AMOXICILLIN powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX USA LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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), 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

Product summary:

Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted bubble-gum-flavored pink suspension contains 200 or 400 mg amoxicillin as the trihydrate.                                              200 mg/5 mL                     50 mL bottle                                               NDC 65862-070-50                   75 mL bottle                                               NDC 65862-070-75                 100 mL bottle                                               NDC 65862-070-01                                              400 mg/5 mL                     50 mL bottle                                               NDC 65862-071-50                   75 mL bottle                                               NDC 65862-071-75                 100 mL bottle                                               NDC 65862-071-01 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN - AMOXICILLIN POWDER, FOR SUSPENSION
STAT RX USA LLC
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AMOXICILLIN POWDER, FOR SUSPENSION
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 pink suspensions. Inactive ingredients: Sucrose, sodium
citrate, sodium benzoate, edetate
disodium, FD and 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
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
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 administered doses of amoxicillin suspension, 125 mg/5 mL and
250