AMOXICILLIN powder, for suspension AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 400 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension, USP and other antibacterial drugs, amoxicillin for oral suspension, USP 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 for oral suspension, USP is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: 1.1 Infections of the Ear, Nose, and Throatdue to Streptococcus species (α- and   β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.1.2 Infections of the Genitourinary Tract due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.1.3 Infections of the Skin and Skin Structuredue to Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.1.4 Infections of the Lower Respiratory Tractdue to Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.1.5 Gonorrhea, Acute Uncomplicated (ano-genital and urethral infections) due to Neisseria gonorrhoeae. Because of high rates of amoxicillin resistance, amoxicillin for oral suspension, USP is not recommended for empiric treatment of gonorrhea. Amoxicillin for oral suspension, USP use should be limited to situations where N. gonorrhoeae isolates are known to be susceptible to amoxicillin.1.6 Triple Therapy for Helicobacter pylori with Clarithromycin and Lansoprazole Amoxicillin for oral suspension, USP, 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.1.7 Dual Therapy for H. pylori with Lansoprazole Amoxicillin for oral suspension, USP, 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. Amoxicillinfor oral suspension is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin for oral suspension or to other β-lactam antibiotics (e.g., penicillins and cephalosporins). 8.1 Pregnancy 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.8.2 Labor and Delivery 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. 8.3 Nursing Mothers 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.8.4 Pediatric Use 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). [See Dosage and Administration (2.2).]8.5 Geriatric Use 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.8.6 Dosing in Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR <30 mL/min). See Dosage and Administration (2.4) for specific recommendations in patients with renal impairment.

Product summary:

Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted bubble-gum-flavored pink suspension contains 200 mg or 400 mg amoxicillin as the trihydrate.                200 mg/5 mL       50 mL Bottle          NDC 65862-070-50       75 mL Bottle          NDC 65862-070-75       100 mL Bottle        NDC 65862-070-01             400 mg/5 mL       50 mL Bottle             NDC 65862-071-50       75 mL Bottle             NDC 65862-071-75       100 mL Bottle           NDC 65862-071-01 Store dry powder 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
DIRECT RX
----------
AMOXICILLIN
INDICATIONS & USAGE SECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
amoxicillin for oral suspension, USP and other antibacterial drugs,
amoxicillin for oral
suspension, USP 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 for oral suspension, USP is indicated in the treatment of
infections due to
susceptible (ONLY β-lactamase–negative) isolates of the designated
bacteria in the
conditions listed below:
1.1 Infections of the Ear, Nose, and Throatdue to Streptococcus
species (α- and β-
hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus
spp., or
Haemophilus influenzae.1.2 Infections of the Genitourinary Tract
due to Escherichia coli, Proteus mirabilis, or Enterococcus
faecalis.1.3 Infections of the
Skin and Skin Structuredue to Streptococcus spp. (α- and β-hemolytic
isolates only),
Staphylococcus spp., or E. coli.1.4 Infections of the Lower
Respiratory Tractdue to
Streptococcus spp. (α- and β-hemolytic isolates only), S.
pneumoniae, Staphylococcus
spp., or H. influenzae.1.5 Gonorrhea, Acute Uncomplicated (ano-genital
and urethral
infections)
due to Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, amoxicillin for oral
suspension, USP is
not recommended for empiric treatment of gonorrhea. Amoxicillin for
oral suspension,
USP use should be limited to situations where N. gonorrhoeae isolates
are known to be
susceptible to amoxicillin.1.6 Triple Therapy for Helicobacter pylori
with Clarithromycin
and Lansoprazole
Amoxicillin for o