AMOXICILLIN capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

PD-Rx Pharmaceuticals, Inc.

INN (Medzinárodný Name):

AMOXICILLIN

Zloženie:

AMOXICILLIN ANHYDROUS 500 mg

Typ predpisu:

PRESCRIPTION DRUG

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

AMOXICILLIN- AMOXICILLIN CAPSULE
PD-RX PHARMACEUTICALS, INC.
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PRESCRIBING INFORMATION
AMOXICILLIN CAPSULES, USP 500 MG
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
other antibacterial drugs, amoxicillin is to be used only to treat or
prevent infections that are proven or
strongly suspected to be caused by bacteria.
DESCRIPTION
Formulations of amoxicillin capsules, USP contain amoxicillin, a
semi-synthetic 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.
Capsules of Amoxicillin are intended for oral administration.
Each capsule contains amoxicillin trihydrate equivalent to 250 mg or
500 mg amoxicillin.
Caramel opaque cap and buff opaque body of the 250 mg capsule are
imprinted with AA and 820
respectively. Each 250 mg capsule contains the following inactive
ingredients: magnesium stearate,
sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, FD&C Blue
No. 1, FD&C Red
No. 3, titanium dioxide and gelatin.
Buff opaque cap and buff opaque body of the 500 mg capsule are
imprinted with AA and 825
respectively. Each 500 mg capsule contains the following inactive
ingredients: magnesium stearate,
sodium lauryl sulfate, D&C Yellow No. 10, FD&C Yellow No. 6, titanium
dioxide and gelatin.
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 me