pefloksatsina | Abactal tablets are coated. 400 mg, 10 pcs.

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SKU
BID494963
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Latin name

ABAKTAL
Latin name

ABAKTAL

Release form

Film-coated tablets.

Packing

10 pcs. 400 mg each.

Pharmacological action

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

Abactal is active against: Staphylococcus aureus, Escherichia coli, Klebsiella spp., Enterobacter spp., Serratia spp., Proteus mirabilis, indole-positive strains of Proteus spp., Citrobacter spp., Salmonella spp., Shigella spp., Haemophilus influenzae, Neisseria gonorrhoeae.

Moderately sensitive to the preparation: 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:

Kidney and urinary tract infections.

Pelvic infections (including adnexitis, prostatitis).

Lower respiratory tract infections.

Infections of ENT organs (including chronic sinusitis, severe external otitis media).

Severe bacterial infections of the gastrointestinal tract (including salmonellosis, typhoid fever).

Infections of the liver and biliary tract.

Infections of the abdominal cavity (intra-abdominal abscesses, peritonitis).

Infections of bones, joints and connective tissue (including osteomyelitis).

Infections of the skin and soft tissues (including those caused by penicillin-resistant staphylococcus).

Meningeal infections.

sepsis.

Bacterial endocarditis.

Gonorrhea.

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

The drug is effective in the prevention of infections in patients with immunodeficiency.

Contraindications

Pregnancy.

Lactation (breastfeeding).

Age to 18 years.

Hypersensitivity to quinolones.

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

Pregnancy and lactation

Abactal is contraindicated in pregnancy.

If you need to use the drug during lactation, you should decide whether to stop breastfeeding.

Composition

1 film-coated tablet contains:

Active ingredient: pefloxacin mesylate dihydrate 558.5 mg, which corresponds to a pefloxacin content of 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.

Shell composition: hypromellose - 13.166 mg, titanium dioxide - 2.09 mg, talc - 854 μg, macrogol 400 - 1.79 mg, carnauba wax - 100 μg.

Dosage and administration

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 some infections of the genitourinary system: the appointment of Abactal in a dose of 400 mg (1 tab.) 1 time / day in the morning or in the evening is possible.

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

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

Tablets should be taken with food to avoid gastrointestinal disturbances.

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

In order to achieve faster therapeutic concentrations, a first dose of 800 mg is allowed. The maximum daily dose is 1.2 g.

For the prevention of infectious complications in surgery: I / v administration of the drug in a dose of 400-800 mg 1 hour before surgery is recommended.

For patients with liver disease: a single dose for iv drip is 8 mg / kg body weight for 1 hour. The frequency of infusion in patients with jaundice is 1 time in 24 hours in patients with ascites - 1 time in 36 h in patients with jaundice and ascites - 1 time in 48 hours.

In elderly patients: especially with concomitant impaired renal function, the dose should be reduced both when taken orally and with iv.

Side effects of the digestive system: loss of appetite, dyspepsia, diarrhea, nausea, taste change, vomiting, a transient increase in the activity of liver enzymes, alkaline phosphatase and bilirubin level very rarely - pseudomembranous colitis.

From the side of the central nervous system: headache, anxiety, dizziness, a state of increased mental agitation, depression, insomnia, visual impairment, confusion, hallucinations, tremors rarely - convulsions.

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

On the part of the musculoskeletal system: myalgia, arthralgia, tendonitis in very rare cases - Achilles tendon rupture.

Local reactions: phlebitis.

Allergic reactions: skin rash, itching, hives, redness of the skin rarely - bronchospasm, photosensitivity.

Other: transient changes in the picture of peripheral blood.

Drug Interaction

The absorption of pefloxacin is slowed by simultaneous administration with antacids containing aluminum hydroxide and magnesium hydroxide (the interval between doses should be at least 2 h).

Concomitant administration of Abactal with cimetidine and ranitidine leads to an increase in T1 / 2 of pefloxacin.

Pefloxacin reduces the metabolism of theophylline and NSAIDs in the liver, leading to increased plasma concentrations and CNS.

With the simultaneous use of Abactal and indirect anticoagulants, the latter may be enhanced.

When fluoroquinolones and cyclosporine are used together, cyclosporin concentrations and blood creatinine levels may increase.

The combination of pefloxacin with tetracyclines and chloramphenicol has antagonistic action.

Pharmaceutical Interaction

Pefloxacin must not be mixed with solutions containing chlorine ions to avoid precipitation.

Overdose

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

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

Storage conditions

The drug should be stored in a dry, protected from light, out of reach of children at a temperature not exceeding 25 РC.

Expiration

3 years.

Deystvuyuschee substances

pefloksatsina

pharmacy terms for

pharmacy Prescription

dosage form

dosage form

tablets

sandoz, switzerland

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