Meropenem Trihydrate USP

Trade name:  Merom injection

GENERIC NAME: Meropenem Trihydrate USP

THERAPEUTIC CLASS: Antibacterial (Carbapenem)

DESCRIPTION

Merom is an ultra-broad spectrum injectable antibiotic used to treat a wide variety of infections, including meningitis and pneumonia. It is a beta-lactam antibiotic and belongs to the subgroup of carbapenem.

FORMULATION

Merom 500mg IV Injection: Each vial contains Meropenem trihydrate equivalent to Meropenem 500mg.

Merom 1gm IV Injection: Each vial contains Meropenem trihydrate equivalent to Meropenem 1gm.

MECHANISM OF ACTION

Merom (Meropenem) exerts its bactericidal action by interfering with bacterial cell wall synthesis. Thus it penetrates into bacterial cells, its high level of stability to all _-lactamases and its marked affinity for the Penicillin Binding Proteins (PBPs) explain in the potent bactericidal activity of meropenem against a broad spectrum of aerobic and anaerobic and anaerobic bacteria.

PBPs involoved in the final stages of the synthesis of peptidoglycan

                                 |--------------------------                        Merom -------------|

            To growth, cell division and maintaining the cellular structure in bacteria

Inhibition of PBPs leads to irregularities in cell wall structure such as elongation

Lesions, loss of selective permeability, and eventual cell death and lysis.

                                 |_______________________________________________

MICROBIOLOGY

Merom is effective against aerobic & facultative gram-positive microorganisms such as – Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes, Staphy lococcus epidermidis etc.

Merom also covers most aerobic & facultative gram-positive microorganisms such as-Escherichia cole, Heamophilus influenzae, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Klebsiella oxytoca etc.

Merom is also effective against most anaerobic microorganisms such as-Bacteraoides fragilis, Bacteraoides thetaiotaomicron, Peptostreptococcus species, Bacteroides vulgatus, Clostridium difficile etc.

CLINICAL INDICATIONS

·        Meningitis

·        Febrile neutropenia

·        Urinsry tract infections

·        Intra abdominal infections

·        Lower respiratory tract infections: Pneumonia, chronic bronchition of chronic        bronchitis.

·        Septicemia

·        Gynecological & obstetric infections

·        Peneumonia & nososcomial pneumonia

·        Skin & skin structure infections

·        Pulmonary infection

·         

DOSAGE & ADMINISTRATION

Adults:

The recommended daily doses are based depending upon the severity of the infections & condition of the patients. Peneumonia, UTI, gynaecological infections such as endometritis, skin & skin structure infections-500mg i.v every 8 houre. Noscomial Pneumonias, peritonitis, presumed infections in neutropenic patients & septicaemia- 1gm i.v every 8 hours. Meningitis-2gm every 8 hours.

Children (3 months to 12 years):

10-20mg/kg i.v every m8 hours depending on the type & severity of infections, susceptibility of the pathogens & condition of the patients. Children over 50kg body weight- adult dosage. Meningitis-40mg/kg every 8 hours.

 SIDE EFFECT

·        Stomach upset & pain, diarrhea,

·        Indigestion, constipation

·        Dry mouth, Headache, seizures

·        Fatigue and dizziness etc.

DRUG INTERACTIONS

-Probenecid: It may increases the levelos of meropenem in the blood.

-Sodium valporate: may7 reduce the serum valporic acid level.

CONTRAINDICATIONS

Merom is contraindicated in patients with known allergy to this active ingredient.

BRAND INFORMATION

Preparation	Pack size	MRP(in Tk.)
Merom 500mg IV injection	1 vial	950
Merom 1gm IV injection	1vial	1800

PRODUCT POSITIONING                                     Success Rate 

·        First line antibiotic for ICU patients                                        

·        Intra abdominal infections (IAI)                             100%

·        Febrile neutropenia                                                  55% (vs 43% for  ceftazidime)

·        Urinary tract infections                                           100%

·        Pneumonias & Nosocomial Pneumonias                100%

·        Bacterial septicemia                                                100%

·        Meningitis                                                                 99%

·        Pulmonary infections                                              100%

·        Cystic fibrosis                                                         100%

TARGET DOCTORS

• ICU consultant/Incharge
• Anesthesiologists
•  Oncologist
• Medicine Specialist
• Gynecologist
• ENT specialist
• Gastroenterologist

COMPETITIVE PRICE

Competitor	Brand name	Pack size	MRP/500mg	MRP/1gm
Renata	Meropen	1 vial	995	1950
Incepta	I-Penam	1 vial	995	1950
Popular	Merobac	1 vial	950	1850
Square	Specbac	1 vial	995	1950
ACI	Meronem	1 vial	950	2545.85
Techno Drugs	Merom	1 vial	950	1800

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Ceftriaxone Sodium Injection Iinformation

TRADE NAME

Cefixon Injection

GENERIC NAME

Ceftriaxone sodium Injection USP

THERAPEUTIC CLASS

Antibacterial(3^rd Generation Cephalosporin)

DESCRIPTION

Ceftriaxone injection USP is a third generation cephalosporin antibiotic. Like other third generation cephalosporins, it has board spectrum activity against Gram positive and Gram negative bacteria.

There are several generation of cephalosporins mentioned below:

1^st generation cephalosporins: First generation cephalosporins are moderate spectrum agents, with a spectrum of activity that includes penicillinase-producing, methicillin-susceptible staphylococci and streptococci, though they are not the drugs of choice for such infections. e.g. Cefadroxil (Sefadol), Cephradine (Dolocef), Ceftezole etc.

2^nd generation cephalosporins: The generation cephalosporins have a grater Gram-negative spectrum while retaining some activity against Gram-positive cocci. They are also some more resistant to beta-lactamase. e.g. Cefaclor (Sefalor), Cefuroxime, Cefonicid etc.

 3^rd  generation cephalosporins: Third generation cephalosporins have a broad spectrum of activity and further increased activity against Gram-negative organisms . e.g. Ceftriaxone (cefixon), Cefixime (Loxim), Cefpodoxime etc.

4th generation cephalosporins: Fourth generation cephalosporins are extended-spectrum agents with similar activity against Gram-positive organisms as first-generation organisms as first-generation cephalosporins & and more active against Gram-negetive organism e.g. Cefipime, Cefpirome etc.

Formulation

Cefixon 250mg IV/IM injection: Each vial contains Ceftriaxone sodium USP equivalent to 250mg Ceftriaxone.  

Cefixon 500mg IV/IM injection: Each vial contains Ceftriaxone sodium USP equivalent to 500mg Ceftriaxone.   

Cefixon 1mg IV/IM injection: Each vial contains Ceftriaxone sodium USP equivalent to 1mg Ceftriaxone.  

Cefixon 2mg IV/IM injection: Each vial contains Ceftriaxone sodium USP equivalent to 2mg Ceftriaxone.

MECHAHANISM OF ACTION

Cefixon: belongs to a group of antibiotics gram called the cephalosporin. It kills bacteria by interfering with transpeptidase enzyme which is responsible for the synthesis of bacteria cell wall, peptidoglycan. The bacteria therefore break up and die.

               

                  Transpeptidation

                              |      Transpeptidation       <  -  Cefixon

                                        

                    Peptidoglycan

                              |

 

 Stability & rigidity of bacterial cell wall

MICROBIOLOGY

 Cefixon : covers aerobic gram negative microorganism such as  -   Acinetobacter calcoaceticus, Enterobacter aerogenes, Escherichia coli, Heamophilus influenzae, Klebsiella pneumoniae, Proteus vulgaris, Salmonella species etc.

Cefixon : covers aerobic gram positive microorganism such as  -  Staphyloccoccus aureus, Staphyloccoccus epidermidis, Streptococcus pneumoniae, Streptococcus pyogenes etc.  

     

Cefixon : covers anaerobic gram microorganism such as  -   Bacteroides fragilis, Clostridium species, Peptostreptococcus species, Prevotella (Bacteroides) bivius etc.

CLINICAL INDICATIONS

Infections caused by pathogens sensitive to Ceftriaxone, e.g.:

·        Preoperative prophylaxis of infections.

·        Meningitis

·        Pneumonia

·        Sepsis

·        Abdominal infactions (peritonitis, infections of the biliary and gastrointestinal tracts)

·        Infections of the bones, joints, soft tissue, skin and of wounds

·        Infections in patients with impaired defense mechanisms

·        Renal and urinary tract infections

·        Ear, nose and throat infections

·        Genital infections, including gongrrhoea.

DOSAGE & ADMINISTRATION

Cefixon is intended for intravenous use only.

Adultd & children over 12 years:

·        The usual dosage is 1-2 gm of Cefixon once daily (every 24 hours).

In severe cases or in infections caused by moderately sensitive organisms, the dosage may be raised to 4 gm once daily.

·        In uncomplicated gonorrhoea or cystitis: 1gm pre-operative single dose.

·        In prophylaxis of postoperative infection: 1gm pre-operative single dose.

Neonates, infants and children up to 12 years:

The flowing dosage schedules are recommended for once daily administration:

·        Neonates (up to 14 days): 20-50 mg/kg bodyweight once daily. The daily dose should not exceed 50 mg\kg.

·        Infants and children (15 days to 12 years): 20-80 mg/kg once daily.

·        For children with bodyweights of kg or more: Adult dose.

SIDE EFFECTS

·        Headache, rash, itching (pruritus), diarrhea

·        Allergic reaction to active ingredient

·        Pain and inflammation of the blood vassel at the site of injection

·        Dizziness, nausea and vomiting

·        Inflammation of the pancreas (pancreatitis) & large intestine (colitis)

·        Increase in the time it takes for blood to clot

Drug interactions

Probenecid: The removal of ceftriaxone from the body may slowed if given with probenecid.

CONTRAINDICATIONS

Cefixon is contraindicated in patients with know allergy to the cephalosporin class of antibiotics.

BRAND INFORMATION

Preparation	Pack size	MRP(in BDT.)
Cefixon 250mg IV/IM injection	1 vial	80
Cefixon 500mg IV/IM injection	1 vial	120
Cefixon 1gm IV/IM injection	1 vial	160
Cefixon 2gm IV/IM injection	1 vial	250

PRODUCT POSITIONING

                                                                                       SUCCESS RATE                                       

v     Pneumonia                                                                          100%                                       

v     Bacterial Meningitis                                                             100%

v     Multi-drug-Resistant salmonella typhii                                  100%

v     Infectious diarrohoea                                                           100%

v     Uncomplicated Acute Otitis Media                                      100%

v     Enteric fever                                                                        100%

TRGET DOCTORS

v     Surgeons

v     Medicine Specialists

v     Urologists

v     Gynecologists

v     ENT specialists

v     GP’s

v     DGP’s

COMPETITIVE PRICE

Competitor	Brand Name	Pack size	MRP/250 mg	MRP/500 mg	MRP/1gm	MRP/2gm
Renata	Ceftizone	1’s	100	140	190	340
Popular Pharma	Eracef	1’s	85	120	180	300
Ziska	Triphin	1’s	80	120	160	250
Orion Laboratories	Vertex	1’s	90	120 1	95	230
Opsinin Pharma	Traxon	1’s	90	120 1	60	450
Techno Drugs	cefixon	1’s	80	120	160	250

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