Product Name: Ofloxacin
Common Brand Names: Ocuflox; Floxin
Pharmaceutical Category: Eye Care
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There is an additional general information about this medication active ingredient ofloxacin:
Ofloxacin is an antimicrobial agents of broad-spectrum action type from fluoroquinolone group. Bactericidal action of ofloxacin is due to blockage of the enzyme DNA gyrase in bacterial cells. This medication is highly active against most of gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitidis, Mycoplasma spp., Legionella pneumophila, Acinetobacter spp., and Chlamydia spp.
Ofloxacin is active against some gram-positive bacteria (including Staphylococcus spp., Streptococcus spp., especially beta-hemolytic streptococci).
Enterococcus faecalis, Streptococcus pneumoniae, Pseudomonas spp. are moderately susceptible to ofloxacin.
Anaerobic bacteria (except Bacteroides ureolyticus) are insensitive to ofloxacin.
This drug is resistant to beta-lactamases.
After oral administration Ofloxacin is rapidly and completely absorbed from the gastrointestinal tract. Ingestion has a little effect on the extent of absorption but may slow its speed. Cmax plasma levels reached in 2 hours.
The protein binding is 25%. Ofloxacin is widely distributed in tissues and body fluids (organs of urinary system, reproductive organs, prostate, lung, ENT organs, gall bladder, bone, skin).
This medicine is excreted in the urine in unchanged form (about 80% in 24 h). A small portion of the active substance (4%) is excreted in the feces. T1/2 is 6 h.
Why is Ofloxacin prescribed?
Infectious-inflammatory diseases caused by microorganisms sensitive to ofloxacin, including: diseases of the lower respiratory tract, ear, nose, throat, skin, soft tissues, bones, joints, infectious and inflammatory diseases of the abdominal organs (except bacterial enteritis) and pelvic infection, kidney and urinary tract, prostatitis, gonorrhea.
Dosage and administration
Dosing regimen of Ofloxacin is individual. Daily dose of 200-800 mg, the multiplicity of application 2 times / day. For patients with impaired renal function (creatinine clearance 20-50 ml / min), the first dose is 200 mg, then 100 mg every 24 hours. When CC is less than 20 ml / min, the first dose is 200 mg, then 100 mg every 48 hours.
Ofloxacin side effects, adverse reactions
Digestive system: nausea, vomiting, diarrhea, abdominal pain and cramps, appetite loss, dry mouth, flatulence, gastrointestinal dysfunction, constipation; rarely - liver damage, liver necrosis, jaundice, hepatitis, intestinal perforation, pseudomembranous colitis, bleeding from the gastrointestinal tract, disorders of the oral mucosa, heartburn, elevated liver enzymes, including GGT and LDH, increased serum bilirubin.
CNS and peripheral nervous system: insomnia, dizziness, fatigue, drowsiness, nervousness; rarely - convulsions, anxiety, cognitive changes, depression, abnormal dreams, euphoria, hallucinations, paresthesia, syncope, tremor, confusion, nystagmus, suicidal thoughts or attempts, disorientation, psychotic reactions, paranoia, phobia, agitation, aggressiveness, emotional instability, peripheral neuropathy, ataxia, incoordination, exacerbation of extrapyramidal disorders, speech disorder.
Allergic reactions: skin rash, itching, rarely - angioedema, urticaria, vasculitis, allergic pneumonitis, anaphylactic shock, erythema multiforme, Stevens-Johnson syndrome, erythema nodosum, exfoliative dermatitis, toxic epidermal necrolysis, conjunctivitis.
Sexual system: an itch on the external genitalia in women, vaginitis, vaginal discharge; rare - burning, irritation, pain and rash in the genital area of women, dysmenorrhea, menorrhagia, metrorrhagia, vaginal candidiasis.
Cardiovascular system: rarely - heart failure, edema, hypertension, hypotension, palpitation, vasodilatation, cerebral thrombosis, pulmonary edema, and tachycardia.
Urinary system: rarely - dysuria, urinary frequency, urinary retention, anuria, polyuria formation of kidney stones, kidney failure, nephritis, hematuria, albuminuria, candiduria.
Musculoskeletal system: rarely - arthralgia, myalgia, tendonitis, muscle weakness, exacerbation of myasthenia gravis.
Metabolism: rarely - thirst, weight loss, hyper- or hypoglycemia (especially in patients with diabetes mellitus receiving insulin or oral hypoglycemic agents), acidosis, increase in serum triglycerides, cholesterol, potassium.
Respiratory system: rarely - cough, runny nose, respiratory failure, dyspnea, bronchospasm, stridor.
Sensory organs: rarely - hearing loss, tinnit, diplopia, nystagmus, impaired clarity of vision, disturbances of taste, smell, photophobia.
Dermatological reactions: rarely - photosensitivity, hyperpigmentation, vesicle-bullous eruption.
Hematopoietic system: rarely - anemia, hemorrhage, pancytopenia, agranulocytosis, leukopenia, reversible suppression of bone marrow hematopoiesis, thrombocytopenia, thrombocytopenic purpura, petechiae, ecchymosis, increased prothrombin time.
Other: chest pain, sore throat, fever, body aches, rarely - fatigue, chills, malaise, epistaxis, increased sweating.
Pregnancy, lactation, childhood and adolescence to 18 years, increased sensitivity to ofloxacin or other quinolone derivatives.
Using during pregnancy and breastfeeding
Ofloxacin is contraindicated during pregnancy and lactation.
Category effects on the fetus by FDA - C.
Use with caution in patients with impaired renal function and liver.
During the period of treatment required to conduct monitoring of blood glucose. Long-term therapy is necessary to periodically monitor the kidney function, liver and peripheral blood picture.
When using Ofloxacin it should be ensure adequate hydration of the body, the patient should be subjected to ultraviolet irradiation.
In experimental studies the mutagenic potential was not been identified. Long-term studies to determine the carcinogenicity of ofloxacin were not conducted.
Safety and efficacy in children and adolescents under the age of 18 is not defined.
Use with caution in patients whose activities are connected with the necessity of high concentration of attention and quickness of psychomotor reactions.
Ofloxacin drug interactions
Simultaneous administration of Ofloxacin with:
antacids containing calcium, magnesium or aluminum, with sucralfate, with preparations containing two-and trivalent cations, such as iron, or multivitamins containing zinc it may be in breach absorption of quinolones, resulting in a decrease in their concentration in the body. These medications should not be used for 2 hours before or within 2 hours after taking ofloxacin.
NSAIDs increases the risk of stimulating effect on the central nervous system and seizures.
theophylline may increase its concentration in blood plasma (including the equilibrium state), increasing half-life. This increases the risk of adverse reactions associated with the action of theophylline.
beta-lactam antibiotics, aminoglycosides and metronidazole there were observed additive interaction.
Ofloxacin in case of emergency / overdose
Symptoms: drowsiness, nausea, vomiting, dizziness, disorientation, lethargy, confusion.
Treatment: gastric lavage, maintenance of vital functions.