AMOXICILLIN- amoxicillin powder, for suspension for suspension

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 125 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 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 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 Throat – due 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 S

Product summary:

Amoxicillin Capsules USP are supplied as follows: 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 as the trihydrate. They are available in bottles of 100 and 500 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 as the trihydrate. They are available in bottles of 50 and 500 capsules. Amoxicillin for Oral Suspension USP is supplied as follows: 125 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 125 mg amoxicillin as the trihydrate. It is available in bottles of 80 mL, 100 mL, and 150 mL. 250 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 250 mg amoxicillin as the trihydrate. It is available in bottles of 80 mL, 100 mL, and 150 mL. Amoxicillin Tablets USP (Chewable) are supplied as follows: 125 mg: White to off-white, capsule-shaped tablet, debossed 93 on one side and 2267 on the other side and contain 125 mg amoxicillin as the trihydrate. They are available in bottles of 100 tablets. 250 mg: 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 as the trihydrate. They are available in bottles of 100 and 500 tablets. 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 POWDER, FOR SUSPENSION FOR SUSPENSION
DIRECT RX
----------
AMOXICILLIN
INDICATIONS AND 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 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 Throat
– due 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 Structure
– due to Streptococcus spp. (α- and β-hemolytic isolates only),
Staphylococcus spp., or E. coli.
1.4 Infections of the Lower Respiratory Tract
– due 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 in Males and Females)
– due to Neisseria gonorrhoeae.
Because of high rates of amoxicillin resistance, amoxicillin is not
recommended for empiric
treatment of gonorrhea. Amoxicillin 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, in combination with clarithromycin plus lansoprazole as
triple therapy, is indicated for
the treatment of patients with H. pylori infection and duodenal ulcer
disease