Amoxil - Indications & Dosage

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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

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