Clarithromycin (Page 2 of 10)

2.3 Combination Dosing Regimens for H. pylori Infection

  • Triple therapy: clarithromycin/lansoprazole/amoxicillin
    The recommended adult dosage is 500 mg clarithromycin tablets, 30 mg lansoprazole, and 1 gram amoxicillin, all given every 12 hours for 10 or 14 days [see Indications and Usage ( 1.8) and Clinical Studies ( 14.3)] .
  • Triple therapy: clarithromycin/omeprazole/amoxicillin
    The recommended adult dosage is 500 mg clarithromycin tablets, 20 mg omeprazole, and 1 gram amoxicillin; all given every 12 hours for 10 days. In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief [see Indications and Usage ( 1.8) and Clinical Studies ( 14.3)] .
  • Dual therapy: clarithromycin/omeprazole The recommended adult dosage is 500 mg clarithromycin tablets given every 8 hours and 40 mg omeprazole given once every morning for 14 days. An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief [see Indications and Usage ( 1.8) and Clinical Studies ( 14.3)] .

2.4 Pediatric Dosage

The recommended daily dosage is 15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose). Refer to dosage regimens for mycobacterial infections in pediatric patients for additional dosage information [see Dosage and Administration ( 2.5)] .

2.5 Dosage Regimens for Mycobacterial Infections

For the treatment of disseminated infection due to Mycobacterium avium complex (MAC), clarithromycin tablets are recommended as the primary agents. Clarithromycin tablets should be used in combination with other antimycobacterial drugs (e.g. ethambutol) that have shown in vitro activity against MAC or clinical benefit in MAC treatment [see Clinical Studies ( 14.1)].

Adult Patients

For treatment and prophylaxis of mycobacterial infections in adults, the recommended dose of clarithromycin tablets is 500 mg every 12 hours.

Pediatric Patients

For treatment and prophylaxis of mycobacterial infections in pediatric patients, the recommended dose is 7.5 mg/kg every 12 hours up to 500 mg every 12 hours. [See Use in Specific Populations ( 8.4) and Clinical Studies ( 14.1)] .

Clarithromycin tablets therapy should continue if clinical response is observed. Clarithromycin tablets can be discontinued when the patient is considered at low risk of disseminated infection.

2.6 Dosage Adjustment in Patients with Renal Impairment

See Table 2 for dosage adjustment in patients with moderate or severe renal impairment with or without concomitant atazanavir or ritonavir-containing regimens [see Drug Interactions ( 7)].

Table 2. Clarithromycin Tablets Dosage Adjustments in Patients with Renal Impairment
Recommended Clarithromycin Tablets Dosage Reduction

Patients with severe renal impairment (CL cr of <30 mL/min)

Reduce the dosage of

clarithromycin tablets by 50%

Patients with moderate renal impairment (CL cr of 30 to 60 mL/min) taking concomitant atazanavir or ritonavir-containing regimens

Reduce the dosage of

clarithromycin tablets by 50%

Patients with severe renal impairment (CL cr of <30 mL/min) taking concomitant atazanavir or ritonavir-containing regimens

Reduce the dosage of

clarithromycin tablets by 75%

2.7 Dosage Adjustment Due to Drug Interactions

Decrease the dose of clarithromycin tablets by 50 % when co-administered with atazanavir [see Drug Interactions ( 7)] . Dosage adjustments for other drugs when co-administered with clarithromycin tablets may be recommended due to drug interactions [see Drug Interactions ( 7)] .

3 DOSAGE FORMS AND STRENGTHS

Clarithromycin tablets, USP (white, oval shaped, film-coated tablets)

  • 250 mg: debossed GG C6 on one side and plain on the reverse side
  • 500 mg: debossed GG C9 on one side and plain on the reverse side

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs [see Warnings and Precautions ( 5.1)] .

4.2 Cisapride and Pimozide

Concomitant administration of clarithromycin tablets with cisapride and pimozide is contraindicated [see Drug Interactions ( 7)] .

There have been postmarketing reports of drug interactions when clarithromycin is co‑administered with cisapride or pimozide, resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of metabolism of these drugs by clarithromycin tablets. Fatalities have been reported.

4.3 Cholestatic Jaundice/Hepatic Dysfunction

Clarithromycin tablets are contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with prior use of clarithromycin.

4.4 Colchicine

Concomitant administration of clarithromycin tablets and colchicine is contraindicated in patients with renal or hepatic impairment.

4.5 Lomitapide, Lovastatin, and Simvastatin

Concomitant administration of clarithromycin tablets with lomitapide is contraindicated due to potential for markedly increased transaminases [see Warnings and Precautions ( 5.4) and Drug Interactions ( 7)].

Concomitant administration of clarithromycin tablets with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin) is contraindicated, due to the increased risk of myopathy, including rhabdomyolysis [see Warnings and Precautions ( 5.4) and Drug Interactions ( 7)].

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.