Registered Zambia · ZAMRA

Safexin 500mg capsules

Cephalexin 500 mg

249/003 Capsules 500 mg antiinfectives for systemic use

What it does

Cefalexin is an antibiotic used to treat various bacterial infections.

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

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Registration & product details

Registration no.
249/003
Registration date
2024-11-21
Expiry date
2029-11-20
Status
Registered/Compliant
Active ingredient
Cephalexin 500 mg
Dosage form
Capsules
Strength
500 mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
J01DB - First-generation cephalosporins
RxNorm RxCUI
2231
Manufacturer / MAH
Saga Lifesciences
Applicant / LTR
Saga Lifesciences Limited
Country of origin
India
Manufacturer location
One42, 404, 405, Ambli Rd, nr. Ashok Vatika, Ashok Vatika, Iskcon, Ahmedabad, Gujarat 380058, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-03-12 00:04:57 · updated 2026-09-14 03:37:01

Drug Interactions

3
Check interactions

Pharmacodynamic Warnings

Cefalexin 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 Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About this medicine

Cefalexin is an antibiotic used to treat various bacterial infections.

What it treats

  • bacterial infections
  • skin infections
  • respiratory tract infections
  • urinary tract infections

How it works

Cefalexin works by killing bacteria or preventing their growth.

Who it's for

Cefalexin is for people who have bacterial infections.

Drug class

Cephalosporins

Cautions

  • • Be cautious if you are taking other drugs 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.

Clinical monograph: Cefalexin

BNF-referenced

Cefalexin, also known as Cephalexin, is a first-generation cephalosporin antibiotic used primarily for the treatment of bacterial infections. It is effective against a wide range of Gram-positive and some Gram-negative bacteria. Its mechanism of action involves the inhibition of bacterial cell wall synthesis, which leads to cell lysis and death. Cefalexin is commonly prescribed for skin infections, urinary tract infections, and other superficial infections.

Indications

  • Bacterial infections due to sensitive Gram-positive and Gram-negative bacteria
  • Skin infections
  • Soft-tissue infections
  • Uncomplicated urinary-tract infections
  • Acute diverticulitis (in combination with metronidazole)
  • Prophylaxis of recurrent urinary-tract infections

Dosage

Children: Child 1 month–11 years: 25 mg/kg 2–4 times a day (max. per dose 500 mg). Child

Adults: 250 mg every 6 hours, alternatively 500 mg every 8–12 hours; increased to 1–1.5 g every 6–8 hours for severe infections.

Mechanism of action

Cefalexin inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins located in the bacterial cytoplasmic membrane. This action prevents the cross-linkage of peptidoglycan chains, which is essential for bacterial cell wall strength and rigidity. Consequently, this leads to cell lysis and death, particularly in rapidly dividing bacteria.

Pharmacodynamics

Cefalexin is bactericidal and exhibits activity primarily against Gram-positive bacteria. It is effective in treating superficial infections resulting from minor wounds or lacerations. By interfering with the cross-linking reaction between N-acetyl muramic acid and N-acetylglucosamine in the bacterial cell wall, cefalexin promotes cell lysis, making it a widely used antibiotic in clinical practice.

Pharmacokinetics

Cefalexin is well absorbed when taken orally, with peak plasma concentrations typically occurring within 1 hour of administration. It is widely distributed throughout body tissues and fluids, including bile, urine, and synovial fluid. The drug is primarily excreted unchanged in the urine, and its half-life is approximately 1 hour. Renal impairment may necessitate dosage adjustments.

Contra-indications

  • Hypersensitivity to cephalosporins
  • History of immediate hypersensitivity to penicillin and other beta-lactams

Adverse effects

  • Abdominal pain
  • Diarrhoea
  • Dizziness
  • Eosinophilia
  • Headache
  • Leucopenia
  • Nausea
  • Neutropenia
  • Pseudomembranous enterocolitis
  • Skin reactions
  • Thrombocytopenia
  • Vomiting
  • Vulvovaginal candidiasis
  • Anaphylactic reaction
  • Angioedema
  • Agranulocytosis
  • Hemolytic anemia
  • Tubulointerstitial nephritis
  • Severe cutaneous adverse reactions (SCARs)

Interactions

  • Probenecid may increase the serum concentration of cephalexin
  • Antacids may decrease the absorption of cephalexin
  • Other nephrotoxic drugs may increase the risk of kidney damage

Precautions

  • Use with caution in patients with renal impairment
  • Monitor for signs of superinfection during prolonged therapy
  • Caution in patients with a history of gastrointestinal disease, particularly colitis

Pregnancy

Not known to be harmful.

Breast-feeding

Present in milk in low concentration, but generally considered appropriate to use.

Storage

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

Formulations

  • Capsules: 250 mg, 500 mg
  • Oral suspension: 125 mg/5 mL, 250 mg/5 mL
BNF 85 (British National Formulary) p.594 BNF for Children 2019-2020 p.349 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: Cefalexin

PubChem CID 27447

Molecular formula: C16H17N3O4S

Mechanism of action

Cephalexin is a first generation cephalosporin antibiotic. Cephalosporins contain a beta lactam and dihydrothiazide. Unlike penicillins, cephalosprins are more resistant to the action of beta lactamase. Cephalexin inhibits bacterial cell wall synthesis, leading breakdown and eventualy cell death. CEPHALOTHIN & ITS CONGENERS INHIBIT BACTERIAL CELL-WALL SYNTHESIS IN MANNER SIMILAR TO THAT OF PENICILLIN. /CEPHALOSPORINS/ The penicillins and their metabolites are potent immunogens because of their ability to combine with proteins and act as haptens for acute antibody-mediated reactions. The most frequent (about 95 percent) or "major" determinant of penicillin allergy is the penicilloyl determinant produced by opening the beta-lactam ring of the penicillin. This allows linkage of the penicillin to protein at the amide group. "Minor" determinants (less frequent) are the other metabolites formed, including native penicillin and penicilloic acids. /Penicillins/ Bactericidal; action depends on ability to reach and bind penicillin-binding proteins located in bacterial cytoplasmic membranes; cephalosporins inhibit bacterial septum and cell wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. This prevents cross-linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity. Also, cell division and growth are inhibited, and lysis and elongation of susceptible bacteria frequently occur. Rapidly dividing bacteria are those most susceptible to the action of cephalosporins. /Cephalosporins/ CEPHALOSPORIN C IS VERY RESISTANT TO ACTION OF PENICILLINASE, FOR WHICH IT IS BOTH COMPETITIVE & NONCOMPETITIVE INHIBITOR, DEPENDING ON SUBSTRATE TESTED... /CEPHALOSPORINS/

Pharmacodynamics

Cephalexin (also called Cefalexin) is a first generation cephalosporin antibiotic. It is one of the most widely prescribed antibiotics, often used for the treatment of superficial infections that result as complications of minor wounds or lacerations. It is effective against most gram-positive bacteria through its inihibition of the cross linking reaction between N-acetyl muramicacid and N-acetylglucosamine in the cell wall, leading to cell lysis.

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.