IMIPEN® 500imipenem/ cilastatin

500 mg /500 mg injection

Prepared By:

Masum Chowdhury

Product Executive

PMD

APPROPRIATE, ALTERNATIVE,

EMPIRIC ANTIBIOTIC THERAPY

Reviews,Overviews, &Updates of

Carbapenem

History of Carbapenem

In the 1970s Beecham research Laboratoriesidentified a Carbapenem group, called olivanic acid, which were beta-lactamase inhibitors and broad spectrum antibiotics.

Imipenem has one of the widest spectrum

of the beta-lactam antibiotics. It is active

against nearly all common bacterial species,

including those resistant to

aminoglycosides and newer Cephalosporin.

History of Carbapenem

The Carbapenem are a group of bicyclic

beta-lactam compounds with a common

Carbapenem nucleus.

Imipenem is one of them.

Imipenem has high activity against

both aerobic and anaerobic, atypical

bacteria

We Introduces a New Unique

Family in antibiotic segment

Carbapenem1. Meropenem

2. Imipenem + cilastatin

3. Ertapenem

We Introduces a New concept in

this Family……..

Carbapenem

Feropenem® Tablet

Which is approved by FDA

Very recently

Distribution of nosocomial infections among adult patients in medical intensive care units

UTI 31%

PNEU 27%

BSI 19%

GI 5%

CVS 4%

ENT 4%

LRTI 4% Other 5%

Blood stream Infections

In 1970s Merck, Sharp and Dohme

Research Laboratories independently

identified thienamycin, derived from

streptococcus catteleya.

History of IMIPEN

What is IMIPEN® 500 ?

IMIPEN for intravenous use is supplied

as a white sterile powder in 100 mL

vials. Each 100 ml vial contains 500 mg

of imipenem equivalent and 500 mg

cilastatin equivalent.

Therapeutic Class

Cilastatin is a competitive,

reversible and specific inhibitor

of dehydropeptidase-I enzyme.

Therapeutic Uses of IMIPEN® 500

Intra-abdominal infections

Lower respiratory tract infections

Febrile Neutropenia

Gynaecological infections

Septicaemia

Genitourinary tract infections

Bone and joint infections

Skin and soft tissue infections

Endocarditis

The importance of using the most

appropriate empiric antibiotic early

to treat nosocomial infections

Nosocomial infections in

ICU

Antibiotic Prescribing in

The

ICU

Choosing an appropriate antibiotic for ICU

Patients in the ICU displaying signs of sepsis

belong to one of the following categories:

infected with a known organism from an

identified site

infected with a known organism from an

unidentified site

infected, but no causal agent has been

identified

uninfected.

Choosing an appropriate antibiotic for ICU

Occasionally the clinical signs of an

infection suggest the causal organism

and the appropriate antibiotic.

However, the choice of antibiotic is often

guided by the results of microbiological

investigation.

Correlation between organism and

site of infection

Spectrum of activity of some antibiotics

Spectrum of activity of some antibiotics

FROM THIS DISCUSSIONS I LIKE TO

SAY

THAT

IMIPEN® 500 IS THE MOSTADVANCE , APPROPRIATE,

ALTERNATIVE,

EMPIRICAL

ANIBIOTIC THERAPY

81.9%

58.9%

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

Empiric Antibiotic

Therapy Appropriate

(n=238)

Empiric Antibiotic

Therapy Inappropriate

(n=56)

Pat

ient

s w

ith

Clin

ical

Suc

cess

, %

p<0.05

*Successful outcome was defined as resolution with no change in treatment.

Davey P et al. Presented at the International Society of Pharmacoeconomics and

Outcomes Research Sixth Annual International Meeting, 2001.

In an observational study (n=348) in patients with acute peritonitis, IAI

patients with adequate empiric therapy were significantly more likely to

have successful clinical outcomes.*

Appropriate Empiric Therapy for IAI:

Successful Clinical Outcome

Abdominal sepsis

Sepsis originating from the large bowel such as

peritonitis, abdominal abscesses, gangrenous

appendicitis and diverticulitis.

Infection Types: Mixed Aerobic & anaerobic

Infections

Doses & administrations: 500mg imipenem/cilastatin given 6 or 8 hourly is recommended.

Maximum dose should be increased to

1000mg three or four times daily.

Intra-abdominal Infections

Appendicitis

Peritonitis

Intra-abdominal Abscess

Diverticulitis

Antibiotic-Associated Diarrhea

(Clostridium difficile)

Food Poisoning/Traveler’s Diarrhea

Helicobacter pylori

Pelvic Inflammatory Disease

Intra-abdominal Infections

Infections contained within the peritoneum or retroperitoneal space.

Peritoneal cavity contains:

Stomach

Jejunum, Ileum

Appendix

Large intestine (colon)

Liver, gallbladder and spleen

Retroperitoneal space:

Duodenum

Pancreas

Kidneys

Appendicitis

One of the most common causes of intra-abdominal infections.

Treatment: Both Surgical and Antibiotics

Depends on presentation of appendix:

Normal, inflamed, gangrenous or perforated

Begin antibiotics before appendectomy is performed

Appropriate Therapy: Imipenem

Continue antibiotics for 7 to 10 days if appendix is perforated or gangrenous (Switch to oral equivalents)

Deep Gynaecological &

Obstetric Infections

Septic abortions, postoperative infections after vaginal hysterectomy and infections. Similar to the intra-abdominal infections. These infections are caused by a aerobic & anaerobic flora

Doses & administrations: 500mg imipenem/cilastatin given 6 or 8 hourly is recommended.

Maximum dose should be increased to 1000mg three or four times daily.

Empirical Treatment of

Septicaemia

IMIPEN® 500 is effective in patients

with Bacterial septicemia

Doses & Administrations

The dose should be 500 to 1000mg every 6 to 8 hr depending on the severity of infections.

Lower Respiratory Tract Infection

In patients with pneumoniae caused by

Gram – Negative pathogens IMIPEN® 500

at a dose of 1000mg three times daily

may be used.

Cystic fibrosis

In patients with cystic fibrosis IMIPEN®

500 at a dose of 1000mg three times

daily may be used.

Urinary Tract infections

IMIPEN® 500 at a dose of 500mg three

times daily can be used in cases of

hospital acquired lower or upper urinary

tract infections.

Infections in Neutropenic

Patients

First Line Therapy: IMIPEN® 500

Conventional Antibiotic:

Aminoglycosides + Cephalosporin's

Dose: The dose documented in 1gm every

6 hours.

Bone & Joint Infections

IMIPEN® 500 has been used to treat

osteomyelitis resulting from accidents or

prosthesis implantation, involving gram

– positive and gram negative organisms.

Dose: The dose documented in 1gm every

6 hours.

Skin & soft tissue

infections

Moderately severe to severe soft

tissue infections.

Success rate: 95%

Where u will promote IMIPEN 500

INTENSIVE CARE UNIT

IMIPEN (imipenem/cilastatin) as

empirical monotherapy for serious

bacterial infections in the………

ICU

Why IMIPEN® 500 is used in ICU ?

IMIPEN 500 (imipenem/cilastatin) is

used as empirical monotherapy in

intensive care unit (ICU) patients with

serious bacterial infections.

Serious bacterial infections are

common in patients in the intensive care

unit (ICU) and they result in considerable

morbidity and mortality.

What is Serious Bacterial

Infections ?

Approximately 45% of the 10,038 ICU

patients included in the European

Prevalence of Infection in Intensive Care

(EPIC) Survey of 1992 had at least one

bacterial infection [1].

Serious Bacterial Infections

enhances Morbidity rate in ICU?

Pneumonia and other lower respiratory

tract infections (LRTIs) are the most

prevalent infections (64.7%), followed by

urinary tract (17.6%) and bloodstream

infections (12.0%).

What are the Serious Bacterial

Infections occur in ICU ?

Fifty-five percent of ICU-acquired infections are polymicrobial.

What is CAPD PERITONITIS ?

CAPD means continues

ambulatory peritoneal dialysis

(CAPD PERITONITIS)

CAPD

Primary response, relapse and overall

cure rate were 93%, 4%, 89%

respectively in imipenem/cilastatin

treatment.

Success rate in IMIPEN® 500

It can be concluded that

Imipenem/cilastatin first-line

treatment is highly efficient in CAPD

peritonitis.

Why IMIPEN® 500 called

Broad Spectrum Antibiotic ?

The activity of IMIPEN® 500 against an

unusually broad spectrum of pathogens

makes it particularly useful in the

treatment of polymicrobic mixed

aerobic/anaerobic infections as well as

initial therapy prior to the identification of

the causative organisms.

Dosage and Administration

of IMIPEN® 500

The dosage recommendations for

IMIPEN® 500 (for intravenous use only)

represent the quantity of imipenem to be

administered. An equivalent amount of

cilastatin is also present.

Dosage and Administration

of IMIPEN® 500

The total daily dosage of IMIPEN® 500

should be based on the type or severity

of infection and given in equally divided

doses based on consideration of degree

of susceptibility of the pathogens, renal

function and body-weight.

Adult Dosage Schedule for

Patients

Most infections respond to a daily

dose of 1-2 g administered in 3-4

divided doses.

Adult Dosage Schedule for

Patients

For the treatment of moderate infection,

a 1 g b.i.d. dosage regimen may also be

used.

Adult Dosage Schedule for

Patients

In infections due to less susceptible

organisms, the daily dosage of IMIPEN®

500 may be increased to a maximum of

4 g/day or 50 mg/kg/day, whichever is

lower.

Adult Dosage Schedule for

Patients

Each dose of 250 - 500 mg of IMIPEN®

500 should be given by intravenous

infusion over 20 to 30 minutes.

Adult Dosage Schedule for

Patients

Each dose 1000 mg should be infused

over 40 to 60 minutes. In patients who

develop nausea during the infusion,

the rate of infusion may be slowed.

In patients who develop nausea

during the infusion, the rate of

infusion may be slowed.

IV dosage schedule for adults with normal

renal function and body weight

Severity of

Infection

Dose of IMIPEN Dosage Interval Total Daily

Moderate 500mg

1000mg

8 hrs 1.5gm

Severe –Full susceptible

500mg 6 hrs 2gm

Severe and/or

Life threatening

– due to less

susceptible

organisms

1000mg

1000mg

8 hrs

6 hrs

3gm

4gm

Due to high antimicrobial activity of

IMIPEN® 500 , it is recommended that

the maximum total daily dosage not

exceed 50 mg/kg/day or 4 g/day.

However cystic fibrosis patients with

normal renal function have been treated

with IMIPEN® 500 at doses up to 90

mg/kg/day in divided doses not

exceeding 4 g/day.

Maximum Dose for Patients

with Normal Renal Function

IMIPEN® 500 has been used successfully as monotherapy in immunocompromised cancer patients for confirmed or suspected infections such as sepsis.

Maximum Dose for Patients

with Normal Renal Function

Paediatric Dosing Schedule

(3 months or older)

For children and infants the following dosage schedule is recommended:

CHILDREN >40 kg body weight should receive adult doses.

Paediatric Dosing Schedule

(3 months or older)

CHILDREN AND INFANTS <40 kg body weight should receive 15 mg/kg at six-hour intervals. The total daily dose should not exceed 2 g.

TREATMENT OF SERIOUS INFECTIOUS

COMPLICATIONS IN BURNED PATIENTS WITH-

IMIPENEM/CILASTATIN

The use of Imipenem/Cilastatin in the

treatment of severe infections in patients

with extensive deep Burns.

The results of the treatment were evaluated as

very good (80.0%) . The symptoms of infection

initially resolved before the 36th hour.

TREATMENT OF SERIOUS INFECTIOUS

COMPLICATIONS IN BURNED PATIENTS WITH-

IMIPENEM/CILASTATIN

Imipenem/Cilastatin is a correct choice in

empirical treatment and improved serious

cases, including mixed infections, with

multiresistant bacterial pathogens.

Treatment of uncomplicated gonorrhea

with single-dose imipenem-cilastatin.

Single 500-mg intramuscular doses of

imipenem-cilastatin cured 116 (95%) of

122 men and 9 of 9 women with

uncomplicated gonorrhea due to beta-

lactamase-negative Neisseria

gonorrhoeae. Most co-existing

Chlamydia trachomatis infections

persisted. Imipenem-cilastatin is

effective for uncomplicated gonorrhea .

Mode of Action of IMIPEN

Imipenem prevents the bacteria from making

the cell wall, so the cells die. Cilastatin sodium

is added to prevent an enzyme made by the

kidneys from breaking down the antibiotic

imipenem. The drug is used to treat gram

positive and negative bacteria. It is used to treat

infections of the lower respiratory tract, urinary

tract, abdomen, pelvis, skin, bones and joints.

Pharmacokinetics

IV admin only

half life of both drugs approx 1 hour

when given together 2/3 of dose of Imipenem is excreted unchanged in urine; remaining 1/3 in hyrolysed form

< 1% excreted in bile - too little to disturb colonic flora

plasma protein binding of Imipenem only 20%

Cilastatin excreted almost entirely by kidney

Reconstitution, Intravenous

Solution

IMIPEN® 500 for intravenous infusion is

supplied as a white sterile powder in

vials containing 500 mg imipenem

equivalent and 500 mg cilastatin

equivalent.

Reconstitution, Intravenous

Solution

IMIPEN® 500 is buffered with sodium

bicarbonate to provide solutions in the pH range of 6.5 to 8.5. There is no

significant change in pH when solutions

are prepared and used as directed.

Reconstitution of IMIPEN® IV

Dose of IMIPEN® IV

(mg of Imipenem)

Volume of Diluent

to be Added (ml)

Approximate

average

concentration of

Imipen IV

(mg/ml of

Imipenem)

500 100 5

A suggested procedure is to add approximately 10 mL from

the appropriate infusion solution to the vial. Shake well and

transfer the resulting suspension to the infusion solution

container.

Where can you keep my

medicine?

Imipenem-cilastatin is usually given in a

hospital. You may be given imipenem-

cilastatin to take home to complete your

treatment. If you are given this medicine

to take at home, store at room

temperature or as directed until it is time

to mix the medicine.

Compatibility

IMIPEN® 500 is compatible with the following infusion fluids:

0.9% sodium chloride intravenous infusion

5% or 10% glucose intravenous infusion

5% glucose intravenous infusion with 0.02% sodium bicarbonate

5% glucose and 0.9% sodium chloride intravenous infusion

5% glucose with 0.225% sodium chloride intravenous infusion

5% glucose with 0.15% potassium chloride intravenous infusion

2.5% and 10% mannitol intravenous infusion

normosol-M in 5% glucose intravenous infusion.

IMIPEN® IV

Price Informations

Brand Name MRP/Tk. MRP/Unit Price

IMIPEN® 500 Tk.1150.00 Tk.1150.00

Competitors

Price Informations

NO

Target Doctors

Pediatricians

Gynecologists

Obstetricians

Gasenterologists

Urologists

Medicine Specialists

Target Promotional Area

ICUHospital

Clinics

Questions

THANK YOU ALL

THIS IS THE END OF OUR PRESENTATION.

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