Antimicrobial drug - Biseptol suspension: instructions for use for children and effective analogues. Biseptol suspension: instructions for use Biseptol for children indications for use

100 ml suspension contains

active substances: trimethoprim 0.8 g,

sulfamethoxazole 4.0 g

Excipients: macrogol glyceryl hydroxystearate, aluminum magnesium silicate, carmellose sodium, citric acid monohydrate, sodium hydrogen phosphate dodecahydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, sodium saccharinate, strawberry flavor, propylene glycol, purified water.

Description

Suspension of white or light cream color with strawberry smell. The suspension is homogeneous after shaking the drug.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Sulfonamides and trimethoprim. Sulfonamides in combination with trimethoprim and its derivatives. Co-trimoxazole.

ATX code J01EE 01

Pharmacological properties"type="checkbox">

Pharmacological properties

Pharmacokinetics

After oral administration in a therapeutic dose, the active substances are rapidly and almost completely (90%) absorbed in the upper segment. small intestine and after 60 min. reach a therapeutic concentration in the blood and tissues, which persists for 12 hours. Maximum concentrations active substances in blood plasma are reached in 1-4 hours. Plasma protein binding is 66% for sulfamethoxazole and 45% for trimethoprim. The drug is well distributed in the body.

The drug penetrates into the mother's milk and through the placental barrier. Sulfamethoxazole and trimethoprim are metabolized in the liver.

The half-life ranges from 10 to 12 hours.

Pharmacodynamics

Biseptol - combined chemotherapeutic medicine containing sulfamethoxazole and a diaminepyridine derivative - trimethoprim in a ratio of 5:1. Sulfamethoxazole disrupts the utilization of para-aminobenzoic acid, and, consequently, the synthesis of dihydrofolic acid. Trimethoprim inhibits an enzyme that is involved in the conversion of dihydrofolate to active tetrahydrofolate. The combination of both components made it possible to obtain a bactericidal effect. Biseptol is active against gram-positive bacteria: streptococci (Streptococcus pneumoniae, S. agalactiae, S. viridans), staphylococci (Staphylococcus aureus, Staphylococcus epidermidis), Listeria monocytogenes, Nocardia asteroides and gram-negative, including most rods Enterobacteriaceae(kinds Salmonella, Shigella, Klebsiella, Proteus mirabilis, Enterobacter, part of the strains Escherichia coli), part of the strains H.influenzae, Legionella spp., Yersinia enterocolitica, Brucella spp., Neisseria meningitidis, Neisseria gonorrhoeae, as well as Pneumocystis carinii. Sticks are resistant to the drug ( Mycobacteriaceae), viruses, most anaerobic bacteria and mushrooms.

Indications for use

Respiratory infections - exacerbation of chronic bronchitis, treatment and prevention (primary and secondary) of pneumonia caused by, Pneumocystis carinii in adults and children

Sinusitis, acute otitis media

Infections of the gastrointestinal tract: typhoid and paratyphoid, bacterial dysentery (shigellosis), diarrhea, cholera

Sharp and chronic infections urinary system and prostate (urethritis, cystitis, prostatitis)

Chancroid

Brucellosis, osteomyelitis, nocardiosis, actinomycosis, toxoplasmosis and

South American blastomycosis (possibly combined with other

antibiotics)

Dosage and administration

The drug is taken orally during or immediately after a meal with plenty of liquid.

Shake before use until a homogeneous suspension is obtained.

5 ml of suspension contains 200 mg of sulfamethoxazole and 40 mg of trimethoprim.

A measuring cup with a scale is included with the package.

In children, trimethoprim 6 mg and sulfamethoxazole 30 mg per kg of body weight per day are usually used. In severe infections, doses can be increased by 50%.

Children:

Adults and children over 12 years old - Usually 20 ml every 12 hours. The maximum dose (for use in especially severe cases) is 30 ml of suspension every 12 hours.

At acute infections Biseptol should be taken for at least 5 days or until the patient has no symptoms for 2 days. If after 7 days of treatment there is no clinical improvement, the patient's condition should be re-evaluated for possible correction treatment.

For infections caused Pneumocystis carinii - 120 mg/kg/day every 6 hours for 14-21 days.

The course of treatment for urinary tract infections and acute otitis media - 10 days, shigellosis - 5 days.

Patients with impaired renal function

With creatinine clearance> 30 ml / min, the usual dose is prescribed, with creatinine clearance from 15 to 30 ml / min - half the usual dose, and with a decrease in creatinine clearance to< 15 мл/мин применять Бисептол не рекомендуется.

Side effects"type="checkbox">

Side effects

Usually the drug is well tolerated.

Frequency not known

Nausea, vomiting, lack of appetite, diarrhea, abdominal pain, gastritis, stomatitis, glossitis

Leukopenia, neutropenia, thrombocytopenia

Fever, shivering

Rash, urticaria, much less often polymorphic erythema, itching

Pseudomembranous enterocolitis

Candidiasis

Hypersensitivity reactions that manifest as fever, angioedema, anaphylactoid reactions - pulmonary infiltrates of the type of eosinophilic, allergic alveolitis with cough or shortness of breath

Reversible hyperkalemia, hypoglycemia, hyponatremia

Headache, dizziness, hallucinations, sleep disturbance, depression

Neuropathy (including peripheral neuritis and paresthesia)

Increased activity of transaminases and bilirubin concentration, hepatitis, cholestasis, liver necrosis

photosensitization

Kidney dysfunction, interstitial nephritis, increased nitrogen

blood urea, serum creatinine, crystalluria, increased diuresis,

especially in patients with edema of cardiac origin

In isolated cases

Agranulocytosis, pancytopenia, megaloblastic, hemolytic anemia, methemoglobinemia

Periarteritis nodosa, allergic myocarditis

Aseptic meningitis

Purpura of Shenlein-Henoch

Rhabdomyolysis

Stevens-Johnson Syndrome

Lyell's syndrome

Arthralgia, myalgia

Contraindications

Hypersensitivity to sulfonamides, trimethoprim and/or

to other components of the drug

Co-administration with dofetilide

Severe impairment of liver or kidney function (creatinine clearance

below 15 ml/min)

Megaloblastic anemia due to folic acid deficiency

Treatment of streptococcal angina

Pregnancy and lactation

Children's age up to 3 months

Drug Interactions"type="checkbox">

Drug Interactions

Biseptol, used simultaneously with diuretics, especially from the thiazide group, increases the possibility of thrombocytopenia with bleeding. May prolong prothrombin time in patients taking anticoagulants (eg warfarin).

Enhances the effect of antidiabetic agents, sulfonylurea derivatives.

Inhibits the metabolism of phenytoin in the liver (increases its half-life to 39%). May also increase the concentration of free methotrexate in plasma (increases the release of methotrexate from its compounds with proteins).

Like other sulfonamides, Biseptol can potentiate the effect of oral hypoglycemic drugs from the sulfonylurea group.

With the simultaneous appointment of Biseptol to patients who receive pyrimethamine for the prevention of malaria in doses of more than 25 mg per week, they may develop megaloblastic anemia.

In patients receiving Biseptol and cyclosporine after kidney transplantation, there may be a reversible deterioration in kidney function, manifested by an increase in creatinine levels.

When taken simultaneously with Biseptol, it is necessary to reduce the dose of indomethacin.

It is possible to increase the serum concentration of digoxin, especially in elderly patients, while taking Biseptol.

With the simultaneous use of Biseptol and zidovudine, an increase in the risk of hematological disorders is possible. If it is necessary to use Biseptol and zidovudine, the blood picture should be monitored.

The effectiveness of tricyclic antidepressants may decrease when taken with Biseptol.

Laboratory research

Biseptol may affect the results of determining the concentration of methotrexate in serum by the method of competitive protein binding, when bacterial dihydrofolate reductase is used as a ligand. When determining methotrexate by the radioimmune method, distortion does not occur.

Biseptol can interfere with the reaction of creatinine determination using Jaffe alkaline picrinate (increases creatinine levels by approximately 10%).

special instructions"type="checkbox">

special instructions

In elderly and senile patients, as well as with concomitant diseases of the liver and kidneys or while taking other drugs, there is a higher risk of developing severe allergic reactions, such as Stevens-Johnson syndrome, Lyell's syndrome and acute liver necrosis. To reduce the risk of such reactions, treatment with Biseptol should be as short as possible, especially in elderly patients.

At the first appearance of a skin rash or any other severe adverse reaction the drug should be discontinued. Patients with a tendency to allergic reactions and bronchial asthma Biseptol should be prescribed with caution.

With the duration of the course of therapy for more than 14 days and / or an increase in the dose of the drug, it is necessary to control the picture of peripheral blood; when pathological changes should take into account the appointment of folic acid.

In elderly patients, as well as in patients with folic acid deficiency or renal insufficiency, hematological changes characteristic of folic acid deficiency may occur.

When prescribing Biseptol to patients who are already receiving anticoagulants, one should be aware of a possible increase in the anticoagulant effect. In such cases, it is necessary to re-determine the clotting time.

The drug should not be administered to patients with hereditary fructose intolerance.

Patients receiving long-term treatment with Biseptol (especially with renal failure) should be regularly taken general analysis urine and monitor kidney function. During treatment, it is necessary to ensure sufficient fluid intake in the body, adequate diuresis to prevent crystalluria.

Due to the possibility of hemolysis, patients with deficiency of glucose-6-phosphate dehydrogenase are prescribed Biseptol only according to absolute indications and in minimal doses.

Caution should be exercised in patients with porphyria or impaired function thyroid gland.

In most cases, doctors of ordinary clinics prescribe to exclude the development of any complications. antibacterial drugs children and adults, regardless of age and characteristics of the body. Biseptol was widely known among antibiotics two decades ago. The local pediatrician, any specialist in a narrow field, and even a neighbor with a friend could recommend the medicine. However, treatment with Biseptol cannot be completely safe for the child's body, so parents should know the features and rules for taking this drug.

Composition and form of release of the drug

Biseptol is an antimicrobial antibacterial drug, which stops the growth of pathogenic microflora due to the interaction of a combination of two active ingredients - sulfamethoxazole and trimethoprim (co-trimoxazole). Sulfamethoxazole stops the production of dihydrofolic (DHFC) and aminobenzoic (PABA) acids, which provide an increase in bacteria, and trimethoprim maintains the effects of sulfamethoxazole and prevents protein metabolism and the division of disease-causing cells. Auxiliary components may be different depending on the form of release:

Shelf life of the drug - no more than 3 years. After opening, Biseptol should be stored in a carefully closed bottle away from direct sunlight, at a temperature not exceeding +20 degrees. You can take and store the opened drug for 8 months.

Pharmacological action of Biseptol

Biseptol for children cannot be called an antibiotic, but at the same time it is included in the group of bactericidal drugs that can kill pathogenic microbes, except for anaerobic bacteria, tubercle bacillus, leptospira, mycobacteria and viruses. The main substances of the drug effectively destroy pathogens - cocci (staphylo- and strepto-), salmonella, as well as intestinal, typhoid and dysentery bacilli due to the fact that they alternately block the cellular metabolism in bacteria.

Sulfamethoxazole inhibits, and then completely stops the production of dihydrofolic acid, and trimethoprim does not allow this acid to turn into tetrahydrofolic acid, which is necessary for the further division of pathogens. Thus, the synthesis of proteins is disrupted, which leads to the death of microorganisms. The active substances are absorbed into circulatory system from the digestive tract and reach the highest concentration after 3 hours. The medicine acts for seven hours, then it is excreted from the body through the kidneys.

Instructions for use

All types of the drug are sold complete with detailed instruction on application, which indicates the basic rules for admission. Before buying this medicine, young parents need to agree on a treatment regimen with the attending pediatrician and familiarize themselves with the action of Biseptol in order to exclude an undesirable reaction of the baby's body to this medication. Throughout the course, you need to control the level of sulfamethoxazole in the blood of the child. This indicator should be within 150 μg / ml.

In what cases is the drug prescribed?

Biseptol has a wide range of applications, therefore it is often prescribed by doctors for the treatment of children (pediatricians, otolaryngologists, urologists). The specialist first collects the necessary tests in order to find out the etiology of the pathogen or inflammatory process, after which he makes a decision: will Biseptol be useful? Most often, pediatricians prescribe this drug for the following types of diseases:

Are there any contraindications?

Biseptol, like any medication, has certain limitations. It is strictly forbidden for babies under the age of 6 weeks. Before prescribing it for treatment, the doctor must find out individual characteristics the child's body and analyze the presence of possible pathologies:

Scheme of application and dosage calculation

Parents need to remember that any drug can be given to a child only with the permission or on the recommendation of the attending physician who is familiar with clinical picture baby illness. Despite the presence in the instructions for calculating the dosage, it is the specialist who determines the dosage regimen and the optimal dose that will help the child. In addition, you need to follow a few simple rules:

• the minimum course of taking the drug should be 5 days (as when taking antibiotics) - to minimize the risk of relapse and the occurrence of complications;
• between doses, you need to maintain an interval of up to 12 hours - to maintain the activity of the active ingredients;
• a child should not take a tablet, suspension or syrup on an empty stomach - to prevent damage to the tissues lining the walls of the stomach.

From the moment the kids are able to swallow solid medicine on their own, they are prescribed Biseptol in this form of release. Most often, tablets begin to be prescribed to children aged 5 to 12 years. At this age, 480 mg tablets are prescribed and the dose is determined up to 20 ml (960 mg) per day. The dosage is also calculated depending on the amount of active substances in one tablet.

What adverse reactions may occur in a child?

With careful observance of the regimen of taking the medication and all the accompanying recommendations of the doctor, side effects practically do not appear. Biseptol is usually well tolerated by young children, but in rare situations, allergic manifestations on the skin (urticaria, redness and itching) or disruption of the normal functioning of the digestive system (lack of appetite, diarrhea, nausea) may occur. Rarely enough, stomatitis and nephritis can occur.

These reactions are mild and episodic, and therefore do not require discontinuation of the drug. However, if the child takes Biseptol long time in a large dose, the side effects may be more intense. In this case, you will need to seek the advice of the attending pediatrician to reduce the dose or choose another medication.

What are the symptoms of an overdose and what to do in such cases?

Experts believe that when choosing Biseptol, children need to calculate the dose so that it does not exceed 720 mg of medication per day.

A doctor's mistake or non-compliance with the recommended dose by parents can cause an overdose, manifested in the form increased sweating, intestinal colic, headache, confusion, dizziness, vomiting, a sharp increase in body temperature, fever. In this case, it is necessary to immediately seek medical help for gastric lavage, the appointment of sorbents and antipyretics.

With prolonged use of large doses of the drug, the baby develops jaundice, hematuria, crystalluria, inhibition of functions bone marrow in the form of thrombocytopenia, leukopenia and megaloblastic anemia. In especially severe cases, the baby undergoes a hemodialysis procedure and forced urinalysis, calcium folinate and drugs are prescribed that reduce the effectiveness of the active components of Biseptol.

How does it interact with other drugs?

To exclude an additional deterioration in the child's health, Biseptol cannot be combined with certain groups of drugs for various purposes:

Effective analogues of Biseptol

The most effective analogues of Biseptol include:

• Sumetrolim - tablets containing 480 mg of co-trimoxazole. Approved for the treatment of children from one year of age.
• Asacol - tablets with the active substance mesalazine. They are prescribed for the treatment of inflammation in the intestines for children from 2 years of age.
• Soluseptol is a syrup with a low content of co-trimoxazole. Recommended for the treatment of children up to a year.
• Berlocid, Groseptol - analogues of Biseptol in tablets, differ in cost and dosage. Produced in Germany.
• Co-trimoxazole, Biseptine - contain sulfamethoxazole and trimethoprim in a similar dosage. They are only less popular.
• Oriprim, Septrin - suspensions with a similar active ingredient. They are distinguished by a higher price due to the fact that they are produced in India and the UK.
• Bactrim is the Yugoslav analogue of Biseptol, has a similar composition and a list of indications for use, as well as a pleasant banana taste that the baby will like. Available in the form of suspension and syrup.
• Amoxicillin, Sumamed, Clarithromycin are broad-range antibiotics that experts prescribe as an alternative to Biseptol treatment.

Thanks

The site provides reference information for informational purposes only. Diagnosis and treatment of diseases should be carried out under the supervision of a specialist. All drugs have contraindications. Expert advice is required!

The drug Biseptol

Biseptol is active against the following pathogens: staphylococci, streptococci, pneumococci, dysentery bacillus, typhoid bacillus, proteus, E. coli, salmonella, pneumocystis, plasmodium, causative agent of leishmaniasis, meningococcus, vibrio cholerae, actinomycetes, Klebsiella, chlamydia, causative agent of diphtheria and some types of diphtheria mushrooms.

The drug is ineffective against Pseudomonas aeruginosa, the causative agent of leptospirosis, the causative agent of tuberculosis, spirochetes and viruses.
Biseptol also has an effect on microorganisms that are resistant to other sulfanilamide drugs.

Biseptol is rapidly and well absorbed from the stomach and reaches its maximum concentration in the blood 1-3 hours after ingestion. Therapeutic concentration of the drug is maintained up to 7 hours.

The drug penetrates well into biological fluids and tissues of the body: bile, saliva, cerebrospinal fluid, sputum, prostate gland, kidneys, lungs. It is excreted from the body mainly with urine.

Release form

• 120 mg tablets (100 mg sulfamethoxazole and 20 mg trimethoprim);
• 480 mg tablets (400 mg sulfamethoxazole and 80 mg trimethoprim);
• Tablets "Bactrim forte" 960 mg (800 mg of sulfamethoxazole and 160 mg of trimethoprim);
• Syrup (or suspension) - for oral administration 100 ml (in 1 ml - 40 mg of sulfamethoxazole and 8 mg of trimethoprim);
• Concentrate for solution for injection 480 mg (in 1 ml of concentrate - 80 mg of sulfamethoxazole and 16 mg of trimethoprim).

Instructions for use Biseptol

Indications for use

• diseases respiratory tract(bronchitis in acute and chronic form; pneumonia; pleural empyema - purulent inflammation of the membranes of the lungs; abscess or abscess of the lung; bronchiectasis - expansion of the lumen of the bronchi due to the disease);
• ENT pathology (otitis media, or inflammation of the ear; sinusitis, or inflammation paranasal sinuses nose);
• intestinal infections (dysentery, paratyphoid A and B, cholera, typhoid fever);
• urinary tract infections (urethritis - inflammation of the urethra; prostatitis - inflammation of the prostate gland; pyelonephritis - inflammation of the renal pelvis and the kidney tissue itself; salpingitis - inflammation of the uterine appendages);
• gonorrhea (venereal disease);
• soft tissue and skin infections (pyoderma, or pustular skin lesions; acne; furuncle, or boil);
• meningitis (inflammation of the meninges) and abscess (abscess) of the brain;
• septicemia (a form of "infection" of the blood);
• infectious diseases: brucellosis, malaria, toxoplasmosis, borreliosis, scarlet fever;
• wound infections and osteomyelitis;
• prevention and treatment of pneumocystis pneumonia in HIV-infected patients.

Contraindications

• with severe cardiovascular insufficiency;
• with diseases of the hematopoietic organs;
• with severe renal failure;
• mothers when breastfeeding;
• with deficiency of glucose-6-phosphate dehydrogenase (hereditary disease);
• children under the age of 3 months and premature babies;
• at elevated level bilirubin in children;
• with hypersensitivity to the components that make up the drug, or to other sulfanilamide drugs.

With caution, Biseptol can be used if the patient has previously been allergic to other drugs; with bronchial asthma; patients with folic acid deficiency; with diseases of the thyroid gland; early childhood and in old age.

Treatment with Biseptol should be carried out under medical supervision and blood tests should be carefully monitored.

Side effects

• From the side of the digestive system: in rare cases - diarrhea, abdominal pain, loss of appetite, nausea, vomiting; in isolated cases - colitis (inflammation of the intestine); reactive inflammation of the liver with bile stasis - cholestatic hepatitis; glossitis - inflammation of the tongue; stomatitis - inflammation of the oral mucosa; pancreatitis - inflammation of the pancreas.
• From the side nervous system in some cases: dizziness, headache, depression, fine trembling of the fingers of the extremities.
• From the side of the kidneys in rare cases: an increase in the volume of urine, inflammation of the kidneys (nephritis), excretion of blood in the urine.
• On the part of the respiratory system: bronchospasm, cough, choking or a feeling of lack of air.
• On the part of the hematopoietic organs in isolated cases: a decrease in the number of leukocytes in the blood, a decrease in the number of neutrophils (a type of leukocyte that protects the body from infections), a decrease in platelets (platelets involved in blood clotting), folic acid deficiency anemia.
• From the side skin: skin rash in the form of urticaria ; itching; in isolated cases - Lyell's syndrome and Stevens-Johnson syndrome (the most severe variants allergic manifestations on the skin and mucous membranes with necrosis and rejection); Quincke's edema (local or diffuse edema subcutaneous tissue and mucous membranes) hypersensitivity to ultraviolet rays.
• There have been isolated cases of chills and fever after taking Biseptol (drug fever).
• Pain in joints and muscles.
• Thrombophlebitis (at the injection site).
• Decreased levels of potassium, sodium and blood sugar.

With prolonged use (more than 5 days) and with the use of higher dosages, as well as with the appearance of changes in the blood test during treatment, folic acid should be taken at 5-10 mg per day.

drug interaction
Biseptol should not be taken simultaneously with Aspirin, Butadion, Naproxen.

Biseptol enhances the effect of drugs that reduce blood clotting, such as warfarin.

Biseptol enhances the effect of some antidiabetic drugs (Gliquidone, Glibenclamide, Glipizide, Chlorpropamide, Gliclazide).

Biseptol increases activity anticancer drug methotrexate and the anticonvulsant drug phenytoin.

Biseptol is not recommended to be administered simultaneously with thiazide diuretics (Chlorothiazid, Diuril, Naturetin, Metolazone, Diukardin, Furosemide, etc.) - this contributes to increased bleeding.

Biseptol in combination with diuretics, as well as with the antidiabetic agents listed above, can cause an allergic cross reaction.

Hexamethylenetetramine, ascorbic acid and other drugs that acidify urine increase the risk of "sand" in the urine when used simultaneously with Biseptol.

Biseptol may increase the concentration of digoxin in the blood in elderly patients.

The simultaneous use of Biseptol and Pyrimethamine (an antimalarial drug) increases the risk of anemia.

Benzocaine, Procaine (drugs for local anesthesia) reduce the effectiveness of Biseptol.

Dosage of Biseptol
The dose of the drug and the duration of administration is prescribed by the doctor individually, depending on the severity of the condition and concomitant diseases.

Adult patients are usually prescribed 960 mg 2 times a day (2 tablets of 480 mg or 1 tablet forte 2 times) every 12 hours for 5-14 days.

If necessary long-term treatment 480 mg is prescribed 2 times a day (1 tablet 480 mg 2 times).

Suspension of Biseptol is prescribed to adults at 20 ml every 12 hours.

In the case of a severe course of the disease (sometimes with chronic disease) the dose can be increased up to 50%.

And with a duration of treatment over 5 days, and with an increase in the dose of Biseptol, it is necessary to control the complete blood count.

But microbes adapt to drugs that are often used, and over time lose their sensitivity to these drugs; medicines stop working. So it happened with Biseptol. Therefore, the attitude towards the appointment of Biseptol for cystitis is very restrained at the present time.

The correct tactic in relation to the treatment of cystitis is the selection of medications in accordance with their sensitivity. For this purpose, urine culture is prescribed for microflora and its sensitivity to drugs. The doctor will receive the result 3-4 days after the test and select the correct treatment.

In some cases, the doctor initially prescribes Biseptol, and after receiving the result of the sensitivity of the flora to drugs, if necessary, changes the treatment. Sometimes Biseptol is prescribed due to intolerance to antibiotics or other drugs. Assign Biseptol in the usual dosage (2 tablets 2 times a day) for 5-10 days.

Biseptol's analogs and synonyms

Analogues are called drugs that have different active ingredients in their composition, differ in names, but are used in the treatment of the same diseases, because. have the same effect. Analogues may differ in strength of action, tolerability of the drug, contraindications, side effects.

Analogues of Biseptol are antibiotics of different groups, tk. they also have antimicrobial activity. Depending on the sensitivity of the pathogen and the spectrum of action, antibiotics are used to treat the same diseases as Biseptol.

Analogues of Biseptol are other sulfanilamide preparations:

• Asacol (active ingredient: mesalazine);
• Dermazin (active ingredient: sulfadiazine);
• Ingalipt (active ingredients: streptocide, sodium sulfathiazole);
• Ingaflu (active ingredient: streptocide) and other sulfa drugs.

Preparations-synonyms of Biseptol: Bactrim, Bacterial, Bactramin, Abatsin, Andoprim, Bactifer, Abactrim, Bactramel, Hemitrin, Bactrizol, Ectapprim, Berlocid, Bacticel, Doktonil, Ekspektrin, Gantrin, Falprin, Methomide, Infectrim, Primazol, Microcetim, Oradin, Potesept, Oribact, Resprim, Sumetrolim, Septocid, Uroxen, Bactecod, Trixazole, Trimexazole, Blackson, Vanadil, Aposulfatrin, Bactreduct, Groseptol, Cotrimol, Cotribene, Eriprim, Primotren, Sulfatrim, Rancotrim, Expazol, Novotrimed, Oriprim, Cotrimaxol, Cotrimaxazole, Sinersul, Sulotrim, Trimosul.

100 ml suspension contains

active substances: trimethoprim 0.8 g,

sulfamethoxazole 4.0 g

excipients: macrogol glyceryl hydroxystearate, aluminum magnesium silicate, carmellose sodium, citric acid monohydrate, sodium hydrogen phosphate dodecahydrate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, maltitol, sodium saccharinate, strawberry flavor, propylene glycol, purified water.

Description

Suspension of white or light cream color with strawberry smell. The suspension is homogeneous after shaking the drug.

Pharmacotherapeutic group

Antibacterial drugs for systemic use. Sulfonamides and trimethoprim. Sulfonamides in combination with trimethoprim and its derivatives. Co-trimoxazole.

ATX code J01EE 01

Pharmacological properties

Pharmacokinetics

After ingestion in a therapeutic dose, the active substances are quickly and almost completely (90%) absorbed in the upper segment of the small intestine and already after 60 minutes. reach a therapeutic concentration in the blood and tissues, which persists for 12 hours. The maximum concentration of active substances in the blood plasma is reached after 1-4 hours. Plasma protein binding is 66% for sulfamethoxazole and 45% for trimethoprim. The drug is well distributed in the body.

The drug penetrates into the mother's milk and through the placental barrier. Sulfamethoxazole and trimethoprim are metabolized in the liver.

The half-life ranges from 10 to 12 hours.

Pharmacodynamics

Biseptol is a chemotherapeutic combination drug containing sulfamethoxazole and a diaminpyridine derivative - trimethoprim in a ratio of 5:1. Sulfamethoxazole disrupts the utilization of para-aminobenzoic acid, and, consequently, the synthesis of dihydrofolic acid. Trimethoprim inhibits an enzyme that is involved in the conversion of dihydrofolate to active tetrahydrofolate. The combination of both components made it possible to obtain a bactericidal effect. Biseptol is active against gram-positive bacteria: streptococci (Streptococcus pneumoniae, S. agalactiae, S. viridans), staphylococci (Staphylococcus aureus, Staphylococcus epidermidis), Listeria monocytogenes, Nocardia asteroides and gram-negative, including most Enterobacteriaceae (Salmonella, Shigella, Klebsiella, Proteus mirabilis, Enterobacter, some strains of Escherichia coli), some strains of H.influenzae, Legionella spp., Yersinia enterocolitica, Brucella spp., Neisseria meningitidis, Neisseria gonorrhoeae, and Pneumocystis carinii. Sticks (Mycobacteriaceae), viruses, most anaerobic bacteria and fungi are resistant to the drug.

Indications for use

Respiratory infections - exacerbation of chronic bronchitis, treatment and prevention (primary and secondary) of pneumonia caused by Pneumocystis carinii in adults and children

Sinusitis, acute otitis media

Infections of the gastrointestinal tract: typhoid and paratyphoid, bacterial dysentery (shigellosis), diarrhea, cholera

Acute and chronic infections of the urinary system and prostate gland (urethritis, cystitis, prostatitis)

Chancroid

Brucellosis, osteomyelitis, nocardiosis, actinomycosis, toxoplasmosis and

South American blastomycosis (possibly combined with other

antibiotics)

Dosage and administration

The drug is taken orally during or immediately after a meal with plenty of liquid.

Shake before use until a homogeneous suspension is obtained.

5 ml of suspension contains 200 mg of sulfamethoxazole and 40 mg of trimethoprim.

A measuring cup with a scale is included with the package.

In children, trimethoprim 6 mg and sulfamethoxazole 30 mg per kg of body weight per day are usually used. In severe infections, doses can be increased by 50%.

Children:

Adults and children over 12 years old - Usually 20 ml every 12 hours. The maximum dose (for use in especially severe cases) is 30 ml of suspension every 12 hours.

In acute infections, Biseptol should be taken for at least 5 days or until the patient has no symptoms for 2 days. If after 7 days of treatment there is no clinical improvement, the patient's condition should be re-evaluated for possible correction of treatment.

For infections caused by Pneumocystis carinii - 120 mg / kg / day, every 6 hours for 14-21 days.

The course of treatment for urinary tract infections and acute otitis media - 10 days, shigellosis - 5 days.

Patients with impaired renal function

With creatinine clearance> 30 ml / min, the usual dose is prescribed, with creatinine clearance from 15 to 30 ml / min - half the usual dose, and with a decrease in creatinine clearance to< 15 мл/мин применять Бисептол не рекомендуется.

Side effects

Usually the drug is well tolerated.

Frequency not known

Nausea, vomiting, lack of appetite, diarrhea, abdominal pain, gastritis, stomatitis, glossitis

Leukopenia, neutropenia, thrombocytopenia

Fever, shivering

Rash, urticaria, much less often polymorphic erythema, itching

Pseudomembranous enterocolitis

Candidiasis

Hypersensitivity reactions that manifest as fever, angioedema, anaphylactoid reactions - pulmonary infiltrates of the type of eosinophilic, allergic alveolitis with cough or shortness of breath

Reversible hyperkalemia, hypoglycemia, hyponatremia

Headache, dizziness, hallucinations, sleep disturbance, depression

Neuropathy (including peripheral neuritis and paresthesia)

Increased activity of transaminases and bilirubin concentration, hepatitis, cholestasis, liver necrosis

photosensitization

Kidney dysfunction, interstitial nephritis, increased nitrogen

blood urea, serum creatinine, crystalluria, increased diuresis,

especially in patients with edema of cardiac origin

In isolated cases

Agranulocytosis, pancytopenia, megaloblastic, hemolytic anemia, methemoglobinemia

Periarteritis nodosa, allergic myocarditis

Aseptic meningitis

Purpura of Shenlein-Henoch

Rhabdomyolysis

Stevens-Johnson Syndrome

Lyell's syndrome

Arthralgia, myalgia

Contraindications

Hypersensitivity to sulfonamides, trimethoprim and/or

to other components of the drug

Co-administration with dofetilide

Severe impairment of liver or kidney function (creatinine clearance

below 15 ml/min)

Megaloblastic anemia due to folic acid deficiency

Treatment of streptococcal angina

Pregnancy and lactation

Children's age up to 3 months

Drug Interactions

Biseptol, used simultaneously with diuretics, especially from the thiazide group, increases the possibility of thrombocytopenia with bleeding. May prolong prothrombin time in patients taking anticoagulants (eg warfarin).

Enhances the effect of antidiabetic agents, sulfonylurea derivatives.

Inhibits the metabolism of phenytoin in the liver (increases its half-life to 39%). May also increase the concentration of free methotrexate in plasma (increases the release of methotrexate from its compounds with proteins).

Like other sulfonamides, Biseptol can potentiate the effect of oral hypoglycemic drugs from the sulfonylurea group.

With the simultaneous appointment of Biseptol to patients who receive pyrimethamine for the prevention of malaria in doses of more than 25 mg per week, they may develop megaloblastic anemia.

In patients receiving Biseptol and cyclosporine after kidney transplantation, there may be a reversible deterioration in kidney function, manifested by an increase in creatinine levels.

When taken simultaneously with Biseptol, it is necessary to reduce the dose of indomethacin.

It is possible to increase the serum concentration of digoxin, especially in elderly patients, while taking Biseptol.

With the simultaneous use of Biseptol and zidovudine, an increase in the risk of hematological disorders is possible. If it is necessary to use Biseptol and zidovudine, the blood picture should be monitored.

The effectiveness of tricyclic antidepressants may decrease when taken with Biseptol.

Laboratory research

Biseptol may affect the results of determining the concentration of methotrexate in serum by the method of competitive protein binding, when bacterial dihydrofolate reductase is used as a ligand. When determining methotrexate by the radioimmune method, distortion does not occur.

Biseptol can interfere with the reaction of creatinine determination using Jaffe alkaline picrinate (increases creatinine levels by approximately 10%).

special instructions

In elderly and senile patients, as well as with concomitant diseases of the liver and kidneys or while taking other drugs, there is a higher risk of developing severe allergic reactions, such as Stevens-Johnson syndrome, Lyell's syndrome and acute liver necrosis. To reduce the risk of such reactions, treatment with Biseptol should be as short as possible, especially in elderly patients.

At the first appearance of a skin rash or any other severe adverse reaction, the drug should be discontinued. Patients with a tendency to allergic reactions and bronchial asthma Biseptol should be prescribed with caution.

With the duration of the course of therapy for more than 14 days and / or an increase in the dose of the drug, it is necessary to control the picture of peripheral blood; when pathological changes appear, the appointment of folic acid should be taken into account.

In elderly patients, as well as in patients with folic acid deficiency or renal insufficiency, hematological changes characteristic of folic acid deficiency may occur.

When prescribing Biseptol to patients who are already receiving anticoagulants, one should be aware of a possible increase in the anticoagulant effect. In such cases, it is necessary to re-determine the clotting time.

The drug should not be administered to patients with hereditary fructose intolerance.

Patients receiving long-term treatment with Biseptol (especially with renal failure) should regularly do a general urine test and monitor kidney function. During treatment, it is necessary to ensure sufficient fluid intake in the body, adequate diuresis to prevent crystalluria.

Due to the possibility of hemolysis, patients with deficiency of glucose-6-phosphate dehydrogenase are prescribed Biseptol only according to absolute indications and in minimal doses.

Hi all!

Today I will talk about medicinal product, which was purchased for a child, and also helped me out. This is Biseptol in the form of a suspension - inexpensive medicine with antimicrobial properties, but is not an antibiotic.

Combined antibacterial drug, contains sulfamethoxazole and trimethoprim.

❤GENERAL INFORMATION❤

• Full name - Antimicrobials Medana Biseptol Suspension
• Where to buy - any pharmacy, there is no shortage
• Cost - about 130 rubles per bottle of 80 ml
• Shelf life - 3 years
• Country of origin - Poland
• Vacation - I took a prescription without it, no one asked for a prescription

❤APPEARANCE❤

outer carton packaging, appearance standard, "pharmacy". But I'm curious that this square is depicted on the front part, consisting of a hodgepodge of colors)) looks unusual.

The bottle contains some information about active substance, expiration date and storage conditions, manufacturer.

Inside - a bottle of dark brown glass with an identical design, a measuring cup and a kilometer long instructions for use. I will hide the instruction, as usual, in a quote.

The bottle is neat and heavy. It has a manufacturing date and an expiration date stamped on it.

The top of the bottle is closed with a small screw cap. Unscrewing it is easy, there is no child protection, so hide it away ...

The neck is rather narrow and gets dirty, so after I measure out the right portion, I wipe the neck, otherwise the whole bottle will gradually become sticky.

The measuring cup has a scale with divisions, making it easy to measure the right portion. It is convenient for an adult to drink a suspension from such a glass, and even older children can also be given a drug from it.

But for a 3-year-old child, taking medicine from a glass turned out to be inconvenient, and I used a measuring syringe from Nurofen, or, in principle, pour the suspension into an ordinary teaspoon.

❤ COMPOSITION❤

Per 5 ml suspension: sulfamethoxazole 200 mg, trimethoprim 40 mg

Excipients: macrogol glyceryl hydroxystearate, magnesium aluminosilicate, carmellose sodium, citric acid monohydrate, methyl hydroxybenzoate, propyl hydroxybenzoate, sodium saccharinate, sodium hydrogen phosphate dodecahydrate, maltitol, strawberry flavor, propylene glycol, purified water.

❤INDICATIONS FOR USE❤

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

Respiratory tract infections: chronic bronchitis (exacerbation), pneumocystis pneumonia (treatment and prevention) in adults and children;

ENT infections: otitis media (in children);

Urinary tract infections: urinary tract infections, soft chancre;

Gastrointestinal infections: typhoid fever, paratyphoid fever, shigellosis (caused by susceptible strains of Shigella flexneri and Shigella sonnei);

Traveler's diarrhea caused by enterotoxic strains of Escherichia coli, cholera (in addition to fluid and electrolyte replacement);

Other bacterial infections (combination with antibiotics is possible): nocardiosis, brucellosis (acute), actinomycosis, osteomyelitis (acute and chronic), South American blastomycosis, toxoplasmosis (as part of complex therapy).

❤CONTRAINDICATIONS❤

Hepatic and/or kidney failure(creatinine clearance less than 15 ml/min);

Aplastic anemia, B12 deficiency anemia, agranulocytosis, leukopenia;

Deficiency of glucose-6-phosphate dehydrogenase;

Simultaneous reception with dofetilide;

lactation period;

Infant age up to 2 months or up to 6 weeks if born from a mother with HIV infection;

Hypersensitivity to sulfonamides, trimethoprim and / or other components of the drug.

FROM caution: thyroid dysfunction, severe allergic reactions in history, bronchial asthma, folic acid deficiency, porphyria, pregnancy.

❤ TASTE, COLOR, FLAVOR OF BISEPTOL SUSPENSION❤

Biseptol suspension is a viscous liquid of medium density.

By color - opaque, with yellowish or figs you will understand what shade.

Aroma - well, just like washing powder, that's honest. Chemistry chemistry. Although the flavoring is declared as strawberry)). Well, I only have associations with cheap strawberry soap.

Taste is tricky. Just pour the suspension into your mouth, it seems sweet. You swallow - and here it is, an unpleasant bitter aftertaste. It is good that according to the instructions the medicine can and should be washed down with water.

❤ABOUT DOSAGE❤

Inside, after eating with a sufficient amount of liquid.

Adults and children over 12 years of age: 960 mg every 12 hours; at severe infections- 1440 mg every 12 hours; at urinary tract infections- 10-14 days, with exacerbation of chronic bronchitis- 14 days, with travelers' diarrhea and shigellosis- 5 days. The minimum dose and dose for long-term treatment (more than 14 days) - 480 mg every 12 hours.

Children: 2 months (or 6 weeks if born to mothers with HIV infection) to 5 months- 120 mg each, from 6 months to 5 years- 240 mg each, 6 to 12 years old- 480 mg every 12 hours, which approximately corresponds to a dose of 36 mg / kg per day.

❤APPLICATION EXPERIENCE❤

📎For the first time, Biseptol in the form of a suspension was prescribed to a child autumn, when the daughter once again caught the virus in kindergarten and got a temperature. The pediatrician called to the house said that the throat was red, but serious antibiotics such as Amoxiclav could be dispensed with, but Biseptol would have to be drunk. Of course, the treatment included other medicines - nose drops, Miramistin for treating the throat, plentiful warm drinks.

Biseptol was prescribed at a dosage of 5 ml, or a teaspoon without top, twice a day, after meals. The temperature subsided 3-4 hours after taking the suspension and did not rise again. The child became more active. On day 3 complex treatment the daughter felt fine, she had no complaints about her neck. Biseptol, fortunately, did not cause any side effects. From the gastrointestinal tract, too, although I was preparing for the worst, since after antibacterial agents, my daughter most often develops constipation.

📎My experience with Biseptol. Once, while eating a delicious store-bought pizza (the expiration dates were the freshest, oddly enough), I had abdominal discomfort, namely bloating, cramps, and after a while - diarrhea (I hope no one is eating at the time of reading this review ). Diarrhea was not single, but recurring. And then I decided to self-medicate (I don’t advise anyone to do this, although let’s be honest - 90% are already treated themselves😀).

Since the relationship between eaten pizza and problems in the gastrointestinal tract was obvious, it’s quite understandable - I either have poisoning in more or less mild form, or an intestinal disorder. Biseptol took a full measuring cup, that is, 15 ml, twice a day. The bottle with the remnants of the suspension from the child ran out - I bought a new one. After a couple of hours from taking the first dose, the rumbling in the abdomen decreased, the diarrhea stopped. On the second day, there was still a slight discomfort, in total I drank Biseptol for 3 days, and more liquid stool no, everything was back to normal. side effects did not have.

❤TOTAL❤

Biseptol in the form of a suspension - inexpensive effective medicine, which is no worse than antibiotics in action, but has a milder effect and does not violate the natural flora in the intestines. Of course, the taste is not very good, and there are flavors in the composition, so if your child or you personally are prone to allergies, be careful. And of course, you need to take this drug only as directed by a doctor, especially when it comes to young children.