Tsiprolet tablets 250mg, No. 10

Infectious and inflammatory diseases caused by microorganisms sensitive to ciprofloxacin, including:

• respiratory tract infections;

• infections of the ENT organs;

• kidney and urinary tract infections;

• genital infections;

• gastrointestinal tract infections (including mouth, teeth, jaws); gallbladder and biliary tract infections;

• infections of the skin, mucous membranes and soft tissues;

• musculoskeletal system infections;

• sepsis;

• peritonitis.

• Prevention and treatment of infections in patients with reduced immunity (during therapy with immunosuppressants).

The dose of Tsiprolet depends on the severity of the disease, the type of infection, the condition of the body, age, body weight and kidney function.

In uncomplicated diseases of the kidneys and urinary tract, 250 mg is prescribed 2 times / day, and in severe cases, 500 mg 2 times / day.

For diseases of the lower respiratory tract of moderate severity - 250 mg 2 times / day, and in more severe cases - 500 mg 2 times / day.

For the treatment of gonorrhea, a single dose of CiproletЃ is recommended at a dose of 250-500 mg.

For gynecological diseases, enteritis and colitis with severe course and high fever, prostatitis, osteomyelitis, 500 mg is prescribed 2 times / day (for the treatment of common diarrhea, you can use a dose of 250 mg 2 times / day).

The tablets should be taken on an empty stomach with plenty of fluids.

The duration of treatment depends on the severity of the disease, but treatment should always be continued for at least another 2 days after the symptoms of the disease disappear. Usually the duration of treatment is 7-10 days.

Patients with severe renal impairment should be given half the dose of the drug.

Film-coated tablets of white or almost white color, round, biconvex, with a smooth surface on both sides; at the break there is a white or almost white mass.

1 tab.

ciprofloxacin hydrochloride 291.106 mg,

which corresponds to the content of ciprofloxacin 250 mg

Excipients: corn starch - 50.323 mg, microcrystalline cellulose - 7.486 mg, croscarmellose sodium - 10 mg, colloidal silicon dioxide - 5 mg, talc - 5 mg, magnesium stearate - 3.514 mg.

• Pseudomembranous colitis;

• pregnancy;

• lactation period (breastfeeding);

• children and adolescents up to 18 years old;

• hypersensitivity to ciprofloxacin or other drugs from the fluoroquinolone group.

  Care should be taken to prescribe the drug for severe atherosclerosis of the cerebral vessels, cerebrovascular accident, mental illness, convulsive syndrome, epilepsy, severe renal and / or hepatic failure, as well as elderly patients.

pharmachologic effect

A broad-spectrum antibacterial drug from the group of fluoroquinolones. It has a bactericidal effect. The drug inhibits the enzyme DNA-gyrase of bacteria, as a result of which DNA replication and the synthesis of bacterial cellular proteins are disrupted. Ciprofloxacin acts both on multiplying microorganisms and on those in the resting phase.

Gram-negative aerobic bacteria are susceptible to ciprofloxacin: Escherichia coli, Salmonella spp., Shigella spp., Citrobacter spp., Klebsiella spp., Enterobacter spp., Proteus mirabilis, Proteus vulgaris, Serratia marcescens, Hafhiia telvea spp., Edwardsella morganii, Vibrio spp., Yersinia spp .; other gram-negative bacteria: 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.

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

The sensitivity of bacteria Streptococcus pneumoniae, Enterococcus faecalis is moderate.

Corynebacterium spp., Bacteroides fragilis, Pseudomonas cepacia, Pseudomonas maltophilia, Ureaplasma urealyticum, Clostridium difficile, Nocardia asteroides are resistant to the drug. The effect of the drug against Treponema pallidum is not well understood.

Pharmacokinetics

When taken orally, ciprofloxacin is rapidly absorbed from the gastrointestinal tract. The bioavailability of the drug is 50-85%. The Cmax of the drug in the blood serum of healthy volunteers after oral administration of the drug (before meals) at a dose of 250, 500, 750 and 1000 mg is achieved after 1-1.5 hours and is 1.2, 2.4, 4.3 and 5.4 ?g / ml, respectively.

Orally taken ciprofloxacin is distributed into tissues and body fluids. High concentrations of the drug are observed in bile, lungs, kidneys, liver, gallbladder, uterus, seminal fluid, prostate tissue, tonsils, endometrium, fallopian tubes and ovaries. The concentration of the drug in these tissues is higher than in serum. Ciprofloxacin also penetrates well into bones, eye fluid, bronchial secretions, saliva, skin, muscles, pleura, peritoneum, lymph.

The accumulating concentration of ciprofloxacin in blood neutrophils is 2-7 times higher than in serum.

Vd in the body is 2-3.5 l / kg. The drug penetrates into the cerebrospinal fluid in a small amount, where its concentration is 6-10% of that of the serum.

The degree of binding of ciprofloxacin to plasma proteins is 30%.

In patients with unchanged renal function, T1 / 2 is usually 3-5 hours. The main route of elimination of ciprofloxacin from the body is through the kidneys. 50-70% is excreted in the urine. From 15 to 30% is excreted in the feces.

With impaired renal function, T1 / 2 increases.

Patients with severe renal insufficiency (CC below 20 ml / min / 1.73 m2) should be prescribed half the daily dose of the drug.

Side effect

From the digestive system: nausea, diarrhea, vomiting, abdominal pain, flatulence, anorexia, cholestatic jaundice (especially in patients with previous liver diseases), hepatitis, hepatonecrosis, increased activity of hepatic transaminases and alkaline phosphatase.

From the nervous system: dizziness, headache, increased fatigue, anxiety, tremor, insomnia, nightmares, peripheral paralgesia (anomaly in the perception of pain), sweating, increased intracranial pressure, anxiety, confusion, depression, hallucinations, and other manifestations psychotic reactions (occasionally progressing to states in which the patient can harm himself), migraine, fainting, cerebral artery thrombosis.

From the senses: disturbances in taste and smell, visual impairment (diplopia, change in color perception), tinnitus, hearing loss.

From the side of the cardiovascular system: tachycardia, cardiac arrhythmias, decreased blood pressure, rush of blood to the skin of the face.

From the hematopoietic system: leukopenia, granulocytopenia, anemia, thrombocytopenia, leukocytosis, thrombocytosis, hemolytic anemia.

On the part of laboratory parameters: hypoprothrombinemia, hypercreatininemia, hyperbilirubinemia, hyperglycemia.

From the urinary system: hematuria, crystalluria (primarily with alkaline urine and low urine output), glomerulonephritis, dysuria, polyuria, urinary retention, albuminuria, urethral bleeding, hematuria, decreased renal nitrogen excretion function, interstitial nephritis.

Allergic reactions: pruritus, urticaria, blistering with bleeding and small nodules that form scabs, drug fever, punctate hemorrhages (petechiae), swelling of the face or larynx, shortness of breath, eosinophilia, increased photosensitivity, vasculitis, erythema nodosum, erythema nodosum, effusion , Stevens-Johnson syndrome (malignant exudative erythema), toxic epidermal necrolysis (Lyell's syndrome).

From the musculoskeletal system: arthralgia, arthritis, tendovaginitis, tendon ruptures, myalgia.

Others: general weakness, superinfection (candidiasis, pseudomembranous colitis).

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

special instructions

Patients with epilepsy, a history of seizures, vascular diseases and organic brain lesions due to the threat of adverse reactions from the central nervous system CiproletЃ should be prescribed only for health reasons.

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

If pain occurs in the tendons or when the first signs of tendovaginitis appear, treatment should be discontinued due to the fact that isolated cases of inflammation and even rupture of tendons during treatment with fluoroquinolones have been described.

During the period of treatment with Tsiprolet, it is necessary to provide a sufficient amount of fluid while maintaining normal diuresis.

During the treatment with Tsiprolet, contact with direct sunlight should be avoided.

Influence on the ability to drive vehicles and mechanisms

Patients taking TsiproletЃ should be careful when driving a car and engaging in other potentially hazardous activities that require increased attention and speed of psychomotor reactions (especially with the simultaneous use of alcohol).

Overdose

Treatment: it is necessary to carefully monitor the patient's condition, do a gastric lavage, carry out the usual emergency measures, and ensure an adequate supply of fluid. With the help of hemo- or peritoneal dialysis, only a small (less than 10%) amount of the drug can be removed. The specific antidote is unknown.

Drug interactions

With the simultaneous use of Ciprolet with didanosine, the absorption of ciprofloxacin is reduced due to the formation of complexes of ciprofloxacin with aluminum and magnesium salts contained in didanosine.

The simultaneous administration of Ciprolet and theophylline can lead to an increase in the concentration of theophylline in the blood plasma, due to competitive inhibition in the binding sites of cytochrome P450, which leads to an increase in T1 / 2 of theophylline and an increase in the risk of developing a toxic effect associated with theophylline.

The simultaneous administration of antacids, as well as preparations containing aluminum, zinc, iron or magnesium ions, can cause a decrease in the absorption of ciprofloxacin, therefore the interval between the appointment of these drugs should be at least 4 hours.

With the simultaneous use of Tsiprolet and anticoagulants, the bleeding time is lengthened.

With the simultaneous use of Tsiprolet and cyclosporine, the nephrotoxic effect of the latter is enhanced.