Furazolidone 50 mg (10 tablets)

The instruction for use

of medicine for experts

FURASOLIDONE

(Furazolidonum)

A trade name

Furasolidone

the International unlicensed

name Furasolidone Dosage Form

of the Tablet of 0.05 g

Structure

One tablet contains

active agent furasolidone of 0.05 g,

excipients: sugar milk, potato starch, calcium stearate, aerosil.

The description

of the Tablet from yellow till chartreuse color, ploskotsilindrichesky, with a facet

Pharmacotherapeutic group

Other antiseptic and antimicrobial means for use in gynecology.

The code of automatic telephone exchange G01AX06

the Pharmacological

Pharmacokinetics At properties intake is well soaked up in digestive tract. The maximum concentration of furasolidone in blood plasma after reception in a dose of 100 mg makes 0.25-0.43 mkg/ml and is reached in 1.85-3.0 h.

Easily gets through a placenta, a blood-brain barrier. In therapeutic concentration it is found in urine and excrements.

Is exposed to biotransformation in a liver with formation of an amin derivative. It is brought out of an organism with urine, at the same time the share of not changed medicine makes 65% and also with excrements.

Pharmacodynamics

Synthetic antimicrobial broad-spectrum agent. Works bacteriostatically and bakteritsidno.

The mechanism of action is connected with restoration of furasolidone in cells of microorganisms under the influence of flavoprotein (at aerobic organisms) and ferredoksinreduktaza (at anaerobic organisms and parasitic protozoa) in active the intermediant who damages ribosomalny proteins, breaks synthesis of protein, DNA, RNA.

It is active concerning gram-positive aerobic bacteria: Staphylococcus spp., Streptococcus spp., gram-negative aerobic bacteria: Escherichia coli, Enterobacter spp., Helicobacter pylori, Klebsiella spp., Salmonella spp., Shigella spp., Proteus spp. It is active concerning Enterococcus spp., sort Candida mushrooms. It is active concerning the simplest Trichomonas vaginalis, Giardia lamblia. Causative agents of dysentery, typhoid and paratyphoid are most sensitive to drug (Salmonella spp., Shigella spp.) Poorly influences on causative agents of a purulent and mephitic gangrene Pseudomonas aeruginosa, Acinetobacter spp. Microbic drug resistance develops slowly.

Indications

- dysentery

- paratyphus

- food toxicoinfections and acute bacterial diarrheas

- an eradikation of H. pylori at treatment of a peptic ulcer of a stomach and duodenum, chronic gastritis (as a part of the scheme of the second row of therapy)

- mecotic colpitises, uretrita

- a giardiasis.

The route of administration and doses

use Drug inside, after a meal, washing down with a large amount of water.

The adult on 100-150 mg 4 times a day, a course of treatment of 7-10 days. It is recommended to carry out treatment by cycles for 3-6 days at an interval of 3-4 days in the same doses. The maximum dose for adults: single 200 mg, daily 800 mg.

To children drug appoint in a dose 10 mg/kg/days in 3-4 receptions.

At treatment of a giardiasis, furasolidone is appointed by the adult on 100 mg by 4 times a day.

In mecotic colpitises carry out the combined treatment by furasolidone inside on 100 mg 3-4 times a day 3-4 days, at the same time intravaginalno enter 5-6 g of the powder containing furasolidone in mix with milk sugar in the ratio 1:400-500 rektalno use suppositories with furasolidone. Treatment is carried out daily within 7-14 days.

At an eradikation of H. pylori at persons with a peptic ulcer of a stomach and duodenum, chronic gastritis furasolidone apply in a dose 400 mg/days in 4 inclusion in combinations with amoxicillin (2000 mg/days) and N+/K+-ATFazy inhibitors in standard doses. Course of treatment of 10-14 days. (The scheme of the second row of therapy recommended by the III Maastricht agreement).

Side effects

- nausea, vomiting, anorexia

- dizziness, polyneurites

- skin allergic reactions (in the form of skin rash).

Contraindications

- the profound renal failures, a renal failure, an oliguria

- insufficiency glyukozo-6-fosfatdegidrogenazy,

- a sharp porphyria

- children's age up to 2 years

- the I trimester of pregnancy

- hypersensitivity to furasolidone.

The medicinal interactions

of Means alkalizing urine (Natrii hydrocarbonas, Trisaminum) reduce effect of furasolidone (due to acceleration of its removal with urine), and the means acidifying urine (solutions of amino acids, ascorbic acid, methionine, orotat potassium) raise it.

Aminoglycosides and tetracyclines strengthen antimicrobial effect of furasolidone.

At combined use with chloramphenicol and Ristomycinum strengthens gematotoksichesky effect (ability to oppress a hemopoiesis) of these medicines.

Possesses disulfiramopodobny action, sensibilizing an organism to ethanol metabolism products. During treatment by furasolidone use of the drinks containing alcohol is contraindicated.

Furasolidone inhibits MAO, at its use it is necessary to exclude from a diet the fermented foodstuff containing tyramine (red wines, smoked meat and meat products, oysters, soft grades of cheese, chocolate, products with soy protein). Acid fruit juice enhances effect of furasolidone, up to a possibility of development of toxic effect.

At combined use with antidepressants from group of MAO inhibitors (Nialamidum, Tranylcyprominum, moklobemid), risk of developing hypertensive crisis arises tricyclic antidepressants (Imipraminum, amitriptyline), sympathomimetics (ephedrine, cocaine).

Vitamins of group B weaken neurotoxic undesirable effect of furasolidone.

Special instructions
when assigning it is necessary
to be careful at persons with electrolytic disturbances, renal failures, group B vitamin deficiency since strengthening of neurotoxic effect of drug is possible.

Pregnancy and a lactation

Use in II and III trimester of pregnancy of furasolidone is possible only after careful assessment of a ratio advantage/risk for mother and a fruit. 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 children 2 years

Influence on ability to driving of motor transport and control of mechanisms

In therapeutic doses are younger furasolidone has no undesirable impact on ability of control of the vehicle or other operator activity.

Overdose

At introduction of high doses the emergence of neurotoxic reactions, polyneurites, acute toxic hepatitis, disturbances from the haematogenic system is possible.

Help measures: drug withdrawal, reception of a large amount of liquid for increase in excretion of drug with urine, a hemodialysis, symptomatic therapy (antihistamines, group B vitamins). 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.

To Store storage conditions in the dry, protected from light place, at a temperature from 5 to 30 Pages.

To store out of children's reach!

3 years

not to apply an expiration date after expiry date.

Prescription status

According to the prescription

RUP Producer the Borisovsky plant of medications,

Republic of Belarus. Minsk Region, Borisov, Chapayev St., 64/27