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Moxifloxacin – Teva 400 mg 250 ml

$50.00

Moxifloxacin is an 8-methoxyfluoroquinolone agent with a broad spectrum of bactericidal action. In vitro, moxifloxacin is effective against many gram-positive and gram-negative microorganisms. It has been established that moxifloxacin is effective against bacteria resistant to β-lactam and macrolide drugs. The bactericidal action of moxifloxacin is caused by the inhibition of both types of topoisomerase II (DNA gyrase and topoisomerase IV), which are necessary for replication, transcription and repair of bacterial DNA.
Moxifloxacin has concentration-dependent bactericidal activity. Minimum bactericidal concentrations (MBC) usually correspond to minimum inhibitory concentrations (MICs).

Description

Buy Moxifloxacin – Teva  400 mg 250 ml solution for infusion

Description of Moxifloxacin – Teva 400 mg 250 ml:

This medical product from the manufacturer Teva the main active ingredient of which is moxifloxacin, is sensitive to a variety of gram-positive and gram-negative microorganisms that enter the human body.

This is an infusion solution. It has a dosage of 250 ml. Externally, such a solution is transparent greenish-yellow, without foreign impurities.

Ingredients:

Active substance: moxifloxacin;
1 bottle (250 ml of solution) contains moxifloxacin 400 mg in the form of moxifloxacin hydrochloride anhydrous;
Excipients: propylene glycol, water for injections.

Pharmacologial Properties of Moxifloxacin – Teva 400 mg 250 ml:

After entering the body, Moxifloxacin inhibits pathogens and atypical anaerobes. It provokes a violation of the process of reproduction of microbes and the synthesis of their DNA. This, in turn, leads to the rapid death of dangerous microorganisms and the restoration of the general condition of the patient.

Microbiological sensitivity:
Usually sensitive types of microorganisms:

1. Aerobic gram-positive microorganisms: Staphylococcus aureus*, Streptococcus agalactiae (group B), Streptococcus milleri group* (S. anginosus, S. constellatus та S. intermedius), Streptococcus pneumoniae*, Streptococcus pyogenes* (group A), Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus).

2. Aerobic gram-negative microorganisms: Acinetobacter baumanii, Haemophilus influenzae*, Legionella pneumophila, Moraxella (Branhamella) catarrhalis*.

3. Anaerobic microorganisms: Prevotella spp.

4. Other microorganisms: Chlamydophila (Chlamydia) pneumoniae*, Coxiella burnetii, Mycoplasma pneumoniae*.

*Effectiveness sufficiently demonstrated in clinical studies.

Indications for use Moxifloxacin – Teva 400 mg 250 ml:

1. Community-acquired pneumonia, including community-acquired pneumonia, the causative agents of which are strains of microorganisms with multiple antibiotic resistance *;

2. Complicated infections of the skin and soft tissues (including an infected diabetic foot);

3. Complicated intra-abdominal infections, including polymicrobial infections (including intraperitoneal abscesses).

4. *Multiple antibiotic-resistant Streptococcus pneumoniae includes penicillin-resistant strains and strains resistant to two or more antibiotics from groups such as penicillins (minimum inhibitory activity ≥2 mg/mL), second-generation cephalosporins (cefuroxime), macrolides, tetracyclines and trimethoprim / sulfamethoxazole.

Contraindications for use Moxifloxacin – Teva 400 mg 250 ml:

  • Hypersensitivity to moxifloxacin, other antibiotics of the quinolone group or any of the excipients of the drug
  • Children’s age (up to 18 years)
  • The period of pregnancy or breastfeeding (see the section “Use during pregnancy or breastfeeding”).
  • A history of tendon disease/pathology associated with the use of quinolones.

.In preclinical and clinical studies, after the use of moxifloxacin, changes in the electrophysiology of the heart, manifested by prolongation of the QT interval, were detected. Therefore, moxifloxacin is contraindicated in patients with the following conditions:

  • congenital or acquired prolongation of the QT interval;
  • electrolyte imbalance, especially uncorrected hypokalemia;
  • clinically significant bradycardia;
  • clinically significant heart failure with a decrease in the ejection fraction of the left ventricle;
    symptomatic arrhythmia in the anamnesis.

Moxifloxacin cannot be used simultaneously with drugs that prolong the QT interval (see also the section “Interaction with other drugs and other types of interactions”).
Due to insufficient clinical experience, the drug is contraindicated in patients with impaired liver function (class C according to the Child-Pugh scale) and an increase in transaminase levels five times or higher.

Overdose:

There are limited data on overdose of moxifloxacin. No side effects were noted when using Avelox at a dose of up to 1200 mg once and 600 mg for 10 days or more.
Treatment: in case of overdose, according to the clinical situation, symptomatic and supportive therapy with ECG monitoring is carried out.
The use of activated charcoal immediately after oral administration of the drug may help prevent excessive systemic exposure to moxifloxacin in cases of overdose.

Side effects:

Adverse reactions observed in clinical trials and in the post-marketing period with the use of moxifloxacin at a dose of 400 mg per day (intravenous therapy only, stepwise [intravenous / oral] and oral).

  • Infections: often – fungal superinfections.
  • On the part of the hematopoietic system: infrequently – anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, prolongation of prothrombin time / increase in INR; rarely – a change in the concentration of thromboplastin; very rarely – an increase in the concentration of prothrombin / a decrease in INR.
  • From the side of the immune system: infrequently – allergic reactions, urticaria, itching, rash, eosinophilia; rarely – anaphylactic / anaphylactoid reactions, angioedema, including laryngeal edema (potentially life-threatening); very rarely – anaphylactic / anaphylactoid shock (including potentially life-threatening).
  • From the side of metabolism: infrequently – hyperlipidemia; rarely – hyperglycemia, hyperuricemia; very rarely – hypoglycemia.
  • Mental disorders: infrequently – anxiety, psychomotor hyperreactivity, agitation; rarely – emotional lability, depression (in very rare cases, behavior with a tendency to self-harm is possible, such as suicidal thoughts or suicidal attempts), hallucinations; very rarely – depersonalization, psychotic reactions (potentially manifested in behavior with a tendency to self-harm, such as suicidal thoughts or suicidal attempts).
  • From the nervous system: often – dizziness, headache; infrequently – paresthesia, dysesthesia, taste disturbances (including in very rare cases ageusia), confusion, disorientation, sleep disturbances, tremor, vertigo, drowsiness; rarely – hypoesthesia, impaired sense of smell (including anosmia), atypical dreams, impaired coordination (including gait disturbance due to dizziness or vertigo, in very rare cases leading to injuries due to falls, especially in elderly patients), convulsions with various clinical manifestations (including .h “grand mal” seizures), attention disorders, speech disorders, amnesia, peripheral neuropathy, polyneuropathy; very rarely – hyperesthesia.
  • On the part 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 organ of hearing: rarely – tinnitus, hearing impairment, including deafness (usually reversible).
  • From the side of the cardiovascular system: often – prolongation of the QT interval in patients with concomitant hypokalemia; infrequently – prolongation of the QT interval, palpitations, tachycardia, vasodilation; rarely – increased blood pressure, decreased blood pressure, fainting, ventricular tachyarrhythmias; very rarely – nonspecific arrhythmias, polymorphic ventricular tachycardia (pirouette type), 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 an asthmatic condition.
  • From the digestive system: often – nausea, vomiting, abdominal pain, diarrhea; infrequently – reduced appetite and reduced food intake, constipation, dyspepsia, flatulence, gastroenteritis (except erosive gastroenteritis), increased amylase activity; rarely – dysphagia, stomatitis, pseudomembranous colitis (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 – abnormal liver function (including increased LDH activity), increased bilirubin concentration, increased activity of GGT and alkaline phosphatase; rarely – jaundice, hepatitis (mainly cholestatic); very rarely – fulminant hepatitis, potentially leading to life-threatening liver failure (including fatal cases).
  • On the part of 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 – tendinitis, increased muscle tone and cramps, muscle weakness; very rarely – arthritis, tendon ruptures, gait disturbance 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 as a result of dehydration, which can lead to kidney damage, especially in elderly patients with pre-existing impaired renal function).
  • On the part of the body as a whole: often – reactions at the injection / infusion site; infrequently – general malaise, nonspecific pain, sweating.

The frequency of development of the following adverse reactions was higher in the group receiving stepwise therapy: often – an increase in GGT activity; infrequently – ventricular tachyarrhythmias, arterial 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 pre-existing impaired renal function).

Precautions of Moxifloxacin – Teva 400 mg 250 ml:

One bottle of the medicine is intended for single use only. Unused solution must be disposed of.
The following solutions have been found to be compatible with moxifloxacin, solution for infusion 400 mg: water for injections; 0.9% sodium chloride solution; 1-molar sodium chloride solution; glucose solution 5%, 10%, 40%; xylitol solution 20%; Ringer’s solution; complex solutions of sodium lactate (Hartmann’s solution, Ringer’s lactate solution).
Moxifloxacin infusion solution should not be administered simultaneously with other medicinal products.
The drug should not be used in the presence of visible solid impurities or in the case of cloudiness of the solution.
When stored in a cool place, precipitation may occur, which dissolves at room temperature. Therefore, it is not recommended to store the infusion solution below 15 °C.

Incompatibility

Moxifloxacin infusion solution cannot be administered simultaneously with incompatible solutions, which include: 10% sodium chloride solution; 20% sodium chloride solution; sodium bicarbonate solution 4.2%; 8.4% sodium bicarbonate solution.

Storage:

The medicinal product does not require special storage conditions. Keep out of the reach of children.

Shelf life:

5 year.

Before using the drug, be sure to consult your doctor.

Dosage and administration

Dosage

The drug is administered intravenously as a continuous infusion lasting at least 60 minutes.

If indicated, the solution for infusion can be administered through a T-shaped catheter along with compatible infusion solutions.

Impaired kidney/liver function

Patients with mild to severe renal impairment and patients on chronic dialysis, such as those undergoing hemodialysis and long-term ambulatory peritoneal dialysis, do not require dose adjustment.

Regarding patients with impaired liver function, there is not enough information.

Other special patient groups

Elderly patients and patients with reduced body weight do not need dose adjustment.

Children.

Due to the negative effect on the cartilage of young animals (see section “Pharmacological properties”), the use of moxifloxacin in children (under 18 years of age) is contraindicated.

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

Application Features

The use of moxifloxacin should be avoided in patients who have experienced serious adverse reactions with quinolones or fluoroquinolones in the past. Treatment of these patients with moxifloxacin should only be started if no alternative treatment options are available and after a careful benefit-risk assessment.

The benefits of moxifloxacin treatment, especially for non-severe infections, need to be evaluated.

Prolonged, disabling and potentially irreversible serious adverse drug reactions

Very rare cases of prolonged (months or years), disabling and potentially irreversible serious adverse drug reactions affecting various, sometimes several, body systems have been observed in patients treated with quinolones and fluoroquinolones, regardless of their age and the presence of risk factors. (musculoskeletal, nervous systems, psyche, sense organs).

Moxifloxacin should be used with caution in patients with conditions that contribute to the development of arrhythmias (for example, acute myocardial ischemia), since such patients are at increased risk of ventricular arrhythmia (including polymorphic ventricular torsade de pointes) and cardiac arrest. Moxifloxacin should be used with caution in patients taking medicinal products that may decrease potassium levels.

Moxifloxacin should be used with caution in patients receiving medicinal products associated with clinically significant bradycardia.

Women and elderly patients may be more sensitive to the effects of drugs that prolong the QTc interval, such as moxifloxacin, so these patients require special attention.

Aortic aneurysm and dissection (dissection), regurgitation/failure of heart valves

Epidemiological studies indicate an increased risk of aortic aneurysm and dissection, especially in elderly patients, and aortic and mitral valve regurgitation after the use of fluoroquinolones.

Therefore, fluoroquinolones should only be used after a careful benefit/risk assessment and after consideration of other possible treatment options in patients with a family history of aneurysm or congenital valvular disease, or in patients with an already diagnosed aneurysm and/or aortic dissection, or heart disease. or if there are other risk factors or favorable conditions:

as for aortic aneurysm and dissection, as well as for regurgitation/failure of the heart valve (for example, connective tissue disorders such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, Behcet’s disease, hypertension, rheumatoid arthritis) or additionally,
with aneurysm and dissection of the aorta (for example, vascular disorders such as Takayasu’s arteritis or giant cell arteritis, or diagnosed atherosclerosis, or Sjögren’s syndrome) or additionally,
with regurgitation / insufficiency of the heart valve (for example, infective endocarditis).

The risk of aneurysm and aortic dissection and their rupture may be increased in patients receiving concomitant systemic corticosteroids.

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

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

Hypersensitivity/allergic reactions

Hypersensitivity and allergic reactions have been reported after the first use of fluoroquinolones, including moxifloxacin. Anaphylactic reactions can take the form of life-threatening shock even after the first use of the drug. In cases of clinical manifestations of severe hypersensitivity reactions, it is necessary to stop the use of moxifloxacin and start appropriate treatment (for example, shock therapy).

Severe liver dysfunction

When using moxifloxacin, cases of fulminant hepatitis have been reported, which can lead to the development of liver failure, in particular, with a fatal outcome. In the event of symptoms of fulminant hepatitis, such as rapidly developing asthenia accompanied by jaundice, dark urine, bleeding tendency or hepatic encephalopathy, patients are advised to consult a doctor before continuing treatment.

If there are signs of liver dysfunction, a liver function test should be performed.

Severe adverse skin reactions

During the use of moxifloxacin, cases of severe skin adverse reactions such as Stevens-Johnson syndrome (SSD), toxic epidermal necrolysis (TEN or Lyell’s syndrome), acute generalized exanthematous pustulosis (AGEP), which can be life-threatening, have been reported. h. lethal (see section “Adverse reactions”). Patients should be informed about the signs and symptoms of severe skin adverse reactions and carefully monitored for their condition when using the drug.

If signs and symptoms suggestive of severe skin reactions develop, moxifloxacin should be discontinued immediately and alternative treatment options considered. If a patient has experienced a serious reaction (SSc, TEN, or AGEP) while taking moxifloxacin, treatment with moxifloxacin should not be restarted.

Patients prone to seizures

Quinolones are known to cause seizures. They should be used with caution in patients with CNS disorders or other risk factors that may induce seizures or lower the seizure threshold. If seizures occur, moxifloxacin should be discontinued and appropriate measures taken.

Peripheral neuropathy

Sensory or sensorimotor polyneuropathy has been reported in patients treated with quinolones and fluoroquinolones, including moxifloxacin, resulting in paresthesia, hypesthesia, dysesthesia, or weakness. Patients using moxifloxacin are advised to report the development of symptoms of neuropathy such as pain, burning, tingling, numbness or weakness to their doctor before continuing treatment, in order to prevent the development of a potentially irreversible condition.

Reactions from the psyche

Mental reactions may occur even after the first use of fluoroquinolones, including moxifloxacin. In rare cases, depression or mental reactions have progressed to the development of suicidal thoughts and manifestations of self-injury, such as suicide attempts. If the patient develops such reactions, treatment with moxifloxacin should be discontinued and appropriate measures taken. Caution should be exercised when prescribing moxifloxacin to patients with a history of or current mental illness.

Diarrhea associated with antibiotic use, including colitis

Cases of antibiotic-associated diarrhea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhea, have been observed in association with the use of broad-spectrum antibiotics, including. The severity of these phenomena can range from mild diarrhea to fatal colitis. Therefore, it is important to consider the possibility of such a diagnosis in patients who develop severe diarrhea during or after the use of moxifloxacin. In the event of suspected or confirmed AAD or AAK, treatment with antimicrobial agents, including moxifloxacin, should be discontinued and appropriate therapeutic measures initiated immediately. In addition, it is necessary to take appropriate measures aimed at controlling the infection in order to reduce the risk of its transmission. Patients who develop severe diarrhea are contraindicated in drugs that suppress peristalsis.

Patients with severe myasthenia gravis

Moxifloxacin should be used with caution in patients with severe myasthenia gravis (Myasthenia gravis), as its symptoms may worsen.

Tendinitis and tendon rupture

Tendinitis and rupture of the tendon (especially but not limited to the Achilles tendon), sometimes bilateral, can occur with quinolones and fluoroquinolones as early as 48 hours from the start of treatment. It was also reported about such cases, which were observed a few months after the cessation of treatment. The risk of tendinitis and tendon rupture is increased in elderly patients, patients with impaired renal function, patients after solid organ transplantation, and patients receiving concomitant treatment with corticosteroids. Therefore, concomitant corticosteroid therapy should be avoided.

At the onset of the first symptoms of tendinitis (eg, painful swelling, inflammation), treatment with moxifloxacin should be discontinued and alternative treatment should be considered. Appropriate treatment of the affected limb (eg, immobilization) should be provided. Corticosteroids should not be used if signs of tendinopathy appear.

Patients with impaired renal function

Elderly patients with kidney problems should be given moxifloxacin with caution if they are unable to maintain adequate fluid volume in the body, since dehydration increases the risk of kidney failure.

From the organs of vision

In case of deterioration of vision or any effect on the organs of vision, you should immediately seek advice from an ophthalmologist.

Dysglycemia

As with all fluoroquinolones, abnormal blood glucose levels, both hypoglycemia and hyperglycemia, have been reported during treatment with moxifloxacin. Dysglycemia has developed predominantly in elderly patients with diabetes who received oral hypoglycemic agents (eg, sulfonylurea) or insulin concomitantly with treatment with moxifloxacin. Cases of hypoglycemic coma have been reported. Patients with diabetes are advised to carefully monitor their blood glucose levels.

Prevention of photosensitivity reactions

When using quinolones, photosensitivity reactions were recorded in patients. According to studies, when using moxifloxacin, the risk of inducing photosensitivity reactions was low. However, patients should avoid exposure to prolonged and/or intense sunlight or ultraviolet exposure during treatment with moxifloxacin.

Patients with glucose-6-phosphate dehydrogenase deficiency

Patients with insufficiency of glucose-6-phosphate dehydrogenase activity, as well as patients who have this pathology in a related history, are prone to the development of hemolytic reactions during treatment with quinolones. Thus, moxifloxacin should be used with caution in this category of patients.

Inflammation of tissues in the periarterial area

Moxifloxacin, solution for infusion, is for intravenous use only. Intra-arterial administration should be avoided, since in preclinical studies with this method of administration, inflammation of the tissues in the peri-arterial area was observed.

Patients with specific complicated infections of the skin and subcutaneous tissue.

The clinical efficacy of moxifloxacin in the treatment of severe burn infections, fasciitis, and infected “diabetic foot” associated with osteomyelitis has not been established.

Impact on biological tests

Moxifloxacin may interfere with test results for the presence of Mycobacterium spp. by inhibiting mycobacterial growth, which, in turn, can lead to false negative results in patients taking moxifloxacin.

Patients with methicillin-resistant Staphylococcus aureus (MRSA) infections

Moxifloxacin is not recommended for the treatment of infections caused by methicillin-resistant Staphylococcus aureus (MRSA). If MRSA infection is suspected or confirmed, treatment with an appropriate antibacterial should be started.

Use during pregnancy or lactation.

Pregnancy

The safety of moxifloxacin during pregnancy in humans has not been studied. Animal studies indicate reproductive toxicity. The potential risk to humans has not been established. Given the experimentally established risk of harmful effects of fluoroquinolones on the cartilage bearing the main load in mature animals, and given the development of reversible joint damage in children treated with certain fluoroquinolones, moxifloxacin should not be prescribed to pregnant women.

Lactation

There are no data on the use of the drug during breastfeeding in women. The results of preclinical studies indicate that a small amount of moxifloxacin passes into breast milk. Due to the lack of data on the effect on nursing infants and given the experimental risk of harmful effects of fluoroquinolone on the cartilage of mature animals that carry the main load, breast-feeding is contraindicated during treatment with moxifloxacin.

Fertility

Animal studies had no effect on fertility.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

Studies of the effect of moxifloxacin on the ability to drive vehicles and work with mechanisms have not been conducted. However, fluoroquinolones, including moxifloxacin, can affect the reaction rate when driving motor vehicles or working with other mechanisms, causing reactions from the central nervous system (for example, dizziness, acute temporary loss of vision) or acute and short-term loss of consciousness (fainting). Patients are advised to test their response to moxifloxacin before driving or operating machinery.

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Additional information

Weight 350 g
Country/Region of Manufacture

Greece

Manufacturer

Pharmathen

Forms of release

Solution for injections

Volume/Weight

250 ml

Packing

Cardboard Box, Glass bottle

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