for medical use of medicine
the Trade name
the International unlicensed
name Phthalylsulfathiazole Dosage Form
of the Tablet of 0.5 g
One tablet contains Structure
active agent: phthalylsulfathiazole of 0.500 g,
excipients: potato starch, talc, calcium stearate.
of the Tablet of color, white or white with slightly yellowish shade, a ploskotsilindrichesky form with risky and a facet.
Intestinal antimicrobial and anti-inflammatory drugs. Streptocides. Phthalylsulfathiazole.
The ATX A07AB02 code
Pharmacokinetics Drug properties is slowly soaked up from digestive tract: its main quantity is late in an intestines gleam. In a small intestine breaks up with formation of sulphathiazole (Norsulfazolum) having high antimicrobial activity.
The created high concentration of sulphathiazole in intestines, taking into account specific bacteriostatic activity concerning indestinal flora, cause efficiency of phthalylsulfathiazole in intestinal infections.
Ftalazolum possesses a wide range of antimicrobial action. It is active concerning a row gram-positive (Streptococcus, Pneumococcus, Staphylococcus) and gram-negative (Meningococcus, Gonococcus, Shigella dysenteriae, Eschericha coli, Pseudomonas aeruginosa, Proteus vulgaris) microorganisms, including causative agents of intestinal infections.
Shows bacteriostatic action.
– acute dysentery
– chronic dysentery in an aggravation stage
– colitis (including ulcer)
– a gastroenteritis
– amoebic dysentery and paratyphoid infections (as supportive application in complex therapy)
– prevention of purulent complications at surgeries on intestines
In acute form of dysentery by the adult appoint the Route of administration and doses inside in 1 – the 2nd day on 6 g a day (each 4 hours on 1 g), in 3 – the 4th day – on 1 g 4 times a day (each 6 hours), in 5 – the 6th day – on 1 g 3 times a day (each 8 hours). On a course of treatment of only 25 – 30 g.
After the first course of treatment (in 5-6 days) conduct the second year: 1-the 2nd day – on 1 g in 4 hours (at night in 8 hours), only 5 times a day, 3 – the 4th day – on 1 g 4 times a day (do not appoint at night), only 4 g a day, the 5th day – on 1 g 3 times a day (do not give at night), only 3 g a day. During the second year the general dose of 21 g, at the easy course of the disease a dose on the second year – 18 g.
In other infections the adult in the first 2-3 days on 1-2 g each 4-6 hours, in the next 2-3 days – half doses. The highest doses for adults: single – 2 g, daily – 7 g.
In acute dysentery to children aged from 6 up to 12 years on 0.5 – 0.75 g on reception 4 times a day.
In other infections to children appoint in the 1st day 0.1 g/kg of body weight a day. Each 4 h with a break for the night give drug equal doses. In the next days each 6-8 h give 0.25-0.5 g. A course of treatment – up to 7 days.
– a headache, dizziness, suppressed mood
– nausea, vomiting, a diarrhea, damages of a mucous membrane of an oral cavity (stomatitis, an ulitis, a glossitis), gastritis, a cholangitis, hepatitis, group B vitamin deficiency (owing to intestinal microflora oppression)
– an agranulocytosis, aplastic anemia, a leukopenia, thrombocytopenia
– allergic and toksiko-allergic reactions, seldom allergic hypostasis of lips, persons, a nodular periarteritis
of the Contraindication
– hypersensitivity to streptocides
– blood diseases
– an acute hepatitis
– children’s age up to 6 years
– a diffusion toxic craw
– chronic kidney disease, an acute hepatitis
– a glomerulonephritis
– pregnancy and the period of a lactation
of PASK (p-aminosalicylic acid) and barbiturates – amplifies activity of streptocides
salicylates – the activity and toxicity of streptocides
a methotrexate and Phenytoinum amplifies – the toxicity of streptocides
thioacetazone, levomycetinum amplifies – the possibility of development of an agranulocytosis
nitrofurans increases – the risk of developing of anemias and a methemoglobinemia
anticoagulants of indirect action increases – anticoagulating action
Oxacillinum amplifies – the activity of an antibiotic decreases.
At the combined use of Ftalazolum with the drugs containing ethers of paraaminobenzoic acid (Procainum, benzocaine, tetracaine) the antibacterial activity of streptocide on the competitive mechanism is inactivated.
The effect of action is enhanced by antibiotics and well soaking up streptocides.
Depending on the nature of a disease Ftalazolum can be applied in combination with antibiotics. Along with drug it is reasonable to appoint streptocides which are well soaked up (Sulfadimezinum, Etazolum, Etazolum-sodium, etc.).
With care appoint at nefroza, nephrites.
Pregnancy and the period of a lactation
Drug easily gets through a placenta, and in researches on animals its adverse action on a fruit is revealed therefore drug is not used during pregnancy.
In mother’s milk the concentration of drug equals its concentration in blood serum and can cause a kernicterus in children and also hemolytic anemia in children with deficit glyukozo-6-fosfatdegidrogenazy therefore drug is not appointed during feeding a breast.
Features of influence of medicine on ability to run motor transport or potentially dangerous mechanisms
Drug does not affect ability to run motor transport or potentially dangerous mechanisms.
Symptoms: the nausea, vomiting, diarrhea, dispeptic disorders, stomach aches, allergic reactions disappearing after the termination of administration of drug.
Treatment: artificial vomiting, gastric lavage (in the first 1-2 hours after reception), therapy of the observed symptoms. At the phenomena of a renal failure dialysis can be necessary.
A form of release and packing
On 10 tablets in planimetric bezjyacheykovy packing with a polyethylene covering. Planimetric bezjyacheykovy packings together with iinstruktion on medical 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 not above 25 °C
to Store out of children’s reach!
A period of storage
not to use after an expiration date
According to the prescription
JSC Irbit Chemical and Pharmaceutical Plant Producer,
Russian Federation 623856, Sverdlovsk Region, Irbit, Kirov St., 172 Ph. / fax (34355) 3-60-90
The owner of the registration certificate
of JSC Irbit Chemical and Pharmaceutical Plant, the Russian Federation
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products
of JSC Irbit Chemical and Pharmaceutical Plant,
623856, Russian Federation, Sverdlovsk Region, Irbit,
Kirov St., 172 Ph. / fax (34355) 3-60-90
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