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Amoxicillin

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Amoxil

Amoxil

INDICATIONS

To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXIL (amoxicillin) and other antibacterial drugs, AMOXIL should be used only to treat infections that are proven or strongly suspected to be caused by 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.

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

Infections of the ear, nose, and throat

due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.

Infections of the genitourinary tract

due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.

Infections of the skin and skin structure

due to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.

Infections of the lower respiratory tract

due to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.

Gonorrhea, acute uncomplicated (ano-genital and urethral infections in males and females)

due to Neisseria gonorrhoeae.

Because of high rates of amoxicillin resistance, AMOXIL is not recommended for empiric treatment of gonorrhea. AMOXIL use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.

Triple therapy for Helicobacter pylori with clarithromycin and 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.

Dual therapy for H. pylori with 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.

DOSAGE AND ADMINISTRATION

Dosing for Adult and Pediatric Patients > 3 Months of Age

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. In some 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.

Table 1: Dosing Recommendations for Adult and Pediatric Patients > 3 Months of Age

Infection Severitya Usual Adult Dose Usual Dose for Children > 3 Monthsb
Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hours or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours
or
20 mg/kg/day in divided doses every 8 hours
Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours
Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours
or
40 mg/kg/day in divided doses every 8 hours
Gonorrhea Acute, uncomplicated ano-genital and urethral infections in males and females   3 grams as single oral dose Prepubertal children: 50 mg/kg AMOXIL, combined with 25 mg/kg probenecid as a single dose.
Note: since probenecid is contraindicated in children under 2 years, do not use this regimen in children under 2 years of age.
a Dosing for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
b The children's dosage is intended for individuals whose weight is less than 40 kg. Children weighing 40 kg or more should be dosed according to the adult recommendations.

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

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. 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 every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.

Dosing for H. pylori Infection

Triple therapy

The recommended adult oral dose is 1 gram AMOXIL, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.

Dual therapy

The recommended adult oral dose is 1 gram AMOXIL and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.

Please refer to clarithromycin and lansoprazole full prescribing information.

Dosing in Renal Impairment

  • 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 a 875-mg dose.
  • 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 glomerular filtration rate less than 10 mL/min 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.

Directions for Mixing Oral Suspension

Tap bottle until all powder flows freely. Add approximately 1/3 of the total amount of water for reconstitution (see Table 2) and shake vigorously to wet powder. Add remainder of the water and again shake vigorously.

Table 2: Amount of Water for Mixing Oral Suspension

Strength Bottle Size Amount of Water Required for Reconstitution
Oral Suspension 125 mg/5 mL 80 mL 62 mL
100 mL 78 mL
150 mL 116 mL
Oral Suspension 200 mg/5 mL 50 mL 39 mL
75 mL 57 mL
100 mL 76 mL
Oral Suspension 250 mg/5 mL 80 mL 59 mL
100 mL 74 mL
150 mL 111 mL
Oral Suspension 400 mg/5 mL 50 mL 36 mL
75 mL 54 mL

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.

NOTE: SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.

HOW SUPPLIED

Dosage Forms And Strengths

Capsules: 250 mg, 500 mg. Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500.

Tablets: 500 mg, 875 mg. Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each filmcoated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side.

Powder for Oral Suspension: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL. Each 5 mL of reconstituted bubble-gum-flavored suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

Storage And Handling

Capsules: Each capsule of AMOXIL, with royal blue opaque cap and pink opaque body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The cap and body of the 250-mg capsule are imprinted with the product name AMOXIL and 250; the cap and body of the 500 mg capsule are imprinted with AMOXIL and 500.

250-mg Capsule

NDC 43598-025-01 Bottles of 100
NDC
43598-025-05 Bottles of 500

500-mg Capsule

NDC 43598-005-01 Bottles of 100
NDC 43598-005-05 Bottles of 500

Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsuleshaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side.

500-mg Tablet

NDC 43598-024-01 Bottles of 100
NDC
43598-024-05 Bottles of 500

875-mg Tablet

NDC 43598-019-01 Bottles of 100
NDC
43598-019-14 Bottles of 20

Powder for Oral Suspension: Each 5 mL of reconstituted bubble-gum-flavored suspension contains 125 mg, 200 mg, 250 mg, or 400 mg amoxicillin as the trihydrate.

125 mg/5 mL

NDC 43598-022-80 80-mL bottle
NDC
43598-022-52 100-mL bottle
NDC
43598-022-53 150-mL bottle

200 mg/5 mL

NDC 43598-023-50 50-mL bottle
NDC 43598-023-51 75-mL bottle
NDC 43598-023-52 100-mL bottle

250 mg/5 mL

NDC 43598-009-80 80-mL bottle
NDC
43598-009-52 100-mL bottle
NDC
43598-009-53 150-mL bottle

400 mg/5 mL

NDC 43598-007-50 50-mL bottle
NDC
43598-007-51 75-mL bottle
NDC
43598-007-52 100-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) - 500 mg and 875 mg Tablets & 200 mg and 400 mg unreconstituted powder. Dispense in a tight container.

Dr Reddy's Laboratories, Bridgewater, NJ 08807

Last reviewed on RxList: 12/6/2011
This monograph has been modified to include the generic and brand name in many instances.

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