The instruction for medical use
of BISEPTOLUM medicine
A trade name
the International unlicensed name
Is not present
the Dosage form
Suspension for oral administration of 240 mg / 5 ml of 80 ml
of 100 ml of suspension contain
active agents: Trimethoprimum of 0.8 g,
sulfamethoxazole of 4.0 g
excipients: a macrogoal glitserilgidroksistearat, magnesium aluminosilicate, sodium of a karmelloz, citric acid monohydrate, hydrophosphate sodium dodecahydrate, methylparahydroxybenzoate, propyl-parahydroxybenzoate, maltitol, sodium saccharinate, fragrance strawberry, propylene glycol, water purified.
Suspension of white or light-cream color with a strawberry smell.
Antimicrobial drugs for system use.
Streptocides in a combination with Trimethoprimum and its derivatives.
The code of automatic telephone exchange J01EE01
Pharmacokinetics Later properties of intake in a therapeutic dose active agents quickly and almost completely (90%) are soaked up in an upper piece of a small intestine and already 60 min. later reach therapeutic concentration in blood and fabrics which remains during the 12th hour. The maximum concentration of active agents in blood plasma are reached in 1-4 hours. Communication with proteins of plasma makes 66% at sulfamethoxazole and 45% at Trimethoprimum. Drug is well distributed in an organism.
Drug gets into milk of mother and through a placental barrier. Sulfamethoxazole and Trimethoprimum are metabolized in a liver.
Elimination half-life fluctuates from 10 to 12 hours.
Biseptolum – the chemotherapeutic combined medicine containing sulfamethoxazole and derivative diaminpyridine – Trimethoprimum in the ratio 5:1. Sulfamethoxazole breaks utilization of paraaminobenzoic acid and therefore, synthesis of dihydrofolic acid. Trimethoprimum inhibits enzyme which participates in transformation of dihydrofolate into active tetrahydrofolate. The combination of both components allowed to receive bactericidal action. Biseptolum is active concerning gram-positive bacteria: streptococci (Streptococcus pneumoniae, S. agalactiae, S. viridans), stafilokokk (Staphylococcus aureus, Staphylococcus epidermidis), Listeria monocytogenes, Nocardia asteroides and gram-negative, including majority of sticks of Enterobacteriaceae (types of Salmonella, Shigella, Klebsiella, Proteus mirabilis, Enterobacter, part of strains of Escherichia coli), part of strains of H.influenzae, Legionella spp., Yersinia enterocolitica, Brucella spp., Neisseria meningitidis, Neisseria gonorrhoeae and also Pneumocystis carinii. Sticks (Mycobacteriaceae), viruses, the majority of anaerobic bacteria and mushrooms are resistant to drug.
– respiratory infections exacerbation of chronic bronchitis, treatment and prevention (primary and secondary) the pneumonia caused Pneumocystis carinii at adults and children
– sinusitis, acute average otitis
– digestive tract infections: typhoid and paratyphoid, bacterial dysentery (shigelloses), diarrhea, cholera.
– acute and persistent infections of an urinary system and a prostate (urethritis, cystitis, prostatitis)
– a venereal ulcer
– a brucellosis, osteomyelitis, a nocardiosis, actinomycosis, toxoplasmosis and
the South American zymonematosis (the combination to other
antibiotics is possible)
The route of administration and doses
take the Drug inside in time or right after food with a large amount of liquid.
Before the use to shake up before receiving uniform suspension.
5 ml of suspension contain 200 mg of sulfamethoxazole and 40 mg of Trimethoprimum.
The measured cap with a scale is applied to packing.
At children 6 mg of Trimethoprimum and 30 mg of sulfamethoxazole on 1 kg of body weight a day are usually applied. In heavy infections of a dose it is possible to increase by 50%.
from the 3rd month
to 6 months
from the 7th month
to 3 years
from 4 of life
to 6 years
from 7 of life
to 12 years
Adults and children is more senior than 12 years usually of 20 ml, each 12 hours. The maximum dose (for use in especially hard cases) 30 ml of suspension each 12 hours.
In acute infections it is necessary to accept Biseptolum not less than 5 days or until symptoms at the patient are not absent within 2 days. If in 7 days of treatment of clinical improvement does not come, it is necessary to estimate repeatedly the patient’s condition for possible correction of treatment.
In infections of the caused Pneumocystis carinii of 120 mg/kg/days, each 6 hours within 14-21 days.
A course of treatment in an infection of urinary tract and acute otitis of 10 days, shigelloses of 5 days.
Patients with a renal failure
At clearance of creatinine & gt, 30 ml/min. appoint a usual dose, at clearance of creatinine from 15 to 30ml/mines a half of a usual dose, and at decrease in clearance of creatinine to & lt, 15 ml/min. is not recommended to apply Biseptolum.
Usually drug is well transferred.
Frequency is not known
– nausea, vomiting, lack of appetite, diarrhea, an abdominal pain, gastritis, stomatitis, a glossitis
– a leukopenia, a neutropenia, thrombocytopenia
– temperature increase, a shiver
– rash, urticaria, the polymorphic erythema, an itching
– a pseudomembranous coloenteritis
– reactions of hypersensitivity which are shown in the form of fervescence, a Quincke’s disease, anaphylactoid reactions – pulmonary infiltrates as an eosinophilic, allergic alveolitis with cough or short wind
– a reversible hyperpotassemia, a hypoglycemia, a hyponatremia
– a headache, dizziness, hallucinations, a sleep disorder, a depression
– neuropathy (including, peripheral neuritis and paresthesias)
– increase in activity of transaminases and concentration of bilirubin, hepatitis, a cholestasia, liver necrosis
– a photosensitization
– a renal failure, interstitial nephrite, increase
in urea nitrogen of blood, serum creatinine, a crystalluria, increase in a diuresis, especially at patients with hypostases of warm origin
In isolated cases
– an agranulocytosis, a pancytopenia, megaloblastichesky anemia, hemolytic is much more rare, the methemoglobinemia
– a nodular periarteritis, allergic myocarditis
– aseptic meningitis
– Shenleyn-Genokh’s purpura
– a rhabdomyolysis
– Stephens-Johnson’s syndrome
– a Lyell’s disease
– an arthralgia,
– hypersensitivity to streptocides, Trimethoprimum and/or
to other components of drug
– a concomitant use with dofetilidy
– the profound abnormal liver functions or kidneys (the clearance of creatinine
is lower than 15 ml/min.)
– the megaloblastny anemia caused by deficiency of folic acid
– treatment of a streptococcal tonsillitis
– pregnancy and the period of a lactation
– children’s age up to 3 months
Biseptolum applied along with diuretics, especially from group of tiazid raises a possibility of manifestation of thrombocytopenia with bleeding. Can extend a prothrombin time at the patients accepting anticoagulants (for example warfarin).
Strengthens action of anti-diabetic means, sulphonylurea derivatives.
Slows down metabolism of Phenytoinum in a liver (raises its half-life period to 39%). Can also increase concentration of a free methotrexate in blood plasma (increases release of a methotrexate from its connections with proteins).
As well as effect of oral glucose-lowering drugs from group of sulphonylurea can exponentiate other streptocides, Biseptolum.
At Biseptolum co-administration by the patient which receive Pyrimethaminum for prevention of malaria in doses more than 25 mg a week at them megaloblastichesky anemia can develop.
At the patients receiving Biseptolum and cyclosporine after transplantation of a kidney the reversible deterioration in function of kidneys which is shown increase in level of creatinine can be observed.
At a concomitant use with Biseptolum it is necessary to lower an indometacin dose.
Increase in serumal concentration of digoxin, especially at elderly patients is possible, at a concomitant use with Biseptolum.
At simultaneous use of Biseptolum and a zidovudine growth of risk of hematologic disturbances is possible. In case of need uses of Biseptolum and a zidovudine it is necessary to control a blood pattern.
The efficiency of tricyclic antidepressants can decrease at reception with Biseptolum.
researches Biseptolum can affect results of definition of concentration of a methotrexate in serum by method of competitive linking with proteins when as a ligand the bacterial digidrofolatreduktaza is applied. When determining a methotrexate by a radio immune method of distortions does not arise.
Biseptolum can break reaction of definition of creatinine with use of the alkaline pikrinat of Jaffe (increases creatinine level approximately by 10%).
patients of advanced and senile age and also in associated diseases of a liver and kidneys or at the same time intake of other drugs have higher risk of development of heavy allergic reactions, such as Stephens-Johnson’s syndrome, Lyell’s disease and acute necrosis of a liver. For reduction of risk similar reactions treatment by Biseptolum has to be as much as possible short-term, especially at elderly.
At the first appearance of skin rash or any other heavy side reaction, drug should be cancelled. Patients with tendency to allergic reactions and with bronchial asthma should appoint Biseptolum with care.
At therapy course duration more than 14 days and/or increase in a dose of drug it is necessary to control a pattern of peripheral blood, at emergence of pathological changes it is necessary to take prescribing of folic acid into account.
Patients of advanced age and also at patients with deficiency of folic acid or a renal failure can have hematologic changes characteristic of a lack of folic acid.
When prescribing Biseptolum the patients who already receive anticoagulants should remember possible strengthening of anticoagulative effect. In such cases it is necessary to define a blood clotting time repeatedly.
Patients should not appoint drug with hereditary intolerance of fructose.
The patient, it is long Biseptolum receiving treatment (especially in a renal failure), it is regularly necessary to do the general analysis of urine and to control function of kidneys. During treatment it is necessary to provide sufficient intake of liquid in an organism an adequate diuresis for prevention of a crystalluria.
Because of a possibility of hemolysis by the patient with deficiency of glyukozo-6-phosphate-dehydrogenase Biseptolum is appointed only according to absolute indications and in the minimum doses.
Neobkhodimimo to be careful at patients with a porphyria or dysfunction of a thyroid gland.
At the patients accepting Biseptolum in high doses it is regularly necessary to control potassium content in serum. High doses of Biseptolum what are used at treatment of pneumocystic pneumonia can lead to progressing, but to reversible increase in content of potassium in serum at considerable number of patients. Even reception of the recommended Biseptolum doses can cause a hyperpotassemia if it is appointed against the background of disturbances of potassium exchange, a renal failure or a concomitant use of the drugs provoking a hyperpotassemia.
At treatment by high doses of Biseptolum it is necessary to consider a possibility of development of a hypoglycemia, usually in several days after an initiation of treatment. The risk of a hypoglycemia is higher at patients with renal failures, liver diseases, malnutrition.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Should be limited performance of work, mental and physical reactions and driving of the car demanding high speed, in case of such side effects as: headache, dizziness, drowsiness and hallucinations
Symptoms of acute overdose: nausea, vomiting, diarrhea, headache, dizziness, drowsiness, loss of consciousness, fever, disorders of vision, disorientation, crystalluria, hamaturia and anury.
Symptoms of chronic overdose: hemopoiesis oppression (thrombocytopenia, a leukopenia) and also other pathological changes of a picture of blood owing to insufficiency of folinovy acid.
Treatment (depending on symptomatology): prevention of further absorption of drug (for example, intake of activated carbon), strengthening of renal excretion by an artificial diuresis, a hemodialysis (peritoneal dialysis is inefficient). It is necessary to control a blood count and content of electrolytes. For elimination of gematotoksichesky effect it is possible to appoint folinat calcium in a dose 5-15 mg a day before restoration of a normal gematopoez.
The form of release and packing
On 80 ml of drug place in bottles from orange glass with a white polyethylene cover. On 1 bottle together with the instruction for medical use in the state Russian languages and a measured glass with a scale pack into a cardboard pack.
To Store storage conditions in original packing at a temperature not over 25C.
To store out of children’s reach.
Period of storage
After the first opening of packing – 8 months.
Not to apply after an expiration date.
According to the prescription
of Medan of JSC Pharm
98-200 Seradz, V. Loketk St. 10, Poland
the Owner of the registration certificate
of JSC Khimfarm, Kazakhstan
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods)
of JSC Khimfarm,
Shymkent, REPUBLIC OF KAZAKHSTAN, Rashidov St.,/N, ph.: 560882
Phone number 7252 (561342)
Fax number 7252 (561342)
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