Basijen - instructions for use, analogs, reviews and release forms (injections in ampoules for injections and infusions in a solution of 2 mg in 1 ml in a 100 ml bottle) of a drug for the treatment of pneumonia, pyelonephritis in adults, children and pregnancy

In this article, you can read the instructions for using the drug Basijen. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of experts on the use of Basijena in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Basijena in the presence of existing structural analogs.Use for the treatment of pneumonia, pyelonephritis, gonorrhea in adults, children, as well as during pregnancy and lactation.

Basijen - broad-spectrum antimicrobial agent, quinolone derivative. It interferes with the synthesis of deoxyribonucleic acid (DNA), suppressing the bacterial DNA-gyrase enzyme, and disrupts the growth and division of bacteria. Causes marked morphological changes, including cell wall and membranes, and rapid death of the bacterial cell. It acts bactericidal on gram-negative organisms during rest and division, on gram-positive microorganisms it operates only in the period of division.

Low toxicity for macroorganism cells is explained by the absence of DNA-gyrase in them. Against the background of taking Ciprofloxacin (active ingredient Basijen) there is no parallel development of resistance to other antibiotics not belonging to the group of DNA gyrase inhibitors, which makes it highly effective against bacteria that are resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines .

Ciprofloxacin is sensitive to Gram-negative aerobic bacteria: enterobacteria (Escherichia coli (E. coli), Salmonella spp.(salmonella), Shigella spp. (shigella), Citrobacter spp., Klebsiella spp. (Klebsiella), Enterobacter spp., Proteus mirabilis (proteus), Proteus vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.), Other gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.), Some intracellular pathogens - Legionella pneumophila (legionella), Brucella spp., Listeria monocytogenes, Mycobacterium tuberculosis (Mycobacterium kansasii; Gram-positive aerobic bacteria: Staphylococcus spp. (Staphylococcus aureus) (Staphylococcus aureus, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus), Streptococcus spp. (Streptococcus pyogenes, Streptococcus agalactiae). It is active against Bacillusanthracis.

The majority of staphylococci, resistant to methicillin, are resistant to ciprofloxacin. Sensitivity of Streptococcus pneumoniae, Enterococcus faecalis, Mycobacterium avium (located intracellularly) - moderate (high concentrations are required to repress).

For drug resistant: Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides. It is ineffective against Treponema pallidum.

Resistance develops very slowly, because on the one hand, after the action of ciprofloxacin are left with persistent microorganisms, and on the other - the bacterial cells do not have the enzymes that inactivate it.

Composition

Ciprofloxacin + excipients.

Pharmacokinetics

After intravenous infusion of 200 mg of the drug, the time to reach its maximum concentration in the blood is 60 minutes, the connection with plasma proteins is 20-40%. It is well distributed in the tissues of the body.Concentration in tissues is 2-12 times higher than in plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gall bladder, bile, intestine, abdominal and pelvic organs (endometrium, fallopian tubes and ovaries, uterus), seminal fluid, prostate tissue, kidney and urinary organs, lung tissue, bronchial secretion, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. In cerebrospinal fluid penetrates in a small amount, where its concentration in the absence of inflammation of the meninges is 6-10% of that in the blood plasma, and when inflamed - 14-37%. Ciprofloxacin well penetrates also into the eye fluid, pleura, peritoneum, lymph, through the placenta. The concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in blood plasma. Metabolised in the liver (15-30%) with the formation of low-activity metabolites. It is excreted mainly by the kidneys in unchanged form (50-70%) and in the form of metabolites (10%), the rest - through the gastrointestinal tract. A small amount is excreted in breast milk. After intravenous administration, the concentration in the urine within the first 2 hours after administration is almost 100 times greater than in the blood plasma.In chronic renal insufficiency, the percentage of the drug output through the kidneys decreases, but cumulation in the body does not occur due to a compensatory increase in the metabolism of the drug and excretion through the gastrointestinal tract.

Indications

Bacterial infections caused by microorganisms sensitive to ciprofloxacin:

• diseases of the lower respiratory tract (exacerbation of chronic bronchitis, pneumonia, bronchiectasis, infectious complications of cystic fibrosis);
• infection of ENT organs (acute sinusitis - inflammation of the paranasal sinuses);
• infection of the kidneys and urinary tract (cystitis, pyelonephritis);
• Complicated intra-abdominal infections (in combination with metronidazole), including peritonitis (inflammation of the peritoneum);
• chronic bacterial prostatitis (inflammation of the prostate gland);
• uncomplicated gonorrhea;
• typhoid fever;
• infectious diarrhea (including campylobacteriosis, shigellosis, diarrhea "travelers");
• infections of the skin and soft tissues (infected ulcers, wounds, burns, abscesses, phlegmon);
• infection of bones (osteomyelitis) and joints (septic arthritis);
• septicemia (severe form of sepsis);
• infection against the background of immunodeficiency that occurs with the treatment of immunosuppressive drugs or in patients with neutropenia (low neutrophil count in the blood);
• prevention and treatment of pulmonary form of anthrax;
• prevention of infections during surgical interventions;
• therapy of complications caused by Pseudomonas aeruginosa in children aged 5 to 17 years with cystic fibrosis;
• prevention and treatment of pulmonary form of anthrax (infection with Bacillus anthracis).

Forms of release

Solution for infusions 2 mg in 1 ml, a bottle of polyethylene 100 ml.

Instructions for use and dosing regimen

Solution for infusion is administered intravenously drip. The duration of the intravenous infusion of 200 mg (100 ml infusion solution) should be at least 30 minutes. Infusion solutions ready for use can be mixed with 0.9% sodium chloride solution, Ringer's and Ringer's lactate solution, 5% and 10% Dextrose solution, 10% fructose solution, and also a solution containing 5% dextrose solution with 0.225-0.45% solution of sodium chloride.

In infections of the lower respiratory tract - 200-400 mg 2 times a day.

With infections of the urinary tract: acute uncomplicated - 100 mg 2 times a day; cystitis in women (before menopause) - once 100 mg; Complicated - 200 mg 2 times a day.

With uncomplicated gonorrhea - 100 mg once, with extragenital - 100 mg 2 times a day.

Infectious diarrhea - 200 mg 2 times, the course of treatment - 5-7 days.

Especially severe infections (streptococcal pneumonia, infectious complications of cystic fibrosis, infections of bones and joints, septicemia, peritonitis), especially caused by Pseudomonas, Staphylococcus - 400 mg 3 times a day.

Pulmonary form of anthrax (treatment and prophylaxis) - 400 mg 2 times a day.

For the prevention of infections during surgical interventions - 200-400 mg for 0.5-1 hour before surgery; When the duration of the operation is more than 4 hours, re-enter in the same dose.

In other infections (depending on the severity of the flow) - 200-400 mg 2 times a day.

Older patients are prescribed lower doses, depending on the severity of the infection and the creatinine clearance (CC).

In Pediatrics

In the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years - 10 mg per 1 kg of body weight 3 times a day (maximum dose of 1200 mg). Duration of treatment is 10-14 days.

With pulmonary form of anthrax (prevention and treatment) - 10 mg per 1 kg of body weight 2 times a day. The maximum single dose is 400 mg, the daily dose is 800 mg. The total duration of taking ciprofloxacin is 60 days.

Use in patients with chronic renal failure

At a glomerular filtration rate (CK 31-60 ml per minute at 1.73 square meters or a plasma creatinine concentration of 1.4 to 1.9 mg per 100 ml), the maximum daily dose is 800 mg. At the glomerular filtration rate (CC below 30 ml per minute at 1.73 square meters or plasma creatinine concentration above 2 mg per 100 ml) and during hemodialysis the maximum daily dose is 400 mg; when hemodialysis ciprofloxacin is administered after a hemodialysis session. With peritoneal dialysis, the infusion solution is added to the dialysate (intraperitoneally) at a dose of 50 mg per liter of dialysate 4 times a day (every 6 hours).

The average course of treatment: 1 day - with acute uncomplicated gonorrhea and cystitis; up to 7 days - with infections of the kidneys, urinary tract and abdominal cavity; during the whole period of the neutropenic phase in patients with weakened protective forces of the body, but no more than 2 months - with osteomyelitis and 7-14 days - with all other infections. With streptococcal infections due to the danger of late complications, treatment should last at least 10 days.

Treatment should be carried out at least 3 days after the normalization of body temperature or the disappearance of clinical symptoms.

After intravenous administration, you can continue treatment orally.

Side effect

• nausea, vomiting;
• diarrhea;
• abdominal pain;
• flatulence (bloating);
• decreased appetite;
• Cholestatic jaundice (especially in patients with liver disease);
• hepatitis, hepatonecrosis (liver necrosis);
• dizziness, headache;
• increased fatigue;
• anxiety, insomnia;
• tremor (trembling of limbs or trunk);
• "nightmarish" dreams;
• peripheral paralgesia (anomaly of perception of a feeling of pain);
• increased intracranial pressure;
• confusion, fainting;
• depression;
• hallucinations;
• migraine;
• thrombosis of the cerebral arteries;
• impairment of taste and smell;
• impaired vision (diplopia, change in color perception);
• noise in the ears, hearing loss;
• tachycardia (heart palpitations), heart rhythm disturbances, lowering blood pressure;
• leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia;
• hypoprothrombinemia, increased activity of "liver" transaminases and alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, hyperglycemia;
• hematuria (blood in the urine), crystalluria (crystals of salts in the urine);
• glomerulonephritis;
• dysuria (urination disorder), polyuria (increased urine formation), urinary retention;
• albuminuria (protein in the urine);
• urethral bleeding;
• decrease in renal excretion;
• interstitial nephritis;
• skin itching, urticaria, the formation of blisters accompanied by bleeding, and the appearance of small nodules that form scabs;
• drug fever;
• point hemorrhages on the skin (petechiae);
• swelling of the face or larynx, dyspnea;
• eosinophilia;
• vasculitis (inflammation of blood vessels);
• erythema nodosum;
• multiforme exudative erythema, including Stevens-Johnson syndrome;
• toxic epidermal necrolysis (Lyell's syndrome);
• arthralgia (joint pain);
• arthritis;
• Tendovaginitis (inflammation of the membrane surrounding the tendon), tendon ruptures;
• Myalgia (pain in the muscle);
• at the injection site - phlebitis (inflammation of the vein), soreness;
• asthenia;
• superinfection (candidiasis, pseudomembranous colitis);
• increased sweating;
• "tides" of blood to the face;
• increased photosensitivity.

Contraindications

• hypersensitivity to ciprofloxacin, any other component of the drug, or other drugs from the group of fluoroquinolones;
• simultaneous reception with tizanidine (risk of pronounced reduction in blood pressure, drowsiness);
• children and adolescents under 18 years (except for the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years old and prevention and treatment of pulmonary form of anthrax);
• with caution: pronounced atherosclerosis of cerebral vessels, cerebral circulation disorder, mental illness, epilepsy, marked renal and / or hepatic insufficiency, elderly age, tendon damage with prior treatment with quinolones.

Application in pregnancy and lactation

Basijen is contraindicated in pregnancy and lactation.

Use in children

The drug is contraindicated in children and adolescents under 18 years (except for the treatment of complications caused by Pseudomonas aeruginosa in children with cystic fibrosis of the lungs from 5 to 17 years).

Application in elderly patients

With caution: the elderly. Older patients are prescribed lower doses, depending on the severity of the infection and the CC score.

special instructions

Ciprofloxacin is not a drug of choice in suspected or established pneumonia caused by Streptococcus pneumoniae.

With simultaneous intravenous administration of Basijena and drugs for general anesthesia from the group of barbituric acid derivatives, continuous monitoring of the heart rate, blood pressure, and electrocardiogram is necessary. To avoid the development of crystalluria, exceeding the recommended daily dose is inadmissible, adequate fluid intake and maintenance of acid urine reaction are also necessary.

Patients with epilepsy, seizures in the anamnesis, vascular diseases and organic brain lesions, in connection with the threat of the development of adverse reactions from the central nervous system, Basijen should be appointed only on "vital" indications.

If a severe and prolonged diarrhea occurs during or after treatment, the diagnosis of pseudomembranous colitis should be deleted, which requires immediate discontinuation of the drug and the appointment of appropriate treatment.

When pain occurs in the tendons or the first signs of tendovaginitis treatment should be discontinued (individual cases of inflammation and even rupture of tendons during treatment with fluoroquinolones are described).

During the treatment should avoid contact with direct sunlight, artificial UV-irradiation.

Influence on the ability to drive machinery and car

Patients receiving Basijen should refrain from driving the car and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions.

Drug Interactions

Due to the decrease in the activity of microsomal oxidation in hepatocytes, it increases the concentration and lengthens the half-life of theophylline and other xanthines (eg, caffeine), oral hypoglycemic drugs, indirect anticoagulants (increased action), and decreases the prothrombin index.

When combined with other antimicrobial drugs (beta-lactam antibiotics, aminoglycosides, clindamycin, metronidazole), synergy is usually observed; can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp .; with mezlocillin, azlocillin and other beta-lactam antibiotics - with streptococcal infections; with isoxazolylpenicillins and Vancomycin - with staphylococcalinfections; with Metronidazole and Clindamycin - with anaerobic infections.

Increases the nephrotoxic effect of cyclosporine, there is an increase in the serum creatinine concentration, in such patients monitoring of this indicator is required 2 times a week.

Non-steroidal anti-inflammatory drugs (excluding acetylsalicylic acid) increase the risk of seizures.

The joint administration of uricosuric medicines leads to a delay in excretion (up to 50%) and an increase in the plasma concentration of ciprofloxacin.

The infusion solution is pharmaceutically incompatible with all infusion solutions and drugs that are physico-chemically unstable under acidic conditions (the pH of the infusion solution of ciprofloxacin is 3.5-4.6). Do not mix the intravenous solution with solutions having a pH of more than 7.0.

Analogs of Basigen product

Structural analogs for the active substance:

• Afenoxin;
• Betaciprol;
• Vero-Ciprofloxacin;
• Zindolin 250;
• Isfipro;
• Quintor;
• Quipro;
• Liprokhin;
• Microfleks;
• Nirtsip;
• Oftotsipro;
• PROCIPRO;
• Recipro;
• Rozip;
• Siflox;
• Ceprova;
• Ciloxane;
• Ciprinol;
• Ciprobay;
• Ciprobide;
• Ciprobrin;
• Citrodox;
• Ciproxyl;
• Ciprolake;
• Tsiprolet;
• Ciprolone;
• Cipromed;
• Cipropane;
• Ciprosan;
• Ciprosine;
• Ciprosol;
• Ciprofloxabol;
• Ciprofloxacin;
• Cytar;
• Cifloxinal;
• Tsifran;
• Cyphrazide;
• Ecocylol.

Structural analogs of the pharmacological group (quinolones / fluoroquinolones):

• Abaktal;
• Aquamox;
• Afenoxin;
• Betaciprol;
• Vigamox;
• Glaoufos;
• Gramurin;
• Dancyl;
• Zanotsin;
• Zofloks;
• Ivacin;
• Isfipro;
• Quintor;
• Xenacvin;
• Levoxime;
• Levoflox;
• Levofloxacin;
• Lefokcin;
• Liprokhin;
• Lomflow;
• Lofox;
• Maxiflox;
• Microfleks;
• Moxigram;
• Moxiflo;
• Moxifloxacin;
• Nevigramon;
• The Negroes;
• Nolycin;
• Norbaktin;
• Norfloxacin;
• Ofloxacin;
• Oftakwix;
• Pefloxabol;
• Pefloxacin;
• Remedy;
• Rotomox;
• Rozip;
• Siflox;
• Sofazine;
• Sparfloxacin;
• Tavanik;
• Taricin;
• Ultramox;
• Uniflox;
• Flexine;
• Floracid;
• Hayleflex;
• Ciloxane;
• The cynobacterium;
• Citrodox;
• Tsiprolet;
• Cipromed;
• Cipropane;
• Chibroxin;
• Ecology;
• Utibid.

Feedback from an otorhinolaryngologist

I work in the ENT department of the city hospital. Basigen is used to treat patients with severe forms of acute purulent sinusitis, especially when not one but several paranasal sinuses are affected.The combination of intravenous drip of Basigena solution with sanation of sinuses with the help of the catheter Yamik (without puncturing) and other local procedures gives an excellent therapeutic effect. With timely treatment, usually a 7-10-day course of antimicrobial therapy is sufficient. Adverse reactions to Basidzhene injection are most often manifested by nausea, discomfort in the abdomen, increased sweating. Rarely, but it happens that patients complain of insomnia.

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