Oral suspension "Biseptol" is used for infections caused by microorganisms sensitive to cotrimoxazole:
- infections of the upper and lower respiratory tract and ear infections: exacerbation of chronic bronchitis, bronchiectasis, pneumonia (including pneumonia caused by Pneumocystis jiroveci), sinusitis, otitis media;
- infections of the genitourinary system: acute and chronic cystitis, pyelonephritis, urethritis, prostatitis;
- infections of the digestive tract, including typhoid and paratyphoid fever (including treatment of chronic carriers) and cholera (in addition to fluid and electrolyte restoration);
- other bacterial infections caused by susceptible microorganisms: acute brucellosis, nocardiosis, actinomycetoma (except those caused by true fungi), American blastomycosis (Paracoccidioides brasiliensis).
For osteomyelitis - as a last-line drug (for example, if vancomycin is contraindicated), if the sensitivity of multidrug-resistant pathogens to cotrimoxazole is proven.
Official recommendations regarding the appropriate use of antibiotics should be followed, especially recommendations for use to prevent increased antibiotic resistance.
Compound
5 ml of suspension contains (active ingredients):
- sulfamethoxazole - 200 mg;
- trimethoprim - 40 mg.
Excipients: polyethylene glycol (macrogol) hydroxystearate, sodium carmellose, aluminum magnesium silicate, citric acid monohydrate, sodium hydrogen phosphate dodecahydrate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), liquid maltitol, sodium saccharin, strawberry flavor (aromatics, propylene glycol ), propylene glycol, purified water.
Contraindications
- hypersensitivity to the active substances, to sulfonamides or trimethoprim or to any of the excipients;
- severe parenchymal liver disease;
- severe renal impairment (creatinine clearance <15 ml/minute), if it is not possible to periodically determine the concentration of trimethoprim and sulfamethoxazole in the blood plasma;
- megaloblastic anemia caused by folate deficiency;
- immune thrombocytopenia caused by the use of trimethoprim and/or sulfonamides;
- hematological disorders;
- combination with dofetilide;
- deficiency of glucose-6-phosphate dehydrogenase;
- should not be used in children under 2 months of age;
- porphyria;
- last trimester of pregnancy and breastfeeding.
Biseptol Susp. for oral administration 240 mg|5 ml 80 ml №1
Pharmacokinetic interaction
Trimethoprim is an inhibitor of organic cation transporter 2 (OCT2), as well as a weak inhibitor of the CYP2C8 isoenzyme. Sulfamethoxazole is a weak inhibitor of the CYP2C9 isoenzyme.
Systemic exposure to drugs transported by OCT2 (eg, dofetilide, amantadine, memantine, and lamivudine) may be increased when trimethoprim-sulfamethoxazole is coadministered.
Trimethoprim-sulfamethoxazole and dofetilide should not be used simultaneously. Trimethoprim inhibits the renal excretion of dofetilide, increases the area under the concentration-time curve AUC by 103% and the maximum concentration of dofetilide by 93%. Increasing concentrations of dofetilide may cause serious ventricular arrhythmias with QT prolongation, including torsades de pointes.
Patients receiving amantadine or memantine have an increased risk of developing nervous system adverse events (such as delirium and myoclonus).
Systemic exposure to drugs predominantly metabolized by CYP2C8 (e.g., paclitaxel, amiodarone, dapsone, repaglinide, rosiglitazone and pioglitazone) may be increased when trimethoprim-sulfamethoxazole is coadministered.
Paclitaxel and amiodarone have a low therapeutic index; their simultaneous use with trimethoprim-sulfamethoxazole is not recommended.
Dapsone and trimethoprim-sulfamethoxazole may cause the development of methemoglobinemia, as there is a potential for their pharmacokinetic and pharmacodynamic interactions. Patients receiving dapsone and trimethoprim-sulfamethoxazole should be closely monitored for the development of methemoglobinemia. If necessary, alternative therapy should be prescribed. Patients receiving repaglinide or pioglitazone should be regularly monitored for the development of hypoglycemia.
Systemic exposure to drugs predominantly metabolized by the CYP2C9 isoenzyme (for example, coumarins (warfarin, acenocoumarol), phenytoin and sulfonylurea derivatives (glibenclamide, gliclazide and glipizide)) may be increased when combined with trimethoprim-sulfamethoxazole.
Blood clotting should be monitored in patients receiving coumarins. Biseptol may inhibit the hepatic metabolism of phenytoin. After administration of standard doses of trimethoprim and sulfamethoxazole, an increase in the half-life of phenytoin by 39% and a decrease in its clearance by 27% were observed. Patients receiving phenytoin should be monitored for phenytoin toxicity. Patients receiving sulfonylurea derivatives (glibenclamide, gliclazide and glipizide) should be monitored for the development of hypoglycemia.
The drug Biseptol can reduce the effectiveness of oral contraceptives. During therapy with Biseptol, women are recommended to use additional methods of contraception.
The simultaneous use of trimethoprim-sulfamethoxazole and indomethacin may cause an increase in the concentration of sulfamethoxazole in the blood plasma.
Biseptol may increase serum digoxin concentrations, especially in elderly patients, so monitoring of serum digoxin concentrations is necessary.
Pharmacodynamic interactions and interactions with unknown mechanism
The incidence and severity of myelotoxic and nephrotoxic adverse events may be increased with concomitant use of trimethoprim-sulfamethoxazole and other drugs that have a myelosuppressive effect or can cause renal impairment (nucleoside analogues, tacrolimus, azathioprine or mercaptopurine). Patients receiving such drugs concomitantly with trimethoprim-sulfamethoxazole should be monitored for the development of hematologic and/or renal toxicity.
Concomitant use with clozapine should be avoided, since the latter is known to cause agranulocytosis.
In elderly and senile patients, with the simultaneous use of certain diuretics (mainly thiazide), an increase in the number of cases of thrombocytopenia was observed.
In patients receiving diuretics, platelet levels in the blood should be regularly monitored.
Patients receiving trimethoprim-sulfamethoxazole and cyclosporine after renal transplantation may experience a reversible deterioration in renal function.
Sulfonamides, including sulfamethoxazole, may compete for protein binding and renal transport of methotrexate, thereby increasing free methotrexate concentrations and systemic effect.
Cases of pancytopenia have been described in patients taking trimethoprim and methotrexate. Trimethoprim has low affinity for human dehydrofolate reductase, but may increase the toxicity of methotrexate, especially in the presence of risk factors such as old age, hypoalbuminemia, renal impairment, bone marrow suppression, and in patients receiving high doses of methotrexate. To prevent myelosuppression, such patients should be prescribed folic acid or calcium folinate.
It can be assumed that when trimethoprim-sulfamethoxazole is co-administered to patients receiving pyrimethamine for malaria prophylaxis in doses greater than 25 mg per week, they may develop interregional anemia. Caution must be exercised during the simultaneous use of trimethoprim-sulfamethoxazole and drugs that increase the concentration of potassium in the blood serum (such as ACE inhibitors, angiotensin receptor blockers, potassium-sparing diuretics and prednisolone), due to the potassium-sparing effect of trimethoprim-sulfamethoxazole.
In addition to other drugs that may cause hyperkalemia, the combined use of trimethoprim-sulfamethoxazole (co-trimoxazole) and spironolactone may result in clinically significant hyperkalemia.
Laboratory research
Trimethoprim-sulfamethoxazole and, in particular, trimethoprim, which is part of it, may affect the results of determining the concentration of methotrexate in serum, carried out by the competitive protein binding method using bacterial dihydrofolate reductase as a ligand. However, when methotrexate is determined by the radioimmune method, there is no influence.
Trimethoprim and sulfamethoxazole can also affect the results of the Jaffe test (determination of creatinine by reaction with picric acid in an alkaline medium), and in the normal range the results are overestimated by approximately 10%.
Mode of application
Biseptol should be taken every 12 hours. The drug is best used after meals with sufficient liquid. For acute infections, Biseptol is prescribed for a period of at least 5 days.
The drug should be administered orally.
Before use, shake until a homogeneous suspension is obtained.
The bottle comes with a graduated measurement.
Children and teenagers:
- 2-5 months - 2.5 ml (morning and evening) with an interval of 12 hours;
- 6 months - 5 years - 5 ml twice a day with an interval of 12 hours;
- 6-12 years - 10 ml twice a day with an interval of 12 hours;
- 12 years - 20 ml twice a day with an interval of 12 hours.
The dosage regimen approximately corresponds to a daily dose of 6 mg of trimethoprim and 30 mg of sulfamethoxazole per 1 kg of body weight. For severe infections, the dose can be increased by 50%.
Adults: take 20 ml of suspension every 12 hours. The minimum dose for adults and adolescents over 12 years of age, as well as for long-term treatment (longer than 14 days) is 10 ml of suspension every 12 hours. In particularly difficult cases of infection - 30 ml of suspension every 12 hours.
How to take Biseptol
Biseptol is a synthetic drug with properties similar to an antibiotic, therefore it is used strictly as prescribed by a doctor.
- Adults and children over 12 years of age are prescribed 960 mg 2 times a day.
- Children from 3 to 5 years old are prescribed 2 tablets. 120 mg morning and evening.
- From 6 to 12 years – 1 tablet 480 mg. in the morning and in the evening.
The treatment period is 5 - 14 days. The drug is taken orally after meals with plenty of water.
Biseptol for children is a suspension. It is a white liquid with a strawberry flavor. In 5 ml. Biseptol, which is taken orally, contains 200 mg of sulfamethoxazole and 40 mg of trimethoprim. The drug should be taken every 12 hours after meals and with plenty of water. Biseptol is prescribed for a period of at least 5 days.
Used for children:
- From 6 weeks, children born with HIV infection take 120 mg of syrup.
- From 2 to 5 months, take 120 mg. suspensions.
- From 6 months to 5 years - 240 mg.
- From 6 to 12 years - 480 mg. every 12 hours.
- From 12 years and adults 960 mg. every 12 hours
The course of treatment is 5-10 days.
Features of application
Pregnant
Trimethoprim and sulfamethoxazole cross the placental barrier; their safety in pregnant women has not been established. It is not recommended to prescribe the drug during pregnancy, especially in the first trimester, unless the expected benefit to the mother outweighs the risk to the fetus.
Children
The drug can be used in children from 2 months. Biseptol should not be prescribed to premature infants, as well as newborns during the first 2 months of life, given the increased risk of kernicterus (bilirubin encephalopathy).
Drivers
Biseptol usually does not have a direct effect on the ability to drive vehicles or operate other machinery. However, there is a possibility of side effects from the nervous system and psyche that may affect this ability, in some cases to a significant extent.
Popular questions about Biseptol
What is Biseptol for?
The medicine is used for infections caused by microorganisms susceptible to cotrimoxazole:
- upper and lower respiratory tract infections, and ear infections
- genitourinary system infections
- digestive tract infections
- also bacterial infections
How to take Biseptol?
Do not take the drug on an empty stomach, washing it down with a sufficient amount of water every 12 hours. For acute infections, Biseptol is prescribed for a period of at least 5 days.
How to take Biseptol for cystitis?
For cystitis, the dosage of the antibiotic and the duration of use are determined individually for each patient. If the patient does not receive specific recommendations, then taking Biseptol to treat inflammation of the bladder must be done in accordance with the instructions.
- Children from 2 years old take one tablet weighing 120 mg in the morning and evening.
- Children from 6-12 years old: 240 mg in two doses.
- After 12 and adults, 2 tablets of 480 mg in the morning and evening.
How to give Biseptol to children?
The drug should be administered orally. Before each dose, the drug should be shaken to a homogeneous suspension. The bottle comes with a graduated measuring spoon for easy dosing. The drug should be taken after meals with a sufficient amount of liquid every 12 hours. prescribed for a period of 5 to 7 days.
Overdose
Symptoms of acute overdose: nausea, vomiting, diarrhea, colic, headache, vertigo, dizziness, drowsiness, loss of consciousness, confusion, fever, intellectual and visual disturbances, jaundice, changes in blood composition, in severe cases - crystalluria, hematuria and anuria.
Symptoms of chronic overdose: inhibition of hematopoiesis (thrombocytopenia, leukopenia, megaloblastic anemia), as well as other pathological changes in the blood picture due to folic acid deficiency.
Treatment (depending on symptoms): gastric lavage, taking medications that induce vomiting, increasing renal excretion by forced diuresis (alkalinization of urine promotes the excretion of sulfamethoxazole), hemodialysis (peritoneal dialysis is ineffective). It is necessary to monitor the blood picture and electrolyte levels. In case of pronounced pathological changes in the blood picture or jaundice, specific treatment is prescribed. To eliminate the effect of trimethoprim on hematopoiesis, calcium folinate can be prescribed at a dose of 3-6 mg for 5-7 days.
Side effects
- Nervous system dysfunctions are characterized by headaches, sleep disturbances, and irritation.
- Allergies, which are accompanied by skin rash, fever, runny nose, and hives.
- Gastrointestinal disorders: diarrhea, nausea, vomiting.
- Impaired functions of the urinary system.
Store in secondary packaging at temperatures up to 25°C, out of the reach of children. Shelf life: 3 years. Once opened, store with the lid tightly closed for 8 months.
Note!
Description of the drug Biseptol Susp. 200mg/40mg/5ml vial. 80ml on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
