Drug Information

Drug Interaction:

Co-administration with probenecid inhibits the renal excretion of ertapenem

and is therefore not recommended.

The concomitant use of ertapenem and valproic acid/divalproex sodium

is generally not recommended. Anti-bacterials other than carbapenems

should be considered to treat infections in patients whose seizures are

well controlled on valproic acid or divalproex sodium.

Indication:

U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

15.Ertapenem for injection 1gm/vial 15-01-08

For the prophylaxis of surgical site infections following

colorectal surgery

U.S FDA APPROVED DRUGS DURING 2007

53. Ertapenam For Injection (1g/vial) 10-04-07

INVANZ (ertapenem for injection) for intravenous (IV) or

intramuscular (IM) use Initial U.S. Approval: 2001

To reduce the development of drug-resistant bacteria and maintain the

effectiveness of INVANZ and other antibacterial drugs,

INVANZ should be used only to treat or prevent infections that are

proven or strongly suspected to be caused by susceptible bacteria.

Complicated intra-abdominal ifections

Community acquired pneumonia

Patent Expiry Date of drugs (Ref - IDMA Publication)

Chemical Category Manufacturer/ US Patent

Ingredient- Marketer Expiration Date

Ertapenem Antiobitics/ Merck& Co 02-02-2013 Antifungals

Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Ertapenem for Injection 10-04-2007

Antibiotic

2. Ertapenem for Injection 15-01-2008

1gm/vial

Addl.Indication

For the prophylaxis of surgical site infections following effective

colorectal surgery

Adverse Reaction:

Adults:

The most common adverse reactions (.5%) in patients treated with INVANZ,

including those who were switched to therapy with an oral antimicrobial,

were diarrhea, nausea, headache and infused vein complication.

In the prophylaxis indication the overall adverse experience profile was

generally comparable to that observed for ertapenem in other clinical trials.

Pediatrics:

Adverse reactions in this population were comparable to adults.

The most common adverse reactions (.5%) in pediatric patients treated

with INVANZ, including those who were switched to therapy with an oral

antimicrobial, were diarrhea, vomiting and infusion site pain.

Contra-Indications:

CONTRAINDICATIONS

Known hypersensitivity to product components or anaphylactic reactions

to Beta-lactams.

Due to the use of lidocaine HCl as a diluent, INVANZ administered

intramuscularly is contraindicated in patients with a known hypersensitivity to

local anesthetics of the amide type.

WARNINGS AND PRECAUTIONS

Serious hypersensitivity (anaphylactic) reactions have been reported

in patients receiving £]-lactams.

Seizures and other central nervous system adverse experiences have been

reported during treatment.

Co-administration of INVANZ with valproic acid or divalproex sodium

reduces the serum concentration of valproic acid potentially increasing

the risk of breakthrough seizures.

Clostridium difficile-associated diarrhea (ranging from mild diarrhea

to fatal colitis): Evaluate if diarrhea occurs.

Caution should be taken when administering INVANZ intramuscularly

to avoid inadvertent injection into a blood vessel.

Dosages/ Overdosage Etc:

Indication-

Complicated intra-abdominal ifections
Community acquired pneumonia

Dosage-

1g once daily

Children - 3 months -12 years 15mg/kg body weight twice daily

INDICATIONS AND USAGE

INVANZ is a penem antibacterial indicated in adult patients and

pediatric patients (3 months of age and older) for the treatment of the

following moderate to severe infections caused by susceptible bacteria:

Complicated intra-abdominal infections.

Complicated skin and skin structure infections, including diabetic

foot infections without osteomyelitis.

Community-acquired pneumonia.

Complicated urinary tract infections including pyelonephritis.

Acute pelvic infections including postpartum endomyometritis,

septic abortion and post surgical gynecologic infections.

INVANZ is indicated in adults for the prophylaxis of surgical site infection

following elective colorectal surgery.

DOSAGE AND ADMINISTRATION

Do not mix or co-infuse INVANZ with other medications.

Do not use diluents containing dextrose (alpha D glucose).

INVANZ should be infused over 30 minutes in both the Treatment

and Prophylactic regimens.

Dosing considerations should be made in adults with advanced

or end-stage renal impairment and those on hemodialysis.

Treatment regimen:

Adults and pediatric patients 13 years of age and older.

The dosage should be 1 gram once a day intravenously

or intramuscularly.

Patients 3 months to 12 years of age should be administered 15 mg/kg

twice daily (not to exceed 1 g/day intravenously or intramuscularly.)

Intravenous infusion may be administered in adults and pediatrics

for up to 14 days or intramuscular injection for up to 7 days.

Prophylaxis regimen for adults:

1 gram single dose given 1 hour prior to elective colorectal surgery.

DOSAGE FORMS AND STRENGTHS

Vial 1 gram. (3) „h ADD-VantageR vial: 1 gram.

Patient Information:

PATIENT COUNSELING INFORMATION

1. Instructions for Patients

Patients should be advised that allergic reactions, including serious allergic reactions

could occur and that serious reactions may require immediate treatment.

Advise patients to report any previous hypersensitivity reactions to INVANZ,

other beta-lactams or other allergens.

Patients should be counseled to inform their physician if they are taking valproic acid

or divalproex sodium. Valproic acid concentrations in the blood may drop below

the therapeutic range upon coadministration with INVANZ.

If treatment with INVANZ is necessary and continued, alternative or supplemental

anti-convulsant medication to prevent and/or treat seizures may be needed.

Patients should be counseled that antibacterial drugs including INVANZ should only

be used to treat bacterial infections. They do not treat viral infections

(e.g., the common cold).

When INVANZ is prescribed to treat a bacterial infection, patients should be told

that although it is common to feel better early in the course of therapy, the medication

should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may

(1) decrease the effectiveness of the immediate treatment and

(2) increase the likelihood that bacteria will develop resistance and will not be

treatable by INVANZ or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the

antibiotic is discontinued.

Sometimes after starting treatment with antibiotics, patients can develop watery and

bloody stools (with or without stomach cramps and fever) even as late as

two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

By: Laboratoires Merck Sharp & Dohme-Chibret

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Pharmacology/ Pharmacokinetics:

CLINICAL PHARMACOLOGY

1. Mechanism of Action

Ertapenem sodium is a carbapenem antibiotic

2 Pharmacokinetics

The area under the plasma concentration-time curve (AUC) of ertapenem in adults

increased less-than dose-proportional based on total ertapenem concentrations

over the 0.5 to 2 g dose range, whereas the AUC increased greater-than

dose-proportional based on unbound ertapenem concentrations.

Ertapenem exhibits non-linear pharmacokinetics due to concentration-dependent

plasma protein binding at the proposed therapeutic dose

Pregnancy and lactation:

USE IN SPECIFIC POPULATIONS

1. Pregnancy

Pregnancy Category B

There are, no adequate and well-controlled trials 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.

2. Nursing Mothers

Ertapenem is excreted in human breast milk . Caution should be exercised when

INVANZ is administered to a nursing woman. INVANZ should be administered to

nursing mothers only when the expected benefit outweighs the risk.

3. Pediatric Use

Safety and effectiveness of INVANZ in pediatric patients 3 months to 17 years of age

are supported by evidence from adequate and well-controlled trials in adults,

.

INVANZ is not recommended in infants under 3 months of age as no data are available.

INVANZ is not recommended in the treatment of meningitis in the pediatric population

due to lack of sufficient CSF penetration.

4. Geriatric Use

Of the 1,835 patients in Phase 2b/3 trials treated with INVANZ, approximately 26 percent

were 65 and over, while approximately 12 percent were 75 and over.

No overall differences in safety or effectiveness were observed between these patients

and younger patients. but greater sensitivity of some older individuals cannot be ruled out.

Ertapenan - Carbapenem-(Jan 2008)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation