Amoxicillin (Page 5 of 6)

General:

It should be recognized that in the treatment of chronic urinary tract infections, frequent bacteriological and clinical appraisals are necessary. Smaller doses than those recommended above should not be used. Even higher doses may be needed at times. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Except for gonorrhea, treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.

H. pylori eradication to reduce the risk of duodenal ulcer recurrence:

Triple therapy:

Amoxicillin/clarithromycin/lansoprazole

The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (q12h) for 14 days. (See INDICATIONS AND USAGE.)

Dual therapy:

Amoxicillin/lansoprazole

The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (q8h) for 14 days. (See INDICATIONS AND USAGE.)

Please refer to clarithromycin and lansoprazole full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally impaired patients.

Dosing recommendations for adults with impaired renal function:

Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Severely impaired patients with a glomerular filtration rate of <30 mL/min. should not receive the 875-mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/min. should receive 500 mg or 250 mg every 12 hours, depending on the severity of the infection. Patients with a less than 10 mL/minute glomerular filtration rate should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection.

Hemodialysis patients should receive 500 mg or 250 mg every 24 hours, depending on severity of the infection. They should receive an additional dose both during and at the end of dialysis.

There are currently no dosing recommendations for pediatric patients with impaired renal function.

HOW SUPPLIED

Capsules: Amoxicillin Capsules USP, 500 mg are available as ivory cap and ivory body. The cap of the 500 mg capsule is imprinted with West-ward and the body with 939.

Amoxicillin capsules USP, 250 mg, are available as caramel cap and ivory body. The cap of the 250 mg capsule is imprinted with West-ward and the body with 938.

Amoxicillin capsules USP, 250 mg are available in:

Amoxicillin capsules USP, 500 mg are available in:

55700-075-20

Store at 20°- 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

CLINICAL STUDIES

H. pylori eradication to reduce the risk of duodenal ulcer recurrence:

Randomized, double-blind clinical studies performed in the United States in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14-day therapy, or in combination with amoxicillin capsules as dual 14-day therapy, for the eradication of H. pylori. Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established:

Triple therapy: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily.

Dual therapy: Amoxicillin 1 gram three times daily/lansoprazole 30 mg 3 times daily.

All treatments were for 14 days. H. pylori eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment.

Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies.

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

H. pylori Eradication Rates – Triple Therapy (amoxicillin/ clarithromycin /lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)
* This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within one year) and H. pylori infection at baseline defined as at least two of three positive endoscopic tests from CLOtest® , (Delta West Ltd., Bentley, Australia), 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 (active or within one year). All dropouts were included as failures of therapy.
‡ (p<0.05) versus lansoprazole/amoxicillin and lansoprazole/clarithromycin dual therapy.
§ (p<0.05) versus clarithromycin/amoxicillin dual therapy.
Study Triple Therapy Triple Therapy
Evaluable Analysis* Intent-to-TreatAnalysis†
Study 1 92‡ 86‡
[80 -- 97.7] [73.3 -- 93.5]
(n = 48) (n = 55)
Study 2 86§ 83§
[75.7 -- 93.6] [72 -- 90.8]
(n = 66) (n = 70)
H. pylori Eradication Rates – Dual Therapy (amoxicillin/lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients)
* This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within one year) and H. pylori infection at baseline defined as at least two of three 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 (active or within one year). All dropouts were included as failures of therapy.
‡ (p<0.05) versus lansoprazole alone.
§ (p<0.05) versus lansoprazole alone or amoxicillin alone.
Study Dual Therapy Dual Therapy
Evaluable Analysis* Intent-to-Treat
Analysis†
Study 1 77‡ 70‡
[62.5 -- 87.2] [56.8 -- 81.2]
(n = 51) (n = 60)
Study 2 66§ 61§
[51.9 -- 77.5] [48.5 -- 72.9]
(n = 58) (n = 67)

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