Levomak 5's 500 mg film-coated tablets

The instruction for medical
use

of LEVOMAK 250 medicine
LEVOMAK 500


the Trade name
Levomak 250
Levomak 500

International unlicensed


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

Structure
One tablet contains
active agent - a levofloksatsina gemigidrat
is equivalent a levofloksatsina of 250 mg and 500 mg,
excipients: microcrystalline cellulose, starch prezhelanitizirovanny, polysorbate-80, krospovidon, cellulose microcrystalline (PH 302), talc cleaned, silicon dioxide colloidal anhydrous, magnesium stearate,
structure of a cover: gipromelloza of 15 cps, titan E171 dioxide, propylene glycol, diethyl phthalate, gland (III) oxide red E 172, gland (III) oxide yellow E 172.

The description
of the Tablet, film coated henna-red color, round shape, biconvex, smooth from two parties (for a dosage of 250 mg).
Tablets, film coated henna-red color, a capsulovidny form, biconvex, smooth from two parties (for a dosage of 500 mg).

Pharmacotherapeutic group
Antibacterial drugs – derivatives of a hinolon. Ftorkhinolona
Kod by automatic telephone exchange of J01MA12

the Pharmacological

Pharmacokinetics Active Agent properties of drug - levofloxacin quickly and almost is completely soaked up after intake. Peak plasma concentration are reached through one - two hours after oral administration. The absolute bioavailability is 99%. Communication with proteins of plasma makes 30-40%, extent of binding does not depend on concentration of drug.
The average volume of distribution of a levofloksatsin is 74 - 112 l that demonstrates wide distribution of drug in body tissues. Peak levels of a levofloksatsin are reached in skin tissues in 3 hours after administration of drug. Levofloxacin well gets into pulmonary fabric. Concentration of drug in pulmonary fabric are 2-5 times higher than plasma concentration and make from 2.4 to 11.3 mkg/g in 24 hours after reception of a single oral dose of 500 mg. Levofloxacin remains stereokhimichesk stable in plasma and urine and is not metabolized to an enantiomer. 87% are removed with urine in the form of not changed substance within 48 hours, less than 4% of a dose - with a stake within 72 hours, less than 5% - with urine in the form of metabolites. Average final elimination half-life of a levofloksatsin makes 6 - 8 hours of plasma.
The pharmacodynamics
the Mechanism of effect of left poppy consists in suppression bacterial DNK-girazy. Left poppy has bactericidal effect when assigning in the concentration equal or a little exceeding the inhibiting concentration. Left poppy has activity concerning a wide number of gram-positive and gram-negative microorganisms: Enterococcus faecalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Moraxella catarrhalis, Proteus mirabilis, Pseudomonas aeruginosa, Chlamydia pneumoniae, Mycoplasma pneumoniae.

Indications
- acute sinusitis
- exacerbation of chronic bronchitis
- community-acquired pneumonia
- uncomplicated infections of skin and soft tissues (easy and moderately severe)
- the uncomplicated and complicated infections of urinary tract (easy and
moderately severe)
- acute pyelonephritis (easy and moderately severe)

the Route of administration and doses
the Average daily dose makes 250 mg or 500 mg, maximum – 1.5 g.

Infection Duration the Daily dose
of treatment
Exacerbation
of chronic bronchitis of 7-10 days of 500 mg 1-2 times a day
depending on weight
Community-acquired pneumonia of 7-10 days of 500 mg 1-2 times a day
Acute sinusitis of 7 - 10 days of 500 mg
the Complicated infections
of skin and soft tissues of 7 - 10 days of 750 mg
Uncomplicated infections
of skin and soft tissues of 7 - 10 days of 500 mg
the Complicated infections
of urinary tract of 7 days of 250 mg 2 times a day
Acute pyelonephritis of 7 days of 250 mg
Uncomplicated infections
of urinary tract of 7 days of 250 mg

In a renal failure:
Exacerbation of chronic bronchitis, community-acquired pneumonia, acute sinusitis, uncomplicated infections of skin and soft tissues:
(KK – clearance of creatinine)

the Condition of kidneys the Initial dose the Subsequent dose
of KK from 50 to 80 ml/min. is not required to dose adjustment
of KK from 20 to 49 ml/min. 500 mg 250 mg each 24 hours
of KK from 10 to 19 ml/min. 500 mg 250 mg each 48 hours
the Hemodialysis of 500 mg 250 mg each 48 hours
Chronic out-patient
peritoneal dialysis of 500 mg 250 mg each 48 hours

the Complicated infections of skin and soft tissues:
KK from 50 to 80 ml/min. is not required to dose adjustment
of KK from 20 to 49 ml/min. 750 mg 750 mg each 48 hours
of KK from 10 to 19 ml/min. 750 mg 500 mg each 48 hours
the Hemodialysis of 750 mg 500 mg each 48 hours
Chronic out-patient
peritoneal dialysis of 750 mg 500 mg each 48 hours

the Complicated infections of urinary tract, acute pyelonephritis:
KK of 20 ml/min. is not required to dose adjustment
of KK from 10 to 19 ml/min. 250 mg 250 mg each 48 hours

Side effects
Often
- nausea, diarrhea, increase in activity of enzymes of a liver (for example,
alaninaminotranspherases and aspartate aminotransferases)
- pain and reddening in the injection site, phlebitis
Sometimes
- loss of appetite, vomiting, abdominal pain, dyspepsia
- an itching, rash and erubescence
- a headache, dizziness, drowsiness, sleep disorders
- increase in level of bilirubin and creatinine in blood serum
- an eosinophilia, a leukopenia
- the general weakness (asthenia)
- reproduction of fungal flora and resistant microorganisms
is rare
- urticaria, a bronchospasm, short wind
- diarrhea with blood impurity
- paresthesias, a tremor, concern, the increased uneasiness, a depression,
attacks of spasms and confusion of consciousness
- tachycardia, falling of arterial blood pressure
- a neutropenia, thrombocytopenia that can be followed by strengthening
of bleeding
- a tendinitis (for example, an Achilles tendon), articulate and muscular pains
Very seldom
- a Quincke's edema, hypotension, shock, anaphylactoid reactions,
a photosensitization, an allergic pneumonitis, a vasculitis, fever
- a hypoglycemia (especially at patients with diabetes)
- a disorder of vision and hearing, disturbance of flavoring sensitivity and
sense of smell, a hypesthesia, a hallucination
- a rupture of sinews (for example, an Achilles tendon - this side reaction
can be observed within 48 hours after an initiation of treatment and have
bilateral character), the muscle weakness which is of particular importance for
patients with a heavy myasthenia
- hepatitis, a coloenteritis, pseudomembranous colitis
- depression of function of kidneys up to an acute renal failure,
interstitial nephrite
- an agranulocytosis
In some cases
- a heavy enanthesis with formation of bubbles, Stephens's syndrome -
Johnson, a toxic epidermal necrolysis (Lyell's disease) and
an exudative mnogoformny erythema
- lengthening of an interval of QT
- a rhabdomyolysis
- hemolytic anemia, a pancytopenia
- extrapyramidal symptoms and other disturbances of muscular coordination
- bad attacks of a porphyria at patients with a porphyria
- mental reactions with autoaggressive behavior, including with
suicide thoughts or actions

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

Medicinal interactions
At co-administration with antacids, sukralfaty, cations of metals, polyvitaminic drugs absorption Left poppy from digestive tract can decrease.
At joint appointment of Levomak with the theophylline, non-steroidal anti-inflammatory drugs or other drugs reducing a convulsive threshold the risk of developing of spasms increases.
Left poppy does not interact from calcium a carbonate, digoxin and warfarin.
At joint appointment with probenetsidy, Cimetidinum, ranitidine and furosemide Levomak's concentration in blood increases.
At a concomitant use of drug with anti-diabetic means the stringent control of level of glucose of blood is recommended.

Special instructions
Levomak should be accepted in two hours prior to or in two hours after reception of the antacids containing magnesium, aluminum of the sukralfat, cations of metals (iron preparations), the polyvitaminic drugs containing zinc, a didanozin, chewable and buferirovanny tablets or children's powders for preparation of oral solutions.
Left poppy should be applied with care in a renal failure
and if necessary to adjust a dose.
During treatment it is necessary to avoid solar and artificial ultra-violet radiation in order to avoid reactions of a photosensitization.
The feature of influence of medicine on ability to drive the car or potentially dangerous mechanisms
during treatment needs to be careful during the driving of motor transport and occupation other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Overdose
Symptoms: nausea, erosive damages of mucous membranes of digestive tract, lengthening of an interval of QT on the ECG, confusion of consciousness, dizziness, spasms.
Treatment: gastric lavage, prescribing of activated carbon, adequate hydration, symptomatic treatment. Dialysis is inefficient.

A form of release and packing
On 5 tablets in blister strip packaging from a film of polyvinylchloride and aluminum foil.
On 1 blister strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.


To Store storage conditions in the dry, protected from light place, at a temperature not over 30 of 0C.
To store out of children's reach!


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

A release form from drugstores
According to the prescription



Macleods Pharmaceuticals Limited 304, Atlanta Arcade, Marol Church Road, Andheri (East), Mumbai Producer – 400,059, India.

The owner of the registration certificate
of Macleods Pharmaceuticals Limited, India

the Address of the organization admitting claims from consumers on quality of products Representation to RK "Macleods Pharmaceuticals Limited" RK, Almaty, Tulebayev St. 38, office 307/ATel. / fax. +7,727 3562832E-mails:

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