AMOXICILLIN capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

American Antibiotics,Inc

INN (mednarodno ime):

AMOXICILLIN

Sestava:

AMOXICILLIN 250 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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

Povzetek izdelek:

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 15749-820-04 bottles of 100 NDC 15749-820-10 bottles of 500 NDC 15749-820-11 bottles of 1000 500 mg Capsule Buff opaque cap and buff opaque body of the 500 mg capsule are imprinted with AA and 825 respectively. NDC 15749-825-02 bottles of 50 NDC 15749-825-04 bottles of 100 NDC 15749-825-10 bottles of 500 Store capsules at 20 o C to 25 o C (68 o F to 77 o F) [See USP Controlled Room Temperature]

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

AMOXICILLIN - AMOXICILLIN CAPSULE
AMERICAN ANTIBIOTICS,INC
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AMOXICILLIN CAPSULES, USP 250 MG AND 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 meal. However, food ef