Ломфлокс

General characteristics. Structure:

Active agent: ломефлоксацин (in the form of a hydrochloride) 400 mg

Excipients: lactose, starch, polyvinylpirrolidone, starch sodium glycollate, кросповидон, the talc purified sodium lauryl sulfate, magnesium stearate, propylene glycol, silicon dioxide colloid.

Structure of a film cover: isopropanol, gidroksipropilmetiltsellyuloz, methylene dichloride, titanium dioxide.

Pharmacological properties:

Lomefloksatsin is synthetic antimicrobic drug of ftorkhinolonovy group of a wide range of bactericidal action. Blocks DNK-girazu bacteria, forming a complex with its tetramer and breaks a transcription and DNA replication, leads to death of a microbic cell.
It is active concerning gram-negative and gram-positive microorganisms: gram-negative aerobes (Citrobacter diversus and freundii, Enterobacter cloacaae, aerogenes and agglomerans, Escherichia coli, Haemophilus influenzae, parainfluenzae, Klebsiella pneumonia, oxytoca and ozaenae, Moraxella catarralis, Proteus mirabilis, stuartii, vulgaris, Pseudomonas aeruginosa, Morganella morganii, Legionella pneumophilla, Salmonella spp., Shigella spp., Providencia rettgeri, Serratia liquefaciens and marcescens, Neisseria gonorrhoeae, Neisseria meningitidis), gram-positive aerobes (Staphylococcus saprophyticus, aureus and epidermidis), chlamydias, tuberculosis mycobacteria (as out of - and intracellularly located), some strains of a mycoplasma and an uroplazma. In acid medium efficiency decreases, resistance develops slowly. Has the expressed post-antibiotic effect. Streptococci (most of groups A, B, D, G), Streptococcus pneumoniae, Pseudomonas cepacia, Ureaplasma urealyticum, Mycoplasma hominis and anaerobe bacterias are steady against action of a lomefloksatsin.

Pharmacokinetics. After intake ломефлоксацин it is almost completely soaked up from a GIT. At reception in a dose of 400 mg in a blood plasma of Cmax it is reached in 1.5-2 h and makes 3-5.2 mg/l. At purpose of drug in a dose of 400 mg/days concentration of a lomefloksatsin exceeds MPK for the majority of activators, at least, during 12 h.

Linkng with proteins of plasma makes 10%. Lomefloksatsin quickly gets into the majority of fabrics. Concentration in fabrics and biological liquids of an organism are, as a rule, 2-7 times higher, than in plasma, especially in pulmonary macrophages, tissues of a prostate gland and in urine. T1/2 of a lomefloksatsin makes 7-9 h. About 70-80% are removed in not changed view with urine during 24 h.
At patients with renal failures of T1/2 of a lomefloksatsin significantly increases.

Indications to use:

The infectious and inflammatory diseases caused by microorganisms, sensitive to a lomefloksatsin:
— infections of lower parts of respiratory tracts (including exacerbations of chronic bronchitis and pneumonia);
— average otitis;
— the uncomplicated and complicated infections of urinogenital system;
— acute and chronic gonococcal, Chlamidia and multi-infections;
— infections of skin and soft tissues;
— infections of bones and joints (including chronic osteomyelitis);
— infectious coloenterites and cholecystitises;
— a pulmonary tuberculosis (ostroprogressiruyushchy forms of tuberculosis, multiple medicinal resistance of mycobacteria, bad portability of rifampicin, tuberculosis and the accompanying nonspecific inflammatory processes);
Prevention of infectious complications at transurethral surgical interventions.

Route of administration and doses:

Inside (regardless of meal, washing down with enough liquid), on 400 mg of 1 times/days. At an impaired renal function in the first day of 400 mg, then 200 mg/days. The dose and duration of a course depend on disease severity and sensitivity of the activator.

The recommended doses and duration of treatment lomefloksatsiny are given below:

Disturbance	Dose/scheme	Treatment duration
Uncomplicated infection of uric ways	400 mg of 1 times /	3 days
The complicated infection of uric ways	400 mg of 1 times /	10-14 days
Infections of skin and skin structures	400 mg of 1 times /	10-14 days
Exacerbation of chronic bronchitis	400 mg of 1 times /	7-10 days
Prevention of an infection of uric ways after transurethral operation	400 mg	Single dose for 2-6 h before operation
Prevention at a transrectal biopsy of a prostate	400 mg	Single dose for 2-6 h before a biopsy
Acute uncomplicated gonorrhea	400 mg	1-3 days
The chronic complicated gonorrhea	400 mg	7-14 days
Acute clamidiosis	400 mg	14 days
Recurrent clamidiosis, including the mixed bacterial chlamydial infection	400 mg	14-21 days
Tuberculosis as a part of complex therapy	400 mg	28 days
Treatment of the accompanying infection at tuberculosis	400 mg	2-3 weeks

At treatment of TB patients ломефлоксацин combine with an isoniazid, Pyrazinamidum, Ethambutolum. Co-administration of a lomefloksatsin with rmfampitsiny as these drugs are competitive antagonists at the microbic level is not recommended.
The risk of photochemical reaction can be reduced, accepting ломефлоксацин in the evening.

Features of use:

It is necessary to consider that at cirrhosis correction of the mode of dosing is not required if functions of kidneys are not broken.

During treatment it is necessary to avoid influence of ultraviolet rays.

The antiacid means, vitamins and other drugs containing magnesium, aluminum, iron should not be taken for 2 h to and during 2 h after reception of a lomefloksatsin.

Influence on ability to driving of motor transport and to control of mechanisms
Lomefloksatsin can cause dizziness and disturbance of attention therefore the question of a possibility of occupations potentially dangerous types of activity requiring special attention and speed of psychomotor reactions should be solved only after assessment of individual reaction of the patient to drug.

Side effects:

Photosensitization, allergic reactions, including anaphylactic reaction and a Quincke's edema.
Cardiovascular system: oppression of cardiopulmonary function, vasculitis.
Respiratory system: throat hypostasis, fluid lungs.
GIT: morbidity mucous mouth, pseudomembranous colitis.
Liver: hepatitis
Urinary system: intersticial nephrite, polyuria, renal failure, ischuria.
Skeletal and muscular system: arthralgia, mialgiya, tendinitis, rupture of sheaves.
Central and peripheral nervous system: ataxy, spasms, tremor, dizziness, headache; mental disorders: uneasiness, depression, frustration of a dream, confusion of consciousness, hallucination, food faddism; vision disorders: diplopia, photophobia.
Skin: exfoliative dermatitis, hyperpegmentation, Stephens-Johnson's syndrome, toxic epidermal necrolysis.
Metabolism: hypoglycemia
Blood: thrombocytopenia, hemolitic anemia.

Interaction with other medicines:

Increases activity of peroral anticoagulants and increases toxicity of non-steroidal anti-inflammatory drugs.
Antacids and сукральфат slow down absorption and reduce bioavailability (form chelate connections), пробенецид - renal excretion.
Is a mutual antagonist of rifampicin.

Contraindications:

— cerebral atherosclerosis, epilepsy and other states with predisposition to spasms;
— pregnancy, lactation;
— children's age up to 15 years;
— hypersensitivity to a lomefloksatsin and other hinolona.

Use of the drug LOMFLOKS® at pregnancy and feeding by a breast
Contraindication: pregnancy, lactation.

Use at renal failures
At an impaired renal function in the first day of 400 mg, then 200 mg/days.

Use for children
Contraindication: children's age up to 15 years.

Overdose:

Now about cases of overdose of drug of Lomfloks it was not reported.

Storage conditions:

To store at a temperature below 25 °C, in the dry, protected from light place unavailable to children.

Issue conditions:

According to the recipe

Packaging:

Tablets, покр. film cover, 400 mg: 4, 5, 16, 20 or 25 pieces.