Gatifloxacin
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. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Gatifloxacin is an antibacterial drug.
Release form and composition
Dosage forms of Gatifloxacin release:
- solution for infusion 2 mg / ml (in polyethylene bottles of 200 or 400 ml);
- coated tablets (in cans of 10 pcs.).
Composition of 1 ml of infusion solution:
- active substance: gatifloxacin - 2 mg;
- auxiliary components: anhydrous glucose, water for injection.
Composition of 1 tablet:
- active substance: gatifloxacin - 200 or 400 mg;
- auxiliary components: polyethylene glycol-6000, microcrystalline cellulose, titanium dioxide, starch, magnesium stearate, talc, sodium starch glycolate, dibutyl phthalate, hydroxypropyl methylcellulose, calcium hydrogen phosphate, sodium propylparaben, sodium methylparaben.
Indications for use
Gatifloxacin is prescribed for the treatment of the following infectious and inflammatory diseases, which are caused by microorganisms sensitive to the action of the active substance:
- infections of the lower respiratory tract (cystic fibrosis, bronchitis in acute and exacerbations of a chronic disease, acute pneumonia), skin and soft tissues, kidneys and urinary system (pyelonephritis in acute / chronic course, cystitis, prostatitis, chronic infections of the urinary system), digestive tract, joints and bones;
- acute otitis media;
- gonorrhea (uncomplicated urethral in men, rectal and endocervical in women);
- postoperative infectious complications.
Contraindications
- diabetes mellitus (tablets);
- age up to 18 years;
- pregnancy and the period of breastfeeding;
- individual intolerance to the components of the drug, including the presence of hypersensitivity to other fluoroquinolones.
Method of administration and dosage
Method of application of Gatifloxacin:
- tablets: inside, regardless of food intake;
- infusion solution: intravenous drip, the drug should be injected every 24 hours.
A skin tolerance test is recommended before starting therapy.
The dose and duration of Gatifloxacin administration is determined by the physician individually.
The standard dosage regimen for oral administration of the drug is 400 mg once a day or 200 mg twice a day.
The duration of the course is determined by the indications:
- bronchitis (acute and complicated), pneumonia, infections of the skin and subcutaneous tissue, acute pyelonephritis, complicated infections of the urinary tract: 7-10 days;
- acute sinusitis: 7-14 days.
With creatinine clearance <40 ml / min, including those on hemodialysis or prolonged ambulatory peritoneal dialysis patients, dose adjustment is required.
Application for other indications:
- uncomplicated urinary tract infections (cystitis): 200 or 400 mg for 3 days (with functional impairment of the kidneys, in the case of 200 mg, dose adjustment is not performed);
- uncomplicated urethral gonorrhea in men, cervical gonorrhea in women: once at a dose of 400 mg (with functional impairment of the kidneys, dose adjustment is not performed).
Gatifloxacin infusion solution is used in the same daily doses, the frequency of administration of the drug is 1 time per day.
Side effects
- nervous system: disturbances in taste, ototoxicity, headache, paresthesia, dizziness, anxiety, agitation, confusion, tremor, nervousness, agitation, sleep disturbances, insomnia, drowsiness, paranoia, nightmares, convulsions, depression, panic attacks, depersonalization, leg muscle cramps, photophobia, hostility, hyperesthesia, migraine, ataxia, visual impairment, eye photosensitivity;
- musculoskeletal system: arthralgias, arthropathies, myalgias, tendinitis, seizures, increased risk of tendon rupture, tendovaginitis;
- hepatobiliary system: increased level of liver enzymes, hepatitis, cholestatic jaundice;
- digestive system: anorexia, nausea, dyspepsia, diarrhea, abdominal pain, constipation, flatulence, gastrointestinal bleeding, gastritis, oral ulcers, glossitis, stomatitis, vomiting, gingivitis;
- cardiovascular system: cyanosis, tachycardia, arterial hypertension, bradycardia, ECG lengthening of the QT interval;
- urinary system: dysuria, crystalluria, hematuria, transient nephritis;
- respiratory system: shortness of breath, pharyngitis;
- skin and allergic reactions: peripheral / generalized edema, maculopapular / vesicular-bullous rashes, edema of the mucous membrane of the mouth, face and tongue;
- others: bronchospasm, hyperventilation, fever, vaginitis, hypoglycemia, arthritis, thirst, fever, dry skin, metrorrhagia, chills, hematuria, pain in the ears, bones, chest, back.
special instructions
In cases of the appearance of the first manifestations of hypersensitivity (for example, in the form of a skin rash), Gatifloxacin is immediately canceled (due to the likelihood of severe hypersensitivity and / or anaphylactic reactions).
It is necessary to consider the risk of pseudomembranous colitis, which can manifest itself in moderate or life-threatening forms. Patients suffering from diarrhea after taking medications need special attention.
In some patients, Gatifloxacin can potentiate the prolongation of the QT interval on the ECG. Due to the lack of clinical data, the appointment of the drug for hypokalemia, prolonged QT interval, combined use with class IA antiarrhythmic drugs (quinidine, procainamide) and class III (amiodarone, sotalol) should be avoided.
Caution is required when using Gatifloxacin in patients with heart disease, including bradycardia and acute myocardial ischemia.
With an increase in the concentration of Gatifloxacin, the likelihood of lengthening the QT interval may increase, therefore it is recommended to strictly adhere to the prescribed dosage regimen. Prolongation of the QT interval may increase the likelihood of ventricular arrhythmias.
Medicines such as erythromycin, cisapride, tricyclic antidepressants, and antipsychotics also prolong the QT interval. Due to the fact that the additive effect of Gatifloxacin with these drugs cannot be ruled out, combination therapy should be carried out with caution.
Cases of tendon rupture have been reported during treatment. The likelihood of this complication increases with combined use with corticosteroids, especially in elderly patients. It must be borne in mind that tendon ruptures can be observed after the end of therapy.
Rare cases of sensory-motor / sensory polyneuropathy have been recorded, which manifest themselves as paresthesia, hypesthesia, dysesthesia, weakness, as well as in the form of seizures, increased intracranial pressure, psychoses. Gatifloxacin can also affect the nervous system, which is manifested by the development of tremors, insomnia, seizures, hallucinations, paranoia, depression, night delirium. Such disturbances can appear with the first dose. In these cases, therapy must be canceled.
Do not drink alcohol while using Gatifloxacin.
When using the drug, severe anaphylactic reactions may develop, which in some cases are accompanied by tinnitus, arterial hypotension / shock, cardiovascular collapse, loss of consciousness, convulsions, angioedema (including edema of the tongue, throat, larynx, face), acute respiratory distress - syndrome, shortness of breath, urticaria, itching and other serious skin reactions. When such symptoms appear, therapy is canceled and appropriate measures are taken (oxygen, corticosteroids, antihistamines, pressor amines).
Elderly patients are prescribed Gatifloxacin according to the standard scheme, however, therapy should be carried out under close monitoring of the condition.
With renal failure, the drug is prescribed with caution. Dose adjustment is required for patients with renal creatinine clearance up to 40 ml / min, including patients who are on continuous ambulatory peritoneal dialysis and patients who need dialysis.
In patients with diabetes mellitus, when combined with oral hypoglycemic agents, blood glucose levels are often disturbed, including symptomatic hypo- and hyperglycemia. Such patients need constant monitoring of laboratory parameters. With a decrease / increase in sugar levels, therapy with Gatifloxacin is canceled.
Due to the high likelihood of developing photosensitization, exposure to ultraviolet rays should be avoided.
Due to the risk of disturbances in the speed of psychomotor reactions, it is recommended to refuse to drive vehicles during the treatment period.
Drug interactions
With the combined use of Gatifloxacin with certain drugs / substances, the following effects may develop:
- warfarin or its derivatives: an increase in their effects (monitoring of prothrombin time or other appropriate clotting tests is necessary);
- glyburide (in patients with type II diabetes mellitus): impaired blood glucose levels, including the development of symptomatic hypo- and hyperglycemia;
- probenecid: a significant increase in the systemic elimination of gatifloxacin;
- digoxin: an increase in its concentration (it is necessary to monitor patients for the presence of symptoms of intoxication; a dose adjustment of digoxin may be required);
- cisapride, phenothiazine derivatives, tricyclic antidepressants, erythromycin: increased likelihood of developing cardiac arrhythmias;
- non-steroidal anti-inflammatory drugs: an increase in the likelihood of developing central nervous system disorders and seizures;
- drugs that increase the duration of the QT interval (tricyclic antidepressants, cisapride, antipsychotics, erythromycin), or those that inhibit heart rate [antiarrhythmic drugs IA (procainamide, quinidine) and class III (sotalol, amiodarone)]: an increase in the likelihood of ventricular arrhythmias.
Analogs
Analogues of Gatifloxacin are: Gatispan, Tabris, Zarquin, Tekvin.
Terms and conditions of storage
Store in a dark place at temperatures up to 25 ° C (tablets) or 30 ° C (solution). Keep out of the reach of children. Do not freeze the solution.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
