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Biseptol tablets instructions for use

Biseptol tablets instructions for use

Biseptol is a combined antibacterial drug that has a wide spectrum of action and activity against a large number of different bacteria of infectious agents. In connection with a wide spectrum of action, Biseptol tablets are used for infectious pathology of various localizations in the body.

Form of issue and composition

Biseptol tablets are round in shape and white in color. In the middle of the tablet, there is a dividing risk for a convenient fracture in half if you need to reduce the dosage. In one tablet, the concentration of active ingredient co-trimoxazole is 120 mg (sulfamethoxazole 100 mg and trimethoprim 20 mg) and 480 mg (sulfamethoxazole 400 mg and trimethoprim 80 mg). It also contains auxiliary substances, which include:

  • Potato starch.
  • Magnesium stearate.
  • Talc.
  • Polyvinyl alcohol.
  • Aseptin P,
  • Aseptin M,
  • Propylene glycol.

Tablets are packaged in a planar cell pack of 20 pieces. One carton pack contains one contoured cell pack with tablets and instructions for use.



pharmachologic effect

The active substance of the tablets is co-trimoxazole. It is a combination of two compounds - sulfamethoxazole and trimethoprim. These substances have an antimicrobial effect due to inhibition of the synthesis of folic acid in a bacterial cell. Sulfamethoxazole blocks the formation of dihydrofolic acid, and trimethoprim subsequently converts it to tetrafolic acid. Folic acid is essential for the normal flow of nucleotide base exchange processes in the bacterial cell that make up the genetic material (DNA and RNA). Due to this mechanism, Biseptol tablets in low concentration have bacteriostatic effect (inhibit the growth and multiplication of bacteria), and with increasing concentration - bactericidal action (cause the death of bacterial cells). Co-trimoxazole has activity against a wide range of different types of bacteria:

  • Gram-negative bacilli (rod-shaped bacteria that are stained pink in Gram staining) are Enterobacter cloacae, Enterobacter aerogenes, Haemophilus parainfluenzae, Citrobacter freundii, Citrobacter spp., Klebsiella oxytoca, Klebsiella spp., Yersinia enterocolitica, Yersinia spp., Vibrio cholerae. Also Hafnia alvei, Serratia marcescens, Serratia liquefaciens, Serratia spp., Cinetobacter lwoffi, Acinetobacter anitratus, Aeromonas hydrophila.
  • Gram-positive cocci (globular bacteria, have a violet color in a smear stained by Gram) - Staphylococcus aureus (methicillin-sensitive and methicillin-resistant), Staphylococcus spp. (Coagulase-negative), Streptococcus pneumoniae (penicillin-sensitive and penicillin-resistant).

Resistance (resistance) to the active substance of the drug has causative agents of specific infectious diseases ( tuberculosis , syphilis ) - Mycoplasma spp., Mycobacterium tuberculosis, Pseudomonas aeruginosa and Treponema pallidum.

After taking the tablets inside, the active substance is absorbed into the blood from the lumen of the small intestine. The therapeutic concentration in the blood is reached in 20-30 minutes after taking the pill, and the active substance is almost completely absorbed from the intestine (bioavailability above 90%). Co-trimoxazole penetrates well into all tissues of the body from the blood, penetrates the blood-brain barrier, accumulates in the brain tissues. At a lower concentration, it accumulates in the fetus during pregnancy (passes through the placental barrier) and breast milk during lactation. Almost half of the active substance is excreted in the urine by the kidneys unchanged. Partially, co-trimoxazole is processed in the liver to intermediate decay products, which are excreted in the urine and bile.

Indications for use

The use of Biseptol tablets is indicated for various infectious processes in the body caused by bacteria that are sensitive to co-trimoxazole, including:

  • Infections of the upper respiratory tract - rhinitis (inflammation of the nasal mucosa), pharyngitis (bacterial process in the pharynx), laryngitis (inflammation of the larynx).
  • Lower respiratory tract infections - tracheitis (trachea inflammation), bronchitis ( bronchitis ), pneumonia (pneumonia, including pneumocystis pneumoniae caused pneumonia).
  • Pathology of ENT organs - sinusitis (inflammation of the mucous membrane of the paranasal sinuses), tonsillitis (infectious process in the tonsils) and otitis (inflammation of the outer, middle or inner ear).
  • Infections of the urogenital system - prostatitis (inflammation of the prostate gland in men), pathological infectious process in the appendages of the uterus in women, damage to the kidneys, bladder, ureters and urethra.
  • Infections of the digestive and gastrointestinal tract organs - enterocolitis (inflammation of the small and large intestine), gastritis (bacterial lesions of the stomach), pancreatitis (inflammation of the pancreas), infectious purulent processes in the liver and bile ducts. Biseptol tablets are also used to treat especially dangerous infections with digestive system damage, in particular cholera.
  • Some generalized specific bacterial infections caused by co-trimoxazole-sensitive bacteria - brucellosis, actinomycosis (in case it is not caused by true fungi by actinomycetes).

Biseptol is usually a second-line antibiotic, its use is advisable in the case of resistance in bacteria to first-line antibiotics. Biseptol tablets can also be used to treat osteomyelitis (purulent process in the bones) with confirmation of sensitivity to co-trimoxazole in bacteria of pathogens.

Contraindications for use

Biseptol tablets are contraindicated for use in a number of pathological and physiological conditions of the body, which include:

  • Individual intolerance or hypersensitivity to co-trimoxazole or excipients of the drug.
  • Parenchymal pathology of baking with pronounced damage or death of hepatocytes (liver cells).
  • Renal failure, especially in those cases where it is not possible to conduct laboratory monitoring of the functional state of the kidneys and the level of co-trimoxazole in the blood.
  • Anemia (anemia), associated with an insufficient amount of folic acid in the body.
  • Violations of the functional state of the blood system, accompanied by changes in hematological indicators.
  • Immunological decrease in the number of platelets in the past, caused by the use of co-trimoxazole.
  • Pregnancy at any time of pregnancy and breastfeeding - co-trimoxazole may lead to a deficiency of folic acid, which is necessary for the normal development of the fetus or infant.

The presence of possible contraindications is determined before the use of Biseptol tablets.


Dosing and Administration

Biseptol tablets are taken orally after a meal and are washed down with a sufficient amount of liquid. They are taken every 12 hours (2 times a day). The recommended therapeutic dose is different for people of different ages:

  • Children aged 2 to 6 years - 240 mg 2 times a day.
  • Children aged 6 to 12 years - 480 mg 2 times a day.
  • Children over 12 years and adults - 960 mg 2 times a day.

Also, the dosages of the drug differ, depending on the type of pathogen and the severity of the infectious process in the body:

  • With pneumonia, the dose to be administered is calculated based on 100 mg per 1 kg of body weight.
  • With gonorrhea (infection of the urinary and genital system caused by gonococcus) - 2 g of the drug 2 times a day.

The duration of the course of the drug is prescribed by the doctor individually. Usually it is 5-14 days.

Side effects

Receiving tablets Biseptol can lead to the development of negative reactions and side effects from various organs and systems, which include:

  • The digestive system - nausea, vomiting, loosening of the stool, stasis of bile in the bile ducts with the development of cholestatic hepatitis (inflammation of the liver), pseudomembranous colitis (specific inflammation of the intestine caused by a deficiency of folic acid).
  • The hemopoietic system and blood - anemia (decrease in hemoglobin and erythrocytes), leukopenia (decrease in the number of leukocytes in the blood) with neutropenia (reduction of neutrophils). It is also possible an autoimmune decrease in the number of platelets in the blood (thrombocytopenia).
  • The urinary system is hematuria (the appearance of blood in the urine), nephritis (a specific inflammation of the kidneys).
  • The central nervous system is a headache, depression (a decrease in mood, depression), periodic dizziness.
  • Allergic reactions - skin rash, itching, urticaria (a characteristic swelling and a rash that looks like a nettle burn), angioedema of Quincke (pronounced edema of the skin and subcutaneous tissue with predominant localization in the face and external genital organs) may develop. Severe allergic reaction is characterized by the development of anaphylactic shock (multiple organ failure with a progressive decrease in systemic blood pressure).

In case of signs and symptoms of side effects, the drug should be stopped and seek medical help. Side effects are reversible and disappear after drug withdrawal.

special instructions

Biseptol tablets can be used only after the appointment of a doctor, conducted a study and the diagnosis. With regard to their application, there are a few special instructions that you should pay attention to:

  • The drug is used with caution in patients with bronchial asthma, other allergies (provided that it has not developed to the components of the drug), acute or chronic hepatic or renal insufficiency, and elderly people.
  • Simultaneous reception of Biseptol tablets with thiazide diuretics (diuretics) increases the risk of hypokalemia (decreased levels of potassium ions in the blood) and bleeding.
  • It is not advisable to simultaneously use Biseptol with salicylates, rifampicin, cyclosporine, warfarin.
  • Biseptol tablets and alcohol can not be combined, since there is a high risk of developing toxic hepatitis.
  • During the use of the drug, it is necessary to ensure that sufficient fluids enter the body.
  • With prolonged use of Biseptol tablets, laboratory monitoring of the functional state of the liver, kidneys and hematologic parameters of the blood should be carried out.
  • The drug is contraindicated for use in pregnant and lactating women.
  • Tablets do not have a direct effect on the speed of psychomotor reactions and concentration of attention. However, when they are used, there is a risk of side effects from the central nervous system, so during the reception it is advisable to refrain from controlling the vehicles or mechanisms.

In pharmacies, Biseptol tablets are dispensed on prescription. Do not use the drug yourself or on the recommendations of third parties who are not specialists. If you have any questions or doubts about taking the drug, you should consult your doctor.

Overdose

If the recommended therapeutic dose is significantly exceeded, the symptoms of acute poisoning develop - nausea, vomiting, abdominal pain, headache, impaired consciousness. In this case, the drug should be discontinued and seek medical help. Disintoxication therapy includes gastric, intestinal and symptomatic washing. Chronic overdose can lead to oppression of hemopoiesis with a significant decrease in the number of all blood cells.

Analogues of Biseptol tablets

The active substance co-trimoxazole is part of such preparations, which are analogues of Biseptolum - Groseptol, Berlocid, Bactrim, Co-trimoxazole.

Terms and conditions of storage

Shelf life of Biseptol tablets since their manufacture is 5 years. Keep the drug in a dry, inaccessible place with an air temperature of no higher than 25 ° C.

Biseptol price

Biseptol tablets 120 mg - from 27 to 37 rubles.

Biseptol tablets 480mg - from 83 to 109 rubles.

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