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Alev 10s 500 mg film-coated tablets

$27.10

64158612faf4
Brands:: Alkem (India)

Description

Trade name

of Alevo Mezhdunarodnoye the unlicensed

name Levofloxacin Dosage Form
of the Tablet, film coated 250 mg, 500 mg

Structure
One tablet contains
active agent – a levofloksatsin of the gemigidrat of 250 mg and 500 mg,
excipients: microcrystalline cellulose, starch, silicon dioxide kolloydny, talc, sodium of starch glikolit, magnesium stearate, instakoat Akwa III (IA-III 40521)

the Description
of the Tablet, barrel-shaped form, film coated, from risky on one party, light-peach color

Pharmacotherapeutic group
Antibacterial drugs for system use. Antimicrobial drugs – derivatives of a hinolon. Ftorkhinolona. Levofloxacin
the ATX J01MA12 Code

the Pharmacological

Pharmacokinetics Levofloxacin properties is quickly and almost completely soaked up at oral administration. The peak of concentration in plasma is usually reached in 1 – 2 hour after reception. The absolute bioavailability of a levofloksatsin is about 99%. Cmax after reception of 250 mg and 500 mg a day makes 2.8 and 5.7 mkg/ml respectively.
The maximum concentration of a levofloksatsin in a mucous membrane of bronchial tubes and liquid of an epithelial layer is reached in an hour after oral administration of drug in a dose of 500 mg and makes 8.3 mkg/g and 10.8 mkg/ml, respectively. Levofloxacin well gets into pulmonary fabric, reaching the maximum concentration in 4-6 hours after intake. After oral administration, levofloxacin is removed from plasma rather slowly. Elimination half-life of a levofloksatsin averages 6-8 hours. There are no essential differences in pharmacokinetics of a levofloksatsin after oral and intravenous introductions, both methods of administration are interchanged.
A pharmacodynamics
Levofloxacin – antibacterial, microbicide of a broad spectrum of activity from group of ftorkhinolon, active agent – levofloxacin – left-handed isomer of an ofloksatsin. The mechanism of action of Levofloksatsin consists in suppression of activity bacterial DNK-girazy and topoisomerases IV.
Levofloxacin is active concerning the majority of strains of microorganisms such as:
Aerobic gram-positive bacteria
of Staphylococcus aureus sensitive to Methicillinum, Staphylococcus saprophyticus, Streptokokki group of C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes
Aerobic gram-negative bacteria
of Burkholderia cepacia, Eikenella corrodens, Haemophilus influenzae, Haemophilus para-influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Moraxella catarrhalis, Pasteurella multocida, Proteius vulgaris, Providencia rettgeri
Anaerobic bacteria
of Peptostreptococcus
Other
Chlamydophylia pneumoniae, Chlamydophylia psittaci, Chlamydia trachomatis, Legionella pneumophila, Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum
Microorganisms at which the acquired resistance
Aerobic gram-positive bacteria
of Enterococcus faecalis is possible, Staphylococcus aureus resistant to Methicillinum, Staphylococcus coagulase spp.
Aerobic gram-negative bacteria
of Acinetobacter baumannii, Citrobacter freundii, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Morganella morganii, Proteus mirabilis, Providencia stuartii, Pseudomonas aeruginosa, Serratia marcescens
Anaerobic bacteria
of Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotamicron, Bacteroides vulgatus, Clostridium difficile
In the hospital infections caused by Pseudomonas aeruginosa the combination therapy can be required.

The indications
of an infection of light and average severity caused by microorganisms, sensitive to a levofloksatsin:
– acute bacterial sinusitis
– chronic bronchitis during aggravation
– intrahospital pneumonia
– the complicated infections of urinary tract, including acute pyelonephritis
– infections of skin and soft tissues
– uncomplicated infections of urinary tract
– prostatitis

the Route of administration and
Alevo’s doses of a tablet of 250 mg or 500 mg accept inside one or two times a day. Doses are defined by character and weight of an infection and also sensitivity of the expected activator. The drug can be taken before food or between meals. It is necessary to observe strictly instructions for use as otherwise Alevo can cause inadequate effect. Patients with normal or moderately reduced function of kidneys (clearance of creatinine & gt, 80 ml/min.) can recommend the following mode of drug dosing:
– exacerbation of chronic bronchitis: on 250-500 mg once a day within
7-10 days
– a pnevomoniya: on 500 mg once a day within 7-14 days
– sinusitis: on 500 mg once a day within 10-14 days
– uncomplicated infections of urinary tract: 250 mg once a day within 3 days,
– the complicated infections of urinary tract: on 250 mg once a day within 7-10 days,
– chronic bacterial prostatitis: on 500 mg once a day for 28 days,
– acute pyelonephritis on 250 mg once a day within 7-10 days,
– in infections of skin and soft tissues on 250-500 mg 1-2 times a day inside within 7-10 days,
Levofloxacin is removed mainly through kidneys therefore at treatment of patients with impaired renal function it is required to reduce a drug dose.
The relevant information about it contains in the following table.

Clearance of creatinine

of 250 mg / 24 hour

of 500 mg / 24 hour

of 500 mg / 12 hour

the first dose: 250 mg

the first dose: 500 mg

the first dose: 500

mg 50-80 ml/min.

then: on 125 mg / 24 hour

then: 250 mg / 24 hour

then: 250 mg / 12 hour

of 10-19 ml/min.

then: on 125 mg / 48 hour

then: 125 mg / 24 hour

then: 125 mg / 12 hour

& lt, 10 ml/min. (including a hemodialysis and PAPD *

then: on 125 mg / 48 hour

then: 125 mg / 24 hour

then: 125 mg / 24
* after a hemodialysis or the continuous out-patient peritoneal dialysis (COPPD) are not required hour introductions additional dosed
the Pill it is necessary to take without chewing and to wash down with 1 glass of water.

Side effects
Often
– candidiasis
– a headache, dizziness, insomnia, irritability
– an asthma, a bronchospasm
– nausea, diarrhea, a constipation, an abdominal pain, vomiting, dyspepsia, a meteorism
– rash, an itching
– a vaginitis
– breast, back and extremities pain
it is rare
– anemia, thrombocytopenia, a pancytopenia, a neutropenia
– a hyperglycemia, a hypoglycemia, a hyperpotassemia
– excitement, confusion of consciousness, a depression, hallucinations, a sleep disorder, anorexia, a tremor, a depression, agitation, a psychotic state
– a tremor, spasms, paresthesias, dizziness, a hypertension, drowsiness, a syncope, the general weakness
– heartbeat, tachycardia, arrhythmia, lengthening of an interval of QT, vascular collapse
– gastritis, stomatitis, pancreatitis, an esophagitis, a gastroenteritis, a glossitis, pseudomembranous colitis, diarrhea with blood impurity
– increase in level of liver enzymes, increase bilious phosphotazy, jaundice
– a tendinitis, an arthralgia, myalgia, skeletal pains, a rupture of sinews, a rhabdomyolysis
– a renal failure, an acute renal failure, interstitial nephrite
– Stephens-Johnson’s syndrome, a Lyell’s disease, pseudomembranous colitis, a vasculitis, a toxic epidermal necrolysis, a mnogoformny erythema, a hyperhidrosis
– extrapyramidal symptoms and other disturbances of muscular coordination
– an agranulocytosis
Very seldom
– a Quincke’s edema, an acute anaphylaxis, anaphylactoid reactions can develop after reception of the first dose, the photosensitization, an allergic pneumonitis, fever
– a hypoglycemia, in particular at patients with diabetes
– disorder of vision and hearing
– loss of flavoring feelings
– disturbance of sense of smell before its total loss
– hepatitis, liver necrosis cases, an acute liver failure
– touch and sensomotor peripheral neuropathy
– mental reactions with autoaggressive behavior, including with suicide thoughts and actions

of the Contraindication
– hypersensitivity to a levofloksatsin or to other hinolona, or to any of drug components
– the damages of sinews observed at the previous use of hinolon
– epilepsy
– children’s and teenage age up to 18 years
– pregnancy, the lactation period

Medicinal interactions
accords Meal small effect on absorption of a levofloksatsin. Iron preparations and antacids considerably reduce bioavailability of a levofloksatsin. Actions of a levofloksatsin decreases at simultaneous appointments with sukralfaty, the drugs containing magnesium and aluminum. Therefore it is necessary to appoint it in 2 hours or in 2 hours after their reception. The medicines capable to prolong QT interval (antiarrhythmic means of classes I A and III, tricyclic antidepressants, macroleads) should be applied with care at simultaneous use with Alevo. Cimetidinum and probenitsid reduce renal clearance of a levofloksatsin (by 24% and 34%, respectively) as both drugs can block canalicular secretion of a levofloksatsin in kidneys. At the simultaneous use of medicines of type of a probenitsid and Cimetidinum blocking canalicular secretion, treatment with Alevo should be carried out with care, especially at disturbance of renal function. Simultaneous use of hinolon with the theophylline, non-steroidal anti-inflammatory drugs or other drugs reducing a cerebral convulsive threshold can lead to the significant decrease in a cerebral convulsive threshold.

Special instructions
of Alevo, should not appoint children and teenagers, in view of the probability of damage of articulate cartilages. At treatment of patients of senile age it must be kept in mind that patients of this group often have renal failures.
In hard cases of pneumococcal pneumonia of Alevo it can be not the most optimum therapy.
Experience of use of other hinolon demonstrates that they are capable to cause aggravation of a porphyria (very rare disease of a metabolism) in the patients who are available in the anamnesis. The similar effect is not excluded also at drug Alevo use.
In an abnormal liver function the special selection of doses as levofloxacin is metabolized in a liver slightly is not required.
Any antibiotic treatment can cause disturbance of normal microflora of the person. For this reason there can be a strengthened reproduction of the bacteria and mushrooms resistant to the applied antibiotic (consecutive infection and superinfection) which in rare instances can demand additional treatment. At suspicion of pseudomembranous colitis the treatment by the tablets Alevo needs to be stopped immediately, the patient needs immediately to appoint the supporting and specific therapy.
The drug Alevo is contraindicated to patients with epilepsy in the anamnesis. Besides, also as well as with other hinolona, it is necessary to observe the maximum care in case of the patients inclined to spasms, for example, of patients with already available damages of the central nervous system, at simultaneous treatment fenbufeny and similar, the non-steroidal anti-inflammatory drugs or drugs lowering a cerebral convulsive threshold such as theophylline.
During treatment it is necessary to avoid alcohol intake.
Patients with the latent or demonstrating insufficient activity of glyukozo-6-phosphate-dehydrogenase can be prone to hemolytic reactions at treatment of a hinolonama therefore it is necessary to be careful at Alevo’s use.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Some side effects (for example, dizziness, the increased drowsiness, disorders of vision) can reduce ability of the patient to concentration of attention and speed of motor reactions that can constitute danger in situations where such abilities are especially important.

Overdose
Symptoms: confusion of consciousness, dizziness, spasms, nausea, erosive damages of a mucous membrane of digestive tract, lengthening of an interval of QT.
Treatment: symptomatic. Levofloxacin is not removed by means of a hemodialysis or peritoneal dialysis. Excessive increase in system influence of a levofloksatsin can prevent prescribing of activated carbon. And monitoring of the ECG owing to lengthening of an interval of QT is also necessary. There is no specific antidote.

A form of release and packing
On 10 tablets in blister strip packaging from a film of polyvinylchloride and printing aluminum foil.
On 1 planimetric packing together with the instruction for medical use in the state and Russian languages place in a cardboard pack.

Storage conditions
In the dry, protected from light place at a temperature not above 30o S.
Hranit out of children’s reach!

3 years
not to apply a period of storage after an expiration date.

Prescription status
According to the prescription

the Develop Producer “Alkem Laboratories Ltd”

Additional information

Ingredient

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