amoxicillin tablet
1 INDICATIONS AND USAGE Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 – 1.4 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5 ) 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. ( 1.6 ) 1.1 Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species (α- and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . 1.2 Infections of the Genitourinary Tract: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . 1.3 Infections of the Skin and Skin Structure: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli . 1.4 Infections of the Lower Respiratory Tract: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae . 1.5 Helicobacter pylori Infection Triple therapy for Helicobacter pylori with clarithromycin and lansoprazole: Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected . (See the clarithromycin package insert, MICROBIOLOGY ) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. 1.6 Usage 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.
DAVA Pharmaceuticals, Inc.
CAPSULE ORANGE WC 731
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16 HOW SUPPLIED/STORAGE AND HANDLING 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 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 CHILDREN.
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