AMOXICILLIN powder, for suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Rebel Distributors Corp

INN (International Name):

AMOXICILLIN

Sammensetning:

AMOXICILLIN ANHYDROUS 200 mg in 5 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) strains of the designated microorganisms in the conditions listed below: Infections of the ear, nose, and throat – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae , Staphylococcus spp., or H. influenzae . Infections of the genitourinary tract – due to E. coli, P. mirabilis , or E. faecalis . Infections of the skin and skin structure – due to Streptococcus spp. (α- and β-hemolytic strains only), Staphylococcus spp., or E. coli . Infections of the lower respiratory tract – due to Streptococcus spp. (α- and β-hemolytic strains only), S. pneumoniae, Staphylococcus spp., or H. influenzae . Gonorrhea, acute uncomplicated (ano-genital and urethral infections) – due to N. gonorrhoeae (males and females). H. pylori eradication to reduce the risk of duodenal ulcer recurrence Amoxicillin/clarithromycin/lansoprazole Amoxicillin, in combination with clarithromycin plus lansoprazole

Produkt oppsummering:

Each 5 mL of reconstituted fruity-flavored suspension contains 125, 200, 250, or 400 mg amoxicillin as the trihydrate. 200 mg/5 mL 100 mL bottle Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMOXICILLIN- AMOXICILLIN POWDER, FOR SUSPENSION
REBEL DISTRIBUTORS CORP
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AMOXICILLIN POWDER FOR ORAL SUSPENSION
RX ONLY
11/2009
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 or
prevent infections that are proven
or strongly suspected to be caused by bacteria.
DESCRIPTION
Formulations of amoxicillin powder for oral suspension contain
amoxicillin, a semisynthetic antibiotic,
an analog of ampicillin, with a broad spectrum of bactericidal
activity against many gram-positive and
gram-negative microorganisms. Chemically, it is
(2_S_,5_R_,6_R_)-6-[(_R_)-(-)-2-amino-2-(_p_-
hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid
trihydrate. It may be represented structurally as:
The amoxicillin molecular formula is C
H N O S•3H O, and the molecular weight is 419.45.
Powder for oral suspension of amoxicillin is intended for oral
administration.
POWDER FOR ORAL SUSPENSION
Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg,
or 400 mg amoxicillin as the
trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg and 400 mg
reconstituted suspension contains
0.1898 mEq (4.3635 mg) of sodium.
Amoxicillin trihydrate for oral suspension 125 mg/mL, 200 mg/mL, 250
mg/5 mL, and 400 mg/5 mL are
fruity flavored white to off-white suspensions which contain the
following inactive ingredients:
colloidal silicon dioxide, hypromellose, sodium benzoate, sucrose,
trisodium citrate dihydrate, tutti
frutti flavor, and xanthan gum.
CLINICAL PHARMACOLOGY
Amoxicillin is stable in the presence of gastric acid and is rapidly
absorbed after oral administration.
The effect of food on the absorption of amoxicillin from the tablets
and suspension of amoxicillin has
been partially investigated. The 400 mg and 875 mg formulations have
been studied only when
administered at the start of a light meal. However, food effect
studies have not been performed with the
200 mg an