Avelox infusion solution 1.6 mg / ml 250 ml 4 pcs. (Moxifloxacin)

Latin name

AVELOX

Release form

The solution for infusion is transparent, yellow or yellow with a greenish color.

Pharmacological action of

Antimicrobial, fluoroquinolone

Indications

Infectious and inflammatory diseases in adults caused by microorganisms sensitive to the drug:

- acute sinusitis

- exacerbation of chronic bronchitis

- community-acquired pneumonia (including those caused by microorganism strains with multiple infection) skin and soft tissue

- complicated infections of the skin and subcutaneous structures (including infected diabetic foot)

- complicated intra-abdominal infections, including polymicrobial and fektsii, including

intraperitoneal abscesses - uncomplicated inflammatory diseases of the pelvic organs (including salpingitis and endometritis).

* - Streptococcus pneumoniae with multiple antibiotic resistance include penicillin-resistant strains and strains resistant to two or more antibiotics from groups such as penicillins (with MIC 2 mg / ml), II generation cephalosporins (cefuroxime), macrolides, tetracyclines and trimethoprim / sulfamethoxazole.

It is necessary to take into account the current official guidelines on the rules for the use of antibacterial agents.

Contraindications

- history of tendon pathology developed as a result of treatment with

quinolone antibiotic series - preclinical and clinical studies after the administration of moxifloxacin showed a change in cardiac electrophysiological parameters, expressed in lengthening of the QT interval. Concerning, the use of moxifloxacin is contraindicated in patients of the following categories: congenital or acquired documented prolongation of the QT interval, electrolyte disturbances, especially uncorrected hypokalemia, clinically significant bradycardia, clinically significant heart failure with a reduced left ventricular ejection fraction, history of rhythm disturbances accompanied by clinical symptoms cannot be used other drugs that extend the QT interval

- due to the presence in ve lactose drug, its reception is contraindicated in congenital lactose intolerance, lactase deficiency, glucose-galactose malabsorption (for tablets)

- due to the limited amount of clinical data, the use of moxifloxacin is contraindicated in patients with impaired liver function (Child Pugh class C classification) and in patients with an increase in transaminases more than 5 times higher than

VGN - pregnancy

- lactation (breastfeeding)

- under the age of 18 years

- hypersensitivity to moxifloxacin, other quinolones or any other component of the drug.

Use with caution in diseases of the central nervous system (including diseases suspicious of central nervous system involvement) predisposing to the occurrence of convulsive seizures and lowering the threshold for convulsive readiness in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia, especially in women and elderly patients with myasthenia gravis with liver cirrhosis while taking with potassium-lowering drugs.

Use during pregnancy and lactation

The safety of using moxifloxacin during pregnancy has not been established and its use is contraindicated. Cases of reversible joint damage in children receiving some quinolones are described, however, the manifestation of this effect in the fetus (when used by the mother during pregnancy) was not reported.

Reproductive toxicity has been shown in animal studies. The potential risk to humans is unknown.

Like other quinolones, moxifloxacin causes damage to the cartilage of large joints in premature animals. Preclinical studies have found that a small amount of moxifloxacin is excreted in breast milk. Data on its use in women during lactation are not available. Therefore, the appointment of moxifloxacin during breastfeeding is contraindicated.

Special instructions

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

With the use of AveloxВ®, some patients may experience longer QT intervals.

AveloxВ® should be used with caution in women and elderly patients. Because women have a longer QT interval compared to men, they may be more sensitive to drugs that extend the QT interval. Elderly patients are also more susceptible to drugs that affect the QT interval.

The degree of lengthening of the QT interval may increase with increasing concentration of the drug, so the recommended dose should not be exceeded. Lengthening the QT interval is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia. However, in patients with pneumonia, a correlation between the concentration of moxifloxacin in the blood plasma and the prolongation of the QT interval was noted. None of the 9,000 patients treated with AveloxВ® had cardiovascular complications or fatal cases. associated with prolongation of the QT interval.

When using AveloxВ®, the risk of ventricular arrhythmias in patients with conditions predisposing to arrhythmias may increase.

In this regard, AvelloxВ® is contraindicated in:

- for patients with established QT interval extension

- for patients with uncorrected hypokalemia

- for patients with conditions predisposing to arrhythmias, such as clinically significant bradycardia.

AveloxВ® should be used with caution:

- in patients with potentially proarrhythmic conditions, such as acute myocardial ischemia

- in patients with cirrhosis (since in this category of patients the risk of developing an extended QT interval cannot be ruled out).

When taking AveloxВ®, cases of fulminant hepatitis have been reported, potentially leading to liver failure (including fatal cases). The patient should be informed that in case of symptoms of liver failure, it is necessary to consult a doctor before continuing treatment with AveloxВ®.

When taking AveloxВ®, cases of the development of bullous skin lesions (such as Stevens-Johnson syndrome or toxic epidermal necrolysis) have been reported. The patient should be informed that in case of symptoms of skin or mucous membrane lesions, it is necessary to consult a doctor before continuing treatment with AveloxВ®.

The use of quinolone preparations is associated with a possible risk of seizures. AveloxВ® should be used with caution in patients with central nervous system diseases and disorders of the central nervous system, predisposing to the occurrence of seizures or lowering the threshold of convulsive activity.

The use of broad-spectrum antibacterial drugs, including AveloxВ®, is associated with a risk of developing pseudomembranous colitis associated with taking antibiotics. This diagnosis should be borne in mind in patients who develop severe diarrhea during treatment with AveloxВ®. In this case, appropriate therapy should be prescribed immediately. Drugs that inhibit intestinal motility are contraindicated in the development of severe diarrhea.

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

On the background of quinolone therapy, including moxifloxacin, the development of tendonitis and tendon rupture is possible, especially in the elderly and patients receiving corticosteroids. The cases described which occurred within a few months after completion of treatment. At the first symptoms of pain or inflammation at the site of damage, the drug should be stopped and the affected limb unloaded.

When using quinolones, photosensitivity reactions are noted. However, during preclinical and clinical studies, as well as when using AveloxВ®, no photosensitivity reactions were observed in practice. However, patients receiving AveloxВ® should avoid exposure to direct sunlight and ultraviolet light.

The use of the drug in the form of tablets for oral administration is not recommended in patients with complicated inflammatory diseases of the pelvic organs (for example, associated with tubo-ovarian or pelvic abscesses).

Moxifloxacin is not recommended for the treatment of infections, caused by strains of Staphylococcus aureus resistant to methicillin. In case of suspected or confirmed infections caused by MRSA, treatment with appropriate antibacterial drugs should be prescribed.

The ability of AveloxВ® to inhibit the growth of mycobacteria can cause the in vitro interaction of moxifloxacin with the test for Mycobacterium spp., leading to false negative results in the analysis of samples of patients who are treated with AveloxВ® during this period. In patients who have been treated with quinolones, including AveloxВ®, cases of sensory or sensorimotor polyneuropathy have been described, leading to paresthesias, hypesthesia, dysesthesia, or weakness. Patients who are treated with AveloxВ® warn about the need to immediately consult a doctor before continuing treatment in case of symptoms of neuropathy, including pain, burning, tingling, numbness or weakness.

Mental reactions can occur even after the first administration of fluoroquinolones, including moxifloxacin. In very rare cases, depression or psychotic reactions progress to suicidal thoughts and behavior, with a tendency to self-harm, including suicidal attempts. If such reactions develop in patients, AveloxВ® should be discontinued and necessary measures taken. Caution should be exercised when prescribing AveloxВ® to patients with psychoses and patients with a history of psychiatric diseases.

Due to the wide spread and growing incidence of infections, caused by Neisseria gonorrhoeae resistant to fluoroquinolones in the treatment of patients with inflammatory diseases of the pelvic organs, moxifloxacin monotherapy should not be carried out, unless the presence of N. gonorrhoeae resistant to fluoroquinolones is excluded. If it is not possible to exclude the presence of fluoroquinolone-resistant N. gonorrhoeae, it is necessary to decide on the addition of empirical therapy with moxifloxacin with an appropriate antibiotic that is active against N. gonorrhoeae (for example, cephalosporin).

Patients on a low-salt diet (for heart failure, renal failure, and nephrotic syndrome) should be aware that sodium chloride is contained in the infusion solution.

Influence on the ability to drive vehicles and control mechanisms

Fluoroquinolones, including moxifloxacin, may impair patients' ability to drive and engage in other potentially dangerous activities that require increased attention and speed of psychomotor reactions due to effects on the central nervous system and visual impairment.

Composition

1 vial. - moxifloxacin hydrochloride 436 mg, which corresponds to the content of moxifloxacin 400 mg

Excipients: sodium chloride - 2 g, sodium hydroxide solution 2N - 0-50 mg, hydrochloric acid 1N - 0-20 mg, water d / i - 248.659-248.664 g .

Dosage and administration

The drug is administered orally and iv 400 mg 1 time / day.

The duration of treatment with Avelox when administered orally and iv is determined by the severity of the infection and the clinical effect and is: with exacerbation of chronic bronchitis - 5-10 days with community-acquired pneumonia, the total duration of step therapy (iv with subsequent oral administration) - 7- 14 days first in / in, then inside, or 10 days inside for acute sinusitis and uncomplicated infections of the skin and soft tissues - 7 days for complicated infections of the skin and subcutaneous tissues, the total duration of step therapy (iv with subsequent oral administration) is 7-21 days for complicated intra-abdominal infections, the total duration of step therapy (iv administration of the drug with subsequent oral administration) is 5-14 days for uncomplicated inflammatory diseases of the pelvic organs - 14 days.

Avelox treatment can be as long as 21 days.

Dosage regimen changes in elderly patients not required.

The efficacy and safety of moxifloxacin in children and adolescents has not been established.

Patients with impaired liver function do not need to change the dosage regimen.

In patients with impaired renal function (including in severe renal failure with a CK? 30 ml / min / 1.73 m2), as well as in patients undergoing continuous hemodialysis and prolonged outpatient peritoneal dialysis, no dosage regimen changes are required .

In patients of different ethnic groups, changing the dosage regimen is not required.

Tablets should be taken without chewing, with a little water, regardless of the meal. Do not exceed recommended dose.

The solution for infusion should be administered iv for 60 minutes. The drug can be administered either in diluted or undiluted form using a T-adapter). Avelox solution is compatible with the following solutions: water for injection, sodium chloride solution 0.9%, sodium chloride solution 1M, dextrose solution 5%, dextrose solution 10%, dextrose solution 40%, xylitol solution 20%, ringer's solution, ringer-lactate solution.

Use only a clear solution.

After dilution with compatible solvents, Avelox solution remains stable for 24 hours at room temperature. Since the solution cannot be frozen or cooled, it cannot be stored in the refrigerator. Upon cooling, the solution may precipitate, but at room temperature the precipitate usually dissolves. The solution should be stored in its packaging.

If the solution for infusion is prescribed in conjunction with other drugs, then each drug should be administered separately.

Side effects of

Adverse reactions reported with moxifloxacin 400 mg (by mouth, with step-by-step therapy [intravenous administration of the drug followed by oral administration] and only intravenous obtained from clinical studies and post-marketing messages (in italics). Adverse reactions listed in the group often occurred with a frequency below 3%, with the exception of nausea and diarrhea.

In each frequency group, adverse drug reactions are listed in decreasing order of importance. Determination of the frequency of adverse reactions: often (from? 1/100 to <1/10), infrequently (from? 1/1000 to <1/100), rarely (from? 1/10000 to <1/1000), very rarely (<1/10 000).

Infections: fungal infections.

From the hemopoietic system: infrequently - anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, prolongation of prothrombin time and an increase in INR rarely - a change in the concentration of thromboplastin is very rare - an increase in the concentration of prothrombin and a decrease in INR.

From the side of the immune system: infrequently - allergic reactions, urticaria, pruritus, rash, eosinophilia rarely - anaphylactic / anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening), very rarely - anaphylactic / anaphylactoid shock (including life threatening).

From the side of metabolism: infrequently - hyperlipidemia rarely - hyperglycemia, hyperuricemia.

Mental disorders: infrequently - anxiety, psychomotor hyperreactivity, agitation rarely - emotional lability, depression (in very rare cases, behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts, is possible), hallucinations are very rare - depersonalization, psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts).

On the part of the nervous system: often - dizziness, headache infrequently - paresthesia, dysesthesia, impaired taste (including very rare cases of agovesia), confusion, disorientation, sleep disturbances, tremor, vertigo, drowsiness rarely - hypesthesia, impaired smell ( including anosmia), atypical dreams, impaired coordination (including impaired gait due to dizziness or vertigo, in very rare cases leading to injuries from a fall, especially in elderly patients), convulsions with various clinical manifestations (including grand mal seizures), impaired attention, speech impairment, amnesia, peripheral neuropathy, polyneuropathy very rarely - hyperesthesia.

From the side of the organ of vision: infrequently - visual impairment (especially with reactions from the central nervous system) very rarely - transient loss of vision (especially with reactions from the central nervous system).

On the part of the hearing organ: rarely - tinnitus, hearing impairment, including deafness (usually reversible).

From the cardiovascular system: often - prolongation of the QT interval in patients with concomitant hypokalemia infrequently - prolongation of the QT interval, sensation of palpitations, tachycardia, vasodilation rarely - increased blood pressure, decreased blood pressure, fainting, ventricular tachyarrhythmias very rarely - non-specific arrhythmias, polymorphic ventricular tachycardia (such as pirouette), cardiac arrest (mainly in individuals with conditions predisposing to arrhythmias, such as clinically significant bradycardia, acute myocardial ischemia).

From the respiratory system: infrequently - shortness of breath, including asthma.

From the digestive system: often - nausea, vomiting, abdominal pain, diarrhea infrequently - decreased appetite and reduced food intake, constipation, dyspepsia, flatulence, gastroenteritis (except for erosive gastroenteritis), increased amylase activity rarely - dysphagia, stomatitis, pseudomembranous (in very rare cases, associated with life-threatening complications).

From the side of the liver and biliary tract: often - increased activity of hepatic transaminases infrequently - impaired liver function (including increased activity of LDH), an increase in the concentration of bilirubin, an increase in the activity of GGT and alkaline phosphatase is rare - jaundice, hepatitis (mainly cholestatic) is very rare - fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases).

From the skin: very rarely - bullous skin reactions, for example, Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening).

From the musculoskeletal system: infrequently - arthralgia, myalgia rarely - tendonitis, increased muscle tone and cramps, muscle weakness very rarely - arthritis, tendon ruptures, impaired gait due to damage to the musculoskeletal system, increased symptoms of myasthenia gravis.

From the urinary system: infrequently - dehydration (caused by diarrhea or decreased fluid intake) rarely - impaired renal function, renal failure due to dehydration, which can lead to kidney damage, especially in elderly patients with preexisting renal impairment).

On the part of the body as a whole: infrequently - general malaise, nonspecific pain, sweating.

Local reactions: often - reactions at the injection / infusion site infrequently - phlebitis / thrombophlebitis at the infusion site.

The incidence of the following adverse reactions was higher in the group receiving step therapy: often - increased GGT activity infrequently - ventricular tachyarrhythmias, hypotension, edema, pseudomembranous colitis (in very rare cases associated with life-threatening complications), convulsions with various clinical manifestations (including grand mal seizures), hallucinations, impaired renal function, renal failure (as a result of dehydration, which can lead to kidney damage, especially in elderly patients with preexisting renal impairment).

Drug Interactions

Dose adjustment is not required when Avelox® is used together with atenolol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecinomecinomecinecene (no probenecinomecenicene).

The possible additive effect of the prolongation of the QT interval of moxifloxacin and other drugs that affect the prolongation of the QT interval should be considered. Due to the combined use of moxifloxacin and drugs that affect the prolongation of the QT interval, the risk of developing ventricular arrhythmias, including polymorphic ventricular tachycardia of the pirouette type, increases. The combined use of moxifloxacin with the following drugs that affect the prolongation of the QT interval is contraindicated: class IA antiarrhythmic drugs (including quinidine, hydroquinidine, disopyramide) class III antiarrhythmic drugs (including amiodarone, sotalol, dofetilide, ibutilide) antipsychotics ( including phenothiazine, pimozide, sertindole, haloperidol, sultoprid) tricyclic antidepressants antimicrobials (sparfloxacin, iv erythromycin, pentamidine, antimalarials, especially halofantrine) antihistamines ( erfenadin, astemizole, mizolastine) others (cisapride, vincamine w / w), bepridil, difemanil.

The ingestion of Avelox® and antacids, multivitamins and minerals may interfere with the absorption of moxifloxacin due to the formation of chelate complexes with polyvalent cations contained in these preparations. As a result, the concentration of moxifloxacin in blood plasma can be significantly lower than therapeutic. In this regard, antacid, antiretroviral (e.g. didanosine) and other drugs containing calcium, magnesium, aluminum, iron, sucralfate, zinc should be taken at least 4 hours before or 4 hours after ingestion of Avelox.

With the combined use of Avelox with warfarin, the prothrombin time and other parameters of blood coagulation do not change.

In patients receiving anticoagulants in combination with antibiotics, including with moxifloxacin, there are cases of increased anticoagulant activity of anticoagulant drugs. Risk factors are the presence of an infectious disease (and a concomitant inflammatory process), the age and general condition of the patient. Despite the fact that the interaction between moxifloxacin and warfarin is not detected, in patients receiving combined treatment with these drugs, it is necessary to monitor INR and, if necessary, adjust the dose of indirect anticoagulants.

Moxifloxacin and digoxin do not significantly affect each other's pharmacokinetic parameters. With repeated administration of moxifloxacin, Cmax digoxin increased by approximately 30%. In this case, the ratio of AUC and Cmin digoxin does not change.

With the simultaneous use of activated carbon and moxifloxacin inside at a dose of 400 mg, the systemic bioavailability of the drug decreases by more than 80% as a result of a slowdown in its absorption. In case of overdose, the use of activated carbon at an early stage of absorption prevents a further increase in systemic exposure.

In the case of iv administration with the simultaneous oral administration of activated carbon, the systemic bioavailability of the drug slightly decreases (approximately 20%) due to the adsorption of moxifloxacin in the lumen of the gastrointestinal tract during enterohepatic circulation.

Absorption of moxifloxacin does not change while eating (including dairy products). Moxifloxacin can be taken without regard to meals.

Incompatibility

The moxifloxacin infusion solution cannot be administered simultaneously with the following drugs: sodium chloride solution 10%, sodium chloride solution 20%, sodium bicarbonate solution 4.2%, sodium bicarbonate solution 8.4%.



overdose There is limited data on an overdose of moxifloxacin. No side effects were observed with Avelox up to 1200 mg once and 600 mg for 10 days or more.

Treatment: In case of overdose, symptomatic and supportive therapy with ECG monitoring is performed according to the clinical situation.

The use of activated charcoal immediately after oral administration of the drug may help prevent excessive systemic effects of moxifloxacin in cases of overdose.

Storage Conditions

The infusion solution should be stored out of the reach of children at 15 ° C to 30 ° C.

shelf life

5 years

Active substance

Moxifloxacin

Terms and conditions

prescription

dosage form

infusion solution

Appointment

Appointment

Adults doctor's prescription

Plant Medsintez, Russia



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