Fosmitsin

General characteristics. Structure:

Active ingredient: 1 or 2 grams of a fosfomitsin of sodium.

Excipients: anhydrous citric acid.

Pharmacological properties:

Pharmacodynamics. Fosfomitsin − antibiotic of a broad spectrum of activity. It is effective concerning the majority gram-positive (Enterococcus spp., including Enterococcus faecalis, Staphylococcus spp., including Staphylococcus aureus, Staphylococcus saprophyticus, Staphylococcus epidermidis, Streptococcus spp., including Streptococcus faecalis) and gram-negative activators (Escherichia coli, Citrobacter spp., including Citrobacter diversus, Citrobacter freundii, Enterobacter spp., including Enterobacter aerogenes, Klebsiella spp., including Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Serratia spp., including Serratia marcescens, Pseudomonas spp., including Pseudomonas aeruginosa).

Does not affect anaerobic flora.

Pharmacokinetics. Communication with proteins of plasma − 10%. The maximum concentration in a blood plasma at slow intravenous infusion of 0,5 g and 1 g − 28 mg/l and 46 mg/l respectively. Equilibrium concentration − 20 mg/l at infusion of 4 g each 6 hours. Elimination half-life − 1,5-2 hours. An insignificant part − with bile is brought to 90-100% by kidneys within 24 hours in not changed look.

Indications to use:

The bacterial infections of various localization caused by microorganisms, sensitive to a fosfomitsin (at the heavy course of infections in combinations with other antibiotics, is more often with β-laktamny):

• respiratory infections (pneumonia),
• infections of urinogenital system (pyelonephritis),
• infections of a digestive tract and abdominal cavity (peritonitis),
• gynecologic infections (endometritis),
• surgical infections,
• sepsis.

Route of administration and doses:

The adult the daily dose makes 2-4 g.

To children 5 years a daily dose are more senior makes 100-200 mg/kg of body weight.

Intravenous drop administration. To part a single dose of drug in 100-500 ml 0,9% of solution of sodium of chloride, to enter kapelno within 1-2 hours 2 times a day.

Internally bolyusno. To dissolve 2 g of a fosfomitsin in 20 ml 0,9% of solution of sodium of chloride, to enter bolyusno within 5 min. and more than 2-4 times a day.

The term of treatment is determined by the doctor depending on character and the course of a disease, usually the course of treatment makes 7-10 days.

Features of use:

Use during pregnancy or feeding by a breast. Adequate and strictly controlled researches concerning use of drug during pregnancy were not conducted therefore, considering ability of a fosfomitsin to get through a placenta, drug is not used during this period.

For treatment it is necessary to stop feeding by a breast.

Children. Safety and efficiency of use of drug to children under 5 years was not defined.

Features of use. Before purpose of drug at the patient it is necessary to collect carefully the allergic anamnesis for the purpose of an exception of a possibility of development of an acute anaphylaxis.

Fosmitsin with care appoint to patients with individual or family predisposition to allergic reactions such as bronchial asthma, rash or small tortoiseshell.

As there are no appropriate measures of forecasting of potential risks of emergence of shock or anaphylactic reactions owing to use to Fosm_tsin it is necessary to take the following measures:

• it is necessary to collect in detail the anamnesis about the above-stated reactions,
• it is necessary to be sure that the patient in the anamnesis had no allergic reactions to an antibiotic or other components,
• at emergence of heavy allergic reactions, it is necessary to take urgently urgent measures for treatment of shock and to stop use of this drug,
• at the beginning of drug use the patient has to be under careful observation of the doctor.

Patients who receive long therapy by Fosmitsin need to control periodically function of a liver, kidneys and hematologic indicators. At patients with abnormal liver functions at use of drug the exacerbation of a disease is possible.

Usually at confirmation of sensitivity of a microorganism to drug use duration to Fosm_tsin has to be minimum necessary and be defined proceeding from a condition of the patient to avoid development of resistant microorganisms.

Drug with care is appointed to patients with arterial hypertension and heart failure.

At a renal failure decrease in clearance of a fosfomitsin is possible that can demand reduction of a dose.

Fosfomitsin is brought preferential by kidneys. Probable development of side reactions, especially at elderly patients as at them function of kidneys is usually reduced. At treatment of patients of advanced age care at selection of doses as they can need the reduced consumption of sodium through a heart or renal failure, arterial hypertension is necessary. At people 75 years the increased risk of a hepatotoxic of a fosfomitsin are more senior.

The precautionary measures concerning administration of drug. It is recommended to administer the drug by intravenous drop infusion always when it is possible. It is known that after administration of this medicine phlebitis can develop and be noted pain in an injection site. Therefore it is necessary to be attentive at the choice of an injection site and technology of introduction, and rate of administering has to be slower.

At intravenous administration Fosm_tsin in combination with other antibiotic cannot combine both drugs in the same solution. At first other antibiotic is entered фосфомицин, and then.

In case of prolonged treatment drug recommends to control periodically function of a liver and kidneys, and also to do the general and biochemical analyses of blood.

The remains of divorced and unused drug are liable to destruction.

Ability to influence speed of response at control of motor transport or work with other mechanisms. At use of drug it is necessary to abstain from control of motor transport or work with other mechanisms.

Side effects:

From a nervous system: a headache, dizziness, paresthesia, spasms (at use of high doses), a hypesthesia, catalepsy.

From a digestive tract: diarrhea, nausea, vomiting, heartburn, pseudomembranous colitis, stomatitis, anorexia, abdominal pain.

From gepatobiliarny system: an abnormal liver function, including tranzitorny increase in activity of alaninaminotranspherase, aspartate aminotransferase, an alkaline phosphatase, lactate dehydrogenase and bilirubin in blood serum, jaundice.

From cardiovascular system: a sensation of discomfort in breasts, feeling of compression in a thorax, a cardiopalmus.

From system of blood: pancytopenia, agranulocytosis, anemia, granulocytopenia, leukopenia, thrombocytopenia, eosinophilia.

Allergic reactions: skin rashes, erythema, urticaria, itch, acute anaphylaxis.

From an urinary system: a renal failure, including increase in concentration of urea in a blood plasma, a proteinuria, decrease or increase in concentration of electrolytes (sodium and potassium).

From respiratory system: cough, bronchospasm, rhinitis.

General disturbances: weakness, inflows, indisposition, thirst, fever, peripheral hypostases, vaginitis, dysmenorrhea, pharyngalgia, dorsodynia.

Local disturbances: changes in an injection site, including pain and infiltrate, phlebitis, feeling of pain on the vein course.

Interaction with other medicines:

Metoclopramidum reduces concentration of a fosfomitsin in blood serum and urine.

In a combination with Vancomycinum drug shows high performance concerning resistant strains of St. aureus.

Not to mix with other medicines.

Contraindications:

Hypersensitivity to drug components. The expressed renal failure (clearance of creatinine less than 10 ml/min.).

Overdose:

About cases of overdose it was not reported.

Treatment: drug should be cancelled. Therapy is symptomatic.

Storage conditions:

To store in original packaging at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

On 1 g in a bottle; on 10 bottles in packaging.

On 2 g in a bottle; on 10 bottles in packaging.