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SANDOZ CLARITHROMYCIN is a brand name for Clarithromycin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sandoz Clarithromycin (clarithromycin tablets) may be indicated in the treatment of mild to moderate infections caused by susceptible strains of the designated microorganisms in the diseases listed below: • Upper Respiratory Tract • Pharyngiitis/tonsillitis, caused by Streptococcus pyogenes (Group A beta-hemolytic…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment. o Patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including torsades de pointes. 4 Drug-Drug Interactions. o Patients with electrolyte disturbances (hypokalaemia or hypomagnesaemia, due to the risk of prolongation of the QT interval and torsades de pointes).
Sandoz Clarithromycin Page 6 of 90 Protected B / Protégé B o Concomitant therapy with astemizole, cisapride, domperidone, pimozide, terfenadine. There have been post-marketing reports of drug interactions when clarithromycin and/or erythromycin are co-administered with astemizole, cisapride, pimozide or terfenadine resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of hepatic metabolism of these drugs by erythromycin and clarithromycin.
Fatalities have been reported. 4 Drug-Drug Interactions, Table 11. o Concomitant therapy with saquinavir due to potentially life- threatening cardiac arrhythmia. Concomitant therapy with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin) due to an increased risk of myopathy, including rhabdomyolysis.
4 Drug-Drug Interactions, Table 11. , ergotamine or dihydroergotamine) as this may result in ergot toxicity. 4 Drug-Drug Interactions, Table 11. Concomitant administration with oral midazolam. 4 Drug- Drug Interactions, Table 11. o Concomitant administration with lomitapide.
See 9 DRUG INTERACTIONS. Concomitant therapy with colchicine due to the risk of life threatening and fatal colchicine toxicity. This risk may be further increased with concomitant medications metabolized by P-glycoprotein or strong CYP3A inhibitors.
4 Drug-Drug Interactions, Table 11. o Concomitant therapy with ivabradine due to potential increase in ivabradine levels and risk of excessive bradycardia. 4 Drug-Drug Interactions, Table 11. o Concomitant therapy with ticagrelor or ranolazine*.
* Not marketed in Canada. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Sandoz Clarithromycin Page 7 of 90 Protected B / Protégé B erious Warnings and Precautions • Clarithromycin should not be used in pregnancy except where no alternative therapy is appropriate, particularly during the first 3 months of pregnancy.
If pregnancy occurs while taking the drug, the patient should be apprised of the potential hazard to the fetus. 1 Pregnant Women. • The concomitant administration of clarithromycin and drugs metabolized by CYP3A and/or transported by P-gp may result in significant safety concerns.
2 Drug Interactions Overview. 1 Dosing Considerations • Sandoz Clarithromycin may be given with or without meals. • In patients with a combination of hepatic (mild to moderate) and renal impairments or in the presence of severe renal impairment, decreased dosage of clarithromycin or prolonged dosing intervals might be appropriate.
2 Recommended Dose and Dosage Adjustment. • Clarithromycin is contraindicated in patients with severe hepatic failure in combination with renal impairment. See 2 CONTRAINDICATIONS. , up to 250 mg once daily, or 250 mg twice daily in more severe infections.
Dosage should not be continued beyond 14 days in these patients. 2 Recommended Dose and Dosage Adjustment • Adults with Respiratory Tract or Skin Infections o The adult dosage of Sandoz Clarithromycin is 250 mg to 500 mg every 12 hours (Table 1) for 7 to 14 days.
For infections caused by less susceptible organisms, the upper dosage should be used. d. = twice daily o In the treatment of Group A streptococcus infections, therapy should be continued for 10 days. The usual drug of choice in the treatment of streptococcal infections and the prophylaxis of rheumatic fever is penicillin administered by either the intramuscular or the oral route.
o Clarithromycin is generally effective in the eradication of S. pyogenes from the nasopharynx; however, data establishing the efficacy of clarithromycin in the subsequent prevention of rheumatic fever are not presently available. e.
250 mg once daily, or 250 mg twice daily in more severe infections. Dosage should not be continued beyond 14 days in these patients. The safety and efficacy of 500 mg clarithromycin in patients with severe renal impairment has not been established.
• Hepatic Impairment o In patients with a combination of hepatic (mild to moderate) and renal impairments, decreased dosage of clarithromycin or prolonged dosing intervals may be appropriate. Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function.
o Clarithromycin is contraindicated in patients with severe hepatic failure in combination with renal impairment. See 2 CONTRAINDICATIONS. • Eradication of […]
Fatalities have been reported. Elderly patients may be more susceptible to drug-associated effects on the QT interval. , < 50 bpm), or when concomitantly taking with other medicinal products associated with QT prolongation, due to the risk for QT prolongation and torsades de pointes.
See
, General 03/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ................................................................................................................. 1 Pediatrics .......................................................................................................................
2 Geriatrics ....................................................................................................................... 5 2 CONTRAINDICATIONS ....................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 6 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ..................................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................. 4 Administration .............................................................................................................. 5 Missed Dose ..................................................................................................................
9 5 OVERDOSAGE ................................................................................................................ 9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................... 10 7 WARNINGS AND PRECAUTIONS....................................................................................
1 Pregnant Women ..................................................................................................... 2 Breast-feeding .........................................................................................................
3 Pediatrics.................................................................................................................. 4 Geriatrics ..................................................................................................................
17 8 ADVERSE REACTIONS ................................................................................................... 1 Adverse Reaction Overview ........................................................................................
2 Clinical Trial Adverse Reactions .................................................................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other ............. 23 Quantitative Data..............................................................................................................
5 Post-Market Adverse Reactions.................................................................................. 25 9 DRUG INTERACTIONS ...................................................................................................
1 Serious Drug Interactions........................................................................................... 2 Drug Interactions Overview ........................................................................................
3 Drug-Behavioural Interactions ................................................................................... 4 Drug-Drug Interactions ..............................................................................................
5 Drug-Food Interactions ............................................................................................... 6 Drug-Herb Interactions ...............................................................................................
7 Drug-Laboratory Test Interactions.............................................................................. 48 10 CLINICAL PHARMACOLOGY ..........................................................................................
1 Mechanism of Action ................................................................................................ 2 Pharmacodynamics ...................................................................................................
3 Pharmacokinetics ...................................................................................................... 48 11 STORAGE, STABILITY AND DISPOSAL ............................................................................
56 12 SPECIAL HANDLING INSTRUCTIONS............................................................................... 57 PART II: SCIENTIFIC INFORMATION ......................................................................................
58 13 PHARMACEUTICAL INFORMATION ............................................................................... 58 14 CLINICAL TRIALS ...........................................................................................................
1 Trial Design and Study Demographics ...................................................................... 2 Study Results .............................................................................................................
3 Comparative Bioavailability Studies ......................................................................... 67 15 MICROBIOLOGY ...........................................................................................................
69 16 NON-CLINICAL […]
03/2025 7 WARNINGS AND PRECAUTIONS, General 03/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS ................................................................................................................. 1 Pediatrics .......................................................................................................................
2 Geriatrics ....................................................................................................................... 5 2 CONTRAINDICATIONS ....................................................................................................
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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