Registered Kenya · PPB

MEDACEF 125MG DRY SUSPENSION

CEFACLOR MONOHYDRATE

CTD 1636 125MG/ 5 ML GENERIC/BIOSIMILARS antiinfectives for systemic use INN generic

What it does

Cefaclor is an antibiotic used to treat infections caused by bacteria.

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

Read more in plain English ↓

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

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Registration & product details

Registration no.
CTD 1636
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
CEFACLOR MONOHYDRATE
Dosage form
125MG/ 5 ML
Strength
-
Pack size
100ML
Therapeutic class
GENERIC/BIOSIMILARS
ATC class (WHO)
J01DC - Second-generation cephalosporins
RxNorm RxCUI
2176
Manufacturer / MAH
Goodman Agencies
Country of origin
FOREIGN
Manufacturer location
PQQX+68W Goodman Plaza, Waiyaki Wy, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:39:25 · updated 2026-07-26 11:29:57

Drug Interactions

6
Check interactions

Pharmacodynamic Warnings

Cefaclor appears in TABLE 2: Drugs that cause nephrotoxicity

Unknown (6)

Cefaclor - increases exposure

Leflunomideispredictedtoincreasetheexposuretocefaclor. oTheoretical

Unknown Theoretical

Cefaclor - increases exposure

Nitisinone is predicted to increase the exposure to cefaclor.

Unknown Study

Cefaclor - increases exposure

Teriflunomide is predicted to increase the exposure to cefaclor. Ceritinib → see TABLE 6 p. 1518 (bradycardia), TABLE 15 p. 1520 (myelosuppression), TABLE 9 p. 1519 (QT-interval prolongation)

Unknown Study

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: exact

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

About this medicine

Cefaclor is an antibiotic used to treat infections caused by bacteria.

What it treats

  • bacterial infections
  • respiratory tract infections
  • urinary tract infections

How it works

Cefaclor works by killing bacteria or stopping their growth, helping to clear up the infection.

Who it's for

Cefaclor is for individuals with bacterial infections who need antibiotic treatment.

Drug class

Cephalosporins

Cautions

  • • Be cautious if 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.

Clinical monograph: Cefaclor

BNF-referenced

Cefaclor is a second-generation cephalosporin antibiotic that is primarily used to treat bacterial infections caused by susceptible strains of Gram-positive and Gram-negative bacteria. It acts by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. Cefaclor is effective against various infections, including respiratory tract infections, skin infections, and urinary tract infections.

Indications

  • Susceptible infections due to sensitive Gram-positive bacteria
  • Susceptible infections due to sensitive Gram-negative bacteria
  • Respiratory tract infections
  • Skin infections
  • Urinary tract infections
  • Surgical prophylaxis

Dosage

Adults: 500 mg three times a day, maximum 4 g per day. For severe infections

Mechanism of action

Cefaclor, 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 weakening of the cell wall structure leads to cell lysis, which is further mediated by bacterial cell wall autolytic enzymes such as autolysins. Cefaclor may also interfere with an autolysin inhibitor, enhancing its antibacterial effect.

Pharmacodynamics

Cefaclor exhibits bactericidal activity through the inhibition of cell wall synthesis, which is characteristic of cephalosporins. The drug is effective against a broad spectrum of bacteria, including Staphylococci (both coagulase-positive and coagulase-negative strains), Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Haemophilus influenzae, Klebsiella species, and Proteus mirabilis. Its action is confirmed by both in vitro and in vivo studies demonstrating efficacy against most strains of these pathogens.

Pharmacokinetics

Cefaclor is administered orally and is well absorbed from the gastrointestinal tract. It achieves peak plasma concentrations within 1 to 2 hours after administration. The drug is widely distributed in body tissues and fluids, including the lungs, skin, and urine, where it exerts its therapeutic effects. Cefaclor is primarily excreted unchanged in the urine, and its half-life is approximately 0.6 to 1 hour. Dose adjustments may be necessary in patients with renal impairment.

Adverse effects

  • Rash
  • Nausea
  • Diarrhea
  • Abdominal pain
  • Allergic reactions
  • Hepatic dysfunction
  • Renal impairment

Interactions

  • Leflunomide: Unknown (increases exposure)
  • Nitisinone: Unknown (increases exposure)
  • Teriflunomide: Unknown (increases exposure)

Precautions

  • Use with caution in patients with a history of hypersensitivity to penicillins or cephalosporins
  • Monitor renal function in patients with renal impairment
  • Consider potential for Clostridium difficile-associated diarrhea

Pregnancy

Not known to be harmful.

Breast-feeding

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

Storage

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

Formulations

  • Oral suspension: 125 mg/5 mL
  • Capsules: 250 mg, 500 mg
  • Powder for solution for injection: 1 g
BNF 85 (British National Formulary) p.596 BNF for Children 2019-2020 p.350 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: Cefaclor

PubChem CID 51039

Molecular formula: C15H14ClN3O4S

Mechanism of action

Cefaclor, 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 cefaclor interferes with an autolysin inhibitor.

Pharmacodynamics

Cefaclor is a second generation cephalosporin antibiotic with a spectrum resembling first-generation cephalosporins. <i>In vitro</i> tests demonstrate that the bactericidal action of the cephalosporins results from inhibition of cell-wall synthesis. As indicated by _in vitro_ and _in vivo_ clinical studies, cefaclor was shown to be effective against most strains of Gram positive aerobes - Staphylococci (including coagulase-positive, coagulase-negative, and penicillinase-producing strains), <i>Streptococcus pneumoniae</i>, <i>Streptococcus pyogenes</i> (group A &szlig;-hemolytic streptococci), as well as Gram-negative aerobes - <i>Escherichia coli</i>, <i>Haemophilus influenzae</i> (including &szlig;-lactamase-producing ampicillin-resistant strains), <i>Klebsiella sp</i>, and <i>Proteus mirabilis</i>.

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.