Moxifloxacin STADA (solution)

Hypersensitivity

In some cases, after the first use of the drug, hypersensitivity and allergic reactions may develop, which should be reported to your doctor immediately. Very rarely, even after the first use of the drug, anaphylactic reactions can progress to life-threatening anaphylactic shock. In these cases, treatment with moxifloxacin should be stopped and the necessary therapeutic measures (including anti-shock) should be started immediately.

Severe skin adverse reactions

Severe cutaneous adverse reactions have been observed during treatment with moxifloxacin, including toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome and acute generalized exanthematous pustulosis, which can be life-threatening or fatal (see section "Side effects"). When prescribing the drug, patients should be advised of the signs and symptoms of serious skin reactions and the patient should be carefully monitored for the possibility of these reactions occurring. If signs and symptoms suggestive of these reactions occur, moxifloxacin should be discontinued immediately and alternative treatment considered. If a patient develops a serious reaction, such as toxic epidermal necrolysis, Stevens-Johnson syndrome, or generalized exanthematous pustulosis while using moxifloxacin, treatment with this drug should not be restarted under any circumstances.

Heart disorders

QT interval prolongation may occur in some patients when using moxifloxacin. Because women have a longer QT interval than men, they may be more sensitive to drugs that prolong the QT interval. Elderly patients are also more susceptible to drugs that affect the QT interval.

Prolongation of the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia.

The degree of QT interval prolongation may increase with increasing drug concentrations, so the recommended dose and infusion rate (400 mg over 60 minutes) should not be exceeded. However, in patients with pneumonia, no correlation was observed between moxifloxacin plasma concentrations and QT interval prolongation. None of the 9,000 patients treated with moxifloxacin experienced cardiovascular complications or deaths associated with QT prolongation. When using moxifloxacin, the risk of developing ventricular arrhythmias may increase in patients with conditions predisposing to arrhythmias.

In this regard, moxifloxacin is contraindicated in:

changes in electrophysiological parameters of the heart, expressed in prolongation of the QT interval: congenital or acquired documented prolongation of the QT interval, electrolyte disturbances, especially uncorrected hypokalemia, clinically significant bradycardia; clinically significant heart failure with reduced left ventricular ejection fraction; a history of rhythm disturbances accompanied by clinical symptoms;
use with other drugs that prolong the QT interval (see section “Interaction with other drugs”).

The drug should be used with caution:

in patients with potentially proarrhythmic conditions such as acute myocardial ischemia and cardiac arrest;
in patients with liver cirrhosis (since in this category of patients the risk of developing QT prolongation cannot be excluded).

If signs of cardiac arrhythmias occur during treatment with moxifloxacin, treatment should be stopped and an ECG performed.

Aortic aneurysm and dissection, heart valve regurgitation/regurgitation

Epidemiological studies have reported an increased risk of aortic aneurysm and aortic dissection, especially in elderly patients, as well as aortic and mitral valve regurgitation after the use of fluoroquinolones. In patients receiving fluoroquinolones, there have been cases of aortic aneurysm and dissection, sometimes complicated by rupture (including death), as well as regurgitation/insufficiency of any of the heart valves (see section “Side Effects”).

Therefore, fluoroquinolones should be used only after careful benefit-risk assessment and consideration of other treatment options in patients with a family history of aortic aneurysm or congenital heart valve disease, or in patients with a known aortic aneurysm and/or aortic dissection or disease heart valve, or in the presence of other risk factors or conditions predisposing to the development of:

both aortic aneurysm and dissection and heart valve regurgitation/insufficiency (eg, connective tissue diseases such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behçet's disease, hypertension, rheumatoid arthritis);

or additionally:

aortic aneurysms and dissections (eg, vascular diseases such as Takayasu arteritis, giant cell arteritis, confirmed atherosclerosis, Sjögren's syndrome);
regurgitation/insufficiency of the heart valve (eg, infective endocarditis).

The risk of developing aortic aneurysm and dissection, as well as their rupture, may be increased in patients concomitantly receiving systemic corticosteroids.

If patients experience sudden pain in the abdomen, chest, or back, they should contact their doctor immediately at the emergency room.

Patients should be advised to seek immediate medical attention if they experience acute shortness of breath, new palpitations, or swelling of the abdomen or lower extremities.

Liver disorders

Cases of fulminant hepatitis, potentially leading to liver failure (including fatal cases), have been reported with the use of moxifloxacin (see section "Side effects"). The patient should be informed that if signs and symptoms of fulminate hepatitis occur and rapidly develop, such as rapidly developing asthenia associated with jaundice, dark urine, increased bleeding or hepatic encephalopathy, it is necessary to consult a doctor before continuing treatment with moxifloxacin. If signs of liver dysfunction occur, liver function tests/liver function tests should be performed.

Convulsions

The use of fluoroquinolone drugs is associated with a possible risk of developing seizures. Moxifloxacin should be used with caution in patients with diseases of the central nervous system and with disorders of the central nervous system (eg, lowered seizure threshold, history of seizures, decreased cerebral perfusion, brain damage and stroke) that predispose to seizures or lower the seizure threshold.

If seizures occur, therapy with moxifloxacin should be discontinued and appropriate measures taken.

Gastrointestinal disorders

The use of broad-spectrum antibacterial drugs, including moxifloxacin, is associated with a risk of developing pseudomembranous colitis. This diagnosis should be considered in patients who develop severe diarrhea during treatment with moxifloxacin. If pseudomembranous colitis is suspected or confirmed, therapy with moxifloxacin should be discontinued and appropriate therapeutic measures should be taken. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea.

Renal dysfunction

Elderly patients with kidney disease should use caution when taking moxifloxacin if they are unable to drink adequate fluids, as dehydration may increase the risk of developing kidney failure.

Visual impairment

If visual acuity decreases or other vision-related symptoms occur, you should immediately consult an ophthalmologist (see section “Side Effects”).

Myasthenia gravis

Moxifloxacin should be used with caution in patients with myasthenia gravis due to possible exacerbation of the disease.

Tendonitis and tendon rupture

During therapy with fluoroquinolones, including moxifloxacin, tendonitis and tendon rupture (mainly Achilles), sometimes bilateral, may develop within the first 48 hours of treatment. Cases have been described that occurred within several months after completion of treatment. The risk of developing tendinopathy may be increased in older patients during vigorous exercise, in patients receiving corticosteroid treatment, in patients with renal failure, or in patients with solid organ transplants. At the first symptoms of tendonitis (eg, painful swelling, inflammation) at the site of injury, use of the drug should be discontinued, the affected limb should be off-loaded, any inappropriate exercise should be avoided, and a doctor should be consulted.

Photosensitivity reactions

When using fluoroquinolones, photosensitivity reactions are observed. However, during preclinical and clinical studies, as well as with the use of moxifloxacin in practice, no photosensitivity reactions were observed. However, patients receiving moxifloxacin should avoid exposure to direct sunlight and ultraviolet light.

Treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA) strains

The use of moxifloxacin is not recommended to treat infections caused by methicillin-resistant Staphylococcus aureus (MRSA). In cases of suspected or confirmed infections caused by MRSA, treatment with appropriate antibacterial drugs should be prescribed (see section "Pharmacodynamics").

Effect on laboratory parameters

The ability of moxifloxacin to inhibit the growth of mycobacteria may cause in vitro interaction between moxifloxacin and the test for Mycobacterium spp., leading to false-negative results when analyzing samples from patients who are being treated with moxifloxacin during this period.

Peripheral neuropathy

In patients treated with fluoroquinolones, including moxifloxacin, cases of sensory or sensorimotor polyneuropathy leading to paresthesia, hypoesthesia, dysesthesia or weakness have been described. Patients treated with moxifloxacin should be warned to seek immediate medical attention before continuing treatment if symptoms of neuropathy, including pain, burning, tingling, numbness or weakness, occur (see section "Side Effects").

Mental disorders

Psychiatric reactions may occur even after the first use of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to the occurrence of suicidal thoughts and behavior with a tendency to self-harm, including suicide attempts (see section "Side effects"). In case of development of any side effects from the central nervous system, including mental disorders, it is necessary to immediately discontinue the drug Moxifloxacin STADA and begin appropriate therapy. In these cases, it is recommended to switch to therapy with an antibiotic other than a fluoroquinolone, if possible. Caution should be exercised when using moxifloxacin in patients with psychosis and/or a history of psychiatric illness.

Dysglycemia

As with other fluoroquinolones, changes in blood glucose concentrations, including hypo- and hyperglycemia, were observed with the use of moxifloxacin. During therapy with moxifloxacin, 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 moxifloxacin in such patients, the risk of developing hypoglycemia, including hypoglycemic coma, increases. 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 a patient develops hypoglycemia, the attending physician must independently decide whether to discontinue/change therapy. When treating elderly patients with diabetes mellitus with moxifloxacin, careful monitoring of blood glucose concentrations is recommended.

Glucose-6-phosphate dehydrogenase deficiency

Patients with a diagnosed or family history of glucose-6-phosphate dehydrogenase deficiency are prone to developing hemolytic reactions during quinolone therapy. Therefore, moxifloxacin should be used with caution in these patients.

Inflammation of periarterial tissues

Moxifloxacin solution for infusion is intended for intravenous administration only. Periarterial administration should be avoided as preclinical studies have demonstrated inflammation of periarterial tissues following such administration.

Specific complicated infections of the skin and subcutaneous tissue

The clinical effectiveness of moxifloxacin in the treatment of severe burn infections, fasciitis and diabetic foot syndrome with osteomyelitis has not been proven.

Prolonged, disabling and potentially irreversible serious adverse reactions

Cases of long-term (lasting months or years), incapacitating and potentially irreversible serious adverse reactions affecting various, sometimes multiple body systems (musculoskeletal system, nervous system, mental state and sensory organs) have been reported in patients taking quinolones and fluoroquinolones, regardless of their age and pre-existing risk factors. If the first signs or symptoms of any serious adverse reactions occur, moxifloxacin should be discontinued immediately and the patient should seek the advice of their physician.

Children

Since the risk of damage to the cartilaginous growth zones of bones in a child cannot be completely excluded, the use of moxifloxacin in children and adolescents under 18 years of age is contraindicated (see section “Contraindications”).

Information on excipients

Patients on a low-salt diet (with heart failure, renal failure, nephrotic syndrome) should take into account that the solution for infusion contains sodium chloride. The daily dose of sodium in the drug is 34 mmol.

Pharmacological properties of the drug Moxifloxacin

Antibacterial drug of the fluoroquinolone group. Has a bactericidal effect. The mechanism of action is due to the inhibition of bacterial topoisomerases II and IV, which leads to disruption of the DNA synthesis of the microbial cell. In vitro, it is active against a wide range of gram-negative and gram-positive bacteria, anaerobes, acid-fast bacteria and atypical forms, including Mycoplasma, Chlamydia, Legionella. Effective against bacteria resistant to β-lactam and macrolide antibiotics. Gram-positive bacteria are sensitive to moxifloxacin - Staphylococcus aureus (including strains sensitive to methicillin), Streptococcus pneumoniae (including strains resistant to penicillin and macrolides), Streptococcus pyogenes (group A), Streptococcus milleri, Streptococcus mitior , Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohni, Staphylococcus epidermidis (including strains sensitive to methicillin), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae ; gram-negative bacteria - Haemophilus influenzae (including strains producing β-lactamases), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including strains producing β-lactamases), Escherichia coli, Enterobacter cloacae; Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter intermedius, Enterobacter sakazakii, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii; anaerobic bacteria - Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides unoformis, Fusobacterium spp., Porphyromonas spp. (including Porphyromonas anaerobus, Porphyromonas asaccharolytica, Porphyromonas magnus), Prevotella spp., Propionibacterium spp., Clostridium perfringens, Clostridium ramnosum . Moxifloxacin is also active against Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Caxiella burnettii . It has a clinically significant post-antibiotic effect against gram-positive and gram-negative microorganisms (on average 2 hours). When taken orally, it is quickly and almost completely absorbed from the gastrointestinal tract (food intake does not affect the absorption of moxifloxacin). Absolute bioavailability is 86–92%. The maximum concentration in the blood serum is reached after 1–2.5 hours and after oral administration of 400 mg of moxifloxacin is 2.5–4.98 mg/l. Plasma protein binding is 39.4–48%. It is well distributed in tissues and body fluids, the volume of distribution is 3–3.5 l/kg. Creates high concentrations in bronchial secretions, alveolar macrophages, the mucous membrane of the maxillary sinus and bronchial secretions, which exceed the level of moxifloxacin in the blood. Metabolized in the liver without the participation of the cytochrome P450 system with the formation of two inactive metabolites - acetyl glucuronide and N-sulfate, the first of which binds to proteins by 89.5%, and the second practically does not bind to albumin (4.8%). The half-life is 12–14 hours. Total clearance is 254 ml/min, renal clearance is 50 ml/min. 42% is excreted in the urine (22% unchanged, 20% in the form of metabolites), as well as in bile (12% unchanged, 27% in the form of metabolites).

Moxifloxacin overdose, symptoms and treatment

There were no side effects observed in healthy volunteers with single use of moxifloxacin in doses of up to 1.2 g or at a dose of 600 mg/day for 10 days. In case of overdose, symptomatic therapy is carried out in accordance with the clinical situation. In case of oral overdose of moxifloxacin, it is advisable to use activated carbon. After intravenous administration, activated charcoal slightly (approximately 20%) reduces the systemic exposure of moxifloxacin.

List of pharmacies where you can buy Moxifloxacin:

Moscow
Saint Petersburg

Side effects of the drug Moxifloxacin

From the digestive system: often - abdominal pain, nausea, diarrhea, vomiting, dyspepsia, taste disturbances, changes in the results of liver function tests; rarely - dry mouth, flatulence, constipation, candidiasis of the oral mucosa, anorexia, stomatitis, glossitis, gastrointestinal dysfunction; in some cases - gastritis, discoloration of the tongue, dysphagia, transient jaundice. From the central nervous system and peripheral nervous system: often - headache, dizziness; rarely - insomnia, nervousness, drowsiness, anxiety, tremor, paresthesia; in isolated cases - hallucinations, depersonalization, increased muscle tone, coordination disorders, agitation, amnesia, aphasia, emotional lability, sleep disorders (including parasomnias), speech disorders, cognitive impairment, hypoesthesia, convulsions, confusion, depression. From the cardiovascular system: often - prolongation of the QT in patients with concomitant hypokalemia; rarely - tachycardia, hypertension (arterial hypertension), palpitations, prolongation of the QT with normal potassium levels in the blood serum; in some cases - arterial hypotension, vasodilation, peripheral edema. From the blood system: rarely - leukopenia, increased prothrombin time, eosinophilia, thrombocytosis; in isolated cases - decreased thromboplastin levels, decreased prothrombin time, thrombocytopenia, anemia. Metabolism: rarely - increased amylase activity; in isolated cases - hyperglycemia, hyperuricemia, increased LDH activity. From the musculoskeletal system: rarely - arthralgia, myalgia; in isolated cases - arthritis, tendinopathy. From the respiratory system: rarely - shortness of breath; in isolated cases - BA. From the reproductive system: rarely - vaginal candidiasis, vaginitis. From the urinary system: in isolated cases - impaired renal function. From the senses: in isolated cases - visual impairment, amblyopia, loss of taste sensitivity, parosmia. On the skin: rarely - rash, itching, increased sweating. Allergic reactions: in isolated cases - urticaria. Local reactions: often - swelling, allergic reactions, inflammation, pain in the area of drug administration, rarely - phlebitis at the infusion site. Other: rarely - asthenia, candidiasis, general discomfort, chest pain; in some cases - pain in the pelvis, swelling of the face, back pain, abnormal laboratory tests, pain in the legs.

Use of the drug Moxifloxacin

Take 400 mg orally, regardless of food intake, once a day for 5–10 days. The IV drug is prescribed at a dose of 400 mg once a day. The duration of treatment depends on the indications for use and is: for chronic bronchitis in the acute phase - 5 days, for community-acquired pneumonia - 10 days, for acute sinusitis - 7 days, for infections of the skin and soft tissues - 7 days. Moxifloxacin can be used intravenously throughout the entire course of treatment. It is possible to use it in the form of a solution for infusion at the initial stages of treatment, followed by a transition to taking moxifloxacin orally. The solution for infusion should be administered intravenously slowly over 60 minutes.

Drug interactions Moxifloxacin

With the simultaneous use of moxifloxacin and GCS, the risk of developing tendovaginitis or tendon rupture increases. There was no interaction of moxifloxacin with probenecid, warfarin, or oral contraceptives. No clinically significant interaction has been established between moxifloxacin and glibenclamide. Moxifloxacin slightly changes the pharmacokinetic parameters of digoxin. When used concomitantly, moxifloxacin does not affect the pharmacokinetics of theophylline. With parenteral use of morphine and moxifloxacin, there is no decrease in the bioavailability of the latter. Moxifloxacin infusion solution is incompatible with the following infusion solutions: sodium chloride 10%, sodium chloride 20%, sodium bicarbonate 4.2%, sodium bicarbonate 8.4%.