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TARO-CLARITHROMYCIN XL is a brand name for Clarithromycin, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TARO-CLARITHROMYCIN (Clarithromycin Tablets) TARO-CLARITHROMYCIN 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…
Verbatim from this product's HC label. Tap a section to expand.
, Table 2. 2 Geriatrics Geriatrics (> 65 years of age): Dosage adjustment should be considered in elderly patients with severe renal impairment. 4 Geriatrics. 2 CONTRAINDICATIONS TARO-CLARITHROMYCIN, TARO-CLARITHROMYCIN XL and TARO-CLARITHROMYCIN are contraindicated in: o Patients with a known hypersensitivity to clarithromycin, erythromycin, other macrolide antibacterial agents or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
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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 9 DRUG TARO-CLARITHROMYCIN (Clarithromycin Tablets), TARO-CLARITHROMYCIN XL (Clarithromycin Extended-Release Tablets), RAN-CLARITHROMYCIN (Clarithromycin for Oral Suspension) Page 17 of 118 Unclassified / Non classifié INTERACTIONS.
Clarithromycin must not be given to patients with electrolyte disturbances such as hypomagnesaemia or hypokalemia. See 2 CONTRAINDICATIONS. Clarithromycin is contraindicated in patients with congenital or documented acquired QT prolongation or history of ventricular arrhythmia, including torsades de pointes.
Clarithromycin is also contraindicated in patients with hypokalaemia due to the risk of QT prolongation and torsades de pointes. Concomitant administration of clarithromycin with astemizole, cisapride, domperidone, pimozide, terfenadine and saquinavir is also contraindicated.
See 2 CONTRAINDICATIONS. Epidemiological studies investigating the risk of adverse cardiovascular outcomes with macrolides have shown variable results. Studies have identified risks of arrhythmia, myocardial infarction and cardiovascular mortality associated with macrolides including clarithromycin.
Consideration of these findings should be balanced with treatment benefits when prescribing clarithromycin. Driving and Operating Machinery There are no data on the effect of clarithromycin on the ability to drive or use machines. The potential for dizziness, vertigo, confusion and disorientation, which may occur with the medication, should be taken into account before patients drive or use machines.
Endocrine and Metabolism RAN-CLARITHROMYCIN contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. When prescribing to diabetic patients, the sucrose content should be taken into account.
; General 07/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
5 1 INDICATIONS ...................................................................................................................... 1 Pediatrics................................................................................................................................
2 Geriatrics ................................................................................................................................ 7 2 CONTRAINDICATIONS .........................................................................................................
7 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ..................................................................... 8 4 DOSAGE AND ADMINISTRATION ......................................................................................... 1 Dosing Considerations ...........................................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................................... 3 Reconstitution ......................................................................................................................
4 Administration ..................................................................................................................... 5 Missed Dose .........................................................................................................................
01/2025 7 WARNINGS AND PRECAUTIONS; General 07/2025 TABLE OF CONTENTS Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
5 1 INDICATIONS ...................................................................................................................... 1 Pediatrics................................................................................................................................
2 Geriatrics ................................................................................................................................ 7 2 CONTRAINDICATIONS .........................................................................................................
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Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Clarithromycin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. Phenylketonuric Patients RAN-CLARITHROMYCIN contains aspartame. Aspartame contains phenylalanine which may pose safety risks in phenylketonuric (PKU) patients. See 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Gastrointestinal Clostridioides difficile-Associated Disease Clostridioides difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including clarithromycin. CDAD may range in severity from mild diarrhea to fatal colitis.
It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridioides difficile. Clostridioides difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. TARO-CLARITHROMYCIN (Clarithromycin Tablets), TARO-CLARITHROMYCIN XL (Clarithromycin Extended-Release Tablets), RAN-CLARITHROMYCIN (Clarithromycin for Oral Suspension) Page 18 of 118 Unclassified / Non classifié If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated.
Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridioides difficile. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridioides difficile.
Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe cases. See 8 ADVERSE REACTIONS. Hepatic/Biliary/Pancreatic Caution is advised in patients with impaired hepatic function.
Clarithromycin is principally excreted by the liver and kidney. In patients with a combination of hepatic (mild to moderate) and renal impairments, decreased dosage of clarithromycin or prolonged dosing intervals might be appropriate.
See 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment. Clarithromycin is contraindicated in patients with severe hepatic failure in combination with renal impairment. See 2 CONTRAINDICATIONS. Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with clarithromycin.
This hepatic dysfunction may be severe and is usually reversible. In some instances, hepatic failure with fatal outcomes 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, such as anorexia, jaundice, dark urine, pruritus, or tender abdomen. , acute generalized exanthematous pustulosis (AGEP), Stevens- Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) and drug rash with eosinophilia and systemic symptoms (DRESS)), clarithromycin therapy should be discontinued immediately and appropriate treatment should be urgently initiated.
Renal Caution […]
13 5 OVERDOSAGE ................................................................................................................... 13 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................................ 13 7 WARNINGS AND PRECAUTIONS ........................................................................................
1 Special Populations .............................................................................................................. 1 Pregnant Women ..............................................................................................................
2 Breast-feeding ................................................................................................................... 3 Pediatrics...........................................................................................................................
4 Geriatrics ........................................................................................................................... 21 8 ADVERSE REACTIONS ........................................................................................................
1 Adverse Reaction Overview ................................................................................................. 2 Clinical Trial Adverse Reactions ...........................................................................................
1 Clinical Trial Adverse Reactions – Pediatrics..................................................................... 3 Less Common Clinical Trial Adverse Reactions ....................................................................
1 Less Common Clinical Trial Adverse Reactions – Pediatrics ............................................. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...........................................................................................................................................
5 Post-Market Adverse Reactions........................................................................................... 32 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....................................................................................... 44 10 CLINICAL PHARMACOLOGY .............................................................................................
1 Mechanism of Action ......................................................................................................... 2 Pharmacodynamics ............................................................................................................
3 Pharmacokinetics ............................................................................................................... 44 11 STORAGE, STABILITY AND DISPOSAL […]