AMOXICILLIN capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN - UNII:804826J2HU)

Saadav alates:

Altura Pharmaceuticals, Inc.

INN (Rahvusvaheline Nimetus):

AMOXICILLIN

Koostis:

AMOXICILLIN 250 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 susceptible 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 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), Streptococcus 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

Toote kokkuvõte:

Capsules: Amoxicillin Capsules USP, 500 mg are available as ivory cap and ivory body. The cap of the 500 mg capsule is imprinted with West-ward and the body with 939. Amoxicillin capsules USP, 250 mg, are available as caramel cap and ivory body. The cap of the 250 mg capsule is imprinted with West-ward and the body with 938. They are supplied by Altura Pharmaceuticals, Inc. as follows: Store at 20°- 25°C (68°- 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

AMOXICILLIN - AMOXICILLIN CAPSULE
ALTURA PHARMACEUTICALS, INC.
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AMOXICILLIN CAPSULES USP, 250 MG AND
AMOXICILLIN CAPSULES USP, 500 MG
RX ONLY
REV. 5/10
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 capsules 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:
STRUCTURAL FORMULA
The amoxicillin molecular formula is C
H N O S•3H O, and the molecular weight is 419.45.
Each amoxicillin capsule USP, for oral administration, contains either
250 mg or 500 mg of amoxicillin
as the trihydrate. In addition, the capsules also contain the
following inactive ingredients:
croscarmellose sodium, gelatin, magnesium stearate, titanium dioxide,
and yellow iron oxide.
Additionally, the 250 mg capsules contain black iron oxide and red
iron oxide. The 250 mg capsule with
caramel cap and ivory body is imprinted with West-ward 938, while the
500 mg capsule with ivory cap
and ivory body is imprinted with West-ward 939.
CLINICAL PHARMACOLOGY
Amoxicillin is stable in the presence of gastric acid and is rapidly
absorbed after oral administration.
Amoxicillin diffuses readily into most body tissues and fluids, with
the exception of brain and spinal
fluid, except when meninges are inflamed. The half-life of amoxicillin
is 61.3 minutes. Most of the
amoxicillin is excreted unchanged in the urine; its excretion can be
delayed by concurrent administration
of probenecid. In blood serum, amoxicillin is approximately 20%
protein-bound.
Orally administere