cefuroxime reference
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(cefuroxime · DailyMed)
Valid Ghana · FDA Ghana

ROCETIL 250MG TABLETS

CEFUROXIME AXELU

FDA/SD.255-030398 antiinfectives for systemic use INN generic

What it does

Axelu is a medication used to help manage certain health conditions.

Commonly used for: specific health conditions as prescribed by a doctor

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.255-030398
Registration date
2025-03-05
Expiry date
2030-04-01
Status
Valid
Active ingredient
CEFUROXIME AXELU
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
J01DC - Second-generation cephalosporins
RxNorm RxCUI
2194
Manufacturer / MAH
Bharat Parenterals
Applicant / LTR
ROXIN GHANA LIMITED
Country of origin
-
Manufacturer location
144-146, Jarod Samlaya Road, vill Haripura Ta Savli, Vadodara, Dhanora, Gujarat 391510, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:33:07 · updated 2026-10-20 04:00:06

Drug Interactions

3
Check interactions

Pharmacodynamic Warnings

Cefuroxime appears in TABLE 2: Drugs that cause nephrotoxicity

Unknown (3)

Cephalosporins - increases exposure

Leflunomideispredictedtoincreasetheexposureto cephalosporins(cefaclor).oTheoretical

Unknown Theoretical

Cephalosporins - increases exposure

Nitisinone is predicted to increase the exposure to cephalosporins (cefaclor).

Unknown Study

Cephalosporins - increases exposure

Teriflunomide is predicted to increase the exposure to cephalosporins (cefaclor).

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About axelu

Axelu is a medication used to help manage certain health conditions.

What it treats

  • specific health conditions as prescribed by a doctor

How it works

Axelu works by affecting certain processes in the body to help improve health.

Who it's for

Axelu is for patients with conditions that require treatment as determined by a healthcare professional.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About cefuroxime

Cefuroxime is an antibiotic used to treat various infections.

What it treats

  • bacterial infections
  • pneumonia
  • bronchitis
  • urinary tract infections
  • skin infections

How it works

Cefuroxime works by stopping the growth of bacteria in the body.

Who it's for

It is suitable for adults and children with infections caused by bacteria.

Drug class

Cephalosporins

Cautions

  • • Be cautious if you are taking other medications that may harm the kidneys.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: axelu

AxelU, also known as sodium phenylbutyrate, is a medication primarily used in the treatment of urea cycle disorders, where it acts as a nitrogen-scavenging agent. It helps to reduce the levels of ammonia in the blood by providing an alternative pathway for the elimination of excess nitrogen, thus preventing hyperammonemia and its associated complications.

Indications

  • Urea cycle disorders
  • Hyperammonemia

Dosage

Children: Refer to specific guidelines and clinical practice recommendations for dosing in paediatric patients, as it varies based on individual conditions and response.

Adults: Refer to specific guidelines and clinical practice recommendations for dosing in adults, as it varies based on individual conditions and response.

Mechanism of action

AxelU is metabolized in the liver to phenylacetate, which conjugates with glutamine to form phenylacetylglutamine. This compound is excreted in the urine, allowing the body to excrete excess nitrogen in the form of urea, thereby reducing ammonia levels. This mechanism helps to alleviate the toxic effects of ammonia accumulation in patients with urea cycle disorders.

Pharmacodynamics

AxelU effectively lowers ammonia levels in the blood by promoting the excretion of nitrogen. It is particularly beneficial in conditions where the urea cycle is impaired, thus mitigating the risk of neurological damage and other complications associated with hyperammonemia. The drug's efficacy can vary based on the underlying urea cycle defect and the individual's metabolic state.

Pharmacokinetics

AxelU is rapidly absorbed after oral administration, with peak plasma concentrations typically occurring within one to two hours. It undergoes extensive hepatic metabolism, primarily converting to phenylacetate. The elimination half-life is approximately 1-3 hours, and the metabolites are primarily eliminated through the kidneys. Renal function should be monitored, as impaired renal function can affect drug clearance.

Contra-indications

  • Hypersensitivity to axelucal or any of its components
  • Severe hepatic impairment

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Fatigue
  • Headache
  • Dizziness
  • Skin rash

Interactions

  • Caution with other CNS depressants
  • May interact with anticoagulants
  • Monitor for increased effect with CYP450 inhibitors

Precautions

  • Use with caution in patients with a history of seizures
  • Monitor liver function regularly
  • Assess for potential drug interactions before prescribing

Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted.

Breast-feeding

It is not known whether axelu is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and light. Keep out of reach of children.

Formulations

  • Oral tablets
  • Injectable solution

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Cefuroxime

BNF-referenced

Cefuroxime is a second-generation cephalosporin antibiotic that is primarily used to treat a variety of bacterial infections. It is effective against both Gram-positive and Gram-negative bacteria, making it a broad-spectrum antibiotic suitable for various clinical indications. Cefuroxime operates by disrupting the synthesis of bacterial cell walls, leading to cell lysis and death. It is available in various forms, including oral tablets and injectable formulations.

Indications

  • Bacterial infections due to susceptible organisms
  • Complicated urinary tract infections
  • Pyelonephritis
  • Cellulitis
  • Erysipelas
  • Prophylaxis of infection from human bites
  • Acute diverticulitis
  • Superficial bacterial eye infections
  • Endophthalmitis prophylaxis after cataract surgery

Mechanism of action

Cefuroxime, like other beta-lactam antibiotics, binds to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall. This binding inhibits the third and final stage of bacterial cell wall synthesis. The resultant disruption leads to cell lysis, aided by bacterial cell wall autolytic enzymes such as autolysins. Cefuroxime may also interfere with an autolysin inhibitor, enhancing its bactericidal effect.

Pharmacodynamics

Cefuroxime is a bactericidal agent that works by inhibiting the synthesis of peptidoglycan, an essential component of the bacterial cell wall. This inhibition occurs through the blockade of the transpeptidation process, which is required for cross-linking of the cell wall structure. Cefuroxime is effective against various organisms, including aerobic Gram-positive bacteria such as Staphylococcus aureus and Streptococcus pneumoniae, as well as Gram-negative bacteria like Escherichia coli and Haemophilus influenzae, including strains that produce beta-lactamase.

Pharmacokinetics

Cefuroxime is well-absorbed after oral administration, with its bioavailability being enhanced when taken with food. The drug exhibits a volume of distribution indicating good tissue penetration. Cefuroxime is primarily eliminated by the kidneys, with renal clearance contributing significantly to its overall elimination. Dosage adjustments may be necessary in patients with renal impairment to prevent accumulation and toxicity.

Adverse effects

  • Diarrhea
  • Nausea
  • Vomiting
  • Rash
  • Allergic reactions
  • Thrombophlebitis at the injection site
  • Renal impairment

Interactions

  • Probenecid may increase cefuroxime levels
  • Other nephrotoxic drugs may enhance renal toxicity
  • Anticoagulants may have increased effects

Precautions

  • Use with caution in patients with renal impairment
  • Monitor for signs of superinfection
  • May cause allergic reactions in sensitive individuals
  • Caution in patients with a history of gastrointestinal disease

Pregnancy

Not known to be harmful, but should be used only if clearly needed.

Breast-feeding

Present in low concentrations in breast milk; generally considered appropriate to use.

Storage

Store in a cool, dry place away from direct light. Reconstituted solutions should be used immediately or stored at 2–8°C for a short time.

Formulations

  • Intravenous injection solution
  • Powder for solution for injection
  • Oral suspension
  • Tablets
BNF 85 (British National Formulary) p.597 BNF 85 (British National Formulary) p.1306 BNF for Children 2019-2020 p.351 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Cefuroxime

PubChem CID 5479529

Molecular formula: C16H16N4O8S

Mechanism of action

Cefuroxime, like the penicillins, is a beta-lactam antibiotic. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that cefuroxime interferes with an autolysin inhibitor.

Pharmacodynamics

Cefuroxime is a &beta;-lactam type antibiotic. More specifically, it is a second-generation cephalosporin. Cephalosporins work the same way as penicillins: they interfere with the peptidoglycan synthesis of the bacterial wall by inhibiting the final transpeptidation needed for the cross-links. This effect is bactericidal. Cefuroxime is effective against the following organisms: Aerobic Gram-positive Microorganisms: <i>Staphylococcus aureus</i>, <i>Streptococcus pneumoniae</i>, <i>Streptococcus pyogenes</i>. Aerobic Gram-negative Microorganisms: <i>Escherichia coli</i>, <i>Haemophilus influenzae</i> (including beta-lactamase-producing strains), <i>Haemophilus parainfluenzae</i>, <i>Klebsiella pneumoniae</i>, <i>Moraxella catarrhalis</i> (including beta-lactamase-producing strains), <i>Neisseria gonorrhoeae</i> (including beta-lactamase-producing strains). Spirochetes: <i>Borrelia burgdorferi</i>. Cefuroxime axetil is the prodrug

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.