AMOXICILLIN capsule

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

RedPharm Drug, Inc.

INN (International Name):

AMOXICILLIN

구성:

AMOXICILLIN ANHYDROUS 500 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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. Triple Therapy Amoxicillin/Clarithromycin/Lansoprazole Amoxicillin, in combination with clarithromycin plus lansoprazole a

제품 요약:

Each capsule contains amoxicillin trihydrate equivalent to 250 mg or 500 mg amoxicillin. 250 mg Capsule Caramel opaque cap and buff opaque body of the 250 mg capsule are imprinted with AA and 820 respectively. NDC 42582-213-10 bottles of 100 NDC 42582-213-18 bottles of 500 500 mg Capsule Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. NDC 42582-214-10 bottles of 100 NDC 42582-214-18 bottles of 500 Store capsules at 20oC to 25o C (68o F to 77 o F) [See USP Controlled Room Temperature]

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

AMOXICILLIN- AMOXICILLIN CAPSULE
REDPHARM DRUG, INC.
----------
SPL UNCLASSIFIED SECTION
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 (2S, 5R,
6R)-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:
[image description]
The amoxicillin molecular formula is C16H19N3O5S·3H2O, 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 meal. However, food effect
studies