AMOXICILLIN capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 500 mg

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 infections that are proven or strongly suspected to be caused by 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 a penicillin-class antibacterial indicated for treatment of infections due tosusceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below: Infections of the Ear, Nose, and Throat – due to Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. Infections of the Genitourinary Tract – due to Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. Infections of the Skin a

Product summary:

Amoxicillin Capsules, USP are supplied as follows: Amoxicillin Capsules, USP 250 mg. Peach/orange capsule marked WC 730. Each capsule contains amoxicillin trihydrate equivalent to 250 mg amoxicillin as the trihydrate. NDC 67253-140-10 250 mg - Bottles of 100 NDC 67253-140-50 250 mg - Bottles of 500 Amoxicillin Capsules, USP 500 mg. Peach/orange capsule marked WC 731. Each capsule contains amoxicillin trihydrate equivalent to 500 mg amoxicillin as the trihydrate. NDC 67253-141-10 500 mg - Bottles of 100 NDC 67253-141-50 500 mg - Bottles of 500 NDC 67253-141-11 500 mg - Bottles of 1000 Amoxicillin for Oral Suspension, USP is available as a powder which when reconstituted as directed yields a pink, bubble gum flavored suspension and is supplied as follows: Amoxicillin for Oral Suspension, USP 125 mg/5 mL Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 125 mg amoxicillin. NDC 67253-142-08 125 mg/5 ml - 80 mL individual bottles NDC 67253-142-10 125 mg/5 ml - 100 mL individual bottles NDC 67253-142·15 125 mg/5 ml - 150 mL individual bottles Amoxicillin for Oral Suspension, USP 250 mg/ 5 mL Each 5 ml of reconstituted suspension contains amoxicillin trihydrate equivalent to 250 mg amoxicillin. NDC 67253-143-08 250 mg/5 mL - 80 ml individual bottles NDC 67253-143-10 250 mg/5 mL -100 ml individual bottles NDC 67253-143-15 250 mg/5 mL - 150 ml individual bottles After reconstitution, the suspension is stable for 14 days. Refrigeration is preferable but not required. Keep bottle tightly closed. Amoxicillin Tablets, USP are supplied as follows: Amoxicillin Tablets, USP 875 mg. White, oblong, film-coated tablet engraved S score line 145 on one side. Each tablet contains 875 mg amoxicillin as the trihydrate. NDC 67253-145-02 20 Tablets NDC 67253-145-10 100 Tablets NDC 67253-145-50 500 Tablets Amoxicillin Tablets, USP (Chewable) are supplied as follows: Amoxicillin Tablets, USP (Chewable) 125 mg. Pink, biconvex, oval embossed 231 on one side and logo on reverse. Each tablet contains 125 mg amoxicillin as the trihydrate. NDC 67253-151-06 60 Tablets Amoxicillin Tablets, USP (Chewable) 250 mg. Pink, biconvex, oval embossed 232 on one side and logo on reverse. Each tablet contains 250 mg amoxicillin as the trihydrate. NDC 67253-152-10 100 Tablets NDC 67253-152-50 500 Tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHIL

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN- AMOXICILLIN CAPSULE
DIRECT RX
----------
AMOXICILLIN
OTHER SAFETY INFORMATION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
other antibacterial drugs, amoxicillin capsules, amoxicillin for oral
suspension, amoxicillin tablets and
amoxicillin tablets (chewable) should be used only to treat infections
that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION SECTION
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 (2S,5R,6R)-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. The structural
formula is:
Amoxicillin Capsules, USP
Each capsule, for oral administration, provide amoxicillin trihydrate
equivalent to 250 mg or 500 mg
amoxicillin
Inactive Ingredients: CAPSULES-DRUG PRODUCT: Magnesium Stearate,
Sodium Lauryl Sulfate.
CAPSULE SHELL AND PRINT CONSTITUENTS: Gelatin, Sodium Lauryl Sulfate,
Titanium Dioxide,
D&C Red No. 33; FD&C Blue No. 1; FD&C Red No. 40; FD&C Yellow No. 6.
In addition, 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 for Oral Suspension, USP
Each 5 mL of reconstituted suspension contains amoxicillin trihydrate
equivalent to 125 mg or 250 mg
of amoxicillin, when the dry powder is reconstituted according to
directions.Inactive Ingredients:
SUSPENSION: Carboxymethylcellulose Sodium, Colloidal Silicon Dioxide,
Flavors, Microcrystalline
Cellulose, Sodium Citrate, Sodium Propionate, Sucrose, FD&C Red No.
40, FD&C Yellow No. 6. In
addition, each 5 mL of the 125 mg reconstituted suspension contains up
to 0.209 mEq (4.80 mg) of
sodium; each 5 mL of the 250 mg reconstituted suspension contains up
to 0.417 mEq (9.60 mg) of
sodium.
Amoxicillin Tablets, USP
Each tablet, for oral administration, provi