SiproMЕР solution for infusions 2mg/ml

  • Trade name of the preparation: SIPROMER
  • Active ingredient (INN): ciprofloxacin
  • Dosage form: solution for infusion
  • Composition
  • 100 ml of solution contain:
  • active substance: ciprofloxacin lactate equivalent to ciprofloxacin – 200 mg
  • excipient: sodium chloride, water for injection
  • Description: Transparent, from slightly yellowish to light yellow-green solution.          Pharmacotherapeutic group: Antibacterial synthetic agents (gr. Fluoroquinolones).
  • ATX Code: J01MA02

Pharmacological properties

Pharmacodynamics

A broad-spectrum antimicrobial agent from the group of fluoroquinolones.

It is bactericidal. The mechanism of action is associated with inhibition of the enzyme DNA

bacterial gyrase, as a result of which DNA replication and cellular synthesis are disrupted

bacteria proteins. Ciprofloxacin acts as a multiplying microorganism,

and those in a resting phase. Sensitive to ciprofloxacin

gram-negative aerobic bacteria: enterobacteria (Eschenchia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus

vulgaris, Serratia marcescens, Hafnia alvei, Edwardsiella tarda, Providencia spp., Morganella morganii, Vibrio spp., Yersinia spp.), other gram-negative bacteria (Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarhalisomas aeromisella ples. Campylobacter jejuni, Neisseria spp.);

Some intracellular pathogens: Legionella pneumophila, Brucella spp.,

Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium aviumintracellulare.

Gram-positive aerobic bacteria are also sensitive to ciprofloxacin: Staphylococcus spp. (S.aureus, S.haemolyticus, S.hominis, S.saprophyticus Streptococcus spp. (St.pyoganes, St.agalactiae).

Most methicillin-resistant staphylococci are also resistant to ciprofloxacin. The sensitivity of bacteria Streptococcus pneumoniae, Enterococcus faecalis is mild.

Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas mallophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroids are resistant to the drug.

Pharmacokinetics

After intravenous administration of ciprofloxacin 200 mg and 400 mg maximum

plasma concentration (Cmax) after 60 minutes is 2.1 and 4.6 mg / ml, after 12

hours – 0.1-0.2 mg / ml, respectively. Ciprofloxacin is well distributed in the body and reaches therapeutic concentrations in most organs and tissues

2 hours after intravenous administration. Plasma protein binding is negligible (20–40%). Distribution volume – 2-3 l / kg. The half-life is 5-6 hours. Approximately 50-70% of the prescribed dose is excreted unchanged in

within 24 hours by glomerular filtration and tubular secretion of the kidney, 1-

2% is excreted in the form of a metabolite through bile, and 15% is excreted in the feces for 5

days after admission.

Indications for use

pneumonia, bronchopneumonia, infectious pleurisy, emphysema, abscesses,

infectious bronchiectasis, acute and chronic bronchitis, cystic fibrosis;

– peritonitis, intraabdominal abscesses, cholangitis, cholecystitis, biliary empyema

a bubble;

– acute and chronic pyelonephritis, prostatitis, cystitis, chronic epidemic;

– external and average otitis media, sinusitis, mastoiditis;

– salpingitis, endometritis;

– acute and chronic osteomyelitis, septic arthritis;

– infected ulcers, wounds, burns;

– sepsis, bacteremia;

– chlamydia, gonorrhea;

-conjunctivitis, blepharoconjunctivitis, blepharitis, keratitis, keratoconjunctivitis, bacterial corneal ulcer;

– prevention of postoperative infections.

Dosage and administration

For intravenous administration, a single dose is 200 mg (for severe infections 400 mg),

the frequency of administration is 2 times / day. Duration of treatment depends on severity

diseases, but treatment should always continue for 2 more days after disappearance

symptoms of the disease. Typically, the duration of treatment is 7-10 days. A solution of ciprofloxacin 200 mg in 100 ml for intravenous administration is prescribed drip within 30-60 minutes.

In acute gonorrhea – once intravenously 100 mg. For prophylaxis

postoperative infections – 200-400 mg 30-60 minutes before surgery.

Side effects

– nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice, hepatitis, candidiasis, pseudomembranous colitis;

– dizziness, headache, fatigue, tremors, insomnia,

sweating, increased intracranial pressure, confusion, depression, hallucinations, megraine;

– tachycardia, heart rhythm disturbance, lowering blood pressure;

– leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia;

– hematuria, crystalluria, glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding;

– skin rash, urticaria, fever, eosinophilia, erythema nodosum, exudative erythema multiforme, Stevens-Johnson syndrome, Lyell syndrome;

– disturbances in taste and smell, diplopia, a change in color perception, tinnitus,

hearing loss;

– arthralgia, arthritis, tenosynovitis, myalgia;

– itching and burning at the injection site, phlebitis.

Contraindications

– Hypersensitivity to ciprofloxacin;

– pseudomembranous colitis;

– children’s age up to 18 years;

– pregnancy and lactation.

Drug interactions

Due to a decrease in the activity of the microsomal oxidation process in hepatocytes, it increases the concentration and prolongs T1/2 of theophylline (and other xanthines, for example, caffeine), oral hypoglycemic drugs, indirect anticoagulants, and helps to reduce the prothrombin index.

When combined with other antimicrobials (beta-lactams, aminoglycosides, clindamycin, metronidazole), synergism is usually observed.

Special instructions

If severe or prolonged diarrhea occurs during or after treatment with ciprofloxacin, the diagnosis of pseudomembranous colitis should be excluded, this requires immediate withdrawal of the drug and the appointment of appropriate treatment.

If there are pains in the tendons or when the first signs of tendovaginitis appear, treatment should be discontinued.

During treatment with Ciprofloxacin, it is necessary to provide a sufficient amount of fluid while observing normal diuresis.

During treatment with Ciprofloxacin, contact with direct sunlight should be avoided.

Influence on the ability to drive vehicles and other mechanisms.

Given the side effects, caution should be exercised when driving vehicles and moving machinery.

Overdose

Symptoms: nausea, vomiting, diarrhea, headache, fainting, hallucinations, cramps.

Treatment: symptomatic, there is no specific antidote.

With the help of hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be withdrawn.

Release form

Infusion solution 2 mg / ml, 100 ml vials or bottles.

Storage conditions

In a dry, dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life

2 years. Do not use after expiration date.

Pharmacy sales terms

On prescription.