AMOXICILLIN tablet, film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Aurobindo Pharma Limited

INN (mednarodno ime):

AMOXICILLIN

Sestava:

AMOXICILLIN ANHYDROUS 500 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Adults and Pediatric Patients - Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets 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 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 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 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 tablets, in combination with clarithromycin plus lansoprazole as triple therapy, are 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 tablets, in combination with lansoprazole delayed-release capsules as dual therapy, are 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 tablets and other antibacterial drugs, amoxicillin tablets 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 tablets are contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin tablets or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). Teratogenic Effects : Pregnancy Category B. 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.

Povzetek izdelek:

Amoxicillin Tablets, USP contains 500 mg or 875 mg amoxicillin as the trihydrate. 500 mg Tablet Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and “66” on the other side.       Bottles of 20                    NDC 65862-014-20                  Bottles of 100                  NDC 65862-014-01          Bottles of 500                  NDC 65862-014-05 875 mg Tablet Pink colored, capsule shaped, film coated tablets debossed with “A” on one side and with a score line in between “6” and “7” on the other side.       Bottles of 20                    NDC 65862-015-20       Bottles of 100                  NDC 65862-015-01       Bottles of 500                  NDC 65862-015-05 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AMOXICILLIN - AMOXICILLIN TABLET, FILM COATED
AUROBINDO PHARMA LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN TABLETS.
AMOXICILLIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1974
RECENT MAJOR CHANGES
Warnings and Precautions, Drug-Induced Enterocolitis
Syndrome (DIES) (5.3) 01/2024
INDICATIONS AND USAGE
Amoxicillin tablets are 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
and other antibacterial drugs, amoxicillin tablets 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)
The upper dose for neonates and infants aged 3 months or younger is 30
mg/kg/day divided every 12
hours. (2.3)
Dosing for _H. pylori _Infection (in Adults): Triple therapy: 1 gram
amoxicillin, 500 mg clarithromycin, and
30 mg lansoprazole, all given twice daily (every 12 hours) for 14
days. Dual therapy: 1 gram amoxicillin
and 30 mg lansoprazole, each given three times daily (every 8 hours)
for 14 days. (2.4)
Reduce the dose in patients with severe renal impairment (GFR greater
than 30 mL/min). (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 500 mg and 875