Ofloxacin Sanofi pills 200mg, 10pcs

Composition

Active ingredient:  ofloxacin-200.00 mg;

excipients:  core: lactose monohydrate-95.20 mg, corn starch-47.60 mg, povidone 25-12.00 mg, crospovidone-20.00 mg, poloxamer-0.20 mg, magnesium stearate-8.00 mg, talc – 4.00 mg; film shell:  hypromelose 2910/5 – 9.42 mg, macrogol 6000-0.53 mg, talc-0.70 mg, titanium dioxide-2.35 mg

Pharmacological action

Ofloxacin DS is a broad-spectrum antimicrobial agent from the group of fluoroquinolones, which acts on the bacterial enzyme DNA gyrase, which provides supercoiling and, thus, stability of bacterial DNA (destabilization of DNA chains leads to their death). It has a bactericidal effect. It is active against beta-lactamase-producing microorganisms and fast-growing atypical mycobacteria. Sensitive: Staphylococcus aureus, Staphylococcus epidermidis, Neisseria gonorrhoeae, Neisseria meningitidis, Escherichia coli, Citrobacter, Klebsiella spp. (including Klebsiella pneumonia), Enterobacter spp., Hafnia, Proteus spp. (including Proteus mirabilis, Proteus vulgaris – indole-positive and indole-negative), Salmonella spp., Shigella spp. (including Shigella sonnei), Yersinia enterocolitica, CamPylobacter jejuni, Aeromonas hydrophila, Plesiomonas aeruginosa, Vibrio cholerae, Vibrio parahaemolyticus, Haemophilus influenzae, Chlamydia spp., Legionella spp., Serratia spp., Providencia spp., Haemophilus ducreyi, Bordetella parapertussis, Bordetella pertussis, Moraxella catarrhalis, Propionibacterium acnes, Staphylococcus spp., Brucella spp. Enterococcus faecalis, Streptococcus pyogenes, pneumoniae and viridans, Serratio marcescens, Pseudomonas aeruginosa, Acinetobacter, Mycoplasma hominis and pneumoniae, Mycobacterium tuberculosis, as well as Mycobacterium fortuim, Ureaplasma urealyticum, Clostridium perfringens, Corynebacterium spp., Helicobacter pylori, Listeria monocytogenes, Gardnerella vaginalis. In most cases, they are insensitive: Nocardia asteroides, anaerobic bacteria (for example, Bacteroides spp., Peptococcus spp., Peptostreptococcus spp., Eubacterium spp., Fusobacterium spp., Clostridium difficile). It does not work on Treponema pallidu.

Indications

Infections of the respiratory tract (bronchitis, pneumonia), ENT organs (sinusitis, pharyngitis, otitis media, laryngitis), skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal cavity and biliary tract (except for bacterial enteritis), kidneys (pyelonephritis), urinary tract (cystitis, urethritis), pelvic organs (endometritis, salpingitis, oophoritis, cervicitis, parametritis, prostatitis), genitals (colpitis, orchitis, epididymitis), gonorrhea, chlamydia; meningitis; prevention of infections in patients with impaired immune status (including neutropenia).

Contraindications

Hypersensitivity, glucose-6-phosphate dehydrogenase deficiency, epilepsy (including in the anamnesis), reduced seizure threshold (including after a traumatic brain injury, stroke, or inflammatory processes in the central nervous system); age up to 18 years (until skeletal growth is completed), pregnancy, lactation. With caution-atherosclerosis of the cerebral vessels, cerebral circulatory disorders (in the anamnesis), chronic renal failure, organic lesions of the central nervous system.

Side effects

The information presented below is based on data obtained from clinical trials and extensive post-marketing experience with the drug. Determination of the frequency of adverse reactions according to the WHO classification: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10 000, <1/1000), very rare (Infectious and parasitic diseases: infrequently-fungal infection, resistance of pathogenic microorganisms. From the blood and lymphatic system: very rarely – anemia, hemolytic anemia, leukopenia, eosinophilia, thrombocytopenia; frequency unknown-agranulocytosis, pancytopenia, suppression of bone marrow hematopoiesis. From the immune system: rarely – anaphylactic reaction, anaphylactoid reaction, angioedema; very rarely-anaphylactic shock, anaphylactoid shock. From the side of metabolism and nutrition: rarely – anorexia; frequency unknown-hyperglycemia, hypoglycemia, hypoglycemic coma (in patients with diabetes mellitus receiving hypoglycemic drugs). Mental disorders: infrequently-agitation, sleep disturbance, insomnia; rarely-psychotic disorders (hallucinations), anxiety, nervousness, confusion, nightmares, depression; frequency unknown-psychotic disorders and depression with self-destructive behavior, including suicidal thoughts and suicide attempts. From the nervous system: infrequently-dizziness, headache; rarely-drowsiness, paresthesia, dysgeusia (taste perception disorder), parosmia (olfactory disorder); very rarely – peripheral sensory neuropathy, peripheral sensory-motor neuropathy, convulsions, extrapyramidal symptoms, including tremor, and other disorders of muscle coordination; frequency unknown – ageusia (loss of the ability to taste), increased intracranial pressure. From the side of the organ of vision: infrequently-irritation of the mucous membrane of the eye, conjunctivitis; rarely-visual impairment (diplopia, color perception disorder); frequency unknown – uveitis. From the side of the organs of hearing and labyrinth disorders: infrequently-vertigo; very rarely-ringing or tinnitus, hearing loss. Cardiac disorders: rarely-tachycardia; infrequently-palpitation sensation; frequency unknown-ventricular arrhythmia of the “pirouette” type (observed mainly in patients with risk factors for prolongation of the QT interval), prolongation of the QT interval on the ECG. Vascular disorders: rarely-increased blood pressure, decreased blood pressure. From the respiratory system: infrequently-cough, nasopharyngitis; rarely – shortness of breath, bronchospasm; frequency unknown-allergic pneumonitis, severe shortness of breath. From the digestive system: infrequently-abdominal pain, diarrhea, nausea, vomiting, loss of appetite; rarely-enterocolitis (sometimes hemorrhagic); very rarely – pseudomembranous colitis; frequency unknown-dyspepsia, flatulence, constipation, pancreatitis, stomatitis. From the liver and biliary tract: rarely-increased activity of hepatic transaminases (ACT, ALT, LDH, GGT and/or alkaline phosphatase) and / or bilirubin concentrations; very rarely – cholestatic jaundice, frequency unknown – hepatitis (may be severe) with the use of ofloxacin (mainly in patients with impaired liver function). Cases of severe hepatic insufficiency, including acute hepatic insufficiency, have been reported, sometimes with fatal outcomes. From the skin and subcutaneous tissues: infrequently – rash, pruritus; rarely – urticaria, “hot flashes” of blood to the skin, increased sweating, pustular rash; very rarely – erythema multiforme, toxic epidermal necrolysis, photosensitization reaction, drug rash, vascular purpura, vasculitis (which can lead in some cases to skin necrosis); frequency unknown – Stevens-Johnson syndrome; acute generalized exanthematous pustulosis, exfoliative dermatitis. Musculoskeletal and connective tissue disorders: rarely-tendinitis; very rarely – arthralgia, myalgia, tendon rupture (Achilles tendon, as with other fluoroquinolones, this side effect may occur within 48 hours after the start of treatment and may be bilateral); frequency unknown – rhabdomyolysis and/or myopathy, muscle weakness (which may be especially important in patients with pseudoparalytic myasthenia gravis]), muscle tear, muscle tear, ligament tear, arthritis. From the urinary system: rarely-increased serum creatinine; very rarely-acute renal failure; frequency unknown-acute interstitial nephritis, increased blood urea concentration. Common disorders: frequency unknown-asthenia, fever, back pain, chest pain, and limb pain. Congenital, hereditary and genetic disorders: frequency unknown-exacerbation of porphyria in patients with porphyria.

Interaction

Antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate, or preparations containing zinc or iron

Antacids containing aluminum hydroxide, sucralfate, magnesium hydroxide, aluminum phosphate, or preparations containing zinc or iron reduce the absorption of ofloxacin, forming insoluble complexes. When using the above medications and ofloxacin, an approximately two-hour interval should be observed between their administration.

Theophylline, fenbufen or similar nonsteroidal anti-inflammatory drugs

No pharmacokinetic interactions of ofloxacin with theophylline have been identified in clinical trials. However, a marked decrease in the threshold of convulsive brain activity can be observed with the simultaneous use of quinolones with theophylline, NSAIDs or other drugs that reduce the threshold of convulsive brain activity (including fenbufen).

Drugs that cause prolongation of the QT interval

Ofloxacin, like other fluoroquinolones, should be used with caution in patients receiving drugs that cause prolongation of the QT interval on the ECG (for example, class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, neuroleptics).

Vitamin K antagonists (coumarin derivatives, including warfarin)

Increased values of prothrombin time/international normalized ratio and / or the development of bleeding (including severe) were observed in patients with the combined use of ofloxacin and vitamin K antagonists (for example, warfarin). With the simultaneous use of vitamin K antagonists and ofloxacin, it is necessary to monitor the parameters of the blood coagulation system.

Glibenclamide

Ofloxacin can cause a slight increase in the concentration of glibenclamide in the blood plasma when they are used together, so for patients receiving both ofloxacin and glibenclamide, careful monitoring of blood glucose concentrations is recommended.

Other oral hypoglycemic agents and insulin

Ofloxacin increases the risk of hypoglycemia, and more careful monitoring of blood glucose levels is required.

Probenecid, cimetidine, furosemide and methotrexate

When using quinolones together with drugs that are excreted from the body by renal tubular secretion (such as probenecid, cimetidine, furosemide, methotrexate), there may be a mutual slowing of excretion and an increase in serum concentrations (especially in the case of high doses).

Glucocorticosteroids

When used concomitantly with glucocorticosteroids, the risk of tendon rupture increases, especially in elderly patients.

Drugs that alkalize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate)

Concomitant use of ofloxacin with drugs that alkalize urine (carbonic anhydrase inhibitors, citrates, sodium bicarbonate) increases the risk of crystalluria and nephrotoxic effects.

How to take, course of use and dosage

Inside. Doses are selected individually depending on the location and severity of the infection, as well as the sensitivity of microorganisms, the general condition of the patient, and liver and kidney function. Adults – 200-800 mg per day, the course of treatment is 7-10 days, the frequency of use is 2 times a day. A dose of up to 400 mg per day can be administered in 1 dose, preferably in the morning. For gonorrhea – 400 mg once. In patients with impaired renal function (with a creatinine clearance of 50-20 ml / min), a single dose should be 50% of the average dose with a multiplicity of 2 times a day, or a full single dose should be administered 1 time a day. If creatinine clearance is less than 20 ml / min, a single dose is 200 mg, then 100 mg per day every other day. For hemodialysis and peritoneal dialysis-100 mg every 24 hours. The maximum daily dose for hepatic insufficiency is 400 mg per day. Tablets are taken whole, washed down with water before or during meals. The duration of the course of treatment is determined by the sensitivity of the pathogen and the clinical picture; treatment should be continued for at least 3 more days after the disappearance of symptoms of the disease and full normalization of temperature. In the treatment of salmonellosis, the course of treatment is 7-8 days, in uncomplicated lower urinary tract infections, the course of treatment is 3-5 days.

Overdose

Symptoms: the most important symptoms of overdose are symptoms from the central nervous system (such as dizziness, confusion, disorientation, convulsions), prolongation of the QT interval, as well as symptoms from the gastrointestinal tract, such as nausea and erosion on the mucous membranes.

Treatment: gastric lavage, use of activated charcoal and other adsorbents, symptomatic therapy. Antacids can be used to protect the gastric mucosa. ECG monitoring should always be performed due to possible prolongation of the QT interval. Fractions of ofloxacin can be removed from the body by hemodialysis. There is no specific antidote.

Active ingredient

Ofloxacin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Inflammation of the lungs, Otitis media, Inflammation of the female genital organs, Skin infections, Inflammatory eye diseases, Bronchitis, Urethritis, Urinary tract infections, Osteomyelitis, Sinusitis