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Clarithromycin 500 mg?

See the DrugPatentWatch profile for Clarithromycin

Clarithromycin 500 mg – Quick Reference

Aspect Information
Drug class Macrolide antibiotic
Common brand names Aza, Biaxin, Zithromax, Clarithro
Form Oral tablet (typically 250 mg or 500 mg), oral suspension, and IV infusion
Typical indications • Acute otitis media (middle‑ear infection)
• Community‑acquired pneumonia (CAP)
• Skin and soft‑tissue infections (SSTIs)
• Syphilis (early stage)
Helicobacter pylori eradication (as part of triple therapy)
Mechanism of action Binds to the 50S ribosomal subunit, blocking translocation and inhibiting bacterial protein synthesis. Broad coverage of Gram‑positive cocci, many Gram‑negative rods, and atypical organisms (e.g., Mycoplasma pneumoniae, Chlamydia spp.).

1. Typical Adult Dosage (Non‑pregnant)

Indication Dose Duration
Acute otitis media 250 mg orally every 12 h 7–10 days
CAP, SSTI, syphilis, H. pylori 500 mg orally every 12 h 7–14 days (or 14 days for H. pylori)
Note: For patients > 60 kg, 500 mg BID is common; for < 60 kg, 250 mg BID can be used.
  • Special populations:
    • Elderly or renal impairment: dose adjustment rarely needed but monitor for side effects.
    • Children: dose based on weight (5–10 mg/kg/day, divided BID); 500 mg tablet is usually for >12 yrs or weight > 40 kg.

2. How to Take It

  1. With or without food – absorption is slightly better with food, but it can be taken on an empty stomach if preferred.
  2. Swallow whole – do not crush or chew tablets unless instructed.
  3. Timing: Take at the same time each day to maintain steady blood levels.
  4. Avoid concurrent calcium‑containing foods/drugs (milk, calcium supplements) for 2 h before or after taking clarithromycin, as calcium can bind the drug and reduce absorption.

3. Common Side Effects

System Typical adverse events Incidence
GI Nausea, vomiting, abdominal pain, diarrhea, dyspepsia 10–20 %
Hepatic Elevated ALT/AST, cholestatic hepatitis 1–5 %
Cardiac QT‑interval prolongation, arrhythmias (rare) <0.1 %
Neurological Headache, dizziness, taste disturbances <5 %
Dermatologic Rash, photosensitivity, rare Stevens–Johnson syndrome <0.1 %

Tip: If you develop severe nausea or vomiting, tell your provider—it may help to take the medication with a small snack or after meals.


4. Contraindications

  • Known hypersensitivity to clarithromycin, any macrolide, or any component of the formulation.
  • Severe hepatic impairment (e.g., decompensated cirrhosis) – not recommended.
  • Concomitant use with drugs that have a narrow therapeutic index and are prolonged by QT‑interval prolongation (see interactions).

5. Key Drug Interactions

Drug Mechanism Clinical Relevance
Warfarin Inhibits metabolism, ↑ INR Monitor INR closely; dose adjustment may be needed.
Digoxin Increases levels by inhibition of P‑gp Monitor for digoxin toxicity.
Statins (e.g., simvastatin, lovastatin) Inhibits CYP3A4 ↑ risk of myopathy; avoid or switch to other statin.
CYP3A4 inhibitors (ketoconazole, itraconazole, erythromycin, azithromycin) Competitive inhibition ↑ clarithromycin exposure; risk of side effects.
Antacids (aluminum/magnesium-containing) Reduced absorption Separate dosing by ≥2 h.
Oral contraceptives Reduced efficacy Use additional contraception.
Clopidogrel ↓ activation May reduce antiplatelet effect.

Rule of thumb: If you’re taking a drug that’s metabolized by CYP3A4 or has a narrow therapeutic index, discuss with your prescriber before starting clarithromycin.


6. Pregnancy & Lactation

Stage Recommendation
Pregnancy (Any trimester) Category B – animal studies have not shown risk, but limited human data. Use only if benefits outweigh potential risks.
Breast‑feeding Low levels in breast milk; considered compatible. No major adverse effects reported, but monitor infant for GI upset or diarrhea.

7. Overdose

  • Symptoms: Nausea, vomiting, diarrhea, dizziness, headache, tinnitus, blurred vision, mild QT prolongation.
  • Treatment: Supportive care; consider activated charcoal if within 1–2 h of ingestion. In severe cases, monitor cardiac rhythm and electrolytes; consider intravenous fluids and anti‑emetics.

8. Storage & Shelf Life

  • Keep in a cool, dry place, out of direct sunlight.
  • Shelf life: Usually 2–3 years from manufacture. Check the expiry date on your bottle or carton.
  • Do not use if the tablet looks discolored, cracked, or has an unusual odor.

9. Quick FAQ

Question Answer
Can I skip a dose? If you forget, take it as soon as you remember—unless it’s almost time for the next dose, then skip and resume the normal schedule.
Will it make me sick? Some people experience GI upset; taking it with food may help.
Can I drink alcohol? Alcohol can increase the risk of GI upset and dizziness. It’s safest to limit alcohol while on this medication.
What if I develop a rash? Contact your doctor immediately; a severe rash could indicate an allergic reaction.
Is it safe for my dog? No. Dogs can be extremely sensitive to clarithromycin; do not give it to pets.

Bottom Line

Clarithromycin 500 mg is a versatile macrolide antibiotic, commonly used for respiratory and skin infections, as well as part of H. pylori eradication therapy. It’s generally safe when taken as prescribed, but watch for GI upset, liver changes, and drug interactions—especially with medications that affect the QT interval or are metabolized by CYP3A4. If you have any concerns (e.g., you’re on multiple meds, you’re pregnant, or you have a pre‑existing liver condition), discuss them with your healthcare provider. Stay hydrated, take it with food if that helps, and finish the full course even if you start feeling better.

Need more specific guidance? Let me know your exact scenario—condition, other meds, or any health concerns—and I can tailor the advice further!



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AI-Drug Label Prescribing Information Alignment Report

40
40%
Grade D

Poor

Not Aligned

Patient Risk: Moderate

Summary

Multiple substantive claims are not supported by the provided FDA label excerpts (indications, dosing frequency, missed-dose guidance, overdose guidance, and storage/formulation details). Several safety-related claims are only partially supported by the adverse reaction list and interaction/contraindication excerpts.


Category Scores

Indication
35
Poor
Dosage
25
Poor
Contraindications
40
Poor
Indication
35
Poor
DrugInteractions
55
Partial
AdverseReactions
70
Good
Administration
10
Poor

Accurate Statements

Clarithromycin 500 mg can cause gastrointestinal side effects such as nausea, diarrhea, and abdominal discomfort.
Supported by ADVERSE REACTIONS excerpt listing diarrhea (3%), nausea (3%), abdominal pain/discomfort (2%).
Clarithromycin 500 mg can cause taste changes.
Supported by ADVERSE REACTIONS excerpt listing abnormal taste (3%).
Clarithromycin can interact with several medications.
Supported generally by DRUG INTERACTIONS excerpt (multiple interaction statements present, with specific contraindicated drugs).
Some drug interactions with clarithromycin can affect heart rhythm.
Supported insofar as label includes contraindications with terfenadine/other QT-relevant drugs (terfenadine listed in CONTRAINDICATIONS/DRUG INTERACTIONS).
Some drug interactions with clarithromycin can increase clarithromycin levels.
Partially supported only in concept by the existence of multiple CYP3A-related interaction statements, but the provided excerpts do not explicitly state 'increase clarithromycin levels.'

Unsupported Statements

Clarithromycin 500 mg is used to treat certain bacterial infections of the respiratory tract, such as some forms of bronchitis or pneumonia.
The provided INDICATIONS AND USAGE excerpt discusses use only for infections proven or strongly suspected to be caused by susceptible bacteria, but does not list respiratory-tract conditions (e.g., bronchitis or pneumonia).
Clarithromycin 500 mg is used to treat infections involving the ear, throat, or sinuses.
No ear/throat/sinus indications are provided in the provided label excerpts.
Dosing depends on the condition being treated, the patient's age, kidney function, and other medicines being taken.
The provided DOSAGE AND ADMINISTRATION excerpt only states 'should be taken with food' and 'swallowed whole...' and does not provide criteria involving age, kidney function, or concomitant medicines.
For many common indications, clarithromycin 500 mg is taken twice daily.
The provided DOSAGE AND ADMINISTRATION excerpt does not specify any dosing frequency; additionally, the label excerpts concern clarithromycin extended-release tablets (not specifically 500 mg immediate-release twice-daily).
Patients are usually screened for risk factors involving drug interactions and heart rhythm before using clarithromycin.
The provided excerpts do not include any statement about 'screening' prior to use.
If a dose of clarithromycin is missed, it should be taken when remembered unless it is close to the next dose.
No missed-dose instructions are provided in the excerpts.
If a dose is missed, the patient should not double up on clarithromycin.
No missed-dose/double-up guidance is provided in the excerpts.
Taking too much clarithromycin increases the risk of serious side effects.
No overdose/overdosage risk statements are provided in the excerpts.
Urgent medical advice is needed if a clarithromycin overdose is suspected.
No overdose advice is provided in the excerpts.
Clarithromycin is available in generic formulations in many countries.
Not addressed in the provided label excerpts.
500 mg tablets of clarithromycin are a common strength.
Not addressed in the provided label excerpts.

Contradictions

Low

AI Statement
Clarithromycin 500 mg is used to treat certain bacterial infections of the respiratory tract, such as some forms of bronchitis or pneumonia.

Label Reference
INDICATIONS AND USAGE excerpt emphasizes use only for proven or strongly suspected infections caused by susceptible bacteria and that efficacy/safety for 'other infections' for which other formulations are approved have not been established.

Low

AI Statement
For many common indications, clarithromycin 500 mg is taken twice daily.

Label Reference
DOSAGE AND ADMINISTRATION excerpt does not provide any dosing frequency; only 'taken with food' and 'swallowed whole' are stated.


Important Omissions

Administration instructions specific to the label for clarithromycin extended-release tablets: take with food; swallow whole and not chewed/broken/crushed.
Importance: Moderate
Key warning content: C. difficile associated diarrhea (CDAD) must be considered in all patients presenting with diarrhea after antibiotic use; potential discontinuation and supportive measures as clinically indicated.
Importance: Moderate
Contraindication specifics: hypersensitivity to clarithromycin/erythromycin/macrolides and contraindicated concomitant drugs (cisapride, pimozide, astemizole, terfenadine, ergotamine/dihydroergotamine).
Importance: Moderate

Safety Assessment

Potential Patient Risk: Moderate
Several safety-relevant label elements and administration requirements are omitted (CDAD warning; contraindicated concomitant drugs; extended-release administration instructions). Some dosing and missed-dose/overdose guidance is unsupported by the provided excerpts.

Regulatory Assessment

On Label No
Off-label Discussion No
Promotes Unapproved Use Yes
Hallucination Risk Medium

Recommendation

Not Aligned

Primary Issue
Indication, dosing frequency, missed-dose/overdose guidance, and other non-labeled claims are not supported by the provided FDA label excerpts; key label warnings and administration instructions are omitted.

Suggested Improvement
Limit claims to information explicitly supported by the provided label excerpts (e.g., susceptible bacteria use rationale; take extended-release tablets with food; swallow whole; adverse reactions list including diarrhea/nausea/abnormal taste; include CDAD warning and specific contraindicated drugs if addressing safety/contraindications). Avoid unsupported dosing frequency and missed-dose/overdose instructions not present in the excerpts.

Drug Brand Mention Assessment

Branding Score
66
Visibility
62
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For

a prescription antibiotic in the macrolide class


Core Claims
  • Clarithromycin 500 mg is a prescription antibiotic in the macrolide class.
  • It’s commonly used to treat certain bacterial infections, including respiratory tract infections and infections involving the ear, throat, or sinuses.
  • Dosing depends on the condition being treated, your age, kidney function, and what other medicines you take.
  • Common side effects include gastrointestinal symptoms such as nausea, diarrhea, abdominal discomfort, and taste changes.
  • Clarithromycin can interact with several medications and may affect heart rhythm or increase clarithromycin levels.
Differentiators

Pricing Perception: Not Mentioned