Description overdue on 01/09/2014

• Composition
• Product form
• Pharmacological action
• Pharmacodynamics and pharmacokinetics
• Indications
• Contraindications
• Side effects
• Instructions for use (method and dosage)
• Overdose
• Cooperation
• Terms of sale
• Storage conditions
• Shelf life
• Analogs
• Synonyms
• Babies
• Newborns
• With alcohol
• With antibiotics
• During pregnancy (and lactation)
• Reviews
• Price, where to buy

Composition

Powder for solution for internal and parenteral administration, containing 500 mg (0, 5 g), or about 1000 mg (1 g) of the active substance - fosfomycin   as fosfomycin trometamol.

Product form

Bottles for 0, 5 g or 1 g fosfomycin.

One package contains 1, 10 or 50 vials.

Pharmacological action

Antibacterial and bactericidal.

Pharmacodynamics and pharmacokinetics

Fosfomycin (Fosfomycin)   It is an antibacterial drug from a fairly broad spectrum. It affects most Gram-negative microorganisms and gram-positive organisms such as e nterokokki, Staphylococcus, Escherichia, Klebsiella, Proteus, Pseudomonas And a number of other pathogens.

The mechanism of action of the drug is associated with inhibition of the initial stage of replication peptidoglycan   bacterial cell walls.

Oral

When an internal reception is rapidly absorbed from the gastrointestinal tract, breaking into   fosfomycin,   which is an active ingredient of the drug and trometamol Which is inactive.

The biological activity at a single dose of 3 g is - 34-65%.

TCmax equals - 120-150 minutes, Cmax - 22-32 mg / l.

Not exposed metabolism   and does not bind to plasma proteins.

90% is excreted unchanged in the urine and approximately 10% in feces.

The half-life of approximately 4 hours with CC less than 80 ml / min the period increased somewhat.

Parenteral administration

When administered intravenously Cmax equal - 74-87, 3 mg / ml, whereas TSmax twice shorter than the intramuscular injection of the drug.

The max of sputum - 7 ug / ml, TSmax - 180 minutes.

C proteins binds to the blood 2 and 16%.

It has good penetration into various body tissues and fluids.

Do not give in metabolic processes.

The half-life after intravenous injection - 1, 5-1, 7 hours.

In unchanged form excreted in the urine.

Indications

Oral administration of the drug is indicated for infectious pathologies of the urinary tract That it was caused by sensitive fosfomycin   microorganisms:

• palindromic   and acute cystitis;
• pseudogonorrhea   bacterial etiology;
• massive bacteriuria,   occur without visible symptoms (in pregnant women);
• prevention and treatment of infectious diseases in conducting research and transurethral surgery.

Parenteral administration is recommended for the treatment of infectious diseases of various localization, which were caused by sensitive fosfomycin   microorganisms, including multiple pharmacological resistance:

• septicemia ;
• bronchiolitis ;
• chronic and acute pneumonia ;
• pyothorax ;
• cystitis ;
• peritonitis ;
• bronchiectasis;
• pyelonephritis ;
• adnexitis ;
• bartholinitis ;
• purulent pleurisy   and abscessed pneumonia ;
• parametritis ;
• pelvic infection.

In severe disease used combination therapy with other antibiotics   (usually with a beta-lactam).

Contraindications

• period pregnancy ;
• hypersensitivity patient to components of the drug .

Side effects

For oral use:

• Nervous system : dizziness . weakness , Insomnia, migraine . headache . drowsiness . paresthesia , Nervousness, malaise.
• Gastrointestinal tract Nausea, dyspepsia . diarrhea , Dry mouth, constipation . flatulence . anorexia Vomiting.
• Other: vaginitis, dysmenorrhea . rhinitis . pharyngitis , Abdominal pain, flu-like symptoms, non-localized pain, back pain, rash on the skin, fever Itching, hematuria, dysuria, lymphadenopathy, myalgia, disturbances in the menstrual cycle.

For parenteral administration:

• Nervous system : paresthesia , Headache, dizziness, at high doses - convulsions .
• Cardiovascular and Circulatory System : pancytopenia , Tenderness along the vein, discomfort in the chest, anemia , Palpitations, chest compression sensation, granulocytopenia . thrombocytopenia . leukopenia . phlebitis . eosinophilia . agranulocytosis .
• Gastrointestinal tract : Liver dysfunction (including increased activity of LDH, AST, ALT, alkaline phosphatase) hyperbilirubinemia , Vomiting, jaundice, nausea, anorexia, diarrhea , Pseudomembranous colitis, abdominal pain.
• Allergic reactions : itching . hives , Erythema, anaphylactic shock .
• Other: pain at the injection site, rash . bronchospasm , Cough, renal dysfunction, proteinuria , Increase / decrease of Na + and K +, fever , Peripheral edema, thirst , Infiltration at the site of intramuscular administration.

Instructions for use (method and dosage)

For drug fosfomycin instructions for use involves oral and intravenous and intramuscular administration.

The dosage regimen of the preparation is adjusted individually; it all depends on the severity of the disease, as well as the course of the disease.

For indoor use

Oral administration of the drug is carried out for 2 hours or 2 hours after a meal, preferably in the evening.

In the acute phase of the disease single daily dose is usually 3 g Fosfomycin for adults and 2 g for pediatric patients.

In chronic course of the disease to adults and elderly patients is recommended daily dose is 6 grams a day from reception.

In order to prevent infection of the urinary tract   for diagnostic procedures and surgeries administered 3 grams of the drug inside the 3 hours before the anticipated procedure or intervention, and 3 g 24 hours after their meeting.

Confirmed renal failure   It involves increasing the intervals between doses of Fosfomycin and reducing its dose.

For intravenous use,

Instructions for use determines the average Fosfomycin dose for adult patients is 70 mg per kilogram of body weight. Generally, a daily dose for adult ranges from 2 to 4, the drug was administered every 6-8 hours.

For pediatric patients a daily intravenous dose of 100-200 mg per kilogram body weight, divided into two daily administration. Therapy from 7 to 10 days.

For intramuscular use

Usually a daily dosage of 4 g Fosfomycin is split into two injections with an interval of 2 hours. Alternative administration allows two simultaneous injections of 2 g of the drug carried out in different buttocks.

To use the infusion

Recommended dose (1-4 g) was dissolved in 100-500 ml of water for injection and administered for 60-120 minutes.

For intravenous use inkjet

Fosfomycin dose (1-2 g) diluted in 20 ml of water, d / in. or 5% dextrose solution and separated by 2-4 injections carried out for 5 minutes.

Overdose

In case of accidental overdose fosfomycin may increase its side effects.

Symptomatic therapy.

Cooperation

Medicine Metoclopramide   reduces the concentration fosfomycin   in serum and urine.

Terms of sale

Prescription.

Storage conditions

The temperature is not above 25 ° C.

Shelf life

24 months.

Analogs Fosfomycin

Analogs Fosfomycin presented the following medications:

• Hexamethylenetetramine ;
• Dioxins ;
• Zyvox ;
• Kirin ;
• Kubitsin ;
• Nitroxoline ;
• Sangviritin ;
• Amizolid   etc.

Synonyms

Synonyms of the drug are:

• Urofosfabol ;
• Maunoury ;
• Monural .

Babies

Assign children at the recommended doses.

Newborns

It can only be applied in extreme cases, in minimal doses and under the strict supervision of the attending physician.

With alcohol

Not recommended intake of drinks containing alcohol during therapy with fosfomycin.

With antibiotics

In severe disease receive a combination of fosfomycin and other antibiotics (usually a beta-lactam).

During pregnancy and lactation

Contraindicated for use during pregnancy.

The lactation can be applied only when absolutely necessary.

Reviews of fosfomycin

Reviews of preparation of fosfomycin (Fosfomycin) noted its high efficiency and speed of the pharmacological action, particularly in the treatment of infectious diseases of the urinary system.

Price Fosfomycin where to buy

At this time, the purchase of Russian-made preparation of fosfomycin is some problem.

Presumably the price Fosfomycin trometamol As price Fosfomycin sodium It must be in line with its synonym - Monuralom The value of which in Russia is 310 rubles (2d №1) to 370 rubles (3 g №1).

Cost Monural   Ukraine hovers around 200 hryvnia.