AMOXICILLIN powder, for suspension

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Dispensing Solutions Inc.

SNN (starptautisko nepatentēto nosaukumu):

AMOXICILLIN

Kompozīcija:

AMOXICILLIN 400 mg in 5 mL

Ievadīšanas:

ORAL

Receptes veids:

PRESCRIPTION DRUG

Produktu pārskats:

Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted bubble-gum-flavored pink suspension contains 200 or 400 mg amoxicillin as the trihydrate. Amoxicillin is supplied as follows:  Store dry powder at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

AMOXICILLIN - AMOXICILLIN POWDER, FOR SUSPENSION
DISPENSING SOLUTIONS INC.
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AMOXICILLIN
RX ONLY
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 for oral suspension, USP 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.
Amoxicillin for oral suspension is intended for oral administration.
Each 5 mL of reconstituted suspension contains amoxicillin trihydrate
equivalent to 200 mg or 400 mg
anhydrous amoxicillin. Each 5 mL of the 200 mg and 400 mg
reconstituted suspension contains 0.16
mEq (3.61 mg) of sodium.
Amoxicillin trihydrate for oral suspension 200 mg/5 mL and 400 mg/5 mL
(reconstituted) are bubble-
gum flavored light pink suspensions. Inactive ingredients: Sucrose,
sodium citrate, sodium benzoate,
edetate disodium, FD&C Red No. 3, xanthan gum, bubble-gum flavor, and
colloidal silicon dioxide.
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 formulation has been studied
only when administered at the start
of a light meal. 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