clarithromycin reference
Reference image
(clarithromycin · DailyMed)
Registered Rwanda · Rwanda FDA

CLARYL-500

CLARITHROMYCIN USP

Rwanda FDA-HMP-MA-1940 TABLETS 500MG antiinfectives for systemic use INN generic

What it does

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

Commonly used for: bacterial infections, chest infections (pneumonia), skin infections, ear infections (otitis media)

Read more in plain English ↓

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

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
Rwanda FDA-HMP-MA-1940
Registration date
17/08/2024
Expiry date
16/08/2029
Status
Registered
Active ingredient
CLARITHROMYCIN USP
Dosage form
TABLETS
Strength
500MG
Pack size
10x10 Tablets
Therapeutic class
-
ATC class (WHO)
J01FA - Macrolides
RxNorm RxCUI
21212
Manufacturer / MAH
Umedica Laboratories
Applicant / LTR
UMEDICA LABORATORIES LTD
Country of origin
INDIA
Manufacturer location
9WFH+HC9, Phase 2, GIDC, Vapi, Chharwada, Gujarat 396195, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:04 · updated 2026-09-14 02:30:15

Drug Interactions

211
Check interactions

Pharmacodynamic Warnings

Clarithromycin appears in TABLE 9: Drugs that prolong the QT interval

Severe (35)

Acalabrutinib - increases exposure

Clarithromycin is predicted to increase the exposure to acalabrutinib. Avoid.

Severe Study

Alprazolam - increases exposure

Clarithromycin moderately increases the exposure to benzodiazepines (alprazolam). Avoid.

Severe Study

Antihistamines,non-Sedating - increases exposure

Clarithromycin is predicted to increase the exposure to antihistamines, non-sedating (mizolastine). Avoid.

Severe Study

Avapritinib - increases exposure

Clarithromycin is predicted to increase the exposure to avapritinib. Avoid.

Severe Study

Benzodiazepines - increases exposure

Clarithromycin moderately increases the exposure to benzodiazepines (alprazolam). Avoid.

Severe Study

Moderate (50)

Alfentanil - increases exposure

Clarithromycin is predicted to increase the exposure to opioids (alfentanil, buprenorphine, fentanyl, oxycodone). Monitor and adjust dose.

Moderate Study

Aminophylline - increases exposure

Clarithromycin is predicted to increase the exposure to aminophylline. Adjust dose.

Moderate Theoretical

Amlodipine - increases exposure

Clarithromycin is predicted to increase the exposure to calcium channel blockers (amlodipine, felodipine, lacidipine, nicardipine, nifedipine, nimodipine). Monitor and adjust dose.

Moderate Study

Antiarrhythmics - increases exposure

Clarithromycin is predicted to increase the exposure to antiarrhythmics (propafenone). Monitor and adjust dose.

Moderate Study

Anticholinesterases, Centrally Acting - increases exposure

Clarithromycin is predicted to increase the exposure to anticholinesterases, centrally acting (galantamine). Monitor and adjust dose.

Moderate Study

Unknown (126)

Abemaciclib - increases exposure

Clarithromycin is predicted to increase the exposure to abemaciclib. Avoid or adjust abemaciclib dose, p. 1056.

Unknown Study

Afatinib - increases exposure

Macrolides are predicted to increase the exposure to afatinib.

Unknown Study

Alitretinoin - increases exposure

Clarithromycin is predicted to increase the exposure to retinoids (alitretinoin). Adjust alitretinoin dose, p. 1382.

Unknown Theoretical

Almotriptan - increases exposure

Clarithromycin increases the exposure to triptans (almotriptan).

Unknown Study

Alphablockers - increases exposure

Clarithromycin is predicted to increase the exposure to alpha blockers (doxazosin).

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 Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About this medicine

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

What it treats

  • bacterial infections
  • chest infections (pneumonia)
  • skin infections
  • ear infections (otitis media)

How it works

It works by stopping the growth of bacteria, helping your body to fight off the infection.

Who it's for

It is for adults and children with certain bacterial infections.

Drug class

Macrolides

Cautions

  • • Be cautious if you are taking other medications that affect heart rhythm.

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

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: 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.