amoxicillin reference
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(amoxicillin · DailyMed)
Retained Kenya · PPB

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Amoxicillin Tablets BP 1000 mg, Clarithromycin…

H2011/22344/R1 Tablet alimentary tract and metabolism INN generic

What it does

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

Commonly used for: infections of the ear, nose, and throat, urinary tract infections, pneumonia, skin 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.
H2011/22344/R1
Registration date
2026 May 18
Expiry date
2031 April 01
Status
Retained
Active ingredient
Amoxicillin Tablets BP 1000 mg, Clarithromycin…
Dosage form
Tablet
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
A02BD - Combinations for eradication of Helicobacter pylori
RxNorm RxCUI
723
Manufacturer / MAH
Pro Med Pharmaceuticals Ltd
Applicant / LTR
PRO MED PHARMACEUTICALS LTD
Country of origin
India
Manufacturer location
Telčská 377/1, 140 00 Praha 4-Michle, Czechia

Source: Pharmacy and Poisons Board · fetched 2026-08-27 13:05:35 · updated 2026-10-20 02:11:16

Drug Interactions

7
Check interactions

Severe (1)

Penicillins - increases risk of adverse effects

Valproate increases the risk of adverse effects when given with penicillins (pivmecillinam). Avoid.

Severe Anecdotal

Unknown (6)

Amoxicillin - increases risk of skin rash

Allopurinol increases the risk of skin rash when given with penicillins (amoxicillin, ampicillin).

Unknown Study

Penicillins - increases risk of skin rash

Allopurinol increases the risk of skin rash when given with penicillins (amoxicillin, ampicillin).

Unknown Study

Penicillins - increases exposure

Leflunomide is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Theoretical

Penicillins - increases exposure

Nitisinone is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Study

Penicillins - increases exposure

Teriflunomide is predicted to increase the exposure to penicillins (benzylpenicillin).

Unknown Study

Phenindione - increases risk of bleeding events

Penicillins are predicted to increase the risk of bleeding events when given with phenindione.

Unknown Theoretical

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 Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

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

What it treats

  • infections of the ear, nose, and throat
  • urinary tract infections
  • pneumonia
  • skin infections

How it works

It kills bacteria or stops their growth, helping to clear up infections.

Who it's for

Amoxicillin is suitable for adults and children who have bacterial infections.

Drug class

Penicillins

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

Clinical monograph: Amoxicillin

BNF-referenced

Amoxicillin is a broad-spectrum antibiotic belonging to the penicillin class, effective against a variety of bacterial infections. It is commonly used to treat conditions such as urinary tract infections, sinusitis, community-acquired pneumonia, and salmonellosis.

Indications

  • Bacterial infections
  • Urinary tract infections
  • Sinusitis
  • Uncomplicated community-acquired pneumonia
  • Salmonellosis
  • Oral infections
  • Lyme disease (under expert supervision)
  • Acute exacerbation of bronchiectasis
  • Anthrax (treatment and post-exposure prophylaxis)

Dosage

Children: 1 month–11 years: 30 mg/kg 3 times a day for 21 days; children 1–4 years: 250 mg 3 times a day; children 5–11 years: 500 mg 3 times a day.

Adults: 500 mg 3 times a day; increased if necessary up to 1 g 3 times a day in severe infections.

Mechanism of action

Amoxicillin works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. It binds to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, interfering with the transpeptidation process necessary for cell wall integrity.

Pharmacodynamics

Amoxicillin exhibits bactericidal activity against susceptible bacteria. Its action is time-dependent, meaning that its effectiveness is related to the duration of time that the drug concentration remains above the minimum inhibitory concentration (MIC) for the target pathogen.

Pharmacokinetics

Amoxicillin is well absorbed from the gastrointestinal tract, with peak plasma concentrations achieved within 1-2 hours after oral administration. It is widely distributed in body tissues and fluids, and it is excreted primarily via the kidneys. The elimination half-life is approximately 1 hour, and renal impairment may necessitate dosage adjustments.

Adverse effects

  • Skin rash
  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Allergic reactions (including anaphylaxis)
  • Superinfection (due to resistant organisms)

Interactions

  • Allopurinol (increases risk of skin rash)

Precautions

  • History of penicillin allergy
  • Renal impairment (reduce dose)
  • Use with caution in patients with mononucleosis

Pregnancy

Use only if clearly needed; no adequate studies in pregnant women.

Breast-feeding

Amoxicillin is excreted in breast milk; use with caution.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

  • Phenoxymethylpenicillin 250mg/5ml oral solution
  • Phenoxymethylpenicillin 250 mg tablets
BNF for Children 2019-2020 p.373 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: Clarithromycin

BNF-referenced

Clarithromycin is a macrolide antibiotic effective against a range of bacterial infections. It is primarily used in the treatment of community-acquired pneumonia, skin infections, and as a prophylactic measure for certain infections. Clarithromycin works by inhibiting bacterial protein synthesis, making it a crucial agent in combating gram-positive and some gram-negative bacteria.

Indications

  • Bacterial infections
  • Community-acquired pneumonia
  • Skin infections
  • Prophylaxis for certain infections

Dosage

Adults: 500 mg once daily for

Mechanism of action

Clarithromycin is metabolized to 14-OH clarithromycin, which is active. It penetrates bacterial cell walls and reversibly binds to domain V of the 23S ribosomal RNA of the 50S ribosomal subunit, blocking the translocation of aminoacyl-tRNA and inhibiting polypeptide synthesis. It may be bactericidal in high concentrations against susceptible organisms, particularly Streptococcus pyogenes, S. pneumoniae, Haemophilus influenzae, and Chlamydia trachomatis. Additionally, clarithromycin inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein.

Pharmacodynamics

Clarithromycin exhibits a broad spectrum of activity against numerous gram-positive bacteria, including Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes. It also shows activity against gram-negative bacteria such as Haemophilus influenzae and Moraxella catarrhalis, as well as against various anaerobic bacteria, mycobacteria, and other organisms like Mycoplasma, Ureaplasma, and Chlamydia. While typically bacteriostatic, it can sometimes demonstrate bactericidal properties depending on the concentration and the organism.

Pharmacokinetics

Clarithromycin is well absorbed after oral administration, with its bioavailability enhanced by food. It is extensively metabolized in the liver, primarily via CYP3A4, leading to active metabolites. The drug has a half-life of approximately 3 to 4 hours, but its active metabolite, 14-OH clarithromycin, has a longer half-life, contributing to its prolonged activity. Renal impairment can significantly affect its clearance, necessitating dosage adjustments in patients with reduced renal function.

Adverse effects

  • Nausea
  • Diarrhea
  • Abdominal pain
  • Dysgeusia
  • Headache
  • Rash
  • Liver enzyme elevations
  • QT prolongation

Interactions

  • Clarithromycin + acalabrutinib: Severe (increases exposure)
  • Clarithromycin + antiarrhythmics: Severe (increases exposure)
  • Clarithromycin + dronedarone: Severe (increases exposure)
  • Clarithromycin + non-sedating antihistamines: Severe (increases exposure)
  • Clarithromycin + mizolastine: Severe (increases exposure)
  • Clarithromycin + lurasidone: Severe (increases exposure)
  • Clarithromycin + quetiapine: Severe (increases exposure)
  • Clarithromycin + avapritinib: Severe (increases exposure)
  • Clarithromycin + benzodiazepines: Severe (increases exposure)
  • Clarithromycin + alprazolam: Severe (increases exposure)

Precautions

  • Caution in hepatic impairment
  • Use with caution in renal impairment
  • Monitor for signs of QT prolongation
  • Consider alternative therapy in patients with history of arrhythmias
  • Use with caution in patients with myasthenia gravis due to potential exacerbation

Pregnancy

Manufacturers advise use only if adequate alternatives are not available.

Breast-feeding

Present in milk; use only if no suitable alternatives.

Storage

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

Formulations

  • Oral suspension 200 mg/5 mL
  • Capsules 250 mg
BNF 85 (British National Formulary) p.611 BNF for Children 2019-2020 p.362 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: Amoxicillin

PubChem CID 33613

Molecular formula: C16H19N3O5S

Mechanism of action

Amoxicillin competitively inhibits penicillin-binding protein 1 and other high molecular weight penicillin binding proteins. Penicillin bind proteins are responsible for glycosyltransferase and transpeptidase reactions that lead to cross-linking of D-alanine and D-aspartic acid in bacterial cell walls. Without the action of penicillin binding proteins, bacteria upregulate autolytic enzymes and are unable to build and repair the cell wall, leading to bacteriocidal action. 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/ Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.

Pharmacodynamics

Amoxicillin competitively inhibit penicillin binding proteins, leading to upregulation of autolytic enzymes and inhibition of cell wall synthesis. Amoxicillin has a long duration of action as it is usually given twice daily. Amoxicillin has a wide therapeutic range as mild overdoses are not associated with significant toxicity. Patients should be counselled regarding the risk of anaphylaxis, _Clostridium difficile_ infections, and bacterial resistance.

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

Molecular reference: Clarithromycin

PubChem CID 84029

Molecular formula: C38H69NO13

Mechanism of action

Clarithromycin is first metabolized to 14-OH clarithromycin, which is active and works synergistically with its parent compound. Like other macrolides, it then penetrates bacteria cell wall and reversibly binds to domain V of the 23S ribosomal RNA of the 50S subunit of the bacterial ribosome, blocking translocation of aminoacyl transfer-RNA and polypeptide synthesis. Clarithromycin also inhibits the hepatic microsomal CYP3A4 isoenzyme and P-glycoprotein, an energy-dependent drug efflux pump. Clarithromycin usually is bacteriostatic, although it may be bactericidal in high concentrations or against highly susceptible organisms. Bactericidal activity has been observed against Streptococcus pyogenes, S. pneumoniae, Haemophilus influenzae, and Chlamydia trachomatis. Clarithromycin inhibits protein synthesis in susceptible organisms by penetrating the cell wall and binding to 50S ribosomal subunits, thereby inhibiting translocation of aminoacyl transfer-RNA and inhibiting polypeptide synthesis. The site of action of clarithromycin appears to be the same as that of erythromycin, clindamycin, lincomycin, and chloramphenicol.

Pharmacodynamics

Clarithromycin is a macrolide antibiotic whose spectrum of activity includes many gram-positive (<i>Staphylococcus aureus, S. pneumoniae, and S. pyogenes</i>) and gram-negative aerobic bacteria (<i>Haemophilus influenzae, H. parainfluenzae, and Moraxella catarrhalis</i>), many anaerobic bacteria, some mycobacteria, and some other organisms including <i>Mycoplasma, Ureaplasma, Chlamydia, Toxoplasma</i>, and <i>Borrelia</i>. Other aerobic bacteria that clarithromycin has activity against include <i>C. pneumoniae and M. pneumoniae</i>. Clarithromycin has an in-vitro activity that is similar or greater than that of erythromycin against erythromycin-susceptible organisms. Clarithromycin is usually bacteriostatic, but may be bactericidal depending on the organism and the drug concentration.

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.