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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. Directions for Mixing Oral Suspension: Text Continues Below
Prepare suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately 1/ 3 of the total amount of water for reconstitution (see table below) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously. 125 mg/ 5 mL Amount of Water Required for Reconstitution Bottle Size
150 mL 116 mL
Each teaspoonful (5 mL) will contain 125 mg amoxicillin.
200 mg/ 5 mL Amount of Water Required for Reconstitution Bottle Size
50 mL 39 mL
75 mL 57 mL
100 mL 76 mL
Each teaspoonful (5 mL) will contain 200 mg amoxicillin.
250 mg/ 5 mL Amount of Water Required for Reconstitution Bottle Size
100 mL 74 mL
150 mL 111 mL
Each teaspoonful (5 mL) will contain 250 mg amoxicillin.
400 mg/ 5 mL Amount of Water Required for Reconstitution Bottle Size
50 mL 36 mL
75 mL 54 mL
100 mL 71 mL
Each teaspoonful (5 mL) will contain 400 mg amoxicillin.
Directions for Mixing Pediatric Drops: Prepare pediatric drops at time of dispensing as follows: Add the required amount of water (see table below) to the bottle and shake vigorously. Each mL of suspension will then contain amoxicillin trihydrate equivalent to 50 mg amoxicillin.
Amount of Water
Required for Reconstitution
Bottle Size
15 mL 12 mL
30 mL 23 mL NOTE: SHAKE BOTH ORAL SUSPENSION AND PEDIATRIC DROPS WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration preferable, but not required. HOW SUPPLIED Capsules of AMOXIL. Each capsule contains 250 mg or 500 mg amoxicillin as the trihydrate.
250-mg Capsule NDC 0029-6006-32 bottles of 500 500-mg Capsule NDC 0029-6007-32 bottles of 500
Tablets of AMOXIL. Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.
500-mg Tablet NDC 0029-6046-12 bottles of 20 NDC 0029-6046-20 bottles of 100
NDC 0029-6046-25 bottles of 500
875-mg Tablet NDC 0029-6047-12 bottles of 20 NDC 0029-6047-20 bottles of 100
NDC 0029-6047-25 bottles of 500 Chewable Tablets of AMOXIL. Each cherry-banana-peppermint-flavored tablet contains
200 mg or 400 mg amoxicillin as the trihydrate.
200-mg Tablet NDC 0029-6044-12 bottles of 20 NDC 0029-6044-20 bottles of 100
400-mg Tablet NDC 0029-6045-12 bottles of 20 NDC 0029-6045-20 bottles of 100
AMOXIL for Oral Suspension. Each 5 mL of reconstituted strawberry-flavored suspension contains 125 mg amoxicillin as the trihydrate. Each 5 mL of reconstituted bubble-gum-flavored suspension contains 200, 250, or 400 mg amoxicillin as the trihydrate.
125 mg/ 5 mL NDC 0029-6008-22 150-mL bottle 200 mg/ 5 mL NDC 0029-6048-54 50-mL bottle
NDC 0029-6048-55 75-mL bottle
NDC 0029-6048-59 100-mL bottle
250 mg/ 5 mL NDC 0029-6009-23 100-mL bottle NDC 0029-6009-22 150-mL bottle
400 mg/ 5 mL NDC 0029-6049-54 50-mL bottle NDC 0029-6049-55 75-mL bottle
NDC 0029-6049-59 100-mL bottle
Pediatric Drops of AMOXIL for Oral Suspension. Each mL of bubble-gum-flavored reconstituted suspension contains 50 mg amoxicillin as the trihydrate. NDC 0029-6035-20 15-mL bottle
NDC 0029-6038-39 30-mL bottle
Store at or below 20° C (68° F) 250 mg and 500 mg capsules 125 mg and 250 mg unreconstituted powder
Store at or below 25° C (77° F) 200 mg and 400 mg unreconstituted powder 200 mg and 400 mg chewable tablets
500 mg and 875 mg tablets
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 3 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) Triple Therapy Triple Therapy Study
Evaluable Analysis * Intent-to-Treat Analysis *
Study 1 92 *
[80.0– 97.7]
(n = 48) 86 *
[73.3– 93.5]
(n = 55)
Study 2 86 §
[75.7– 93.6]
(n = 66) 83 §
[72.0– 90.8]
(n = 70) *
This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) and H. pylori infection at baseline defined as at least 2 of 3 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 1 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. H. pylori Eradication Rates – Dual Therapy (amoxicillin/ lansoprazole) Percent of Patients Cured [95% Confidence Interval] (Number of Patients) Dual Therapy Dual Therapy Study
Evaluable Analysis * Intent-to-Treat Analysis * Study 1 77 **
[62.5– 87.2]
(n = 51) 70 **
[56.8– 81.2]
(n = 60)
Study 2 66 §§
[51.9– 77.5]
(n = 58) 61 §§
[48.5– 72.9]
(n = 67) *
This analysis was based on evaluable patients with confirmed duodenal ulcer (active or within 1 year) 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 (active or within 1 year). All dropouts were included as failures of therapy. ** (p< 0.05) versus lansoprazole alone. §§
(p< 0.05) versus lansoprazole alone or amoxicillin alone. REFERENCES 1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically -Fourth Edition; Approved Standard.
NCCLS Document M7-A4, Vol. 17, No. 2. NCCLS, Wayne, PA, January 1997.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests -Sixth Edition; Approved Standard. NCCLS Document M2-A6, Vol. 17, No. 1. NCCLS, Wayne, PA, January 1997.
3. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in children less than six years of age. Vet Hum Toxicol
1988; 30: 66-67. DATE OF ISSUANCE MAY 2003
©2003, GlaxoSmithKline
All rights reserved. GlaxoSmithKline Research Triangle Park, NC 27709
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