Amoxicillin 500 MG Oral Capsule
1 INDICATIONS AND USAGE Amoxicillin capsules are 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 capsules and other antibacterial drugs, amoxicillin capsules 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 capsules are 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 capsules are 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 capsules are 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 capsules are 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 capsules 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 capsules, 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 capsules and other antibacterial drugs, amoxicillin capsules 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.
Apotheca Inc.
CAPSULE BLUE A 45
A 45 CAPSULE BLUE
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16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin capsules, USP contains 250 mg or 500 mg amoxicillin USP as the trihydrate. 250 mg capsule blue/pink size “1” hard gelatin capsule filled with white to off white granular powder and imprinted with “A44” on pink body with black ink. NDC 12634-183-00 Bottles of 10 NDC 12634-183-01 Bottles of 100 NDC 12634-183-09 Bottles of 35 NDC 12634-183-40 Bottles of 40 NDC 12634-183-50 Bottles of 50 NDC 12634-183-52 Blister Pack of 12 NDC 12634-183-54 Blister Pack of 14 NDC 12634-183-57 Blister Pack of 20 NDC 12634-183-59 Blister Pack of 30 NDC 12634-183-60 Bottles of 60 NDC 12634-183-61 Blister Pack of 10 NDC 12634-183-63 Blister Pack of 3 NDC 12634-183-66 Blister Pack of 6 NDC 12634-183-67 Blister Pack of 7 NDC 12634-183-69 Blister Pack of 9 NDC 12634-183-71 Bottles of 30 NDC 12634-183-74 Bottles of 24 NDC 12634-183-78 Bottles of 28 NDC 12634-183-79 Bottles of 25 NDC 12634-183-80 Bottles of 20 NDC 12634-183-81 Bottles of 21 NDC 12634-183-82 Bottles of 12 NDC 12634-183-85 Bottles of 15 NDC 12634-183-91 Blister Pack of 1 NDC 12634-183-94 Bottles of 4 NDC 12634-183-95 Bottles of 5 NDC 12634-183-96 Bottles of 6 500 mg capsule blue/pink size “0EL” hard gelatin capsule filled with white to off white granular powder and imprinted with “A45” on pink body with black ink. NDC 12634-185-00 Bottles of 10 NDC 12634-185-01 Bottles of 100 NDC 12634-185-09 Bottles of 35 NDC 12634-185-40 Bottles of 40 NDC 12634-185-50 Bottles of 50 NDC 12634-185-52 Blister Pack of 12 NDC 12634-185-54 Blister Pack of 14 NDC 12634-185-57 Blister Pack of 20 NDC 12634-185-59 Blister Pack of 30 NDC 12634-185-60 Bottles of 60 NDC 12634-185-61 Blister Pack of 10 NDC 12634-185-63 Blister Pack of 3 NDC 12634-185-66 Blister Pack of 6 NDC 12634-185-67 Blister Pack of 7 NDC 12634-185-69 Blister Pack of 9 NDC 12634-185-71 Bottles of 30 NDC 12634-185-74 Bottles of 24 NDC 12634-185-78 Bottles of 28 NDC 12634-185-79 Bottles of 25 NDC 12634-185-80 Bottles of 20 NDC 12634-185-81 Bottles of 21 NDC 12634-185-82 Bottles of 12 NDC 12634-185-85 Bottles of 15 NDC 12634-185-91 Blister Pack of 1 NDC 12634-185-94 Bottles of 4 NDC 12634-185-95 Bottles of 5 NDC 12634-185-96 Bottles of 6 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container.
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