Dvaseptol - instructions for use, doses, side effects, contraindications

Combined antibacterial preparation. Co-trimoxazole - a chemotherapeutic agent with a broad spectrum bactericidal action due to the blocking of biosynthesis of folate in microbial cells: sulfamethoxazole synthesis gives dihydrofolic acid, trimethoprim prevents the conversion of dihydrofolic acid into tetrahydrofolic - the active form of folic acid that is responsible for protein metabolism, and division of microbial cells.

The activity of the drug is manifested in the following microorganisms: Staphylococcus spp., Streptococcus spp. (Hemolytic strains are more sensitive to penicillin) Neisseria meningitidis, Neisseria gonorrhoeae, Escherichia coli (including enterotoxigenic strains), Salmonella spp. (including Salmonella typhi and Salmonella paratyphi). Shigella spp., Jersinia spp., 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. (including Mycobacterium leprae), Citrobacter, Enterobacter spp., Legionella pneumophila, Providencia, some species Pseudomonas (Besides Pseudomonas aeruginosa), Senatia marcescens, Moiganella spp., Pneumocystis carinii, Chlamydia spp. (including Chlamydia trachomatis, Chlamydia psittaci); protozoa: Plasmodium spp., Toxoplasma gondii; pathogenic fungi, Actinomyces israelii, Coccidioides immitis, Histoplasma capsulatum, Leishmania spp.

Pharmacokinetics:

When ingestion, both components of the drug are completely absorbed from the gastrointestinal tract. The maximum concentration of the active components of the drug is observed after 1-4 hours.

Trimethoprim differs by good penetration into cells and through tissue barriers - into the lungs, kidneys, prostate, bile, saliva, sputum, liquor. The binding of trimethoprim to proteins is 50%, the half-life of it is normal from 8.6 to 17 hours. The main way to excrete trimethoprim is through the kidneys, 50% unchanged.

Sulfamethoxazole: its binding to plasma proteins is 66%, the half-life is from 9 to 11 hours in normal. The main way of elimination is the kidney, and, from 15 to 30% in active form.

Indications:The drug is used to treat infections: the respiratory system (bronchitis, pneumonia, lung abscess, pleural empyema, bronchoectic disease) and ENT organs (otitis media, sinusitis); urogenital system (pyelonephritis, urethritis, cystitis, salpingitis, prostatitis), including gonorrhea; gastrointestinal (dysentery, cholera, typhoid fever, paratyphoid, diarrhea); meningitis, brain abscess; skin and soft tissues (pyoderma,furunculosis, etc.).

Contraindications:

Hypersensitivity to trimethoprim and / or sulfonamides, severe hepatic and / or renal failure, hematological diseases (aplastic anemia, B12-deficiency anemia, agranulocytosis, leukopenia), glucose-6-phosphate dehydrogenase deficiency, children under 3 years of age (for this drugof the form), hyperbilirubinemia in children, pregnancy, lactation.

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

Dosing and Administration:

The dosage regimen is individual, depending on the severity of the disease, the sensitivity and type of pathogen, the age of the patient. At uncomplicated infections appoint:

Children from 3 to 5 years: 2 tablets (120 mg) 2 times a day.

Children from 6 to 12 years: 4 tablets (120 mg) or 1 tablet (480 mg) 2 times a day.

Adults and children over 12 years: 960 mg 2 times a day, with prolonged therapy of 480 mg 2 times a day.

Duration of treatment from 5 to 14 days. In severe casesand and / or with the chronic form of infectious diseases, an increase in the single dose by 30-50% is permissible.

The drug is taken during or after a meal.In the process of treatment, a plentiful drink is recommended.

In case of prolongation of the course of treatment for more than 5 days and / or increasing the dose, hematological control should be performed; in case of a change in the blood picture, folic acid should be prescribed at 5-10 mg per day.

Side effects:

On the part of the digestive system: nausea, vomiting, decreased appetite, abdominal pain, diarrhea, hastrethitis, glossitis, stomatitis, cholestasis, increased activity of "liver transaminases," cholestatic hepatitis, hepatonecrosis, pseudomembranous enterocolitis.

From the nervous system: headache, dizziness, in a separateIn other cases - aseptic meningitis, tremor, peripheral neuritis.

From the respiratory system: bronchospasm, pulmonary infiltrates.

From the hemopoiesis: ledikopenia, neutropenia, thrombocytopenia, agranulocytosis, interregional anemia.

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

From the musculoskeletal system: arthralgia, myalgia.

Allergic reactions: itching, rash, exudative erythema multiforme, toxic epidermal necrolyse (Lyell syndrome), exfoliative dermatitis, hyperthermia, angioedema, photosensitivity, allergic myocarditis, hyperplasia sclera.

Other: hypoglycemia.

Overdose:

Symptoms - nausea, vomiting, blurred consciousness.

Treatment: withdrawal of the drug, gastric lavage (no later than 2 hours after taking an excessive dose), copious drink, forced diuresis, calcium folinate (5-10 mg / day).

Interaction:

The drug is not recommended to be taken concurrently with thiazide diuretics because of the risk of thrombocytopenia.

Strengthens the anticoagulant activity of warfaria and anticonvulsant activity of phenytoin (prolongs its T1 / 2 by 39%).

Trimethoprim potentiates the action of hypoglycemic drugs - derivatives of sulfonylurea. Between diuretics (thiazides, furosemide and others) and oral hypoglycemic drugs (sulfonylureas derivatives), on the one hand, and antimicrobial sulfonamides - with others, it is possible to develop a cross-allergic reaction.

Rifampicin withthe half-life of trimethoprim.

Co-administration of co-trimoxazole and cyclosporineand after kidney surgery worsens the condition of patients.

The effect is reduced when used simultaneously with benzocaine, procaine, procainamide and other drugs, as a result of the metabolism of which PAEK is formed.

Phenytoin, barbiturates, PASC intensify manifestations of deficiency of folic acid It is not recommended simultaneous administration of the drug with salicylates, butadione, naproxen. Ascorbic acid, hexamethylenetetramine and other drugs, acidifying urine, increase the risk of crystalluria.

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

Drugs that inhibit bone marrow hematopoies increase the risk of myelosuppression. Pyrimethamine in doses exceeding 25 mg / week, increases the risk of megaloblastic anemia. Reduces the reliability of oral contraception (inhibits the intestinal microflora and reduces the intestinal-hepatic circulation of hormonal compounds).

Special instructions:

Excessive sunlight and UV irradiation should be avoided.

Form release / dosage:Tablets of 120 mg and 480 mg.

Packaging:For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil printed lacquered. 2 contour packs together with instructions for use are placed in a pack of cardboard.

Storage conditions:

List B. 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:

2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000743 / 01

Date of registration:17.10.2007

Expiration Date:Unlimited

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp19.03.2017

Illustrated instructions

Instructions

Dvaseptol® (Dvaseptol)