Dispermox (Amoxicillin) - Indications and Dosage

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DisperMox and other antibacterial drugs, DisperMox 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.

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY ß-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:

Amoxicillin/clarithromycin/lansoprazole

Amoxicillin, 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:

Amoxicillin/lansoprazole

Amoxicillin, 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.)

DOSAGE AND ADMINISTRATION

Amoxicillin may be given without regard to meals.

Directions for DisperMox (Amoxicillin Tablets for Oral Suspension):

Mix one tablet in a small amount of water [approximately 2 teaspoonfuls]. Drink the entire mixture. Rinse the container with an additional small amount of water and drink the contents to assure the whole dose is taken. Do not chew or swallow the tablets. The tablets will not rapidly dissolve in your mouth.

The tablet is not recommended to be mixed with any liquid other than water, as studies have only been conducted using water.

ALL RECOMMENDED DOSAGES FOR AMOXICILLIN ARE INCLUDED IN THIS SECTION FOR INFORMATIONAL PURPOSES ONLY. THE 200 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 200 mg DOSE. THE 400 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 400 mg DOSE. THE 600 mg TABLET FOR ORAL SUSPENSION IS APPROPRIATE ONLY FOR A 600 mg DOSE.

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 amoxicillin is 30 mg/kg/day divided q12h.

Adults and pediatric patients > 3 months

Infection	Severity‡	Usual Adult Dose	Usual Dose for Children > 3 months§
Ear/Nose/Throat	Mild/Moderate	500 mg every 12 hours or 250 mg every 8 hours	25 mg/kg/day in divided doses every 12 hours o r 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 o r 4 0 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 o r 40 mg/kg/day in divided doses every 8 hours
Skin/Skin Structure	Mild/Moderate	500 mg every 12 hours or 250 mg every 8 hours	25 mg/kg/day in divided doses every 12 hours o r 2 0 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 o r 4 0 mg/kg/day in divided doses every 8 hours
Genitourinary Tract	Mild/Moderate	500 mg every12 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 o r 4 0 mg/kg/day in divided doses every 8 hours
Gonorrhea Acute, Uncomplicated		3 grams as single oral dose	Prepubertal children: 50 mg/kg amoxicillin, combined with
ano-genital and urethral infections in males and females			25 mg/kg probenecid as a single dose. N OTE: SINCE PROBENECID IS C ONTRAINDICATED I N CHILDREN U NDER 2 YEARS, D O NOT USE THIS R EGIMEN IN THESE C ASES.

^‡ Dosing for infections caused by less susceptible organisms should follow the recommendations for severe infections.

^§ 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.

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:

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/minute should not receive the 875 mg tablet. Patients with a glomerular filtration rate of 10 to 30 mL/minute 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

Amoxicillin Tablets for Oral Suspension:

Each tablet for oral suspension contains 200 mg, 400 mg or 600 mg amoxicillin as the trihydrate.

200 mg Tablet for Oral Suspension

200 mg light pink colored, strawberry flavored, circular, biconvex, unscored, mottled tablets, debossed with “RX565” on one side and plain on the other.

NDC 10631-565-20 Bottles of 20

NDC 10631-565-60 Bottles of 60

NDC 10631-565-10 Bottles of 1000

NDC 10631-565-80 Strip unit-dose pack of 100s

400 mg Tablet for Oral Suspension

400 mg light pink colored, strawberry flavored, circular, biconvex, unscored, mottled tablets, debossed with “RX567” on one side and plain on the other.

NDC 10631-567-20 Bottles of 20

NDC 10631-567-60 Bottles of 60

NDC 10631-567-05 Bottles of 500

NDC 10631-567-80 Strip unit-dose pack of 100s

600 mg Tablet for Oral Suspension

600 mg light pink colored, circular, biconvex mottled tablet debossed with ‘RX176’ on one side and plain on the other side with a characteristic strawberry flavor.

NDC 10631-176-20 Bottles of 20

NDC 10631-176-60 Bottle of 60

NDC 10631-176-01 Bottles of 100

NDC 10631-176-80 Strip unit-dose pack of 100s

The product is also available as:

Amoxicillin Capsules

Each capsule contains 250 mg or 500 mg amoxicillin as the trihydrate.

250 mg Capsule

250 mg yellow opaque cap and yellow opaque body, size 2, printed “RX654” on both cap and body.

NDC 63304-654-20 Bottles of 20

NDC 63304-654-30 Bottles of 30

NDC 63304-654-01 Bottles of 100

NDC 63304-654-05 Bottles of 500

NDC 63304-654-77 Strip unit-dose pack of 100s

500 mg Capsule

500 mg maroon opaque cap and yellow opaque body, size 0-el, printed “RX655” on both cap and body.

NDC 63304-655-20 Bottles of 20

NDC 63304-655-30 Bottles of 30

NDC 63304-655-40 Bottles of 40

NDC 63304-655-50 Bottles of 50

NDC 63304-655-01 Bottles of 100

NDC 63304-655-05 Bottles of 500

NDC 63304-655-77 Strip unit-dose pack of 100s

Amoxicillin Tablets:

Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate.

500 mg Tablet

500 mg pink colored, film coated, capsule shaped tablets; debossed with “RX762” on one side and plain on the other.

NDC 63304-762-82 Bottles of 12

NDC 63304-762-20 Bottles of 20

NDC 63304-762-01 Bottles of 100

NDC 63304-762-13 Bottles of 120

NDC 63304-762-05 Bottles of 500

875 mg Tablet

875 mg pink colored, film coated, capsule shaped tablets; debossed with “RX763” on one side and scored on reverse side.

NDC 63304-763-82 Bottles of 12

NDC 63304-763-20 Bottles of 20

NDC 63304-763-01 Bottles of 100

NDC 63304-763-13 Bottles of 120

NDC 63304-763-05 Bottles of 500

Amoxicillin Chewable Tablets:

Each chewable tablet contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.

125 mg Tablet

125 mg pink colored, strawberry flavored, oval biconvex tablets, with mottled appearance; debossed with “RX514” on one side.

NDC 63304-514-01 Bottles of 100

NDC 63304-514-05 Bottles of 500

200 mg Tablet

200 mg light pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX760” on one side.

NDC 63304-760-20 Bottles of 20

NDC 63304-760-01 Bottles of 100

NDC 63304-760-05 Bottles of 500

250 mg Tablet

250 mg pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX515” on one side.

NDC 63304-515-30 Bottles of 30

NDC 63304-515-01 Bottles of 100

NDC 63304-515-04 Bottles of 250

400 mg Tablet

400 mg light pink colored, strawberry flavored, circular, flat faced, beveled edge tablets, with mottled appearance; debossed with “RX761” on one side.

NDC 63304-761-20 Bottles of 20

NDC 63304-761-01 Bottles of 100

NDC 63304-761-05 Bottles of 500

Amoxicillin For Oral Suspension:

200 mg /5mL

The 200 mg per 5 mL oral suspension* is off white to light orange granular powder forming a light orange to orange suspension* on constitution with water. The resulting suspension has a characteristic fruity flavor and is available as follows:

NDC 63304-969-03 50 mL Bottles

NDC 63304-969-01 75 mL Bottles

NDC 63304-969-04 100 mL Bottles

400 mg /5mL

The 400 mg per 5 mL oral suspension* is off white to light orange granular powder forming a light orange to orange suspension* on constitution with water. The resulting suspension has a characteristic fruity flavor and is available as follows:

NDC 63304-970-03 50 mL Bottles

NDC 63304-970-01 75 mL Bottles

NDC 63304-970-04 100 mL Bottles

*SHAKE ORAL SUSPENSION WELL BEFORE USING.

Store at 20 – 25°C (68 – 77°F) [See USP Controlled Room Temperature].

Dispense in a tight container.