Teva-Ofloxacin tab n / 200mg film about 10 pc

$4.48

Teva-Ofloxacin tab n / 200mg film about 10 pc

Quantity:

Description

Composition
Active substance:
1 tablet contains: ofloxacin 200.0 or 400.0 mg ;.
Excipients:
Lactose monohydrate 105.6 / 211.2 mg, pregelatinized starch 54.0 / 108.0 mg Hypromellose 20.0 / 40.0 mg Croscarmellose sodium 16.0 / 32.0 mg silica colloidal 0.4 / 0.8 mg magnesium stearate 4.0 / 8.0 mg. sheath: White Opadry II 33G28707 (hypromellose-IWU 6.00 / 9.60 mg Titanium dioxide E171 3.60 / 5.76 mg lactose monohydrate 3.30 / 5.28 mg macrogol 3000 1.20 / 1 92 mg triacetin 0.90 / 1.44 mg).
Description:
200 mg Tablets: White Round biconvex tablets, film-coated, with the notch on both sides. On one side – the engraving “FXN” on one side of the risks and “200” – on the other side of the risks. On the cross-section – the core of a white or nearly white.
400 mg Tablets: white oval biconvex tablets, film-coated, with the mark on one side and engraving «FXN» and “400” – to another. On the cross-section – the core of a white or nearly white.
Product form:
Tablets, film-coated, 200 mg, 400 mg.
10 tablets in blisters made of aluminum foil / PVC / PVDC; 1, 2 or 5 blisters with instructions for use in a cardboard package.
Contraindications
Hypersensitivity, epilepsy (including history), decrease the seizure threshold (including after head trauma, stroke or CNS inflammation in), tendon lesion at the previously held treatment fluoroquinolones; age 18 years (not yet completed skeletal growth), pregnancy, lactation.
Carefully.
Cerebral atherosclerosis, cerebrovascular disease (disorder), chronic renal failure, hepatic failure, organic CNS disorders, predisposition to convulsive reactions, myasthenia, hepatic porphyria, deficiency of glucose-6-phosphate dehydrogenase, diabetes, congenital elongation syndrome interval QT, heart disease (CH, myocardial infarction, bradycardia), psychosis and other mental disorders in history.; simultaneous reception PM prolonging the interval QT (IA and III antiarrhythmics of classes, tricyclic and tetracyclic antidepressants, antipsychotics, macrolides, antifungals, imidazole derivatives, some antihistamines, including astemizole, terfenadine, ebastine) for general anesthesia from the group consisting of barbiturates, drugs that reduce blood pressure.
Indications
respiratory infections (bronchitis, pneumonia), ENT (sinusitis, pharyngitis, otitis, laryngitis, tracheitis), of the skin, soft tissue, bone, joints, infectious and inflammatory diseases of the abdominal cavity and biliary tract, kidney (pyelonephritis), lower urinary tracts (cystitis, urethritis), genitals and pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis, colpitis, orchitis, epididymitis), gonorrhea, chlamydia; sepsis (only in / in); prevention of infections in patients with impaired immune status (including the neutropenia).
Interaction with other drugs
Reduces the clearance of theophylline is 25% (while the application should reduce the dose of theophylline).
It increases the concentration of glibenclamide in plasma.
Increases serum concentration of cyclosporine.
Cimetidine, furosemide, methotrexate, and drugs that block tubular secretion, increase the concentration of ofloxacin in the blood plasma.
Together with the admission indirect anticoagulants (coumarin derivatives including warfarin) necessary to control the blood coagulation system.
In the appointment of NSAIDs derivatives nitroimidazole and methylxanthines increases the risk of neurotoxic effects, including seizures.
When concomitant administration with corticosteroids increase the risk of tendon rupture, particularly in elderly people.
When assigning the LAN, urine alkalizing (carbonic anhydrase inhibitors, citrates, sodium hydrogencarbonate), increases the risk of crystalluria and nephrotoxic effects.
While the appointment of hypoglycemic agents available both hypo- and hyperglycemia, and therefore it is necessary to control the plasma glucose concentration.
Suitable for infusion solutions: 0.9% solution of NaCl, Ringer’s solution, 5% fructose solution, 5% dextrose solution.
Do not mix with heparin (risk of precipitation).
Food products, antacids containing Al3 +, Ca2 +, Mg2 + or Fe salts, reduce the absorption of ofloxacin, forming insoluble complexes (the time interval between administration of these drugs must be at least 2 hours).
Overdose
Symptoms: dizziness, confusion, lethargy, disorientation, drowsiness, vomiting.
Treatment: gastric lavage, symptomatic therapy.
pharmachologic effect
Pharmacological group:
The antimicrobial agent – fluoroquinolone.
Pharmacodynamics:
The antimicrobial agent of a broad spectrum fluoroquinolone acts on the bacterial enzyme DNA gyrase, and thus providing supercoiling stability of bacterial DNA (DNA destabilization chains leads to their destruction). It has a bactericidal effect.
The antimicrobial spectrum includes Gram-positive aerobes: Staphylococcus aureus (methicillin sensitive), Staphylococcus epidermidis (methicillin sensitive), Staphylococcus saprophyticus, Streptococcus pneumoniae (penicillin sensitive), Streptococcus pyogenes.
Gram-negative aerobes: Acinetobacter calcoaceticus, Bordetella pertussis, Citrobacter freundii, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Haemophilus ducreyi, Haemophilus influenzae, Klebsiella oxytoca, Moraxella catarrhalis, Morganella morganii, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris , Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa (quickly develop resistance), Serratia marcescens.
Anaerobes: Clostridium perfringens.
Others: Chlamydia trachomatis, Chlamydia pneumoniae, Gardnerella vaginalis, Legionella pneumophlia, Mycoplasma hominis, Mycoplasma pneumoniae, Ureaplasma urealyticum.
In most cases insensitive: Nocardia asteroides, anaerobic bacteria (including Bacteroides spp, Peptococcus spp, Peptostreptococcus spp, Eubacterium spp, Fusobacterium spp, Clostridium difficile…..), Enterococcus spp, most Streptococcus spp, no.. It acts on Treponema pallidum.
Pharmacokinetics:
Absorption after oral administration is fast and complete (95%). Bioavailability – over 96%, bond with plasma proteins – 25%, TCmax orally – 1-2 h, Cmax after receiving a dose of 100, 300 and 600 mg of 1, 3, 4 and 6.9 mg / l, respectively, and depends on the dose: after a single dose of 200 and 400 mg it is 2.5 and 5 .mu.g / ml, respectively. Food can slow down the absorption, but has no significant effect on bioavailability.
The apparent volume of distribution – 100 l. Distribution: cells (leukocytes, alveolar macrophages), skin, soft tissues, bones, abdominal organs and pelvis, respiratory system, urine, saliva, bile, prostate secretion; well it penetrates the blood-brain barrier, the placental barrier, is secreted in human milk. Penetrates into CSF ​​(14-60%).
It is metabolized in the liver (about 5%) to give the N-oxide and ofloxacin dimetilofloksatsina. T1 / 2 – 4.5-7 h (regardless of dose). Excreted by the kidneys – 75-90% (in unmodified form), about 4% – with bile. Extrarenal clearance – less than 20%.
After a single application of 200 mg in the urine is detected for 20-24 hours. When removal becomes slow renal / hepatic failure. Not accumulates. In hemodialysis removes 10-30% of the formulation.
Pregnancy and breast-feeding
Pregnancy.
Ofloxacin should not be used during pregnancy (see. Section “Contraindications”).
During breastfeeding.
Since ofloxacin is excreted into breast milk, in view of the risk to the baby, breastfeeding women should not take ofloxacin, or, if necessary, of its use, should stop breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
From the digestive system: gastralgia, loss of appetite, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, increased activity “liver” enzymes, hyperbilirubinemia, cholestatic jaundice, pseudomembranous colitis, mucosal dryness of the mouth, throat.
From the nervous system: headache, dizziness, lack of movement, tremors, convulsions, numbness and paresthesias of extremities, intense dreams, “nightmarish” dream, psychotic reactions, anxiety, state of arousal, phobias, depression, confusion, hallucinations, increased intracranial pressure , insomnia, nervousness.
On the part of the musculoskeletal system: tendonitis, myalgias, arthralgias, tenosynovitis, tendon rupture, pain in the limbs.
From the sensory organs: impaired color vision, diplopia, disturbances of taste, smell, hearing and balance.
From the CCC: tachycardia, increase or decrease in blood pressure, collapse (at / in the introduction, with a sharp decrease in blood pressure introduction is stopped).
Allergic reactions: skin rash, pruritus, urticaria, hypersensitivity pneumonitis, allergic nephritis, eosinophilia, fever, angioneurotic edema, bronchospasm; erythema multiforme (including Stevens-Johnson syndrome) and toxic epidermal necrolysis (Lyell’s syndrome), photosensitivity, vasculitis, anaphylaxis, pruritus external genitalia in women.
For the skin: petechial hemorrhages (petechiae), hemorrhagic bullous dermatitis, maculopapular rash with a crust, showing vascular involvement (vasculitis).
From the side of hematopoiesis: leukopenia, agranulocytosis, anemia (including aplastic and haemolytic), thrombocytopenia, pancytopenia.
From the urinary system: acute interstitial nephritis, renal failure, hypercreatininemia, increasing concentrations of urea, dysuria, urinary retention.
Other: intestinal dysbiosis, superinfection, hypoglycemia (in patients with diabetes), vaginitis, breast pain, fatigue, asthenia, fatigue, vaginal discharge, nasal bleeding, thirst, weight loss.
Local reactions: pain, redness at the injection site, thrombophlebitis (at / in the introduction).
special instructions
It is not the drug of choice for pneumonia caused by pneumococcus. Not indicated in the treatment of acute tonsillitis.
Not recommended exposed to sunlight, irradiation with UV light (mercury quartz lamp, solarium).
For the prevention of giperkontsentratsii urine and subsequent crystalluria during treatment is recommended adequate hydration.
In case of side effects of the central nervous system, allergy, pseudomembranous colitis requires removal of the drug. If pseudomembranous colitis, confirmed by colonoscopy and / or histologically demonstrated oral vancomycin and metronidazole.
Rarely occurring tendonitis can lead to rupture of the tendon (predominantly Achilles tendon), especially in elderly patients. In the event of signs of tendinitis should stop treatment immediately, to produce immobilization of the Achilles tendon and consult a podiatrist.
During treatment can not use ethanol.
In applying the drug to women is not recommended to use tampons because of the increased risk of developing thrush.
The treatment possible worsening of myasthenia gravis, frequent attacks of porphyria in predisposed patients.
May lead to false negative results when bacteriological diagnosis of tuberculosis (prevents separation Mycobacterium tuberculosis).
In patients with impaired liver or kidney function requires monitoring of ofloxacin concentration in plasma. In severe renal and hepatic impairment increases the risk of toxic effects (reducing required dose adjustment).
During the period of treatment must be careful when driving and other lesson. Potentially hazardous activities that require high concentration and psychomotor speed reactions.
Storage conditions
Store at a temperature not higher than 25 ° C, protected from light.
Keep out of the reach of children.
Dosing and Administration
Inside. ofloxacin dose and duration of treatment depends on the severity and type of infection and the general state of the patient’s renal function.
Adult patients with normal renal function (creatinine clearance greater than 50 mL / min) The preparation is administered in a daily dose of 400 mg, divided in 2 divided doses (every 12 hours).
The daily dose may be increased to 600-800 mg in severe infections or in treating patients with overweight.
In uncomplicated infections drug lower urinary tract is administered in a dose of 200 mg per day for 3-5 days.
In gonorrhea administered 400 mg once.
The daily dose of 400 mg can be administered in one administration, preferably in the morning. The daily dose of more than 400 mg should be divided into 2 doses with equal time intervals.
The tablets should be swallowed whole, squeezed with sufficient water. The drug can be taken both before and during the meal. It is necessary to avoid the simultaneous administration of the drug with antacids.
Special patient groups.
Elderly patients.
The age of patients does not require a dose adjustment of ofloxacin. However, when using the drug in elderly patients should focus on renal function, as in the case of its reduction and may require appropriate correction of dosing regimen.
Patients with impaired liver function.
If violations of liver function is recommended not to exceed a daily dose of 400 mg of ofloxacin.
Patients with impaired renal function.
In renal dysfunction, the recommended dosing regimen depending on creatinine clearance:
Creatinine clearance, 50-20 ml / min, the dose is 100-200 mg-1 times a day (every 24 hours)
Creatinine clearance, less than 20 ml / min is 100 mg-1 times a day (every 24 hrs) or 200 mg every other day (every 48 hours).
Gemodializ- dose is 100 mg-1 times a day (every 24 hrs) or 200 mg every other day (every 48 hours.).
Peritoneal dialysis, the dose is 100 mg to 1 times a day (every 24 hrs) or 200 mg every other day (every 48 hours).
The duration of treatment.
The duration of treatment depends on the severity of the disease. Like any antimicrobial therapy, ofloxacin treatment should continue for at least 48-72 hours after normalization of body temperature or in the presence confirmation bacterial eradication.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

TEVA

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