Amoxicillin 500 MG Oral Capsule
1 INDICATIONS AND USAGE Adults and Pediatric Patients • Upper Respiratory Tract 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. • 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. • 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. • 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. Adult Patients Only • Helicobacter pylori Infection and Duodenal Ulcer Disease Triple therapy for Helicobacter pylori (H.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. 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. Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1 ) Adults and Pediatric Patients ( 1 ) • Upper Respiratory Tract Infections of the Ear, Nose, and Throat • Infections of the Genitourinary Tract • Infections of the Skin and Skin Structure • Infections of the Lower Respiratory Tract Adult Patients Only ( 1 ) • Helicobacter pylori Infection and Duodenal Ulcer Disease 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 or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
Sandoz Inc
CAPSULE YELLOW AMOX 500 GG 849
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16 HOW SUPPLIED/STORAGE AND HANDLING
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. NDC 0781-2020-76............................................ bottles of 30 × 12's NDC 0781-2020-01.................................................... bottles of 100 NDC 0781-2020-05.................................................... bottles of 500 500 mg: yellow, opaque, hard gelatin capsules imprinted AMOX 500 on one side and GG 849 on the other side. NDC 0781-2613-76............................................ bottles of 30 × 12's NDC 0781-2613-01.................................................... bottles of 100 NDC 0781-2613-05.................................................... bottles of 500
AMOXICILLIN Tablets, USP equivalent to 500 mg or 875 mg
AMOXICILLIN as the trihydrate and are supplied as: 500 mg: oval-shaped, unscored, white to slightly yellowish film-coated tablets embossed GG-961 on one side and 500 on the other side. NDC 0781-5060-20...................................................... bottles of 20 NDC 0781-5060-01.................................................... bottles of 100 875 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. NDC 0781-5061-20...................................................... bottles of 20 NDC 0781-5061-01.................................................... bottles of 100
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 NDC 0781-6039-58...................................................... 80 mL bottle NDC 0781-6039-46.................................................... 100 mL bottle NDC 0781-6039-55.................................................... 150 mL bottle 200 mg/5 mL NDC 0781-6156-52...................................................... 50 mL bottle NDC 0781-6156-57...................................................... 75 mL bottle NDC 0781-6156-46.................................................... 100 mL bottle 250 mg/5 mL NDC 0781-6041-58...................................................... 80 mL bottle NDC 0781-6041-46.................................................... 100 mL bottle NDC 0781-6041-55.................................................... 150 mL bottle 400 mg/5 mL NDC 0781-6157-52...................................................... 50 mL bottle NDC 0781-6157-57...................................................... 75 mL bottle NDC 0781-6157-46.................................................... 100 mL bottle Store capsules, tablets and unreconstituted powder for oral suspension at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight container.
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