Abaktal pills coated 400mg N10
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Active ingredients
Pefloxacin
Release form
Pills
Composition
1 tablet contains: Active ingredient: pefloxacin mesilate dihydrate 558.5 mg, which corresponds to the content of pefloxacin 400 mg. Excipients: lactose monohydrate - 79.5 mg, corn starch - 32 mg, povidone - 32 mg, sodium carboxymethyl starch - 32 mg, talc - 27 mg, anhydrous colloidal silicon dioxide - 2 mg, magnesium stearate - 7 mg. The composition of the shell: hypromellose - 13.166 mg, titanium dioxide - 2.09 mg, talc - 854 mcg, macrogol 400 - 1.79 mg, carnauba wax - 100 mcg.
Pharmacological effect
Synthetic antibacterial drug from the group of fluoroquinolones. It has a bactericidal effect, inhibiting bacterial DNA replication at the level of DNA gyrase. Abaktal is active against Staphylococcus aureus, Escherichia coli, Klebsiella spp., Enterobacter spp., Serratia spp., Proteus mirabilis, indole-positive strains of Proteus spp., Citrochoterm , Salmonella spp., Shigella spp., Haemophilus influenzae, Neisseria gonorrhoeae. Streptococcus spp. Is moderately sensitive to the drug. (including Streptococcus pneumoniae), Pseudomonas spp., Acinetobacter spp., Clostridium perfringens, Mycoplasma spp., Chlamydia spp. Gram-negative anaerobes are resistant to the drug, Spirochaeta spp., Mycobacterium tuberculosis.
Pharmacokinetics
Absorption: After oral administration, pefloxacin is well absorbed from the gastrointestinal tract. Cmax is achieved in 1-1.5 h after administration. Bioavailability is about 100%. Distribution: The degree of binding to plasma proteins is 25-30%. Vd - 1.7 L / kg. Pefloxacin penetrates rapidly into the tissues, organs and body fluids (aortic valves, mitral valve, heart muscle, bones, abdominal cavity, peritoneal fluid, gallbladder, prostate gland, saliva, sputum). The concentration of pefloxacin in the listed fluids and tissues is higher than the concentration in the blood plasma. Metabolism and excretion: Biotransformed in the liver. T1 / 2 is approximately 10.5 hours. With normal liver and kidney function, about half of the administered dose is excreted in the urine unchanged and as metabolites within 48 hours. About 20–30% of pefloxacin is excreted in the bile. Pharmacokinetics in special clinical situations: In case of impaired renal function, the plasma concentration of pefloxacin and T1 / 2 do not change. When liver dysfunction, plasma clearance of pefloxacin is significantly reduced, and T1 / 2 increases accordingly.
Indications
The drug Abactal is used in antibacterial therapy of the following diseases caused by microorganisms sensitive to pefloxacin: Infections of the central nervous system (CNS) (bacterial meningitis caused by meningococci or gram-negative bacteria, including postoperative or post-traumatic).Infections of the upper respiratory tract and upper respiratory tract (acute and chronic sinusitis, mastoiditis). Lower respiratory tract infections (acute and exacerbation of chronic bronchitis, bronchiectasis, community-acquired and nosocomial pneumonia caused by gram-negative bacteria or intracellular pathogens). Infections of the abdominal cavity (cholecystitis, cholangitis, treatment and prevention of infectious complications of pancreatitis, local and widespread peritonitis, including postoperative). Complicated and uncomplicated infections of the kidneys and urinary tract (acute and exacerbation of chronic pyelonephritis, infectious complications after surgery for urinary tracts Infections of the pelvic organs in women (pelvioperitonitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bartholinitis). Infections of the reproductive system in men (orchitis, orthoepididymitis, prostatitis). . osteomyelitis caused by gram-negative microorganisms). Bacterial endocarditis. Sexually transmitted infections (gonorrhea, urogenital chlamydiosis). Bacterial infections of the gastrointestinal tract, including colibacillosis, shigellosis, cholera, salmonellosis, typhoid fever, paratyphoid A, B, C, yersiniosis. Prevention of infections in patients with immunodeficiency.
Contraindications
Hypersensitivity to fluoroquinolones. Patients with glucose-6-phosphate dehydrogenase deficiency (hemolytic anemia). Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome. Children's age up to 18 years. Pregnancy and lactation. With care: Disturbance of the central nervous system (including Epileptic syndrome of unknown etiology). Combined hepato-renal failure, severe liver failure.
Precautionary measures
With caution, the drug is prescribed for disorders of the central nervous system (including epileptic syndrome of unknown etiology), concomitant renal-hepatic insufficiency, and severe hepatic insufficiency.
Use during pregnancy and lactation
Abaktal is contraindicated for use during pregnancy.If necessary, the use of the drug during lactation should decide on the termination of breastfeeding.
Dosage and administration
Inside In order to avoid gastrointestinal disorders, pills should be taken with meals. The average dose is 800 mg per day. The drug is prescribed 1 tablet (400 mg) twice a day, every 12 hours. The maximum daily dose is 1200 mg. In the treatment of certain infections of the urogenital system, it is possible to administer Abaktal at a dose of 1 tablet (400 mg) once a day, in the morning or in the evening. For the treatment of uncomplicated gonorrhea in men and women, 800 mg of the drug Abaktal is prescribed once. In patients with severe hepatic impairment, pefloxacin excretion slows down significantly, therefore the recommended daily dose of the drug is 400 mg every 24–48 hours after determining its serum concentrations. In patients with impaired renal function, pefloxacin excretion remains almost unchanged, since the largest part of the drug is excreted by the liver. In this regard, reducing the dose of pefloxacin for patients with impaired renal function is not required. At the initial stages of treatment, the drug Abaktal can be used parenterally; after achieving positive dynamics and, if there are indications, to continue the therapy, they switch to the oral form of the drug.
Side effects
From the nervous system and sensory organs depression, headache, dizziness, fatigue, insomnia, increased convulsive readiness, anxiety, irritability, agitation, nightmares, visual disturbances, confusion, hallucinations, tremors, convulsions (including epileptic seizures). On the digestive system, nausea, vomiting, diarrhea, abdominal pain, changes in taste, loss of appetite, flatulence, pseudomembranous colitis, transient increase in peche activity night transaminases, as well as alkaline phosphatase and bilirubin concentrations, cholestatic jaundice, hepatitis, liver necrosis. From the urogenital system, crystalluria, glomerulonephritis, dysuria, interstitial nephritis. Allergic reactions, skin rashes, skin itching, hyperemia, hyperemia, women, women, women, women, women, women, women, skin irritants, skin irritations, skin irritations, skin irritations, skin irritations, glomerulonephritis, interstitial nephritis. lightas well as to ultraviolet radiation (UV)), photoonicholysis, angioedema, bronchospasm, arthralgia. On the side of the blood system and hematopoietic organs, leukopenia, neutropenia, thrombocytopenia (when used in high doses), agranulocytosis, eosinophilia. and / or arthralgia, arthropathy, tendonitis, rupture of the Achilles tendon. Other tachycardias, candidiasis, prolongation of the QT interval.
Overdose
Symptoms: nausea, vomiting, confusion, mental agitation; in severe cases - loss of consciousness, convulsions. Treatment: gastric lavage, activated carbon. It is necessary to provide medical monitoring of the patient’s condition, sufficient fluid intake into the patient’s body; if necessary, conduct symptomatic therapy. Hemodialysis is not an effective method of removing quinolone derivatives from the body.
Interaction with other drugs
Pefloxacin absorption slows down while taking antacids containing aluminum hydroxide and magnesium hydroxide (the interval between doses must be at least 2 hours). The simultaneous use of Abactal with cimetidine and ranitidine leads to an increase in T1 / 2 pefloxacin. Pefloxacin reduces the metabolism of theophylline and NSAIDs in the liver, which leads to an increase in their concentration in the blood plasma and central nervous system. With the simultaneous use of Abaktal and indirect anticoagulants, it is possible to enhance the effect of the latter. The combined use of fluoroquinolones and cyclosporine may increase the concentration of cyclosporine and the level of creatinine in the blood. The combination of pefloxacin with tetracyclines and chloramphenicol has an antagonistic effect. Pharmaceutical interaction: Pefloxacin should not be mixed with solutions containing chlorine ions, in order to avoid precipitation.
special instructions
Injection solution is used only in a hospital. Due to possible photosensitization during the period of treatment with Abactal, UV exposure and direct sunlight should be avoided for 6 days after cessation of therapy. If you experience an allergic reaction or changes in the central nervous system, as well as suspected tendonitis, you should immediately cancel the drug. Risk factors for the development of tendinitis with fluoroquinolone therapy include: age over 60 years, renal failure, dialysis, concomitant GCS therapy, dyslipidemia.The patient should be warned about the need to cancel the drug when the initial signs of tendinitis appear, eliminate the load on the affected limb and consult a doctor. False-positive results may be observed in the determination of glucose in the urine using the copper reduction method (using copper sulfate), therefore, enzymatic analysis methods should be used. The drug can be used in combination with beta-lactam antibiotics, metronidazole, vancomycin and rifampicin. Care must be taken when administering pefloxacin and isoniazid. Impact on the ability to drive vehicles and control mechanisms: Against the background of the use of Abaktal, care should be taken when engaging in potentially hazardous activities that require increased attention and speed of psychomotor reactions.