AMOXIL is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) strains of the designated microorganisms in the conditions listed below:

Infections of the ear, nose, and throat – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Infections of the genitourinary tract – due to E. coli, P. mirabilis, or E. faecalis.

Infections of the skin and skin structure – due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli.

Infections of the lower respiratory tract – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N. gonorrhoeae (males and females).

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

Triple Therapy: AMOXIL/clarithromycin/lansoprazole

AMOXIL, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

Dual Therapy: AMOXIL/lansoprazole

AMOXIL, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION.)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL and other antibacterial drugs, AMOXIL should be used only to treat or prevent 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.

Indicated surgical procedures should be performed.

Capsules, chewable tablets, and oral suspensions of AMOXIL may be given without regard to meals. The 400-mg suspension, 400-mg chewable tablet, and the 875-mg tablet have been studied only when administered at the start of a light meal. However, food effect studies have not been performed with the 200-mg and 500-mg formulations.

Neonates and Infants Aged ≤12 Weeks (≤3 Months)

Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of AMOXIL is 30 mg/kg/day divided q12h.

Adults and Pediatric Patients >3 Months:

After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. To be certain the child is receiving full dosage, such preparations should be consumed in entirety.

All patients with gonorrhea should be evaluated for syphilis. (See PRECAUTIONS: Laboratory Tests.)

Larger doses may be required for stubborn or severe infections.

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

AMOXIL/clarithromycin/lansoprazole

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

Dual Therapy

AMOXIL/lansoprazole

The recommended adult oral dose is 1 gram AMOXIL 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/min. 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.

Directions for Mixing Oral Suspension

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.

200 mg/5 mL

Each teaspoonful (5 mL) will contain 200 mg amoxicillin.

250 mg/5 mL

Each teaspoonful (5 mL) will contain 250 mg amoxicillin.

400 mg/5 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.

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.

Capsules of AMOXIL: Each capsule contains 500 mg amoxicillin as the trihydrate.

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 0029-6046-20 bottles of 100

875-mg Tablet

NDC 0029-6047-20 bottles of 100

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

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 bubble-gum-flavored suspension contains 200, 250, or 400 mg amoxicillin as the trihydrate.

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
NDC 0029-6048-18 5-mL unit dose 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
NDC 0029-6048-18 5-mL unit dose bottle

Pediatric Drops of AMOXIL for Oral Suspension: Each mL of bubble-gum-flavored reconstituted suspension contains 50 mg amoxicillin as the trihydrate.

NDC 0029-6038-39 30-mL bottle

Store at or below 20°C (68°F)

• 500-mg capsules
• 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.

AMOXIL and AUGMENTIN are registered trademarks of GlaxoSmithKline.
CLINITEST is a registered trademark of Miles, Inc.
CLINISTIX is a registered trademark of Bayer Corporation. CLOtest is a registered trademark of Kimberly-Clark Corporation.
GlaxoSmithKline
Research Triangle Park, NC 27709
©YEAR, GlaxoSmithKline. All rights reserved.
FDA rev date: 1/26/2006

Bookmark this page: