Finus L

Finus L Uses, Dosage, Side Effects, Food Interaction and all others data.

Cefixime is a semi-synthetic, broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic, kills bacteria by interfering in the synthesis of the bacterial cell wall. Cefixime is highly stable in the presence of beta-lactamase enzymes. Cefixime has marked in -vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms including beta lactamase producers.

Clinical efficacy of Cefixime has been demonstrated in infections caused by commonly occurring pathogens including Gram-positive organism Streptococcus pneumoniae, Streptococcus pyogenes, Gram-negative organism Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative), Salmonella typhi and Enterobacter species.

Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.

Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

Levofloxacin is bactericidal and exerts its antimicrobial effects via inhibition of bacterial DNA replication. It has a relatively long duration of action in comparison with other antibiotics that allows for once or twice daily dosing. Levofloxacin is associated with QTc-interval prolongation and should be used with caution in patients with other risk factors for prolongation (e.g. hypokalemia, concomitant medications).

Levofloxacin has demonstrated in vitro activity against a number of aerobic gram-positive and gram-negative bacteria and may carry some activity against certain species of anaerobic bacteria and other pathogens such as Chlamydia and Legionella. Resistance to levofloxacin may develop, and is generally due to mutations in DNA gyrase or topoisomerase IV, or via alterations to drug efflux. Cross-resistance may occur between levofloxacin and other fluoroquinolones, but is unlikely to develop between levofloxacin and other antibiotic classes (e.g. macrolides) due to significant differences in chemical structure and mechanism of action.

As antimicrobial susceptibility patterns are geographically distinct, local antibiograms should be consulted to ensure adequate coverage of relevant pathogens prior to use.

Finus L
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Finus L
Generic	Cefixime + Levofloxacin
Type	Tablet
Therapeutic Class
Manufacturer	Cronus Biotech Ltd
Available Country	India
Last Updated:	September 19, 2023 at 7:00 am

Uses

Cefixime is used for the following infectious diseases -

Respiratory Tract Infections:

Pneumonia

Sinusitis

Pharyngitis and Tonsillitis

Acute Bronchitis and Acute Exacerbations of Chronic

Bronchitis (AECB)

Otitis Media

Typhoid Fever

Urinary Tract Infections

Uncomplicated gonorrhea (cervical/urethral)

Levofloxacin Tablet is used for Acute maxillary sinusitis , Acute bacterial exacerbation of chronic bronchitis , Nosocomial pneumonia Community acquired pneumonia, Uncomplicated urinary tract infections Complicated urinary tract infections, Acute pyelonephritis, Uncomplicated & complicated skin and skin structure infections, Chronic bacterial prostatitis

Levofloxacin Injection is used to treat Acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, nosocomial pneumonia, community acquired pneumonia, uncomplicated urinary tract infections, complicated urinary tract infections, acute pyelonephritis, uncomplicated & complicated skin and skin structure infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, chronic bacterial prostatitis and typhoid fever.

Levofloxacin Injection has

Proven clinical success in hospital infections
Reaches high concentrations in lung, urine, skin and prostate
Ensures excellent gram-positive and gram-negative bacterial coverage, Offers better option for switch therapy

Levofloxacin Eye drops is used for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:

Gram-positive Bacteria: Corynebacterium species, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Viridans group streptococci
Gram-negative Bacteria: Pseudomonas aeruginosa, Serratia marcescens.

How Finus L works

Like all beta-lactam antibiotics, cefixime binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, causing the inhibition of the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefixime interferes with an autolysin inhibitor.

Levofloxacin, like other fluoroquinolone antibiotics, exerts its antimicrobial activity via the inhibition of two key bacterial enzymes: DNA gyrase and topoisomerase IV. Both targets are type II topoisomerases, but have unique functions within the bacterial cell. DNA gyrase is an enzyme found only in bacteria that introduces negative supercoils into DNA during replication - this helps to relieve torsional strain caused by the introduction of positive supercoils during replication, and these negative supercoils are essential for chromosome condensation and the promotion of transcription initiation. It is comprised of four subunits (two A subunits and two B subunits) of which the A subunits appear to be the target of fluoroquinolone antibiotics. Bacterial topoisomerase IV, in addition to contributing to the relaxation of positive supercoils, is essential at the terminal stages of DNA replication and functions to “unlink” newly replicated chromosomes to allow for the completion of cell division.

Inhibition of these enzymes by levofloxacin likely occurs via complexation with the topoisomerase enzymes. The end result is a blockade of DNA replication, thus inhibiting cell division and resulting in cell death.

Dosage

Finus L dosage

The usual treatment of Cefixime is 7 days. This may be continued for up to 14 days according to the severity of infection.

Cefixime Capsule

Adult and child over 12 years: 200 or 400 mg daily as a single dose or in two divided doses.

Cefixime Suspension

Child over 6 months: 8 mg/kg daily as a single dose or in 2 divided doses

Acute sinusitis: 500 mg once daily for 10-14 days or 750 mg once daily for 5 days

Exacerbation of chronic bronchitis: 500 mg once daily for 7 days

Community acquired pneumonia: 500 mg once daily for 7-14 days or750 mg once daily for 5 days

Nosocomial pneumonia: 750 mg once daily for 7-14 days

Uncomplicated urinary tract infections: 250 mg once daily for 3 days

Complicated urinary tract infections and acute pyelonephritis: 250 mg once daily for 10 days

Complicated urinary tract infections and acute pyelonephritis: 750 mg once daily for 5 days

Uncomplicated skin and skin structure infections: 500 mg once daily for 7-10 daysComplicated skin and skin structure infections: 750 mg once daily for 7-14 days

Chronic bacterial prostatitis: 500 mg once daily for 28 days

Levofloxacin solution for infusion is administered by slow intravenous infusion once or twice daily. The dosage depends on the type and severity of the infection and the sensitivity of the causative pathogen. The duration of treatment varies according to the severity of the disease.Adult:

Community-acquired pneumonia: 500 mg once or twice daily,
Complicated urinary tract infections (including pyelonephritis): 250 mg once daily,
Chronic bacterial prostatitis: 500 mg once daily,
Skin and soft tissue infections: 500 mg twice daily
Enteric fever: 500 mg once daily.

Children:

Levofloxacin can be used in children aged as low as 6 months. The usual dose for children in community acquired pneumonia is:

Children aged 6 months to less than 5 years: 10 mg/kg b.i.d. (up to 500 mg per day) for 10 days,
Children aged 5 years to 16 years: 10 mg/kg q.d. (up to 500 mg per day) for 10 days.

The usual dose for children in recurrent or persistent Acute Otitis Media is:

Children aged 6 months to less than 5 years: 10 mg/kg per day (maximum dose: 500 mg/day) given twice daily for 10 days.

Paediatric Use: Levofloxacin is not recommended for children less than 6 (six) months of age.

Levofloxacin ophthalmic solution:

Days 1 through 3: Instill one to two drops in the affected eye(s) every 30 minutes to 2 hours while awake and approximately 4 and 6 hours after retiring.
Day 4 through treatment completion: Instill one to two drops in the affected eye(s) every 1 to 4 hours while awake.

0.5%ophthalmic solution:

Days 1 and 2: Instill one to two drops in the affected eye(s) every 2 hours while awake, up to 8 times per day.
Days 3 through 7: Instill one to two drops in the affected eye(s) every 4 hours while awake, up to 4 times per day.

Direction for Reconstitution of Suspension

• To prepare 50 ml suspension, 25 ml boiled and cooled water is required.

• To prepare 40 ml suspension, 20 ml boiled and cooled water is required.

• To prepare 30 ml suspension, 15 ml boiled and cooled water is required.

• To prepare 50 ml DS suspension, 25 ml boiled and cooled water is required.

Tap the bottle several times to loosen powder contents prior to reconstitution. Add approximately half of the total amount of water and shake well. Add remainder of water, and then shake again.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator and unused portion should be discarded after 14 days.

Administration of Levofloxacin (solution for infusion) should be continued for a minimum of 48 to 72 hours after the patient has become febrile or evidence of bacterial eradication has been obtained. Levofloxacin solution for infusion is only intended for slow intravenous infusion; it is administered once or twice daily. The infusion time must be at least 30 minutes for 250 mg or 60 minutes for 500 mg Levofloxacin solution for infusion. It is possible to switch from an initial intravenous application to the oral route at the same dosage after a few days.

Side Effects

Cefixime is generally well tolerated. The majority of adverse reactions observed in clinical trials are mild and self limiting in nature.

Gastro-intestinal disturbance: Diarrhea (if severe diarrhea occurs, Cefixime should be discontinued), changes in the color of stool, nausea, abdominal pain, dyspepsia, vomiting, flatulence have been reported. CNS disturbances: Headache, dizziness.

Others: Hypersensitivity reactions which usually subsided upon discontinuation of therapy; infrequent and reversible hematological changes; elevation of serum amylase.

The most frequently reported adverse events were headache and a taste disturbance following instillation. Other adverse events included decreased/blurred vision, diarrhea, dyspepsia, fever, infection, instillation site irritation/discomfort, ocular infection, nausea, ocular pain/discomfort, and throat irritation.

Toxicity

Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting.

The LD₅₀ following oral administration in mice and rats is 1803 mg/kg and 1478 mg/kg, respectively.

Levofloxacin exhibits low potential for acute toxicity - following a single high dose of levofloxacin in several different test animals (e.g. mice, rats, monkeys) observed symptoms included ataxia, ptosis, decreased motor activity, dyspnea, tremors, and convulsions. Treatment of acute overdosage should involve stomach emptying (e.g. with activated charcoal) and general supportive measures. Consider monitoring of the patient's ECG to ensure QTc values remain within range. Levofloxacin is not efficiently removed by dialysis (peritoneal or hemodialysis) and is therefore of little benefit in cases of overdose.

Precaution

Cefixime should be prescribed with caution in individuals with a history of gastrointestinal diseases, particularly colitis. Dosage adjustment is only necessary in severe renal failure (creatinine clearance < 20 ml/min)

The following measures should be taken during administration of Levofloxacin: While taking Levofloxacin adequate amount of water should be drunk to avoid risk of crystalluria. Dose adjustment should be exercised during Levofloxacin ingestion in presence of renal insufficiency & hepatic insufficiency.

While taking Levofloxacin adequate amount of water should be drunk to avoid risk of crystalluria. Dose adjustment should be exercised during Levofloxacin ingestion in presence of renal insufficiency & hepatic insufficiency.

Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles or after expiry date.

If an allergic reaction to levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.

Prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Patients should be advised not to wear contact lenses if they have signs and symptoms of corneal ulcer. Avoid contaminating the applicator tip with material from the eye, fingers or other source.

Interaction

Increased prothrombin time (with or withot bleeding) with anticoagulants (e.g. warfarin). Increased plasma carbamazepine concentrations with concomitant use. Increased bioavailability with nifedipine. Increased serum concentration with probenecid.

Specific drug interaction studies have not been conducted with this drug. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, and enhance the effects of the oral anticoagulant warfarin and its derivatives, and has been associated with transient elevations in serum creatinine in patients receiving systemic cyclosporine concomitantly.

Volume of Distribution

Levofloxacin is widely distributed in the body, with an average volume of distribution following oral administration between 1.09-1.26 L/kg (~89-112 L). Concentrations in many tissues and fluids may exceed those observed in plasma. Levofloxacin is known to penetrate well into skin tissue, fluids (e.g. blisters), lung tissue, and prostatic tissue, amongst others.

Elimination Route

About 40%-50% absorbed orally whether administered with or without food, however, time to maximal absorption is increased approximately 0.8 hours when administered with food.

Absorption of levofloxacin following oral administration is rapid and essentially complete, with an oral bioavailability of approximately 99%. Due to its nearly complete absorption, the intravenous and oral formulations of levofloxacin may be interchangeable. The T_max is generally attained 1-2 hours following administration and the C_max is proportional to the given dose - an intravenous dose of 500mg infused over 60 minutes resulted in a C_max of 6.2 ± 1.0 µg/mL whereas a 750mg dose infused over 90 minutes resulted in a C_max of 11.5 ± 4.0 µg/mL. Oral administration with food prolongs the T_max by approximately 1 hour and slightly decreases the C_max, but these changes are not likely to be clinically significant.

Systemic absorption following oral inhalation is approximately 50% lower than that observed following oral administration.

Half Life

3-4 hours (may range up to 9 hours). In severe renal impairment (5 to 20 mL/min creatinine clearance), the half-life increased to an average of 11.5 hours.

The average terminal elimination half-life of levofloxacin is 6-8 hours.

Clearance

The average apparent total body clearance of levofloxacin ranges from 8.64-13.56 L/h, and its renal clearance ranges from 5.76-8.52 L/h. The relative similarity of these ranges indicates a small degree of non-renal clearance.

Elimination Route

The majority of administered levofloxacin is excreted unchanged in the urine. Following the administration of a single oral dose of levofloxacin, approximately 87% was eliminated unchanged in the urine within 48 hours and less than 4% was eliminated in the feces within 72 hours.

Pregnancy & Breastfeeding use

Pregnancy: Pregnancy category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Lactation: It is not known whether Cefixime is excreted in human milk. Consideration should be given to discontinuing nursing temporarily during treatment with this drug.

Use in Elderly

No special precautions are necessary. No dosage adjustment is required for elderly

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Contraindication

Patients with known hypersensitivity to cephalosporin antibiotics, children under 6 months.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to Levofloxacin, quinolone antimicrobial agents, or any other components of this product.

Special Warning

Use in Children: Safety and effectiveness of cefixime in children aged less than 6 months have not been established. For children younger than 12 years or weighing less than 50 kg, the usual dose is 8 mg/kg/day.

Use in elderly: No special precautions are necessary. Old age is not an indication for dose adjustment.

Dosage in renal impairment:

Creatinine clearance: 20 ml/min or greater: normal dose
Creatinine clearance: <20 ml/min or chronic ambulatory peritoneal dialysis
Haemodialysis: daily dose should not exceed 200 mg.

Use in Children: From clinical studies, it is evident that Levofloxacin can be used in children aged as low as 6 months.The usual dose for children in community acquired pneumonia (CAP) is-

Children aged 6 months to less than 5 years: 10 mg/kg b.i.d. (up to 500 mg per day) for 10 days.
Children aged 5 years to 16 years: 10 mg/kg q.d. (up to 500 mg per day) for 10 days.

The usual dose for children in recurrent or persistent Acute Otitis Media (AOM) is Children aged 6 months to less than 5 years: 10 mg/kg per day (maximum dose: 500 mg/day) given twice daily for 10 days.

Acute Overdose

Gastric lavage may be indicated; otherwise, no specific antidote exists. Cefixime is not removed in significant quantities from the circulation by hemodialysis or peritoneal dialysis. Adverse reactions in small numbers of healthy adult volunteers receiving single doses up to 2 g of Cefixime did not differ from the profile seen in patients treated at the recommended doses.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.