Aronem^®

Aronem is the preparation of Meropenem which is a broad-spectrum carbapenem antibiotic which is active against gram-positive and gram- negative bacteria. It is relatively stable to human dehydropeptidase-1 (DHP-1). Meropenem exerts its bactericidal action by interfering with bacterial cell wall synthesis. The basis of the potent bactericidal action of Meropenem against a broad spectrum of aerobic and anaerobic bacteria are ease of penetration into bacterial cell walls, high level of stability to all ß-lactamases and marked affinity for the penicillin binding proteins (PBPs).

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Aronem is indicated for treatment of:

• Pneumonia and nosocomial pneumonia
• Urinary tract infections
• Intra-abdominal infections
• Gynaecological infections
• Skin and skin structure infections
• Meningitis
• Septicaemia
• Empiric treatment for presumed infections in adult patients with febrile neutropenia
• Polymicrobial infections
• Surgical prophylaxis
• Respiratory tract infections in cystic fibrosis

Route of administration: Aronem® should be administered in intravenous route.

Adult patients
The adult dose is Aronem 500 mg to 1 g three times daily by IV infusion over 15-30 minutes or as IV bolus over 3-5 minutes.

Pneumonia, UTI, gynaecological infections, skin and skin structure infections: 500 mg IV injection or infusion every 8 hours.
Nosocomial pneumonia, peritonitis, presumed infections in neutropenic patients and septicaemia: 1g IV every 8 hours.
Intra-abdominal infections: 500 mg to 1 g IV every 8 hours.
Exacerbations of chronic lower respiratory tract infections in cystic fibrosis: Upto 2 g IV every 8 hours.
Meningitis: 2 g IV every 8 hours.

Pediatric patients
For children over 3 months to 12 years of age: 10 to 20 mg/kg every 8 hours.
For children aged 4 to 18 years with cystic fibrosis: 25 to 40 mg/kg every 8 hours.
Intra-abdominal infections: 20 mg/kg every 8 hours.
In meningitis: 40 mg/kg every 8 hours.
In children of 50 kg weight, adult dosage should be used. Dose should be depended on type and severity of infection, pathogen and the condition of the patient.

Renal impairment
Dosage should be reduced in patients with CrCl < 51 ml/min as below:
CrCl 26-50 ml/min: Recommended dose every 12 hours.
CrCl 10-25 ml/min: Half of recommended dose every 12 hours.
CrCl <10 ml/min: Half of recommended dose every 24 hours.
In patients under hemodialysis, it should be administered after haemodialysis. There is no experience with the use of Aronem in patients under peritoneal dialysis.

Administration Instruction
The content of one vial is to be dissolved in 5 ml water for injection for 250 mg IV injection, 10 ml water for injection for 500 mg IV injection and in 20 ml water for injection for 1 g IV injection.

Preparation for injection
Bolus
Aronem® 500 mg IV injection vials should be constituted with 10 ml sterile water for injection / Aronem 1 g IV injection vials should be constituted with 20 ml sterile water for injection (5 ml per 250 mg Meropenem). Aronem® 250 mg vial is reconstituted with 5 ml water for injection. This provides an approximate concentration of 50 mg/ml.

Infusion
Aronem® (500 mg and 1 g) 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.

Aronem® 250 mg
Preparation of 1 mg/ml infusion
Discard 5 ml of solution from 250 ml of sodium chloride (0.9%) and mix 5 ml reconstituted meropenem solution with sodium chloride (0.9%) to prepare 250 ml meropenem infusion.
Preparation of 20 mg/ml infusion
5 ml reconstituted meropenem solution is mixed with 7.5 ml sodium chloride (0.9%) to prepare 12.5 ml solution.

Aronem is compatible with following infusion fluids: 0.9% sodium chloride, 5% or 10% glucose, 5% glucose with 0.02% sodium bicarbonate, 5% glucose with 0.9% sodium chloride, 5% glucose with 0.225% sodium chloride, 5% glucose with 0.15% potassium chloride and mannitol 2.5% or 10% solution.

Pregnancy: There are no adequate and well-controlled studies in pregnant women with meropenem. Meropenem should not be used in pregnancy unless the potential benefit justifies the potential risk to the fetus.

Lactation: There is no information regarding the presence of meropenem in human milk, the effects on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on the breastfed infant from meropenem or from the underlying maternal condition.

Use in children and adolescents
Safety and effectiveness have not been established in children under 3 months of age.

Monitor serum transaminase and bilirubin levels when used in hepatic disease. Meropenem is 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 when used as monotherapy for known or suspected Pseudomonas aeruginosa lower respiratory tract infections.

The most common side effects are thrombocythaemia, headache, diarrhoea, vomiting, nausea, abdominal pain, rash, pruritus, disturbances in liver function test, inflammation and pain in administration site.

It is contraindicated in patients with history of known hypersensitivity to meropenem or β-lactams or any other components of this product.

Drug interaction with medication: Caution should be taken in concomitant use with warfarin and potentially nephrotoxic drugs. Concomitant use with probenecid is not recommended. Meropenem may reduce serum valproic acid level.

Drug interaction with food and others: Not applicable.

In case of overdose, treatment should be symptomatic and supportive measures instituted as required.

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Aronem 250 mg IV injection/infusion: Each vial contains Meropenem USP 250 mg as Meropenem Trihydrate.
Aronem 500 mg IV injection: Each vial contains Meropenem USP 500 mg as Meropenem Trihydrate.
Aronem 1 g IV injection: Each vial contains Meropenem USP 1 g as Meropenem Trihydrate.

Storage
Powder for injection/infusion: Store below 30⁰C in a dry place, protected from light. Keep away from the reach of children.

For injection: Reconstituted vial can be stored for 3 hours at up to 25°C.
Reconstituted vial can be stored for 13 hours at (2-8)°C.

For infusion: Reconstituted vial mixed with sodium chloride (0.9%) injection can be stored for 1 hour at up to 25°C & 15 hours at (2-8)°C.

Packing
Aronem® 250 mg IV injection/infusion: Carton containing one vial of Meropenem USP 250 mg sterile powder and one ampoule of 5 ml water for injection BP, one disposable syringe (5 ml), one alcohol pad, one first aid bandage & one baby needle.

Aronem® 500 mg IV injection: Carton containing one vial of Meropenem USP 500 mg sterile powder and one ampoule of 10 ml water for injection BP, one disposable syringe (10 ml), one butterfly needle, one alcohol pad & one first aid bandage.

Aronem® 1 g IV injection: Carton containing one vial of Meropenem USP 1 g sterile powder and two ampoules of 10 ml water for injection BP, one disposable syringe (20 ml), one butterfly needle, one alcohol pad & one first aid bandage.