Basigen
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Terms and conditions of storage
Basigen is a quinolone derivative, a broad spectrum antimicrobial agent.
Release form and composition
Dosage form - solution for infusion: transparent, with a yellowish tint (100 ml in polyethylene bottles, 1 bottle in a cardboard box).
Active ingredient: ciprofloxacin, in 1 bottle - 200 mg.
Additional components: disodium edetate, lactic acid, citric acid monohydrate, sodium chloride, sodium hydroxide, water for injection.
Indications for use
For adults:
- infections of the kidneys and urinary tract (cystitis, pyelonephritis);
- infections due to immunodeficiency arising from neutropenia or treatment with immunosuppressive drugs;
- chronic bacterial prostatitis;
- complicated intra-abdominal infections, including peritonitis (used in combination with metronidazole);
- infections of bones and joints (osteomyelitis, septic arthritis);
- ENT infections (acute sinusitis);
- infections of the skin and soft tissues (infected wounds, ulcers, abscesses, burns, phlegmon);
- typhoid fever;
- diseases of the lower respiratory tract (bronchiectasis, pneumonia, exacerbation of chronic bronchitis, infectious complications of cystic fibrosis);
- infectious diarrhea (including shigellosis, campylobacteriosis, traveler's diarrhea);
- septicemia;
- uncomplicated gonorrhea;
- pulmonary anthrax (prevention and treatment);
- prevention of infections during surgery.
For kids:
- treatment of complications caused by Pseudomonas aeruginosa in children 5–17 years old with pulmonary cystic fibrosis;
- therapy and prevention of pulmonary anthrax (infection with Bacillus anthracis).
Contraindications
Absolute:
- pregnancy, lactation period;
- age up to 18 years (with the exception of complications caused by Pseudomonas aeruginosa in children 5–17 years old and pulmonary anthrax);
- the simultaneous use of tizanidine;
- hypersensitivity to the components of Basigen or other drugs of the fluoroquinolone group.
Carefully:
- mental illness;
- violation of cerebral circulation;
- epilepsy;
- cerebral atherosclerosis;
- damage to the tendons during previous treatment with quinolones;
- severe hepatic and / or renal failure;
- elderly age.
Method of administration and dosage
Basigen is injected intravenously at a rate of approximately 0.3 ml per minute (100 ml of the solution is infused over a minimum of 30 minutes).
Ready-to-use infusion solutions can be mixed with solutions of Ringer's and Ringer's lactate, sodium chloride 0.9%, dextrose 5 and 10%, fructose 10%, dextrose 5% with sodium chloride solution 0.225-0.45%.
Recommended dosing regimens for adults, depending on the indication:
- urinary tract infections: acute uncomplicated - 100 mg 2 times a day; cystitis in women (before menopause) - 100 mg once; complicated - 200 mg 2 times a day;
- respiratory tract diseases: 200-400 mg 2 times a day;
- infectious diarrhea: 200 mg 2 times a day for 5-7 days;
- gonorrhea: uncomplicated - 100 mg once; extragenital - 100 mg 2 times a day;
- pulmonary anthrax (prevention and treatment): 400 mg 2 times a day;
- prevention of infections during surgery: 200-400 mg 30-60 minutes before surgery; if the operation is performed for more than 4 hours, the drug is administered in the same dose again
- especially severe infections (peritonitis, septicemia, infections of bones and joints, infectious complications of cystic fibrosis, streptococcal pneumonia), especially caused by Staphylococcus and Pseudomonas: 400 mg 3 times a day;
- other infections: 200-400 mg 2 times a day.
For elderly patients, Basigen is prescribed in lower doses, taking into account the creatinine clearance (CC) parameters and the severity of the infectious process.
Recommended dosages for children:
- complications caused by Pseudomonas aeruginosa in children 5–17 years old with cystic fibrosis of the lungs: 10 mg / kg 3 times a day (but not more than 1200 mg / day) for 10–14 days;
- pulmonary anthrax (prevention and treatment): 10 mg / kg 2 times a day. The maximum single dose is 400 mg, the daily dose is 800 mg. The duration of treatment is 60 days.
Use in patients with chronic renal failure
Maximum daily doses:
- CC 31-60 ml / minute / 1.73 m 2 or plasma creatinine concentration 1.4-1.9 mg / 100 ml - 800 mg;
- CC below 30 ml / minute / 1.73 m 2 or plasma creatinine concentration above 2 mg / 100 ml, hemodialysis * - 400 mg.
* Basigen is administered after the session.
In peritoneal dialysis, an infusion solution of ciprofloxacin is added to the dialysate at a dose of 50 mg per liter of dialysate. Introduce intraperitoneally 4 times a day (at intervals of 6 hours).
Average duration of treatment:
- cystitis and acute uncomplicated gonorrhea - 1 day;
- infections of the abdominal cavity, kidneys and urinary tract - up to 7 days;
- streptococcal infections - at least 10 days;
- neutropenia - during the entire period of the neutropenic phase, but not more than 2 months with osteomyelitis and 7-14 days - with all other infections.
After normalization of body temperature, treatment is recommended to continue for at least 3 days.
After intravenous administration of Basigen, it is possible to transfer the patient to oral forms of drugs containing ciprofloxacin as an active substance.
Side effects
- local reactions: soreness at the injection site, phlebitis;
- from the digestive system: decreased appetite, abdominal pain, diarrhea, nausea, flatulence, vomiting, hepatitis, cholestatic jaundice (especially in patients with previous liver disease), hepatonecrosis;
- on the part of the cardiovascular system: lowering blood pressure, heart rhythm disturbances, tachycardia;
- on the part of the urinary system: urinary retention, interstitial nephritis, decreased nitrogen excretion function of the kidneys, urethral bleeding, glomerulonephritis, albuminuria, hematuria, polyuria, dysuria, crystalluria (mainly with alkaline urine reaction and low urine output);
- from the nervous system: increased intracranial pressure, nightmares, insomnia, anxiety, hallucinations, increased fatigue, dizziness, confusion, tremor, headache, migraine, depression, peripheral paralgesia (anomaly in the perception of pain), thrombosis of the cerebral arteries, fainting, as well as other manifestations of psychotic reactions (in rare cases, they progress to conditions in which the patient can harm himself);
- on the part of the hematopoietic organs: thrombocytopenia, anemia, leukocytosis, hemolytic anemia, granulocytopenia, leukopenia, thrombocytosis;
- from the side of the musculoskeletal system: tendon ruptures, tendovaginitis, myalgia, arthritis, arthralgia;
- from the senses: impairment of smell and taste, hearing loss, tinnitus, visual impairment (change in color perception, diplopia);
- allergic reactions: blistering with bleeding, pruritus, vasculitis, the appearance of small nodules that form scabs, urticaria, pinpoint hemorrhages on the skin (petechiae), drug fever, erythema nodosum, eosinophilia, shortness of breath, edema of the face or larynx, toxic epidermal exudative erythema multiforme;
- laboratory parameters: increased alkaline phosphatase and hepatic transaminase activity, hyperglycemia, hypercreatininemia, hypoprothrombinemia, hyperbilirubinemia;
- others: increased photosensitivity, increased sweating, asthenia, flushing of the face, superinfection (candidiasis, pseudomembranous colitis).
special instructions
Ciprofloxacin is not the drug of choice for established or suspected Streptococcus pneumoniae pneumonia.
Patients with a history of seizures, epilepsy, organic brain lesions and vascular diseases due to a high risk of side effects from the central nervous system, Basigen can be prescribed only for health reasons.
In order to avoid the development of crystalluria, the recommended daily dose of the drug must not be exceeded. Adequate fluid intake and maintaining acidic urine are also essential.
If it is necessary to carry out surgery during treatment with Basigen with the use of a general anesthetic from the group of barbituric acid derivatives, blood pressure, heart rate and electrocardiogram should be carefully monitored.
In the event of prolonged and / or severe diarrhea, it is necessary to discontinue the drug and conduct an examination of the patient in order to exclude pseudomembranous colitis.
Treatment should be discontinued in the event of pain in the tendons or the first signs of tendovaginitis.
During treatment, it is recommended to avoid exposure to direct sunlight and contact with artificial ultraviolet radiation, as well as to refrain from driving and performing potentially hazardous types of work that require increased attention and speed of psychomotor reactions.
Drug interactions
- theophylline and other xanthines (for example, caffeine), oral hypoglycemic drugs: their concentration increases and the half-life is lengthened;
- indirect anticoagulants: their effect increases, the prothrombin index decreases;
- cyclosporine: the nephrotoxic effect increases, the concentration of serum creatinine increases (this indicator should be monitored 2 times a week);
- non-steroidal anti-inflammatory drugs (with the exception of acetylsalicylic acid): the risk of seizures increases;
- tizanidine: the likelihood of a pronounced decrease in blood pressure and the appearance of drowsiness increases;
- uricosuric agents: the excretion of ciprofloxacin slows down (up to 50%), its plasma concentration increases;
- other antimicrobial drugs (aminoglycosides, beta-lactam antibiotics, metronidazole, clindamycin): there is a synergistic effect.
Basigen can be used in combination with clindamycin and metronidazole - for anaerobic infections; with azlocillin, mezlocillin or other beta-lactam antibiotics - for streptococcal infections; with ceftazidime and with azlocillin - for infections caused by Pseudomonas spp.; with vancomycin and isoxazolylpenicillins - for staphylococcal infections.
The infusion solution is pharmaceutically incompatible with all drugs and other infusion solutions that are physico-chemically unstable in an acidic environment (the pH of the ciprofloxacin solution is 3.5-4.6). Do not mix the solution for intravenous administration with solutions having a pH greater than 7.
Terms and conditions of storage
Store in a dry, dark place, out of reach of children, at temperatures up to 25 ° C. Do not freeze.
The shelf life is 3 years.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
