AMOXICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Liberty Pharmaceuticals, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Store at 20° - 25°C (68° - 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container. Amoxicillin Capsules, USP 250 mg . (peach/orange capsule marked WC 730) each capsule contains amoxicillin trihydrate equivalent to 250 mg amoxicillin. NDC 0440-7100-30      250 mg - Bottles of 30

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN CAPSULE
LIBERTY PHARMACEUTICALS, INC.
----------
AMOXICILLIN CAPSULES, USP 250 MG AND 500 MG
AMOXICILLIN TABLETS, USP 875 MG
AMOXICILLIN FOR ORAL SUSPENSION, USP 125 MG/5 ML AND 250 MG/5 ML
R ONLY
PRESCRIBING INFORMATION
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
Amoxicillin is 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 capsules, tablets and powder for oral suspension are
intended for oral administration.
Amoxicillin Capsules provide amoxicillin trihydrate equivalent to 250
mg or 500 mg amoxicillin.
Amoxicillin Capsules, USP also contain Magnesium Stearate, NF; Sodium
Lauryl Sulfate, NF. The
capsule shell contains D&C red No. 33; FD&C blue No. 1; FD&C red No.
40; FD&C yellow No. 6;
Gelatin, NF; Sodium Lauryl Sulfate, NF Titanium Dioxide, USP. Each 250
mg capsule contains up to
0.0027 mEq (0.062 mg) of sodium; the 500 mg capsule contains up to
0.0052 mEq (0.119 mg) of
sodium.
Amoxicillin Tablets provide amoxicillin trihydrate equivalent to 875
mg. In addition each tablet contains
the following inactive ingredients: Sodium Starch Glycolate, NF;
Pregelatinized Starch, NF; Colloidal
Silicon Dioxide, NF; Povidone, USP; Magnesium Stearate, NF; Polyvinyl
Alcohol, USP; Titanium
X
16
19
3
5
2
Dioxide, USP; Talc, NF; Polyethylene Glycol, NF and Lecithin, NF. Each
tablet contains up to 0.032
mEq (0.74 mg) of Sodium.
Amoxicillin for Oral Suspension is a