Bi-Septin - instructions for use, dose, side effects, contraindications

Flat round tablets white or white with a yellowish tinge color with a bevelled edge, with the inscription 120 on one side, on the other side engraving NP against the background of a tree.

BI-SEPTIN tablets 480 mg:

Flat round tablets white or white with a yellowish tinge color with a bevelled edge, with a risk on one side, on the other side engraving NP 480 on the background of wood

Pharmacotherapeutic group:Antimicrobial combination

ATX: & nbsp

J.01.E.E.01 Co-trimoxazole [sulfamethoxazole in combination with trimethoprim]

Pharmacodynamics:

Combined antimicrobial drug consisting of sulfamethoxazole and trimethoprim.

Sulfamethoxazole, similar in structure to PABA, disrupts the synthesis of dihydrofolic acid in bacterial cells, preventing the inclusion of PABA in its molecule.

Trimethoprim enhances the action of sulfamethoxazole, disrupting the reduction of dihydrofolic acid into a tetrahydrofolic - active form of folic acid, responsible for protein metabolism and division of the microbial cell.

It is a broad-spectrum bactericidal drug that is active infollowing microorganisms: Streptococcus spp. (haemolytic strains more sensitive to penicillin), Staphylococcus spp., Streptococcus pneumoniae, Neisseria meningitides, Neisseria gonorrhoeae, Escherichia coli (including enterotoxogenic strains), Salmonella spp. (including Salmonella typhi and Salmonella paratyphi), Vibrio cholerae, Bacillus anthracis, Haemophilus influenzae (including ampicillin-resistant strains), Listeria spp., Nocardia asteroids, Bordetella pertussis, Enterococcus faecalis, Klebsiella spp., Proteus spp., Pasteurella spp., Francisella tularensis, Brucella spp., Mycobacterium spp. (incl. Mycobacterium leprae), Citrobacter, Enterobacter spp., Legionella pneumopnia, Providencia, some species Pseudomonas (Besides Ps. aeruginosa), Serratia marcescens. Shigella (flexneri and sonnei), Yersinia spp., Morganella spp., Pneumocystis carini; large viruses - Chlamydia spp. (incl. Chlamydia trachomatis, Chlamydia psittaci); protozoa: Plasmodium spp., Toxoplasma gondii, pathogenic fungi, Actinomyces israelii, Coccidiodes immitis, Histoplasma capsulatum, Leishmania spp. Resistant to the drug: Corynebacterium spp .. Pseudomonas aeruginosa, Mycobacterium tuberculosis, Treponema spp., Leptospira spp., viruses.

Inhibits the vital activity of E. coli, which leads to a decrease in the synthesis of thiamine, riboflavin, nicotinic acid, etc. vitamins of group B in the intestine. The duration of the therapeutic effect is 7 hours.

Pharmacokinetics:

When oralAbsorption is 90%. TSmoh -1 to 4 hours, the therapeutic level of concentration is 7 hours after a single dose. Well distributed in the body. It penetrates the GEB, the placental barrier and into breast milk. In the lungs and urine creates concentrations exceeding the content in the plasma. To a lesser extent, they accumulate in the bronchial secretion, vaginal secretions,secretion and tissue of the prostate, middle ear fluid, cerebrospinal fluid, bile, bones, saliva, watery eyes, breastmilk, interstitial fluid. Connection with plasma proteins -66 % at sulfamethoxazole, in trimethoprim - 45%.

More sulfamethoxazole is metabolized with the formation of acetylated derivatives. Metabolites do not have antimicrobial activity.

It is excreted by the kidneys in the form of metabolites (80 % for 72 hours) and unchanged (20 % sulfamethoxazole, 50% trimethoprim); a small amount - through the intestine. T1 / 2 sulfamethoxazole - 9-11 h, trimethoprim - 10-12 h, in children - significantly less depends on age; before the first year, 7-8 hours, 1-10 years - 5-6 hours. In elderly and patients with impaired renal function, T1 / 2 increases.

Indications:

Urinary tract infections: urethritis, cystitis, pyelitis, pyelonephritis, prostatitis, epididymitis, gonorrhea (male and female), mild chancroid, venereal lymphogranuloma, inguinal granuloma; respiratory tract infections: bronchitis (acute and chronic), bronchiectasis, croupous pneumonia, bronchopneumonia, pneumocystic pneumonia, pleural empyema, lung abscess; infection of the ENT organs: otitis media,sinusitis, laryngitis, tonsillitis: gastrointestinal infections: typhoid, paratyphoid, salmonellonositelstvo, cholera, dysentery, bacterial diarrhea, cholecystitis, cholangitis, gastroenteritis, caused by strains enterotoksichnymi E. coli; infections of the skin and soft tissues: acne, furunculosis, pyoderma, absess and wound infection; osteomyelitis (acute and chronic), brucellosis (acute), osteoarticular infections, South American blastomycosis, malaria (Plasmodium falciparum), toxoplasmosis and pertussis (as part of complex therapy), scarlet fever.

Contraindications:Hypersensitivity (including sulfonamide or trimethoprim), hepatic and / or renal failure (creatinine clearance less than 15 mL / min), aplastic anemia, B12 deficiency anemia, agranulocytosis, leukopenia, deficiency of glucose-6-phosphate dehydrogenase, hyperbilirubinemia in children, lactation, pregnancy, children under 3 years (for this dosage form).

Carefully:

Deficiency of folic acid, bronchial asthma, thyroid gland diseases.

Dosing and Administration:

The drug is taken orally after a meal with a sufficient amount of liquid.

Dose is administered individually.

Adults and children over 12 years of age - 960 mg once or 480 mg twice a day. In severe infections - 480 mg 3 times a day, for chronic infections, the maintenance dose is 480 mg 2 times a day.

Children 3-6 years - 120-240 mg 2 times a day, 6-12 years - 240-480 mg 2 times a day.

The minimum duration of treatment is 4 days; After the disappearance of symptoms, therapy is continued for 2 days. With chronic infections, the course of treatment is longer. In acute brucellosis - 3-4 weeks, with typhoid fever and paratyphoid - 1-3 months.

To prevent the recurrence of chronic urinary tract infections, adults and children over 12 years of age - 480 mg once a day at night, children under 12 years - 12 mg / kg / day. Duration of treatment - 3-12 months. The course of treatment of acute cystitis in children 7-16 years - 480 mg 2 times a day for 3 days.

With gonorrhea - 1920-2880 mg / day for 3 doses.

With gonorrheal pharyngitis (with hypersensitivity to penicillin) - 4320 mg once a day for 5 days.

With pneumonia caused by Pneumocistis carinii -120 mg / kg / day with an interval of 6 hours for 14 days.

To achieve maximum efficacy, a constant concentration of trimethoprim in plasma or serum should be maintained at 5 μg / ml or higher.

Side effects:

Usually the drug is well tolerated. In some cases, there are:

From the side of the nervous system: headache, dizziness; in some cases - aseptic meningitis, depression, apathy, tremor, peripheral neuritis.

On the part of the respiratory system: bronchospasm, pulmonary infiltrates.

On the part of the digestive system: nausea, vomiting, decreased appetite, diarrhea, gastritis, abdominal pain, glossitis, stomatitis, cholestasis, rheumatismExercise of "hepatic" transaminases, hepatitis, hepatonecrosis, pseudomembranous enterocolitis.

Co sides of hemopoiesis: leukopenia, neutropenia, thrombocytopenia, agranulocytosis, megaloblastic anemia.

From the urinary system: polyuria, interstitial nephritis, renal dysfunction, crystalluria, hematuria, increased urea concentration, hypercreatininaemia, toxic nephropathy with oliguria and anuria.

From the musculoskeletal system: arthralgia, myalgia.

Allergic reactions: itching, photosensitivity, rash, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), exfoliative dermatitis, allergic myocarditis, fever, angioedema, hyperemia sclera.

Other: hypoglycaemia.

Overdose:

Symptoms; nausea, vomiting, intestinal colic, dizziness, headache, drowsiness, depression, fainting, confusion, visual impairment, fever, hematuria, crystalluria; with prolonged overdose - thrombocytopenia, leukopenia, megaloblastic anemia, jaundice.

Treatment: gastric lavage, urine acidification increases the excretion of trimethoprim, intake of fluid inside, in / m - 5-15 mg / day of calcium folinate (eliminates the effect of trimethoprim on the bone marrow), if necessary - hemodialysis.

Interaction:

The drug is not recommended to be taken simultaneously with thiazide diuretics because of the risk of thrombocytopenia (bleeding). Co-trimoxazole enhances the anticoagulant activity of warfarin and anticonvulsant phenytoin.

Reduces the reliability of oral contraception (inhibits the intestinal microflora and reduces the intestinal-hepatic circulation of hormonal compounds).

Pyrimethamine in doses exceeding 25 mg / week increases the risk of megaloblastic anemia.

Kolestyramine lowers absorption, so it should be taken 1 hour after or 4-6 hours before taking co-trimoxazole.

Trimethoprim potentiates the action of antidiabetic drugs of sulfonylurea derivatives. Rifampicin reduces the half-life of trimethoprim. Co-administration of co-trimoxazole and cyclosporine after kidney surgery worsens the condition of patients.

It is not recommended simultaneous administration of the drug with salicylates, butudionum, naproxen and paraaminobenzoic acid derivatives.

Special instructions:

With long (more than a month) treatment courses, regular blood tests are necessary, since there is a possibility of hematological changes (most often asymptomatic).

For the prevention of crystalluria it is recommended to maintain a sufficient volume of excreted urine.

It is also inappropriate to use food products containing large quantities of PABC, green parts of plants (cauliflower, spinach, beans), carrots, tomatoes.

Excessive sunlight and UV irradiation should be avoided.

It is not recommended for use in tonsillitis and pharyngitis caused by beta-hemolytic streptococcus group A, due to widespread resistance of strains.

Form release / dosage:

Tablets 120 mg and 480 mg.

For 10.20 tablets in a PVC blister/ AL or 2,4, 6,10, 12, 14 tablets in a strip AL / AL.

For 1, 2, 3, 4, 5 blisters or 1, 2, 3, 4, 5, 10, 15 strips in a cardboard box with instructions for use.

Storage conditions:Store in a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Terms of leave from pharmacies:On prescription

Registration number:П N014348 / 01

Date of registration:29.12.2006

Expiration Date:29.12.2011

The owner of the registration certificate:Natur Product Europe BVNatur Product Europe BV Netherlands

Manufacturer: & nbsp

NATUR PRODUKT EUROPE, B.V. Netherlands

Representation: & nbspNatur Product International Inc.Natur Product International Inc.Russia

Information update date: & nbsp25.01.2017

Illustrated instructions

Instructions

Bi-Septin (Bi-Septin)