MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION
INSTRUCTIONS for the use of the drug for medical use
Tradename Biseptol 480
International non-proprietary name of active ingredients Co-trimoxazole [Sulfamethoxazole + Trimethoprim]
Dosage Form Concentrate for solution for infusion
The composition of 1 ml of concentrate Active substances: sulfamethoxazole 80.00 mg + trimethoprim 16.00 mg. Excipients: propylene glycol 400.00 mg, ethyl alcohol 96% 100.00 mg. benzyl alcohol 15.00 mg, sodium disulfite (E223)
Description Transparent colorless or slightly yellowish liquid.
Pharmacotherapeutic group Antimicrobial agent combined.
ATX code: J01EE01
Pharmacological properties Pharmacodynamics Biseptol is a combination antibacterial agent containing co-trimoxazole – a mixture in the ratio of 5: 1 sulfamethoxazole and trimethoprim. Sulfamethoxazole inhibits folic acid synthesis by competitive antagonism with para-aminobenzoic acid,
Indications for use Infectious and inflammatory diseases caused by microorganisms sensitive to co-trimoxazole:
- urinary tract infections: urinary tract infections, soft chancre;
- respiratory tract infections: chronic bronchitis, treatment and prevention of pneumonia caused by Pneumocystis jiroveci (formerly P. carinii) (PCP);
- infections of upper respiratory tract: otitis media (in children);
- gastrointestinal infections: typhoid and paratyphoid fever, cholera, dysentery, gastroenteritis caused by enterotoxic Escherichia coli strains;
- other bacterial infections: nocardiosis, brucellosis, actinomycosis, South American blastomycosis, toxoplasmosis.
Biseptol 480 should be used in cases where oral medication is impossible (or not recommended), or, in the opinion of the physician, it is necessary to use a medicine containing two antibacterial ingredients.
- Hypersensitivity to sulfonamides, trimethoprim, co-trimoxazole or any auxiliary component of the drug;
- severe damage to the liver parenchyma;
- severe renal failure (CC less than 15 ml / min);
- liver failure;
- severe hematological disorders: aplastic anemia, B12-deficient anemia, agranulocytosis, leukopenia, deficiency of glucose-6-phosphate dehydrogenase;
- the administration of a drug diagnosed with porphyria or patients who are at risk of developing acute porphyria should be avoided,
Carefully Care should be taken when prescribing Biseptol 480 patients with folic acid deficiency (for example, people with alcohol dependence, treatment with anticonvulsants, malabsorption syndrome and the elderly); patients with asthma and severe allergies; patients with circulatory and respiratory diseases,
Dosage and administration Biseptol 480, a concentrate for preparing an infusion solution, is intended only for intravenous administration and should be diluted immediately before use. After the injection of Biseptol 480 into the solution for infusion, the resulting mixture should be shaken vigorously with the aim of complete mixing. If a precipitate is found or crystals appear before mixing or during infusion, the mixture should be destroyed and a new one prepared. The following scheme is recommended for dilution of the Biseptol 480 drug: 1 ampoule (5 ml) of the Biseptol 480 preparation in 125 ml of the solution for infusions; 2 ampoules (10 ml) of Biseptol 480 in 250 ml solution for infusion; 3 ampoules (15 ml) of Biseptol 480 preparation in 500 ml solution for infusion. The use of the following solutions for infusion for the dilution of the drug Biseptol 480 is allowed:
- 5% and 10% dextrose solution;
- 0.9% NaCl solution;
- ringer’s solution;
- 0.45% NaCl solution with 2.5% dextrose solution.
The prepared solution for infusions of the drug Biseptol 480 should not be mixed with other drugs or different solutions for infusions other than the above. The duration of the infusion should be approximately 60 to 90 minutes and depends on the degree of hydration of the patient. If the patient is contraindicated in the administration of a large amount of liquid, a higher concentration of co-trimoxazole is allowed – 5 ml in 75 ml of 5% dextrose. Dispose of unused solution. Acute infections Adults and children over the age of 12 years: usually use 2 ampoules (10 ml) every 12 hours. Children aged 3 to 12 years: at the rate of 30 mg of sulfamethoxazole and 6 mg of trimethoprim per kg of body weight per day, in 2 doses. Dosing scheme of the drug Biseptol 480 (before the introduction of the drug should be diluted as described above):
- children aged 3 to 5 years: 2.5 ml every 12 hours.
- children aged 6 to 12 years: 5 ml every 12 hours.
In the case of very serious infections in all age groups, the dose can be increased by 50%. Treatment should be carried out for at least five days or within two days after the disappearance of symptoms. Patients with renal insufficiency: in the case of adults and children over 12 years old (data on children under the age of 12 years old are not available) with renal insufficiency, the dosage of the drug should be modified depending on the clearance of creatinine.
Side effect From the side of the central nervous system: headache, apathy, tremor, aseptic meningitis, convulsions, neuritis, ataxia, dizziness, tinnitus, depression, hallucinations. On the part of the respiratory system: bronchospasm, cough, shallow breathing, pulmonary infiltrates. On the part of the digestive system: gastritis, abdominal pain, cholestasis, nausea, vomiting, diarrhea, stomatitis, pseudomembranous colitis, cholestatic hepatitis, increased activity of “hepatic” transaminases, hyperbilirubinemia, liver necrosis, glossitis, pancreatitis. From the side of hematopoietic organs: leukopenia, neutropenia, thrombocytopenia, hypoprothrombinemia, agranulocytosis, megaloblastic anemia, aplastic anemia, hemolytic anemia, methemoglobinemia, eosinophilia, purpura, hemolysis in a hypertensive patient, with a deficit-ny; On the part of the urinary system: polyuria, crystalluria, hematuria, increased urea, hypercreatininemia, toxic nephropathy with oliguria and anuria, renal dysfunction, interstitial nephritis. From the musculoskeletal system: arthralgia, myalgia. On the part of the immune system: serum sickness, anaphylactic reactions, allergic myocarditis, vasomotor rhinitis, drug fever, hemorrhagic vasculitis (Schönlein-Genoch), periarteritis nodosa, systemic lupus erythematosus. On the part of the skin and subcutaneous tissue: skin rash, photosensitivity, exfoliative dermatitis, persistent drug rash, polymorphic erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), Quincke edema, redness sclera. Disturbance of metabolism and alimentation: hyperkalemia, hypoglycemia, hyponatremia, anorexia. Infections and parasitic diseases: candidiasis. Local reactions: thrombophlebitis, pain at the injection site.
Overdose Symptoms: nausea, vomiting, dizziness, headache, confusion. In severe form of trimethoprim overdose, bone marrow depression was noted. Treatment: if side effects occur, the drug should be discontinued immediately. Fluid injection, correction of electrolyte disturbances. If necessary, hemodialysis.
Interaction with other drugs Co-trimoxazole is compatible with the following drugs: 5% dextrose for the IV infusion, 0.9% sodium chloride for the IV infusion, a mixture of 0.18% sodium chloride and 4% dextrose for the IV infusion, 6% dextran 70 for iv infusions in 5% dextrose or in saline, 10% dextran 40 for iv infusions in 5% dextrose or saline, Ringer’s solution for injection. In elderly patients, Biseptol in combination with diuretics, in particular with thiazide diuretics, increases the risk of thrombocytopenia. Simultaneous use with cyclosporine reduces its concentration in the blood. It should not be administered intravenously in combination with drugs and solutions containing bicarbonates. Increases the anticoagulant activity of indirect anticoagulants, enhances the effect of hypoglycemic agents and methotrexate. Reduces the intensity of the hepatic metabolism of phenytoin (extends its T1 / 2 by 39%) and warfarin, increasing their
special instructions During the use of the drug should maintain proper diuresis. In debilitated patients, the risk of sulfonamide crystals increases. In the case of long-term administration of the drug, regular blood tests are recommended, since there is a possibility of hematological changes associated with a folic acid deficiency. After use of the drug may appear diarrhea, which may be a symptom of pseudomembranous colitis. It is necessary to stop the use of the drug and to cancel the anti-diarrheal drugs. Do not use the drug Biseptol 480 in the treatment of pharyngitis caused by beta-hemolytic streptococcus group A. Caution must be exercised in patients using other drugs that can cause hyperkalemia, including potassium-sparing diuretics. It is recommended to monitor the concentration of potassium in the serum, given the risk of increasing its concentration (hyperkalemia). In the event of the first symptoms of skin rash, discontinue use of the drug. Given the content of benzyl alcohol in the preparation Biseptol 480 (15 mg of benzyl alcohol in 1 ml of solution), the drug should not be used in premature babies and infants. Benzyl alcohol can cause intoxication and anaphylactoid reactions in infants and children under 3 years of age.
Use during pregnancy and during breastfeeding You should not prescribe the drug during pregnancy and during breastfeeding.
Influence on ability to steer the car and other mechanisms During the period of treatment, care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and psychomotor reactions.
Release form and packaging Concentrate for solution for infusion (80.00 mg + 16.00 mg) / ml. On 5 ml in ampoules from colorless hydrolytic glass (class 1, Heb. Pharm.). Above the notch of the ampoule is a dot of white or red, as well as a strip in the form of a ring of yellow. On 5 ampoules place in the pallet for ampoules from PVC. Two pallets in a cardboard pack with instructions for use.
Storage conditions Store in a dark place at a temperature not exceeding 25 ° C. Do not freeze!
Shelf life 5 years. Do not use after the expiration date printed on the package.
Vacation conditions On prescription.
Manufacturer and owner of registration certificate AO Warsaw Pharmaceutical Plant Polfa Karolkowa 22/24, 01-207 Warsaw, Poland.
Representation in the Russian Federation: 121248 Moscow, Kutuzov Avenue, 13, office 85