Carbanem500 mg/vial

Carbanem is a broad-spectrum carbapenem antibiotic administered by intravenous injection or infusion, reserved for treatment of serious and often resistant bacterial infections under hospital or close medical supervision.

Established / FDA-approved uses

• Complicated intra-abdominal infections (e.g. peritonitis, complicated appendicitis)
• Complicated skin and skin structure infections
• Bacterial meningitis (pediatric patients 3 months and older; also used in adults based on guideline support)

Guideline-supported / widely used indications

• Hospital-acquired and ventilator-associated (nosocomial) pneumonia
• Complicated urinary tract infections
• Septicaemia (bloodstream infections) and sepsis due to susceptible organisms
• Gynaecological infections, including endometritis
• Empiric treatment of presumed infection in febrile neutropenia (used as part of combination or empiric regimens)
• Infections caused by multidrug-resistant Gram-negative organisms when susceptibility is confirmed

Adjunct / specialised use

• Pulmonary exacerbations in cystic fibrosis patients (guideline/expert-supported use)

Carbanem should be used based on culture and sensitivity results whenever possible, and is generally reserved for serious infections or as an alternative when first-line antibiotics are unsuitable.

Each vial contains Meropenem Trihydrate equivalent to meropenem (anhydrous) as the active pharmaceutical ingredient, formulated as a sterile powder for reconstitution into a solution for intravenous injection or infusion. Common strengths available include 250 mg, 500 mg, and 1 g vials.

Carbanem is a carbapenem-class beta-lactam antibiotic with broad-spectrum bactericidal activity against many Gram-positive and Gram-negative aerobic and anaerobic bacteria. It is more stable than earlier carbapenems to renal dehydropeptidase-I, so it can be administered without a dehydropeptidase inhibitor.

Because of its broad spectrum and role as a "last-line" agent against resistant organisms, Carbanem is typically reserved for serious infections, is administered only by intravenous route in a hospital or clinical setting, and its use is guided by antibiotic stewardship principles to preserve its effectiveness.

Carbanem belongs to the carbapenem class of beta-lactam antibiotics.

Meropenem Trihydrate exerts its bactericidal effect by inhibiting bacterial cell wall synthesis. It penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding proteins (PBPs). Its high affinity for these PBPs results in rapid disruption of cell wall synthesis, leading to cell lysis and bacterial death.

Meropenem Trihydrate is stable against hydrolysis by most beta-lactamases, including penicillinases and cephalosporinases produced by Gram-negative and Gram-positive bacteria, giving it activity against a broad range of pathogens.

After intravenous administration, it distributes widely into body tissues and fluids, including cerebrospinal fluid when the meninges are inflamed. It is primarily eliminated by the kidneys, largely unchanged, with a plasma half-life of approximately one hour in adults with normal renal function.

Carbanem is given only by a healthcare professional, either as a slow intravenous (IV) bolus injection over 3-5 minutes or as an IV infusion over 15-30 minutes, after reconstitution and (for infusion) further dilution with a compatible IV fluid. It must not be mixed with or physically added to solutions containing other drugs.

Valproic acid / divalproex sodium: Co-administration with Carbanem significantly reduces serum valproic acid concentrations, which can lead to loss of seizure control and breakthrough seizures. Concurrent use is generally not recommended; if Carbanem must be used, alternative or supplemental anticonvulsant therapy and close monitoring of valproic acid levels and seizure activity should be considered.

Probenecid: Inhibits renal tubular secretion of meropenem, increasing plasma half-life and concentration. Concurrent administration of probenecid with Carbanem is not recommended.

Oral anticoagulants: Concurrent use with antibacterials including carbapenems may enhance the anticoagulant effect; monitoring of coagulation parameters is advised when used together.

Most adverse effects with Carbanem are mild to moderate. Commonly reported effects (each in ≤2% of patients) include:

• Diarrhea, nausea, vomiting, constipation
• Headache
• Rash, pruritus (itching)
• Pain, inflammation, or thrombophlebitis at the injection site
• Anemia and other changes in blood counts
• Elevated liver enzymes

Less common but serious effects include hypersensitivity reactions (see Contraindications and Precautions), Clostridioides difficile-associated diarrhea (see Precautions), seizures and other CNS effects (see Precautions), and rare reports of severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) and hemolytic anemia. Report any severe or persistent symptoms to your physician promptly.

Pregnancy: Data on the use of Carbanem in human pregnancy are limited. Animal studies have not shown evidence of fetal harm at doses relevant to clinical use. Carbanem should be used during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus; use should be under the guidance of a physician, generally reserved for serious infections where alternatives are unsuitable.

Lactation: Meropenem is excreted in low amounts in human breast milk. Caution is advised when administering Carbanem to a nursing mother; a physician should weigh the benefits of treatment against any potential risk to the breastfeeding infant.

Seizures and CNS effects: Seizures and other CNS adverse events have been reported with Carbanem, particularly in patients with a history of seizure disorders, CNS infections (e.g. meningitis) with underlying CNS abnormalities, or renal impairment where dosing has not been adjusted. Adhere strictly to the prescribed dose and interval, especially in renal impairment.

Clostridioides difficile-associated diarrhea (CDAD): As with nearly all antibacterial agents, Carbanem can cause CDAD, ranging from mild diarrhea to fatal colitis. This should be considered in any patient who develops diarrhea during or after treatment. If CDAD is suspected or confirmed, discontinue Carbanem if possible and manage appropriately.

Hypersensitivity reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported with beta-lactam antibiotics, including Carbanem. Discontinue immediately if an allergic reaction occurs and institute appropriate emergency treatment.

Renal impairment: Dose adjustment is required in patients with reduced creatinine clearance (see Dosage and Administration) to reduce the risk of seizures and other toxicity.

Hepatic impairment: Monitor liver function (transaminases, bilirubin) in patients with pre-existing liver disease during treatment.

Interaction with valproic acid: See Interactions section — concurrent use is generally not recommended due to risk of breakthrough seizures.

Antibiotic stewardship: Take Carbanem exactly as prescribed by your physician; do not stop, extend, skip doses, or share this medicine with others without medical advice, in order to reduce the risk of antibiotic resistance and treatment failure.

There is no specific antidote for Carbanem overdosage. In the event of a suspected overdose, seek immediate medical attention or contact emergency services / a poison control center. Carbanem can be removed from the body by hemodialysis, which may be considered in patients with significant renal impairment who receive an excessive dose. Treatment of overdose is supportive and symptomatic, guided by a physician.

Store at room temperature (below 30°C), away from light and moisture, unless otherwise directed on the pack. Do not freeze reconstituted or diluted solutions. Keep out of reach of children. Reconstituted/diluted solutions should be used promptly as directed by the healthcare provider or pharmacy, and any unused solution should be discarded appropriately.

Renal impairment

Dose adjustment is required based on creatinine clearance (see Dosage and Administration) to minimize the risk of seizures and other adverse effects.

Hepatic impairment

No dose adjustment is generally required, but liver function should be monitored during treatment with Carbanem in patients with pre-existing hepatic disease.

Elderly patients

Carbanem should be used with attention to age-related decline in renal function; dose adjustment may be needed based on creatinine clearance.

Pediatric patients

Carbanem is approved for use in infants and children 3 months of age and older for the labeled indications, with weight-based dosing (see Dosage and Administration). Safety and efficacy in infants younger than 3 months have not been established.

Duration of treatment with Carbanem depends on the type, site, and severity of the infection and the patient's clinical response, and is determined by the treating physician. Typical courses for most indications range from about 5 to 14 days; meningitis and certain deep-seated or severe infections may require longer courses. Treatment should not be stopped early even if symptoms improve, unless directed by a physician, to reduce the risk of relapse or resistance.

Carbanem powder for injection must be reconstituted before use, prepared by a healthcare professional under aseptic conditions.

• For IV bolus injection: Reconstitute with Sterile Water for Injection to a concentration of approximately 50 mg/mL. The resulting solution should be used within 3 hours at or below 25°C, or within 13 hours if stored at or below 5°C (refrigerated) prior to administration.
• For IV infusion: Reconstitute and further dilute with compatible IV fluid such as 0.9% Sodium Chloride Injection (stable up to 1 hour at or below 25°C, or 15 hours at or below 5°C) or 5% Dextrose Injection (use immediately after preparation).

Do not mix Carbanem with or physically add it to solutions containing other medications. Discard any unused reconstituted/diluted solution after the stated time.

Carbapenem antibiotic (beta-lactam class).

Meropenem Trihydrate inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs) on the bacterial cell wall. This binding disrupts the cross-linking of peptidoglycan, a key structural component of the bacterial cell wall, leading to cell wall breakdown, osmotic instability, and ultimately bacterial cell lysis and death (bactericidal action). It resists breakdown by many bacterial beta-lactamase enzymes, which broadens its spectrum of activity against resistant organisms.

B

Carbanem is approved for use in pediatric patients 3 months of age and older for complicated skin and skin structure infections, complicated intra-abdominal infections, and bacterial meningitis, using weight-based dosing (see Dosage and Administration). It is also commonly used, based on clinical guidelines, for other serious infections such as febrile neutropenia and hospital-acquired infections in this age group.

Safety and efficacy of Carbanem in infants younger than 3 months have not been established; use in this age group should be under close specialist supervision only when no suitable alternative exists.