Ofloxacin-Teva, 200 mg 10 pcs

Pharmacotherapeutic group: antimicrobial agent – fluoroquinolone.

ATX code: JMA0101

Pharmacological properties .

Pharmacodynamics

Ofloxacin is a synthetic antibacterial drug of broad spectrum

from the group of fluoroquinolones with bactericidal action. The main

the mechanism of action of quinolones is specific inhibition of bacterial

DNA-gyrase. DNA-gyrase is essential for replication, transcription, repair and recombination of bacterial DNA. Its inhibition leads to the unwinding and destabilization of bacterial DNA and, consequently, to the death of the microbial cell.

Highly active against most gram-negative and gram-positive 2

microorganisms.

Fluoroquinolones have concentration-dependent bactericidal activity and

moderate postantibacterial action. The ratio of AUC to minimum

suppressive concentration (MCC) or the ratio of maximum concentration to

MCC is a predictive factor for successful clinical treatment.

Sensitive microorganisms

.Non-permanently susceptible microorganisms (possibly due to acquired

resistance): Citrobacter freundii, Escherichia coli, Klebsiella oxytoca, Klebsiella

pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Pseudomonas aeruginosa, Serratia spp,

Staphylococcus spp. (coagulazonegative 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), (methicillin-

resistant strains), Nocardia spp.

Resistance

Resistance to ofloxacin develops as a result of a stepwise process of mutations

of the genes encoding both topoisomerase type II: DNA-gyraza and topoisomerase IV. Other

resistance mechanisms, such as the mechanism for influencing the permeability of the outer

structures of the microbial cell (a mechanism characteristic of Pseudomonas aeruginosa) and

the efflux mechanism (active elimination of the antimicrobial agent from the microbial

cell) can also affect the sensitivity of microorganisms to ofloxacin.

MBC limit values

The European Committee for the Susceptibility of Antibiotics (EUCAST) approved limit values (mg/L) for ofloxacin.

Microorganisms

Sensitive (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

>0.53

Neisseria gonorrhoeae

≤0.12

>0.25

/p>

Borderline MPC values,

not associated with a specific

microbial species

≤0.5

>1

Pharmacokinetics

After oral administration, ofloxacin is rapidly and almost completely absorbed from the

gastrointestinal tract. Bioavailability is almost 100%.

The maximum plasma concentration of ofloxacin after a single dose of 200

mg is 2.5-3 mcg/ml and is reached after 1 hour. Binding to plasma proteins

is 25%. The volume of distribution is approximately 120 liters. Less than 5% of Ofloxacin

is biotransformed.

It is excreted mainly by the kidneys (80-90% of the dose is unchanged). Two main metabolites are detected in the urine: N-desmethylofloxacin and ofloxacin

N-oxide. About 4% ofloxacin is excreted with the bile as glucuronides. The elimination half-life is 6-7 hours. Concentrations ofloxacin in the urine and in

infected urinary tract exceed concentrations ofloxacin in serum

blood by 5-100 times.

Special patient groups

Elderly patients

. Elderly patients have an increased half-life, but

the maximum concentration does not change.

Renal failure

In renal failure, the half-life is prolonged; total and renal

clearance decrease in proportion to the decrease in creatinine clearance.

Indications

Treatment of infectious and inflammatory diseases caused by sensitive to
ofloxacin by microorganisms:
Pyelonephritis and complicated urinary tract infections; prostatitis, epididymitis, orchitis;
infections of the pelvic organs (as part of combination therapy);
For the treatment of the following infectious and inflammatory diseases, ofloxacin can
use only as an alternative to other antimicrobials: skin and soft tissue infections;
cystitis, uncomplicated urinary tract infections;
4 infections of bones and joints;
acute sinusitis;
exacerbation of chronic bronchitis, community-acquired pneumonia;
prevention of infections caused by those sensitive to ofloxacin
microorganisms, in patients with a significant decrease in immune status
(for example, with neutropenia).
When using the drug Ofloxacin-Teva, you should take into account official
national recommendations for the appropriate use of antibacterial agents
drugs, as well as the sensitivity of pathogenic microorganisms in a particular
region.

Pharmacological effect

Pharmacotherapeutic group: antimicrobial agent – fluoroquinolone.

ATX code: J01MA01

Pharmacological properties

Pharmacodynamics

Ofloxacin is a synthetic broad-spectrum antibacterial drug

actions from the group of fluoroquinolones, which have a bactericidal effect. Main

The mechanism of action of quinolones is the specific inhibition of bacterial

DNA gyrases. DNA gyrase is required for replication, transcription, repair and

recombination of bacterial DNA. Its inhibition leads to unwinding and

destabilization of bacterial DNA and, as a result, the death of the microbial cell.

Highly active against most gram-negative and gram-positive 2

microorganisms.

Fluoroquinolones have concentration-dependent bactericidal activity and

moderate post-antibacterial effect. AUC to minimum ratio

inhibitory concentration (MIC) or the ratio of maximum concentration and

BMD is a predictive factor for successful clinical treatment.

Sensitive microorganisms

Variably 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

Resistance to ofloxacin develops as a result of a stepwise process of mutations

genes encoding both type II topoisomerases: DNA gyrase and topoisomerase IV. Other

resistance mechanisms, such as the mechanism of influence on the permeability of external

microbial cell structures (a mechanism characteristic of Pseudomonas aeruginosa) and

efflux mechanism (active removal of an antimicrobial agent from microbial

cells) – may also affect the sensitivity of microorganisms to ofloxacin.

MPC boundary values

MIC breakpoint values ​​(mg/l) of ofloxacin approved by the European Committee

Antibiotic Susceptibility Test (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

>0.53

Neisseria gonorrhoeae

≤0.12

>0.25

Boundary values ​​of the MPC,

not related to specific

type of microorganisms

≤0.5

>1

Pharmacokinetics

After oral administration, ofloxacin is rapidly and almost completely absorbed from

gastrointestinal tract. Bioavailability is almost 100%.

The maximum concentration of ofloxacin in blood plasma after taking a single dose is 200

mg is 2.5-3 mcg/ml and is achieved after 1 hour. Plasma protein binding

is 25%. Distribution volume – approximately 120 l. Less than 5% ofloxacin

undergoes biotransformation.

It is excreted mainly by the kidneys (80-90% of the dose – unchanged). In urine

two main metabolites are found: N-desmethylofloxacin and ofloxacin

N-oxide About 4% of ofloxacin is excreted in the bile in the form of glucuronides. Period

half-life is 6-7 hours. Concentrations of ofloxacin in urine and

infected urinary tracts exceed serum concentrations of ofloxacin

blood 5-100 times.

Special patient groups

Elderly patients

In elderly patients, there is an increase in half-life, but

the maximum concentration does not change.

Kidney failure

In renal failure, the half-life increases; general and renal

clearance decreases in proportion to the decrease in creatinine clearance.

Special instructions

Disability and potential irreversible serious adverse reactions associated with fluoroquinolones

The use of fluoroquinolones, including ofloxacin, has been associated with disability and the development of irreversible serious adverse reactions from various body systems that can develop simultaneously in the same patient. Adverse reactions caused by fluoroquinolones include tendonitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and nervous system side effects (hallucinations, anxiety, depression, insomnia, headaches, and confusion). These reactions may develop from several hours to several weeks after the start of ofloxacin therapy. The development of these adverse reactions was observed in patients of any age or without the presence of previous risk factors. If the first signs or symptoms of any serious adverse reaction occur, ofloxacin should be discontinued immediately. Fluoroquinolones, including ofloxacin, should be avoided in patients who have experienced any of these serious adverse reactions.

Kidney failure

Due to the fact that ofloxacin is excreted mainly by the kidneys, dosage adjustment of ofloxacin is necessary in patients with renal failure (see sections “Precautions”, “Dosage and Administration”).

Prevention of photosensitivity

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

Secondary infection

As with the use of other antimicrobial drugs, when taking ofloxacin, especially long-term, it is possible to develop a secondary infection associated with the growth of

drug-resistant microorganisms, to exclude and confirm which the patient’s condition should be re-evaluated. If a secondary infection develops during therapy, the necessary measures should be taken to treat it.

Peripheral neuropathy

Sensory and sensorimotor neuropathy, which may have a rapid onset, has been reported in patients receiving fluoroquinolones, including ofloxacin. If patients develop symptoms of neuropathy, treatment with ofloxacin should be discontinued to help minimize the possible risk of developing irreversible conditions. Patients should be informed to report any symptoms of neuropathy to their healthcare provider. Fluoroquinolones should not be prescribed to patients with a history of peripheral neuropathy (see section “Precautions”).

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients diagnosed with glucose-6-phosphate dehydrogenase deficiency may be predisposed to hemolytic reactions when treated with quinolones. Therefore, caution should be exercised when using ofloxacin in such patients (see section “Caution”).

Pseudomembranous colitis caused by Clostridium difficile

The appearance of diarrhea, especially severe, persistent and/or bloody diarrhea, during or after treatment with ofloxacin may be a manifestation of pseudomembranous colitis. If the development of pseudomembranous colitis is suspected, treatment with ofloxacin should be stopped immediately, and appropriate specific antibacterial therapy (oral vancomycin, oral teicoplanin or oral metronidazole) should be immediately prescribed. If this clinical situation occurs, drugs that suppress intestinal motility are contraindicated.

Patients predisposed to developing seizures

Like other quinolones, ofloxacin should be used with caution in patients predisposed to the development of seizures (patients with a history of central nervous system lesions, patients concomitantly receiving drugs that lower the threshold of convulsive activity of the brain (theophylline, fenbufen and other similar non-steroidal anti-inflammatory drugs) (see section “With caution”). If seizures develop, treatment with ofloxacin should be discontinued.

Tendonitis and tendon rupture

Tendinitis, which rarely occurs with quinolone use, can sometimes lead to rupture of tendons, including the Achilles tendon, especially in older patients and in

patients simultaneously taking glucocorticosteroids. This one is unwanted

the effect can develop within 48 hours after the start of treatment and be bilateral. Elderly patients are more prone to developing tendinitis; In patients taking fluoroquinolones, the risk of tendon rupture may be increased with concomitant use of corticosteroids. In addition, post-transplant patients have an increased risk of developing tendinitis, so it is recommended to be careful when prescribing fluoroquinolones in this category of patients. In patients with impaired renal function, the daily dose should be

adjust based on creatinine clearance. Patients should be advised to remain calm at the first sign of tendonitis or tendon rupture and to contact their healthcare provider. If you suspect the development of tendinitis or tendon rupture, you should immediately stop treatment with the drug and begin appropriate treatment of the affected tendon, for example, by providing it with sufficient immobilization (see sections “Contraindications”, “Side effects”).

QT prolongation

Some caution is necessary when taking fluoroquinolones, including

ofloxacin, in patients with known risk factors for QT prolongation, such as

How:

old age;

uncorrected electrolyte imbalance (eg, hypokalemia,

hypomagnesemia);

congenital prolongation of the QT interval;

diseases of the cardiovascular system (heart failure, heart attack

myocardium, bradycardia);

simultaneous use of drugs that prolong the QT interval (classes IA and III

antiarrhythmic drugs, tricyclic antidepressants, macrolides,

neuroleptics).

Pseudoparalytic myasthenia gravis (myasthenia gravis)

Fluoroquinolones, including ofloxacin, are characterized by neuromuscular blocking properties.

activity and may increase muscle weakness in patients with myasthenia gravis. In the post-marketing period, serious adverse reactions, including pulmonary failure requiring mechanical ventilation and death, have been observed with the use of fluoroquinolones in patients with myasthenia gravis. The use of ofloxacin in a patient with an established diagnosis of pseudoparalytic myasthenia gravis is contraindicated (see section “Side effects”).

Severe skin reactions

Severe bullous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported when taking ofloxacin. Patients should be informed that if skin reactions and/or mucosal lesions develop, they should immediately consult a physician before continuing treatment with ofloxacin.

Hypersensitivity reactions and allergic reactions

When using fluoroquinolones, the development of hypersensitivity reactions and allergic reactions has been reported after the first use (anaphylactic shock and anaphylactoid reactions, which can progress to a life-threatening condition). In these cases, ofloxacin should be discontinued and appropriate treatment should be initiated.

Psychotic reactions

Psychotic reactions, including suicidal ideation/attempts, have been reported in patients taking fluoroquinolones, including ofloxacin, sometimes after a single dose. In case of development of any side effects from the central nervous system, including mental disorders, ofloxacin should be immediately discontinued and appropriate treatment prescribed. In these cases, it is recommended to switch to therapy with an antibiotic other than a fluoroquinolone, if possible. Ofloxacin should be prescribed with caution to patients with psychotic disorders (including a history) (see section “Caution”).

Liver dysfunction

Ofloxacin should be used with caution in patients with impaired liver function, as liver damage may occur (see section “Caution”).

With the use of fluoroquinolones, cases of development of fulminant

hepatitis leading to the development of liver failure (including fatal cases). Patients should be advised to stop treatment and consult a doctor if symptoms and signs of liver disease are observed, such as anorexia, jaundice, dark urine, itching, abdominal pain.

Dysglycemia (hypo- and hyperglycemia)

As with other fluoroquinolones, changes in blood glucose concentrations, including hypo- and hyperglycemia, were observed with the use of ofloxacin. During therapy with ofloxacin, dysglycemia occurred more often in elderly patients and patients with diabetes mellitus receiving concomitant therapy with oral hypoglycemic drugs (for example, sulfonylureas) or insulin. When using ofloxacin in such patients, the risk of developing

hypoglycemia, up to hypoglycemic coma. It is necessary to inform patients about the symptoms of hypoglycemia (confusion, dizziness, ravenous appetite, headache, nervousness, palpitations or increased heart rate, pale skin, perspiration, trembling, weakness). If the patient develops hypoglycemia, treatment with ofloxacin should be discontinued immediately and appropriate therapy should be initiated. In these cases, it is recommended to switch to therapy with an antibiotic other than a fluoroquinolone, if possible. During treatment

ofloxacin in elderly patients and patients with diabetes mellitus

Close monitoring of blood glucose concentrations is recommended.

Patients taking vitamin K antagonists

Due to a possible increase in prothrombin time/international normalized ratio and/or bleeding in patients taking

simultaneously ofloxacin and vitamin K antagonists (for example, warfarin),

Close monitoring of blood clotting parameters is recommended.

Risk of developing resistance

The prevalence of acquired resistance may vary geographically and over time for individual species. Therefore, regional information on resistance is required. Microbiological diagnostics should be carried out with isolation of the pathogen and determination of its sensitivity, especially in severe infections or

lack of response to treatment.

Escherichia coli infections

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

Escherichia coli to fluoroquinolones.

Infections caused by Neisseria gonorrhoeae

Due to increasing resistance in Neisseria gonorrhoeae, ofloxacin should not be used as empirical treatment for suspected gonococcal infection.

urinary tract. Susceptibility testing of the pathogen to ofloxacin should be performed to guide targeted therapy.

Methicillin-resistant Staphylococcus aureus

There is a high likelihood that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones, including ofloxacin. Therefore, ofloxacin is not recommended for the treatment of known or suspected

infections caused by methicillin-resistant Staphylococcus aureus, if laboratory tests have not confirmed the sensitivity of this microorganism to ofloxacin.

Bone and joint infections

For infections of bones and joints, the need for a combination should be considered.

use of ofloxacin with other antibacterial drugs.

Aneurysm and aortic dissection

Epidemiological studies have reported an increased risk of aortic aneurysm and aortic dissection after taking fluoroquinolones, especially in elderly patients.

Therefore, fluoroquinolones should be used only after a careful benefit-risk assessment and consideration of other treatment options in patients with a family history of aortic aneurysm; in patients with diagnosed aortic aneurysm and/or

aortic dissection; in the presence of other risk factors or conditions,

predisposing to the development of aortic aneurysm and aortic dissection (eg,

Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behçet’s disease, arterial hypertension, atherosclerosis).

In case of sudden pain in the abdomen, chest, or back, patients should immediately consult a doctor at the emergency room.

Effect on laboratory parameters and diagnostic tests

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

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

Other

During the treatment period, it is not recommended to consume ethanol.

Impact on the ability to drive vehicles and machinery

Some adverse reactions, such as dizziness/vertigo, drowsiness and blurred vision, may reduce psychomotor response and ability to concentrate and therefore increase the risk in situations in which the presence of these abilities is especially important (for example, when driving a car or other machinery).

Active ingredient

Ofloxacin

Composition

1 tablet contains: active ingredient ofloxacin 200.0/400.0 mg;
excipients: lactose monohydrate 105.6/211.2 mg, starch
pregelatinized 54.0/108.0 mg, hypromellose 20.0/40.0 mg, croscarmellose sodium
16.0/32.0 mg, colloidal silicon dioxide (anhydrous colloidal silicon dioxide)
0.4/0.8 mg, magnesium stearate 4.0/8.0 mg, Opadry II white shell 33G28707 (hypromellose-
6cP 6.00/9.60 mg, titanium dioxide E171 3.60/5.76 mg, lactose monohydrate 3.30/5.28 mg,
macrogol-3000 1.20/1.92 mg, triacetin 0.90/1.44 mg).

Pregnancy

Pregnancy

Ofloxacin should not be used during pregnancy (see section “Contraindications”).

Breastfeeding period

Since ofloxacin is excreted into breast milk, due to the risk to the baby,

Women who are breastfeeding should not take ofloxacin, or if

If its use is necessary, breastfeeding should be stopped.

Contraindications

Hypersensitivity to ofloxacin, other quinolones or

excipients of the drug.

Epilepsy.

Pseudoparalytic myasthenia gravis (myasthenia gravis) (see sections “Adverse

action”, “Special instructions”).

History of tendon damage when taking fluoroquinolones.

Children and adolescents under 18 years of age (the risk cannot be completely eliminated

lesions of the cartilaginous growth zones of bones in a child).

Pregnancy (the risk of damage to cartilaginous growth plates cannot be completely excluded in

fetus).

Breastfeeding period (the risk of damage cannot be completely eliminated

cartilaginous growth zones of bones in a child).

Hereditary lactose intolerance, lactase deficiency, glucose-galactose

malabsorption (due to the presence of lactose in the composition).

With caution

In patients predisposed to developing seizures (patients with

pre-existing lesions of the central nervous system (CNS), such as

severe atherosclerosis of cerebral vessels, brain disorders

history of blood circulation, organic lesions of the central nervous system, brain injury

history of brain injury; in patients simultaneously receiving drugs that reduce

seizure threshold of the brain, such as fenbufen or others

non-steroidal anti-inflammatory drugs, theophylline).

In patients with latent or manifest glucose-6-5 deficiency

phosphate dehydrogenase (increased risk of hemolytic reactions during treatment

quinolones).

In patients with impaired renal function (mandatory monitoring is required

kidney function, as well as correction of the dosage regimen, see section “Method

application and dose”).

In patients with liver failure (monitoring of function indicators

liver).

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

In patients with risk factors for QT prolongation: in elderly patients

age; with uncorrected electrolyte disturbances (hypokalemia,

hypomagnesemia); with congenital long QT syndrome; at

heart diseases (heart failure, myocardial infarction,

bradycardia); while taking medications that can

prolong QT (class IA and III antiarrhythmic drugs, tricyclics

antidepressants, macrolides, antipsychotics).

In patients with diabetes mellitus receiving oral hypoglycemic agents

drugs (for example, glibenclamide) or insulin (increases the risk of developing

hypoglycemia).

In patients with severe adverse reactions to other quinolones, such as

as severe neurological reactions (increased risk of

similar adverse reactions when using loxacin).

In patients with a history of psychosis and other mental disorders.

In elderly patients.

In patients after transplantation, as well as with concomitant use

glucocorticosteroids (increased risk of tendonitis and rupture

tendons – see section “Special instructions”).

In patients with a family history of aortic aneurysm, or in patients with

diagnosed aortic aneurysm and/or aortic dissection or in the presence

other risk factors or conditions predisposing to the development of an aneurysm

aorta or aortic dissection (eg, Marfan syndrome, Ehlers syndrome,

Danlos vascular type, Takayasu arteritis, giant cell arteritis, disease

Behçet, arterial hypertension, atherosclerosis) (see section “Special instructions”).

Side Effects

The information presented below is based on data obtained from clinical studies and extensive post-marketing experience with the drug.

The side effects listed below are presented in accordance with the following gradations of frequency of their occurrence: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10000, <1/1000); very rare (< 1/10000) (including isolated reports); frequency is unknown (it is not possible to determine the frequency of occurrence based on available data).

Heart disorders

Uncommon: palpitations. Rarely: tachycardia. Not known: QT prolongation, torsade de pointes (TdP) (especially in patients with risk factors for QT prolongation).

Vascular disorders

Rarely: increased blood pressure, decreased blood pressure.

Blood and lymphatic system disorders

Very rarely:

anemia, hemolytic anemia, leukopenia, eosinophilia,

thrombocytopenia. Frequency unknown: agranulocytosis, pancytopenia, bone depression

cerebral hematopoiesis.

Nervous system disorders

Uncommon: dizziness, headache. Rare: drowsiness, paresthesia, dysgeusia

(disorder of taste perception), parosmia (disorder of smell perception). Very

rare: peripheral sensory neuropathy, peripheral sensorimotor

neuropathy, seizures, extrapyramidal symptoms including tremors and other disorders of muscle coordination. Frequency unknown: ageusia, increased intracranial pressure (benign intracranial hypertension, pseudotumor cerebri).

Mental disorders

Uncommon: agitation, sleep disturbances, insomnia. Rare: psychotic disorders

(eg hallucinations), anxiety, nervousness, confusion, nightmares,

depression. Frequency unknown: psychotic disorders and depression with self-harm, in rare cases even suicidal thoughts or attempts, disturbances

memory and attention, disorientation, delirium.

Visual disorders

Uncommon: irritation of the mucous membrane of the eye, conjunctivitis. Rarely: violations

vision (diplopia, color vision impairment). Frequency unknown: uveitis.

Hearing and labyrinth disorders

Uncommon: vertigo. Very rare: hearing impairment (tinnitus), hearing loss.

Respiratory, thoracic and mediastinal disorders

Uncommon: cough, nasopharyngitis. Rarely: shortness of breath, bronchospasm. Frequency unknown:

allergic pneumonitis, severe shortness of breath.

Digestive system disorders

Uncommon: abdominal pain, diarrhea, nausea, vomiting, decreased appetite. Rare: enterocolitis

(sometimes hemorrhagic). Very rare: pseudomembranous colitis. Frequency

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

Disorders of the liver and biliary tract 9

Rarely:

increased activity of “liver” enzymes, such as

alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase

(LDG), gamma-glutamyltransferase (GGT) and/or alkaline phosphatase (ALP) and/or

concentration of bilirubin in the blood. Very rare: cholestatic jaundice. Frequency

unknown: hepatitis, which may be severe; when using ofloxacin

(mainly in patients with impaired liver function) cases have been reported

severe liver failure, including acute liver failure,

sometimes with fatal outcome.

Renal and urinary tract disorders

Rarely: increased serum creatinine concentration. Very rare: acute

renal failure. Frequency unknown: acute interstitial nephritis,

increase in urea concentration in the blood.

Skin and subcutaneous tissue disorders

Uncommon: itching, rash. Rarely: urticaria, hyperhidrosis, pustular rash, flushing

to the skin. Very rare: 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.

Musculoskeletal and connective tissue disorders

Rare: tendinitis. Very rare: arthralgia, myalgia, tendon rupture (eg

Achilles tendon) (as with other fluoroquinolones, this side effect

may develop within 48 hours of starting treatment and may be bilateral).

Frequency unknown: rhabdomyolysis and/or myopathy, muscle weakness, especially

important for patients with pseudoparalytic myasthenia (myasthenia gravis), tear

muscles, muscle rupture, ligament rupture, arthritis.

Metabolic and nutritional disorders

Rarely: anorexia. Frequency unknown: hyperglycemia, severe hypoglycemia, up to

before the development of hypoglycemic coma, especially in elderly patients, in patients with

diabetes mellitus receiving oral hypoglycemic drugs or

insulin).

Infectious and parasitic diseases

Uncommon: fungal infections, resistance of pathogenic microorganisms.

Immune system disorders

Rarely: anaphylactic reactions, anaphylactoid reactions, angioedema.

Very rare: anaphylactic shock, anaphylactoid shock.

Congenital, hereditary and genetic disorders

Not known: exacerbation of porphyria in patients with porphyria.

General and administration site disorders

Frequency unknown: asthenia, increased body temperature, pain in the back, chest, limbs.

Interaction

With antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate, or preparations containing zinc, iron

Antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate, or preparations containing zinc or iron reduce the absorption of ofloxacin.

When using the above drugs and ofloxacin, an approximately two-hour interval should be maintained between their doses.

With vitamin K antagonists

An increase in prothrombin time/international normalized ratio and/or the development of bleeding (including severe) was observed in patients with simultaneous use of ofloxacin and vitamin K antagonists (for example, warfarin). With simultaneous use of ofloxacin, monitoring of the blood coagulation system is necessary.

With glibenclamide

Ofloxacin may slightly increase serum concentrations of glibenclamide when administered concomitantly. When using ofloxacin and glibenclamide simultaneously, it is recommended to carefully monitor the patient’s condition and blood glucose concentrations.

With other hypoglycemic agents for oral administration and insulin

Ofloxacin increases the risk of hypoglycemia; more careful monitoring of blood glucose concentrations is required.

With probenecid, cimetidine, furosemide or methotrexate

When quinolones are used together with drugs that are eliminated from the body by renal tubular secretion (such as probenecid, cimetidine, furosemide, methotrexate), a mutual slowdown in elimination and an increase in serum concentrations are possible (especially when high doses are used).

With drugs that can lower the threshold for seizure activity in the brain, for example, theophylline, fenbufen and other similar non-steroidal anti-inflammatory drugs.

In clinical studies, no pharmacokinetic interactions of ofloxacin with theophylline were established. However, a significant decrease in the threshold of convulsive activity of the brain is possible with simultaneous use

quinolones with drugs that reduce the threshold of convulsive activity of the brain

(theophylline, fenbufen and other similar non-steroidal anti-inflammatory drugs

drugs).

With glucocorticosteroids

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

With drugs that can prolong the QT interval

Ofloxacin, like other fluoroquinolones, should be used with class IA and III drugs, tricyclic antidepressants, macrolides, antipsychotics).

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

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

Overdose

Symptoms. The most important symptoms of overdose are central nervous system symptoms (such as dizziness, confusion, impaired consciousness, convulsions), prolongation of the QT interval, and gastrointestinal reactions (such as nausea and erosions of the gastrointestinal mucous membranes).

Treatment. In case of overdose, it is recommended to perform gastric lavage and symptomatic therapy. Antacids can be used to protect the gastric mucosa. ECG monitoring is necessary as QT interval prolongation is possible. Fractions of ofloxacin can be removed from the body by hemodialysis. There is no specific antidote.

Storage conditions

Store at a temperature not exceeding 25 ° C in a place protected from light. Keep out of the reach of children.

Shelf life

3 years.

Manufacturer

Teva Pharmaceutical Works Private Limited Company, Hungary