The instruction for use
of medicine for experts
A trade name
Mezhdunarodnoye the unlicensed
name Nitrofurantoin Dosage Form
of the Tablet of 0.05 g
One tablet contains
active agent furadonin 0.05 g,
excipients: calcium stearate, potato starch, aerosil.
of the Tablet of yellow or chartreuse color, ploskotsilindrichesky, with a facet.
Antibacterial agents for system use. Nitrofuran derivatives.
The code of automatic telephone exchange J01XE01
Pharmacokinetics At properties intake is well soaked up in a GIT. Bioavailability up to 90%. Presence of food increases bioavailability of medicine. In blood reversibly contacts proteins of plasma (about 60%). Therapeutic effective concentration in blood plasma makes 0.5-2.0 mkg/ml, toxic 3.0-4.0 mkg/ml (children have more than 2 mkg/ml).
Easily gets through a placenta, a blood-brain barrier, it is allocated with breast milk. In therapeutic concentration it is found in urine and excrements. Volume of distribution (Vd) of 0.8 l/kg.
The semi-elimination period at introduction in (T½) is 1.0±, 0.3 h. Is exposed to biotransformation in a liver and muscle tissue. It is removed by glomerular filtration in urine, at the same time the share of not changed medicine makes 30-50%. The general clearance (Cl) is 680 ml/min.
Synthetic antimicrobial broad-spectrum agent. Works bakteritsidno.
The mechanism of action is connected with restoration of a furadonin in bacterial cells under the influence of flavoprotein in active an intermediant who damages ribosomalny proteins, breaks synthesis of protein, DNA, RNA. In high doses breaks permeability of a cellular membrane of bacteria.
It is active concerning gram-positive aerobic bacteria: Staphylococcus spp., Streptococcus spp., gram-negative aerobic bacteria: Escherichia coli, Enterobacter spp., Klebsiella spp., Shigella spp., Proteus spp. It is poorly active concerning Enterococcus spp., sort Candida mushrooms. Acinetobacter spp is not active concerning Pseudomonas aeruginosa.
– uncomplicated infections of urinary tract (acute cystitis, an asymptomatic bacteriuria, an urethritis, a pyelitis, pyelonephritis)
– prevention of infections at urological operations and inspections (tsistoskopiya, catheterization).
The route of administration and doses
use Drug inside, at meal time, washing down with a large amount of water.
The adult on 100-150 mg 4 times a day, a course of treatment of 5-8 days. Treatment continuation within 3 days is in case of need possible (only after control of urine on sterility). The highest doses for adults inside: single 300 mg, daily 600 mg. When performing the long-term supporting treatment of a dose of a furadonin it is necessary to reduce.
For children the daily dose makes 5-8 mg/kg in 4 receptions.
– nausea, vomiting, an abdominal pain, diarrhea, hepatitis, a cholestatic syndrome, pancreatitis, a pseudomembranous coloenteritis
– dizziness, a headache, an asthenia, a nystagmus, drowsiness, peripheral neuropathy
– interstitial changes in lungs (interstitial pneumonitis, a pneumosclerosis), a bronchospasm, cough, a grippopodobny syndrome, thorax pains
– a leukopenia, a granulocytopenia, an agranulocytosis, thrombocytopenia, hemolytic anemia, megaloblastny anemia
– a volchanochnopodobny syndrome, an arthralgia, myalgia, anaphylactic reactions, fever, an eosinophilia, rash, a multiformny exudative erythema (Stephens-Johnson’s syndrome), exfoliative dermatitis
– the superinfection of an urinogenital path more often caused by a pyocyanic stick.
– the profound renal failures
– cirrhosis, chronic hepatitis
– chronic heart failure (the III-IV class on NYHA,
– insufficiency glyukozo-6-fosfatdegidrogenazy
– a sharp porphyria
– children’s age up to 1 month
– hypersensitivity to a furadonin.
the Antiacid means containing magnesium trisilicate reduce antimicrobic effect of drug at simultaneous use due to decrease in its absorption.
Acidum nalidixicum weakens antimicrobic effect of drug.
The antigouty means blocking canalicular secretion (probenetsid, Sulfinpyrazonum) reduce the level of a furadonin in urine (antibacterial action is weakened) and raise in blood (the toxicity amplifies).
Furadonin is incompatible with ftorkhinolona.
Interaction with food components. Acid fruit juice enhances effect of a furadonin, up to a possibility of development of toxic effect.
when assigning it is necessary
to be careful at persons with diabetes, anemia, electrolytic disturbances, group B vitamin deficiency since strengthening of neurotoxic effect of drug is possible.
Furadonin it is not necessary to apply to treatment of diseases of a glomerulonephritis, a purulent paranephritis, prostatitis.
Pregnancy and a lactation
Use during pregnancy of a furadonin is contraindicated. In need of its use in the period of a lactation it is necessary to separate the child from a breast for the entire period of treatment.
Use in pediatrics
is not recommended to be applied at newborns is younger than 1 month and premature children.
Influence on ability to driving of motor transport and control of mechanisms
It is necessary to be careful
At introduction of high doses perhaps appearance of dizziness, nausea, vomiting.
Help measures: drug withdrawal, reception of a large amount of liquid for increase in excretion of drug with urine, a hemodialysis, symptomatic therapy. Specific antidote does not exist.
A form of release and packing
On 10 tablets in planimetric bezjyacheykovy packing. Planimetric bezjyacheykovy packings together with the corresponding number of instructions for use in the state and Russian languages place in group packing.
In the dry, protected from light place, at
a temperature not higher than 25 S. Hranit out of children’s reach!
The 4th year
not to apply an expiration date after expiry date.
According to the prescription
RUP Producer the Borisovsky plant of medications,
Republic of Belarus. Minsk Region, Borisov, Chapayev St., 64/27