AMOXICILLIN tablet, coated

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

QPharma Inc

INN (Mezinárodní Name):

AMOXICILLIN

Složení:

AMOXICILLIN ANHYDROUS 875 mg

Podání:

ORAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

 1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, Amoxicillin Tablets, 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 Tablets, USP are indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: – due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. – due to Escherichia coli , Proteus mirabilis , or Enterococcus faecalis.   – due to Streptococcus spp. (α- and β-hemolytic isolates only), Staphyl

Přehled produktů:

Amoxicillin Tablets, USP 875 mg: Each film-coated tablet contains 875 mg amoxicillin as the trihydrate. Film-coated, capsule-shaped, pink tablet is scored on one side and imprinted WW951 on the other side. Store at 20°-25°C (68°-77°F ) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP using a child resistant closure.

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

AMOXICILLIN- AMOXICILLIN TABLET, COATED
QPHARMA INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN TABLETS, USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN TABLETS,
USP.
AMOXICILLIN TABLETS, USP, FOR ORAL ADMINISTRATION
RX ONLY
INITIAL U.S. APPROVAL: 1974
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.
INDICATIONS AND USAGE
Amoxicillin Tablets, USP are a penicillin-class antibacterial
indicated for treatment of infections due to susceptible strains of
designated microorganisms. (1)
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
ADVERSE REACTIONS
The most common adverse reactions (> 1%) observed in clinical trials
of amoxicillin tablets were diarrhea, rash, vomiting,
and nausea. (6.1) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WEST-WARD
PHARMACEUTICAL CORP. AT 1-877-233-2001 OR
THE FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
•
•
Infections of the ear, nose, throat, genitourinary tract, skin and
skin structure, and lower respiratory tract. (1.1 – 1.5)
In combination for treatment of _H. pylori _infection and duodenal
ulcer disease. (1.6, 1.7)
In adults, 750-1750 mg/day in divided doses every 8-12 hours. In
Pediatric Patients > 3 Months of Age, 20-45
mg/kg/day in divided doses every 8-12 hours. Refer to full prescribing
information for specific dosing regimens. (2.1,
2.2, 2.3)
Treatment of gonorrhea is 3 grams as a single oral dose. (2.1)
The upper dose for neonates and infants ≤ 3 months is 30 mg/kg/day
divided every 12 hours. (2.2)
Dosing for _H. pylori _Infection: Triple therapy: 1 gram amoxicillin,
500 mg clarithromycin, and 30 mg lansoprazole, all
given twice daily (every 12 hou