Danzil eye drops br. bottle-cap 0.3% 5 ml N1
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Active ingredients
Ofloxacin
Release form
Drops
Composition
1 ml of drops contains: Active substance: ofloxacin 3 mg.
Pharmacological effect
Antimicrobial agent group of fluoroquinolones broad-spectrum. The bactericidal action of ofloxacin is associated with the blockade of the DNA gyrase enzyme in bacterial cells. It is highly active against most gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (incl. Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionelimeelowes, anesthesia sneemies, anemioneronelhoe, Myoplasma spp., Legionellower, Myoplasma spp. as well as Chlamydia spp. It is active against some Gram-positive microorganisms (including Staphylococcus spp., Streptococcus spp., especially beta-hemolytic streptococci). bacteria (except Bacteroides ureolyticus). Resistant to the action of? -lactamase.
Pharmacokinetics
After ingestion is rapidly and completely absorbed from the gastrointestinal tract. Eating a little effect on the degree of absorption, but can slow down its speed. Cmax in blood plasma is achieved after 2 hours. Binding to proteins - 25%. Ofloxacin is widely distributed in tissues and body fluids (organs of the urinary system, genitals, prostate gland, lungs, ENT organs, gall bladder, bones, skin). It is excreted in the urine unchanged (about 80% in 24 hours). The concentration of ofloxacin in the urine significantly exceeded the MPK90 for most microorganisms after the last dose (300 mg 2 times / day for 14 days). A small part of the active substance (about 4%) is excreted in the feces. T1 / 2 is 6 hours. In elderly patients with CC, on average 50 ml / min, an increase in T1 / 2 to 13.3 hours is possible.
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to ofloxacin, including: diseases of the lower respiratory tract, ear, throat, nose, skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal organs (except for bacterial enteritis ) and small pelvis, kidney and urinary tract infections, prostatitis, gonorrhea.
Contraindications
Pregnancy, lactation, children and adolescents under 18 years old, hypersensitivity to ofloxacin or other quinolone derivatives.
Use during pregnancy and lactation
Contraindicated for use in pregnancy and lactation. In experimental studies have not revealed a negative impact on fertility in rats.
Dosage and administration
Individual. The daily dose is 200-800 mg, the frequency of use is 2 times / day.For patients with impaired renal function (CC 20-50 ml / min), the first dose is 200 mg, then 100 mg every 24 hours. With CC less than 20 ml / min the first dose is 200 mg, then 100 mg every 48 hours.
Side effects
On the part of the digestive system: nausea, vomiting, diarrhea, pain and cramps in the abdomen, loss of appetite, dry mouth, flatulence, dysfunction of the gastrointestinal tract, constipation; rarely, liver dysfunction, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, gastrointestinal bleeding, disruption of the oral mucosa, heartburn, increased activity of liver enzymes, including GGT and LDH, increased serum bilirubin. nervous system: insomnia, dizziness, fatigue, drowsiness, nervousness; rarely - convulsions, anxiety, cognitive changes, depression, pathological dreams, euphoria, hallucinations, paresthesias, syncope, tremor, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggression, emotional lability, peripheral neuropathy, ataxia, impaired coordination, exacerbation of extrapyramidal disorders, impaired speech. Allergic reactions: skin rash, itching; seldom - angioedema, urticaria, vasculitis, allergic pneumonitis, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, conjunctivitis. vaginal discharge; rarely - burning, irritation, pain and rash in the genital area of women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis. From the cardiovascular system: rarely - cardiac arrest, edema, arterial hypertension, hypotension, palpitation, vasodilation, cerebral thrombus , pulmonary edema, tachycardia. From the urinary system: rarely - dysuria, increased urination, urinary retention, anuria, kidney stone polyuria, renal failure, nephritis, hematuria, albuminuria, candiduria. musculoskeletal system: rarely - arthralgia, myalgia, tendonitis, muscle weakness, myasthenia exacerbation. On the side of metabolism: rarely - thirst, weight loss,hyper- or hypoglycemia (especially in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents), acidosis, an increase in serum TG, cholesterol, potassium. From the respiratory system: rarely - cough, nasal discharge, respiratory arrest, dyspnea, bronchospasm , stridor. From the senses: rarely - hearing impairment, tinnitus, diplopia, nystagmus, impaired clarity of visual perception, taste disturbance, smell, photophobia. Dermatological reactions: rarely - photosensitization, hyperpigmentation, vesiculo boule eznye vysypaniya.So the hemopoietic system: rarely - anemia, bleeding, pancytopenia, agranulocytosis, leukopenia, reversible suppression of medullary hematopoiesis, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymosis, increased prothrombin vremeni.Prochie: chest pain, pharyngitis, increased body temperature, body pain; rarely - asthenia, chills, general malaise, epistaxis, increased sweating.
Overdose
After topical application of an excessive dose of Dancil, the eyes should be washed with clean water at room temperature. Data on systemic manifestations of overdose is not.
Interaction with other drugs
When used simultaneously with antacids containing calcium, magnesium or aluminum, with sucralfate, with preparations containing divalent or trivalent cations, such as iron, or with multivitamins containing zinc, it is possible that absorption of quinolone is impaired, leading to a decrease in their concentration in the body. These drugs should not be used within 2 hours before or within 2 hours after taking ofloxacin. With simultaneous use of ofloxacin and NSAIDs, the risk of a stimulating effect on the central nervous system and seizures increases. If used simultaneously with theophylline, its concentration in blood plasma may increase ( in equilibrium), an increase in T1 / 2. This increases the risk of adverse reactions associated with the action of theophylline. With simultaneous use of ofloxacin with beta-lactam antibiotics, aminoglycosides and metronidazole, additive interaction has been observed.
special instructions
Use with caution in patients with impaired renal and hepatic function. During the period of treatment, it is necessary to monitor the level of glucose in the blood.With long-term therapy, it is necessary to periodically monitor the functions of the kidneys, liver, and the picture of peripheral blood. When using ofloxacin, sufficient hydration of the body should be ensured, the patient should not be exposed to ultraviolet radiation. In experimental studies, no mutagenic potential has been identified. Long-term studies to determine the carcinogenicity of ofloxacin have not been conducted. In studies on young animals, several types of ofloxacin caused arthropathy and osteochondrosis. Safety and effectiveness in children and adolescents under the age of 18 years has not been established. Effect on ability to drive motor vehicles and control mechanismsWith caution in patients whose activities are associated with the need for high concentration of attention and quickness of psychomotor reactions.