AMOXICILLIN capsule AMOXICILLIN tablet, film coated AMOXICILLIN powder, for suspension

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

AMOXICILLIN

הרכב:

AMOXICILLIN ANHYDROUS 250 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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 Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treat

leaflet_short:

Amoxicillin Capsules, USP, for oral administration, contain 250 mg or 500 mg amoxicillin as the trihydrate and are supplied as: 250 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 250 on one side and GG 848 on the other side. 500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side. Amoxicillin Tablets, USP equivalent to 875 mg amoxicillin as the trihydrate and are supplied as: 875 mg: oval-shaped, scored on one side, white to slightly yellowish film-coated tablets embossed GG-962 on one side and 875 on the other side. Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted fruity flavored pink suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. 125 mg/5 mL 200 mg/5 mL 250 mg/5 mL 400mg/5 mL Store capsules, tablets and unreconstituted powder for oral suspension at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Dispense in a tight container.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

AMOXICILLIN - AMOXICILLIN CAPSULE
AMOXICILLIN - AMOXICILLIN TABLET, FILM COATED
AMOXICILLIN - AMOXICILLIN POWDER, FOR SUSPENSION
PHYSICIANS TOTAL CARE, INC.
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AMOXICILLIN CAPSULES, TABLETS AND POWDER FOR ORAL SUSPENSION, USP
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 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.
Capsules, tablets and powder for oral suspension of amoxicillin are
intended for oral administration.
CAPS ULES
Each amoxicillin capsule, with yellow opaque cap and body, contains
250 mg or 500 mg amoxicillin as
the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side
and GG 848 on the other side;
the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the
other side. Inactive
ingredients: Capsule shells - yellow ferric oxide, titanium dioxide,
gelatin, black ferric oxide; Capsule
contents - cellulose microcrystalline and magnesium stearate.
Meets USP Dissolution Test 2.
TABLETS
Each film coated tablet contains 500 mg or 875 mg amoxicillin as the
trihydrate. The tablets are oval-
shaped, unscored and white to yellowish. The 500 mg tablet is embossed
GG-961 on one side and 500
on the other side. The 875 mg tablet is embossed GG-962 on one side
and 875 on the other side. In
addition each amoxicillin tablet contains these inactive ingredients:
colloidal silicon dioxide,
crospovidone, ethy