Aciflox200 mg

Aciflox 200 mg is indicated for the treatment of adults (≥18 years of age) with the following infections caused by susceptible strains of the designated microorganisms: Community-acquired pneumonia (CAP) caused by Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae , or Streptococcus pneumoniae ... Read moreAciflox 200 mg is indicated for the treatment of adults (≥18 years of age) with the following infections caused by susceptible strains of the designated microorganisms: Community-acquired pneumonia (CAP) caused by Chlamydia pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae , or Streptococcus pneumoniae Acute bacterial exacerbations of chronic bronchitis (ABECB) caused by Chlamydia pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Staphylococcus aureus , or Streptococcus pneumoniae. It is also indicated for- Chronic Obstructive Pulmonary Disease (COPD) Acute Maxillary Sinusitis (AMS) Urinary tract infections including gonococcal and nongonococcal urethritis, chancroid and other sexually transmitted diseases. Bacterial prostatitis. Bacterial diarrhoea Osteomyelitis Other uses include treatment of tuberculosis in combination with rifampicinand isoniazid, treatment of leprosy in combination with standard drugs.

4-Quinolone preparations

Aciflox 200 mg is a synthetic, broad-spectrum antibacterial agent from the difluoroquinolone family. It has been reported to be more active in vitro than ciprofloxacin against some organisms, including staphylococci and Mycobacteria, and has a much longer plasma half-life (16 hours).Aciflox 200 mg inhibits the supercoiling activity of DNA gyrase which is an enzyme essential for DNA replication thus promoting the breakage of DNA structures. It has activity against S. pneumoniae, S. aureus, H. influenzae, K. pneumoniae, M. catarrhalis and Mycobacterium spp.

The recommended daily dose of Aciflox 200 mg‚ in patients with normal renal function is two 200 mg tablets taken on the first day as a loading dose. Thereafter, one 200 mg tablet should be taken every 24 hours for a total of 10 days of therapy (11 tablets). The recommended daily dose of Aciflox 200 mg‚ in patients with renal impairment (creatinine clearance <50 mL/min) is two 200 mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 48 hours for a total of 9 days of therapy (6 tablets).

Aciflox 200 mg can be taken with or without food.

Aluminium and Magnesium cations in antacids and sucralfate form chelation complexes with Aciflox 200 mg. Concomitant use with medications known to produce an increase in the QTc interval and/or Torsade de pointes (e.g., terfenadine). Aciflox 200 mg does not interact with theophylline or caffeine, nor with warfarin or cimetidine. Probenecid does not alter the pharmacokinetics of Aciflox 200 mg.

Aciflox 200 mg is contraindicated to the patients who are hypersensitive to any of its ingredient Pregnancy and lactation Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency History of Achilles tendinitis following the use of fluoroquinolones

Most of the side effects are mild to moderate in severity and transient in nature. The most frequently reported events with the recommended dosage were: Photosensitivity reaction, Diarrhea, Nausea, Headache, Dyspepsia, Dizziness, Insomnia, Abdominal pain, Pruritus, Taste perversion, QTc interval prolongation, Vomiting, Flatulence, Vasodilatation.

There are no adequate and well controlled studies in pregnant women. Aciflox 200 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Special warnings: Moderate to severe phototoxic reactions have occurred in patients exposed to direct or indirect sunlight or to artificial ultraviolet light (e.g., sunlamps) during or following treatment. Patients should be advised to discontinue Aciflox 200 mg therapy at the first signs or symptoms of a phototoxicity reaction such as: Sensation of skin burning Swelling Rash Itching Dermatitis Increases in the QTc interval. The safety and effectiveness of Aciflox 200 mg in children, adolescents (under the age of 18 years), pregnant women, and lactating women have not been established.Precaution- Adequate hydration of patients receiving Aciflox 200 mg should be maintained to prevent the formation of a highly concentrated urine. Administer Aciflox 200 mg with caution in the presence of renal insufficiency. Avoid the concomitant prescription of medications known to prolong the QTc interval, e.g., erythromycin, terfenadine etc. Excessive exposure to sunlight should be avoided.

To store this medicine it should be kept out of the reach of children. Stored away from heat and direct light. Stored below 30ºC.

Use in children: Safety and effectiveness have not been established in patients below the age of 18 years.

4-Quinolone preparations

Aciflox 200 mg is a broad-spectrum antibacterial agent that inhibit DNA gyrase and topoisomerase IV and kills many of the types of bacteria that can infect the breathing airways and lungs and has been shown in a large number of clinical trials to be safe and effective for the treatment of bacterial infections. It is found to be more effective in vitro than other fluoroquinolones against some gram positive organisms (Streptococcus pneumoniae, Staphylococcus aureous), Mycobacteria and Chlamydia spp.Absorption: Quinoflox‚ is well absorbed following oral administration with an absolute oral bioavailability of 92%. The mean maximum plasma Aciflox 200 mg concentration following a single 400-mg oral dose was approximately 1.3 (±0.2) µg/mL. The area under the curve following a single 400-mg oral dose was approximately 34 (±6.8) µg·hr/mL. Steady-state plasma concentration was achieved on the first day by giving a loading dose that was double the daily dose. Maximum plasma concentrations for a 200 mg dose were also achieved between 3 to 6 hours after administration with a mean of about 4 hours. Oral absorption of Aciflox 200 mg is unaffected by administration with milk or food, including high fat meals. Concurrent administration of antacids containing magnesium hydroxide and aluminium hydroxide reduces the oral bioavailability of Aciflox 200 mg by as much as 50%.Distribution: Upon reaching general circulation, Quinoflox‚ distributes well into the body, as reflected by the large mean steady-state volume of distribution (Vdss ) of 3.9 (±0.8) L/kg. Aciflox 200 mg exhibits low plasma protein binding in serum at about 45%. Aciflox 200 mg penetrates well into body fluids and tissues. Results of tissue and body fluid distribution studies demonstrated that oral administration of Aciflox 200 mg produces sustained concentrations and that Aciflox 200 mg concentrations in lower respiratory tract tissues and fluids generally exceed the corresponding plasma concentrations. The concentration of Aciflox 200 mg in respiratory tissues (pulmonary parenchyma, bronchial wall, and bronchial mucosa) at 2 to 6 hours following standard oral dosing was approximately 3 to 6 times greater than the corresponding concentration in plasma. Concentrations in these respiratory tissues increase at up to 24 hours following dosing. Aciflox 200 mg is also highly concentrated into alveolar macrophages compared to plasma. Mean pleural effusion to plasma concentration ratios were 0.34 and 0.69 at 4 and 20 hours postdose, respectively.Metabolism: Quinoflox‚ is metabolised by the liver, primarily by phase II glucuronidation, to form a glucuronide conjugate. Its metabolism does not utilize or interfere with cytochrome-mediated oxidation, in particular cytochrome P450.Excretion: The total body clearance and renal clearance of Quinoflox‚ were 11.4 (±3.5) and 1.5 (±0.5) L/hr, respectively. Aciflox 200 mg is excreted in both the feces (50%) and urine (50%). Approximately 10% of an orally administered dose is excreted in the urine as unchanged drug in patients with normal renal function.

There are no adequate and well controlled studies in pregnant women. Aciflox 200 mg should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Geriatric: The pharmacokinetics of Aciflox 200 mg‚ are not altered in the elderly with normal renal function.Paediatric: The pharmacokinetics of Aciflox 200 mg in paediatric subjects have not been studied.Gender: There are no gender differences in the pharmacokinetics of Aciflox 200 mg.Renal insufficiency: In patients with renal impairment (creatinine clearance <50 mL/min), the terminal elimination half-life of Aciflox 200 mg is lengthened. Single or multiple doses of Aciflox 200 mg in patients with varying degrees of renal impairment typically produce plasma concentrations that are twice those observed in subjects with normal renal function.Hepatic impairment: The pharmacokinetics of Aciflox 200 mg are not altered in patients with mild or moderate hepatic impairment without cholestasis.