Registered Kenya · PPB

PIMCEF 1G INJECTION

STERILE MIXTURE OF CEFEPIME HYDROCHLORIDE & L-ARGININE

H2009/19656/569 1000 MG antiinfectives for systemic use INN generic

What it does

Cefepime is an antibiotic used to treat various bacterial infections.

Commonly used for: bacterial infections, pneumonia, urinary tract infections, skin infections

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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.
H2009/19656/569
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
STERILE MIXTURE OF CEFEPIME HYDROCHLORIDE & L-ARGININE
Dosage form
1000 MG
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
J01DE - Fourth-generation cephalosporins
RxNorm RxCUI
20481
Manufacturer / MAH
Harleys
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
63 Westlands Rd, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 22:00:13 · updated 2026-03-23 04:45:21

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About cefepime

Cefepime is an antibiotic used to treat various bacterial infections.

What it treats

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

How it works

Cefepime works by killing bacteria or stopping their growth, helping to clear infections.

Who it's for

Cefepime is for adults and children who have infections caused by bacteria.

Cautions

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

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

About l-arginine

L-arginine is an amino acid that helps improve blood flow and may support heart health.

What it treats

  • angina (chest pain)
  • heart disease
  • erectile dysfunction
  • high blood pressure (hypertension)
  • wound healing

How it works

L-arginine helps the body produce nitric oxide, which relaxes blood vessels and improves blood circulation.

Who it's for

L-arginine may be suitable for adults looking to improve their cardiovascular health or manage related conditions.

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

About mixture

This medicine is a mixture used to treat various health conditions.

What it treats

  • general health issues
  • specific ailments as prescribed by a healthcare provider

How it works

The mixture contains different ingredients that work together to help improve health or relieve symptoms.

Who it's for

This medicine is for individuals needing treatment for specific health problems, as determined by a healthcare professional.

Cautions

  • • Consult a healthcare provider before use, especially if you have other health conditions or are taking other medications.
  • • Do not exceed the recommended usage.
  • • Keep out of reach of children.

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

About sterile

Sterile refers to products that are free from germs and bacteria, ensuring safety for use in medical settings.

What it treats

  • Preparing medications
  • Surgical procedures
  • Injections and infusions

How it works

Sterile products are treated to eliminate all forms of microorganisms, making them safe for medical use.

Who it's for

Patients requiring clean and safe medical products, such as those undergoing surgery or receiving injections.

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

Clinical monograph: Cefepime

BNF-referenced

Cefepime is a fourth-generation cephalosporin antibiotic with broad-spectrum activity against both Gram-positive and Gram-negative bacteria. It is particularly effective in treating severe infections caused by organisms resistant to third-generation cephalosporins. Cefepime acts by inhibiting bacterial cell wall synthesis, leading to cell lysis and death of the bacteria. It is commonly used for hospital-acquired pneumonia, complicated urinary tract infections, and other severe bacterial infections.

Indications

  • Bacterial infections due to sensitive Gram-positive and Gram-negative bacteria
  • Complicated urinary tract infections
  • Acute pyelonephritis
  • Hospital-acquired pneumonia
  • Ventilator-associated pneumonia

Dosage

Adults: By intravenous infusion: 1 g every

Mechanism of action

Cefepime disrupts bacterial cell walls by binding to and inhibiting transpeptidases known as penicillin-binding proteins (PBPs), which are critical for the synthesis of the peptidoglycan layer. This action leads to the lysis and death of susceptible microorganisms. Cefepime exhibits strong binding affinity for PBP-3 and PBP-1 in Escherichia coli and Pseudomonas aeruginosa, and PBP-2 in E. coli and Enterobacter cloacae.

Pharmacodynamics

Cefepime has a broad range of activity against various Gram-negative bacteria, including Enterobacter spp., Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa, as well as Gram-positive bacteria such as Staphylococcus aureus (methicillin-susceptible strains), Streptococcus pneumoniae, Streptococcus pyogenes, and Viridans group streptococci. It is more stable against beta-lactamases compared to third-generation cephalosporins and is less likely to induce resistance mechanisms in bacteria.

Pharmacokinetics

Cefepime is well-absorbed when administered intravenously or intramuscularly. It has a volume of distribution of 0.2 to 0.3 L/kg and is primarily eliminated through the kidneys, with a half-life of approximately 2 hours in patients with normal renal function. Dose adjustments are necessary for patients with renal impairment to prevent accumulation and potential toxicity.

Adverse effects

  • Anemia
  • Hypotension
  • Electrolyte imbalance
  • Thrombocytosis
  • Gastrointestinal disorders
  • Anxiety
  • Constipation
  • Insomnia
  • Angina pectoris
  • Arrhythmias
  • Dyspnoea
  • Genital pruritus
  • Paraesthesia
  • Seizure

Precautions

  • Monitor renal function in patients with renal impairment
  • Use with caution in patients with a history of antibiotic-associated colitis
  • Caution in patients with known allergies to beta-lactam antibiotics

Pregnancy

Manufacturer advises to use only if potential benefit outweighs risk, with toxicity observed in animal studies.

Breast-feeding

Manufacturer advises avoiding use due to lack of available information.

Storage

Store in a cool, dry place, protected from light. Follow specific storage instructions as indicated on the product label.

Formulations

  • Injection, powder for solution for infusion (1 g and 2 g vials)
  • Injection, powder for solution for infusion (500 mg and 1 g vials)
BNF 85 (British National Formulary) p.603 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.

Clinical monograph: larginine

BNF-referenced

L-arginine is a semi-essential amino acid that serves as a precursor for nitric oxide (NO) production in the body. It plays critical roles in various physiological processes, including cardiovascular function, immune response, and tissue repair. L-arginine supplementation is often utilized for its potential benefits in enhancing blood flow, promoting wound healing, and supporting muscle growth.

Indications

  • Cardiovascular diseases
  • Erectile dysfunction
  • Peripheral arterial disease
  • Wound healing
  • Muscle growth and recovery
  • Immune system support

Dosage

Children: For paediatric dosing, it is important to refer to the BNF for Children for appropriate guidelines based on the child's age, weight, and clinical condition.

Adults: The typical dosage for adults varies based on the condition being treated, but common oral doses range from 2 to 30 grams per day, divided into multiple doses. For specific dosing recommendations, please refer to the BNF.

Mechanism of action

L-arginine is converted to nitric oxide by nitric oxide synthase (NOS), which is crucial for vascular function and blood flow regulation. NO activates guanylate cyclase, leading to increased levels of cyclic GMP, a secondary messenger that mediates vasodilation and other cellular responses. This pathway is vital in both the cardiovascular and immune systems, with different isoforms of NOS (eNOS, nNOS, iNOS) contributing to various physiological effects.

Pharmacodynamics

L-arginine has been shown to enhance immune responses, improve wound healing, stimulate growth hormone release, and support muscle hypertrophy and tissue repair. Its role in nitric oxide production aids in vasodilation, improving blood circulation and oxygen delivery to tissues, which is essential for recovery and regeneration.

Pharmacokinetics

L-arginine is absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1-2 hours after oral administration. It is metabolized primarily in the liver and kidneys, with a half-life of approximately 1-2 hours. The bioavailability of L-arginine can be influenced by dietary intake and metabolic conditions.

Adverse effects

  • Gastrointestinal disturbances
  • Nausea
  • Diarrhea
  • Abdominal pain
  • Hypotension
  • Allergic reactions

Interactions

  • Antihypertensive agents may have additive effects leading to increased hypotension
  • Sildenafil and other medications for erectile dysfunction may have enhanced effects when used with L-arginine

Precautions

  • Caution in patients with a history of asthma or allergies
  • Use with caution in patients with hypotension
  • Monitor blood pressure in patients taking antihypertensive medications

Pregnancy

The safety of L-arginine in pregnancy has not been established. Consult a healthcare provider before use.

Breast-feeding

L-arginine is excreted in breast milk, and its safety during breastfeeding is not well established. Consult a healthcare provider.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Oral tablets
  • Powder for oral solution
  • Capsules

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: mixture

A mixture in pharmacological terms typically refers to a combination of two or more active pharmaceutical ingredients in a fixed or variable ratio, often used to enhance therapeutic efficacy, reduce side effects, or target multiple pathways in disease management. Mixtures can come in various formulations such as suspensions, syrups, or emulsions, and are commonly used in treating a variety of conditions, including respiratory diseases, pain management, and infections.

Indications

  • Pain relief
  • Fever reduction
  • Treatment of respiratory conditions
  • Management of inflammation
  • Cough relief
  • Antibiotic therapy

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines tailored to paediatric populations, as dosages will depend on the formulation and active ingredients used in the mixture.

Adults: Refer to specific drug combinations for appropriate dosing recommendations, as dosages will vary widely based on the active ingredients included.

Mechanism of action

The mechanism of action of a mixture depends on the specific active ingredients included. For instance, if the mixture consists of an analgesic and an anti-inflammatory, the analgesic may work by inhibiting cyclooxygenase enzymes, thus reducing prostaglandin synthesis, while the anti-inflammatory may reduce inflammation through modulation of immune cell activity. The synergistic effects can enhance overall therapeutic outcomes.

Pharmacodynamics

Pharmacodynamics of mixtures varies based on the components involved. Each ingredient may exert its pharmacological effects through different pathways, leading to a combined effect that is often greater than the sum of individual drugs. This can involve interactions at receptor sites, modulation of enzyme activity, or alteration of metabolic pathways, improving clinical outcomes for patients.

Pharmacokinetics

Pharmacokinetics of drug mixtures is influenced by the individual pharmacokinetic profiles of each constituent. This includes absorption rates, distribution volumes, metabolism pathways, and elimination half-lives. The presence of multiple active ingredients can lead to altered absorption due to interactions, changes in protein binding, or competition for metabolic enzymes. Understanding these dynamics is crucial for optimizing dosing regimens and minimizing potential adverse effects.

Pregnancy

The safety of this mixture during pregnancy has not been established. Use only if the potential benefits outweigh the risks.

Breast-feeding

Caution is advised when using this mixture while breastfeeding. Consult a healthcare professional for guidance.

Storage

Store in a cool, dry place, away from direct sunlight and moisture. Ensure that the container is tightly closed.

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: sterile

Sterile refers to a state in which a substance, typically a pharmaceutical product or medical device, is free from all living microorganisms, including bacteria, viruses, fungi, and spores. Achieving sterility is essential for products intended for injection, surgical use, or any application where the introduction of microbes could lead to infection or contamination. Sterilization methods include autoclaving, filtration, ethylene oxide gas, and radiation.

Indications

  • Surgical procedures
  • Injection of medications
  • Preparation of sterile pharmaceutical products
  • Management of open wounds
  • Use in controlled environments such as hospitals and laboratories

Dosage

Children: Refer to specific drug monographs for dosage information as sterile itself is not a pharmacological agent.

Adults: Refer to specific drug monographs for dosage information as sterile itself is not a pharmacological agent.

Mechanism of action

Sterility itself does not have a mechanism of action as it is a state of cleanliness and does not interact with biological systems. However, the methods used to achieve sterility, such as heat or chemical agents, act by denaturing proteins, disrupting cellular structures, or damaging nucleic acids in microorganisms, leading to their inactivation or destruction.

Pharmacodynamics

The pharmacodynamics of sterile techniques primarily involves the prevention of microbial infection and contamination when administering medications. By ensuring that products are sterile, the risk of adverse effects related to infections is minimized. The effectiveness of sterilization methods can be influenced by factors such as temperature, duration of exposure, and the type of microorganisms present.

Pharmacokinetics

As sterility does not pertain to a specific drug, pharmacokinetics is not applicable. However, the pharmacokinetics of a drug will depend on its formulation, route of administration, and the presence of preservatives or stabilizers that may be used alongside sterile preparations.

Pregnancy

Sterile preparations are generally considered safe during pregnancy as they are used to provide hydration, nutrition, or medications in a controlled manner, but specific formulations should be assessed individually.

Breast-feeding

Sterile solutions used for hydration or nutritional support are typically safe during breastfeeding, but any specific additives or medications within the solutions should be evaluated for safety.

Storage

Sterile solutions should be stored in a cool, dry place, protected from light, and should be used before the expiration date. Once opened, they may have specific storage requirements based on the formulation.

Formulations

  • Sterile saline solution
  • Sterile water for injection
  • Sterile dextrose solution
  • Sterile electrolyte solutions

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: Cefepime

PubChem CID 5479537

Molecular formula: C19H24N6O5S2

Mechanism of action

Cefepime is a bactericidal cephalosporin with a mode of action similar to other beta-lactam antibiotics. Cefepime disrupts bacterial cell walls by binding and inhibiting transpeptidases known as penicillin-binding proteins (PBPs), which are enzymes involved in the final stages of peptidoglycan layer synthesis. This results in the lysis and death of susceptible microorganisms. Cefepime has a broad spectrum of _in vitro_ activity that includes both Gram-positive and Gram-negative bacteria. Cefepime has affinity for PBP-3 and PBP-1 in _Escherichia coli_ and _Pseudomonas aeruginosa_, as well as PBP-2 in _E. coli_ and _Enterobacter cloacae_.

Pharmacodynamics

Cefepime is a fourth-generation cephalosporin antibiotic. It is active against Gram-negative bacteria such as _Enterobacter_ spp., _Escherichia coli_, _Klebsiella pneumoniae_, _Proteus mirabilis_ and _Pseudomonas aeruginosa_, and Gram-positive bacteria such as _Staphylococcus aureus_ (methicillin-susceptible isolates only), _Streptococcus pneumoniae_, _Streptococcus pyogenes_ and Viridans group streptococci. Compared to third-generation cephalosporins, cefepime has an extended Gram-negative coverage. Whereas other cephalosporins are degraded by plasmid- and chromosome-mediated beta-lactamases, cefepime is stable and not significantly hydrolyzed by these enzymes. Cefepime is also a poor inducer of type 1 beta-lactamases and, therefore, a good alternative against bacteria resistant to third-generation cephalosporins. In animal models of infection, the time that the unbound plasma concentration of cefepime exceeds the minimum inhibitory concentration (MIC) of infecting organisms has been shown to correlate with treatment efficacy. It has been suggested that cefepime can cross the inflamed blood-brain barrier. This, along with its ability to inhibit γ-aminobutyric acid (GABA), could lead to the neurotoxic effects observed in some of the patients treated with cefepime.

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

Molecular reference: l-arginine

PubChem CID 6322

Molecular formula: C6H14N4O2

Mechanism of action

Many of supplemental L-arginine's activities, including its possible anti-atherogenic actions, may be accounted for by its role as the precursor to nitric oxide or NO. NO is produced by all tissues of the body and plays very important roles in the cardiovascular system, immune system and nervous system. NO is formed from L-arginine via the enzyme nitric oxide synthase or synthetase (NOS), and the effects of NO are mainly mediated by 3,'5' -cyclic guanylate or cyclic GMP. NO activates the enzyme guanylate cyclase, which catalyzes the synthesis of cyclic GMP from guanosine triphosphate or GTP. Cyclic GMP is converted to guanylic acid via the enzyme cyclic GMP phosphodiesterase. NOS is a heme-containing enzyme with some sequences similar to cytochrome P-450 reductase. Several isoforms of NOS exist, two of which are constitutive and one of which is inducible by immunological stimuli. The constitutive NOS found in the vascular endothelium is designated eNOS and that present in the brain, spinal cord and peripheral nervous system is designated nNOS. The form of NOS induced by immunological or inflammatory stimuli is known as iNOS. iNOS may be expressed constitutively in select tissues such as lung epithelium. All the nitric oxide synthases use NADPH (reduced nicotinamide adenine dinucleotide phosphate) and oxygen (O2) as cosubstrates, as well as the cofactors FAD (flavin adenine dinucleotide), FMN (flavin mononucleotide), tetrahydrobiopterin and heme. Interestingly, ascorbic acid appears to enhance NOS activity by increasing intracellular tetrahydrobiopterin. eNOS and nNOS synthesize NO in response to an increased concentration of calcium ions or in some cases in response to calcium-independent stimuli, such as shear stress. In vitro studies of NOS indicate that the Km of the enzyme for L-arginine is in the micromolar range. The concentration of L-arginine in endothelial cells, as well as in other cells, and in plasma is in the millimolar range. What this means is that, under physiological conditions, NOS is saturated with its L-arginine substrate. In other words, L-arginine would not be expected to be rate-limiting for the enzyme, and it would not appear that supraphysiological levels of L-arginine which could occur with oral supplementation of the amino acid^would make any difference with regard to NO production. The reaction would appear to have reached its maximum level. However, in vivo studies have demonstrated that, under certain conditions, e.g. hypercholesterolemia, supplemental L-arginine could enhance endothelial-dependent vasodilation and NO production.

Pharmacodynamics

Studies have shown that is has improved immune responses to bacteria, viruses and tumor cells; promotes wound healing and regeneration of the liver; causes the release of growth hormones; considered crucial for optimal muscle growth and tissue repair.

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

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