Ofloxacin 200mg Domesco Treatment of pneumonia, bronchitis (2 blisters x 10 tablets)

ATC code: J01M AO1.

Ofloxacin is a synthetic antibiotic of Quinolon family in the fluoroquinolone group like ciprofloxacin, but ofloxacin when oral is higher than (over 95%).

Ofloxacin has a wide antibacterial spectrum including:

Sensitive strains: Gram -positive bacteria: Bacillus anthracis, Staphylococcus sensitive to methicilin. Gram -negative bacteria: Acinetobacter, mainly acinetobacter baumannii, Branhamella Catatrhalis, Borderella Pertussis, Campylobacter, Citrobacter Freundii, Entobacter Clox, Escherichia Coli, Haemophilus Influenzae, Klebsiella Pneumonia Legionella, Morganella Morganii, Neisseria Pasteurella, Proteus Mirabilis, Proteus Vulgaris, Providencia, Pseudomonas Aeroginosa, Salmonella Serratia, Shigella, Vibrio, Yersinia.

Anaerobic bacteria: Mobiluncus, propionibacterium acnes.

Other bacteria: Mycoplasma Hominis.

Moderate sensitive strains: Gram -positive bacteria: corynebacterium, streptococcus, streptococcus pneumoniae. Other strains: Chlamydiae, Mycoplasma Pneumoniae, Ureaplasma Urealyticum.

Anti -drug strain: Gram -positive bacteria: Enterococcus, Listeria monocytogenes, Nocardia Asteroides, Staphylococcus resistant to methicilin.

Anaerobic bacteria: except Mobiluncus and propionibacterium acnes.

Mycobacterium is not typical: In vitro, ofloxacin are moderately active for some of them Mycobacterium (Mycobacterium tuberculosis, Mycobacterium Fortuitum, worse with mycobacterium kansasii and worse for Mycobacterium avium).

Anti-drugs can develop during treatment through mutations in the genes of chromosomes of DNA-Gyrase or Topoisomerase encoding bacteria or through active drug transportation from cells. The drug resistance has increased since the use of fluoroquinolon, especially for Pseudomonas and Staphylococcus, Clostridium Jejuni Salmonella, Neisseria Gonorrhoeae and S. Pneumoniae.

Ofloxacin has a strong bactericidal effect. The mechanism of action is not fully known. Like other antibacterial quinolones, Ofloxacin inhibits DNA-GYRASE of many Gram-negative bacteria and inhibits Topoisomerase IV of many Gram-positive bacteria that are essential enzymes in the double, code and DNA editing process of bacteria.

pharmacokinetics

ofloxacin absorbs fast and good through the digestive tract. Oral bioavailability is about 100% and has peak concentration in plasma 3-4 micrograms/ml, 1 -2 hours after taking 1 dose of 400 mg. Absorption is slowed upon food but the absorption rate is not affected.

Semi -selling time in plasma is 5 - 8 hours; In the case of renal failure, sometimes lasts 15-60 hours depending on the degree of renal failure, then the dose adjustment.

Ofloxacin is widely distributed into body fluids, including cerebrospinal fluids and well penetrated into tissues. About 25 % of plasma drug concentration attached to plasma proteins. There is relatively high concentration in bile.

When using single dose, less than 10 % ofloxacin is converted into desmethyl-massoxacin and ofloxacin n-oxyd. Desmethyl-Ofloxacin has an average antibacterial effect. However, the kidney is still the main place to eliminate ofloxacin, the drug is filtered through the glomerular and excreted through the renal tubules. Less than 5 % of the drug is excreted in the form of metabolism in urine; 4 - 8 % of the drug excreted through feces. Only a small amount ofloxacin is eliminated by hemolysis.

In the elderly after taking a single dose of 200 mg, the selling time is prolonged but does not change many peak concentrations in plasma.

Instructions on how to handle ADR: Stop treatment if there are mental, nervous and hypersensitivity reactions (severe rash).

Be cautious when using

serious harmful reactions are likely to not recover and cause disabilities, including tendonitis, tendon breakdown, peripheral neuropathy and adverse effects on the central nervous system.

Fluoroquinolon antibiotics are associated with serious harmful reactions that can cause disabilities and non -recovery on different organs of the body. These reactions may appear simultaneously on the same patient. Harmful reactions are often recorded including tendonitis, tendon, joint pain, muscle pain, peripheral neuropathy and adverse effects on the central nervous system (hallucinations, anxiety, depression, insomnia, severe headaches and confusion). These reactions may occur within hours to a few weeks after using the drug. Patients at any age or no risk factors that exist before may have these harmful reactions.

Stop using the drug as soon as there are signs or first symptoms of any serious harmful reactions. In addition, avoid using Fluoroquinolon antibiotics for patients who have had serious reactions related to fluoroquinolon.

S. Aureus bacteria resistant to methicillin (MRSA): very resistant to Fluoroquinolon, including ofloxacin. So ofloxacin is not recommended for the treatment of bacterial infections or doubts by MRSA unless the test results confirm the sensitivity of bacteria with ofloxacin (and antibacterial drugs that are recommended to treat MRSA infections is considered inappropriate).

e. Coli resistant to fluoroquinolon: The most common pathogens related to urinary tract infections. The treating doctor should pay attention to the resistance ratio of each locality of E. coli with fluoroquinolon.

Serious undesirable reactions on the skin: Cases of serious reactions include Stevens-Johnson syndrome or poisoned epidermal necrosis reported when treated with ofloxacin. Patients should immediately contact the doctor before continuing treatment with ofloxacin if the reaction on the skin and/or mucosa appears.

tendonitis and tendon: rare tendonitis occurs. Most often occurs in the heel tendon (Achille) and can lead to tendons. Tendonitis and tendons, sometimes occur in parallel, may occur within 48 hours at the beginning of treatment with ofloxacin and a few months after the stopped treatment has been reported. The risk of tendon and tendonitis increases in patients over 60 years old and in patients using corticosteroids. Daily dose should be adjusted in elderly patients based on creatinine clearance. It is necessary to closely monitor these patients if prescribing Ofloxacin. Patients should consult a doctor if there are symptoms of tendonitis. If suspected of tendonitis, it is necessary to immediately stop treatment with ofloxacin and take appropriate management measures (for example, no movement) (see the contraindications and unwanted effects of the drug).

Hypersensitivity reactions: Ofloxacin can cause serious hypersensitivity reactions that can be fatal (such as anaphylactic reaction and anaphylactic shock), sometimes occurring after the dose of the rash. Patients should stop treating immediately and contact the treating doctor for appropriate treatment.

Clostridium variety: diarrhea, especially severe, prolonged or bloody diarrhea, occurs during or after treatment with ofloxacin (including a few weeks after treatment), may be symptoms of diarrhea related to Clostridium difficile (CDAD). CDAD has a level of mild to life -threatening, the most severe form of fake colitis (see the unwanted effect of the drug). Therefore, it is necessary to consider the diagnosis of CDAD in patients with severe diarrhea during or after treatment with ofloxacin. If suspected or have identified CDAD, it is necessary to stop ofloxacin immediately and take appropriate treatment. Contraindications for drug use reduces bowel motility in this case.

Patients with congenital convulsions: Quinolones can reduce seizures and may cause seizures. Ofloxacin is contraindicated in patients with a history of epilepsy or patients with congenital convulsions (including people with previous central nervous system lesions, simultaneous treatment with fenbufen and similar nonsteroidal anti -inflammatory drugs (NSAIDs) or with drugs that reduce brain convulsions such as theophyllin.

In case of seizures, should stop treatment with ofloxacin.

Patients with renal impairment: Because ofloxacin is excreted mainly through the kidneys, the dose adjustment should be adjusted in patients with renal impairment.

Patients with a history of mental disorders: Mental reactions have been reported in patients using fluoroquinolon. In some cases, there is a suicide or self -dangerous behavior including trying to commit suicide, sometimes after using a single dose.

In this case, Ofloxacin should be discontinued and implemented appropriate measures.

Be cautious when taking ofloxacin in patients with a history of mental disorders or mental patients.

Patients with hepatic impairment: Caution should be used for ofloxacin in patients with liver failure, liver damage may appear. There have been reports of acute hepatitis that can lead to liver failure (including death). Ofloxacin should be discontinued if the patient has manifestations and symptoms showing that progressive liver disease such as anorexia, jaundice, dark urine, itching or bloating.

Patients who are being treated with vitamin K anti -vitamin: Due to the ability to increase blood clotting time (PT/INR) and/or bleeding in patients treated with Ofloxacin with anti -vitamin K (such as warfarin), need to monitor blood clotting tests in patients with simultaneous use of these two drugs.

Academy of myasthenia gravis: fluoroquinolon, including ofloxacin, has a nervous blocking effect and can worsen muscle weakness in patients with myasthenia gravis. There has been a serious reaction report, including death and respiratory support requirements,
is related to the use of fluoroquinolon in patients with myasthenia gravis. Ofloxacin is not recommended in patients with a history of myriadia.

Sino: The use of ofloxacin, especially if prolonged, can lead to excessive growth of non -sensitive bacteria, especially Enteracci, some drug -resistant bacteria or Candida. If the superinfection occurs during treatment, the appropriate treatment is required.

Light sensitivity prevention: There has been an Ofloxacin report that is sensitive to light. It is recommended that patients should not be exposed to strong sunlight or with artificial UV (such as ultraviolet lights, artificial rays) when not needed during treatment and within 48 hours after stopping treatment to prevent light sensitivity.

extends the QT interval: The case is very rare, extending the QT distance reported in patients using fluoroquinolon. Should be cautious when taking ofloxacin in patients with risk factors that extend about QT such as: