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Dexpenem powder for injection

Dexa Medica

Ingredients in every vial

Meropenem 1 g

Each package contains

1 vial of 1 g

Dosage form

Powder for injection

Dosage formPowder for Injection

Flavour

None

W.H.O. classification

J01D
J01D

A.T.C. Level 1

Anatomical Main group

J - Antiinfectives for systemic use
J01D

A.T.C. Level 2

Therapeutic subgroup

J01 - Antibacterials for Systemic Use
J01D

A.T.C. Level 3

Pharmacological subgroup

J01D - Other Beta-Lactam Antibacterials in ATC

Available in

The Philippines

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CONSULT YOUR DOCTORSafety of this item for use while operating heavy machinery has not been established. Please consult your doctor.

Pregnancy

CAUTIONThis item may not be safe for use during pregnancy. Use with caution and after consultation with your doctor.

Lactation

CAUTIONThis item may not be safe for use during lactation. Use with caution and after consultation with your doctor.

Indication

Meropenem trihydrate is indicated as a single agent therapy in adults and children, for the treatment of the following infections caused by single or multiple susceptible strains of the designated microorganisms sensitive to meropenem:
Pneumonias and Nosocomial Pneumonias
Urinary Tract Infections (UTI)
Intra-abdominal infections
Gynecological infections
such as endometritis
Skin and skin-structure infections
Meningitis
Septicemia
Empirical treatment
for presumed infections in adult patients with febrile neutropenia, used as monotherapy or in combination with antiviral or antifungal agents
Meropenem trihydrate has proved efficacious alone or in combination with other antimicrobial agents in the treatment of polymicrobial infections.

There is no experience in pediatric patients with neutropenia or primary or secondary immunodeficiency.

Dosage

18 TO 65 YEARS OLD
The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patients.

The recommended daily dosage is as follows:
– Treatment of pneumonia, UTI, gynecological infections such as endometritis, skin and skin structure infections:
500 mg IV every 8 hours

– Treatment of nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients, septicemia:
1 g IV every 8 hours

– Meningitis:
2 g every 8 hours

As with other antibiotics, particular caution is recommended in using meropenem as monotherapy in critically ill patients with known or suspected Pseudomonas aeruginosa, lower respiratory tract infection. Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection.

12 TO 18 YEARS OLD
The dosage and duration of therapy shall be established depending on type and severity of infection and the condition of the patients.

The recommended daily dosage is as follows:
– Treatment of pneumonia, UTI, gynecological infections such as endometritis, skin and skin structure infections:
500 mg IV every 8 hours

– Treatment of nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients, septicemia:
1 g IV every 8 hours

– Meningitis:
2 g every 8 hours

As with other antibiotics, particular caution is recommended in using meropenem as monotherapy in critically ill patients with known or suspected Pseudomonas aeruginosa, lower respiratory tract infection. Regular sensitivity testing is recommended when treating Pseudomonas aeruginosa infection.

3 MONTHS TO 12 YEARS OLD
The recommended dose is 10 to 20 mg/kg every 8 hours depending on the type and severity of infection, susceptibility of the pathogen and the condition of the patient. In children over 50 kg weight, adult dosage should be used.

In meningitis the recommended dose is 40 mg/kg every 8 hours. There is no experience in children with renal impairment.

65 YEARS OLD AND ABOVE
No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/minute.

METHOD OF ADMINISTRATION
Meropenem trihydrate IV can be given as an intravenous bolus injection over approximately 5 minutes or by intravenous infusion over approximately 15 to 30 minutes.

PATIENTS WITH HEPATIC INSUFFICIENCY
No dosage adjustment is necessary in patients with hepatic insufficiency.

PATIENTS WITH IMPAIRED RENAL FUNCTION
Dosage should be reduced in patients with creatinine clearance less than 51 ml/minute, as below:

CrCl 26-50 ml/minute: 500 mg or 1 g or 2 g every 12 hours.
CrCl 10-25 ml/minute: 250 mg or 500 mg or 1 g every 12 hours.
CrCl <10 ml/minute: 250 mg or 500 mg or 1 g every 24 hours