Description
Description
White or almost white round biconvex tablets with a smooth surface on both sides, film-coated. The view on the fracture is a white or almost white mass.
Release form
Coated tablets.
upacowka
10 pcs.
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 prevention of infections in the patient nt with reduced immunity (patients receiving immunosuppressants or patients with neutropenia)
– selective decontamination of the intestines in immunocompromised patients
– prevention and treatment of pulmonary 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 to excipients (see section “Composition”). The simultaneous use of ciprofloxacin and tizanidine due to clinically significant side effects (hypotension, drowsiness) associated with an increase in the concentration of tizanidine in the blood plasma (see the section “Interactions with other drugs”).
Precautions: Severe liver failure and diseases of the central nervous system (CNS): epilepsy, decreased seizure threshold (or a history of seizures) severe cerebral arteriosclerosis cerebrovascular accident organic brain lesions or stroke mental illness (depression, psychosis) renal failure tendon damage with previous treatment with quinolones increased risk of prolonged QT interval or the development of arrhythmia “Pirouette” [for example, congenital lengthening of the QT interval, heart disease (heart failure, myocardial infarction, b adikardiya), 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) concomitant use with inhibitors of isoenzyme 1A2 (including theophylline, methylxanthine, caffeine, duloxetine, clozapine, ropinirole, olanzapine) myasthenia gravis glucose-6-phosphate dehydrogenase deficiency use in elderly patients.
1 coated tablet contains ciprofloxacin hydrochloride monohydrate in a dose equivalent to 500 mg ciprofloxacin.
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, you can use it at a dose of 250 mg 2 times / day).
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 another 2 days after the disappearance of the symptoms of the disease. 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 appointments), often (1/10 – 1/100 appointments), 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 marked unknown . Infectious and parasitic diseases Infrequently – mycotic superinfection rarely – pseudomembranous colitis (in very rare cases with possible fatal outcome). Disorders of the blood and lymphatic system Infrequently – eosinophilia rarely – leukopenia, anemia, neutropenia, leukocytosis, thrombocytopenia, thrombocythemia very rarely – hemolytic anemia, agranulocytosis, pancytopenia (life-threatening), bone marrow depression. Immune system disorders Rarely, allergic reactions, allergic edema / angioedema very rare – 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 with the goal of self-harm, such as suicidal behavior / thoughts, as well as suicide or failed) hallucinations are very rare – psychotic reactions (increased behavior with the goal of self-harm, such as suicidal acts / thoughts, as well as attempted suicide or successful suicide). Disorders of the nervous system Infrequently – headache, dizziness, sleep disturbance rarely – paresthesia and dysesthesia, hypesthesia, tremors, convulsions (including epilepsy attacks), vertigo very rarely – migraine, impaired coordination of movements, impaired sense of smell, hyperesthesia, intracranial (cerebral pseudotumor symptoms) frequency is 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 very rarely – 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 – photosensitivity, blistering very rarely – petechiae, small erythema of small forms, erythema nodosum, Stevens-Johnson syndrome (malignant exudative erythema), including potentially threatening Lyell’s syndrome of life (toxic epidermal necrolysis), including a potentially life-threatening frequency, is unknown – acute generalized pustular exanthema. Violations of the musculoskeletal and connective tissue Infrequently – arthralgia rarely – myalgia, arthritis, increased muscle tone, muscle cramps very rarely – muscle weakness, tendonitis, rupture of tendons (mainly Achilles), exacerbation of symptoms of myasthenia gravis. 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 are infrequent – pain of a nonspecific etiology, general malaise, fever rarely – swelling, sweating (hyperhidrosis) very rarely – gait disturbance. Laboratory and instrumental data Infrequently – increased alkaline phosphatase activity in the blood rarely – changes in prothrombin content, increased amylase activity frequency is unknown – increased international normalized ratio (INR) in patients receiving vitamin K. antagonists * – more often in patients with a predisposition to the development of 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, and kidney. Rarely – pancytopenia, bone marrow depression, anaphylactic shock, psychotic reactions, migraine, sense of smell, hearing impairment, vasculitis, pancreatitis, necrosis of liver tissue, 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, leading to an increase in T1 / 2 of theophylline and an increased risk of theophylline-related toxicity. Concurrent administration of antacids as well as drugs, containing aluminum, zinc, iron or magnesium ions can cause a decrease in the absorption of ciprofloxacin, so the interval between the administration of these drugs should be at least 4 hours With the simultaneous use of Ciprolet and anticoagulants, bleeding time is prolonged. With the simultaneous use of Ciprolet and cyclosporine the nephrotoxic effect of the latter increases. 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. 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. 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. Dosage form dosage form tablets
