Abaktal, pills 400mg, 10pcs

Composition

1 film-coated tablet contains:

Active ingredient:  

pefloxacin mesylate dihydrate 558.5 mg, which corresponds to the content of pefloxacin 400 mg.

Auxiliary substances:

lactose monohydrate – 79.5 mg,

corn starch-32 mg,

povidone-32 mg,

sodium carboxymethyl starch-32 mg,

talc-27 mg,

colloidal anhydrous silicon dioxide-2 mg,

magnesium stearate-7 mg.

Shell composition:

hypromellose-13.166 mg, titanium dioxide-2.09 mg, talc-854 mcg, macrogol 400-1.79 mg, Carnauba wax-100 mcg.

Pharmacological action

Synthetic antibacterial drug from the group of fluoroquinolones. It has a bactericidal effect by inhibiting bacterial DNA replication at the level of DNA gyrase.

Abaktal is active in relation to:  Staphylococcus aureus, Escherichia coli, Klebsiella spp., Enterobacter spp., Serratia spp., Proteus mirabilis, indole-positive strains Proteus spp., Citrobacter spp., Salmonella spp., Shigella spp., Haemophilus influenzae, Neisseria gonorrhoeae.

Moderately sensitive to the drug:  Streptococcus spp. (including Streptococcus pneumoniae), Pseudomonas spp., Acinetobacter spp., Clostridium perfringens, Mycoplasma spp., Chlamydia spp.

Resistant to the drug:  gram-negative anaerobes, Spirochaeta spp., Mycobacterium tuberculosis.

Indications

Treatment of infectious diseases caused by drug-sensitive microorganisms:

infection of the kidneys and urinary tract;

infections of the pelvic organs (including adnexitis, prostatitis);

— infections of the lower respiratory tract;

infections of ENT organs (including chronic sinusitis, severe otitis externa);

— severe bacterial infection of the gastrointestinal tract (including salmonellosis, typhoid fever);

infection of the liver and biliary tract;

infections of the abdominal cavity (intra-abdominal abscesses, peritonitis);

— infections of the bones, joints and connective tissue (including osteomyelitis);

— infections of skin and soft tissue (including caused by staph that is resistant to penicillin);

— meningeal infection

— sepsis;

bacterial endocarditis;

gonorrhoea.

It is used as monotherapy or in combination with other antimicrobial drugs.

The drug is effective in preventing infections in patients with immunodeficiency.

Contraindications

• Pregnancy.
• Lactation (breastfeeding).
• Under 18 years of age.
• Hypersensitivity to quinolones.

With caution:  prescribe the drug for disorders of the central nervous system (including epileptic syndrome of unknown etiology), combined renal and hepatic insufficiency, with severe hepatic insufficiency.

Side effects

From the digestive system:  loss of appetite, dyspepsia, diarrhea, nausea, taste changes, vomiting, transient increase in the activity of liver enzymes, alkaline phosphatase and bilirubin levels; very rarely – pseudomembranous colitis.

From the central nervous system:  headache, restlessness, dizziness, increased mental arousal, depression, insomnia, visual disturbances, confusion, hallucinations, tremor; rarely-convulsions.

From the urinary system:  crystalluria; rarely-hematuria, interstitial nephritis.

Musculoskeletal disorders:  myalgia, arthralgia, tendinitis; in very rare cases – rupture of the Achilles tendon.

Local reactions:  phlebitis.

Allergic reactions:  skin rash, pruritus, urticaria, redness of the skin; rarely-bronchospasm, photosensitization.

Other services:  transient changes in the peripheral blood picture.

Interaction

Absorption of pefloxacin slows down when taken concomitantly with antacids containing aluminum hydroxide and magnesium hydroxide (the interval between doses should be at least 2 hours).

Simultaneous use of Abaktal with cimetidine and ranitidine leads to an increase in T1 / 2 of pefloxacin.

Pefloxacin reduces the metabolism of theophylline and NSAIDs in the liver, which leads to an increase in their concentration in blood plasma and the central nervous system.

With the simultaneous use of Abaktal and indirect anticoagulants, the effect of the latter may increase.

With the combined use of fluoroquinolones and cyclosporine, it is possible to 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 to avoid precipitation.

How to take, course of use and dosage

The average oral dose is 800 mg / day. The drug is prescribed 400 mg (1 tab. ) 2 times/day, every 12 hours. The maximum daily dose is 1.2 g.

In the treatment of certain infections of the genitourinary system:  it is possible to prescribe Abaktal at a dose of 400 mg (1 tab. ) 1 time/day in the morning or in the evening.

For the treatment of uncomplicated gonorrhea in men and women:  prescribe the drug once in a dose of 800 mg.

With severe hepatic insufficiency:  it is recommended to prescribe the drug at a dose of 400 mg / day (every 24-48 hours).

Tablets should be taken with meals to avoid gastrointestinal disorders.

IV drug is prescribed as an infusion at a dose of 400 mg every 12 hours; the duration of the infusion is 1 h. Previously, the contents of one ampoule (400 mg) are diluted with 250 ml of 5% dextrose (glucose) solution. Abaktal should not be diluted with a sodium chloride solution or any solvent containing chlorine ions.

For faster achievement of therapeutic concentrations, the first dose of 800 mg is allowed. The maximum daily dose is 1.2 g.

For the prevention of infectious complications in surgery:  intravenous use of the drug at a dose of 400-800 mg is recommended 1 hour before surgery.

For patients with liver diseases:  the single dose for intravenous drip use is 8 mg / kg of body weight; the duration of infusion is 1 h. The frequency of infusions is 1 time in 24 hours in patients with jaundice; 1 time in 36 hours in patients with ascites; 1 time in 48 hours in patients with jaundice and ascites.

In elderly patients:  especially with concomitant renal impairment, the dose should be reduced both when taken orally and when administered intravenously.

Overdose

Symptoms:  nausea, vomiting, confusion, mental agitation; in severe cases-loss of consciousness, convulsions.

Treatment:  gastric lavage, activated charcoal. It is necessary to provide medical monitoring of the patient’s condition, sufficient fluid intake into the patient’s body; if necessary, symptomatic therapy is carried out. Hemodialysis is not an effective method of removing quinolone derivatives from the body.

Special instructions

Due to possible photosensitization during treatment with Abaktal, UV radiation and direct sunlight should be avoided for 6 days after discontinuation of therapy.

If there is an allergic reaction or changes in the central nervous system, as well as if tendinitis is suspected, the drug should be discontinued immediately.

Risk factors for the development of tendinitis during fluoroquinolone therapy include: age over 60 years, renal failure, dialysis, concomitant therapy with corticosteroids, dyslipidemia. The patient should be warned about the need to cancel the drug when the initial signs of tendinitis appear, exclude the load on the affected limb and consult a doctor.

False positive results may be observed when determining glucose in the urine by the copper reduction method (using copper sulfate), so enzymatic methods of analysis should be used.

The drug can be used in combination with beta-lactam antibiotics, metronidazole, vancomycin and rifampicin.

Caution should be exercised when concomitantly prescribing pefloxacin and isoniazid.

Influence on the ability to drive motor vehicles and manage mechanisms

Against the background of the use of Abaktal, caution should be exercised when engaging in potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Form of production

Tablets covered with a film-coated white to slightly yellowish color, oval, biconvex.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Pefloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Adults as prescribed by a doctor

Indications

Adnexitis, Bronchitis, Prostatitis, Intestinal Infections, Sinusitis, Skin Infections, Salmonellosis, Biliary Tract Infections, Otitis Media, Osteomyelitis, Urinary Tract Infections, Pneumonia, Sinusitis