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AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN is a brand name for Lansoprazole, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: The components of the AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN [lansoprazole delayed-release capsules, in combination with clarithromycin tablets plus amoxicillin capsules as triple therapy], are indicated for: ● the treatment of patients with Helicobacter pylori (H. pylori) infection and active duodenal ulcer…
Verbatim from this product's HC label. Tap a section to expand.
). In patients with a recent history of duodenal ulcers who are H. pylori positive, eradication therapy may reduce the rate of recurrence of duodenal ulcers. The optimal timing for eradication therapy for such patients remains to be determined.
In patients who fail a therapy combination containing clarithromycin, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, an alternative therapy combination is recommended.
Resistance to amoxicillin has not been demonstrated in clinical studies with lansoprazole delayed-release capsules and amoxicillin. Table 1 summarizes the eradication rates for the H. pylori Triple Therapy treatment regimen. Table 1 - Eradication Rates for the H.
pylori Triple Therapy Treatment Regimens Treatment Regimen Days / Study No. Evaluable (Per Protocol)* % (n/N) ITT (all data)† % (n/N) ITT (Worst Case)‡ % (n/N) Lansoprazole 30 mg capsules / clarithromycin 500 mg / amoxicillin 1000 mg (all twice daily) 14 / M93-131 92 (44/48) 94 (47/50) 86 (47/55) 14 / M95-392 86 (57/66) 87 (58/67) 83 (58/70) Lansoprazole 30 mg capsules / clarithromycin 500 mg / amoxicillin 1000 mg (all twice daily) 10 / M95-399 84 (103/123) 86 (110/128) 81 (110/135) Lansoprazole 30 mg capsules / clarithromycin 250 mg / amoxicillin 1000 mg (all twice daily) 7 / GB 94/110 90 (103/114) 90 (104/116) 86 (104/121) AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN (Lansoprazole Delayed-Release Capsules / Amoxicillin Capsules / Clarithromycin Tablets) Page 5 of 117 Treatment Regimen Days / Study No.
Evaluable (Per Protocol)* % (n/N) ITT (all data)† % (n/N) ITT (Worst Case)‡ % (n/N) Definitions: ITT = intent-to-treat patients * Based on evaluable patients with confirmed duodenal ulcer and/or gastritis and H. pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology and/or culture.
Patients were included in the analysis if they completed the study. Additionally, if patients dropped out of the study due to an adverse event related to the study drug, they were included in the analysis as failures of therapy. † Patients were included in the analysis if they had documented H.
pylori infection at baseline as defined above and had a confirmed duodenal ulcer. ‡ “Worst case” included patients with no available data as failures. Patients were included in the analysis if they had documented duodenal ulcer (active) and H.
). Neurologic Clarithromycin tablets, USP Myasthenia Gravis Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has been reported in patients receiving clarithromycin therapy. Ophthalmologic Lansoprazole delayed-release capsules, USP Retinal atrophy In animal studies, retinal atrophy was observed in rats dosed orally for 2 years with lansoprazole at doses of 15 mg/kg/day and above.
These changes in rats are believed to be associated with the effects of taurine imbalance and phototoxicity in a susceptible animal model. AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN (Lansoprazole Delayed-Release Capsules / Amoxicillin Capsules / Clarithromycin Tablets) Page 20 of 117 Clinical data available from long-term lansoprazole studies are not suggestive of any drug- induced eye toxicity in humans.
In humans, there are presently no concerns for ocular safety with short-term lansoprazole treatment and the risks associated with long-term use for nearly 5 years appear to be negligible. The finding of drug-induced retinal atrophy in the albino rat is considered to be species-specific with little relevance for humans.
2 Pharmacodynamics and 16 NON-CLINICAL TOXICOLOGY, Special Toxicology.
Renal AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN Triple Therapy:
Lansoprazole / clarithromycin / amoxicillin For the eradication of H. pylori, amoxicillin and clarithromycin should not be administered to patients with renal impairment since the appropriate dosage in this patient population has not yet been established.
Lansoprazole delayed-release capsules, USP No dosage adjustment of lansoprazole is necessary in patients with renal impairment. 2 Recommended Dose and Dosage Adjustment and 10 CLINICAL PHARMACOLOGY. Clarithromycin tablets, USP Caution is advised in patients with severe renal insufficiency.
2 Breast-feeding 09/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics ......................................................................................................................
2 Geriatrics ...................................................................................................................... 1 Dosing Considerations ..................................................................................................
2 Recommended Dose and Dosage Adjustment .............................................................. 4 Administration .............................................................................................................. 5 Missed Dose..................................................................................................................
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ....................................... 10 7 WARNINGS AND PRECAUTIONS ......................................................................................... 1 Special Populations .....................................................................................................
1 Pregnant Women ............................................................................................... 2 Breast-feeding .................................................................................................... 3 Pediatrics ...........................................................................................................
4 Geriatrics ............................................................................................................ 24 AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN (Lansoprazole Delayed-Release Capsules / Amoxicillin Capsules / Clarithromycin Tablets) Page 3 of 117 8 ADVERSE REACTIONS .........................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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pylori infection at baseline defined as at least 2 of 3 positive endoscopic tests from CLOtest®, histology and/or culture. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets or amoxicillin capsules and other antibacterial drugs, clarithromycin tablets or amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
1 Pediatrics Pediatrics (1 to 17 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use.
3 Pediatrics. 2 Geriatrics Geriatrics (≥ 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is associated with differences in safety or effectiveness. 4 Geriatrics. g. g. any penicillin or cephalosporin) or AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN (Lansoprazole Delayed-Release Capsules / Amoxicillin Capsules / Clarithromycin Tablets) Page 6 of 117 ▪ any ingredient in the formulations of Lansoprazole Delayed-Release Capsules; Clarithromycin Tablets, or Amoxicillin Capsules, including any non-medicinal ingredient, or component of the container.
For a complete listing, see
2 Recommended Dose and Dosage Adjustment). 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.
For dosage adjustment recommendations, refer to the Clarithromycin Product Monograph. Clarithromycin is contraindicated in patients with severe hepatic failure in combination with renal impairment. See 2 CONTRAINDICATIONS. Amoxicillin (amoxicillin trihydrate) capsules, USP Periodic assessment of renal functions should be made during prolonged amoxicillin therapy.
2 Recommended Dose and Dosage Adjustment). AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN (Lansoprazole Delayed-Release Capsules / Amoxicillin Capsules / Clarithromycin Tablets) Page 21 of 117 Reproductive Health: Female and Male Potential • Fertility Lansoprazole delayed-release capsules, USP Reproductive studies conducted in pregnant rats at oral doses up to 150 mg/kg/day (40 times the recommended human dose based on body surface area), and in rabbits at oral doses up to 30 mg/kg/day (16 times the recommended human dose based on body surface area), revealed no lansoprazole-related impairment of fertility, fetal malformations or developmental toxicity to fetuses or suckling neonates.
• Teratogenic Risk Lansoprazole delayed-release capsules, USP Lansoprazole is not considered to be teratogenic. Maternal toxicity and a significant increase in fetal mortality were observed in the rabbit study at doses above 10 mg/kg/day.
In rats, maternal toxicity and a slight reduction in litter survival and weights were noted at doses above 100 mg/kg/day. See 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology. Clarithromycin tablets, USP Four teratogenicity studies in rats (3 with oral doses and 1 with intravenous doses up to 160 mg/kg/day administered during the period of major organogenesis) and 2 in rabbits (at oral doses up to 125 mg/kg/day or intravenous doses of 30 mg/kg/day administered during gestation days 6 to 18) failed to demonstrate any teratogenicity from clarithromycin.
Two additional oral studies in a different rat strain at similar doses and similar conditions demonstrated a low incidence of cardiovascular anomalies at doses of 150 mg/kg/day administered during gestation days 6 to 15. Plasma levels after 150 mg/kg/day were 2 times the human serum levels.
Four studies in mice revealed a variable incidence of cleft palate following oral doses of 1000 mg/kg/day during gestation days 6 to 15. Cleft palate was also seen at 500 mg/kg/day. The 1000 mg/kg/day exposure resulted in plasma levels 17 times the human serum levels.
In monkeys, an oral dose of 70 mg/kg/day produced fetal growth retardation at plasma levels that were 2 times the human serum levels. Embryonic loss has been seen in monkeys and rabbits (see 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology).
Sensitivity/Resistance Antibiotic Resistance in Relation to H. pylori Eradication To avoid failure of the eradication treatment with a potential for developing antimicrobial AA-LANSOPRAZOLE-AMOXICILLIN-CLARITHROMYCIN (Lansoprazole Delayed-Release Capsules / Amoxicillin Capsules / Clarithromycin Tablets) Page 22 of 117 resistance and a risk of failure with subsequent therapy, patients should be instructed to follow closely the prescribed regimen.
Development of Drug Resistant Bacteria Prescribing clarithromycin tablets or amoxicillin capsules in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and risks the development of drug-resistant bacteria.
Clarithromycin tablets, USP Use of any antimicrobial therapy, such as clarithromycin, to treat H. pylori infection may select for drug-resistant organisms. 7%)] who […]
1 Adverse Reaction Overview ........................................................................................ 2 Clinical Trial Adverse Reactions ..................................................................................
3 Less Common Clinical Trial Adverse Reactions ........................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data .................................................................................................................
5 Post-Market Adverse Reactions .................................................................................. 35 9 DRUG INTERACTIONS .........................................................................................................
1 Serious Drug Interaction ............................................................................................. 2 Drug Interactions Overview ........................................................................................
4 Drug-Drug Interactions ............................................................................................... 5 Drug-Food Interactions ...............................................................................................
6 Drug-Herb Interactions ............................................................................................... 7 Drug-Laboratory Test Interactions ..............................................................................
60 10 CLINICAL PHARMACOLOGY ................................................................................................ 1 Mechanism of Action ..................................................................................................
2 Pharmacodynamics ..................................................................................................... 3 Pharmacokinetics........................................................................................................
65 11 STORAGE, STABILITY AND DISPOSAL.................................................................................. 73 12 SPECIAL HANDLING INSTRUCTIONS ...................................................................................
74 PART II: SCIENTIFIC INFORMATION ........................................................................................... 75 13 PHARMACEUTICAL INFORMATION ....................................................................................
75 14 CLINICAL TRIALS ................................................................................................................. 1 Clinical Trials by […]