenecid, cimetidine, furosemide, methotrexate

The use of quinolones together with drugs that are excreted from the body through renal tubular secretion (such as probenecid, cimetidine, furosemide, methotrexate), there may be a mutual delay in excretion and an increase in serum concentrations (especially in the case of high doses).

With drugs that can reduce blood pressure, drugs for inhalation of general anesthesia from the barbiturate group

With simultaneous application with ofloxacin, a sharp and significant reduction in blood pressure is possible, so in this case, particularly careful monitoring of the functional status of the cardiovascular system is required.

With glucocorticosteroids

When used simultaneously with glucocorticosteroids, the risk of rupture of tendons increases, especially in elderly patients.

With drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium hydrogen carbonate)

When administered with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium hydrogen carbonate), the risk of developing crystalluria and nephrotic effects increases.

Compatibility with other drugs and infusion solutions

A solution of heparin should not be mixed with ofloxacin solution (precipitates may form).

The drug is compatible with 0.9% sodium chloride solution, Ringer's solution, 5% dextrose solution.

Special instructions:

Renal insufficiency

Due to ofloxacin is excreted mainly by the kidneys, patients with renal insufficiency need a dose adjustment of ofloxacin (see sections "With caution", "Method of administration and dose").

Prevention of photosensitization

During the treatment with ofloxacin, due to the risk of photosensitization, exposure to bright sunlight and ultraviolet rays should be avoided.

Secondary infection

As with the use of other antimicrobials with the use of ofloxacin, especially prolonged, it is possible to develop a secondary infection associated with the growth of resistant to the preparation of microorganisms, to exclude and confirm which it is necessary to reassess the patient's condition. If a secondary infection occurs during therapy, appropriate measures should be taken to treat it.

Peripheral Neuropathy

In patients receiving fluoroquinolones, including ofloxacin, reported the development of sensory and sensory-motor neuropathy, which can have a rapid onset. If patients develop neuropathy symptoms, ofloxacin should be discontinued, thereby minimizing the possible risk of developing irreversible conditions (see "With caution" section).

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with diagnosed glucose-6-phosphate dehydrogenase deficiency may be predisposed to hemolytic reactions in the treatment with quinolones. Therefore, such patients should be careful when using ofloxacin (see section "With caution").

Pseudomembranous colitis caused by Clostridium difficile

The appearance of diarrhea, especially in severe form, persistent and / or with an admixture of blood, during or after treatment with ofloxacin may be a manifestation of pseudomembranous colitis. If there is a suspected development of pseudomembranous colitis, ofloxacin should be stopped immediately, and appropriate specific antibacterial therapy should be immediately prescribedvancomycin inside, teicoplanin inside or metronidazole inside). In the emergence of this clinical situation, preparations that suppress the intestinal peristalsis are contraindicated.

Patients who are predisposed to develop seizures

Like other quinolones, ofloxacin should be used with caution in patients predisposed to develop seizures (patients with a history of CNS lesions, in patients who simultaneously receive drugs that reduce the threshold of seizure activity of the brain (theophylline, fenbufen [and other similar non-steroidal anti-inflammatory drugs]) (see "With caution"). With the development of seizures, ofloxacin should be discontinued.

Tendonitis

Tendinitis, rarely caused by the use of quinolones, can sometimes lead to rupture of tendons, including Achilles tendon, especially in elderly patients and patients taking glucocorticosteroids simultaneously. This undesirable effect can develop within 48 hours after the start of treatment and be bilateral. In case of signs of tendonitis (inflammation of the tendon), it is recommended to immediately stop treatment. An appropriate treatment (for example, immobilization) of a damaged tendon may be required.

Interval lengthening QT

Some caution is needed when taking fluoroquinolones, including ofloxacin, in patients with known risk factors for lengthening the interval QT, such as:

- elderly age;

- uncorrected imbalance of electrolytes (eg, hypokalemia, hypomagnesemia);

- congenital lengthening of the interval QT;

- diseases of the cardiovascular system (heart failure, myocardial infarction, bradycardia);

- simultaneous reception of drugs that extend the interval QT (IA and III classes of antiarrhythmic drugs, tricyclic antidepressants, macrolides, neuroleptics).

Pseudo-paralytic myasthenia gravis (myasthenia gravis)

Fluoroquinolones, including ofloxacin, are characterized by neuromuscular blocking of activity and may increase muscle weakness in patients with pseudo-paralytic myasthenia gravis. In the post-marketing period, serious adverse reactions were observed, including pulmonary insufficiency requiring artificial ventilation and fatal outcome, which were associated with the use of fluoroquinolones in patients with established diagnosis of pseudo-paralytic myasthenia gravis. The use of ofloxacin in patients with established diagnosis of pseudo-paralytic myasthenia is not recommended (see section "Side effect").

Severe skin reactions

With the use of ofloxacin, the development of severe bullous reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, has been reported. Patients should be informed that with the development of skin reactions and / or lesions of the mucous membranes, the need to immediately consult a doctor before continuing with ofloxacin treatment.

Hypersensitivity reactions and allergic reactions

With the use of fluoroquinolones, the development of hypersensitivity reactions and allergic reactions (anaphylactic shock and anaphylactoid reactions that can progress to a life-threatening state) has been reported. In these cases, it is necessary to stop the use of ofloxacin and begin appropriate treatment.

Psychotic reactions

Psychotic reactions, including suicidal thoughts / attempts, have been noted in patients taking fluoroquinolones, including ofloxacin. In the case of the development of such reactions ofloxacin should be canceled and appropriate treatment prescribed. Ofloxacin should be administered with caution to patients with psychotic disorders (including history) (see section "With caution").

Dysfunction of the liver

Ofloxacin should be used with caution in patients with impaired liver function, so liver damage can occur (see section "With caution"). With the use of fluoroquinolones, cases of fulminant hepatitis have been reported, leading to the development of hepatic insufficiency (including fatal cases). Patients should be advised to stop treatment and consult a doctor, if symptoms and signs of liver disease such as anorexia, jaundice, darkening of urine, itching, pain in the abdomen are observed.

Disglycemia (hypo- and hyperglycemia)

When using fluoroquinolones, including ofloxacin, reported on the development of both hypoglycemia, hack and hyperglycemia. In patients with diabetes mellitus, receiving both oral and hypoglycemic agents (for example, glibenclamide) or insulin, was reported on the development of hypoglycemic coma. It is recommended to carefully monitor blood glucose concentrations in patients with diabetes mellitus.

Patients taking vitamin K antagonists

Due to a possible increase in the prothrombin time / international normalized ratio and / or the development of bleeding in patients taking both ofloxacin and vitamin K antagonists (eg, warfarin), careful monitoring of blood coagulability is recommended.

Risk of development of resistance

The prevalence of acquired resistance may vary geographically and over time for individual species. Therefore, local information on resistance is required; microbiological diagnostics with isolationcausative agent and the definition of its sensitivity, especially in severe infections or lack of response to treatment.

Infections, caused by Escherichia coli

Resistance to fluoroquinolones Escherichia coli - the most common causative agent of urinary tract infections - varies in different geographical areas. Doctors are advised to take into account local resistance Escherichia coli to fluoroquinolones.

Infections caused by Neisseria gonorrhoeae

In connection with the increase in resistance Neisseria gonorrhoeae, ofloxacin Do not use as an empirical treatment for suspected gonococcal urinary tract infection. It is necessary to perform tests for the sensitivity of the pathogen to ofloxacin in order to provide targeted therapy.

Methicillin-resistant Staphylococcus aureus

There is a high probability that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including ofloxacin. therefore ofloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, if laboratory tests did not confirm the sensitivity of this microorganism to ofloxacin.

Infections of bones and joints

When infections of bones and joints should consider the need for combined use ofloxacin with other antibacterial drugs.

Impact on laboratory performance and diagnostic tests

Ofloxacin can inhibit growth Mycobacterium tuberculosis, leading to false-negative results in the bacteriological diagnosis of tuberculosis.

When determining opiates and porphyrins in urine during ofloxacin treatment, a false positive result is possible. It may be necessary to confirm positive results using more specific methods.

Other

During the period of treatment is not recommended to use ethanol.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Solution for infusion, 2 mg / ml.

Packaging:

100 ml of the drug in a bottle of low density polyethylene with a lid of low density polyethylene.The bottle in a sealed polypropylene bag, along with the instructions for use, is placed in a cardboard box.

Storage conditions:

In dry, dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-004213

Date of registration:27.03.2017

Expiration Date:27.03.2022

The owner of the registration certificate:Rowecq LimitedRowecq Limited United Kingdom

Manufacturer: & nbsp

SCAN BIOTECH, Ltd. India

ROSLEKS PHARM, LLC Russia

Representation: & nbspROUTEC LIMITEDROUTEC LIMITEDUnited Kingdom

Information update date: & nbsp10.05.2017

Illustrated instructions

Instructions

Roflot (Roflo)