Ificipro

Ificipro

Ciprofloxacin solution for infusion
200 mg/100 ml

Pharmacological Action
A broad spectrum antimicrobial drug of fluoroquinolones family; has a Bactericidal effect. The drug inhibits the enzyme DNA gyrase bacteria, which leads to disorders in DNA replication and synthesis of cellular proteins of bacteria. Ciprofloxacin has an action on both breeding microorganisms and microorganisms in the resting stage.  
Gram-negative aerobic bacteria susceptible to ciprofloxacin are– Enterobacteriaceae:  (Escherichia 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.), Haemophilus spp., Pseudomonas aeruginosa, Moraxella catarrhalis, Aeromonas spp., Pasteurella multocida, Plesiomonas shigelloides, Campylobacter jejuni, Neisseria spp.; some intracellular pathogens: Legionella pneumophila, Brucella spp., Chlamydia trachomatis, Listeria monocytogenes, Mycobacterium tuberculosis, Mycobacterium kansasii, Mycobacterium avium-intracellulare.
Some gram-positive aerobic bacteria susceptible to ciprofloxacin are:  Staphylococcus spp. (S.aureus, S.haemolyticus, S.hominis, S.saprophyticus), Streptococcus spp. (St. pyogenes, St.agalactiae). Most of staphylococci resistant to methicillin, are also resistant to ciprofloxacin.
The susceptibility of Streptococcus pneumoniae, Enterococcus faecalis is moderate.  
Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroids are resistant to the drug.

Pharmacokinetics
After intravenous 200mg or 400 mg infusion Cmax is reached within 60 minutes and equals 2.1 mcg/ml and 4.6 mcg/ml, respectively. Vd – 2-3 L/kg, plasma protein binding is 20-40%.
It is well distributed in the body tissues (excluding fat tissues, such as neural tissue). The content in tissues is 2-12 times higher than in plasma. Therapeutic concentrations are achieved in saliva, tonsils, liver, gallbladder, bile, intestine, abdominal cavity and pelvis, uterus, seminal fluid, the prostate tissue, endometrium, fallopian tubes and ovaries, kidney and urinary organs, lung tissue, bronchial secretions, bone, muscle, synovial fluid and articular cartilage, peritoneal fluid, and skin.
Ciprofloxacin is also well penetrated into the aqueous humor, bronchial secretions, pleura, peritoneum, lymph through the placenta. The ciprofloxacin concentration in blood neutrophils is 2-7 times higher than in serum.
In intravenous infusion T 1/2 is 5-6 hours, in chronic renal failure – up to 12 hours.
After intravenous infusion the concentration in the urine during the first 2 hours after infusion is about 100 times greater than in the serum that significantly exceeds the MOU (Maximum Oxygen Uptake) for the majority of urinary tract pathogens.

Dosage
For intravenous administration.
The drug should be administered in the form of intravenous drops within 30 minutes (200mg) and 60 minutes (400mg). Infusion solution can be administered in combination with 0.9% sodium chloride solution, 5% Ringer's solution, 10% dextrose solution, 10% fructose solution, and solution that contains 5% dextrose with 0.222% or 0.45% sodium chloride.
Ciprofloxacin dose depends on the severity of a disease, type of infection, the patient’s body condition, age, weight, and kidney function. The recommended dose is usually as follows:
For intravenous infusion a single dose is 200mg (in severe infections – 400mg), dose frequency - twice a day; the duration of treatment depends on the severity of a disease – 1-2 weeks, if necessary this period can be extended.
In acute gonorrhea – once, 100mg intravenous.
For postoperative infection prevention – 30-60 minutes before the surgery 200-400 mg intravenous.
Co-administration of uricosuric drugs leads to slower excretion (50%) and increase in the plasma concentration of ciprofloxacin.
When administered in combination  with other antimicrobial agents (beta-lactams, aminoglycosides, clindamycin, and metronidazole) synergism is commonly observed; it can be effectively used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp.; with mezlocillin, azlocillin, and other beta-lactam antibiotics – in streptococcal infections; with isoxazole penicillin and vancomycin - in staphylococcal infections; with metronidazole and clindamycin - in anaerobic infections.

Pregnancy and Breastfeeding
Contraindicated.

Side Effects
On the digestive system: nausea, diarrhea, vomiting, abdominal pain, meteorism, anorexia, cholestatic jaundice (especially in patients with a history of liver diseases), hepatitis, and hepatic necrosis.
On the nervous system: dizziness, headache, fatigue, and anxiety.
On the hematopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, and haemolytic anemia.
On the laboratory results: hypoprothrombinemia, elevated liver transaminases and elevated alkaline phosphatase, hypercreatininemia, hyperbilirubinemia, and hyperglycemia.
Allergic reactions: itching, hives, blisters, accompanied by bleeding, and small nodules that form scabs, drug fever, petechial hemorrhages (petechiae), face swelling or throat swelling, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, nodular erythema, exudative erythema multiforme, Stevens-Johnson syndrome (malignant erythematous exudative dermatosis), toxic epidermal necrolysis (Lyell's syndrome).

Indications
Infectious-inflammatory diseases caused by microorganisms susceptible to ciprofloxacin:
- of the respiratory tract
- of ear nose and throat: otitis media, haimoritis, sinusitis, frontitis, mastoiditis, tonsillitis, pharyngitis
- kidney and urinary tract: cystitis, pyelonephritis
- reproductive organs: prostatitis, adnexitis, oophoritis, endometritis, tubo-ovarian abscess, pelvioperitonitis, gonorrhea, chancroid, and chlamydia  
- digestive tract (including mouth, teeth, jaw); gallbladder and biliary tract: peritonitis, intra-abdominal abscesses, salmonellosis, typhoid fever, campylobacteriosis, yersiniosis, shigellosis, cholera
- skin, mucous membranes, and soft tissues: infected ulcers, wounds, burns, abscesses, cellulites
- musculoskeletal system: osteomyelitis, septic arthritis

Surgery Infection Prevention
Ciprofloxacin is indicated for treatment of peritonitis and sepsis, prevention and treatment of infections in immunosuppressed patients (in immunosuppressive therapy).

Contraindications
- pseudomembranous colitis
- infancy (under 18 years old – till skeletal growth completion)
- pregnancy
- breastfeeding
- hypersensitivity

Precautions – patients with cerebral atherosclerosis, cerebrovascular accident, mental illness, convulsion syndrome, epilepsy, severe renal failure and/or severe hepatic impairment, and elderly patients.  

Cautions
If severe and long term diarrhea occurs during or after treatment with ciprofloxacin, diagnosis by exclusion for pseudomembranous colitis that requires immediate discontinuation of the drug and administration of appropriate therapy should be made.  
If pain in tendons or first signs of tendovaginitis appear, the treatment should be discontinued.
During treatment with ciprofloxacin drink sufficient amount of liquid in normal urine output.
During treatment with ciprofloxacin avoid direct sunlight.