Ciprolet tablets coated. 250 mg 10 pcs. (Ciprofloxacin)

Description srdlkopy coated, white, almost white, slightly coated, white or white tablets.

View on a break - white or almost white mass.

Release form

Coated tablets.



packaging 10 pcs

Pharmacological action

Ciprolet is an antimicrobial agent in the fluoroquinolone group.

The mechanism of action of ciprofloxacin is associated with exposure to bacterial DNA gyrase (topoisomerase),

, which plays an important role in the reproduction of bacterial DNA.

Ciprofloxacin has a rapid bactericidal effect on microorganisms,

, which are both at rest and in reproduction.

The spectrum of action of ciprofloxacin includes the following types of gram (-) and gram (+) microorganisms: E. coli, Shigella, Salmonella, Citrobacter, Klebsiella, Enterobacter, Serratia, Hafnia, Edwardsiella, Proteus

(indole-positive and indole-negative, Moriden, Providen Yersinia, Vibrio, Aeromonas, Plesiomonas,

Pasteurella, Haemophilus, Campylobacter, Pseudomonas, Legionella, Neisseria, Moraxella, Branhamella,

Acinetobacter, Brucella, Staphylococcus, Sreptococcus agalactiae, Listeria, Corynebacterium, Chlamydia.

Ciprofloxacin is effective against bacteria producing beta-lactamases.

Sensitivity to ciprofloxacin varies in: Gardnerella, Flavobacterium, Alcaligenes, Streptococcus faecalis,

Streptococcus pyogenes, Streptococcus pneumonia, Streptococcus viridans, Mycoplasma tuberculum tuberculum tuberculum.

Most often resistant: Streptococcus faecium, Ureaplasma urealyticum, Nocardia asteroides.

Anaerobes, with some exceptions, are moderately sensitive (Peptococcus, Peptostreptococcus) or resistant (Bacteroides).

Ciprofloxacin does not act on Treponema pallidum and fungi.

Resistance to ciprofloxacin is produced slowly and gradually,

plasmid resistance is absent. Ciprofloxacin is active against pathogens that are resistant,

for example, to betalactam antibiotics, aminoglycosides or tetracyclines.

Ciprofloxacin does not disturb the normal intestinal and vaginal microflora.

Pharmacokinetics: Ciprofloxacin is rapidly and well absorbed after taking the drug (bioavailability is 70-80%).

Maximum plasma concentrations are reached after 60-90 minutes. Distribution volume - 2-3 l / kg.

Binding to plasma proteins is negligible (20-40%). Ciprofloxacin penetrates well into organs and tissues.

About 2 hours after ingestion or intravenous administration, it is found in tissues and body fluids

many times higher concentrations than in blood serum.

Ciprofloxacin is excreted mainly unchanged mainly through the kidneys.

The elimination half-life from plasma, both after oral administration and after intravenous administration, is from 3 to 5 hours.

Significant amounts of the drug are also excreted in bile and feces, so only significant violations of

renal function lead to a slowdown in excretion.

Indications

Uncomplicated and complicated infections caused by microorganisms sensitive to ciprofloxacin.

Adults

- respiratory tract infection. Ciprofloxacin is recommended for pneumonia caused by Klebsiella spp.,

Enterobacter spp., Proteus spp., Escherichia coli, Pseudomonas aeruginosa, Haemophilus spp., Moraxella catarrhalis, Legionella spp. and staphylococci

- infections of the middle ear (otitis media), sinuses (sinusitis), especially if these infections are caused by gram-negative microorganisms, including Pseudomonas aeruginosa or staphylococci

- infections of the eyes

- infections of the kidneys and / or urinary tract infections

including adnexitis, gonorrhea, prostatitis

- infections of the abdominal cavity (bacterial infections of the gastrointestinal tract, biliary tract, peritonitis)

- infections of the skin and soft tissues

- sepsis

- infections or infection prevention in patients with reduced immunity (patients taking immunosuppressants or patients with neutropenia)

- selective bowel decontamination in patients with reduced immunity

- prevention and treatment anthrax (infection of Bacillus anthracis)

- prevention of invasive infections caused by Neisseria meningitidis.

It is necessary to take into account the current official guidelines on the use of antibacterial drugs.

Children

- treatment of complications caused by Pseudomonas aeruginosa in children with pulmonary cystic fibrosis from 5 to 17 years old

- prevention and treatment of pulmonary anthrax (infection with Bacillus anthracis).

Contraindications

Hypersensitivity to ciprofloxacin or other fluoroquinolone drugs,

, as well as auxiliary substances (see section "Composition").

Concomitant use of ciprofloxacin and tizanidine due to clinically significant side effects (hypotension, drowsiness),

associated with an increase in the concentration of tizanidine in blood plasma (see section "Interactions with other drugs").

Precautions: Severe liver failure and diseases of the central nervous system (CNS):

epilepsy, a decrease in the seizure threshold (or a history of seizures)

severe cerebral arteriosclerosis cerebrovascular accident

organic brain damage or stroke mental illness (depression, psychosis)

renal failure tendon damage with previous treatment with quinolone extension or the development of arrhythmias such as “pirouette”

[for example, congenital lengthening of the QT interval, heart disease (heart failure, nfarkt infarction, bradycardia), or electrolyte imbalances (e.g., hypokalemia, hypomagnesemia)]

simultaneous use of drugs, prolonging the interval QT (including IA and III antiarrhythmics of classes, the tricyclic antidepressants, macrolides, antipsychotics)

simultaneous use with inhibitors of isozyme 1A2 (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine) myasthenia gravis glucose-6-phosphate dehydrogenase deficiency use in elderly patients.

Use in pregnancy and lactation

The safety of ciprofloxacin in pregnant women has not been established.

However, based on the results of animal studies, the likelihood of adverse effects on the articular cartilage of newborns cannot be completely ruled out, and therefore pregnant women should not be prescribed ciprofloxacin.

At the same time, during studies on animals, teratogenic effects (malformations) were not established.

Ciprofloxacin is excreted in breast milk.

Due to the potential risk of damage to the articular cartilage of newborns, ciprofloxacin should not be prescribed to lactating women.

Composition

Each 250 mg film-coated tablet contains: Active ingredient:

ciprofloxacin hydrochloride monohydrate 291.106 mg, equivalent to 250 mg ciprofloxacin.

Excipients:

corn starch 50.323 mg,

microcrystalline cellulose 7.486 mg,

croscarmellose sodium 10,000 mg,

corn starch 7.571 mg,

silicon colloidal 5,000 mg cald

5,000 mg,



Shell: hypromellose (6 cps) 4,800 mg,

sorbic acid 0,080 mg,

titanium dioxide 2,000 mg,

talc 1,600 mg,

macrogol-6,000 1,360 mg,

polysorbate-80 0,080 mg,

dimet.

Each 500 mg film-coated tablet contains: Active ingredient:

ciprofloxacin hydrochloride monohydrate 582.211 mg,

is equivalent to ciprofloxacin 500 mg.

Excipients: corn starch 27.789 mg,

microcrystalline cellulose 5,000 mg, croscarmellose sodium

20,000 mg,

corn starch 9,500 mg,

silica colloidal 5,000 mg,

magnesium tal.

Shell: hypromellose (6 cps) 5,000 mg,

sorbic acid 0.072 mg,

titanium dioxide 1.784 mg,

talc 1.784 mg,

macrogol-6000 1.216 mg,

polysorbate-80 0.072 mg,

dimethicone.

Dosing and Administration

Dose Ciprolet 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 2 times / day are prescribed, 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 Ciprolet® 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 2 times / day are prescribed (for the treatment of ordinary diarrhea, 250 mg 2 times / day can be used).

Pills 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 continue for at least 2 more days after the symptoms disappear.

Typically, the duration of treatment is 7-10 days.

Side effects of

The adverse reactions listed below were classified as follows:

“very often” (> 1/10 prescriptions), “often” (1/10 - 1/100 prescriptions),

“infrequently” (1/100 - 1 / 1000 appointments), “rarely” (1/1000 - 1/10,000 appointments),

“very rare” (<1 / 10,000 appointments), “often unknown”.

Adverse reactions that were recorded only during post-marketing observations and whose frequency was not estimated,

are labeled “unknown”.

Infectious and parasitic diseases

Infrequently - mycotic superinfection rarely - pseudomembranous colitis (in very rare cases with possible fatal outcome).

Disorders from the blood and lymphatic system

Infrequently - eosinophilia rarely - leukopenia, anemia, neutropenia, leukocytosis, thrombocytopenia, thrombocytemia

very rarely - hemolytic anemia, agranulocytosis, life-threatening (life-threatening) bone marrow pancytopenia.

Immune system disorders

Rarely - allergic reactions, allergic edema / angioedema

very rarely - anaphylactic reactions, anaphylactic shock (life-threatening), serum sickness.

Metabolism and nutritional disorders

Infrequently - decreased appetite and food intake rarely - hyperglycemia, hypoglycemia.

Mental disorders

Infrequently - psychomotor hyperactivity / agitation

often - confusion and disorientation, anxiety, dream disturbance (nightmares), depression (increased behavior for self-harm, such as suicidal behavior / thoughts, as well as attempted suicide or successful suicide),

hallucinations are very rare - psychotic reactions (increased behavior for self-harm, such as suicidal behavior / thoughts, as well as attempted suicide or successful suicide).

Violations of the nervous system

Infrequently - headache, dizziness, sleep disturbance

rarely - paresthesia and dysesthesia, hypesthesia, tremors, cramps (including epilepsy), vertigo

very rare - migraine, impaired coordination of movements, impaired sense of smell, intracranial hypertension (cerebral pseudotumor symptoms)

frequency unknown - peripheral neuropathy and polyneuropathy.

Visual disturbances

Rarely - visual disturbances are very rare - color perception disorder.

Hearing impairment and labyrinth disorders

Rarely - tinnitus, hearing loss is very rare - hearing impairment.

Heart abnormalities

Rarely - tachycardia frequency unknown - prolongation of the QT interval, ventricular arrhythmias (including pirouette type) *.

Vascular disorders

Rarely - vasodilation, lowering blood pressure, a sensation of a "rush" of blood to the face

is very rare - vasculitis.

Disorders of the respiratory system, chest and mediastinal organs

Rarely - respiratory failure (including bronchospasm).

Disorders of the gastrointestinal tract

Often - nausea, diarrhea infrequently - vomiting, abdominal pain, dyspepsia, flatulence

is very rare - pancreatitis.

Disorders from the liver and biliary tract

Infrequently - increased activity of hepatic transaminases, increased bilirubin concentration

rarely - impaired liver function, jaundice, hepatitis (non-infectious)

very rarely - liver tissue necrosis (in extremely rare cases, progressing to life-threatening liver failure).

Disorders of the skin and subcutaneous tissue

Infrequently - rash, itching, urticaria

rare - photosensitization,

blistering very rare - petechiae, small erythema of small forms, erythema nodosum, Stevens-Johnson syndrome (malignant exudative, volumetric exudative, potentially life-threatening Lyell syndrome (toxic epidermal necrolysis),

including a potentially life-threatening frequency is unknown - acute generalized pustular exanthema.

Violations of the musculoskeletal and connective tissue

Infrequently - arthralgia

rare - myalgia, arthritis, increased muscle tone, muscle cramps

very rarely - muscle weakness, tendonitis, rupture of tendons (mainly Achilles), aggravation of symptoms of miast.

Disorders of the kidneys and urinary tract

Infrequently - impaired renal function rarely - renal failure, hematuria, crystalluria, tubulointerstitial nephritis.

General disorders and disorders at the injection site

Often - reactions at the injection site

infrequently - pain of a non-specific etiology, general malaise, fever

rarely - edema, sweating (hyperhidrosis) is very rare - gait disturbance.

Laboratory and instrumental data

Infrequently - increased alkaline phosphatase activity in blood

rare - changes in prothrombin content, increased activity of

amylase frequency is unknown - increased international normalized ratio (INR) in patients receiving vitamin K. antagonists

* - more often in patients having a predisposition to develop lengthening of the QT interval.

The frequency of development of the following adverse reactions with intravenous administration and with the use of ciprofloxacin step-by-step therapy (with the intravenous administration of the drug followed by oral administration) is higher than with the oral administration: Often - vomiting, increased activity of hepatic transaminases, rash.

Infrequently - thrombocytopenia, thrombocythemia, confusion and disorientation, hallucinations, paresthesia and dysesthesia,

convulsions, vertigo, visual impairment, hearing loss, tachycardia, vasodilation, decreased blood pressure,

reversible liver dysfunction, jaundice, renal failure, edema.

Rarely - pancytopenia, bone marrow depression, anaphylactic shock, psychotic reactions, migraine, sense of smell,

hearing impairment, vasculitis, pancreatitis, liver tissue necrosis, petechiae, tendon rupture.

Children - Arthropathy has often been reported in children.

Drug Interaction

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

Simultaneous intake of Ciprolet and theophylline may lead to increased plasma concentrations of theophylline,

due to competitive inhibition in cytochrome P450 binding sites, which leads to an increase in T1 / 2 of theophylline and toxin-related toxicity.

Concomitant use of antacids as well as preparations containing aluminum, zinc, iron or magnesium ions,

may cause a decrease in the absorption of ciprofloxacin, so the interval between administration of these drugs should be at least 4 hours.

Bleeding time is prolonged with the use of Ciprolet and anticoagulants.

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

overdose

Treatment: it is necessary to carefully monitor the condition of the patient, to do a gastric lavage, to carry out the usual emergency measures, to ensure sufficient fluid intake.

Only a small (less than 10%) amount of the drug can be removed by hemo- or peritoneal dialysis.

The specific antidote is unknown.

Storage conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children!

The Expiration of

is 3 years.

Active ingredient

Ciprofloxacin

dosage form srdl kp Dosage form

tablets



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