AMOXICILLIN tablet, film coated AMOXICILLIN powder, for suspension AMOXICILLIN tablet, chewable AMOXICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9)

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Adults and Pediatric Patients - Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . - Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli , Proteus mirabilis , or Enterococcus faecalis . - Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . - Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae , Staphylococcus spp., or H. influenzae . Adult Patients only - Helicobacter pylori Infection and Duodenal Ulcer Disease: Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and 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. Dual therapy for H. pylori with 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. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin 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. Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed. Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman. The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. The safety and effectiveness of amoxicillin for the treatment of H. Pylori infection have not been established in pediatric patients. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see Dosage and Administration (2.3)] . An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Dosing in Renal Impairment (2.5) for specific recommendations in patients with renal impairment.

Product summary:

Amoxicillin tablets, USP: 500 mg : Each tablet contains 500 mg of amoxicillin, USP as the trihydrate. Each film-coated, capsule-shaped, off-white, tablet is debossed with “93” on one side and “2263” on the other side. They are available in bottles of 100 (NDC 0093-2263-01) tablets. 875 mg : Each tablet contains 875 mg of amoxicillin, USP as the trihydrate. Each film-coated, capsule-shaped, off-white tablet is scored on one side, debossed with “93” on one side of the score and “2264” on the other side of the score. They are available in bottles of 100 (NDC 0093-2264-01) tablets. Amoxicillin for oral suspension, USP : 200 mg/5 mL :  Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 200 mg amoxicillin, USP as the trihydrate. It is available in bottles of 50 mL (NDC 0093-4160-76), 75 mL (NDC 0093-4160-78), and 100 mL (NDC 0093-4160-73). 250 mg/5 mL :  Each 5 mL of reconstituted mixed berry flavored suspension contains 250 mg amoxicillin, USP as the trihydrate. It is available in bottles of 80 mL (NDC 0093-4155-79), 100 mL (NDC 0093-4155-73), and 150 mL (NDC 0093-4155-80). 400 mg/5 mL :  Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 400 mg amoxicillin, USP as the trihydrate. It is available in bottles of 50 mL (NDC 0093-4161-76), 75 mL (NDC 0093-4161-78), and 100 mL (NDC 0093-4161-73). Amoxicillin Tablets (Chewable), USP: 125 mg :   Each white to off-white, capsule-shaped tablet, debossed 93 on one side and 2267 on the other side and contain 125 mg amoxicillin, USP as the trihydrate. They are available in bottles of 100 tablets (NDC 0093-2267-01). 250 mg :   Each white to off-white, capsule-shaped tablet, debossed 93 (partial bisect between 9 and 3) on one side and 2268 on the other side and contain 250 mg amoxicillin, USP as the trihydrate. They are available in bottles of 100 tablets (NDC 0093-2268-01). Amoxicillin Capsules, USP 250 mg : Opaque caramel cap and opaque buff body, hard gelatin capsule. Printed black “TEVA” on cap and “3107” on body portions of the capsule and contain 250 mg amoxicillin, USP as the trihydrate. They are available in bottles of 100 (NDC 0093-3107-01) and 500 (NDC 0093-3107-05) capsules. 500 mg : Opaque buff cap and opaque buff body, hard gelatin capsules. Printed black “TEVA” on cap and “3109” on body portions of the capsules and contain 500 mg amoxicillin, USP as the trihydrate. They are available in bottles of 50 (NDC 0093-3109-53), 60 (NDC 0093-3109-06), 100 (NDC 0093-3109-01) and 500 (NDC 0093-3109-05) capsules. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN TABLET, FILM COATED
AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
AMOXICILLIN- AMOXICILLIN TABLET, CHEWABLE
AMOXICILLIN- AMOXICILLIN CAPSULE
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN TABLETS,
AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS (CHEWABLE), AND
AMOXICILLIN
CAPSULES, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN
TABLETS, AMOXICILLIN FOR ORAL SUSPENSION, AMOXICILLIN TABLETS
(CHEWABLE), AND
AMOXICILLIN CAPSULES.
AMOXICILLIN TABLETS, FOR ORAL USE
AMOXICILLIN FOR ORAL SUSPENSION,
AMOXICILLIN TABLETS (CHEWABLE), FOR ORAL USE
AMOXICILLIN CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Warnings and Precautions (5) 11/2022
INDICATIONS AND USAGE
Amoxicillin is a penicillin-class antibacterial indicated for
treatment of infections due to susceptible strains
of designated microorganisms. (1)
Adults and Pediatric Patients (1)
Upper Respiratory Tract Infections of the Ear, Nose, and Throat
Infections of the Genitourinary Tract
Infections of the Skin and Skin Structure
Infections of the Lower Respiratory Tract
Adult Patients only (1)
_Helicobacter pylori_ Infection and Duodenal Ulcer Disease
Usage
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin tablets,
amoxicillin for oral suspension, amoxicillin tablets (chewable), and
amoxicillin capsules and other
antibacterial drugs, amoxicillin tablets, amoxicillin for oral
suspension, amoxicillin tablets (chewable), and
amoxicillin capsules should be used only to treat or prevent
infections that are proven or strongly
suspected to be caused by bacteria. (1)
DOSAGE AND ADMINISTRATION
In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours.
In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in
divided doses every 8 to 12 hours.
Refer to full prescribing information for specific dosing regimens.
(2.2, 2.3)
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