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UNDER FOCUS : OUR MAJOR PEDIATRIC PRODUCTS

CEFUCIL: 125 mg GRANULES FOR ORAL SUSPENSION

Superior action in common bacterial infections.

Generic: Cefuroxime Axetil

Cefuroxime Axetil: An orally administered second generation cephalosporin with a broad spectrum of activity against several Gram-positive and Gram-negative organisms. An antibacterial agent of choice for empirical treatment of common bacterial infections due to
  • Broad spectrum of activity
  • Therapeutic effectiveness
  • Convenient twice daily administration
  • Superior tolerability
  • Good patient compliance
Spectrum of activity of Cefuroxime axetil:
  • Cefuroxime axetil is effective against most Gram +ve cocci like Streptococcus pnemoniae,
  • Streptococcus pyogens and Gram -ve organisms like Haemophilus influenza, Moraxella
  • catarrhalis, Neisseria gonorrhoeae and Escherichia coli.
Mechanism of action: Cefuroxime inhibits penicillin-binding proteins (PBPs), which in turn, results in bacterial elongation and leakage, and eventually leads to cell death.

Dosage and administration: Route of Administration: Oral

Adults and adolescents aged 13 years:

Pharyngotonsillitis and sinusitis - 250 mg bid for 10 days

LRTIs, skin and soft tissue infections - 500 mg bid for 10 days

Uncomplicated UTIs - 125 or 250 mg bid for 7-10 days

Sequential Therapy:

Acute Exacerbation of Chronic Bronchitis - Intravenous or intramuscular Cefuroxime 750 mg bid for 2 to 3 days followed by oral Cefuroxime axetil 500 mg bid for 7 days.

Community Acquired Pneumonia - Parenteral Cefuroxime is 1.5 g bid for 2 to 3 days, followed by Cefuroxime axetil 500 mg for 7 days.

Suspension Formulation:

Pharyngotonsillitis - 10 mg/kg bid (maximum of 500 mg/day) for 10 days

Acute otitis media - 15 mg/kg bid (maximum of 1000 mg/day) for 10 days

Acute maxillary sinusitis - 15 mg/kg bid (maximum of 1000 mg/day) for 10 days

Impetigo- 15 mg/kg bid (maximum of 1000 mg/day) for 10 days

Dosage in Special population:
  • Cefuroxime can be used in renal failure without any dosage adjustment [creatinine clearance 1.2 L/h (20 ml/min)], renal dialysis or in elderly at dosages upto 1 g per day.
  • Safety of Cefuroxime in pregnant women has not been proven. It should be used with caution in lactating women.
  • Cefuroxime can be used in children but it should not be given to infants <3 months of age.
  • Excreted in breast milk - caution advised in nursing mothers.
Contraindication: Cefuroxime axetil is contraindicated in patients with known allergy to the cephalosporin group of antibiotics

Presentation: Cefucil is available as 125 mg granules for Oral Suspension in Sachets.


SAVECEF: 100 mg GRANULES FOR ORAL SUSPENSION

Superior action in urinary tract infection

Generic: Cefixime for oral suspension USP 100 mg

Cefixime:
  • Most potent and broad spectrum cephalosporins
  • 2 Stable in the presence of ©-lactamase
Spectrum of activity of Cefixime:

Gram positive Organisms: Streptococcus pneumoniae, Streptococcus pyogenes.

Gram -negative organisms: Haemophilus influenzae (beta-lactamase positive and negative strains), moraxella catarrhalis (most of which are beta-lactamase positive), Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae (including penicillinase-and non-penicillinase -producing strains).

Mechanism of action: Cefixime inhibits penicillin-binding proteins (PBPs), which in turn, results in bacterial elongation and leakage, and eventually leads to cell death.

Dosage and administration: Route of Administration: Oral

Absorption of Cefixime is not significantly modified by the presence of food. The usual course of treatment is 7 days. This may be continued for up to 14 days if required.

Adults and Children over 10 Years: The recommended adult dosage is 200-400 mg daily according to the severity of infection, given either as a single dose or in two divided doses.

The Elderly: Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment.

Children (Use Paediatric Oral Suspension): The recommended dosage for children is 8 mg/kg/day administered as a single dose or in two divided doses. As a general guide for prescribing in children the following daily doses in terms of volume of Paediatric Oral Suspension are suggested:

6 months up to 1 year: 3.75 ml daily

Children 1-4 years: 5 ml daily

Children 5-10 years: 10 ml daily

Children weighing more than 50 kg or older than 10 years should be treated with the recommended adult dose (200 - 400 mg daily depending on the severity of infection).

The safety and efficacy of cefixime has not been established in children less than 6 months.

Dosage In Renal Impairment: Cefixime may be administered in the presence of impaired renal function. Normal dose and schedule may be given in patients with creatinine clearances of 20 ml/min or greater. In patients whose creatinine clearance is less than 20 ml/min, it is recommended that a dose of 200 mg once daily should not be exceeded. The dose and regimen for patients who are maintained on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as that for patients with creatinine clearances of less than 20 ml/min.

Dosage in Special population: There are no adequate and well controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Contraindication: Cefixime is contra-indicated in patients with known allergy to the cephalosporin group of antibiotics.

Presentation: Savecef is available as 100 mg granules for Oral Suspension in sachet, Box of 10 sachets.


SANFETIL : 100 mg GRANULES FOR ORAL SUSPENSION

Superior action in common bacterial infections

Generic: Cefpodoxime Proxetil For Oral Suspension USP 100 mg

Cefpodoxime Proxetil : Cefpodoxime proxetil is a prodrug that is absorbed from the gastrointestinal tract and de-esterified to its active metabolite, cefpodoxime.
  • Inhibits bacterial cell wall synthesis and exhibits a bactericidal action against many gram-positive and gram negative bacteria.
  • Indicated for upper respiratory tract infections, lower respiratory tract infections, Uncomplicated skin and skin structure infections, and Uncomplicated urinary tract infections (cystitis) caused by susceptible organisms. Also indicated for acute, uncomplicated urethral and cervical gonorrhea, and acute, uncomplicated anorectal infections in women due to Neisseria gonorrhoeae
Spectrum of activity of Cefpodoxime Proxetil
  • Cefpodoxime proxetil is one of the first oral third generation cephalosporin to have been developed clinically. It is highly stable to hydrolysis by lactamases.
  • It is active against Streptococcous pnuemoniae, S.Pyogenes and H.influenzae in very low minimum inhibitory concentrations MIC's. These are the organisms implicated in respiratory tract infections.
  • It is active against E.coli, Klebsiella and few Enterococci but not against Pseudomonas and B. Fragilis.
  • Cefpodoxime can be used as empirical first line therapy in respiratory tract infections. It seems to be a promising molecule in pediatric typhoid fever because of its excellent activity against Salmonella typhi (MIC 0.25-0.5 mcg/ml).
Mechanism of action: Cefpodoxime is bactericidal and acts by inhibition of bacterial cell wall synthesis. It passes through porin channels in the bacterial cell wall and binds to the penicillin binding proteins (PBP) in the cell membrane. This leads to reduced synthesis of peptidoglycans and results in damage to cell wall.

Dosage and administration: Route of Administration: Oral

Adults and Adolescents (age 12 years and older)

Type of Infection Total Daily Dose Dose Frequency Duration
Pharyngitis and/or tonsillitis 200 mg 100 mg Q 12 hours 5 to 10 days
Acute community-acquired pneumonia 400 mg 200 mg Q 12 hours 14 days
Uncomplicated gonorrhea (men and women) and rectal gonococcal infections (women) 200 mg single dose
Skin and skin structure 800 mg 400 mg Q 12 hours 7 to 14 days
Acute maxillary sinusitis 400 mg 200 mg Q 12 hours 10 days
Uncomplicated urinary tract infection 200 mg 100 mg Q 12 hours 7 days

Infants and Pediatric Patients (age 2 months through 12 years)


Type of Infection Total Daily Dose Dose Frequency Duration
Acute otitis media 10 mg/kg/day Max 400 mg/day) 5 mg/kg Q 12 h Max 200 mg/dose) 5 days
Pharyngitis and/or tonsillitis 10 mg/kg/day (Max 200 mg/day) 5 mg/kg/dose Q 12 h (Max 100 mg/dose) 5 to 10 days
Acute maxillary sinusitis 10 mg/kg/day (Max 400 mg/day) 5 mg/kg Q 12 hours (Max 200 mg/dose) 10 days


Dosage in Special population

  • Pediatric use: Safety and efficacy in infants less than 2 months of age have not established.
  • Renal impairment: For patients with severe renal impairment (<30 ml/min creatinine clearance), the dosing intervals should be increased to Q 24 hours. In patients maintained on haemodialysis, the dose frequency should be 3 times/week after haemodialysis.
Contraindication: Sanfetil sachet is contraindicated for the following
  • Patients with a known allergy to Cefpodoxime or to the cephalosporin group of antibiotics.
  • Pregnancy and lactation.
Presentation: Sanfetil is available as 100mg granules for oral suspension in sachet, Box of 10 sachets.


CEFDINIR: 125 mg GRANULES FOR ORAL SUSPENSION

Superior action in common bacterial infections

Generic: Cefdinir For Oral Suspension 125 mg

Cefdinir: Cefdinir is a bacteriocidal antibiotic. It can be used to treat infections caused by several Gram-negative and Gram-positive bacteria.

Spectrum of activity of CEFDINIR

Aerobic Gram-Positive Microorganisms: Staphylococcus aureus (including © -lactamase producing strains)
NOTE: Cefdinir is inactive against methicillin-resistant staphylococci, Streptococcus pneumoniae (penicillin-susceptible strains only), Streptococcus pyogenes.

Aerobic Gram-Negative Microorganisms:

Haemophilus influenzae (including © -lactamase producing strains)

Haemophilus parainfluenzae (including © -lactamase producing strains)

Moraxella catarrhalis (including © -lactamase producing strains).

Aerobic Gram-Positive Microorganisms: Staphylococcus epidermidis (methicillin-susceptible strains only), Streptococcus agalactiae, Viridans group streptococci.
NOTE: Cefdinir is inactive against Enterococcus and methicillin-resistant Staphylococcus species.

Aerobic Gram-Negative Microorganisms: Citrobacter diversus, Escherichia coli, Klebsiella pneumonia, Proteus mirabilis.
NOTE: Cefdinir is inactive against Pseudomonas and Enterobacter species.

Mechanism of action: As with other cephalosporins, bactericidal activity of cefdinir results from inhibition of cell wall synthesis. Cefdinir is stable in the presence of some, but not all, © -lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins are susceptible to cefdinir. Cefdinir has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described.

Dosage and administration: Route of Administration: Oral

The recommended dosage and duration of treatment for infections in pediatric patients are described in the following chart; the total daily dose for all infections is 14 mg/kg, up to a maximum dose of 600 mg per day. Once-daily dosing for 10 days is as effective as BID dosing. Once-daily dosing has not been studied in skin infections, Cefdinir for Oral Suspension should be administered twice daily in this infection. Cefdinir for Oral Suspension may be administered without regard to meals.

Type of Infection Dose Frequency Duration
Acute Bacterial Otitis Media 7 mg/kg q12h 5 to 10 days
or 14 mg/kg q24h 10 days
Acute Maxillary Sinusitis 7 mg/kg q12h 10 days
or 14 mg/kg q24h 10 days
Pharyngitis/Tonsillitis 7 mg/kg q12h 5 to 10 days
or 14 mg/kg q24h 10 days
Uncomplicated Skin and Skin Structure Infections 7 mg/kg q12h 10 days

Special indications

Cefdinir for Oral Suspension are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
  • Adults and Adolescents: Community-Acquired Pneumonia, Acute Exacerbations of Chronic Bronchitis , Acute Maxillary Sinusitis , Pharyngitis/Tonsillitis , Uncomplicated Skin and Skin Structure Infections.
  • Pediatric Patients: Acute Bacterial Otitis Media , Pharyngitis/Tonsillitis , Uncomplicated Skin and Skin Structure Infections.
Contraindication: Cefdinir is contraindicated in patients with known allergy to the cephalosporin class of antibiotics.

Presentation: Cefdinir is available as 125 mg granules for Oral Suspension in sachet, Box of 10 sachets.

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