Rofloks scan coated pills 500mg N10
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Description
Rofloks-Scan pills are a synthetic broad-spectrum antibacterial drug from the fluoroquinolone group, containing levofloxacin as the active substance - levorotatory isomer ofloxacin.
Active ingredients
Levofloxacin
Release form
Pills
Composition
The active substance is levofloxacin hemihydrate 512.45 mg. Auxiliary substances (core): corn starch 66.05 mg, microcrystalline cellulose 40.00 mg, sodium carboxymethyl starch 15.00 mg, crospovidone 15.00 mg, colloidal silicon dioxide 15.00 mg , talc 10.00 mg, magnesium stearate 6.50 mg. Auxiliary substances (coating): Opadry II pink (85F540146): 17.00 mg (polyvinyl alcohol (partially hydrolyzed) 6.800 mg, titanium dioxide 4.182 mg, macrogol 3.344 mg, talc 2.516 mg, iron oxide red 0.068 mg.
Indications
Unspecified septicemia, chronic sinusitis, acute sinusitis, acute bronchitis, phlegmon, acute peritonitis, chronic cholecystitis, acute cholecystitis, chronic obstructive pyelonephritis.
Precautionary measures
With caution: - In patients predisposed to the development of seizures [in patients with previous lesions of the central nervous system (CNS), in patients simultaneously receiving drugs that reduce the threshold of convulsive readiness of the brain, such as fenbufen, theophylline] .- In patients with latent or manifested deficiency of glucose-6-phosphate dehydrogenase (increased risk of hemolytic reactions during treatment with quinolones) .- In patients with impaired renal function (mandatory monitoring of renal function is required, as well as correction ma dosing) .- In patients with known risk factors for prolongation of the QT interval: in elderly patients, in female patients, in patients with uncorrected electrolyte disturbances (with hypokalemia, hypomagnesiemia), with congenital lengthening of the ICT interval, with heart disease failure, myocardial infarction, bradycardia), while taking medication that can prolong the QT interval (class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides, neuroleptic tics) .- In patients with diabetes mellitus receiving oral hypoglycemic agents, for example,glibenclamide or insulin preparations (increased risk of hypoglycemia) .- In patients with severe adverse reactions to other fluoroquinolones, such as severe neurological reactions (increased risk of similar adverse reactions when using levofloxacin) .- In patients with psychosis or in patients who have history of mental illness.
Use during pregnancy and lactation
The drug Rofloks-Scan is contraindicated for use in pregnant women and women during breastfeeding.
Dosage and administration
Roflox-Scan pills are taken orally once or twice a day. Tablets should be swallowed without chewing and drinking plenty of liquids (0.5 to 1 cup). If necessary, pills can be broken down at risk. The drug can be taken before meals or at any time between meals, since the meal does not affect the absorption of the drug. The drug should be taken at least 2 hours before or 2 hours after taking drugs containing magnesium and / or aluminum, iron, zinc, or sucralfata. Considering that the bioavailability of levofloxacin when taking the drug Rofloks-Scan in pills is 99-100%, in the case of transferring a patient from an intravenous infusion, the drug Rofloks-Scan for taking the pills should continue treatment in the same dose that was used for infuzii.Propusk-governmental receiving one or more doses preparataEsli accidentally miss a dose, it is necessary as soon as possible, take the next dose and then continue taking the drug Rofloks-Scan according to the recommended dosing regimen it.
Side effects
The following side effects are presented in accordance with the following gradations of the frequency of their occurrence: very often (≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1/1000), very rarely (<1/10000) (including individual messages), the frequency is unknown (according to the available data it is impossible to determine the frequency of occurrence). Disorders of the heartRedko: sinus tachycardia, heartbeat Frequency unknown: prolongation of the QT interval, ventricular arrhythmias, ventricular tachycardia, ventricular tachycardia, etc. pa "pirouette", which can lead to cardiac arrest (seesections "Overdose", "Special instructions"). Violations of the blood and lymphatic system.Often: leukopenia (decrease in the number of leukocytes in the peripheral blood), eosinophilia (increase in the number of eosinophils in the peripheral blood). , thrombocytopenia (decrease in the number of platelets in the peripheral blood). Frequency unknown: pancytopenia (decrease in the number of all the formed elements in the peripheral blood), agranulocytosis (absence or e decrease in the number of 10 granulocytes in the peripheral blood), hemolytic anemia. Violations of the nervous system. Often: headache, dizziness. Frequent: drowsiness, tremor, dysgeusia (taste perversion). Rarely: paresthesia, convulsions (see section "Special instructions") Frequency unknown: peripheral sensory neuropathy, peripheral sensory-motor neuropathy (see section "Special Instructions"), dyskinesia, extrapyramidal disorders, agevziya (loss of taste), parosmia (smell disorder, especially the subject a clear sense of smell, objectively absent), including loss of smell, fainting, benign intracranial hypertension. Disorders of the organ of visionRarely: visual impairment, such as blurred vision.Frequency unknown: transient loss of vision, uveitis. Disorders of the organ of hearing and labyrinth disorders Infrequently: vertigo (feeling of rejection or whirling either your own body or surrounding objects). Rare: tinnitus. Frequency unknown: hearing loss, hearing loss. Respiratory dysfunction system, organs of the chest and mediastinum. Uncommon: shortness of breath. Unknown frequency: bronchospasm, allergic pneumonitis. Disorders of the gastrointestinal tract. Frequently: diarrhea, vomiting, nausea. which in very rare cases can be a sign of enterocolitis, including pseudomembranous colitis (see section "Special instructions"), pancreatitis. Violations of the kidneys and urinary tract.Often: an increase in serum creatinine concentration. Rarely: acute renal failure (for example,due to the development of interstitial nephritis). Disorders of the skin and subcutaneous tissues Infrequently: rash, pruritus, urticaria, hyperhidrosis. see section "Special instructions"), leukocytoclastic vasculitis, stomatitis. Reactions from the skin and mucous membranes can sometimes develop even after taking the first dose of the drug. Disorders of the musculoskeletal system and connective tissue Infrequently: arthralgia, myalgia Rarely: tendon damage, including tendonitis (eg, Achilles tendon), muscle weakness, which can be especially dangerous in patients with pseudo-paralytic myasthenia (myasthenia gravis) (see "Special indications "). Frequency unknown: rhabdomyolysis, tendon rupture (for example, Achilles tendon. This side effect may occur within 48 hours after starting treatment and may be bilateral in nature (see also section "Special instructions")), ligament rupture, muscle rupture, arthritis. Metabolism and nutrition disorders. Infrequently: anorexia. Rare: hypoglycemia, especially in patients with diabetes mellitus (possible signs of hypoglycemia: wolfish appetite, nervousness, perspiration , trembling). Frequency unknown: hyperglycemia, hypoglycemic coma (see section "Special instructions"). Infectious and parasitic diseases Infrequently: fungal infections, development of resistance of pathogenic microorganisms. Disorders of vascular Rare: reduction of arterial pressure.General disordersInfrequent: asthenia.Redko: pyrexia (fever) .Frequency unknown: pain (including pain in the back, chest and limbs). Immune system disordersRedco: angioedema. Frequency unknown: anaphylactic shock, anaphylactoid shock.Anaphyaktectomy and anaphylactoid reactions can sometimes develop even after taking the first dose of the drug. Violations of the liver and biliary tract Frequently: an increase in the activity of "liver" enzymes in the blood (for example, alanine aminotransferase (ALT), aspartate aminotransferase (ACT)),increased alkaline phosphatase (alkaline phosphatase) and gammaglutamyltransferase (GGT) activity. Infrequently: an increase in the concentration of bilirubin in the blood. in patients with sepsis) (see section "Special Instructions"), hepatitis, jaundice. Psychiatric Disorders Often: insomnia. Infrequently: anxiety, anxiety, confusion. Rare: mental disorders (for example p, hallucinations, paranoia), depression, agitation (agitation), sleep disturbances, nightmares. Frequency unknown: mental disorders with behavioral disorders with self-harm, including suicidal thoughts and suicidal attempts. Other possible undesirable effects pertaining to all fluoroquinolones Very rare : bouts of porphyria (a very rare metabolic disease) in patients with porphyria.
Overdose
Overdose symptoms: impairment of consciousness, including confusion, dizziness, convulsions, hallucinations, tremor, nausea, erosive lesions of the mucous membrane of the gastrointestinal tract, prolongation of the QT interval. In case of overdose, careful monitoring of the patient is required, including monitoring of the electrocardiogram. Symptomatic treatment. In the case of an acute overdose of Rofloks-Scan pills, gastric lavage and the introduction of antacids to protect the gastric mucosa are indicated. Levofloxacin is not excreted by dialysis (hemodialysis, peritoneal dialysis, and permanent outpatient peritoneal dialysis). There is no specific antidote.
Interaction with other drugs
Interactions that require caution with drugs containing magnesium, aluminum, iron and zinc, didanosine Preparations containing divalent or trivalent cations, such as zinc or iron salts (drugs for treating anemia), magnesium and / or aluminum-containing drugs (such as antacids), didanosine (only dosage forms containing aluminum or magnesium as a buffer) is recommended to be taken at least 2 hours before or 2 hours after taking Roflox-Scan pills. Calcium salts have a minimum th effect on the absorption of levofloxacin at its reception vnutr.S sukralfatomDeystvie preparation Rofloks-Scan significantly attenuated while the use of sucralfate (the means to protect the gastric mucosa) .Patsientam receiving levofloxacin and sucralfate,it is recommended to take sucralfat 2 hours after taking levofloxacin. With theophylline, fenbufen or similar drugs from the group of nonsteroidal anti-inflammatory drugs that reduce the threshold of convulsive readiness of the brain, no pharmacokinetic interaction of levofloxacin with theophylline was detected. However, with the simultaneous use of quinolone and theophylline, nonsteroidal anti-inflammatory drugs and other drugs that reduce the threshold of convulsive readiness of the brain, a pronounced decrease in the threshold of convulsive readiness of the brain is possible. The concentration of levofloxacin while taking fenbufen simultaneously increases only by 13%. With indirect anticoagulants. ) In patients treated with levofloxacin in combination with indirect anticoagulants (for example, warfarin), an increase was observed otrombinovogo time / international normalized ratio and / or the development of bleeding, including, and heavy. Therefore, with the simultaneous use of indirect anticoagulants and levofloxacin, regular monitoring of blood coagulation parameters is necessary. With probenitsid and cimetidine. While using drugs that violate renal tubular secretion, such as probenicid and cimetidine, and levofloxacin, especially caution should be exercised especially in patients with renal insufficiency. Withdrawal (renal clearance) of levofloxacin is slowed by the action of cimetidine by 24% and probenicid by 34%. It is unlikely that this may have clinical significance in normal renal function. With cyclosporine, Levofloxacin increased T1 / 2 of cyclosporine by 33%. Since this increase is clinically insignificant, dose adjustment of cyclosporine when used simultaneously with levofloxacin is not required. With glucocorticosteroids Simultaneous administration of glucocorticosteroids increases the risk of tendon rupture. With drugs that lengthen the QT interval. Levofloxacin is not used by other waveforms to use patterns and other shapes that do not have to use the same waveforms and other shapes that do not have to use the same waveforms and other shapes that do not have to use the same waveform and other shapes that do not have to use the same waveform and other shapes that do not have to use the same waveform as other waveforms and other shapes should not be used to use the waveform for a QT lesion. receiving drugs that prolong the QT interval (for example, class IA and III antiarrhythmic drugs, tricyclic antidepressants, macrolides,neuroleptics). Other clinical and pharmacological studies to study the possible pharmacokinetic interactions of levofloxacin with digoxin, glibenclamide, ranitidine and warfarin showed that the pharmacokinetics of levofloxacin, when used simultaneously with these drugs, does not change sufficiently to have clinical significance.