Adult Dosing & Uses
Dosing Forms & Strengths
oral suspension
- 125mg/5mL
- 250mg/5mL
tablet, including extended release
- 250mg
- 500mg
Acute Exacerbation of Chronic Bronchitis
250-500 mg PO BID for 7-14 days
1000 mg (two 500 mg ER tablets) PO qDay for 7-14 days PO qDay for 7-14 days
Acute Maxillary Sinusitis
500 mg PO BID for 14 days
1000 mg (two 500 mg ER tablets) PO qDay for 14 days
Mycobacterial Infection (Prevention & Treatment)
500 mg PO BID for 7-14 days
Peptic Ulcer Disease
500 mg PO BID for 10-14 days
Administer in dual or triple combination regimens with bismuth subsalicylate, amoxicillin, an H2 receptor antagonist, or proton inhibitor
Pharyngitis, Tonsilitis
250 mg PO BID for 10 days
Pneumonia
250 mg PO BID for 7-14 days
1000 mg (two 500 mg ER tablets) PO qD for 14 days
Skin & Skin Structure Infection
250 mg PO BID for 7-14 days
Prophylaxis Against Infective Endocarditis
500 mg PO 30-60 minutes prior to procedure
Crohn Disease (Orphan)
Combination of clarithromycin, rifabutin, and clofazimine for treatment of pediatric Crohn disease
Orphan indication sponsor
- RedHill Biopharma Ltd; 42 Givati St; Israel
Renal Impairment
CrCl <30 mL/min: 1/2 normal dose
Administration
Dose Range: 250-500 mg PO q12hr or 1000 mg ER tablets qDay for 7-14 days
Other Indications & Uses
Actinobacillus actinomycetemcomitans, Actinomyces israelii, Actinomyces naeslundii, Actinomyces odontolyticus, Afipia felis, Arachnia propionica, Bartonella henselae, Bartonella quintana, Chlamydia pneumonia (TWAR agent), Bordetella pertussis, Borrelia recurrentis, Calymmatobacterium granulomatis, Campylobacter jejuni, Chlamydia spp., H. ducreyi, H. influenzae, Helicobacter pylori, Legionella pneumophila, MAC, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium genavense, Mycobacterium gordonae, Mycobacterium kansasii, Mycobacterium leprae, Mycobacterium marinum, Mycobacterium scrofulaceum, Mycobacterium simiae, Mycobacterium szulgai, Mycobacterium ulcerans, Mycobacterium xenopi, Mycoplasma pneumoniae, M. catarrhalis, S. aureus,Streptococcus (Group C, G), Streptococcus agalactiae (Group B), Streptococcus bovis (Group D), Streptococcus intermedius group (S. anginosus, S intermedius, S. constellatus), Streptococcus pneumoniae (PCN sensitive, MIC <0.1 mcg/mL), Streptococcus pyogenes (Group A); Viridans streptococci, Ureaplasma urealyticum
H. pylori (with lansoprazole & amoxicillin)
First line: Afipia felis, Bartonella henselae, Bartonella quintana, Bordetella pertussis, Campylobacter jejuni, Chlamydia pneumonia, Haemophilus ducreyi, Helicobacter pylori, Legionella sp, Mycobacterium avium-intracellulare, Mycobacterium chelonae, Mycobacterium fortuitum, Mycobacterium genavense, Mycobacterium gordonae, Mycobacterium marinum, Mycobacterium scrofulaceum, Mycobacterium simiae, Mycobacterium xenopi (others eg Haemophilus influenzae not unanimous)
Pediatric Dosing & Uses
Dosing Forms & Strengths
oral suspension
- 125mg/5mL
- 250mg/5mL
tablet, including extended release
- 250mg
- 500mg
Community-Acquired Pneumonia, Sinusitis, Bronchitis, Skin Infections
15 mg/kg/day PO divided q12hr for 10 days
Mycobacterial Infection (Prevention & Treatment)
7.5 mg/kg (up to 500 mg) BID
<20 months old: Safety of clarithromycin for MAC not studied
Prophylaxis Against Infective Endocarditis
15 mg/kg PO 30-60 minutes before procedure (not to exceed 500 mg)
Other Information
Extended-release tablets: Safety & efficacy not established
Drug Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
GI effects, general (13%)
1-10%
Abnormal taste (adults 3-7%)
Diarrhea (3-6%)
Nausea (adults 3-6%)
Vomiting (adults 1%; children 6%)
Elevated BUN (4%)
Abdominal pain (adults 2%, children 3%)
Rash (children 3%)
Dyspepsia (2%)
Heartburn (adults 2%)
Headache (2%)
Elevated PT (1%)
<1%
Anaphylaxis
Anorexia
Anxiety
AST increased
Bilirubin increased
C Diff colitis
Dizziness
Dyspnea
Elevated LFTs
Glossitis
Hallucinations
Hepatic dysfunction
Hepatitis
Hypoglycemia
Incr alk phos
Jaundice
Leukopenia
Manic behavior
Neuromuscular blockade
Neutropenia
Pancreatitis
Psychosis
QT prolongation
Seizures
Incr serum creatinine
Stevens-Johnson syndrome
Thrombocytopenia
Postmarketing Reports
Allergic reactions: urticaria & skin eruptions
Leukocytoclastic vasculitis
Toxic epidermal necrolysis
Transient CNS effects: psychosis, anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, nightmares, tinnitus, tremor, and vertigo
Hepatic failure
Pruritus
Rash
Acute renal failure
Reversible hearing loss (hypoacusis)
Stomatitis
Torsade de pointes
Contraindications & Cautions
Contraindications
Documented hypersensitivity
Coadministration of pimozide
History of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin
Clarithromycin/ranitidine bicitrate contraindicated in severe renal impairment (CrCl<25 mL/min)
History of acute porphyria
Cautions
Severe renal impairment
Do not refrigerate oral solution
Endocarditis prophylaxis: use only for high risk pts, per recent AHA Guidelines
Hepatic dysfunction
- Increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported
- May be severe and is usually reversible
- In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications
- Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur
Pregnancy & Lactation
Pregnancy Category: C
Lactation: excreted in breast milk, use caution
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Half-Life: 3-7 hr
Peak Plasma Time: 2-4 hr
Absorption: highly stable in presence of gastric acid (unlike erythromycin); food delays but does not affect extent of absorption
Distribution: widely into most body tissues except CNS
Metabolism: partially hepatic (P450 enzyme CYP3A4); converted to 14-OH clarithromycin (active metabolite)
Renal Clearance: approximates normal GFR
Excretion: primarily urine
Mechanism of Action
Semisynthetic macrolide antibiotic that reversibly binds to P site of 50S ribosomal subunit of susceptible organisms and may inhibit RNA-dependent protein synthesis by stimulating dissociation of peptidyl t-RNA from ribosomes, causing bacterial growth inhibition.
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