Gatilin

"Gatilin" is a drug from the group of fluoroquinolones, which refers to antibacterial agents of a wide spectrum of action, active against a large number of various pathogenic microorganisms.

Indications Gatilin

The drug "Gatilin" is effective for infectious and inflammatory diseases of the respiratory system and urogenital system, caused by microorganisms sensitive to the main active substance of the antibiotic.

It is used for the treatment of acute bronchitis, exacerbations of the chronic form of bronchitis (inflammatory process in the bronchi involving an infectious component) and in the treatment of the acute stage of sinusitis (inflammation in the paranasal sinuses that has arisen as a complication after infectious diseases and nose injuries).

Another indication for the use of the drug for the treatment of inflammatory processes affecting the respiratory system is community-acquired (or out-of-hospital) pneumonia. Clearly speaking, this pneumonia, which started under the influence of an infectious agent (pneumococcus, staphylococcus, streptococcus, etc., of the order of 10-11 species), which happens outside the hospital.

With regard to the urinary system, the indications for the use of the drug "Gatilin" are considered to be complicated (severe pyelonephritis with obstruction phenomena, catheter-associated UTIs, etc.) and uncomplicated (primary cystitis, acute pyelonephritis, etc.) urinary tract infections.

The drug is also used to treat diseases transmitted during sexual intercourse. For example, in the treatment of uncomplicated gonorrheal urethritis (inflammatory process in the urethra due to infection of its walls) and cercovitis (inflammation in the vaginal segment of the uterus) of the same nature that are caused by gonococcal infection, uncomplicated rectal gonorrhea in women.

[1], [2], [3], [4]

Release form

Antibiotic "Gatilin" on pharmacy shelves can be found in the form:

• solution for intravenous infusion in 100 ml containers containing 200 mg of active ingredient,
• solution for intravenous infusion in containers containing 400 mg of active ingredient,
• tablets 200 mg,
• tablets 400 mg.

Tabletirovannaya form of release, depending on the dosage can be called "Gatilin-200" or "Gatilin-400".

"Gatilin-200" is presented in the form of white biconvex tablets of a rounded form with a protective coating containing 200 mg of the active substance.

"Gatilin-400" - white oblong tablets, having a protective shell and risk for a fault on one side, which contain 400 mg of antimicrobial.

The main active substance of the drug is a substance with a pronounced antimicrobial effect - gatifloxacin.

The auxiliary substances in tableted forms are: starch, monocrystalline cellulose, calcium hydrogenphosphate, sodium methyl and propyl parabens, magnesium and stearic acid salt, sodium starch glycolate, talc, dibutyl phthalate, polyethylene glycol-6000, titanium dioxide and hydroxypropylmethylcellulose.

In a solution for infusions, gatifloxacin is supplemented with anhydrous glucose, concentrated hydrochloric acid and water for injection, which is a distilled water (free of impurities). If the solution contains 400 mg of active ingredient, then sodium hydroxide is added to it.

Pharmacodynamics

The main active ingredient of the drug -gatifloxacin - is an antimicrobial agent with a pronounced activity of a relatively large number of pathogenic microorganisms. Gatifloxacin adequately copes with both gram-negative and gram-positive bacteria.

The list of pathogenic microorganisms sensitive to gatifloxacin includes: various strains of staphylococcal infection, streptococci, various types of enterobacteria, proteus, phasobacteria, clostridia, chlamydia, mycoplasma bacteria, mycobacterium tuberculosis, Helicobacter pylori and many others.

The antibacterial action of the drug is based on the inhibition of the production of DNA gyrase, which is an indispensable enzyme that takes part in the processes of cell division and synthesis of molecules from the same DNA, transfer of information from DNA to RNA, correction of ruptures and chemical damage in bacterial DNA molecules.

Gatifloxacin also reduces the production in the body of bacteria of another important enzyme topoisomerase IV, responsible for the correct separation of chromosomal DNA in the process of cell division.  

[5], [6], [7], [8], [9], [10], [11], [12], [13], [14], [15]

Pharmacokinetics

Rapid absorption of gatifloxacin from the digestive tract allows you to take pills regardless of eating. Bioavailability of the active substance is slightly less than 100% (more precisely, 96%), and its maximum concentration in the blood is observed after 1.5-2 hours from the time of taking the tablets.

Gatifloxacin is characterized by a rapid distribution in various fluids and tissues of the body, and its concentration in the tissues of the "target" organs will exceed the content of antibiotic in the blood serum.

The drug is excreted from the body mainly by the kidneys, and only 5% comes with feces. More than 70% of the active substance is removed in its original form within the first 2 days.

The half-life of the drug can fluctuate within 7-14 hours, while it does not depend on either the dosage of the drug or the way it is used.

[16], [17], [18], [19]

Dosing and administration

Since with increased sensitivity to the drug "Gatilin", its administration can cause severe allergic reactions, before the first use of the medicine, doctors strongly recommend a skin test for the tolerance of the drug.

The drug is recommended to be taken once a day, preferably at the same time. Eating does not affect the effectiveness of the medication. One-time (the same daily) dose of the drug in most pathologies is 400 mg (1 tablet "Gatilin-400" or 2 tablets "Gatilin-200"), and the course of treatment can vary from 7 to 14 days.

With uncomplicated urinary tract infections, the treatment regimen is different. The doctor can prescribe a 3-day course "Gatilin-200" (1 tablet a day) or a one-time dose of 400 mg.

Single intake of 400 mg of the drug is effective in the treatment of pathologies such as gonorrheal urethritis in men, as well as proctitis and cervicitis in women.

With the removal of the drug, the kidneys are primarily involved in the body, which means that when setting an effective and safe dose of the drug, individual blood flow rates through this important excretory organ (creatinine clearance) must be taken into account. If such an indicator is normal (40 ml per minute) or slightly overestimated, dose adjustment is not required. If the creatinine clearance is below the average (for example, with renal failure), the dosage should be different: the initial dose remains the same - 400 mg, and all subsequent techniques are limited to a dosage of 200 mg.

Correction of the dose is required not only with low creatinine clearance, but also when the patient is on hemodialysis or long-term outpatient peritoneal dialysis, which are methods of extrarenal blood purification for serious pathologies of the kidneys.

The intake of tablets with the same efficacy and dosage can be replaced by intravenous administration with the aid of a dropper. At the same time, the injection rate is 400 mg for 40-60 minutes.

[28], [29], [30], [31]

Use Gatilin during pregnancy

Use of the drug "Gatilin" during pregnancy is unacceptable. During breastfeeding, antibiotic therapy is only possible when switching to milk mixtures.

Contraindications

Antibiotic "Gatilin" is not recommended for patients who have a history of hypersensitivity to the active substance of the drug (gatifloxacin), to any of the auxiliary components used to make tablets and a solution for infusions.

Contraindication to the use of the drug is also increased sensitivity to other drugs from the group of fluoroquinolones.

Do not apply antibiotic and in pediatric practice, i.e. For the treatment of patients under the age of 18 years.

The drug in the form of an infusion solution is not used to treat patients who have diabetes mellitus because of the presence of glucose in its composition.

[20], [21], [22], [23], [24], [25], [26]

Side effects Gatilin

The preparation "Gatilin" has many not only possibilities of application, but also side effects. This does not mean that all of them will take place during the treatment with the drug. The most common side effects that occur in more than 1% of patients are headaches and dizziness, nausea often accompanied by vomiting, abdominal pain, upsetting of the stool towards diarrhea.

Less common are other reactions from various organs and systems of the body. So the immune system is able to respond to antibiotic intake with heat, angioedema, inflammation in the vessels, eczema. In isolated cases, anaphylactic reactions are observed.

The skin can respond to the administration of the drug with itching, rash, increased sensitivity to sunlight, dryness and flaking. Sometimes patients develop signs of hyperhidrosis. Rarely may develop a life-threatening Stephen-Johnson allergy syndrome if the patient has a tendency to allergic reactions.

From the side of the central nervous system, you can observe increased excitability, anxiety, anxious or depressed state, sleep and sensation of the body, trembling in the hands, hallucinations, convulsions, fainting.

The drug intake can affect the taste, auditory and visual perception.

Can give small glitches and cardiovascular system: increased heart rate, chest pain and swelling, vasodilatation, increase or decrease in blood pressure.

Oral administration of the drug may cause some unpleasant symptoms from the gastrointestinal tract: stomach pain, indigestion, stool disorders (constipation or diarrhea), heartburn, increased gas separation, vomiting. Antibiotic can cause the development of pathologies such as gastritis, pancreatitis, stomatitis, glossitis, cause the formation of ulcerative and fungal lesions of the mouth.

The musculoskeletal system in rare cases will remind of itself pains in muscles and joints, inflammation of tendons and increase in probability of their rupture at a load.

The urinary system can give the following symptoms: inflammation or impaired renal function, including acute failure of their functions, impaired urination, the appearance of salt and blood crystals (in excess of the norm) in the urine. True, such violations are very rare.

Among other things, taking the drug may be accompanied by other reactions from various organs and body systems: back pain, blood laboratory abnormalities, nasal and uterine bleeding, various skin and mucosal rashes, dyspnea, hallucinations, impaired consciousness and thinking, changes in glucose level in the blood, etc.

Side effects can be observed with varying frequency and in the case of combined therapy with various drugs.

[27]

Overdose

With intravenous drip introduction in a medical setting, the likelihood of an overdose is negligible, which can not be said about oral administration of the drug, not under the supervision of the doctor or in an inadequate situation, the appointment of an effective and safe dose. To avoid unpleasant consequences, it is necessary to constantly monitor the patient's condition (laboratory parameters, ECG, etc.), especially with prolonged intake of the drug (more than 7-10 days).

Overdosage with the drug "Gatilin" is primarily indicated by violations in the work of the central nervous system. They can be characterized by confusion, convulsions or psychosis. In some cases, fainting occurs. Other side effects of the drug may also increase, indicating an intoxication.

Effective first aid measures will be gastric lavage and dehydration measures (prevention of dehydration due to the introduction of sufficient amounts of liquid into the body or taking special medications, for example, "Regidron").

Further the doctor should appoint or nominate the effective therapy directed on removal of unpleasant signs and the further support of an organism.

Purification of blood from excess gatifloxacin by hemodialysis or peritoneal dialysis is considered ineffective. The cleaning period in this case is too large, and the result is insufficient (for 14 hours you can withdraw no more than half of the entire dose of the drug).

[32]

Interactions with other drugs

The drug "Gatilin" can be taken without consequences in parallel with the hypnotic drug "Midazolam", the bronchodilator "Theophylline", the hypoglycemic drug "Apo-glyburide" used for type 2 diabetes mellitus and their analogs for the active substance. Their simultaneous administration does not affect the pharmacological properties of the drugs. Do not need and correction of their doses.

The same can be said about the preparations "Cimetidine" (antiulcer) and "Calcium Carbonate". They can be taken together with gatifloxacin preparations without dose adjustment.

But the interaction of gatifloxacin with some other drugs may have undesirable consequences.

The heart drug "Digoxin" used in CHD has little effect on the factakokinetics of gatifloxacin, but simultaneous therapy with drugs can cause an increase in the level of "Digoxin" in the blood of the patient, which will lead to an overdose of the drug. Therefore, it is necessary to monitor the laboratory indicators and the patient's condition in time to notice the phenomenon of intoxication.

The drug "Probenecid", used with an elevated urea content in the blood, as well as its analogues in the active substance, can accelerate the removal of gatifloxacin from the patient's body, reducing its effectiveness.

With the simultaneous administration of "Gatilin" and the anticoagulant "Warfarin", there were no noticeable changes in blood clotting rates. Nevertheless, it is desirable to monitor the rate of coagulation, since other antibiotics from the quinolone group are able to influence this rate.

"Gatilin" can contribute to the emergence of various abnormalities from the central nervous system when taken in parallel with NSAIDs.

Caution should also be observed when prescribing antiarrhythmic drugs during Gatilin therapy. Such drugs III and IA classes are dangerous to take simultaneously with gatifloksatsinom due to increased risk of heart rhythm disorders.

For the same reason and in connection with the insufficient study of the drug interaction in parallel with gatifloxacin, it is not recommended to take tricyclic antidepressants, antipsychotics, erythromycin, phenothiazine and its derivatives, cisapride.

It is not recommended to take together gatifloxacin and Didanosine, used to treat HIV infection, as well as certain trace elements (for example, as part of vitamin-mineral complexes or drugs to reduce the acidity of gastric juice). These are compounds of iron, zinc, aluminum, magnesium.

[33], [34], [35], [36]

Storage conditions

To maintain the medicinal properties of the drug throughout the expiration date (2 years), as well as to prevent other undesirable consequences, such as swallowing tablets by the baby, disrupting the integrity of the container with the infusion solution, etc. It is necessary to observe the storage conditions of the medicinal product specified in the instructions.

Storage of the drug "Gatilin" at the appropriate temperature (not more than 25 degrees) outside the children's access zone and sunlight will help to protect you and your family from unforeseen situations.

Special instructions

In some patients, "Gatilin" may cause changes in the cardiogram, in particular an increase in the QT interval, especially with prolonged antibiotic therapy. For this reason, the drug is not prescribed to patients who have this interval already increased, as well as hypercalcemia.

Caution should be observed when administering gatifloxacin to patients with bradycardia and acute myocardial ischemia.

With increased sensitivity to the drug, Gatilin is not categorically prescribed, as there have been severe consequences: anaphylactic shock and even death. Any skin rashes and other allergic manifestations are a signal to cancel the drug.

Correction of the dose and monitoring of the patient's condition are inevitable in case of renal failure.

Gatifloxacin, like other quinolones, can cause the appearance of convulsive syndrome, so it is prescribed with extreme caution to patients who have a history of CNS pathology (mental disorders, epilepsy, severe atherosclerosis of the vessels).

Reception gatifloksatsina increases the risk of rupture of tendons especially against the background of taking corticosteroids in the elderly. If there is such a symptom, the drug must be canceled.

Abolition of the drug is required and with such undesirable symptoms as loss of skin sensitivity, convulsive syndrome, increased intracranial pressure, psychosis, and also if there is a shiver in the hands, sleep disorders with nightmarish dreams and insomnia, hallucinations, delirium, depression.

The intake of "Gatilin", like other antibiotics, should be accompanied by the intake of drugs that normalize the intestinal microflora. Otherwise, there is a high probability of developing antibiotic-associated or pseudomembranous colitis of varying severity.

During the reception gatifloksatsina should abandon alcoholic beverages and a long stay in the open sunlight.

Caution should also be observed when using a solution for infusion. It is not used for damage to the container, the presence of sediment or turbidity of the liquid.

The drug affects the speed of the reaction, so for the duration of therapy it is worth not to manage the car or perform work that requires special attention.

Shelf life

Shelf life 2 years.