Newropenem

Newropenem Uses, Dosage, Side Effects, Food Interaction and all others data.

Newropenem is a carbapenem antibiotic for parenteral use. It is structurally similar to imipenem but is stable to human dehydropeptidase-1 (DHP-1). It shows potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative, aerobic and anaerobic bacteria as it can penetrates bacterial cell wall excellently, it has high level of stability to all serine ß-lactamases and it has marked affinity for the Penicillin Binding Proteins (PBPs).

Newropenem is a broad-spectrum carbapenem antibiotic. It is active against Gram-positive and Gram-negative bacteria. Newropenem exerts its action by penetrating bacterial cells readily and interfering with the synthesis of vital cell wall components, which leads to cell death.

Trade Name Newropenem
Availability Prescription only
Generic Meropenem
Meropenem Other Names Meropenem, Meropenemum
Related Drugs amoxicillin, doxycycline, ciprofloxacin, cephalexin, metronidazole, azithromycin, clindamycin, ceftriaxone, levofloxacin, Augmentin
Type
Formula C17H25N3O5S
Weight Average: 383.463
Monoisotopic: 383.151491615
Protein binding

Approximately 2%.

Groups Approved, Investigational
Therapeutic Class Other beta-lactam Antibiotics
Manufacturer
Available Country South Korea
Last Updated: September 19, 2023 at 7:00 am
Newropenem
Newropenem

Uses

Newropenem IV is used for treatment in adults and children for the following infections caused by single or multiple bacteria sensitive to meropenem.

  • Pneumonia and Nosocomial Pneumonia
  • Urinary Tract Infections
  • Intra-abdominal Infections
  • Gynaecological Infections, such as endometritis and pelvic inflammatory disease
  • Skin and Skin Structure Infections
  • Meningitis
  • Septicaemia

Empiric treatment, for presumed infections in adult patients with febrile neutropenia, used as monotherapy or in combination with anti-viral or anti-fungal agents.

Newropenem is also used to associated treatment for these conditions: Bacterial Infections, Complicated Intra-Abdominal Infections, Meningitis, Bacterial, Complicated Bacterial Urinary Tract Infections, Complicated skin infection bacterial

How Newropenem works

The bactericidal activity of meropenem results from the inhibition of cell wall synthesis. Newropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding- protein (PBP) targets. Its strongest affinities are toward PBPs 2, 3 and 4 of Escherichia coli and Pseudomonas aeruginosa; and PBPs 1, 2 and 4 of Staphylococcus aureus.

Dosage

Newropenem dosage

As with other antibiotics, caution may be required in using Newropenem 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. Newropenem should be given as an intravenous bolus injection over approximately 3-5 minutes or by intravenous infusion over approximately 15 to 30 minutes using the specific available presentations.

Adults:

The dosage and duration of therapy should be established depending on type and severity of infection and the condition of the patient. The recommended daily dosage of adult is as follows:

  • Pneumonias, Urinary tract infections, gynaecological infections such as endometritis and pelvic inflammatory disease; skin and skin structure infections: Newropenem 500 mg IV every 8 hours
  • Nosocomial pneumonias, peritonitis, presumed infections in neutropenic patients and septicaemia: Newropenem 1 g IV every 8 hours
  • Meningitis: Newropenem 2 g IV every 8 hours
  • Cystic fibrosis: Newropenem IV up to 2 g every 8 hours

Children:

  • Children 0 to 3 months: Efficacy and tolerability in children under 3 months old have not been established; therefore Newropenem is not recommended.
  • For children over 3 months to 12 years of age: The recommended dose of Newropenem IV is 10 to 20 mg/kg every 8 hours depending on type and severity of infection, susceptibility of the pathogen and the condition of the patient.
  • For children aged 4 to 18 years with cystic fibrosis: The doses ranging of Newropenem IV is 25 to 40 mg/kg every 8 hours.
  • In children 50 kg weight: Adult dosage should be used.
  • In meningitis: The recommended dose of Newropenem IV is 40 mg/kg every 8 hours.
  • There is no experience in children with hepatic or renal impairment.

Elderly:

  • No dosage adjustment is required for the elderly with normal renal function or creatinine clearance values above 50 ml/min.

The content of one vial is to be dissolved in 10 ml water for injection for Newropenem 500 mg IV injection and 20 ml water for injection for Newropenem 1 gm IV injection.

Preparation for injection:

Bolus: Newropenem 500 mg IV injection vials should be constituted with 10 ml sterile water for injections /Newropenem 1g IV injection vials should be constituted with 20 ml sterile water for injections (5 ml per 250 mg meropenem). This provides an approximate concentration of 50 mg/ml. Injection for bolus administration, may be stored for up to 2 hours at controlled room temperature 25°C or for up to 12 hours at 4°C.

Infusion: Newropenem (500 mg and 1 gm) IV injection vials may be directly constituted with a compatible infusion fluid (50 to 200 ml). Alternatively, an injection vial may be constituted, then the resulting solution added to an IV container and further diluted with an appropriate infusion fluid, as needed.

Side Effects

Newropenem is generally well tolerated. Side effects like inflammation, thrombophlebitis, pain at the site of injection, skin reactions like rash, pruritus, urticaria, abdominal pain, nausea, vomiting, diarrhoea, headache, parasthesiae may occur.

Toxicity

In mice and rats, large intravenous doses of meropenem (2200-4000 mg/kg) have been associated with ataxia, dyspnea, convulsions, and mortalities.

Precaution

Caution in patients with history of hypersensitivity to carbapenems or other β-lactam antibiotics. Before initiating therapy with Newropenem, careful inquiry should be made concerning previous hypersensitivity reactions to β-lactam antibiotics. If an allergic reaction to Newropenem occurs, the drug should be discontinued and appropriate measures should be taken. Monitor transaminase and bilirubin levels when used in hepatic disease. Not recommended for methicillin-resistant staphylococci infections. Monitor for overgrowth of non susceptible organisms. In patients who develop diarrhoea, consider diagnosis of pseudomembranous colitis. Caution in individuals with a history of gastro-intestinal complaints, particularly colitis. Caution if to be co-administered with potentially nephrotoxic drugs. Co-administration with probenicid not recommended. Meronem may reduce serum valproic acid levels, sub-therapeutic levels may occur. No specific drug interaction data are available. Caution when used as monotherapy for known or suspected Pseudomonas aeruginosa lower respiratory tract infections, regular sensitivity testing is recommended.

Interaction

Probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion, with the effect of increasing the elimination half-life and plasma concentration of meropenem. Newropenem may reduce serum valproic acid levels. Sub therapeutic levels may be reached in some patients.

Food Interaction

No interactions found.

Newropenem Hypertension interaction

[Moderate] Parenteral meropenem is formulated with sodium carbonate to adjust the pH of the reconstituted solution and contains 90.2 mg (3.92 mEq) of sodium per each gram of meropenem activity.

The sodium content should be considered in patients with conditions that may require sodium restriction, such as congestive heart failure, hypertension, and fluid retention.

Half Life

Approximately 1 hour in adults and children 2 years of age and older with normal renal function. Approximately 1.5 hours in children 3 months to 2 years of age.

Elimination Route

Approximately 70% of the intravenously administered dose is recovered as unchanged meropenem in the urine over 12 hours, after which little further urinary excretion is detectable.

Pregnancy & Breastfeeding use

The safety of Newropenem in human pregnancy has not been evaluated. Animal studies have not shown any adverse effect on the developing foetus. Newropenem should not be used in pregnancy unless the potential benefit justifies the potential risk to the foetus. Newropenem is detectable at very low concentrations in animal breast milk. It should be used in lactating women unless the potential benefit justifies the potential risk to the baby.

Contraindication

Newropenem is contraindicated in patients who have demonstrated hypersensitivity to this product.

Special Warning

Renal Impairment:

  • CrCl 10-25: Half the usual dose 12 hrly.
  • CrCl 26-50: Usual dose 12 hrly.

Newropenem is cleared by haemodialysis; if continued treatment with Newropenem is necessary, it is recommended that the unit dose (based on the type and severity of infection) is administered at the completion of the haemodialysis procedure to restore therapeutically effective plasma concentrations. There is no experience with the use of Newropenem in patients under peritoneal dialysis.

Hepatic Impairment: No dosage adjustment needed.

Acute Overdose

Accidental overdosage could occur during therapy, particularly in patients with renal impairment. Treatment of overdosage should be symptomatic. In normal individuals, rapid renal elimination will occur; in subjects with renal impairment, haemodialysis will remove meropenem and its metabolite.

Storage Condition

Store in a cool and dry place (below 30° C). It is recommended to use freshly prepared solutions of Newropenem for IV injection and infusion. Reconstituted product should be used immediately and must be stored for no longer than 24 hours under refrigeration, only if necessary.

Innovators Monograph

You find simplified version here Newropenem

Newropenem contains Meropenem see full prescribing information from innovator Newropenem Monograph, Newropenem MSDS, Newropenem FDA label

FAQ

What is Newropenem used for?

Newropenem is an intravenous β-lactam antibiotic used to treat a variety of bacterial infections. Some of these include meningitis, intra-abdominal infection, pneumonia, sepsis, and anthrax. Newropenem injection is used to treat infections caused by bacteria.

How safe is Newropenem?

Newropenem is well tolerated and has good CNS and gastrointestinal tolerability when used for the treatment of serious bacterial infections in a wide range of adult and paediatric patient populations.

How does Newropenem work?

Newropenem exerts its action by penetrating bacterial cells readily and interfering with the synthesis of vital cell wall components, which leads to cell death.

What are the common side effects of Newropenem?

Common side effects of Newropenem are include:

  • Bluish lips or skin.
  • cold, clammy skin.
  • fast heartbeat.
  • fast, weak pulse.
  • itching, skin rash.
  • lightheadedness.
  • rapid, shallow breathing.

Is Newropenem safe during pregnancy?

Newropenem should be used during pregnancy only if clearly needed. Animal studies have failed to reveal evidence of fetal harm, although slight changes in fetal body weight were noted. There are no controlled data in human pregnancy.

Is Newropenem safe during breastfeeding?

Newropenem appears to be acceptable to use during breast-feeding.

How often can I take Newropenem?

Newropenem is usually given every 8 hours. The length of treatment depends on your general health, the type of infection you have, and how well you respond to the medication.

How long does Newropenem take to work?

Newropenem  takes 7–10 days. In influenzae type b infection, it takes 10–14 days for pneumoniae infection.

How long can I be on Newropenem?

Patients were allocated randomly to treatment with Newropenem administered as a 20–30-min, 500-mg intravenous infusion every 8 h for a minimum of 3 days and a maximum of 14 days.

Who should not take Newropenem ?

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Newropenem injection in children 3 months of age and older with complicated skin and skin structure infections and bacterial meningitis, and for children with intra-abdominal infections.

Can I overdose on Newropenem ?

Intentional overdosing of MERREM IV is unlikely, although accidental overdosing might occur if large doses are given to patients with reduced renal function. The largest dose of meropenem administered in clinical trials has been 2 grams given intravenously every 8 hours.

Does Newropenem cause liver problems?

Newropenem can cause severe liver injury.

Can Newropenem cause seizures?

For Newropenem the seizure rate for each agent is reported as less than 1%. However, as their use increases and expands into new patient populations, the rate of seizures with these agents may increase.

When should I stop taking Newropenem?

Continue to use this medication until the full prescribed treatment period is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Tell your doctor if your condition lasts or gets worse.

What happen If I missed Newropenem?

Skipping doses can increase your risk of infection that is resistant to medication. Newropenem will not treat a viral infection such as the flu or a common cold. If you use Newropenem long-term, you may need frequent medical tests.

What should if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

What should if I overdose?

Seek emergency medical attention.

Can Newropenem affects my kidney?

Newropenem is known to be substantially excreted by the kidney, and the risk of adverse reactions to this Newropenem may be greater in patients with renal impairment.

Can Newropenem affect my kidneys?

Newropenem is known to be substantially excreted by the kidney, and the risk of adverse reactions to this Newropenem may be greater in patients with renal impairment.

*** Taking medicines without doctor's advice can cause long-term problems.
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